(19)
(11)EP 2 370 001 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
22.01.2020 Bulletin 2020/04

(21)Application number: 09764674.9

(22)Date of filing:  01.12.2009
(51)International Patent Classification (IPC): 
A61B 17/04(2006.01)
A61B 17/00(2006.01)
A61B 17/06(2006.01)
A61F 2/00(2006.01)
(86)International application number:
PCT/US2009/066201
(87)International publication number:
WO 2010/065504 (10.06.2010 Gazette  2010/23)

(54)

INSERTION DEVICE FOR DELIVERY OF A MESH CARRIER

EINFÜHRVORRICHTUNG ZUM AUSBRINGEN EINES GITTERTRÄGERS

DISPOSITIF D'INSERTION D'UN SUPPORT TISSÉ


(84)Designated Contracting States:
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 SE SI SK SM TR

(30)Priority: 05.12.2008 US 193542 P
23.11.2009 US 623857

(43)Date of publication of application:
05.10.2011 Bulletin 2011/40

(60)Divisional application:
19205498.9

(73)Proprietor: Boston Scientific Scimed, Inc.
Maple Grove, MN 55311-1566 (US)

(72)Inventors:
  • CHU, Michael, S., H.
    Brookline Massachusetts 02446 (US)
  • LAVAKUMAR, Karthik
    Framingham Massachusetts 01701 (US)
  • OLIVIERI, Steven, A.
    Shrewsbury Massachusetts 01545 (US)

(74)Representative: Pfenning, Meinig & Partner mbB 
Patent- und Rechtsanwälte Joachimsthaler Straße 10-12
10719 Berlin
10719 Berlin (DE)


(56)References cited: : 
WO-A1-2009/038781
US-A1- 2002 193 830
US-A1- 2006 089 525
US-A1- 2002 013 608
US-A1- 2003 105 489
  
      
    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

    CROSS-REFERENCE TO RELATED APPLICATIONS



    [0001] This application is a continuation of and claims priority to and the benefit of U.S. Patent Application Serial No. 12/623,857, filed November 23, 2009, which claims priority to and the benefit of Provisional U.S. Patent Application Serial No. 61/193,542, filed December 5, 2008.

    [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 61/193,542, filed December 5, 2008.

    BACKGROUND



    [0003] The disclosed embodiments relate generally to medical devices and more particularly to an insertion device for delivery of a mesh carrier into a body of a patient.

    [0004] The disclosed embodiments have application to a wide variety of surgical procedures. For example, one such procedure is directed to urinary incontinence and includes fixing an implant to tissue within a body of a patient to provide support for the urethra. Another such procedure includes fixing an implant to bodily tissue of a patient to support a bladder of the patient.

    [0005] Mesh carriers may be placed within a body of a patient to provide anchoring points for medical implants. In some procedures, it is necessary for a practitioner, such as a physician, to insert a mesh carrier into bodily tissue of the patient at a location not easily visible to the practitioner. In such procedures, known insertion devices can be used to position a mesh carrier at a first location within bodily tissue and to fix the mesh carrier to the tissue. However, when the mesh carrier is removed from the insertion device, the mesh carrier may be fixed to the tissue at a second location different from the first location. For example, when the mesh carrier is removed from the insertion device, it can be pushed to a location deeper within the tissue than its location when first inserted. In such an instance, over-insertion can occur resulting in misplacement of the mesh carrier. If misplacement of the mesh carrier occurs, the practitioner may remove or pull out the misplaced mesh carrier or implant, which can cause severe or unnecessary trauma to the patient. Document US 2002/013608 A1 discloses an inner shaft of a driver having a cannula extending through its entire length and having openings at the proximal and distal ends to enable sutures to be passed therethrough. This document does not appear to disclose a distal end portion of a stylet defining a ridge configured to be disposed outside of and contact a distal end portion of a tissue anchor, wherein the stylet is configured to ex-tend through a lumen and out of an opening of the tissue anchor such that the ridge defined by the distal end portion of the stylet interacts with the distal end portion of the tissue anchor and helps retain the tissue anchor on the distal end portion of the stylet. Further prior art can be found, e.g., in documents US 2002/193830 A1, US 2006/089525 A1, and US 2003/105489 A1.

    [0006] US2002/193830 A1 discloses a shaft including a cylindrical inner member and cylindrical outer member which are movable relative to each other to release an anchor.

    [0007] Thus, a need exists for an insertion device having a configuration that permits the mesh carrier to remain at a single location within bodily tissue once the mesh carrier has been inserted into the tissue and during removal from the insertion device. A need also exists for an insertion device having a configuration that facilitates deployment of the mesh carrier from the insertion device.

    Summary



    [0008] The insertion device of the invention and the insertion system of the invention are defined in the claims.

    [0009] The insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen between the proximal end portion and the distal end portion. The stylet has a distal end portion and a proximal end portion. The stylet is slidably coupled to the elongate member such that the stylet is configured to move from a first position to a second position with respect to the elongate member. The distal end portion of the stylet is configured to removably couple a mesh carrier thereto. A portion of the distal end portion of the stylet is disposed outside of the lumen of the elongate member when the stylet is in its first position and is disposed within the lumen when the stylet is in its second position.

    [0010] The elongate member includes a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a distal end portion and a proximal end portion, and is configured to move from a first position to a second position. The distal end portion of the stylet may be configured to removably couple a mesh carrier thereto and may be configured to be coupled to the mesh carrier when the stylet is in its first position. The elongate member may be configured to contact the mesh carrier and decouple the mesh carrier from the distal end portion of the stylet in response to the stylet moving from its first position to its second position.

    Brief Description of the Drawings



    [0011] 

    FIG. 1 is a schematic illustration of an insertion device according to one embodiment.

    FIG. 2 is a perspective view of an insertion device with a stylet in a first position according to another embodiment.

    FIG. 3 is a perspective view of the insertion device of FIG. 2 with the stylet in a second position.

    FIG. 4a is a perspective view of the stylet of the insertion device of FIG. 2.

    FIG. 4b is a perspective view of the elongate member of the insertion device of FIG. 2.

    FIG. 5 is an exploded view of the insertion device of FIG. 2 and a mesh carrier.

    FIG. 6 is a perspective view the insertion device of FIG. 2 coupled to a mesh carrier and filament.

    FIG. 7 is a side view of a portion of the stylet of the insertion device of FIG. 2.

    FIG. 8 is a top view of a portion of the stylet of the insertion device of FIG. 2

    FIG. 9 is a side view of a portion of the elongate member of the insertion device of FIG. 2

    FIG. 10 is a top view of a portion of an elongate member of the insertion device of FIG. 2.

    FIG. 11 is a cross-sectional view of a portion of the insertion device of FIG. 2 in its first position.

    FIG. 12 is a cross-sectional view of a portion of the insertion device of FIG. 2 in its second position.

    FIG. 13 is a side view of a distal end portion of the insertion device of FIG. 2.

    FIG. 14 is a cross-section view of the distal end portion taken along line A-A of FIG. 13.

    FIGS. 15a and 15b are cross-sectional views of a distal end portion of the insertion device of FIG. 6 in a first position along line Y-Y of FIG. 6.

    FIG. 16 is a cross-sectional view of a distal end portion of the insertion device of FIG. 6 in a second position along line Y-Y.

    FIGS. 17 and 18 are perspective views of an embodiment of a mesh carrier.

    FIG. 19 is a perspective view of a mesh carrier and a filament according to an embodiment.

    FIG. 20 is a perspective view of a portion of the insertion device of FIG. 6 coupled to a mesh carrier and a filament.

    FIG. 21 is a perspective view of two mesh carriers and a filament according another embodiment.

    FIG. 22 is a side view of an embodiment of an implant shown positioned within a body of a patient.

    FIG. 23 is a perspective view of an insertion device with a stylet in a first position according to another embodiment.

    FIG. 24 is a perspective view of the insertion device of FIG. 23 with the stylet in a second position.

    FIG. 25 is a flowchart of an exemplary method of use of an insertion device according to an embodiment of the invention.


    Detailed Description



    [0012] The insertion device and mesh carrier described herein can be inserted into a body of a patient, such as into bodily tissue. For example, the insertion device can be configured to deliver a first mesh carrier configured to selectively retain an implant (also referred to herein as a "filament", "tape", "implant", "mesh", "sling", or "strap") with respect to bodily tissue. A plurality of such mesh carriers can be anchored within the body of a patient at spaced locations while retaining a filament between the plurality of mesh carriers to provide support for other portions of the body (e.g., organs or portions of organs).

    [0013] The insertion device is configured to place, deposit, or otherwise insert a mesh carrier into a bodily tissue of a patient. The filament is configured to suspend or support a bodily tissue or organ when the filament is retained within the patient by one mesh carrier. Thus, in one embodiment, the insertion device can place the mesh carrier into the obturator extemus muscle for incontinence treatment. Specifically, first and second mesh carriers are placed in the obturator extemus muscle of a patient and the filament is extended between the first and second mesh carriers to support the urethra or bladder neck of the patient. The insertion device can be a variety of different configurations and can have a variety of different components.

    [0014] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and further away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would use an insertion device or a therapeutic device during a procedure. For example, the end of an insertion device first to contact the patient's body would be the distal end, while the opposite end of the insertion device (e.g., the end of the insertion device being operated by the operator) would be the proximal end of the insertion device. Similarly, the end of a insertion device implanted the furthest within the patient's body would be the distal end, while the opposite end of the insertion device (e.g., the end of the insertion device that is implanted the least amount within the body or the end of the insertion device that is disposed outside of the body) would be the proximal end.

    [0015] FIG. 1 is a schematic illustration of an insertion device 100 according to an embodiment of the invention. The insertion device 100 can be inserted into a body of a patient, such as into bodily tissue.

    [0016] The insertion device 100 has a proximal end portion 102 and a distal end portion 104. The insertion device 100 includes an elongate member 110 and a stylet 130. At least a portion of the elongate member 110 and a portion of the stylet 130 are configured to be inserted into a body of a patient. The elongate member 110 includes a proximal end portion 112 and a distal end portion 113 and is configured to move with respect to the stylet 130.

    [0017] The stylet 130, in some embodiments, includes a proximal end portion 132 and a distal end portion 134. The distal end portion 134 is configured to interact with a mesh carrier. The stylet 130 is configured to move with respect to the elongate member 110 from a first position to a second position.

    [0018] When the stylet 130 is in its first position, a portion of the distal end portion 134 of the stylet 130 extends beyond the distal end portion 113 of the elongate member 110, and is configured to be coupled to the mesh carrier. As the stylet 130 is moved proximally from its first position to its second position, the distal end portion 113 of the elongate member 110 contacts the mesh carrier preventing further proximal movement of the mesh carrier. When the stylet 130 is in its second position, the portion of the distal end portion 134 of the stylet 130, which extended beyond the distal end portion 113 of the elongate member 110 when the stylet 130 was in its first position, is disposed within a lumen of the elongate member 110. Thus, as the stylet 130 is moved from its first position to its second position, the mesh carrier is decoupled or removed from the distal end portion 134 of the stylet 130 and is released in bodily tissue.

    [0019] In some embodiments, the elongate member defines a lumen extending between the proximal end portion and the distal end portion. In such an embodiment, the lumen is configured to receive the stylet.

    [0020] In some embodiments, the proximal end portion of the stylet can be configured to be coupled to a handle.

    [0021] Although a mesh carrier is used with insertion device 100 as described in the above disclosed embodiment, it should be understood that in some embodiments, a tissue anchor can be used.

    [0022] FIGS. 2-16 and 20 illustrate one embodiment an insertion device. Insertion device 200 has a proximal end portion 202 and a distal end portion 204 (which includes a portion of both an elongate member 210 and a stylet 230). The elongate member 210 and stylet 230 are configured to be at least partially inserted into a body of a patient.

    [0023] The elongate member 210 includes a proximal end portion 212 and a distal end portion 213, and defines a lumen 218 (shown, for example, in FIG. 13) that extends between the proximal end portion 212 and the distal end portion 213 and is configured to receive at least a portion of the stylet 230. In the illustrated embodiment, the elongate member 210 of the insertion device 200 comprises a substantially flexible material, thereby permitting the elongate member 210 to conform to the shape of the stylet 200.

    [0024] As shown in FIGS. 4b, 9, and 10, the elongate member 210 includes a base member 250 coupled to its proximal end portion 212. The base member 250 includes a distal end portion 252, a proximal end portion 254, and further defines a portion of the lumen 218 of the elongate member 210. Specifically, the base member 250 is configured to be disposed around or to be slidably coupled to at least a portion of the stylet 230 (described in more detail below). The distal end portion 252 is configured to be fixedly coupled to the proximal end portion 212 of the elongate member 210. The distal end portion 252 of the base member 250 can be fixedly coupled to the elongate member 210 by any suitable coupling mechanism. For example, in some embodiments, the base member 250 and the elongate member 210 can be monolithically constructed.

    [0025] The proximal end portion 254 of the base member 250 is configured to be disposed proximate a distal end portion 274 of a handle 270 when the stylet 230 is in a first position (shown, for example, in FIGS. 2 and 11) and is configured to be spaced apart from the distal end portion 274 of the handle 270 when the stylet 230 is in a second position (shown, for example in FIGS. 3 and 12). In the illustrated embodiment, the base member 250 is disposed on and is slidably coupled to a proximal end portion 232 of the stylet 230.

    [0026] In the illustrated embodiment, the base member 250 includes projections 256 and 257 extending therefrom, (shown in FIGS. 10-12) for preventing excessive proximal or distal movement of the elongate member relative to the stylet 230 (discussed in more detail herein). The base member 250 can be constructed of any suitable material. In one embodiment, the base member 250 can be constructed of a polymer. For example, the base member 250 can be constructed of acrylonitrile butadiene styrene (ABS).

    [0027] The stylet 230 includes a distal end portion 234 and a proximal end portion 232. The stylet 230 is slidably disposed within the lumen 218 defined by the elongate member 210. As shown in FIG. 13, the distal end portion 234 of the stylet 230 defines a first ridge 235, a second ridge 236, a tip 237, and a tapered portion 238 extending between the second ridge 236 and the tip 237. The tip 237 can be a variety of shapes, for example, in one embodiment, the stylet tip is pointed. In another embodiment, the stylet tip can be sharp. In yet another embodiment, the tip is blunt.

    [0028] The distal end portion 234 of the stylet 230 is configured to extend through a lumen 291 (shown, for example in FIGS. 15a, 15b, 16, and 20) defined by the mesh carrier 290. The first ridge 235 is configured to interact with a proximal end portion 294 of the mesh carrier 290. The second ridge 236 is configured to be disposed outside of the lumen 291 and interact with a distal end portion 293 of the mesh carrier 290 (described in more detail below).

    [0029] The proximal end portion 232 of the stylet 230 is slidably coupled to the elongate member 210 and extends through the lumen 218 of the elongate member 210. In the illustrated embodiment, the proximal end portion 232 includes detents 231a and 231b and a lip 233 (shown, for example, in FIGS. 7 and 8). The detents 231a are configured to mate with the projections 256, 257 of the base member 250 of the elongate member 210 when the stylet 230 is in its first position (shown in FIG. 11). The detents 231b and the lip 233 are configured to interact and/or contact the projections 256, 257 of the base member 250 when the stylet 230 is moved proximally from a first position to a second position (shown in FIG. 12).

    [0030] As shown in FIG. 13, at least a portion of the stylet 230 defines a first diameter. A portion of the proximal end portion 232 defines a second diameter different from the first diameter of the distal end portion 234. In the illustrated embodiment, the second diameter is greater than the first diameter.

    [0031] The proximal end portion 232 of the stylet 230 is coupled to a handle 270. The handle 270 includes a proximal end portion 272 and a distal end portion 274. As shown, for example, in FIGS. 3, 4a, and 5, the distal end portion 274 of the handle 270 is fixedly coupled to the proximal end portion 232 of the stylet. Thus movement of the handle in a proximal direction with respect to the elongate member 210 causes the stylet to move in a proximal direction, and movement in a distal direction with respect to the elongate member 210 causes the stylet to move in a distal direction.

    [0032] The handle 270 can be coupled to the stylet 230 by any known coupling mechanism, including, but not limited to, a clip, adhesive, interference fit, mating recesses, or the like. In another embodiment, the handle is coupled to the delivery assembly by any combination of the foregoing known coupling mechanisms. In other embodiments, the handle and the stylet can be monolithically constructed. In yet other embodiments, for example, the handle can be insert-molded to the stylet.

    [0033] Although the handle 270 is illustrated as defining a contoured shape (shown, for example, in FIGS. 2 and 3), the handle 270 can define a variety of shapes, sizes, and configurations, such as a cylindrical shape. The handle 270 can further be constructed of any suitable material. For example, in some embodiments, the handle 270 can be constructed of at least one polymer. In other embodiments, for example, the handle 270 can be constructed of acrylonitrile butadiene styrene (ABS). In other embodiments, the handle 270 can include a thermoplastic elastomer (TPE) material covering a portion its outer surface to provide a practitioner a comfortable or secure gripping area.

    [0034] The stylet 230 has a first position (i.e., an extended position), shown, for example, in FIG. 2 and a second position (i.e., a retracted position), shown, for example, in FIG. 3. When the stylet 230 is in its first position, at least a portion of the distal end portion 234 of the stylet 230 extends from the lumen 218 at the distal end portion 213 of the elongate member 210.

    [0035] The portion of the distal end portion 234 is further configured to extend through the lumen 291 and out an opening 291b defined by the mesh carrier 290. Specifically the stylet 230 is configured to extend through the lumen 291 and out of opening 291b of the mesh carrier 290 (as shown, for example, in FIG. 6, 15a-16, and 20) such that the first ridge 235 interacts with the proximal end portion 294 of the mesh carrier 290, and the second ridge 236 defined by the distal end portion 234 of the stylet 230 interacts with distal end 293 of the mesh carrier 290. The interaction of the first ridge 235 and the second ridge 236 with the mesh carrier helps retain the mesh carrier 290 on the distal end portion 234 of the stylet 230. As the stylet 230 is moved from its first position to its second position, the distal end portion 213 of the elongate member 210 contacts the proximal end 294 of the mesh carrier 290 and prevents proximal movement of the mesh carrier 290. When the stylet 230 is in its second position, as illustrated, for example, in FIG. 3, the portion of the distal end portion 234 of the stylet 230, which was disposed outside the lumen 218 when the stylet 230 was its first position, is disposed within the lumen 218 of the elongate member 210. Specifically, in the illustrated embodiment, when the stylet 230 is moved proximally from its first position, the distal end portion 213 of the elongate member 210 contacts the proximal end 294 of the mesh carrier 290 maintaining its location within bodily tissue. The mesh carrier 290 is thereby decoupled or removed from the distal end portion 234 of the stylet 230 and is released in bodily tissue.

    [0036] The stylet 230 can be constructed of any material suitable for insertion into a body of a patient. For example, in some embodiment, the stylet can be constructed of stainless steel. In other embodiments, the stylet can be constructed of a polymer.

    [0037] FIGS. 17 and 18 are perspective views of a mesh carrier 290 that can be used with the insertion device 200 described above. The mesh carrier 290 has a proximal end 294 and a distal end 293 and defines a lumen 291 extending from the proximal end 294 to the distal end 293. The mesh carrier 290 is removably coupled to the distal end portion 234 of the stylet 230, as shown, for example, in FIGS. 5, 6, 15a-16, and 20. The proximal end portion 294 defines an opening 291a in communication with the lumen 291. The opening 291a is configured to receive the distal end portion 234 of the stylet 230. The proximal end 294 of the mesh carrier 290 is proximate the distal end portion 213 of the elongate member 210 of the insertion device 200 when the stylet 230 is in its first position. The proximal end 294 contacts the distal end portion 213 while the stylet 230 is moved from its first position to its second position. Thus, by moving the stylet 230 in a proximal direction from its first position to its second position, the mesh carrier 290 is decoupled from the stylet 230, and fixed to bodily tissue.

    [0038] The proximal end portion 294 of the mesh carrier 290 further includes a retention portion 295, an anchor portion 298 and defines an aperture 292. The retention portion 295 includes four projections 295a, 295b, 295c, and 295d extending therefrom. The retention portion 295 is configured to retain or secure at least a portion of a filament 205 with respect to the mesh carrier 290. Specifically, in the illustrated embodiment, the projections 295a-295d are configured to help prevent movement of the filament 205 with respect to the aperture 292 of the mesh carrier 290 when the mesh carrier 290 is placed into bodily tissue. The projections 295a-295d are configured such that when a portion of the filament 205 extends into the aperture 292, the projections 295a-295d pierce the filament 205 to secure the filament 205 within the aperture 292 of the mesh carrier 290. Thus, the filament 205 is retained in place with respect to the mesh carrier 290 by its interaction with the retention portion 295.

    [0039] Although the retention portion 295 is illustrated and described as including four projections 295a-295b, in one embodiment, the retention portion 295 includes three projections. In another embodiment, the retention portion 295 includes one or two projections. Alternatively, the retention portion 295 can include five of more projections.

    [0040] Although the retention portion 295 is illustrated as including projections 295a-295d configured to engage or secure a filament 205, in one embodiment, the retention portion 295 includes a different mechanism for retaining the filament 205 with respect to the mesh carrier 290. For example, in one embodiment, the retention portion 295 includes a clip, an adhesive or the like. In another embodiment, the retention portion 295 includes any combination of a projection, clip, adhesive, or the like.

    [0041] The anchor portion 298 of the mesh carrier 290 is configured to help retain at least a portion of the mesh carrier 290 in a body of a patient. The anchor portion 298 is configured to help prevent the mesh carrier 290 from moving through the bodily tissue in which it is placed. For example, in one application, the anchor portion 298 is configured to retain or anchor the mesh carrier 290 in one of the obturator internus or obturator externus muscles. As illustrated in FIGS. 17 and 18, the anchor portion 298 is disposed on or proximate to the proximal end portion 294 of the mesh carrier 290. The anchor portion 298 includes protrusions 298a, 298b, 298c, 298d. The protrusions 298a-298d are configured to help anchor the mesh carrier 290 in the bodily tissue of the patient once the mesh carrier 290 is placed within the bodily tissue.

    [0042] In the embodiment illustrated in FIGS. 17 and 18, the protrusions 298a-298d are configured to extend outwardly from the mesh carrier 290 such that when the mesh carrier 290 is placed into bodily tissue and the insertion device is removed, bodily tissue may regress behind the mesh carrier 290, thus helping to anchor the mesh carrier 290 in the bodily tissue.

    [0043] The aperture 292 is configured to receive at least a portion of the filament 205 (shown in FIGS. 19-21) such that the filament 205 is disposed adjacent to the stylet 230 (not shown). The aperture 292 can be configured to provide little or no resistance to movement or adjustment of the filament 205. For example, the aperture 292 can have an opening greater in size than the width or thickness of the filament 205. In such an embodiment, the filament 205 can be readily placed within aperture 292, meeting minimal or no resistance, before the filament 205 is pierced by the projections 295a-295d.

    [0044] In an another embodiment, the aperture 292 can be configured to provide a friction fit with the filament 205 passed through (or received within) the aperture 292. For example, the aperture 292 can be configured to be slightly less (or narrower) than the thickness of the filament 205. In such an embodiment, a force must be applied to move the filament 205 through the aperture 292. This configuration would allow the filament 205 to be further secured by the mesh carrier 290.

    [0045] The aperture 292 can have any suitable size or shape configured to receive the filament 205, for example the shape can be a U-shape, square, rectangle, or any other shape configured to receive a filament 205.

    [0046] The mesh carrier 290 can be constructed of any material suitable for implantation into bodily tissue. For example, the mesh carrier 290 can be constructed of implantable grade polypropylene, implantable grade metal, a polymer, a biocompatible material, or any combination thereof. Suitable biocompatible materials include bioabsorbable, cadaveric, and bovine materials.

    [0047] In some embodiments, the mesh carrier 290 can be preassembled with the filament 205 at a manufacturing facility. The preassembled set can include two mesh carriers 290 and 390 and a filament 205 of a specified or known length. For example, as shown in FIG. 21, a first end portion 205a of the filament 205 can be inserted and secured with respect to a first mesh carrier 290 at the manufacturing facility. Additionally, a second end portion 205b of the filament 205 can be inserted and secured with respect to a second mesh carrier 390. Specifically, in the illustrated embodiment, the first end portion 205a of the filament 205 is pierced by the projections 295a and 295b (others not shown) of the first mesh carrier 290 thereby retaining the first end portion 205a of the filament 205 within the retention portion 295 of the first mesh carrier 290. The second end portion 205b of the filament 205 is pierced by the projections 395c and 395d (others not shown) of the second mesh carrier 390 thereby retaining the second end portion 205a of filament 205 within the retention portion 395 of the second mesh carrier 390. The filament 205 extends between the first mesh carrier 290 and the second mesh carrier 390 creating a fixed length L of filament 205.

    [0048] The filament 205 as discussed above can be constructed of many different suitable materials and have many different suitable configurations. For example, in some embodiments, a polymer mesh implant can be used, which can be used to support the urethra. In other embodiments, a polyform material can be used.

    [0049] In some embodiments, at least a portion of the filament can be reinforced, such as with a reinforcing material. The reinforcing material, or reinforced portion of the filament, can be configured to assist in suspending or supporting the bodily tissue or organ. In one embodiment, the filament can be reinforced by a suture.

    [0050] In some embodiments, at least a portion of the filament can include tangs or a tanged portion to grip or attach to a portion of bodily tissue. The terms "tanged" or "tangs" as used herein mean roughened or jagged edges or areas, such as can result from cutting a woven or knit mesh material or filament. The tangs enhance anchoring of the filament within bodily tissue, such as pubo-urethral tissue. In one embodiment, the filament includes tangs on an edge along an entire length of the filament. In another embodiment, tangs are only on the end portions of the filament.

    [0051] In other embodiments, the filament can be untanged, or detanged, such as by heating the tangs on a polymer mesh so that they fuse and bead up to form a smooth finish.

    [0052] In some embodiments, the filament can include a coating. For example, the filament can include a polymeric coating. In another example, the filament can include a therapeutic agent coating.

    [0053] In some embodiments, the filament can be porous. A porous filament defines openings, or pores, in the filament or between threads of material forming the filament. For example, in one embodiment, the filament is a mesh. The filament can be a micro-porous mesh in which the openings, or pores, are small.

    [0054] FIG. 21 illustrates an example of the first mesh carrier 290 and the second mesh carrier 390 anchored in bodily tissue T of the pelvic region of a patient. A first end portion 205a of a filament 205 is retained by the first mesh carrier 290 and a second end portion 205b of the filament 205 is retained by the second mesh carrier 390. Specifically, the filament 205 extends between the first mesh carrier 290 and the second mesh carrier 390 to provide support to the target tissue T or organ, such as the urethra.

    [0055] Although the stylet 230 as illustrated in FIGS. 2-6 has a curved configuration, it should be understood that other configurations are possible. As shown, for example in FIGS. 23 and 24, stylet 330 can have a substantially straight, or linear, configuration. In such embodiments, a portion of the distal end portion 334 is configured to extend through the mesh carrier (not shown). Specifically, the stylet 330 is configured to extend through the lumen and out of the opening of the mesh carrier such that the second ridge 336 defined by the distal end portion 334 of the stylet 330 interacts with distal end of the mesh carrier and helps retain the mesh carrier on the distal end portion 334 of the stylet 330. As the stylet 330 is moved from its first position to its second position, the distal end portion 313 of the elongate member 310 contacts the proximal end of the mesh carrier and prevents proximal movement of the mesh carrier. When the stylet 330 is in its second position, as illustrated, for example, in FIG. 24, at least a portion of the distal end portion 334 of the stylet 330 is disposed within the lumen of the elongate member 310. Specifically, in the illustrated embodiment, when the stylet 330 is moved proximally from its first position, the distal end portion 313 of the elongate member 310 contacts the proximal end of the mesh carrier maintaining its location within bodily tissue. The mesh carrier is thereby decoupled or removed from the distal end portion 334 of the stylet 330 and is released in bodily tissue.

    [0056] Further examples of such insertion devices with stylets having linear configurations are described in U.S. Publication No. 2006/0089524 to Chu and U.S. Publication No. 2007/0015953 to MacLean. Additional variations in size, shape, and configurations are also described in the above noted publications.

    [0057] FIG. 25 is a flowchart of an exemplary method 400 for delivering a mesh carrier into bodily tissue of a patient using an insertion device according to an embodiment of the invention.

    [0058] At 410, the mesh carrier is coupled to the stylet of the insertion device. For example, the distal end portion of the mesh carrier is engaged with the distal end portion of the stylet.

    [0059] In one exemplary method, at least a portion of a filament is inserted into the aperture defined by the mesh carrier prior to the coupling of the mesh carrier to the stylet,

    [0060] In some exemplary methods, the mesh carrier is coupled to or engaged with the distal end portion of the stylet when the stylet is in its first position. In such an exemplary method, the distal end portion of the stylet extends through the lumen defined by the mesh carrier and is disposed adjacent the filament retained in the retention portion (e.g., projections) of the mesh carrier.

    [0061] At 420, the insertion device is inserted into a body of a patient. For example, in one exemplary method, the insertion device is inserted into the body of the patient through an incision made in bodily tissue. In a procedure for urinary incontinence, a transvaginal approach may be used to insert the delivery instrument into the body of the patient.

    [0062] At 430, the mesh carrier is positioned proximate to a desired portion of bodily tissue, and, the mesh carrier is inserted into the bodily tissue. For example, in a procedure for female urinary incontinence, the mesh carrier is inserted into one of the obturator internus or obturator externus muscles. In one exemplary method, an anterior vaginal incision is made, and the mesh carrier is inserted into the bodily tissue through such incision.

    [0063] At 440, the stylet is moved from its first position to its second position. Specifically, in the illustrated exemplary method, the stylet is moved in a proximal direction, from its first position to its second position, so that the distal end portion of the stylet is withdrawn from the lumen of the mesh carrier. By withdrawing the distal end portion of the stylet from the lumen of the mesh carrier and disposing the distal end portion within the lumen of the elongate member, the distal end portion of the elongate member contacts the proximal end portion of the mesh carrier thereby maintaining the mesh carrier's position within the bodily tissue as the stylet is removed from the lumen of the mesh carrier. Thus, the mesh carrier is decoupled or removed from the stylet thereby fixing the mesh carrier and filament within the bodily tissue. For example, in one procedure, a practitioner concurrently pulls the handle of the elongate member in a proximal direction while holding the base member of the elongate member substantially stationary.

    [0064] In some exemplary methods, the elongate member is moved from a first position to a second position while maintaining the stylet substantially stationary. The elongate member moves relative to the stylet, in a distal direction, from a first position to a second position, such that the distal end portion of the elongate member contacts the proximal end portion of the mesh carrier to decouple the mesh carrier from the stylet. For example, in one procedure, a practitioner concurrently holds the handle of the stylet substantially stationary while pushing the base member of the elongate member in the distal direction to move the elongate member to its second position.

    [0065] At 450, the insertion device is withdrawn from the body of the patient.

    [0066] Although the method of delivering a mesh carrier into bodily tissue has been illustrated and described in one order, the activities can occur in a different order. For example, in some exemplary methods, the mesh carrier is engaged with the stylet of the insertion device prior to inserting the filament into the aperture defined by the mesh carrier.

    [0067] A method for delivering a mesh carrier into bodily tissue of a patient can include delivering more than one mesh carrier for securing a filament to bodily tissue. For example, in one exemplary method, as illustrated in FIG. 22, two mesh carriers are delivered into bodily tissue of the patient. Alternatively, three, four, or more mesh carriers can be delivered into bodily tissue of the patient. In an exemplary method with two or more mesh carriers, the first mesh carrier is delivered as described above. The tension of the filament can be adjusted by inserting the second mesh carrier to a specific location within the patient.

    [0068] In one embodiment, an insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a distal end portion, a proximal end portion, and is slidably coupled to the elongate member. The stylet is configured to move from a first position to a second position with respect to the elongate member. The distal end portion of the stylet is configured to removably couple a mesh carrier thereto. A portion of the distal end portion of the stylet is disposed outside of the lumen of the elongate member when the stylet is in its first position and is disposed within the lumen when the stylet is in its second position.

    [0069] In some embodiments, the stylet includes a curved portion. The distal end portion of the stylet has a first diameter and the proximal end portion of the stylet has a second diameter. The second diameter is greater than the first diameter. The distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip. The ridge is configured to interact with the mesh carrier and is configured to be disposed outside of and contact a distal end portion of the mesh carrier. The distal end portion of the stylet is configured to extend through a lumen defined by the mesh carrier and extend outside of a distal end portion of the mesh carrier.

    [0070] In some embodiments, the proximal end portion of the elongate member includes a base portion having at least one protrusion. The proximal end portion of the stylet includes a stopping portion configured to engage the at least one protrusion of the base portion. The proximal end portion of the stylet includes a stopping portion having lip. The lip is configured to engage a protrusion of the elongate member when the stylet is moved from its first position to its second position.

    [0071] In some embodiments, the insertion device includes a handle coupled to the stylet. The proximal end portion of the elongate member is configured to contact a distal end portion of the handle when the stylet is in its first position and is configured to be spaced apart from the distal end portion of the handle when the stylet is in its second position.

    [0072] In some embodiments, the distal end portion of the elongate member is configured to contact the mesh carrier when the stylet is moved from its first position to its second position. The distal end portion of the elongate member is configured to contact a proximal end portion of the mesh carrier to decouple the mesh carrier from the stylet when the stylet is moved from its first position to its second position.

    [0073] In some embodiments, the stylet includes stainless steel.

    [0074] In another embodiment, an insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a distal end portion and a proximal end portion and is configured to move from a first position to a second position. The distal end portion of the stylet is configured to removably couple a mesh carrier thereto. The distal end portion of the stylet is coupled to the mesh carrier when the stylet is in its first position. The elongate member is configured to contact the mesh carrier and decouple the mesh carrier from the distal end portion of the stylet when the stylet is moved from its first position to its second position.

    [0075] In some embodiments, the distal end portion of the elongate member is configured to contact a proximal end portion of a mesh carrier when the stylet is in its first position. The distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip, the ridge being configured to interact with the mesh carrier. The proximal end portion of the elongate member includes a base portion. The base portion has at least one protrusion. The stylet has a stopping portion configured to engage the at least one protrusion of the base portion.

    [0076] In yet another embodiments, a mesh carrier has a proximal end portion, a distal end portion, and defines a lumen between the proximal end portion and the distal end portion. The proximal end portion defines an aperture configured to receive a portion of a filament therein. The proximal end portion includes a retention portion to secure the portion of the filament with respect to the mesh carrier. The lumen is configured to receive a stylet therein wherein the stylet is disposed adjacent the filament. The distal end portion of the mesh carrier is configured to interact with the stylet.

    [0077] In some embodiments, the retention portion of the proximal end portion of the mesh carrier includes projections configured to pierce the portion of the filament.

    [0078] In some embodiments, the mesh carrier includes an anchor portion configured to anchor the mesh carrier in a bodily tissue of a patient.

    [0079] An exemplary method includes coupling a mesh carrier to a distal end portion of a stylet of an insertion device, wherein the stylet is movably coupled to an elongate member, inserting the insertion device into a body of a patient, moving the stylet with respect to the elongate member from a first position to a second position to decouple the mesh carrier from the stylet of the insertion device; and removing the insertion device from the body.

    [0080] In some embodiments, the coupling of the mesh carrier includes moving the stylet to its first position such that a distal end portion of the stylet extends beyond a distal end portion of the elongate member. The coupling of the mesh carrier also includes inserting the stylet into a lumen defined by the mesh carrier such that a ridge defined by the distal end of the stylet interacts with the mesh carrier.

    [0081] In some embodiments, the moving of the stylet to its second position includes moving the stylet in a distal direction.

    [0082] An exemplary method includes coupling a second mesh carrier to a distal end portion of the stylet and inserting the insertion device into the body of the patient, moving the stylet with respect to the elongate member from its first position to its second position to decouple the second mesh carrier from the insertion device, and removing the insertion device from the body.

    [0083] While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Thus, the scope of the invention should not be limited by any of the above-described embodiments, but should be defined only by following claims. While the invention has been particularly shown and described with reference to specific embodiments thereof, it will be understood that various changes in form and details may be made.

    [0084] The previous description of the embodiments is provided to enable any person skilled in the art to make or use the invention. While the invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in art that various changes in form and details may be made. For example, a delivery instrument can include various combinations and sub-combinations of the various embodiments described herein.


    Claims

    1. An insertion device (200) for a tissue anchor having a lumen (291) forming a proximal opening (291a) and a distal opening (291b), said device comprising:

    an elongate member (210) having a proximal end portion (212), a distal end portion (213), and defining a lumen (218) therethrough; and

    a stylet (230) having a distal end portion (234), a proximal end portion (232), and being slidably coupled to the elongate member (210), the stylet (230) being configured to move from a first position to a second position with respect to the elongate member (210), the distal end portion (234) of the stylet (230) being configured to removably couple the tissue anchor thereto, a portion of the distal end portion (234) of the stylet (230) being disposed outside of the lumen (218) of the elongate member (210) when the stylet (230) is in its first position, the portion of the stylet (230) being disposed within the lumen (218) when the stylet (230) is in its second position, wherein the distal end portion (234) of the stylet (230) defines a ridge (236) configured to be disposed outside of and contact a distal end portion of the tissue anchor, wherein the stylet (230) is configured to extend through the lumen and out of the distal opening of the tissue anchor such that the ridge (236) defined by the distal end portion (234) of the stylet (230) interacts with the distal end portion of the tissue anchor and helps retain the tissue anchor on the distal end portion (234) of the stylet (230).


     
    2. The insertion device (200) of claim 1, wherein the stylet (230) includes a curved portion.
     
    3. The insertion device (200) of claim 1, wherein the distal end portion (234) of the stylet (230) has a first diameter and the proximal end portion (232) of the stylet (230) has a second diameter, wherein the second diameter is greater than the first diameter.
     
    4. The insertion device (200) of claim 1, wherein the distal end portion (234) of the stylet (230) defines a tip (237) and a tapered portion (238) extending between the ridge (236) and the tip (237).
     
    5. The insertion device (200) of claim 1, wherein the proximal end portion (212) of the elongate member (210) includes a base portion having at least one protrusion, the proximal end of the stylet (230) having a stopping portion configured to engage the at least one protrusion of the base portion.
     
    6. The insertion device (200) of claim 1, wherein the proximal end portion (232) of the stylet (230) includes a stopping portion having a lip, the lip configured to engage a protrusion of the elongate member (210) when the stylet (230) is moved from its first position to its second position.
     
    7. An insertion system comprising the insertion device (200) of any of claims 1 to 6 and additionally comprising said tissue anchor.
     
    8. The insertion system of claim 7, wherein the distal end portion of the elongate member (210) is configured to contact the tissue anchor when the stylet (230) is moved from its first position to its second position.
     
    9. The insertion system of claim 7, wherein the distal end portion of the elongate member (210) is configured to contact a proximal end portion of the tissue anchor to decouple the tissue anchor from the stylet (230) when the stylet (230) is moved from its first position to its second position.
     
    10. The insertion system of claim 7, wherein the ridge (236) and a further ridge (235) defined by the distal end portion (234) of the stylet (230) are configured to retain the tissue anchor on the distal end portion (234) of the stylet (230) through an interaction of the ridge (236) with the distal end portion of the tissue anchor and through a further interaction of the further ridge (235) with a proximal end portion of the tissue anchor.
     
    11. The insertion system of claim 7, wherein
    the distal end portion (234) is coupled to the tissue anchor when the stylet (230) is in its first position, the elongate member (210) is configured to contact the tissue anchor and decouple the tissue anchor from the distal end portion (234) of the stylet (230) when the stylet (230) is moved from its first position to its second position.
     
    12. The insertion device (200) of claim 1, or the insertion system of claim 7, wherein the distal end portion (234) of the stylet (230) defines a tip (237) and a tapered portion (238) extending between the ridge (236) and the tip (237).
     
    13. The insertion system of any one of claims 7 to 12, the tissue anchor comprising a proximal end portion and the tissue anchor defining a lumen between the proximal end portion of the tissue anchor and the distal end portion of the tissue anchor, the proximal end portion of the tissue anchor defining an aperture configured to receive a portion of a filament therein, the proximal end portion of the tissue anchor including a retention portion to secure the portion of the filament with respect to the tissue anchor, the lumen configured to receive the stylet (230) therein wherein the stylet (230) is disposed adjacent the filament.
     


    Ansprüche

    1. Einführungsvorrichtung (200) für einen Gewebeanker mit einem Lumen (291), das eine proximale Öffnung (291a) und eine distale Öffnung (291b) bildet, welche Vorrichtung aufweist:

    ein längliches Teil (210) mit einem proximalen Endbereich (212), einem distalen Endbereich (213), das ein Lumen (218) durch dieses hindurch definiert; und

    einen Mandrin (230) mit einem distalen Endbereich (234) und einem proximalen Endbereich (232), welcher Mandrin gleitbar mit dem länglichen Teil (210) gekoppelt ist, wobei der Mandrin (230) konfiguriert ist, sich von einer ersten Position zu einer zweiten Position mit Bezug auf das längliche Teil (210) zu bewegen, der distale Endbereich (234) des Mandrins (230) konfiguriert ist, den Gewebeanker lösbar mit diesem zu koppeln, ein Bereich des distalen Endbereichs (234) des Mandrins (230) außerhalb des Lumens (218) des länglichen Teils (210) angeordnet ist, wenn der Mandrin (230) in seiner ersten Position ist, der Bereich des Mandrins (230) innerhalb des Lumens (218) angeordnet ist, wenn der Mandrin (230) in seiner zweiten Position ist, wobei der distale Endbereich (234) des Mandrins (230) einen Steg (236) definiert, der konfiguriert ist, außerhalb eines distalen Endbereichs des Gewebeankers angeordnet zu sein und diesen zu kontaktieren, wobei der Mandrin (230) konfiguriert ist, sich durch das Lumen und aus der distalen Öffnung des Gewebeankers heraus zu erstrecken, derart, dass der durch den distalen Endbereich (234) des Mandrins (230) definierte Steg (236) mit dem distalen Endbereich des Gewebeankers zusammenwirkt und dazu beiträgt, dass der Gewebeanker auf dem distalen Endbereich (234) des Mandrins (230) zurückgehalten wird.


     
    2. Einführungsvorrichtung (200) nach Anspruch 1, bei der der Mandrin (230) einen gekrümmten Bereich enthält.
     
    3. Einführungsvorrichtung (200) nach Anspruch 1, bei der der distale Endbereich (234) des Mandrins (230) einen ersten Durchmesser hat und der proximale Endbereich (232) des Mandrins (230) einen zweiten Durchmesser hat, wobei der zweite Durchmesser größer als der erste Durchmesser ist.
     
    4. Einführungsvorrichtung (200) nach Anspruch 1, bei der der distale Endbereich (234) des Mandrins (230) eine Spitze (237) und einen konischen Bereich (238), der sich zwischen dem Steg (236) und der Spitze (237) erstreckt, definiert.
     
    5. Einführungsvorrichtung (200) nach Anspruch 1, bei der der proximale Endbereich (212) des länglichen Teils (210) einen Basisbereich mit zumindest einem Vorsprung enthält, wobei das proximale Ende des Mandrins (230) einen Anschlagbereich hat, der konfiguriert ist, mit dem zumindest einen Vorsprung des Basisbereichs in Eingriff zu treten.
     
    6. Einführungsvorrichtung (200) nach Anspruch 1, bei der der proximale Endbereich (232) des Mandrins (230) einen Anschlagbereich mit einer Lippe enthält, wobei die Lippe konfiguriert ist, mit einem Vorsprung des länglichen Teils (210) in Eingriff zu treten, wenn der Mandrin (230) aus seiner ersten Position in seine zweite Position bewegt wird.
     
    7. Einführungssystem, aufweisend die Einführungsvorrichtung (200) nach einem der Ansprüche 1 bis 6 und zusätzlich den Gewebeanker aufweisend.
     
    8. Einführungssystem nach Anspruch 7, bei dem der distale Endbereich des länglichen Teils (210) konfiguriert ist, den Gewebeanker zu kontaktieren, wenn der Mandrin (230) aus seiner ersten Position in seine zweite Position bewegt wird.
     
    9. Einführungssystem nach Anspruch 7, bei dem der distale Endbereich des länglichen Teils (210) konfiguriert ist, einen proximalen Endbereich des Gewebeankers zu kontaktieren, um den Gewebeanker von dem Mandrin (230) zu entkoppeln, wenn der Mandrin (230) aus seiner ersten Position in seine zweite Position bewegt wird.
     
    10. Einführungssystem nach Anspruch 7, bei dem der Steg (236) und ein weiterer Steg (235), der durch den distalen Endbereich (234) des Mandrins (230) definiert ist, konfiguriert sind, den Gewebeanker auf dem distalen Endbereich (234) des Mandrins (230) durch ein Zusammenwirken des Stegs (236) mit dem distalen Endbereich des Gewebeankers und durch ein weiteres Zusammenwirken des weiteren Stegs (235) mit einem proximalen Endbereich des Gewebeankers zurückzuhalten.
     
    11. Einführungssystem nach Anspruch 7, bei dem der distale Endbereich (234) mit dem Gewebeanker gekoppelt ist, wenn der Mandrin (230) in seiner ersten Position ist, das längliche Teil (210) konfiguriert ist zum Kontaktieren des Gewebeankers und zum Entkoppeln des Gewebeankers von dem distalen Endbereich (234) des Mandrins (230), wenn der Mandrin (230) aus seiner ersten Position in seine zweite Position bewegt wird.
     
    12. Einführungsvorrichtung (200) nach Anspruch 1 oder Einführungssystem nach Anspruch 7, bei der/dem der distale Endbereich (234) des Mandrins (230) eine Spitze (237) und einen konischen Bereich (238), der sich zwischen dem Steg (236) und der Spitze (237) erstreckt, definiert.
     
    13. Einführungsvorrichtung nach einem der Ansprüche 7 bis 12, bei dem der Gewebeanker einen proximalen Endbereich aufweist und der Gewebeanker ein Lumen zwischen dem proximalen Endbereich des Gewebeankers und dem distalen Endbereich des Gewebeankers definiert, der proximale Endbereich des Gewebeankers eine Öffnung definiert, die zum Aufnehmen eines Bereichs eines Fadens in dieser konfiguriert ist, der proximale Endbereich des Gewebeankers einen Zurückhaltebereich enthält, um den Bereich des Fadens mit Bezug auf den Gewebeanker zu sichern, und das Lumen konfiguriert ist zum Aufnehmen des Mandrins (230) in diesem, wobei der Mandrin (230) benachbart zu dem Faden angeordnet ist.
     


    Revendications

    1. Dispositif d'insertion (200) pour un ancrage de tissu comportant une lumière (291) qui forme une ouverture proximale (291a) et une ouverture distale (291b), ledit dispositif comprenant :

    un élément allongé (210) qui comporte une partie d'extrémité proximale (212), une partie d'extrémité distale (213) et qui définit une lumière (218) au travers de lui-même ; et

    un stylet (230) qui comporte une partie d'extrémité distale (234), une partie d'extrémité proximale (232) et qui est couplé de façon coulissante à l'élément allongé (210), le stylet (230) étant configuré de manière à ce qu'il soit déplacé depuis une première position jusqu'à une seconde position par rapport à l'élément allongé (210), la partie d'extrémité distale (234) du stylet (230) étant configurée de manière à ce qu'elle soit couplée de façon amovible à l'ancrage de tissu, une partie de la partie d'extrémité distale (234) du stylet (230) étant disposée à l'extérieur de la lumière (218) de l'élément allongé (210) lorsque le stylet (230) est dans sa première position, la partie du stylet (230) étant disposée à l'intérieur de la lumière (218) lorsque le stylet (230) est dans sa seconde position, dans lequel la partie d'extrémité distale (234) du stylet (230) définit une nervure (236) qui est configurée de manière à ce qu'elle soit disposée à l'extérieur d'une partie d'extrémité distale de l'ancrage de tissu et qu'elle soit en contact avec cette même partie, dans lequel le stylet (230) est configuré de manière à ce qu'il s'étende au travers de la lumière et hors de l'ouverture distale de l'ancrage de tissu de telle sorte que la nervure (236) qui est définie par la partie d'extrémité distale (234) du stylet (230) interagisse avec la partie d'extrémité distale de l'ancrage de tissu et contribue à la retenue de l'ancrage de tissu sur la partie d'extrémité distale (234) du stylet (230).


     
    2. Dispositif d'insertion (200) selon la revendication 1, dans lequel le stylet (230) inclut une partie incurvée.
     
    3. Dispositif d'insertion (200) selon la revendication 1, dans lequel la partie d'extrémité distale (234) du stylet (230) présente un premier diamètre et la partie d'extrémité proximale (232) du stylet (230) présente un second diamètre, dans lequel le second diamètre est plus grand que le premier diamètre.
     
    4. Dispositif d'insertion (200) selon la revendication 1, dans lequel la partie d'extrémité distale (234) du stylet (230) définit une pointe (237) et une partie conique (238) qui s'étend entre la nervure (236) et la pointe (237).
     
    5. Dispositif d'insertion (200) selon la revendication 1, dans lequel la partie d'extrémité proximale (212) de l'élément allongé (210) inclut une partie de base qui comporte au moins une protubérance, l'extrémité proximale du stylet (230) comportant une partie d'arrêt qui est configurée de manière à ce qu'elle engage l'au moins une protubérance de la partie de base.
     
    6. Dispositif d'insertion (200) selon la revendication 1, dans lequel la partie d'extrémité proximale (232) du stylet (230) inclut une partie d'arrêt qui comporte une lèvre, la lèvre étant configurée de manière à ce qu'elle engage une protubérance de l'élément allongé (210) lorsque le stylet (230) est déplacé depuis sa première position jusqu'à sa seconde position.
     
    7. Système d'insertion comprenant le dispositif d'insertion (200) selon l'une quelconque des revendications 1 à 6 et comprenant de façon additionnelle ledit ancrage de tissu.
     
    8. Système d'insertion selon la revendication 7, dans lequel la partie d'extrémité distale de l'élément allongé (210) est configurée de manière à ce qu'elle entre en contact avec l'ancrage de tissu lorsque le stylet (230) est déplacé depuis sa première position jusqu'à sa seconde position.
     
    9. Système d'insertion selon la revendication 7, dans lequel la partie d'extrémité distale de l'élément allongé (210) est configurée de manière à ce qu'elle entre en contact avec une partie d'extrémité proximale de l'ancrage de tissu de manière à découpler l'ancrage de tissu vis-à-vis du stylet (230) lorsque le stylet (230) est déplacé depuis sa première position jusqu'à sa seconde position.
     
    10. Système d'insertion selon la revendication 7, dans lequel la nervure (236) et une autre nervure (235) qui est définie par la partie d'extrémité distale (234) du stylet (230) sont configurées de manière à ce qu'elles retiennent l'ancrage de tissu sur la partie d'extrémité distale (234) du stylet (230) par l'intermédiaire d'une interaction de la nervure (236) avec la partie d'extrémité distale de l'ancrage de tissu et par l'intermédiaire d'une autre interaction de l'autre nervure (235) avec une partie d'extrémité proximale de l'ancrage de tissu.
     
    11. Système d'insertion selon la revendication 7, dans lequel la partie d'extrémité distale (234) est couplée à l'ancrage de tissu lorsque le stylet (230) est dans sa première position, l'élément allongé (210) est configuré de manière à ce qu'il entre en contact avec l'ancrage de tissu et découple l'ancrage de tissu par rapport à la partie d'extrémité distale (234) du stylet (230) lorsque le stylet (230) est déplacé depuis sa première position jusqu'à sa seconde position.
     
    12. Dispositif d'insertion (200) selon la revendication 1 ou système d'insertion selon la revendication 7, dans lequel la partie d'extrémité distale (234) du stylet (230) définit une pointe (237) et une partie conique (238) qui s'étend entre la nervure (236) et la pointe (237).
     
    13. Système d'insertion selon l'une quelconque des revendications 7 à 12, l'ancrage de tissu comprenant une partie d'extrémité proximale et l'ancrage de tissu définissant une lumière entre la partie d'extrémité proximale de l'ancrage de tissu et la partie d'extrémité distale de l'ancrage de tissu, la partie d'extrémité proximale de l'ancrage de tissu définissant une ouverture qui est configurée de manière à ce qu'elle reçoive une partie d'un filament en son sein, la partie d'extrémité proximale de l'ancrage de tissu incluant une partie de retenue pour fixer fermement la partie du filament par rapport à l'ancrage de tissu, la lumière étant configurée de manière à ce qu'elle reçoive le stylet (230) en son sein, dans lequel le stylet (230) est disposé de telle sorte qu'il soit adjacent au filament.
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description