(19)
(11)EP 2 826 515 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
20.05.2020 Bulletin 2020/21

(21)Application number: 14171728.0

(22)Date of filing:  10.06.2014
(51)International Patent Classification (IPC): 
A61M 25/00(2006.01)
A61M 27/00(2006.01)

(54)

An improved catheter

Verbesserter Katheter

Cathéter amélioré


(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

(30)Priority: 20.06.2013 US 201313922667

(43)Date of publication of application:
21.01.2015 Bulletin 2015/04

(73)Proprietor: ZCATH LLC
Cuyahoga Falls, OH 44223 (US)

(72)Inventor:
  • Dye, Philip J.
    Akron, OH 44303 (US)

(74)Representative: Raffay & Fleck 
Patentanwälte Grosse Bleichen 8
20354 Hamburg
20354 Hamburg (DE)


(56)References cited: : 
WO-A1-93/24075
US-A- 5 788 680
US-A1- 2005 010 169
US-A1- 2009 124 988
US-A- 504 424
US-A- 6 007 521
US-A1- 2006 264 905
US-A1- 2009 234 227
  
      
    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

    BACKGROUND OF THE INVENTION


    TECHNICAL FIELD



    [0001] The present invention relates generally to a medical device. More particularly, the invention pertains to a catheter for draining urine from a bladder. Specifically, the invention provides a catheter having an opening at a first end and a sidewall that is free of eyelets, and wherein the catheter is configured to drain urine from a patient's bladder faster than conventional catheters.

    BACKGROUND INFORMATION



    [0002] Urinary catheters are extremely useful medical devices. Generally, a urinary catheter is inserted into the urethral canal of a patient to drain urine from the bladder when they need assistance urinating. Current catheter designs have a catheter body sidewall with two to four eyelets or intake apertures formed in the catheter body sidewall at one end and often a hemispheric tip enclosing one end to facilitate insertion into a urethral canal. The eyelets are known to those in the urology field to cause trauma to the urethra. During insertion, the edges of the eyelets can cut the urethra wall, similar to the way a box grater or box shredder cuts a piece of cheese, often leading to serious infections requiring extreme medical attention.

    [0003] Improvements on this basic design have come and gone through the years, such as smoother and polished eyelet designs to decrease the risk of infection often attributed to insertion agitation. Yet, these catheters still have drawbacks. Slow drainage time is often a problem because the eyelet formed in the catheter body sidewall causes turbulent fluid forces within the catheter. Further, friction forces created by the urine flow contacting the inner surface of the catheter decreases the fluid flow or drainage rate. The eyelets also have a likelihood of becoming clogged with mucus or debris contained in the bladder, or clogged with lubricant used during the insertion process.

    [0004] There is a need in the art for an improved catheter that addresses some or all of the drawbacks of the currently known designs.

    [0005] US5788680 describes a dual-lumen suction catheter having a bulbous head and suction opening at the distal end.

    [0006] US504424 describes a urinary catheter with an anchoring head for the bladder.

    [0007] WO93/24075 describes a female urinary catheter having anchoring heads with openings for draining urine.

    SUMMARY



    [0008] The invention is defined in independent claim 1 and subsequent dependent claims 2-13. According to the invention an improved catheter comprises: a tubular member including a first end and a second end that therebetween define a longitudinal axis between, said first end adapted to be inserted into a patient's urethral canal; an outer surface on the tubular member spaced apart from an inner surface, the outer surface having a first outer diameter; a lumen defined by the inner surface adapted to therethrough drain urine from the patient's bladder; an entrance opening to the lumen defined by a rounded end wall formed in the first end of the tubular member including a plane of the opening intersecting the longitudinal axis; and a truncated teardrop-shaped head formed in the first end having a second outer diameter larger than the first outer diameter, wherein the inner surface is non-circular in cross-section.
    In one aspect, an embodiment of the present invention may provide an improved catheter as described above that has a single entrance opening located at the first end instead of the two to four eyelets formed in the sidewall of conventional catheters. Further, the improved catheter maintains a faster flow rate with one entrance opening than the flow rate of a conventional catheter having two eyelets. The improved catheter is structurally strong enough to allow the entrance opening to be introduced first into the urethral canal without the need for a tip.

    [0009] In one aspect, an example not forming part of the invention may provide a catheter as described above comprising: a generally cannular body having an annular sidewall with first and second ends that therebetween define an longitudinal axis, said first end adapted to be inserted into a urethral canal; said body having an outer surface spaced apart from an inner surface; a lumen defined by the inner surface adapted to drain the fluid from a bladder; and a single entrance opening defined in the first end wherein a plane of the opening intersects the longitudinal axis.

    [0010] In another aspect, an example not forming part of the invention may provide a catheter as described above comprising: a body having an annular sidewall extending along a longitudinal axis between first and second ends, said body having an outer surface spaced apart from an inner surface; a lumen defined by the body extending longitudinally from first end to second end adapted to drain fluid from a hollow organ; and an entrance opening formed in the first end in longitudinal alignment with the lumen and including an entrance opening plane intersecting the axis in a generally perpendicular manner.

    [0011] In another aspect, an example not forming part of the invention may provide a catheter as described above comprising: a catheter having first and second ends with a generally cannular body extending therebetween along a longitudinal axis; said body having an outer surface spaced apart from an inner surface; said inner surface having a non-circular cross section when viewed from above; a lumen defined by the non-circular inner surface adapted to drain fluid from a hollow organ; and an entrance opening formed in the first end in fluid communication with the lumen.

    [0012] In one an example not forming part of the invention may provide a urinary catheter as described above comprising: a generally cannular member including first and second ends that therebetween define a longitudinal axis, said first end adapted to be inserted into a patient's urethral canal; an outer surface on the cannular member spaced apart from an inner surface; a lumen defined by the inner surface adapted to therethrough drain fluid from the patient's bladder; and an entrance opening to the lumen formed in the first end of the cannular member including a plane of the opening intersecting the longitudinal axis.

    [0013] In yet another aspect, an example not forming part of the invention may provide a catheter for use in medical procedures as described above comprising: an annular sidewall extending along a longitudinal axis between first and second ends, said sidewall having an outer surface spaced apart from an inner surface; a lumen defined by the sidewall inner surface, said lumen being adapted to permit fluid-flow therethrough; and an inwardly tapered entrance opening formed in the first end, said entrance opening aligned with the lumen and including an entrance opening plane intersecting the longitudinal axis in a generally perpendicular manner.

    [0014] In another aspect, an example not forming part of the invention may provide a urinary catheter as described above comprising: a tubular sidewall having first and second ends extending therebetween along a longitudinal axis; an outer surface spaced apart from an inner surface on the sidewall, said inner surface having a non-circular cross section; a lumen defined by the non-circular inner surface adapted to permit fluid-flow therethrough at a rate faster than that of a similarly sized circular inner surface; and an entrance opening formed in the first end in fluid communication with the lumen.

    [0015] A method for draining a human bladder which is not part of the invention may comprise the steps of: providing a catheter having an annular sidewall with first and second ends that therebetween define a longitudinal axis, and having an entrance opening defined in the first end of the body; wherein a plane of the opening intersects the longitudinal axis; aligning the first end of the catheter body with the entrance to a patient's urethral canal; inserting the first end of the catheter into the urethral canal; moving the catheter through the urethral canal towards the patient's bladder; establishing fluid communication between the catheter and the bladder; causing urine to flow from the bladder through the entrance opening; through a lumen defined in the catheter, where the lumen is longitudinally aligned with the entrance opening; through an aperture defined in the second end of the catheter body, where the aperture is longitudinally aligned with the lumen; and into a drainage tube engaged with the second end of the catheter body; draining a quantity of urine from the bladder; and removing the catheter after the quantity of urine has drained from the bladder.

    BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS



    [0016] A sample embodiment of the invention, illustrative of the best mode in which Applicant contemplates applying the principles, is set forth in the following description, is shown in the drawings and is particularly and distinctly pointed out and set forth in the appended claims.

    Fig. 1 is a perspective view of a PRIOR ART catheter having two eyelets in the catheter's sidewall and a hemispheric tip at a first end of the catheter;

    Fig. 2 is a cross section view taken along line 2-2 in Fig. 1 depicting a PRIOR ART catheter having two eyelets in the body sidewall that do not intersect the longitudinal axis and having a smooth inner and outer surface;

    Fig. 3 is a diagrammatic view of the catheter not forming part of the present invention depicting it in vivo utilization;

    Fig. 4A is a top view of a first end of a first example not forming part of the present invention depicting a catheter body which is of a substantially constant outer diameter along its length, and showing a first interior variation of a catheter lumen having an inner surface with connecting longitudinal channels;

    Fig. 4B is a cross section view taken along line 4B-4B in Fig. 4A;

    Fig. 5A is a top view of the first end of the first example not forming part of the present invention depicting the constant outer diameter catheter body and showing a second variation of the lumen having spaced apart longitudinal channels along inner surface.

    Fig. 5B is a cross section view taken along line 5B-5B in Fig. 5A;

    Fig. 6A is a top view of the first end of the first example not forming part of the present invention depicting the constant outer diameter catheter body and showing a third variation of the lumen having a v-shaped channeled inner surface.

    Fig. 6B is a cross section view taken along line 6B-6B in Fig. 6A;

    Fig. 7A is a top view of the first end of an embodiment of the catheter of the invention depicting a truncated tear drop shaped head and the first interior variation of the inner surface having connecting annular channels;

    Fig. 7B is a cross section view taken along line 7B-7B in Fig. 7A;

    Fig. 8A is a top view of the embodiment depicting the truncated tear drop shaped head with the second interior variation having the spaced apart annular channels along the inner surface.

    Fig. 8B is a cross section view taken along line 8B-8B in Fig. 8A;

    Fig. 9A is a top view of the embodiment depicting the truncated tear-drop shaped head and the third variation of the lumen having the v-shaped channeled inner surface.

    Fig. 9B is a cross section view taken along line 9B-9B in Fig. 9A;

    Fig. 10A is a top view of the first end of an example not forming part of the invention showing the catheter depicting a dimpled outer surface and a fourth variation of the lumen having a dimpled inner surface;

    Fig. 10B is a side elevation view of the example of the catheter depicting the convex dimples extending along the outer surface;

    Fig. 10C is a cross section view taken along line 10C-10C in Fig. 10A;

    Fig. 11A is a top view of the first end of the first example of the catheter depicting a fifth variation of the lumen and showing a smooth inner surface;

    Fig. 11B is a cross section view taken along line 11B-11B in Fig. 11A;

    Fig. 12 is a top view of the first end of an example of the catheter and showing the fifth variation of the lumen having the smooth inner surface;

    Fig. 13 is a top view of the first end of an example of the catheter depicting the fifth variation of the lumen having the smooth inner surface;

    Fig. 14A is a top view of the first end of the first example of the catheter and the fifth variation of the lumen and showing a plurality of spaced-apart friction or tension reducing cutouts positioned at the first end of the inner surface;

    Fig. 14B is a cross section view along line 14B-14B in Fig. 14A;

    Fig. 15 is a top view of the first end of the embodiment of the catheter having the fifth variation of the lumen and depicting the plurality of spaced apart friction or tension reducing cutouts positioned at the first end of the inner surface; and

    Fig. 16 is a top view of the first end of an exemplary catheter having the fifth variation of the lumen and depicting the plurality of spaced apart friction or tension reducing cutouts positioned at the first end of the inner surface.



    [0017] Similar numbers refer to similar parts throughout the drawings.

    DETAILED DESCRIPTION



    [0018] With primary reference to Figs. 1 and 2, a catheter 10 as conventionally known in the PRIOR ART has a first end 12, a second end 14, a catheter body or annular sidewall 16 extending from first end 12 to second end 14, eyelets 18, a first end wall 20 at the first end 12 that forms a tip which is hemispheric in shape and substantially continuous, a sidewall outer surface 22, a sidewall inner surface 24, and a lumen 26 defined by inner surface 24. Catheter body 16 is generally cannular or tubular extending from first end 12 to second end 14 and defining therebetween a longitudinal axis Xpa. Eyelets 18 are formed in the catheter sidewall extending from a start plane Spa along outer surface 22 to and end plane Epa along inner surface 24 proximate the first end 12. The respective start and end planes, Spa, Epa, of the eyelets are parallel to longitudinal axis Xpa. When viewed from a side cross section (Fig. 2) and extrapolated beyond the respective start and end planes, Spa, Epa, eyelets 18 are at right angles to the longitudinal axis Xpa. Eyelets 18 are in fluid communication with lumen 16 permitting fluid to drain through catheter 10 and out and exit opening (not shown) defined in the second end 14, which may be configured to fluidly communicate with a drainage tube or system (not shown). End wall 20 intersects longitudinal axis Xpa and is substantially solid and continuous. However, there are some known prior art catheters 10 that may contain a small or "pin-hole" opening within end wall 20, wherein this pin-hole opening has a substantially smaller diameter than the lumen 16 diameter. The outer and inner surfaces 22, 24 of the catheter sidewall 16 are smooth. One exemplary PRIOR ART catheter is commercially known as the Cure Catheter™ 14 Fr., model number M405F1406, manufactured for and distributed by Cure Medical, LLC of Newport Beach, California.

    [0019] The examples of the catheter not forming part of the present invention are identified using reference number 30A in Figs 4A-6B, 11A-11B, and 14A-14B; reference number 30B for the embodiment is used in Figs. 7A-9B and 15 and for example Fig.12; and reference number 30C in Figs 10A-10C, 13, and 16. As will be further described herein, first exemplary catheter 30A has a sidewall 36 that it of a substantially constant diameter from the first end of the catheter to the second end thereof. Embodiment catheter 30B has a truncated tear-drop shaped first end; and third exemplary catheter 30C has a plurality of dimples on the outer surface of the catheter sidewall. Each example may be configured so that a lumen defined in the catheter has any of five different interior surface configurations, each of which having a unique cross section.

    [0020] With primary reference to Figs. 4A-6B, catheter 30A has a catheter body or sidewall 36 (Fig. 3) comprising a top or first end 32, a bottom or second end 34 (Fig. 3), a first or right side 31, a second or left side 33, and an entrance opening 38 defined by the first end 32. Sidewall 36 has an outer surface 40 and an inner surface 42. A lumen 44 is defined by inner surface 42 and lumen 44 extends from first end 32 to second end 34 along a longitudinal axis X. First end 32 to second end 34 therebetween define a longitudinal direction. Right side 31 to left side 33 therebetween defines a radial direction. Catheter sidewall 36 is generally cannular or tubular and extends longitudinally, having a substantially constant outer diameter OD1 from first end 32 to second end 34 centered about longitudinal axis X as seen in device 30A of Figs. 4A-5B.

    [0021] In accordance with one example not forming part of the present invention, entrance opening 38 is defined by catheter sidewall 36 at the first end 32. Entrance opening 38 is a radial, inwardly tapering, through-opening which intersects the longitudinal axis X. Entrance opening 38 extends longitudinally from a tapered start plane TS to a tapered end plane TE. Tapered start plane TS is a radially extending plane at the top end of a tapered annular surface 46. Tapered end plane TE is a radially extending plane at the bottom end of surface 46. Entrance opening 38 is radially bound by surface 46. Preferably, planes TS, TE of entrance opening 38 intersect longitudinal axis X perpendicularly, however other angled relationships are contemplated. Entrance opening 38 has a diameter (ID1, ID2 - Fig. 4A) that is substantially the same as the diameter (ID1, ID2 - Fig. 4B) of lumen 4. Entrance opening 38 is in longitudinal alignment and in fluid communication with lumen 44. The term longitudinally aligned or longitudinal alignment herein refers to the entrance opening being positioned at the first end and permitting fluid to continue along the same path as lumen 44 without changing directions about longitudinal axis X. Surface 46 permits fluid to flow down the slope thereof and through entrance opening 38. Surface 46 is disposed at an angle α relative to longitudinal axis "X". Slope α begins at end wall 32A. End wall 32A is located at the first end 32 and comprises a rounded rim that is concentric with opening 38. Tapered start plane TS and end plane TE are each disposed at right angles to longitudinal axis X. As seen in Figs. 4B, 5B slope α is shown at a 45 degree angle relative to tapered start plane TS, however slope α may be from about approximately 10 to about approximately 80 degrees relative thereto. Further, the taper of surface 46 generally requires sidewall thickness 37 to be approximately 25% greater in device 30A than a body thickness of a prior art catheter 10 having a substantially similar outer diameter.

    [0022] Inner surface 42 may have five variations of cross sectional shapes or forms when viewed from the first end. It is to be understood that the five forms disclosed herein can be incorporated into any of the three embodiments of device 30A, 30B, and 30C. In a first form, inner surface 42 defines a plurality of channels 50 extending longitudinally and formed within the catheter sidewall 36. As seen in Figs. 4B, 5B, channels 50 start in the surface 46 between the tapered start plane TS and tapered end plane TE. As shown in Figs. 4A and 4B, channels 50 are defined by the longitudinally extending recesses 52A which are half-moon shaped when viewed from first end, connected along longitudinally extending edges 52B.

    [0023] In a second form, as shown in Figs. 5A and 5B, the channels 50 can be defined by a plurality of longitudinally extending half-moon recesses 52 and arcuate separation sections 51. The half-moon recesses 52 or 52A are spaced annularly apart from one another in a manner so as to increase fluid flow through lumen 44 of catheter 30A relative to that of a conventional circular cross-sectional lumen known in the prior art. The separation sections 51 are generally equally spaced between the half-moon recesses 52.

    [0024] In a third form, as shown in Figs. 6A and 6B, channels 50 include at least one section that is straight or planar. In particular, each channel 50 preferably includes two straight sections that form a generally V-shaped channel defined by longitudinally extending edges 54 and connected flat panels 55 forming formed in the inner surface 42 in the catheter sidewall 36. The connected edges 54 and panels 55 provide a generally octagonal cross-section. While this embodiment provides a generally octagonal cross-section, yet other geometric shapes capable of being configured by connected edge 54 and panels 55 are contemplated. Further alternatively, channels 50 may be rifled to increase drainage flow rate. The term rifled in this context means channels 50 may extend concentrically in a helical manner from first end 32 to second end 34 along defined by inner surface 42.

    [0025] Referring to Figs. 4A-5B, 7A-8B sidewall 36 has an outer diameter shown as OD1 extending from right 31 to left 33 side of the surface, a first inner diameter shown as ID1, a second inner diameter shown as ID2, and a radial or sidewall thickness 37. Sidewall 36 may alternatively have a third inner diameter ID3 and a fourth inner diameter ID4 as seen in device 30A of Figs. 6A-6B instead of the first and second inner diameters ID1, ID2. Further alternately, sidewall 36 may have a fifth inner diameter ID5 and a sixth inner diameter ID6 as seen in device 30C of Figs. 10A-10C instead of the first and second inner diameters ID1, ID2. Even further, sidewall 36 may have a single inner diameter, shown as ID7 in device Fig. 11A-16. Outer diameter OD1 extends from right side 31 to left side 33 of outer surface 40 as viewed from the cross section view in Figs. 4B, 5B. As seen in the top view of Fig. 5A, first inner diameter ID1 extends radially across axis X between arcuate separation sections 51 and second inner diameter ID2 between half-moon recesses 52. As shown in the top view of Fig. 5B, third inner diameter ID3 extends radially across axis X between longitudinally extending panels 55 and fourth inner diameter ID4 extending radially between edges 54. As shown in the top view of Fig. 10A, fifth inner diameter ID5 extends radially across axis X from side to side 31, 33 of inner surface 42 and sixth inner diameter extends radially across axis X between dimples 62. As seen in Figs. 4B, 5B, sidewall thickness 37 extends radially between outer surface 40 and inner surface 42. In any of the examples and embodiment illustrated herein, it will be understood that the diameter of opening 38 is substantially of the same diameter of the lumen with which it is in fluid communication.

    [0026] Ordinarily, catheters are characterized by a scale known as the "French Size", each French size having a corresponding outer diameter. For example, a catheter having a French Size 4 has an outer diameter of 0.053 inches or 1.35mm. While a French Size 8 catheter has an outer diameter of 0.105 inches or 2.7mm. Outer diameter OD1 of the present invention is configured to have the same outer diameter as a conventionally known French size.

    [0027] With primary reference to Figs. 7A-9B, the embodiment of catheter 30B is shown having a bulbous or truncated teardrop-shaped head 56 formed in the first end 52 of the catheter sidewall 36. The truncated teardrop-shaped head 56 extends radially outwardly from longitudinal axis X to provide a second outer diameter OD2 that is larger than the outer diameter OD1 of sidewall 36. Outer surface 40 extends continuously along truncated teardrop-shaped head 56 having a first sloped surface 40A, an apex surface 40B, a second sloped surface 40C, and a sidewall surface 40D when viewed from the side. As seen in Fig. 7B, first sloped surface 40A extends a distance from rounded end wall 32A flared radially outward from axis X towards second end 34. Apex surface 40B is positioned below first sloped surface 40A when device 30B is oriented vertically. Apex surface 40B forms an apex from which the outer diameter OD2 of head 56 is determined. Second sloped surface 40C extends a distance from apex surface 40B flared radially inwards to axis X towards second end 34. Sidewall surface 40D continues from second sloped surface 40C to second end 34.

    [0028] With continued reference to Figs. 7A-9B, lumen 44 extends through the truncated teardrop-shaped head 56 in fluid communication with the entrance opening 38 as defined by its surface 46. Channels 50 have the same inner diameter extending from the entrance opening 38 through the truncated teardrop-shaped head 56 and continuing longitudinally through catheter sidewall 36.

    [0029] With primary reference to Figs 10A-10C, an exemplary catheter 30C has a plurality of convexly-shaped dimples 60 along outer surface 40, a plurality of concavely-shaped dimples 62 along outer surface 42, a plurality outer surface retention areas 43, a first outer diameter OD1, a second outer diameter OD3, first inner diameter ID5, second inner diameter ID6, in addition to other elements having similar reference numerals as the other embodiments. Catheter 30C may have a generally non-circular cross section or textured outer surface 40, and a generally non-circular cross section or textured inner surface 42. Convex dimples 60 are formed along the outer surface 40 in the catheter sidewall 36. The term convex with respect to dimples 60 refers to the dimples extending radially out of the catheter sidewall 36 and the dimple surface facing outward as viewed from above as seen in Fig. 10A. Convex dimples 60 have an outer annular edge 60A and an apex 60B. Annular edge 60A is a generally circular edge disposed where dimple 60 connects to outer surface 40 of sidewall 36. Apex 60B is the apex or radially outermost point of dimple 60 surface when viewed from a cross-sectional side view, as seen in Fig. 10C. Second outer diameter OD3 measures radially from right 31 to left 33 at mirroring apexes 60B. First outer diameter OD1 is the outer diameter of outer surface 40. Retention areas 43 are formed along and bound by the outer surface 40 and the spaces between annular edges 60A. Concave dimples 62 are formed along the inner surface 42 in catheter sidewall 36. The term concave with respect to dimples 62 refers to the dimples extending radially into the catheter sidewall 36.

    [0030] As seen in Fig. 11A-13, the exemplary catheter devices 30A, 30B, and 30C may have a substantially smooth inner surface 42 defining lumen 44 having only a single inner diameter ID7. The smooth inner surface 42 extends from first end 32 longitudinally to second end 34. As seen in Figs. 11A, 12, and 13, inner surface 42 has a substantially circular cross section. Inner diameter ID7 is preferably generally equal to inner diameter ID1 in width. Alternatively as seen in Figs. 14A-16, devices 30A, 30B, and 30C may have a substantially smooth inner surface 42 having an inner diameter ID7 in combination with a plurality of notches 50A. Notches 50A extend circumferentially around axis X and are formed in the first end 32 of sidewall 36. Notches 50A are preferably spaced circumferentially adjacent inner annular recess 46 aligned longitudinally along tapered end plane TE. Notches 50A function to reduce surface tension or fluid frictional forces as fluid flows through the entrance opening 38 into lumen 44 having a smooth surface. Preferably, notches 50A extend longitudinally only a short distance passed tapered end plane TE relative to the entire length of inner surface 42. Further preferably, notches 50A have a generally oval edge when viewed from the side (Fig. 14B) permitting notches to extend radially outward into the first end 32 of catheter sidewall 36.

    [0031] In operation, as seen in Fig. 2, the device provides a method not forming part of the invention of draining urine 72 from a human bladder 71. First end 32 of catheter sidewall 36 is first inserted into a urethral canal 70 in a human body until the first end 32 breaches a sphincter wall 73, passes the prostate 74, and is placed in fluid communication with the bladder 71. Bladder 71 contents, namely urine 72, begin to flow toward the first end 32. Urine 72 then flows via gravitational forces over tapered annular recesses 46. Surface 46 tapers inwardly and this permits the fluid to increase velocity or flow rate and decrease its pressure as it approaches entrance opening 38. Urine then passes through entrance opening 38 and longitudinally into lumen 44. As fluid flows through entrance opening 38, it contacts the channels 50. Channels 50 decrease surface side wall friction of the fluid 72 as it exits the bladder 71. The channels 50 on the inner sidewall surface 42 permit fluid 72 to drain faster than a conventional catheter having a smooth inner sidewall side wall 24 as known in the prior art. Fluid exits the lumen 44 through an exit opening (not shown) at the second end 34 of the catheter and to enter a drainage tube 45. The catheter 30 remains in fluid communication with the bladder until all of the urine or a desired quantity of urine has drained out of the exit opening (not shown) provided at second end 34 of catheter sidewall 36. Once all urine has drained completely, the catheter may be extracted by gripping the second end 34 and extracting the device 30A out of the urethral canal 70.

    [0032] One advantage of the present invention 30 is that it allows all of the urine to drain out of the bladder. Prior art catheters having eyelets 18 in their sidewalls have been known to not fully drain the bladder as a two eyelet design creates a negative pressure inside the bladder not permitting all urine, fluid or debris contents to drain.

    [0033] Further, the present invention offers advantages over prior art catheters 10 in that when a patient is sick, the urine 72 may become clogged with mucous or other debris. The entrance opening 38 of the present invention 30 permits mucous and debris to flow readily into lumen 44 and through the catheter without getting clogged or stuck. In prior art catheters 10, clogging problems with the eyelet 18 design are known to occur.

    [0034] Alternative embodiment 30B of the present invention operates by first aligning truncated tear drop head 56 with urethral canal 70, then inserting head 56 into the urethral canal 70. The head 56 outer diameter OD2 is generally equal to or slightly larger than the upstretched diameter of the urethral canal 70. Catheter 30B is manipulated so the truncated tear drop head 56 advances through the urethral canal 70 until it is in communication with the bladder 71. The head 56 operates as a guide to navigate the natural curvature often found in the urethral canal 70 of males.

    [0035] Alternative example 30C operates by the first end 32 being first inserted into the urethral canal 70. The convex dimple apices 60A contact the urethral canal 70 during insertion. The convex dimples 60 reduce the surface area of the urethral canal 70 actually contacting the catheter 30C. Thus, dimples 60 reduce irritation often associated with inserting a catheter 10 having a smooth outer surface. Further, retention areas 43 retain a lubricant as catheter 30C moves through the urethral canal 70 towards bladder 71. An exemplary lubricant is commercially sold as Surgilube® manufactured by Savage Laboratories® a division Fougera Pharmaceuticals, Incorporated, A Sandoz Company, of Melville, New York. The eyelets of prior art catheters 10 have been known to become clogged or partially clogged with lubricant and thus have decreased flow rates. This problem is obviated in the present catheters 30A, 30B, and 30C. Once urine 72 begins to flow, the dimples 62 along the inner surface of catheters 30A, 30B, and 30C cause the fluid to drain faster than it normally would over a smooth inner surface. Similar to a dimpled golf ball, the concave dimples permit urine 72 to pool up in the concave dimple 62 recesses. This reduces the friction factor of the remaining urine 72 draining through the lumen permitting it to increase the drainage flow rate while simultaneously permitting laminar flow through the center of the lumen.

    [0036] While catheters 30A, 30B, and 30C provide for a single entrance opening defined in the first end of the annular sidewall, it is to be understood that more than one opening are possible but do not form part of the invention. For example, a cross member can extend across the opening offering more strength and rigidity to the sidewall. This cross member would bisect the entrance opening into two or more openings.

    [0037] It is contemplated that catheter sidewall 36 will be made from a polyvinylchloride thermoplastic having additional plasticizers to make the PVC material soft and flexible for in vivo use, as conventionally known in the art. However, other materials known in the art such as latex or silicone-based derivatives may be substituted as well. Further, it is preferable that sidewall 36 of urinary catheters 30A, 30B and 30C will be made wholly of PVC, or otherwise free of a reinforcing member that is a different material. However, there may be instances in which having a reinforced tube, such as a fully encapsulated reinforcing braid, may be advantageous. Further, it is preferable that sidewall 36 is non-porous so that no bacteria can build up in material recesses, permitting devices 30A, 30B and 30C to be cleaned or disinfected and reused.

    [0038] Catheters 30A, 30B and 30C may also be used to introduce fluids into a patient's body. Consequently, lumen 44 is able to permit fluid flow out of a patient's body and into a patient's body. It will further be understood that the fluids in question may be liquids or gases.

    [0039] In the foregoing description, certain terms have been used for brevity, clearness, and understanding. Namely, the term "non-circular cross section" with reference to the inner or outer surface refers to the annular wall 36 defining the lumen of the catheter not having a continuous circular extending cross section. Specifically, the inner surface is non-circular because it may contain longitudinally extending straight channels, rifled channels, helical channels, textured dimples, staggered recesses, turbulence reducing molding, or other striations that intentionally break the fluid friction or tension which would ordinarily occur against a smooth inner catheter wall. The term "eyeletless" refers to the absence of any eyelet or opening formed in the sidewall of a catheter sidewall as ordinarily understood and used in the prior art; stated otherwise, the term eyeletless refers a catheter annular sidewall that is continuous. The term "dimples" or "dimpled" refers to a plurality of hemispheric recesses formed on a surface. The dimples on the inner surface of the catheter cause a fluid boundary layer entering the lumen from an entrance opening to transition from laminar to turbulent within the hemispheric recess. The turbulent boundary layer within the hemispheric recess is able to remain attached to the inner surface much longer than a purely smooth surface having a laminar boundary and so creates a narrower, low pressure, wake and hence less pressure drag (i.e., friction). The reduction in pressure drag or friction causes the fluid to drain more rapidly.

    [0040] Some additional aspects not forming part of the invention may provide a urinary catheter comprising: a tubular sidewall having first and second ends extending therebetween along a longitudinal axis; an outer surface spaced apart from an inner surface on the sidewall, said inner surface having a non-circular cross section; a lumen defined by the non-circular inner surface adapted to permit fluid-flow therethrough at a rate faster than that of a similarly sized circular inner surface; and an entrance opening formed in the first end in fluid communication with the lumen. Yet, another aspect not forming part of the invention may provide a catheter for use in medical procedures comprising: an annular sidewall extending along a longitudinal axis between first and second ends, said sidewall having an outer surface spaced apart from an inner surface; a lumen defined by the sidewall inner surface, said lumen being adapted to permit fluid-flow therethrough; and an inwardly tapered entrance opening formed in the first end, said entrance opening aligned with the lumen and including an entrance opening plane intersecting the longitudinal axis in a generally perpendicular manner. Further, another additional aspect not forming part the present invention may provide a urinary catheter comprising: a generally cannular member including first and second ends that therebetween define a longitudinal axis, said first end adapted to be inserted into a patient's urethral canal; an outer surface on the cannular member spaced apart from an inner surface; a lumen defined by the inner surface adapted to therethrough drain fluid from the patient's bladder; and an entrance opening to the lumen formed in the first end of the cannular member including a plane of the opening intersecting the longitudinal axis.


    Claims

    1. A urinary catheter comprising:

    a tubular member (36) including a first end (32) and a second end (34) that therebetween define a longitudinal axis (X), said first end (32) adapted to be inserted into a patient's urethral canal (70);

    an outer surface (40) on the tubular member (36) spaced apart from an inner surface (42), the outer surface (40) having a first outer diameter (OD1);

    a lumen (44) defined by the inner surface (42) adapted to therethrough drain urine (72) from the patient's bladder (71);

    an entrance opening (38) to the lumen (44) defined by a rounded end wall (32A) formed in the first end (32) of the tubular member (36) including a plane (TS) of the opening intersecting the longitudinal axis; and

    a truncated teardrop-shaped head (56) formed in the first end (32) having a second outer diameter (OD2) larger than the first outer diameter (OD1),

    characterized in that the inner surface (42) is non-circular in cross-section.


     
    2. The urinary catheter of Claim 1, further comprising:
    a plurality of channels (50) formed in the inner surface (42), each channel (50) extending longitudinally from adjacent said entrance opening (38) towards said second end (34).
     
    3. The urinary catheter of Claim 2, wherein each of said channels (50) includes one of an arcuate cross section (52) and a V-shaped cross section (54).
     
    4. The urinary catheter of Claim 1, the inner surface (42) comprising at least one longitudinally extending flat wall (55).
     
    5. The urinary catheter of Claim 1, further comprising a tapered annular surface (46) formed in the first end (32) defining the entrance opening (38)
     
    6. The urinary catheter of Claim 1, wherein the plane of the opening (38) perpendicularly intersects the longitudinal axis (X).
     
    7. The urinary catheter of Claim 1, wherein the tubular member (36) is free of openings extending radially therethrough.
     
    8. The urinary catheter of Claim 1, wherein the first end (32) is free of a hemispheric tip intersecting the longitudinal axis (X) when viewed from a side.
     
    9. The urinary catheter of Claim 1, further comprising:

    a first sloped surface (40A) on the truncated teardrop-shaped head (56)

    an apex surface (40B) on the truncated teardrop-shaped head (56), wherein the second outer diameter (OD2) is determined across the apex surface (40B); and

    a second sloped surface (40C) on the truncated teardrop-shaped head (56).


     
    10. The urinary catheter of Claim 9,
    wherein the first sloped surface (40A) adjacent the rounded end wall (32A) and extending radially outward from the longitudinal axis (X);
    the apex surface (40B) surface adjoining the first sloped surface (40A) and defining the second outer diameter;
    the second sloped surface (40C) adjoining the apex surface (40B) and extending radially inwad towards the longitudinal axis (X) and connecting with the outer surface of the tubular member (36).
     
    11. The urinary catheter of Claim 2, further comprising:

    a tapered surface (46) extending from the plane (TS) to to an end plane (TE) defining the entrance opening (38); and

    the channels (50) beginning in the tapered surface (46) between the plane (TS) and the end plane (TE).


     
    12. The urinary catheter of Claim 11, further comprising:
    a plurality of notches (50A) extending circumferentially about the longitudinal axis (X) adjacent the tapered surface (46).
     
    13. The urinary catheter of Claim 1, wherein the tubular member (36) and the truncated teardrop-shaped head (56) are formed from the same material defining a non-inflatable monolithic body.
     


    Ansprüche

    1. Harnkatheter, umfassend:

    ein röhrenförmiges Element (36), beinhaltend ein erstes Ende (32) und ein zweites Ende (34), die dazwischen eine Längsachse (X) definieren, wobei das erste Ende (32) dazu ausgelegt ist, in den Harnkanal (70) eines Patienten eingesetzt zu werden;

    eine Außenfläche (40) an dem röhrenförmigen Element (36), beabstandet von einer Innenfläche (42), wobei die Außenfläche (40) einen ersten Außendurchmesser (OD1) aufweist;

    ein Lumen (44), definiert durch die Innenfläche (42), dazu ausgelegt, dort hindurch Urin (72) von der Blase (71) des Patienten abzulassen;

    eine Eintrittsöffnung (38) zu dem Lumen (44), definiert durch eine abgerundete Abschlusswand (32A), ausgebildet in dem ersten Ende (32) des röhrenförmigen Elements (36), beinhaltend eine Ebene (TS) der Öffnung, welche die Längsachse schneidet; und

    einen abgeschnittenen, tropfenförmigen Kopf (56), ausgebildet in dem ersten Ende (32), mit einem zweiten Außendurchmesser (OD2), der größer als der erste Außendurchmesser (OD1) ist,

    dadurch gekennzeichnet, dass die Innenfläche (42) in ihrem Querschnitt nicht rund ist.


     
    2. Harnkatheter nach Anspruch 1, ferner umfassend:
    eine Vielzahl von Kanälen (50), ausgebildet in der Innenfläche (42), wobei sich jeder Kanal (50) von einer benachbarten Eintrittsöffnung (38) in Richtung des zweiten Endes (34) erstreckt.
     
    3. Harnkatheter nach Anspruch 2, wobei jeder der Kanäle (50) einen bogenförmigen Querschnitt (52) oder einen keilförmigen Querschnitt (54) beinhaltet.
     
    4. Harnkatheter nach Anspruch 1, wobei die Innenfläche (42) mindestens eine sich längs erstreckende flache Wand (55) umfasst.
     
    5. Harnkatheter nach Anspruch 1, ferner umfassend eine sich verjüngende ringförmige Oberfläche (46), ausgebildet in dem ersten Ende (32), das die Eintrittsöffnung (38) definiert.
     
    6. Harnkatheter nach Anspruch 1, wobei die Ebene der Öffnung (38) die Längsachse (X) senkrecht schneidet.
     
    7. Harnkatheter nach Anspruch 1, wobei das röhrenförmige Element (36) frei von Öffnungen ist, die sich radial dort hindurch erstrecken.
     
    8. Harnkatheter nach Anspruch 1, wobei das erste Ende (32) frei von einer halbrunden Spitze ist, die die Längsachse (X) schneidet, wenn von einer Seite betrachtet.
     
    9. Harnkatheter nach Anspruch 1, ferner umfassend:

    eine erste geneigte Fläche (40A) an dem abgeschnittenen tropfenförmigen Kopf (56);

    eine Scheitelfläche (40B) an dem abgeschnittenen tropfenförmigen Kopf (56), wobei der zweite Außendurchmesser (OD2) entlang der Scheitelfläche (40B) bestimmt ist; und

    eine zweite geneigte Fläche (40C) an dem abgeschnittenen tropfenförmigen Kopf (56).


     
    10. Harnkatheter nach Anspruch 9,
    wobei die erste geneigte Fläche (40A) der abgerundeten Abschlusswand (32A) benachbart ist und sich von der Längsachse (X) radial nach außen erstreckt;
    die Scheitelfläche (40B) an die erste geneigte Fläche (40A) angrenzt und den zweiten Außendurchmesser definiert;
    die zweite geneigte Fläche (40C) an die Scheitelfläche (40B) angrenzt und sich in Richtung der Längsachse (X) radial nach innen erstreckt und sich mit der Außenfläche des röhrenförmigen Elements (36) verbindet.
     
    11. Harnkatheter nach Anspruch 2, ferner umfassend:

    eine sich verjüngende Oberfläche (46), die sich von der Ebene (TS) zu einer Abschlussebene (TE) erstreckt, welche die Eintrittsöffnung (38) definiert; und

    die Kanäle (50), beginnend in der sich verjüngenden Oberfläche (46) zwischen der Ebene (TS) und der Abschlussebene (TE) .


     
    12. Harnkatheter nach Anspruch 11, ferner umfassend:
    eine Vielzahl von Aussparungen (50A), die sich umlaufend um die Längsachse (X) erstrecken, der sich verjüngenden Oberfläche (46) benachbart.
     
    13. Harnkatheter nach Anspruch 1, wobei das röhrenförmige Element (36) und der abgeschnittene tränenförmige Kopf (56) aus dem gleichen Material ausgebildet sind, definierend einen nicht aufblasbaren monolithischen Körper.
     


    Revendications

    1. Cathéter urinaire comprenant :

    un élément tubulaire (36) comprenant une première extrémité (32) et une seconde extrémité (34) qui définissent entre elles un axe longitudinal (X), ladite première extrémité (32) étant conçue pour être insérée dans le canal urétral (70) d'un patient;

    une surface extérieure (40) sur l'élément tubulaire (36) espacée d'une surface intérieure (42), la surface extérieure (40) ayant un premier diamètre extérieur (OD1);

    une lumière (44) définie par la surface intérieure (42) conçue pour drainer à travers elle l'urine (72) de la vessie du patient (71);

    une ouverture d'entrée (38) vers la lumière (44) définie par une paroi d'extrémité arrondie (32A) formée dans la première extrémité (32) de l'élément tubulaire (36) comprenant un plan (TS) de l'ouverture coupant l'axe longitudinal; et

    une tête tronquée en forme de larme (56) formée dans la première extrémité (32) ayant un second diamètre extérieur (OD2) plus grand que le premier diamètre extérieur (OD1), caractérisée en ce que la surface intérieure (42) est de section transversale non circulaire.


     
    2. Cathéter urinaire selon la revendication 1, comprenant en outre:
    une pluralité de canaux (50) formés dans la surface intérieure (42), chaque canal (50) s'étendant longitudinalement depuis ladite ouverture d'entrée (38) adjacente vers ladite seconde extrémité (34).
     
    3. Cathéter urinaire selon la revendication 2, dans lequel chacun desdits canaux (50) comprend une section transversale arquée (52) ou une section transversale en forme de V (54).
     
    4. Cathéter urinaire selon la revendication 1, la surface intérieure (42) comprenant au moins une paroi plate s'étendant longitudinalement (55).
     
    5. Cathéter urinaire selon la revendication 1, comprenant en outre une surface annulaire conique (46) formée dans la première extrémité (32) définissant l'ouverture d'entrée (38)
     
    6. Cathéter urinaire selon la revendication 1, dans lequel le plan de l'ouverture (38) coupe perpendiculairement l'axe longitudinal (X).
     
    7. Cathéter urinaire selon la revendication 1, dans lequel l'élément tubulaire (36) est exempt d'ouvertures s'étendant radialement à travers lui.
     
    8. Cathéter urinaire selon la revendication 1, dans lequel la première extrémité (32) est exempte d'une pointe hémisphérique coupant l'axe longitudinal (X) lorsqu'elle est vue de côté.
     
    9. Cathéter urinaire selon la revendication 1, comprenant en outre:

    une première surface inclinée (40A) sur la tête tronquée en forme de larme (56)

    une surface de sommet (40B) sur la tête tronquée en forme de larme (56), dans laquelle le second diamètre extérieur (OD2) est déterminé à travers la surface apex (40B); et

    une seconde surface inclinée (40C) sur la tête tronquée en forme de larme (56).


     
    10. Cathéter urinaire selon la revendication 9,
    dans lequel la première surface inclinée (40A) adjacente à la paroi d'extrémité arrondie (32A) et s'étendant radialement vers l'extérieur à partir de l'axe longitudinal (X);
    la surface du sommet (40B) adjacente à la première surface inclinée (40A) et définissant le seconde diamètre extérieur;
    la seconde surface inclinée (40C) adjacente à la surface du sommet (40B) et s'étendant radialement vers l'intérieur en direction de l'axe longitudinal (X) et se raccordant à la surface extérieure de l'élément tubulaire (36).
     
    11. Cathéter urinaire selon la revendication 2, comprenant en outre:

    une surface conique (46) s'étendant du plan (TS) à un plan d'extrémité (TE) définissant l'ouverture d'entrée (38); et

    les canaux (50) commençant dans la surface conique (46) entre le plan (TS) et le plan final (TE).


     
    12. Cathéter urinaire de la revendication 11, comprenant en outre:
    une pluralité d'encoches (50A) s'étendant circonférentiellement autour de l'axe longitudinal (X) adjacent à la surface conique (46).
     
    13. Cathéter urinaire selon la revendication 1, dans lequel l'élément tubulaire (36) et la tête tronquée en forme de larme (56) sont formés à partir du même matériau définissant un corps monolithique non gonflable.
     




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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