(19)
(11)EP 2 747 833 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
09.05.2018 Bulletin 2018/19

(21)Application number: 12845917.9

(22)Date of filing:  23.08.2012
(51)International Patent Classification (IPC): 
A61M 31/00(2006.01)
A61M 25/02(2006.01)
A61J 15/00(2006.01)
A61M 39/28(2006.01)
(86)International application number:
PCT/US2012/051995
(87)International publication number:
WO 2013/066480 (10.05.2013 Gazette  2013/19)

(54)

IMPROVED SKIN PORT CONNECTOR AND METHOD OF INSTALLATION

VERBESSERTER HAUTANSCHLUSSVERBINDER UND INSTALLATIONSVERFAHREN DAFÜR

RACCORD AMÉLIORÉ D'ORIFICE DE PEAU ET SON PROCÉDÉ D'INSTALLATION


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated Extension States:
BA ME

(30)Priority: 23.08.2011 US 201161526419 P

(43)Date of publication of application:
02.07.2014 Bulletin 2014/27

(60)Divisional application:
17153963.8 / 3181179
17153969.5 / 3181180

(73)Proprietor: Aspire Bariatrics, Inc.
King of Prussia, PA 19406 (US)

(72)Inventor:
  • WOJCIK, Steven, E.
    Shoreline, WA 98177 (US)

(74)Representative: Carpmaels & Ransford LLP 
One Southampton Row
London WC1B 5HA
London WC1B 5HA (GB)


(56)References cited: : 
EP-A2- 0 059 044
US-A- 5 716 347
US-A1- 2006 135 914
US-A1- 2008 033 345
US-A1- 2011 178 480
JP-A- 2005 528 135
US-A1- 2006 100 604
US-A1- 2006 135 914
US-A1- 2008 033 345
US-B2- 6 666 853
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    TECHNICAL FIELD



    [0001] This invention relates to improved skin port connectors for use as part of a percutaneous gastrostomy tube assembly and methods for connecting such a device to such an assembly.

    BACKGROUND



    [0002] Obesity is a major health problem in the United States and other countries. The National Health and Nutrition Examination Survey (1988-1994) reported that approximately 20-25% of Americans are obese, while another study estimated the percentage of overweight Americans to be between 60% and 65% (Flegal K M, Carroll M D, Ogden C L, Johnson C L "Prevalence and trends in obesity among US adults, 1999-2000" JAMA 2002; 288:1723-1727). Obesity can cause numerous health problems, including diabetes, degenerative joint disease, hypertension, and heart disease. Weight reduction can be achieved by increased caloric expenditure through exercise and/or by reduced caloric consumption through diet. However, in most cases, weight gain often recurs and improvements in related co-morbidities are often not sustained.

    [0003] Surgical procedures present an increasingly common solution for obese patients. Surgical procedures include, for example, stapled gastroplasty, banded gastroplasty, gastric banding, gastric bypass surgery, and bilopancreatic bypass. However, these surgical procedures are invasive, risky and expensive to perform, and many patients regain a substantial portion of the lost weight.

    [0004] Gastrostomy is an alternative to these procedures for weight loss management. New methods of connecting the gastrostomy tubes originating in the stomachs of patients to ports which control the movement of material from the stomach to the outside world. The present invention describes embodiments directed to such skin ports.

    [0005] US 2006/100604 discloses an adaptor for use with a gastrostomy feeding tube. Coupling is achieved by pulling the gastrostomy tube over an outer flange of a generally mushroom-shaped tube, and providing a seal by abutting a circumferential flange of a sleeve against the top surface of the outer flange of the mushroom-shaped tube such that a side wall of the sleeve is positioned just outside the outer surface of the outer flange. The mating surface of the circumferential flange of the sleeve is proximally positioned relative to the top surface of the outer flange of the mushroom-shaped tube.

    SUMMARY



    [0006] This invention is defined by the appendend claims and relates to improved skin port connectors for use as part of a percutaneous gastrostomy tube assembly and methods for connecting such a device to such an assembly.

    [0007] This invention provides a skin port connector for use on a flexible percutaneous gastrostomy tube, said flexible percutaneous gastrostomy tube having a tube wall thickness when uncompressed, said skin port connector comprising:(a) a skin flange containing a through-hole channel, said channel having (i) a main inner surface, (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the channel, said channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the channel of the through-hole at a position within the channel; the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;(b) a coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second mean outer cross-sectional dimension and area; and(c) an optional valve assembly adapted for attachment to said skin flange;wherein at least a portion of the coupler fits within the through-hole channel so that the center-line axes of the through-hole channel and the coupler are substantially coaxial;wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another and wherein the circumferential ridge protruding from the main inner surface of the skin flange is distally positioned relative to the circumferential ridge protruding from the outer surface of the sleeve body of the coupler;wherein the second mean outer cross-sectional area defined by the circumferential ridge protruding from the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole; and wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of a tube wall of an uncompressed percutaneous gastrostomy tube, such that when the percutaneous gastrostomy tube is coupled to the connector by press fitting the coupler in the annulus, the tube is compressed radially between the main channel and the coupler.

    [0008] Other examples provide assemblies each comprising a skin port connector and a flexible percutaneous gastrostomy tube, said tube having an inner cross-sectional dimension, an outer cross-sectional dimension, and a tube wall thickness when uncompressed, said skin port connector comprising:
    1. (a) a skin flange containing a through-hole channel, said channel having (i) a main inner surface, (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the channel, said channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the channel of the through-hole at a position within the channel; the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;
    2. (b) a coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second mean outer cross-sectional dimension and area; and
    3. (c) an optional valve assembly adapted for attachment to said skin flange;
    wherein at least a portion of the coupler fits within the through-hole channel so that the center-line axes of the through-hole channel and the coupler are substantially coaxial;
    wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another;
    wherein the second mean outer cross-sectional area defined by the circumferential ridge protruding from the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole; and
    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube.

    [0009] Still other examples provide apparatuses and methods for removing ingested food and/or liquid matter from a patient's stomach via a gastrostomy tube that passes through the patient's abdominal wall in the patient's stomach, wherein each apparatus (and method of using the same) comprises an assembly described herein and a pump for removing ingested food and/or liquid matter from a patient's stomach, said pump being in fluid communication with said assembly. In other embodiments, the apparatus comprises an assembly as described herein to which a second tubing in downstream fluid communication with the valve assembly is connected thereto, allowing for the passage drainage of the food and/or liquid matter from a patient's stomach.

    [0010] Additional examples provide methods of connecting a skin port connector to a flexible percutaneous gastrostomy tube that passes from and through a patient's stomach, and exits through an external stoma on the patient's abdominal wall, said percutaneous gastrostomy tube having a distal end within the patient's stomach and a proximal end to be connected outside of the patient's body, wherein the proximal end of the tube, outside of the patient's body has an inner cross-sectional dimension, an outer cross-sectional dimension, and an uncompressed tube wall thickness, each method comprising:
    1. (a) clamping the gastrostomy tube between the stoma and the end of the tube to be connected, so as to substantially prevent the flow of material out of the stomach;
    2. (b) providing a clamp plate / tray having an area, through which the gastrostomy tube can pass;
    3. (c) optionally trimming the proximal end of the gastrostomy tube at a pre-set distance from the stoma so as to provide an open proximal end;
    4. (d) locating the optionally trimmed proximal end of the gastrostomy tube within a through-hole channel of a skin flange at a pre-determined height relative to through-hole; and
    5. (e) inserting a coupler into the open proximal end of the gastrostomy tube, said coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second mean outer cross-sectional dimension and area;
    so that at least a portion of the coupler fits within the through-hole channel and the center-line axes of the through-hole channel and the coupler are substantially coaxial;
    wherein the clamp plate / tray is capable of distributing any pressure associated with inserting the coupler over the area of the platform;
    wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another;
    wherein the second mean outer cross-sectional area defined by the circumferential ridge protruding from the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole; and
    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube;
    so as to compress the tube radially between the through-hole and the coupler.

    [0011] Other embodiments provide devices for connecting a skin port connector to a flexible percutaneous gastrostomy tube, each device comprising:

    a clamp plate / tray having a base thickness less than about 10 mm, and comprising a tube opening, through which may pass the flexible percutaneous gastrostomy tube;

    a movable clamp jaw attached to said clamp plate / tray and configured to be capable of clamping the flexible percutaneous gastrostomy tube which may pass through the clamp plate / tray; and

    optionally (a) at least one locator fixture capable of mating with the skin flange so as to hold the skin flange in a position fixed relative to the tube opening; and (b) at least one locator fixture capable of holding a tube cutting tool in a position fixed relative to the a position fixed relative to the tube opening.



    [0012] Still other examples provide clamp plate / trays, each comprising features substantially as shown in FIG. 4; tube cutting tool assemblies, each comprising features substantially as shown in FIG. 6; sliding guide pin / mandrel combinations, each comprising features substantially as shown in FIG. 10; and couplers, each comprising features substantially as shown in FIG. 10.

    [0013] Other examples provide kits, each kit comprising at least two of the following components: (a) a clamp plate / tray having a base thickness less than about 10 mm, and comprising a tube opening through which may pass the flexible percutaneous gastrostomy tube and optionally (i) at least one locator fixture capable of holding the skin flange in a position fixed relative to the tube opening; (ii) at least one locator fixture capable of holding a tube cutting tool in a position fixed relative to the a position fixed relative to the tube opening; and (iii) a movable clamp jaw attached to said clamp plate / tray and configured to be capable of clamping the flexible percutaneous gastrostomy tube which may pass through the clamp plate / tray; (b) a tube cutting tool assembly; (c) a sliding guide pin optionally attached to mandrel; and (d) a coupler comprising a sleeve body having a bore therethrough and a circumferential ridge and/or at least one other feature protruding from the outer surface of the sleeve body, said coupler having proximal and distal ends and a center-line axis along the longitudinal axis of the bore, said sleeve body having inner and outer surfaces and an inner mean cross-sectional dimension and area defined by the inner surface and a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located nearer the proximal end of the sleeve body than the distal end and defines a second mean outer cross-sectional dimension and area, wherein said guide pin has an external cross-sectional area substantially similar to that inner cross-sectional area of the coupler, such that the coupler is slidably detachable from the guide pin.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0014] The following drawings are illustrative embodiments of the invention but are not intended to limit the invention as encompassed by the claims forming part of the invention.

    FIG. 1 illustrates one embodiment of a skin port attached to a gastrostomy tube.

    FIG. 2 illustrates a sectioned view of one embodiment of a skin port attached to a gastrostomy tube.

    FIG. 3 illustrates one embodied concept of clamping a gastrostomy tube.

    FIG. 4 illustrates one embodiment of a installing clamp tray, showing one embodied movable clamp jaw, and providing an illustration of its use relative to a gastrostomy tube emerging from the stoma of a patient.

    FIG. 5 illustrates one embodiment of a installing clamp tray, wherein the movable clamp jaw of FIG. 4 is closed, thereby holding the gastrostomy tube in place.

    FIG. 6 illustrates one embodiment of a tube cutting tool, as inserted on the clamped gastrostomy tube of FIG. 5.

    FIG. 7 illustrates one embodiment of a tube cutting tool, positioned on the clamped gastrostomy tube of FIGs. 5 and 6, and positioned as applied on the installing clamp tray of FIGs. 4-6, wherein the cutting blade has cut the clamped gastrostomy tube.

    FIG. 8. illustrates one embodiment of the clamped tube cut to length as held by the installing clamp tray of FIGs. 4-7, after the tube cutting tool of FIG. 7 has been removed. The highlighted elements are exemplary locating and/or fixtures as described herein and useful for the positioning of the skin flange.

    FIG. 9 illustrates one embodiment of the skin flange having been mounted over the clamped tube cut to length as held by the installing clamp tray of FIG. 8.

    FIG. 10 illustrates one embodiment of the sliding guide pin / mandrel assembly as described herein and one embodied coupler of the present invention.

    FIG. 11 illustrates one embodied coupler positioned on one embodied sliding guide pin / mandrel assembly as described herein.

    FIG. 12 illustrates a positioning of the coupler / sliding guide pin / mandrel assembly relative to the open proximal end of a cut gastrostomy tube before insertion of the sleeve body into the tube.

    FIG. 13 illustrates a positioning of the coupler / sliding guide pin / mandrel assembly relative to the open proximal end of a cut gastrostomy tube after insertion of the coupler into the tube.

    FIG. 14 illustrates an alternative embodiment of installing the coupler into the tube, in which a press frame with thumbscrew is employed.

    FIG. 15 follows from FIG. 13, after the sliding guide pin / mandrel assembly has been removed, and the coupler remains positioned in the end of the tube.

    FIG. 16 illustrates one embodied rotary valve assembly positioned to be attached to the skin flange of FIG. 15.

    FIG. 17 follows from FIG. 16, and illustrates the rotary valve installed.

    FIG. 18 is another view of the skin port adaptor attached to the installation clamp frame / tray, in which the rotary valve is closed

    FIG. 19 illustrates the skin port connector attached to the gastrostomy tube after the unclamping of the tube (by opening the latch arm of the movable clamp jaw) and removal of the embodied installation clamp frame / tray


    DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS



    [0015] The present invention relates generally to improved skin port connectors for use as part of a percutaneous gastrostomy tube assembly and methods for connecting such a skin port to such an assembly.

    [0016] More specifically, the present invention(s) relates to a skin port connector with a valve mechanism coupled to the external end of a gastrostomy tube, which itself is in fluid communication with the stomach of a patient. The skin port is a critical part of the system since it seals the end of the gastrostomy tube to prevent the contents of the stomach from leaking until the valve is opened by the patient. Not only must the connection be strong, reliable, and well-sealed, but it should be low-profile to be unobtrusive under clothing, able to be re-connected to the gastrostomy tube as the tube length is shortened after weight loss, and easy to connect without trauma to the patient.

    [0017] U.S. Patent No. 7,648,479 and U.S. Patent Application Publication Ser. Nos. 2008/0039809, 2011/0082442, 2011/0178480, and 2011/0190719 describe systems and methods for removing ingested material from a stomach. For example, Application Publication Ser. No. 2011/0082442 describes one possible method of achieving connecting a skin port connector with a valve mechanism coupled to the external end of a gastrostomy tube. It relies on an external helix on the exterior surface of the gastrostomy tube which connects to the skin port by screwing into the skin port. The present inventors have discovered that, in practice, use of this device can be problematic since the sealing area is not visible and it is possible to misalign the funnel portion of the valve with the end of the tube and damage the end of the tube creating a leak path.

    [0018] An improved skin port and method of installation are described in this disclosure that eliminates the problems and disadvantages of the previous design. For example, the improved skin port allows the use of an elastomeric gastrostomy tube with a smooth constant cross-section, and makes for a more effective seal since the resilient tube material itself can be compressed.

    [0019] The present invention may be understood more readily by reference to the following detailed description taken in connection with the accompanying Tables and Figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific products, methods, conditions or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of any claimed invention. Similarly, any description as to a possible mechanism or mode of action or reason for improvement is meant to be illustrative only, and the invention herein is not to be constrained by the correctness or incorrectness of any such suggested mechanism or mode of action or reason for improvement. Throughout this text, it is recognized that the descriptions refer both to the method of preparing articles and to the resulting, corresponding physical articles themselves, as well as the referenced and readily apparent applications for such articles.

    [0020] In the present disclosure the singular forms "a," "an," and "the" include the plural reference, and reference to a particular numerical value includes at least that particular value, unless the context clearly indicates otherwise. Thus, for example, a reference to "a material" is a reference to at least one of such materials and equivalents thereof known to those skilled in the art, and so forth.

    [0021] When values are expressed as approximations by use of the antecedent "about," it will be understood that the particular value forms another embodiment. In general, use of the term "about" indicates approximations that can vary depending on the desired properties sought to be obtained by the disclosed subject matter and is to be interpreted in the specific context in which it is used, based on its function, and the person skilled in the art will be able to interpret it as such. In some cases, the number of significant figures used for a particular value may be one non-limiting method of determining the extent of the word "about." In other cases, the gradations used in a series of values may be used to determine the intended range available to the term "about" for each value. Where present, all ranges are inclusive and combinable. That is, references to values stated in ranges include each and every value within that range.

    [0022] Where the term "optional" is used to describe a component or element, the invention includes separate embodiments where that component or element is present or absent.

    [0023] It is to be appreciated that certain features of the invention which are, for clarity, described herein in the context of separate embodiments, may also be provided in combination in a single embodiment. For example, the present disclosure recites separate embodiments for skin port connector(s) (including kits), methods of installing, and methods of using said connectors. The invention provides at least for the combination of any given connector or assembly with any given method of use or method of connecting (or as appropriate, with any given device / tool or combination of devices / tools). However, for the sake of brevity, each possible combination and permutation of the recited embodiments is not recited. That is, this specification should be read as providing for each permutation of each embodiment, both within options within and between each given class of embodiments. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any subcombination. Finally, while an embodiment may be described as part of a series of steps or part of a more general composition or structure, each said embodiment may also be considered an independent embodiment in itself.

    [0024] As used herein, the terms "distal" and "proximal" refer to relative positions intended to be directed toward and away from a patient, respectively; i.e., from the perspective of a caregiver. For example, the distal end of a gastrostomy tube is the end of the tube inside the patient and the proximal end of a gastrostomy tube is that end extending away from the patient. Similarly, a distal end of a through-hole channel is that end of the channel closest to the patient when the device is in place (note that reference to "a position within the channel," in the context of the circumferential ridge, refers to a position between the distal and proximal ends; i.e., at a distance intermediate between the two ends) (see, e.g., FIG. 2). The distal end of a coupler is that end of the coupler intended to be inserted into the proximal end of the gastrostomy tube.

    [0025] The improved skin port connector consists of a skin flange, a coupler, and an optional valve assembly (e.g., see FIGs. 1-2).

    [0026] Various embodiments of the present invention provide skin port connectors for use on flexible percutaneous gastrostomy tubes, each tube having an inner mean cross-sectional dimension, an outer mean cross-sectional dimension, and a tube wall thickness when uncompressed, and each skin port connector comprising:
    1. (a) a skin flange containing a through-hole channel, said channel having (i) a main inner surface, said channel having (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the channel, said channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the channel of the through-hole at a position within the channel; the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;
    2. (b) a coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second mean outer cross-sectional dimension and area; and
    3. (c) an optional valve assembly adapted for attachment to said skin flange;
    wherein at least a portion of the coupler fits within the through-hole channel so that the center-line axes of the through-hole channel and the coupler are substantially coaxial;
    wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another;
    wherein the second mean outer cross-sectional area defined by the circumferential ridge protruding from the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole; and
    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube to be used.

    [0027] Other embodiments provide assemblies comprising coupled skin port connectors and flexible percutaneous gastrostomy tubes, each tube having an inner cross-sectional dimension, an outer cross-sectional dimension, and a tube wall thickness when uncompressed, and each skin port connector comprising:
    1. (a) a skin flange containing a through-hole channel, said channel having (i) a main inner surface, said channel having (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the channel, said channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the channel of the through-hole at a position within the channel; the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;
    2. (b) a coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second mean outer cross-sectional dimension and area; and
    3. (c) an optional valve assembly adapted for attachment to said skin flange;
    wherein at least a portion of the coupler fits within the through-hole channel so that the center-line axes of the through-hole channel and the coupler are substantially coaxial;
    wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another;
    wherein the second mean outer cross-sectional area defined by the circumferential ridge protruding from the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole; and
    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube,
    such that the tube is compressed radially between the through-hole and the coupler.

    [0028] The cross-sections of the through-hole, tube, and solid sleeve body may be any shape (e.g., including oval or polygonal, e.g., square, pentagonal, hexagonal, heptagonal, octagonal, or higher), though they are preferably matched in shape (i.e., the cross-sectional shapes of the elements are substantially the same (e.g., all circular or the same polygonal shape). In preferred embodiments, these cross-sectional shapes are substantially circular or round. For non-round cross-sections, the term "mean cross-sectional dimension" refers to an effective diameter corresponding to a constructed circle having the same area as the shape of the actual cross-section. The term "mean cross-sectional area" refers to the area of the constructed circle defined by that effective diameter. In those embodiments wherein the through-hole, tube, and solid sleeve body are all shaped as cylinders having circular cross-sections, the mean cross-sectional dimension is the diameter of the corresponding circular cross-sections and the areas are those areas defined by these diameters.

    [0029] As used herein, the term "center-line axis along the longitudinal axis" of each described element or component refers to the imaginary line which passes along the length of the element, said line defined by points approximately corresponding to the center points of the constructed circles along the length of the element.

    [0030] While the centerline axis of each of the elements should at least be parallel to one another in use, they are preferably "substantially coaxial" (reflecting real differences owing to manufacturing) such that the elements can stack within one another as otherwise described.

    [0031] In various embodiments, the circumferential ridge of the coupler may be continuous or discontinuous and/or may also comprise other features providing the same function as the ridge; e.g., protruding nodes, pins, or other similar features. In other embodiments, the circumferential ridge protruding from the main inner surface into the channel of the through-hole may also be described as a shelf, and/or may comprise similar features as described above for the circumferential ridge of the coupler.

    [0032] As described through-out, unless otherwise stated or apparent, references to various embodiments refer both to the skin port connectors, or parts thereof containing the skin flange, and assemblies containing the skin port connector or parts thereof.

    [0033] As described herein, in various embodiments, the flexible percutaneous gastrostomy tube of the connector or the assembly comprises an elastomeric polymer. Preferred materials include polymers comprising silicone and/or polyurethane or mixtures or copolymers thereof. In preferred embodiments, these materials are durable and medical grade (e.g., bioinert, tissue-friendly) and most preferably suitable for use in human patients (i.e., is approved for use by appropriate regulatory agencies, e.g., the Food and Drug Agency in the United States).

    [0034] In certain embodiments, the flexible percutaneous gastrostomy has a substantially smooth constant inner mean cross-sectional dimension. The inner and outer surfaces of the tube may be substantially smooth. Further embodiments provide that the wall thickness of the uncompressed percutaneous gastrostomy tube is in the range of about 0.5 mm to about 5 mm, preferably in the range of about 1 mm to about 4 mm, in the range of about 1 mm to about 3 mm, or in the range of about 1 mm to about 2 mm.

    [0035] In some embodiments, the length of the through-hole channel of the connector or the assembly has a length in the range of about 2 mm to about 20 mm, preferably in the ranges of about 4 mm to about 20 mm, about 4 mm to about 10 mm, or about 4 mm to about 8 mm.

    [0036] The invention also provides embodiments wherein the coupler or the sleeve body of the coupler has a length in the range of about 4 mm to about 20 mm, preferably in the ranges of about 4 mm to about 20 mm, about 4 mm to about 10 mm, or about 4 mm to about 8 mm. Relative to the length of the through-hole, the coupler or sleeve body may be either longer or shorter, preferably longer.

    [0037] In various embodiments, the main inner surface of the through-hole channel is cylindrical, preferably having a smooth surface. The channel may have a constant diameter along the length of the channel, or may be tapered. If tapered, the distal end of the taper preferably has a smaller diameter / cross-section than the proximal end.

    [0038] In describing various embodiments of the present invention, it is convenient to describe the through-hole channel and the coupler (and/or sleeve body thereof) in context with one another. However, it should be appreciated that each of these are independent components or elements.

    [0039] Accordingly, in various embodiments of the coupler, the outer surface of the sleeve body is cylindrical (independent of the shape of the through-hole channel), preferably having a smooth surface. The sleeve body may have a constant diameter along its length of the channel, or may be tapered. If tapered, the distal end of the taper preferably has a smaller diameter / cross-section than the proximal end. While it may be preferred that any taper associated with the channel and/or the sleeve body be matched, it is not necessary that they do match.

    [0040] It should be appreciated that, in use, the circumferential ridge protruding from the sleeve body sleeve is intended to be used in concert with the circumferential ridge of the through-hole. One purpose of these mating surfaces is to prevent the coupler from passing through the through-hole, when pushed or pulled to do so. The surface is also at least responsible for ensuring the integrity of the connection of the gastrostomy tube to the skin port connector and providing a seal which prevents fluid from leaking from the device when in use. Accordingly, in certain embodiments, mating surface of the circumferential ridge protruding from the sleeve body sleeve is complementary to the shape(s) of the circumferential ridge of the through-hole. That is, when placed together as described and shown, the surfaces of the two elements provide essential or substantially mated pairs of surfaces, whether flat - e.g. orthogonal or otherwise relative to the outer surface of the sleeve body / main inner surface of the through-hole, or whether nodule or slot protrusions from one element fits within grooves of the other element. In some embodiments, the mating surface of the circumferential ridge protruding from the sleeve body and the circumferential ridge of the through-hole are orthogonal to the sleeve body and the main inner surface of through-hole body, respectively. In other embodiments, the mating surfaces are non-orthogonal to their respective components. In sill other embodiments, the mating surfaces may be undulating, so as to increase the actual contact length between the two. Also, while some embodiments are described as circumferential (i.e., closed loop around elements), in other embodiments, these mated surfaces may be matching threads.

    [0041] Further embodiments provide that the difference between the second mean cross-sectional dimension provided by the circumferential ridge of the through-hole and the mean cross-section dimension of the main inner surface is in the range of about 2 mm to about 10 mm, preferably in the range of about 2 mm to about 8 mm or in the range of about 2 mm to about 6 mm (i.e., the ridge extends a distance in the range of about 1 mm to about 5 mm into the channel of the through-hole, preferably in the range of about 1 mm to about 4 mm or in the range of about 1 mm to about 3 mm). In an analogous fashion, the difference between the first outer mean cross-sectional dimension corresponding to the outer surface of the body of the sleeve and the second mean outer cross-sectional dimension provided by the circumferential ridge protruding from the body is in the range of about 2 mm to about 10 mm, preferably in the range of about 2 mm to about 8 mm or in the range of about 2 mm to about 6 mm (i.e., the circumferential ridge and/or at least one other feature protrudes about 1 mm to about 5 mm from the outer surface of the body of the sleeve; preferably in the range of about 1 mm to about 4 mm or in the range of about 1 mm to about 3 mm). When in use, the overlap between these two ridges may be in the range of about 0.5, 1, 1.5, or 2 mm.

    [0042] In certain embodiments, the circumferential ridge or other feature protruding from the sleeve body is located nearer the proximal end of the sleeve body than the distal end of the sleeve body. In preferred embodiments, this ridge or other feature is located within a distance in the range of about 0.5 mm to about 3 mm of the proximal end of the sleeve body, preferably in a range of about 0.5 mm to about 1.5 mm, or about 1 mm. In other embodiments, this ridge or other protruding feature is located within the first 25% of the distance between the proximal and distal ends of the sleeve body.

    [0043] The distal end of the sleeve body may be chamfered, to help guide the sleeve body into the end of the gastrostomy tube during installation. See, e.g., FIG. 10. The coupler may comprise polymer or metal, preferably polymer, provided the material is capable of maintaining its structural integrity under the demands of the application and comprise such a material as resistant to corrosion, pitting, or other destruction which might result from contacting the content of the patient's stomach. Acid resistant thermoplastic materials, including ABS polymer, are suitable materials.

    [0044] The inner surface of the sleeve body of the coupler may be rough, contain internal features (e.g., rifling), be substantially smooth, or polished, wherein the term "substantially smooth" refers to a surface to which no features deliberately added during the manufacturing of the coupler. The coupler is preferably not rough, so as to provide minimal wall friction to the free flow of materials therethrough while in use. Similarly, in certain preferred embodiments, the inner mean cross-sectional dimension of the sleeve body is substantially similar to or even greater than the inner mean cross-sectional dimension of the uncompressed percutaneous gastrostomy tube. This provides for the free-flow of material through the coupler and the connector when in use. This requires that the end of the gastrostomy tube stretch over the end of the coupler as the coupler is inserted into the tube. Therefore, the tubing must be clamped between the surface of the skin and the bottom of the skin flange to install the sleeve body.

    [0045] In various embodiments, the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube to be used in a skin port connector or used in an assembly. In independent embodiments, the width of the annulus is in the range of about 5% to about 90%, about 10% to about 80%, about 20% to about 60%, about 30% to about 50% of the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube to be used in a skin port connector or used in an assembly. In certain embodiments, the width of this annulus is substantially constant around its circumference.



    [0046] As described herein, the end of gastrostomy tube is compressed radially between the through-hole channel of the skin flange and the outer surface of the body sleeve of the coupler. The radial compression on the wall of the tubing is determined by the clearance between the through-hole and the outer diameter(s) of the coupler / sleeve. The compression on the gastrostomy tube wall may be in a range of 5 to 90% depending on the specific durometer and material used for the gastrostomy tube and the desired axial holding strength of the joint. However, higher compression requires greater axial force to insert the sleeve body.

    [0047] The proximal end of the coupler is intended to fit into a hole in the bottom of the valve assembly and so as to be covered by a sliding seal in the valve assembly when the valve is in the closed position. The valve assembly may be similar to the rotary valve described in U.S. Patent Application Publication Ser. Nos. 2008/0039809 and 2011/0190719, or other valve mechanism as long as the seal covers the proximal end in the closed position and uncovers the proximal end to allow flow in the open position.

    [0048] Various embodiments of the connector or the assembly further comprise a valve assembly. The valve assembly may include an actuator (e.g., slide, rotary, toggle, push-button, etc.) that permits the user to open or close the fluid path of the tube, as desired. The valve prevents and allows fluid flow into and out of the tube during use. One preferred embodiment is describe in U.S. Patent Application Ser. Nos. 2008/003 9809.

    [0049] Such an embodiment may comprise (a) a first platform and having a first thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to a patient's skin; (b) a second platform having a second thru-hole that passes therethrough; and (c) a retainer configured to retain the first platform in proximity to the second platform such that the second platform can be rotated with respect to the first platform between a first position and a second position, wherein in the first position the first and second thru-holes align to provide access to the fluid pathway and in the second position the first and second thru-holes offset to provide a fluid tight seal and to prevent access to the fluid pathway.

    [0050] In addition to skin port connectors for use on flexible percutaneous gastrostomy tubes or assemblies comprising coupled skin port connectors and flexible percutaneous gastrostomy tubes, the present invention also encompasses those apparatuses (and methods using the same) for removing ingested food and/or liquid matter from a patient's stomach via a gastrostomy tube that passes through the patient's abdominal wall in the patient's stomach, each apparatus comprising one of the described assemblies and a pump for removing ingested food and/or liquid matter from a patient's stomach, said pump being in fluid communication with said assembly. In other embodiments, the apparatus comprises an assembly as described herein to which a second tubing in downstream fluid communication with the valve assembly is connected thereto, allowing for the passage drainage of the food and/or liquid matter from a patient's stomach. Further features of such systems and methods are generally described in U.S. Patent Nos. 7,648,479 and U.S. Patent Application Ser. Nos. 2008/0039809, 2011/0082442, 2011/0178480, and 2011/0190719.

    [0051] Still other embodiments of the present invention include methods of connecting a skin port connector to a flexible percutaneous gastrostomy tube and devices for use in such methods. Again, for sake of clarity, these may be described in context of one another. However, each of the methods (and steps thereof) and the devices (and parts thereof) represent individual embodiments, which do not necessarily depend on one another. Nothing described herein should be construed as necessarily requiring a particular device for a particular method, or vice versa.

    [0052] Accordingly, embodiments provide methods of connecting a skin port connector to a flexible percutaneous gastrostomy tube that passes from and through a patient's stomach, and exits through an external stoma on the patient's abdominal wall, said percutaneous gastrostomy tube having a distal end within the patient's stomach and a proximal end to be connected outside of the patient's body, wherein the proximal end of the tube, outside of the patient's body has an inner cross-sectional dimension, an outer cross-sectional dimension, and an uncompressed tube wall thickness, wherein each method comprises:
    1. (a) clamping the gastrostomy tube between the stoma and the end of the tube to be connected, so as to substantially prevent the flow of material out of the stomach;
    2. (b) providing a clamp plate / tray having an area, through which the gastrostomy tube can pass;
    3. (c) optionally trimming the proximal end of the gastrostomy tube at a pre-set distance from the stoma so as to provide an open proximal end;
    4. (d) locating the optionally trimmed proximal end of the gastrostomy tube within a through-hole channel of a skin flange at a pre-determined height relative to through-hole; and
    5. (e) inserting a coupler into the open proximal end of the gastrostomy tube, said coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second mean outer cross-sectional dimension and area;
    so that at least a portion of the coupler fits within the through-hole channel and the center-line axes of the through-hole channel and the coupler are substantially coaxial;
    wherein the clamp plate / tray is capable of distributing any pressure associated with inserting the coupler over the area of the platform;
    wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another;
    wherein the second mean outer cross-sectional area defined by the circumferential ridge protruding from the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole; and
    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole and the outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube;
    so as to compress the tube radially between the through-hole and the coupler.

    [0053] These methods may further comprise attaching a valve assembly to the skin flange, such that the valve assembly seals the proximal end of the tube, thereby preventing prevent the flow of material out of the stomach on release of the clamping. These methods may also comprise removing the clamp from the tube after the tube is connected to the skin port connector (i.e., unclamping the gastrostomy tube).

    [0054] Clamping the tubing eliminates the need to plug the gastrostomy tube while the skin port is connected to prevent leakage. Since it is desirable to keep the gap between the skin and bottom of the skin flange as small as possible to hide the skin port under clothing, the clamping mechanism should also be relatively thin. While a pair of locking forceps or similar instrument may be used as a clamp, using a small clamping plate (FIG. 3) or tray has the advantage of providing a stable place to rest the skin flange while the coupler is inserted. Also, the force transmitted to the patient can be minimized by gripping the plate while pressing the coupler in place. The clamping mechanism on the clamp plate could be a simple slot that is slightly less than twice the wall thickness of the gastrostomy tube in which the tubing is forced into or a clamp with at least one movable jaws. An example of such a clamp is shown in FIG. 4 which one jaw of the clamp is part of the clamping plate and the movable jaw hinges on one end and is latched on the other end. A variety of different clamp designs know in the art could be used as long as they are relatively low-profile in the area around the clamped tubing.

    [0055] One embodiment of the general concept of clamping the gastrostomy tube between the stoma and the end of the tube to be connected, so as to substantially prevent the flow of material out of the stomach is shown in FIG. 3. Other embodiments provide that the clamping comprises collapsing the tube using a movable clamp jaw pincer, hinged or otherwise affixed to a clamp plate / tray, or by use of a free-standing or detachable clamp. One non-limiting embodiment of such a movable clamp jaw pincer is illustrated in FIGs. 4-5. In preferred embodiments, a movable clamp jaw pincer is connected to a frame capable of attaching and/or holding a tube cutting tool and/or the skin flange in a substantially fixed and pre-specified position relative to the frame.

    [0056] Once the gastrostomy tube is clamped, other embodiments provide that the proximal end of the tube be positioned through the through-hole channel of a skin flange, for example as shown in FIG. 9, preferably positioned so that the open proximal end of the tube extends above the proximal end of the channel.

    [0057] In some embodiments, the proximal end of the gastrostomy tube is trimmed, either to shorten the tube or provide a clean surface for contacting the later applied valve plate, or both. This trimming can be done either before or after positioning the tube with respect to the through-hole channel of the skin flange. The trimming may effected by a scalpel, scissors, or preferably a specific device configured with a blade oriented perpendicular to the tube. One non-limiting embodiment of this is shown in FIGs. 6-9, wherein the trimming is shown to be done before positioning the tube with respect to the through-hole channel. Other cutting instruments / configurations may also be employed.

    [0058] Once the tube is properly positioned with respect to the through-hole channel, the coupler may be press fit or screwed (depending on its configuration) into the open proximal end of the tube to compress and seal the tubing, as well as secure the tubing to the skin flange. A clamp frame which attaches to the clamp plate with a thumbscrew which presses the coupler into the tubing as the thumbscrew is rotated may also be used, particularly if the compression of the tubing is relatively high (e.g., FIG. 14). Whether press fit or screwed into the open proximal end of the tube, it is inserted to a distance defined by further inability of the circumferential ridge protruding from the sleeve body surface(s) to pass beyond the circumferential ridge protruding from the main inner surface into the channel of the through-hole in the presence of the compressed tube.

    [0059] The insertion of the coupler may be accomplished by hand, with or without the use of tools or devices. A drop of water or saline solution on the end of the tubing may also be used as a lubricant to aid the installation of the coupler but is not required. However, in certain embodiments, the coupler is guided into the open proximal end of the gastrostomy tube using a guide pin, said guide pin having an external cross-sectional area substantially similar to that inner cross-sectional area of the coupler, said coupler being slidably detachable from the guide pin. One non-limiting embodiment of this guide pin is illustrated in FIGs. 10-11. In these figures, the guide pin is shown attached to a mandrel. While preferred, this configuration is not required, and other embodiments provide for the use of a guide pin free of such a mandrel.

    [0060] The purpose of the guide pin is to help hold the coupler while inserting it into the open end of the tube. Accordingly, the inner cross-sectional dimension of the sleeve body of the coupler and the external cross-sectional dimension of the pin are preferably similar, that of the guide pin being "slightly smaller" than that of the inner surface of the sleeve body. It is not necessary that the cross-sectional areas are the same or similar, so long as the guide pin can fulfill its purpose of directing the sleeve body into the open proximal end of the tube; however, "substantially similar" cross-sectional areas is preferred so as to provide that the sleeve body is movable relative to the guide pin, but that the contact friction between the two may be sufficient to hold the sleeve body in place when the guide pin is held vertically (for example, as illustrated in FIG. 12). In certain embodiments, the external cross-sectional area guide pin is tapered, preferably having a "snugger" fit with the sleeve body at the end furthest from the end being inserted into the tube.

    [0061] As discussed above, the guide pin may also optionally have attached a mandrel, which fits over and is capable of moving along the guide pin, so that the coupler is press fit or screwed into the open proximal end of the gastrostomy tube using the mandrel. The mandrel may also help press the coupler to the proper depth into the tubing. One or more notches may be cut into the skin flange above the section where the tubing is compressed to help visually verify that the coupler has been properly installed.

    [0062] Once the coupler is installed (FIG. 15), securing the tubing to the skin flange, a valve assembly as described in US Patent Application 2011/0082442 can be inserted and attached to the skin flange by barbs on the valve assembly which engage corresponding slots in the skin flange (FIGs. 16-17). Once the valve is closed (FIG. 18), the clamp plate can be unlatched, removed (FIG. 19), and the skin port is ready for use.

    [0063] Independent embodiments, which may be useful in enabling these methods, include devices (tools) for connecting the skin port connectors described above to a flexible percutaneous gastrostomy tube, each device comprising:

    a clamp plate / tray having a base thickness less than about 10 mm, and comprising a tube opening, through which may pass the flexible percutaneous gastrostomy tube, and optionally (a) at least one locator fixture capable of mating with the skin flange so as to hold the skin flange in a position fixed relative to the tube opening; and (b) at least one locator fixture capable of holding a tube cutting tool in a position fixed relative to the tube opening; and

    optionally an optional movable clamp jaw attached to said clamp plate / tray and configured to be capable of clamping the flexible percutaneous gastrostomy tube which may pass through the clamp plate / tray.



    [0064] Independent, non-limiting embodiments of various of the device components and methods steps are illustrated in FIGs. 4-19.

    [0065] The clamp plate / tray can also be used to determine the ideal location of the skin port on the gastrostomy tube before the skin port is installed (FIG. 5). The clamp plate may act as a substitute for the skin port as it is initially clamped onto the tubing while the patient stands to check the fit. If the clamp plate is too close to the skin and creates tension on the internal bolster of the gastrostomy tube in the stomach, the clamp can easily be released and repositioned to improve patient comfort.

    [0066] The clamp plate / tray provides a working surface that allows connection of the gastrostomy tube to the connector while minimizing the discomfort to the patient (e.g., to prevent twisting or rotating of the tube which exits through and is attached to an external stoma on the patient's abdominal wall). Accordingly, it is desirable that the clamp plate / tray comprises a sufficiently large working area to allow the necessary manual manipulations of peripheral devices and/or couplers. While not limiting, the working area of the clamp plate / tray is conveniently in the range of about 25,81 cm2 (4 in2) to about 65,52 cm2 (10 in2). This working surface of the clamp plate / tray should also be such as to minimize the distance between the skin flange and the patient's skin. While not limiting, the thickness of the clamp plate / tray is conveniently in the range of about 1 mm to about 10 mm, or in the range of about 2 mm to about 8 mm, depending on the strength of the material(s)s of construction. Since the clamp plate / tray may contact the patient's skin in use, it should be made of a non-irritating polymer or metal material.

    [0067] Additionally, it is convenient, though not required, that the clamp plate / tray comprises walls around this working area, so as to both provide handles for manipulating the plate / tray away from the surface of the patient's skin and to act as a capture surface, for example, should any couplers slide off a guide pin before being inserted into the gastrostomy tube.

    [0068] Additionally, embodiments of the clamp plate / tray provide for the optional presence of at least one locating fixture which is capable of independently mate with either (a) the skin flange (with which the clamp plate / tray is to be used) so as to hold the skin flange in a position fixed relative to the tube opening; or (b) with a tube cutting tool, so as to hold the cutting tube in a position fixed relative to the a position fixed relative to the tube opening; or (c) both skin flange and tube cutting tool. While each of these skin flange or cutting tool may be held in place by a single locating feature, it is envisioned that a plurality (e.g., 2, 3, 4, 5, or more) of such fixtures are present to accommodate each. So some extent, the walls (a portion thereof) of the clamp plate / tray may serve as one such locating fixture; other exemplary locating fixtures may include at least one of one or more of the following elements: locator pins, protruding nodes, ridges, slots, indentations, cavities, clamps or brackets. The skin flange and cutting tool may also comprise complementary mating features to enable the purpose described.

    [0069] Non-limiting examples of locating fixtures are seen in FIG. 4 (showing bracketing clamps and posts).

    [0070] In other embodiments, the clamp plate / tray comprises a clamping device capable of clamping the gastrostomy tube, with which it is to be used. This clamping device may be permanently or semi-permanently affixed to the clamp plate / tray or attachable / detachable thereto. In some embodiments, this clamping device may comprise a screw or otherwise actuated mechanism for pinching the tube closed. In other embodiments, this clamping device may comprise a movable clamp jaw pincer, hinged or otherwise affixed to a clamp plate / tray. One non-limiting example of this latter embodiment is illustrated in FIG. 4.

    [0071] Independent embodiments include clamp plate / trays comprising the features substantially as shown in FIG. 4, tube cutting tool assemblies comprising features substantially as shown in FIG. 6, sliding guide pin / mandrel combinations comprising features substantially as shown in FIG. 10, and couplers comprising features substantially as shown in FIG. 10. In each case, separate embodiments also include those wherein the features of each component (i.e., clamp plate / tray, tube cutting tool assembly, sliding guide pin / mandrel combination, and coupler) are in at least approximate proportionate size and spatial relationship within and relative to one another.

    [0072] Additional embodiments provide kits comprising at least two of the following: (a) at least one clamp plate / tray in any configuration described herein; (b) at least one tube cutting tool assembly in any configuration described herein; (c) at least one a sliding guide pin optionally attached to mandrel; and (d) at least one coupler in any configuration described herein. Independent embodiments provide kits com at least two of the following: (a) a clamp plate / tray comprising features substantially as shown in FIG. 4; (b) a tube cutting tool assembly comprising features substantially as shown in FIG. 6; (c) a sliding guide pin / mandrel combination comprising features substantially as shown in FIG. 10; and (d) a coupler comprising features substantially as shown in FIG. 10.

    [0073] As those skilled in the art will appreciate, numerous modifications and variations of the present invention are possible in light of these teachings, and all such are contemplated.

    [0074] Similarly, it will be appreciated that any described material, feature, or article may be used in combination with any other material, feature, or article.

    [0075] The reference numerals used throughout the figures refer to the following:

    100 - skin flange

    110 - coupler

    111 - chamfered distal edge of coupler

    112 - coupler installation tool with coupler

    113 - coupler installation tool

    114 - coupler installed in end of tubing

    115 - optional viewing notches

    120 - rotary valve

    121 - rotary valve assembly (open position)

    122 - gasket (rotates)

    123 - valve assembly closing tool

    130 - gastrostomy tube

    131 - compressed section of gastrostomy tube

    132 - tubing pinched closed

    133 - clamped gastrostomy tubing

    134 - cut end of gastrostomy tubing

    140 - compress

    150 - clamp plate

    151 - slot in plate

    152 - fixed clamp plate/tray

    153 - clamp tray

    160 - movable clamp jaw

    161 - movable jaw in latched position

    170 - stoma

    180 -jaw pincer

    190 - tube cutting tool

    191 - cutting blade

    192 - blade advanced to cut tubing

    200 - mandrel

    210 - sliding guide pin

    220 - chamfer

    230 - press frame

    240 - thumbscrew

    300 - distal




    Claims

    1. A skin port connector for use on a flexible percutaneous gastrostomy tube, said flexible percutaneous gastrostomy tube having a tube wall thickness when uncompressed, said skin port connector comprising:

    (a) a skin flange (100) containing a through-hole channel, said through-hole channel having (i) a main inner surface, (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the through-hole channel, said through-hole channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the through-hole channel of the through-hole at a position within the through-hole channel; the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;

    (b) a coupler (110) comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler (110) having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the outer surface of the sleeve body defines (viii) a second outer mean cross-sectional dimension and area; and

    (c) an optional valve assembly (120) adapted for attachment to said skin flange (100);

    wherein at least a portion of the coupler (110) fits within the through-hole channel so that the center-line axes of the through-hole channel and the coupler (110) are substantially coaxial;
    wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the through-hole channel and the surface(s) of the circumferential ridge protruding from the outer surface of the sleeve body in closest approach to one another comprise mating surfaces with respect to one another and
    wherein the second outer mean cross-sectional area defined by the circumferential ridge protruding from the outer surface of the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole channel but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole channel; and characterized in that:

    the circumferential ridge protruding from the sleeve body is located nearer the proximal end of the sleeve body than the distal end;

    the circumferential ridge protruding from the main inner surface of the skin flange into the channel of the through-hole is distally positioned relative to the circumferential ridge protruding from the outer surface of the sleeve body of the coupler;

    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole channel and the first outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of a tube wall of the percutaneous gastrostomy tube when uncompressed, such that when the percutaneous gastrostomy tube is coupled to the skin port connector by press fitting the coupler in the annulus, the flexible percutaneous gastrostomy tube is compressed radially between the main through-hole channel and the coupler.


     
    2. An assembly comprising the skin port connector as described in claim 1 and a flexible percutaneous gastrostomy tube (130), wherein the flexible percutaneous gastrostomy tube is attached to the skin port connector by a radial compression between the through-hole channel and the coupler resulting from the press-fit coupling of the coupler and the connector.
     
    3. An apparatus for removing ingested food and/or liquid matter from a patient's stomach via a gastrostomy tube (130) that passes through the patient's abdominal wall in the patient's stomach, the apparatus comprising the assembly of claim 2 and a pump for removing ingested food and/or liquid matter from a patient's stomach, said pump being in fluid communication with said assembly.
     
    4. A method of connecting a skin port connector to a flexible percutaneous gastrostomy tube (130) that passes from and through a patient's stomach, and exits through an external stoma (170) on the patient's abdominal wall, said flexible percutaneous gastrostomy tube (130) having a distal end within the patient's stomach and a proximal end to be connected outside of the patient's body, wherein the proximal end of the flexible percutaneous gastrostomy tube, outside of the patient's body has an inner cross-sectional dimension, an outer cross-sectional dimension, and an uncompressed tube wall thickness, said method comprising:

    (a) clamping (160) the flexible percutaneous gastrostomy tube (130) between the external stoma and the end of the flexible percutaneous gastrostomy tube to be connected, so as to substantially prevent the flow of material out of the stomach;

    (b) providing a clamp plate / tray having an area, through which the gastrostomy tube can pass;

    (c) locating the proximal end of the flexible percutaneous gastrostomy tube (130) within a through-hole channel of a skin flange (100) at a pre-determined height relative to the through-hole channel, said through-hole channel having (i) a main inner surface, (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the through-hole channel, said through-hole channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the through-hole channel of the through-hole at a position within the through-hole channel; the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface; and

    (d) inserting a coupler (110) into the open proximal end of the flexible percutaneous gastrostomy tube (130), said coupler (110) comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler (110) having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the outer surface of the sleeve body is located (viii) nearer the proximal end of the sleeve than the distal end and defines (ix) a second outer mean cross-sectional dimension and area;

    so that at least a portion of the coupler (110) fits within the through-hole channel and the center-line axes of the through-hole channel and the coupler (110) are substantially coaxial;
    wherein the clamp plate / tray is capable of distributing any pressure associated with inserting the coupler (110); wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the through-hole channel and the surface(s) of the circumferential ridge protruding from the sleeve body in closest approach to one another comprise mating surfaces with respect to one another and wherein the circumferential ridge protruding from the main inner surface of the skin flange is distally positioned relative to the circumferential ridge protruding from the outer surface of the sleeve body of the coupler;
    wherein the second outer mean cross-sectional area defined by the circumferential ridge protruding from the outer surface of the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole channel but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole channel; and
    wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole channel and the first outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube (130);
    so as to compress (140) the tube radially between the through-hole and the coupler (110).
     
    5. The assembly of claim 2 wherein the flexible percutaneous gastrostomy tube (130):

    i) comprises an elastomeric polymer; or

    ii) has a substantially smooth constant inner mean cross-sectional dimension.


     
    6. The connector of claim 1 or the assembly of claim 2 wherein:

    i) the wall thickness of the uncompressed percutaneous gastrostomy tube (130) is in the range of 1 mm to 3 mm; or

    ii) the length of the through-hole channel is in the range of 4 mm to 20 mm; or

    iii) the length of the coupler (110) is in the range of 4 mm to 20 mm.


     
    7. The connector of claim 1 or the assembly of claim 2 wherein:

    i) the main inner surface of the through-hole channel is cylindrical, optionally the main inner surface of the through-hole channel is tapered; or

    ii) the mating surface of the circumferential ridge protruding from the outer surface of the sleeve body is complementary to the shape(s) of the circumferential ridge of the through-hole channel; or

    iii) the mating surface of the circumferential ridge protruding from the outer surface of the sleeve body and the circumferential ridge of the through-hole channel are orthogonal to the sleeve body and the main inner surface of through-hole body, respectively.


     
    8. The connector of claim 1 or the assembly of claim 2 wherein:

    i) the difference between the second mean cross-sectional dimension provided by the circumferential ridge of the through-hole channel and the mean cross-section dimension of the main inner surface is in the range of 2 mm to 8 mm; or

    ii) the difference between the first outer mean cross-sectional dimension defined by the outer surface of the sleeve body and the second outer mean cross-sectional dimension provided by the circumferential ridge protruding from the outer surface of the sleeve body is in the range of 3 mm to 10 mm; or

    iii) the circumferential ridge protruding from the outer surface of the sleeve body is located within a distance in the range of 0.5 mm to 3 mm of the proximal end of the sleeve body.


     
    9. The connector of claim 1 or the assembly of claim 2 wherein:

    i) distal end of the sleeve body is chamfered (220); or

    ii) the inner surface of the sleeve body is substantially smooth; or

    iii) the width of the annulus, defined by the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole channel and the first outer mean cross-sectional area defined by the sleeve body defines an annulus, is in the range of 5% to 90% of the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube (130).


     
    10. The connector of claim 1 or the assembly of claim 2, wherein the inner mean cross-sectional dimension of the sleeve body is substantially similar to the inner mean cross-sectional dimension of the uncompressed percutaneous gastrostomy tube (130), optionally the width of the annulus, defined by the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole channel and the first outer mean cross-sectional area defined by the sleeve body defines an annulus, is in the range of 5% to 90% of the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube (130).
     
    11. The connector of claim 1 or the assembly of claim 2, wherein the optional valve assembly (120) comprises:

    a first platform and having a first thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to a patient's skin;

    a second platform having a second thru-hole that passes therethrough; and

    a retainer configured to retain the first platform in proximity to the second platform such that the second platform can be rotated with respect to the first platform between a first position and a second position,

    wherein in the first position the first and second thru-holes align to provide access to the fluid pathway and in the second position the first and second thru-holes offset to provide a fluid tight seal and to prevent access to the fluid pathway.


     
    12. The method of claim 4, further comprising attaching a valve assembly (120) to the skin flange (100), such that the valve assembly (120) seals the proximal end of the tube, thereby preventing the flow of material out of the stomach on release of the clamping, optionally further comprising unclamping the gastrostomy tube (130).
     
    13. The method of claim 4, wherein the clamping comprises collapsing the tube using a movable clamp jaw pincer (180), optionally wherein the movable clamp jaw pincer is connected to a frame (230) capable of attaching and/or holding a tube cutting tool (190) and/or the skin flange (100) in a substantially fixed and pre-specified position relative to the frame.
     
    14. The method of claim 4, further comprising trimming the proximal end of the flexible percutaneous gastrostomy tube (130) at a pre-set distance from the stoma so as to provide an open proximal end.
     
    15. The method of claim 4, wherein the coupler (110) is screwed or press fit into the open proximal end of the tube, optionally the coupler (110) is screwed or press fit into the open proximal end of the tube to a distance defined by further inability of the circumferential ridge protruding from the sleeve body surface(s) to pass beyond the circumferential ridge protruding from the main inner surface into the through-hole channel in the presence of the compressed tube, optionally the coupler (110) is guided into the open proximal end of the gastrostomy tube (130) using a guide pin (210), said guide pin having an external cross-sectional area substantially similar to that inner cross-sectional area of the coupler (110), said coupler (110) being slidably detachable from the guide pin, optionally wherein:

    i) the external cross-sectional area guide pin is tapered; or

    ii) the coupler (110) is screwed or press fit into the open proximal end of the gastrostomy tube (130) using a sleeve mandrel (200), which fits over and is capable of moving along the guide pin (210).


     


    Ansprüche

    1. Hautanschluss-Verbindungselement für die Verwendung an einem flexiblen perkutanen Gastrotomieschlauch, wobei der flexible perkutane Gastrotomieschlauch eine Schlauchwanddicke, wenn nicht komprimiert, aufweist, wobei das Hautanschluss-Verbindungselement umfasst:

    (a) einen Hautflansch (100), der einen Durchgangslochkanal aufweist, wobei der Durchgangslochkanal (i) eine Haupt-Innenoberfläche, (ii) eine mittlere Querschnittsabmessung und -fläche, (iii) ein proximales und (iv) ein distales Ende und (v) eine Mittellinienachse entlang der Längsachse des Durchgangslochkanals aufweist, wobei der Durchgangslochkanal ferner (vi) eine Umfangsrippe, die von der Haupt-Innenoberfläche in den Durchgangslochkanal des Durchgangslochs ragt, an einer Position innerhalb des Durchgangslochkanals aufweist; wobei die Umfangsrippe eine zweite mittlere Querschnittsabmessung und -fläche definiert, die beide kleiner als die mittlere Querschnittsabmessung bzw. -fläche der Haupt-Innenoberfläche sind;

    (b) ein Kopplungselement (110), umfassend einen Hülsenkörper mit einer hindurchgehenden Bohrung und einer Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, wobei das Kopplungselement (110) (i) ein proximales und (ii) ein distales Ende und (iii) eine Mittellinienachse aufweist, die mit der Längsachse der Bohrung zusammenfällt, wobei der Hülsenkörper (iv) eine Innen- und (v) eine Außenoberfläche und (vi) eine innere mittlere Querschnittsabmessung und -fläche, die von der Innenoberfläche definiert sind, und (vii) eine erste äußere mittlere Querschnittsabmessung und -fläche, die von der Außenoberfläche des Hülsenkörpers definiert sind, aufweist, und wobei die Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, (viii) eine zweite äußere mittlere Querschnittsabmessung und -fläche definiert; und

    (c) eine optionale Ventilbaugruppe (120), die zum Befestigen an den Hautflansch (100) ausgelegt ist;

    wobei wenigstens ein Teil des Kopplungselements (110) in den Durchgangslochkanal passt, so dass die Mittellinienachsen des Durchgangslochkanals und des Kopplungselements (110) im Wesentlichen koaxial sind;
    wobei die Oberfläche (n) der Umfangsrippe, die von der Haupt-Innenoberfläche in den Durchgangslochkanal ragt, und die Oberfläche(n) der Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, bei engster Annäherung zueinander Berührungsflächen füreinander umfassen, und
    wobei die zweite äußere mittlere Querschnittsfläche, die von der Umfangsrippe definiert ist, die von der Außenoberfläche des Hülsenkörpers vorragt, kleiner ist als die entsprechende mittlere Querschnittsfläche, die von der Haupt-Innenoberfläche des Durchgangslochkanals definiert ist, aber größer als die entsprechende zweite mittlere Querschnittsfläche, die von der Umfangsrippe des Durchgangslochkanals definiert ist; und dadurch gekennzeichnet, dass:

    die Umfangsrippe, die von dem Hülsenkörper vorragt, näher an dem proximalen Ende des Hülsenkörpers als an dem distalen Ende angeordnet ist;

    die Umfangsrippe, die von der Haupt-Innenoberfläche des Hautflanschs in den Kanal des Durchgangslochs ragt, distal bezogen auf die Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers des Kopplungselements vorragt, angeordnet ist;

    wobei der Unterschied zwischen der zweiten mittleren Querschnittsfläche, die von der Umfangsrippe des Durchgangslochkanals definiert ist, und der ersten äußeren mittleren Querschnittsfläche, die von dem Hülsenkörper definiert ist, einen Ringraum definiert, wobei der Ringraum eine Breite aufweist, die kleiner als die Dicke der Schlauchwand des perkutanen Gastrotomieschlauchs, wenn nicht komprimiert, ist, so dass, wenn der perkutane Gastrotomieschlauch durch Einpressen des Kopplungselements in den Ringraum an das Hautanschluss-Verbindungselement gekoppelt wird, der flexible perkutane Gastrotomieschlauch zwischen dem Haupt-Durchgangslochkanal und dem Kopplungselement radial komprimiert wird.


     
    2. Baugruppe, umfassend das Hautanschluss-Verbindungselement gemäß Anspruch 1 und einen flexiblen perkutanen Gastrotomieschlauch (130), wobei der flexible perkutane Gastrotomieschlauch durch radiale Kompression zwischen dem Durchgangslochkanal und dem Kopplungselement, die durch die Presskopplung des Kopplungselements und des Verbindungselements entsteht, an dem Hautanschluss-Verbindungselement befestigt ist.
     
    3. Vorrichtung zum Entfernen von aufgenommener Nahrung und/oder flüssigen Stoffen aus dem Magen eines Patienten durch einen Gastrotomieschlauch (130), der durch die Abdominalwand des Patienten in den Magen des Patienten verläuft, wobei die Vorrichtung die Baugruppe gemäß Anspruch 2 und eine Pumpe zum Entfernen von aufgenommener Nahrung und/oder flüssigen Stoffen aus dem Magen eines Patienten umfasst, wobei die Pumpe in Fluidverbindung mit der Baugruppe steht.
     
    4. Verfahren zum Verbinden eines Hautanschluss-Verbindungselements mit einem flexiblen perkutanen Gastrotomieschlauch (130), das aus dem und durch den Magen eines Patienten verläuft und durch ein externes Stoma (170) an der Abdominalwand des Patienten austritt, wobei der flexible perkutane Gastrotomieschlauch (130) ein distales Ende innerhalb des Magens des Patienten und ein proximales Ende, das außerhalb des Körpers des Patienten angeschlossen werden soll, aufweist, wobei das proximale Ende des flexiblen perkutanen Gastrotomieschlauchs außerhalb des Körpers des Patienten eine innere Querschnittsabmessung, eine äußere Querschnittsabmessung und eine Wanddicke des nichtkomprimierten Schlauchs aufweist, wobei das Verfahren umfasst:

    (a) Klemmen (160) des flexiblen perkutanen Gastrotomieschlauchs (130) zwischen dem externen Stoma und dem Ende des flexiblen perkutanen Gastrotomieschlauchs, das angeschlossen werden soll, um Fluss von Material aus dem Magen im Wesentlichen zu verhindern;

    (b) Bereitstellen einer Klemmplatte/fläche mit einer Fläche, durch die der Gastrotomieschlauch hindurchgehen kann;

    (c) Anordnen des proximalen Endes des flexiblen perkutanen Gastrotomieschlauchs (130) in einem Durchgangslochkanal eines Hautflanschs (100) in einer vorbestimmten Höhe bezogen auf den Durchgangslochkanal, wobei der wobei der Durchgangslochkanal (i) eine Haupt-Innenoberfläche, (ii) eine mittlere Querschnittsabmessung und -fläche, (iii) ein proximales und (iv) ein distales Ende und (v) eine Mittellinienachse entlang der Längsachse des Durchgangslochkanals aufweist, wobei der Durchgangslochkanal ferner (vi) eine Umfangsrippe, die von der Haupt-Innenoberfläche in den Durchgangslochkanal des Durchgangslochs ragt, an einer Position innerhalb des Durchgangslochkanals aufweist; wobei die Umfangsrippe eine zweite mittlere Querschnittsabmessung und -fläche definiert, die beide kleiner als die mittlere Querschnittsabmessung bzw. -fläche der Haupt-Innenoberfläche sind; und

    (d) Einführen eines Kopplungselements (110) in das offene proximale Ende des flexiblen perkutanen Gastrotomieschlauchs (130), wobei das Kopplungselement (110) einen Hülsenkörper mit einer hindurchgehenden Bohrung und einer Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, umfasst, wobei das Kopplungselement (110) (i) ein proximales und (ii) ein distales Ende und (iii) eine Mittellinienachse aufweist, die mit der Längsachse der Bohrung zusammenfällt, wobei der Hülsenkörper (iv) eine Innen- und (v) eine Außenoberfläche und (vi) eine innere mittlere Querschnittsabmessung und -fläche, die von der Innenoberfläche definiert sind, und (vii) eine erste äußere mittlere Querschnittsabmessung und -fläche, die von der Außenoberfläche des Hülsenkörpers definiert sind, aufweist, und wobei die Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, (viii) näher an dem proximalen Ende der Hülse als an dem distalen Ende angeordnet ist und (ix) eine zweite äußere mittlere Querschnittsabmessung und -fläche definiert;

    so dass wenigstens ein Teil des Kopplungselements (110) in den Durchgangslochkanal passt, so dass die Mittellinienachsen des Durchgangslochkanals und des Kopplungselements (110) im Wesentlichen koaxial sind;
    wobei die Klemmplatte/fläche fähig ist, jeden Druck, der mit dem Einführen des Kopplungselements (110) verbunden ist, zu verteilen;
    wobei die Oberfläche (n) der Umfangsrippe, die von der Haupt-Innenoberfläche in den Durchgangslochkanal ragt, und die Oberfläche(n) der Umfangsrippe, die von dem Hülsenkörper vorragt, bei engster Annäherung zueinander Berührungsflächen füreinander umfassen, und wobei die Umfangsrippe, die von der Haupt-Innenoberfläche des Hautflanschs vorragt, distal bezogen auf die Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers des Kopplungselements vorragt, angeordnet ist;
    wobei die zweite äußere mittlere Querschnittsfläche, die von der Umfangsrippe definiert ist, die von der Außenoberfläche des Hülsenkörpers vorragt, kleiner ist als die entsprechende mittlere Querschnittsfläche, die von der Haupt-Innenoberfläche des Durchgangslochkanals definiert ist, aber größer als die entsprechende zweite mittlere Querschnittsfläche, die von der Umfangsrippe des Durchgangslochkanals definiert ist; und
    wobei der Unterschied zwischen der zweiten mittleren Querschnittsfläche, die von der Umfangsrippe des Durchgangslochkanals definiert ist, und der ersten äußeren mittleren Querschnittsfläche, die von dem Hülsenkörper definiert ist, einen Ringraum definiert, wobei der Ringraum eine Breite aufweist, die kleiner als die Dicke der Schlauchwand des unkomprimierten perkutanen Gastrotomieschlauchs (130) ist;
    um den Schlauch zwischen dem Durchgangsloch und dem Kopplungselement (110) radial zu komprimieren (140).
     
    5. Baugruppe gemäß Anspruch 2, wobei der flexible perkutane Gastrotomieschlauch (130):

    i) ein elastomeres Polymer umfasst; oder

    ii) eine im Wesentlichen glatte konstante innere mittlere Querschnittsabmessung aufweist.


     
    6. Verbindungselement gemäß Anspruch 1 oder Baugruppe gemäß Anspruch 2, wobei:

    i) die Wanddicke des nichtkomprimierten flexiblen perkutanen Gastrotomieschlauchs (130) in dem Bereich von 1 mm bis 3 mm liegt; oder

    ii) die Länge des Durchgangslochkanals in dem Bereich von 4 mm bis 20 mm liegt; oder

    iii) die Länge des Kopplungselements (110) in dem Bereich von 4 mm bis 20 mm liegt.


     
    7. Verbindungselement gemäß Anspruch 1 oder Baugruppe gemäß Anspruch 2, wobei:

    i) die Haupt-Innenoberfläche des Durchgangslochkanals zylindrisch ist, wobei die Haupt-Innenoberfläche des Durchgangslochkanals gegebenenfalls konisch ist; oder

    ii) die Berührungsfläche der Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, komplementär zu der Form/den Formen der Umfangsrippe des Durchgangslochkanals ist; oder

    iii) die Berührungsflächen der Umfangsrippe, die von der Außenoberfläche des Hülsenkörpers vorragt, und der Umfangsrippe des Durchgangslochkanals senkrecht zu dem Hülsenkörper bzw. der Haupt-Innenoberfläche des Durchgangslochkörpers stehen.


     
    8. Verbindungselement gemäß Anspruch 1 oder Baugruppe gemäß Anspruch 2, wobei:

    i) der Unterschied zwischen der zweiten mittleren Querschnittsabmessung, die von der Umfangsrippe des Durchgangslochkanals bereitgestellt wird, und der mittleren Querschnittsabmessung der Haupt-Innenoberfläche in dem Bereich von 2 mm bis 8 mm liegt; oder

    ii) der Unterschied zwischen der ersten mittleren Querschnittsabmessung, die von der Außenoberfläche des Hülsenkörpers definiert ist, und der zweiten äußeren mittleren Querschnittsabmessung, die von der Umfangsrippe bereitgestellt wird, die von der Außenfläche des Hülsenkörpers vorragt, in dem Bereich von 3 mm bis 10 mm liegt; oder

    iii) die Umfangsrippe, die von der Außenfläche des Hülsenkörpers vorragt, mit einem Abstand in dem Bereich von 0,5 mm bis 3 mm von dem proximalen Ende des Hülsenkörpers angeordnet ist.


     
    9. Verbindungselement gemäß Anspruch 1 oder Baugruppe gemäß Anspruch 2, wobei:

    i) das distale Ende des Hülsenkörpers abgeschrägt ist (220); oder

    ii) die Innenoberfläche des Hülsenkörpers im Wesentlichen glatt ist; oder

    iii) die Breite des Ringraums, definiert durch den Unterschied zwischen der zweiten mittleren Querschnittsfläche, die von der Umfangsrippe des Durchgangslochkanals definiert ist, und der ersten äußeren mittleren Querschnittsfläche, die durch den Hülsenkörper definiert ist, einen Ringraum definiert, der in dem Bereich von 5 % bis 90 % der Dicke der Schlauchwand des nichtkomprimierten perkutanen Gastrotomieschlauchs (130) liegt.


     
    10. Verbindungselement gemäß Anspruch 1 oder Baugruppe gemäß Anspruch 2, wobei die innere mittlere Querschnittsabmessung des Hülsenkörpers im Wesentlichen ähnlich wie die innere mittlere Querschnittsabmessung des nichtkomprimierten perkutanen Gastrotomieschlauchs (130) ist, gegebenenfalls wobei die Breite des Ringraums, definiert durch den Unterschied zwischen der zweiten mittleren Querschnittsfläche, die von der Umfangsrippe des Durchgangslochkanals definiert ist, und der ersten äußeren mittleren Querschnittsfläche, die durch den Hülsenkörper definiert ist, einen Ringraum definiert, der in dem Bereich von 5 % bis 90 % der Dicke der Schlauchwand des nichtkomprimierten perkutanen Gastrotomieschlauchs (130) liegt.
     
    11. Verbindungselement gemäß Anspruch 1 oder Baugruppe gemäß Anspruch 2, wobei die optionale Ventilbaugruppe (120) umfasst:

    eine erste Plattform mit einem ersten Durchgangsloch, das hindurch verläuft, wobei die erste Plattform für die Platzierung benachbart zu der Haut eines Patienten ausgelegt ist;

    eine zweite Plattform mit einem zweiten Durchgangsloch, das hindurch verläuft; und

    ein Rückhalteelement, das dafür gestaltet ist, die erste Plattform in Nachbarschaft zu der zweiten Plattform zu halten, so dass die zweite Plattform bezogen auf die erste Plattform zwischen einer ersten Stellung und einer zweiten Stellung gedreht werden kann,

    wobei in der ersten Stellung das erste und das zweite Durchgangsloch fluchten, um Zugang zu dem Fluidweg zu gewähren, und in der zweiten Stellung das erste und das zweite Durchgangsloch versetzt sind, um eine fluiddichte Dichtung zu ergeben und Zugang zu dem Fluidweg zu verhindern.


     
    12. Verfahren gemäß Anspruch 4, ferner umfassend Anbringen einer Ventilbaugruppe (120) an dem Hautflansch (100), so dass die Ventilbaugruppe (120) das proximale Ende des Schlauchs abdichtet und dadurch den Fluss von Material aus dem Magen bei Freigenen des Klemmens verhindert, gegebenenfalls ferner umfassend Entklemmen des Gastrotomieschlauchs (130).
     
    13. Verfahren gemäß Anspruch 4, wobei das Klemmen das Zusammendrücken des Schlauchs unter Verwendung einer beweglichen Backenklemme (180) umfasst, wobei die bewegliche Backenklemme gegebenenfalls mit einem Rahmen (230) verbunden ist, der fähig ist, ein Schlauchschneidewerkzeug (190) und/oder den Hautflansch (100) in einer im Wesentlichen feststehenden und vorgegebenen Position bezogen auf den Rahmen zu befestigen und/oder zu halten.
     
    14. Verfahren gemäß Anspruch 4, ferner umfassend das Abschneiden des proximalen Endes des flexiblen perkutanen Gastrotomieschlauchs (130) in einem vorbestimmten Abstand von dem Stoma, um ein offenes proximales Ende zu erhalten.
     
    15. Verfahren gemäß Anspruch 4, wobei das Kopplungselement (110) in das offene proximale Ende des Schlauchs geschraubt oder eingepresst wird, gegebenenfalls das Kopplungselement (110) in das offene proximale Ende des Schlauchs auf einen Anstand geschraubt oder eingepresst wird, der von der fehlende Fähigkeit der Umfangsrippe, die von der/den Oberfläche(n) des Hülsenkörpers vorragt, definiert ist, in Gegenwart des komprimierten Schlauchs über die Umfangsrippe, die von der Haupt-Innenoberfläche vorragt, weiter in den Durchgangslochkanal zu treten, wobei das Kopplungselement (110) gegebenenfalls unter Verwendung eines Führungsstifts (210) in das offene proximale Ende des Gastrotomieschlauchs (130) geführt wird, wobei der Führungsstift eine äußere Querschnittsfläche aufweist, die im Wesentlichen ähnlich wie die innere Querschnittsfläche des Kopplungselements (110) ist, wobei das Kopplungselement (110) gleitend von dem Führungsstift ablösbar ist, gegebenenfalls wobei:

    i) die äußere Querschnittsfläche des Führungsstifts konisch ist; oder

    ii) das Kopplungselement (110) unter Verwendung eines Hülsendorns (200), der darüber passt und zur Bewegung entlang des Führungsstifts (210) fähig ist, in das offene proximale Ende des Gastrotomieschlauchs (130) geschraubt oder eingepresst wird.


     


    Revendications

    1. Raccord d'orifice de peau à utiliser sur un tube de gastrostomie percutanée souple, ledit tube de gastrostomie percutanée souple présentant une épaisseur de paroi de tube à l'état non comprimé, ledit raccord d'orifice de peau comprenant:

    (a) une collerette de peau (100) contenant un canal à trou traversant, ledit canal à trou traversant présentant (i) une surface intérieure principale, (ii) des dimension et aire de section transversale moyennes, (iii) une extrémité proximale et (iv) une extrémité distale, et (v) un axe médian le long de l'axe longitudinal du canal à trou traversant, ledit canal à trou traversant comprenant en outre (vi) une nervure circonférentielle faisant saillie à partir de la surface intérieure principale dans le canal à trou traversant du trou traversant à une position à l'intérieur du canal à trou traversant; la nervure circonférentielle définissant des deuxièmes dimension et aire de section transversale moyennes qui sont chacune inférieures aux dimension et aire de section transversale moyennes de la surface intérieure principale;

    (b) un coupleur (110) comprenant un corps de manchon présentant un alésage à travers celui-ci et une nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon, ledit coupleur (110) présentant (i) une extrémité proximale et (ii) une extrémité distale et (iii) un axe médian qui coïncide avec l'axe longitudinal de l'alésage, ledit corps de manchon présentant (iv) une surface intérieure et (v) une surface extérieure et (vi) des dimension et aire de section transversale moyennes intérieures définies par la surface intérieure et (vii) des premières dimension et aire de section transversale moyennes extérieures définies par la surface extérieure du corps de manchon, et dans lequel la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon définit (viii) des deuxièmes dimension et aire de section transversale moyennes extérieures; et

    (c) un ensemble de valve optionnel (120) apte à être fixé à ladite collerette de peau (100);

    dans lequel au moins une partie du coupleur (110) s'agence à l'intérieur du canal à trou traversant de telle sorte que les axes médians du canal à trou traversant et du coupleur (110) soient sensiblement coaxiaux;
    dans lequel la/les surface(s) de la nervure circonférentielle faisant saillie à partir de la surface intérieure principale dans le canal à trou traversant et la/les surface(s) de la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon dans une approche la plus proche l'une de l'autre présentent des surfaces de couplage l'une par rapport à l'autre ; et
    dans lequel la deuxième région de section transversale moyenne extérieure définie par la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon est inférieure à l'aire de section transversale moyenne correspondante définie par la surface intérieure principale du canal à trou traversant mais est supérieure à la deuxième aire de section transversale moyenne correspondante définie par la nervure circonférentielle du canal à trou traversant;
    et caractérisé en ce que:

    la nervure circonférentielle faisant saillie à partir du corps de manchon est située plus près de l'extrémité proximale du corps de manchon que l'extrémité distale;

    la nervure circonférentielle faisant saillie à partir de la surface intérieure principale de la collerette de peau dans le canal du trou traversant est positionnée de façon distale par rapport à la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon du coupleur;

    dans lequel la différence entre la deuxième aire de section transversale moyenne définie par la nervure circonférentielle du canal à trou traversant et la première aire de section transversale moyenne extérieure définie par le corps de manchon définit un anneau, ledit anneau présentant une largeur qui est inférieure à l'épaisseur d'une paroi de tube du tube de gastrostomie percutanée à l'état non comprimé, de telle sorte que lorsque le tube de gastrostomie percutanée est couplé au raccord d'orifice de peau par ajustement par pression du coupleur dans l'anneau, le tube de gastrostomie percutanée souple soit comprimé radialement entre le canal à trou traversant principal et le coupleur.


     
    2. Ensemble comprenant le raccord d'orifice de peau selon la revendication 1 et un tube de gastrostomie percutanée souple (130), dans lequel le tube de gastrostomie percutanée souple est attaché au raccord d'orifice de peau par une compression radiale entre le canal à trou traversant et le coupleur qui résulte du couplage par ajustement par pression du coupleur et du raccord.
     
    3. Appareil pour enlever la matière alimentaire et/ou liquide ingérée de l'estomac d'un patient par l'intermédiaire d'un tube de gastrostomie (130) qui passe à travers la paroi abdominale du patient dans l'estomac d'un patient, l'appareil comprenant l'ensemble selon la revendication 2 et une pompe pour enlever la matière alimentaire et/ou liquide ingérée de l'estomac d'un patient, ladite pompe étant en communication fluidique avec ledit ensemble.
     
    4. Procédé de connexion d'un raccord d'orifice de peau à un tube de gastrostomie percutanée souple (130) qui passe à partir de et à travers l'estomac d'un patient, et qui sort à travers une stomie externe (170) sur la paroi abdominale du patient, ledit tube de gastrostomie percutanée souple (130) présentant une extrémité distale à l'intérieur de l'estomac du patient et une extrémité proximale à connecter à l'extérieur du corps du patient, dans lequel l'extrémité proximale du tube de gastrostomie percutanée souple, à l'extérieur du corps du patient, présente une dimension de section transversale intérieure, une dimension de section transversale extérieure, et une épaisseur de paroi de tube à l'état non comprimé, ledit procédé comprenant les étapes suivantes:

    (a) pincer (160) le tube de gastrostomie percutanée souple (130) entre la stomie externe et l'extrémité du tube de gastrostomie percutanée souple à connecter, de manière à empêcher sensiblement tout écoulement de matière hors de l'estomac;

    (b) prévoir une plaque / un plateau de serrage comportant une région, à travers laquelle peut passer le tube de gastrostomie ;

    (c) placer l'extrémité proximale du tube de gastrostomie percutanée souple (130) à l'intérieur d'un canal à trou traversant d'une collerette de peau (100) à une hauteur prédéterminée par rapport au canal à trou traversant, ledit canal à trou traversant présentant (i) une surface intérieure principale, (ii) des dimension et aire de section transversale moyennes, (iii) une extrémité proximale et (iv) une extrémité distale et (v) un axe médian le long de l'axe longitudinal du canal à trou traversant, ledit canal à trou traversant comprenant en outre (vi) une nervure circonférentielle faisant saillie à partir de la surface intérieure principale dans le canal à trou traversant du trou traversant à une position à l'intérieur du canal à trou traversant; la nervure circonférentielle définissant des deuxièmes dimension et aire de section transversale moyennes qui sont chacune inférieures aux dimension et aire de section transversale moyennes de la surface intérieure principale; et

    (d) insérer un coupleur (110) dans l'extrémité proximale ouverte du tube de gastrostomie percutanée souple (130), ledit coupleur (110) comprenant un corps de manchon présentant un alésage à travers celui-ci et une nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon, ledit coupleur (110) présentant (i) une extrémité proximale et (ii) une extrémité distale et (iii) un axe médian qui coïncide avec l'axe longitudinal de l'alésage, ledit corps de manchon présentant (iv) une surface intérieure et (v) une surface extérieure et (vi) des dimension et aire de section transversale moyennes intérieures définies par la surface intérieure et (vii) des première dimension et aire de section transversale moyennes extérieures définies par la surface extérieure du corps de manchon, et dans lequel la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon est située (viii) plus près de l'extrémité proximale du manchon que l'extrémité distale et définit (ix) des deuxièmes dimension et aire de section transversale moyennes extérieures;

    de telle sorte qu'au moins une partie du coupleur (110) s'agence à l'intérieur du canal à trou traversant et que les axes médians du canal à trou traversant et du coupleur (110) soient sensiblement coaxiaux;
    dans lequel la plaque / le plateau de serrage est capable de distribuer toute pression associée à l'insertion du coupleur (110);
    dans lequel la/les surface(s) de la nervure circonférentielle faisant saillie à partir de la surface intérieure principale dans le canal à trou traversant et la/les surface(s) de la nervure circonférentielle faisant saillie à partir du corps de manchon dans une approche la plus proche l'une de l'autre présentent des surfaces de couplage l'une par rapport à l'autre et dans lequel la nervure circonférentielle faisant saillie à partir de la surface intérieure principale de la collerette de peau est positionnée de façon distale par rapport à la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon du coupleur;
    dans lequel la deuxième aire de section transversale moyenne extérieure définie par la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon est inférieure à l'aire de section transversale moyenne correspondante définie par la surface intérieure principale du canal à trou traversant mais est supérieure à la deuxième aire de section transversale moyenne correspondante définie par la nervure circonférentielle du canal à trou traversant; et
    dans lequel la différence entre la deuxième aire de section transversale moyenne définie par la nervure circonférentielle du canal à trou traversant et la première aire de section transversale moyenne extérieure définie par le corps de manchon définit un anneau, ledit anneau présentant une largeur qui est inférieure à l'épaisseur du paroi de tube du tube de gastrostomie percutanée à l'état non comprimé (130);
    de manière à comprimer (140) le tube radialement entre le trou traversant et le coupleur (110).
     
    5. Ensemble selon la revendication 2, dans lequel le tube de gastrostomie percutanée souple (130):

    i) comprend un polymère élastomère; ou

    ii) présente une dimension de section transversale moyenne intérieure sensiblement uniformément constante.


     
    6. Raccord selon la revendication 1 ou ensemble selon la revendication 2, dans lequel:

    i) l'épaisseur de paroi du tube de gastrostomie percutanée à l'état non comprimé (130) se situe dans la gamme de 1 mm à 3 mm; ou

    ii) la longueur du canal à trou traversant se situe dans la gamme de 4 mm à 20 mm; ou

    iii) la longueur du coupleur (110) se situe dans la gamme de 4 mm à 20 mm.


     
    7. Raccord selon la revendication 1 ou ensemble selon la revendication 2, dans lequel:

    i) la surface intérieure principale du canal à trou traversant est cylindrique, optionnellement la surface intérieure principale du canal à trou traversant est conique; ou

    ii) la surface de couplage de la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon est complémentaire à la/aux forme(s) de la nervure circonférentielle du canal à trou traversant; ou

    iii) la surface de couplage de la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon et de la nervure circonférentielle du canal à trou traversant sont orthogonales au corps de manchon et à la surface intérieure principale du corps de trou traversant, respectivement.


     
    8. Raccord selon la revendication 1 ou ensemble selon la revendication 2, dans lequel:

    i) la différence entre la deuxième dimension de section transversale moyenne formée par la nervure circonférentielle du canal à trou traversant et la dimension de section transversale moyenne de la surface intérieure principale se situe dans la gamme de 2 mm à 8 mm; ou

    ii) la différence entre la première dimension de section transversale moyenne extérieure définie par la surface extérieure du corps de manchon et la deuxième dimension de section transversale moyenne extérieure formée par la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon se situe dans la gamme de 3 mm à 10 mm; ou

    iii) la nervure circonférentielle faisant saillie à partir de la surface extérieure du corps de manchon est située à l'intérieur d'une distance comprise dans la gamme de 0,5 mm à 3 mm de l'extrémité proximale du corps de manchon.


     
    9. Raccord selon la revendication 1 ou ensemble selon la revendication 2 dans lequel:

    i) l'extrémité distale du corps de manchon est chanfreinée (220); ou

    ii) la surface intérieure du corps de manchon est sensiblement lisse; ou

    iii) la largeur de l'anneau, définie par la différence entre la deuxième aire de section transversale moyenne définie par la nervure circonférentielle du canal à trou traversant et la première aire de section transversale moyenne extérieure définie par le corps de manchon définissant un anneau, se situe dans la gamme de 5 % à 90 % de l'épaisseur de la paroi de tube du tube de gastrostomie percutanée à l'état non comprimé (130).


     
    10. Raccord selon la revendication 1 ou ensemble selon la revendication 2, dans lequel la dimension de section transversale moyenne intérieure du corps de manchon est sensiblement similaire à la dimension de section transversale moyenne intérieure du tube de gastrostomie percutanée à l'état non comprimé (130), optionnellement la largeur de l'anneau, définie par la différence entre la deuxième aire de section transversale moyenne définie par la nervure circonférentielle du canal à trou traversant et la première aire de section transversale moyenne extérieure définie par le corps de manchon définissant un anneau, se situe dans la gamme de 5 % à 90 % de l'épaisseur de la paroi de tube du tube de gastrostomie percutanée à l'état non comprimé (130) .
     
    11. Raccord selon la revendication 1 ou ensemble selon la revendication 2, dans lequel l'ensemble de valve optionnel (120) comprend:

    une première plate-forme présentant un premier trou traversant qui passe à travers celle-ci, dans lequel la première plate-forme est apte à être placée à proximité de la peau d'un patient;

    une deuxième plate-forme présentant un deuxième trou traversant qui passe à travers celle-ci; et

    un élément de retenue configuré de manière à retenir la première plate-forme à proximité de la deuxième plate-forme de telle sorte que la deuxième plate-forme puisse être tournée par rapport à la première plate-forme entre une première position et une seconde position, dans lequel,

    dans la première position, les premier et deuxième trous traversants s'alignent de manière à offrir un accès au chemin d'écoulement de fluide et, dans la seconde position, les premier et deuxième trous traversants soient décalés de manière à former un joint étanche au fluide et à empêcher tout accès au chemin d'écoulement de fluide.


     
    12. Procédé selon la revendication 4, comprenant en outre la fixation d'un ensemble de valve (120) à la collerette de peau (100), de telle sorte que l'ensemble de valve (120) scelle l'extrémité proximale du tube, empêchant de ce fait tout écoulement de matière hors de l'estomac lors de relâchement du serrage, optionnellement comprenant en outre le desserrage du tube de gastrostomie (130).
     
    13. Procédé selon la revendication 4, dans lequel le serrage comprend l'écrasement du tube en utilisant une pince à mâchoires de serrage mobiles (180), optionnellement dans lequel la pince à mâchoires de serrage mobiles est connectée à un cadre (230) capable d'attacher et/ou de maintenir un outil de coupage de tube (190) et/ou la collerette de peau (100) dans une position sensiblement fixée et préspécifiée par rapport au cadre.
     
    14. Procédé selon la revendication 4, comprenant en outre le rognage de l'extrémité proximale du tube de gastrostomie percutanée souple (130) à une distance préétablie de la stomie de manière à obtenir une extrémité proximale ouverte.
     
    15. Procédé selon la revendication 4, dans lequel le coupleur (110) est vissé ou ajusté par pression dans l'extrémité proximale ouverte du tube, optionnellement le coupleur (110) est vissé ou ajusté par pression dans l'extrémité proximale ouverte du tube jusqu'à une distance définie par une incapacité supplémentaire de la nervure circonférentielle faisant saillie à partir de la/des surface(s) du corps de manchon de passer au-delà de la la nervure circonférentielle faisant saillie à partir de la surface intérieure principale dans le canal à trou traversant en présence du tube à l'état comprimé, optionnellement le coupleur (110) est guidé dans l'extrémité proximale ouverte du tube de gastrostomie (130) en utilisant une broche de guidage (210), ladite broche de guidage présentant une aire de section transversale extérieure sensiblement similaire à l'aire de section transversale intérieure du coupleur (110), ledit coupleur (110) pouvant être détaché de façon coulissante de la broche de guidage, optionnellement dans lequel:

    i) l'aire de section transversale extérieure de la broche de guidage est conique; ou

    ii) le coupleur (110) est vissé ou ajusté par pression dans l'extrémité proximale ouverte du tube de gastrostomie (130) en utilisant un mandrin de manchon (200), qui s'agence sur et est capable de se déplacer le long de la broche de guidage (210).


     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description