WO1996037254B1 - Multiple-type catheter connection system - Google Patents

Abstract

A catheter connection system (32, 340, 394, 634) is defined by a rigid, tubular stem (34, 278, 288, 318, 342, 396, 496, 530, 574, 612) attached at a proximal end thereof to a medical device (016, 222, 246, 274, 312, 366, 636). The stem has one or more engagement barbs (49, 226, 254, 280, 290, 320, 358, 408, 466, 538, 586) encircling and radially, outwardly extending on an exterior surface of the stem. The engagement barbs can be configured having a variety of different sizes and positions. A locking barb (50, 228, 258, 294, 322, 360, 412, 472, 510, 541, 632) also encircles and radially, outwardly extends on the exterior surface of the stem. The locking barb is positioned between the medical device and the engagement barbs. A variety of fastening assemblies (57, 300, 304, 328, 414, 480, 492, 555, 600) are provided for inwardly compressing a portion of a body wall (53, 83, 376) of a selected catheter (54, 58, 244, 302, 330, 386, 416, 474, 518, 544, 594), chosen from two or more catheters, against the engagement barbs or locking barb on the stem when the stem is received in the lumen (54, 58, 244, 302, 330, 386, 416, 474, 518, 544, 594) of the selected catheter. The fastening assemblies create a mechanical joinder and liquid-tight seal between the selected catheter and the stem.

Claims

AMENDED CLAIMS[received by the International Bureau on 20 December 1996 (20.12.%); original claims 1-246 replaced by new claims 1-150 (60 pages)]

1. A catheter connection system for effecting a mechanical joinder between a medical device and a selected catheter chosen from either a first catheter or a second catheter, the first catheter being made from a first 5 material and the second catheter being made from a second material, the second material being less pliant than the first material, the selected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, said 0 connection system comprising:

(a) a rigid stem attached at a proximal end thereof to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween; 5 (b) attachment means on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said 0 stem; and

(c) securing means operative when said distal end of said stem is received in the lumen of the selected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter 5 against a portion of said attachment means on said stem, and for interacting with said attachment means to preclude unintentional disengagement of the selected catheter from said stem, wherein said securing means comprises a set of fastening -0 assemblies, individual of said fastening assemblies corresponding to the first catheter and the second catheter.

2. A catheter connection system as defined in 5 Claim 1, wherein said set of fastening assemblies comprises a first fastening assembly corresponding to the first catheter, said first fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the first catheter against said portion of said attachment means on said stem when said stem is received in the lumen of the first catheter and the first catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and

(b) an annular compression ring extending inwardly from said interior surface of said first locking sleeve.

3. A catheter connection . system as defined in Claim 1, wherein said set of fastening assemblies comprises a second fastening assembly corresponding to the second catheter made from the second material being less pliant than the first material, said second fastening assembly comprising:

(a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said passageway of said second locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the second catheter against said portion of said attachment means on said stem when said stem is received in the lumen of the second catheter and the second catheter with said stem received therein is positioned within said passageway of said compression sleeve; and

(c) an opposing set of radially displacable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

4. A catheter connection system as defined in Claim 1, wherein the first material of the first catheter is silicone.

5. A catheter connection system as defined in Claim 1, wherein the second material of the second catheter is polyurethane.

6. A catheter connection system as defined in

Claim 3 , wherein said second locking sleeve further comprises an annular bracing ring extending inwardly from said interior surface of said second locking sleeve.

7. A catheter connection system as defined in

Claim 6, wherein said bracing ring is positioned at said distal end of said second locking sleeve.

8. A catheter connection system as defined in Claim 6, wherein said compression sleeve further comprises:

(a) a head portion having an exterior surface and a first outer diameter; and

(b) a tail portion having a second outer diameter smaller than said first outer diameter of said head portion.

9. A catheter connection system as defined in Claim 8, wherein said exterior surface of said head portion of said compression sleeve is biased against said interior surface of said locking sleeve between said C-shaped clamps and said bracing ring.

10. A catheter connection system as defined in Claim 8, wherein a portion of said tail portion of said compression sleeve projects beyond said distal end of said second locking sleeve.

11. A catheter connection system as defined in Claim 3, wherein said passageway of said compression sleeve has an inner diameter, the second catheter has a outer diameter, and said inner diameter of said passageway of said compression sleeve is at least as large as the outer diameter of the second catheter.

12. A catheter connection system as defined in Claim 1, wherein said attachment means comprises: (a) an engagement barb radially, outwardly extending on said exterior surface of said stem and encircling said stem; and

(b) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said engagement barb and the medical device.

13. A catheter connection system as defined in Claim 12, wherein said engagement barb has a maximum outer diameter, said locking barb as a maximum outer diameter, and said maximum outer diameter of said locking barb is larger than said maximum outer diameter of said engagement barb.

14. A catheter connection system as defined in

Claim 12, wherein said attachment means further comprises a plurality of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem.

15. A catheter connection system as defined in Claim 12, wherein said locking barb further comprises:

(a) an annular distal side wall encircling said stem and radially extending outward therefrom to a first outside corner having an outer diameter,

(b) a proximal side wall encircling said stem and radially extending outward therefrom to a second outside corner having an outer diameter larger than said outer diameter of said first outside corner, and (c) a frustoconical top surface encircling said stem and extending between said first outside corner and said second outside corner.

16. A catheter connection system as defined in Claim 15, wherein said proximal side wall extends from said exterior surface of said stem to said second outside corner at an angle greater than 90° as measured between said proximal side wall and the longitudinal axis of said stem proximal of said proximal side wall.

17. A catheter connection system as defined in Claim 1, wherein the medical device is an implantable port.

18. A catheter connection system as defined in Claim 17, wherein said implantable port includes an access port with a septum.

19. A catheter connection system as defined in Claim 17, wherein said implantable port includes a leaflet valve.

20. A catheter connection system as defined in Claim 1, wherein the medical device is a catheter termination hub.

21. A catheter connection system as defined in Claim 1, wherein the medical device is a catheter repair and extension assembly.

22. A catheter connection system as defined in

Claim 1, wherein the medical device is a medical tunneling instrument .

23. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a selected catheter chosen from either a first catheter or a second catheter, the first catheter being made from a first material and the second catheter being made from a second material, the second material being less pliant than the first material, the selected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection system comprising: (a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween; (b) attachment means on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem, said attachment means comprising:

(i) an engagement barb radially, outwardly extending on said exterior surface of said stem and encircling said stem, said engagement barb having a maximum outer diameter so sized as to fit within the lumen of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter; and

(ii) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said engagement barb and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said engagement barb; and (c) securing means operative when said distal end of said stem is received in the lumen of the selected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said attachment means on said stem, and for interacting with said attachment means to preclude unintentional disengagement of the selected catheter from said stem.

24. A catheter connection system as defined in Claim 23, wherein said stem, engagement barb, and locking barb are each made of metal .

25. A catheter connection system as defined in Claim 23, wherein said stem, engagement barb, and locking barb are each made of plastic.

26. A catheter connection system as defined in Claim 23, wherein said attachment means further comprises a plurality of comparably sized engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem.

27. A catheter connection system as defined in Claim 23, wherein said attachment means further comprises two or more comparably sized engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem.

28. A catheter connection system as defined in Claim 23, wherein said engagement barb is positioned at said distal end of said stem.

29. A catheter connection system as defined in Claim 23, wherein said locking barb further comprises: (a) a proximal side wall encircling said stem and radially extending outward therefrom to an outside corner; and

(b) a frustoconical top surface encircling said stem and extending at a slope from said outside corner of said proximal side wall to said exterior surface of said stem.

30. A catheter connection system as defined in Claim 23, wherein said locking barb further comprises: (a) an annular distal side wall encircling said stem and radially extending outward therefrom to a first outside corner having an outer diameter,-

(b) a proximal side wall encircling said stem and radially extending outward therefrom to a second outside corner having an outer diameter larger than said outer diameter of said first outside corner; and

(c) a frustoconical top surface encircling said stem and extending between said first outside corner and said second outside corner.

31. A catheter connection system as defined in Claim 23, wherein the medical device is an access port.

32. A catheter connection system as defined in Claim 23, wherein said securing means comprises a set of fastening assemblies, individual of said fastening assemblies corresponding to the firεt catheter and the second catheter.

33. A catheter connection system as defined in

Claim 32, wherein said set of fastening assemblies comprises a first fastening assembly corresponding to the first catheter, said first fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the first catheter against said portion of said attachment means on said stem when said stem is received in the lumen of the first catheter and the first catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and (b) an annular compression ring extending inwardly from said interior surface of said first locking sleeve .

34. A catheter connection system as defined in Claim 32, wherein said set of fastening assemblies comprises a second fastening assembly corresponding to the second catheter made from the second material being less pliant than the first material, said second fastening assembly comprising: (a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said passageway of said second locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally 140 extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the second catheter against said portion of said attachment means on said stem when said stem is received in the lumen of the second catheter and the second catheter with said stem received therein is positioned within said passageway of said compression sleeve; and

(c) an opposing set of radially displacable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

35. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a selected catheter chosen from either a silicone catheter or a polyurethane catheter, the selected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection system comprising:

(a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween;

(b) attachment means on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem; and

(c) a pair of locking sleeves comprising a first locking sleeve corresponding to the silicon catheter and a second locking sleeve corresponding to the polyurethane catheter, each of said first locking sleeve and said second locking sleeve having a distal 141 end, a proximal end, an interior surface defining a passageway longitudinally extending through said sleeve, and an annular securement ring radially inwardly extending from said interior surface of said locking sleeve, said interior surface of said locking sleeve radially inwardly compressing a portion of the body wall of the selected catheter against a portion of said attachment means on said stem when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said locking sleeve .

36. A catheter connection system as defined in Claim 35, wherein said exterior surface of said first locking sleeve comprises :

(a) a first cylindrical portion positioned at said distal end and having an outer diameter; (b) a second cylindrical portion positioned at said proximal end and having an outer diameter larger than said outer diameter of said first cylindrical portion; and

(c) a frustoconical shoulder extending between said first cylindrical portion and said second cylindrical portion.

37. A catheter connection system as defined in Claim 35, wherein said interior surface of said first locking sleeve is substantially cylindrical.

38. A catheter connection system as defined in Claim 35, wherein said annular securement ring of said first locking sleeve comprises a compression ring positioned at said proximal end of said first locking sleeve. 142

39. A catheter connection system as defined in Claim 35, wherein said first locking sleeve is rigid.

40. A catheter connection system as defined in Claim 35, wherein said second locking sleeve is rigid.

41. A catheter connection system as defined in Claim 35, wherein said second locking sleeve further comprises a pliable compression sleeve longitudinally disposed within said passageway of said second locking sleeve and having an interior surface defining a passageway longitudinally extending therethrough.

42. A catheter connection system as defined in Claim 41, wherein said annular securement ring of said second locking sleeve comprises an annular attachment ridge positioned on said interior surface of said second locking sleeve at said proximal end thereof .

43. A catheter connection system as defined in

Claim 42, wherein said second locking sleeve further comprises an annular bracing ring extending inwardly from said interior surface of said second locking sleeve at said distal end thereof .

44. A catheter connection system as defined in Claim 43, wherein said compression sleeve comprises:

(a) a head portion having an exterior surface and a first outer diameter; and (b) a tail portion having a second outer diameter smaller than said first outer diameter of said head portion.

45. A catheter connection system as defined in Claim 44, wherein said interior surface of said head portion is biased against said interior surface of said 143 second locking sleeve between said attachment ridge and said bracing ring.

46. A catheter connection system as defined in Claim 45, wherein a portion of said tail portion of said compression sleeve projects beyond said distal end of said second locking sleeve .

47. A catheter connection system as defined in Claim 42, wherein said proximal end of said second locking sleeve includes a slot extending through said proximal end and through said attachment ridge to enable said attachment ridge to radially expand under a radial force.

48. A catheter connection system as defined in

Claim 35, wherein said attachment means comprises:

(a) an engagement barb radially, outwardly extending on said exterior surface of said stem and encircling said stem; and (b) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said engagement barb and the medical device.

49. A catheter connection system as defined in

Claim 48, wherein said engagement barb has a maximum outer diameter and said locking barb as a maximum outer diameter that is larger than said maximum outer diameter of said engagement barb.

50. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a selected catheter chosen from either a silicone catheter or a polyurethane catheter, the selected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection system comprising:

(a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween;

(b) a plurality of comparably configured engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem, said engagement barbs having a maximum outer diameter so sized as to fit within the lumen of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter; (c) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said engagement barbs and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said engagement barbs; and

(d) a set of fastening assemblies, individual of said fastening assemblies corresponding to each one of the polyurethane catheter and the silicone catheter, said set of fastening assemblies comprising: (i) a first fastening assembly corresponding to the silicone catheter, said first fastening assembly comprising:

(A) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the silicone catheter againεt said locking barb on said stem when said stem is received in the lumen 145 of the silicone catheter and the silicone catheter with said stem received therein is positioned within said paεsageway of said first locking sleeve; and (B) an annular compression ring extending inwardly from said interior surface of said first locking sleeve to interact with said locking barb; and (ii) a second fastening assembly corresponding to the polyurethane catheter, said second fastening assembly comprising:

(A) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway extending through said second locking sleeve;

(B) a pliable compression sleeve longitudinally dispoεed within said passageway of said second locking sleeve and having an interior surface defining a pasεageway longitudinally extending therethrough, εaid interior surface of εaid compreεεion εleeve radially, inwardly compressing a portion of the body wall of the polyurethane catheter against said engagement barbs on said stem when said stem is received in the lumen of the polyurethane catheter and the polyurethane catheter with said stem received therein is positioned within said passageway of said compresεion εleeve; and

(C) an oppoεing set of radially displacable, resilient C-εhaped clampε poεitioned at said proximal end of εaid εecond locking εleeve to graεp said locking barb. 146

51. A catheter connection system as defined in Claim 50, wherein said plurality of engagement barbs are adjacently disposed on said distal end of said stem.

52. A catheter connection system as defined in

Claim 50, wherein εaid locking barb further comprises:

(a) an annular distal side wall encircling said stem and radially extending outward therefrom to a first outside corner having an outer diameter; (b) a proximal side wall encircling said stem and radially extending outward therefrom to a second outside corner having an outer diameter larger than said outer diameter of said first outside corner; and

(c) a frustoconical top surface encircling said stem and extending between said first outside corner and said second outside corner.

53. A catheter connection system as defined in Claim 50, wherein said annular compression ring of the first locking sleeve is longitudinally positioned within said paεεageway so as to reside between said locking barb and the medical device when said stem is received in the lumen of the silicone catheter and the silicone catheter with said stem received therein is positioned within said passageway of said first locking sleeve.

54. A catheter connection system as defined in Claim 50, wherein said compression ring of said first fastening assembly has an inner diameter that is larger than said maximum outer diameter of said locking barb.

55. A catheter connection system as defined in Claim 50, wherein said compression ring of said first fastening assembly has an inner diameter, the silicone catheter has an outer diameter, and said inner diameter of 147 said compresεion ring is larger than the outer diameter of the silicone catheter.

56. A catheter connection εystem as defined in Claim 50, wherein the lumen of the εilicone catheter has an inside diameter that is smaller than said maximum outer diameter of said locking barb.

57. A catheter connection syεtem as defined in Claim 50, wherein εaid interior εurface of εaid firεt locking sleeve radially, inwardly compresses a portion of the body wall of the silicone catheter against said engagement barbs on said stem when said stem is received in the lumen of the silicone catheter and the silicone catheter with said stem received therein is positioned within εaid paεεageway of εaid first locking εleeve.

58. A catheter connection εyεtem aε defined in Claim 50, wherein each of said C-shaped clamps compriseε: (a) an arm longitudinally poεitioned at εaid proximal end of said εecond locking sleeve; and

(b) an attachment ridge radially inwardly extending from said arm.

59. A catheter connection system as defined in

Claim 58, wherein said attachment ridge of said C-shaped clamp is longitudinally positioned on said arm so as to reside between said locking barb and said medical device when said stem is received in the lumen of the polyurethane catheter and the polyurethane catheter with said stem received therein is positioned within said pasεageway of said second locking sleeve.

60. A catheter connection system as defined in Claim 50, wherein said C-shaped clamps have an inner 148 diameter that is smaller than said maximum outer diameter of said locking barb.

61. A catheter connection system as defined in Claim 50, wherein the medical device is an implantable port .

62. A catheter connection system as defined in Claim 50, wherein the medical device is a catheter repair and extension stent .

63. A catheter connection system for mechanically joining a medical tunneling instrument to a selected catheter chosen from either a silicone catheter or a polyurethane catheter, the selected catheter having a body wall with an interior surface defining a longitudinally extending, fluid flow lumen, said connection syεtem comprising:

(a) a rigid, tubular stem attached at a proximal end thereof to the tunneling instrument, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween;

(b) attachment means on said exterior surface of εaid εtem for engaging the interior εurface of the εelected catheter when said distal end of said stem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem; and

(c) securing means operative when εaid distal end of εaid εtem iε received in the lumen of the εelected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said attachment means on said stem, and for interacting with said attachment means to preclude unintentional disengagement of the εelected catheter from εaid εtem, said securing means 149 compriεes a set of fastening asεemblies, individual of εaid fastening assemblies corresponding to the εilicone catheter and the polyurethane catheter.

64. A catheter connection system as defined in

Claim 63, wherein said set of fastening asεemblieε compriεeε a firεt fastening asεembly correεponding to the silicone catheter, said first fastening assembly comprising: (a) a first locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking εleeve radially, inwardly compreεεing a portion of the body wall of the εilicone catheter against a portion of said attachment means on said stem when said stem is received in the lumen of the silicone catheter and the silicone catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and

(b) an annular compreεεion ring extending inwardly from said interior surface of said first locking sleeve .

65. A catheter connection system as defined in

Claim 63, wherein said set of fastening assemblies comprises a second fastening assembly corresponding to the polyurethane catheter, said second fastening assembly comprising: (a) a second locking sleeve having a diεtal end, a proximal end, and an interior εurface defining a paεεageway extending therebetween;

(b) a pliable compreεsion sleeve longitudinally disposed within said passageway of said second locking sleeve and having a distal end, a proximal end, and an interior surface defining a pasεageway longitudinally 150 extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the polyurethane catheter against a portion of said attachment means on said stem when said stem is received in the lumen of the polyurethane catheter and the polyurethane catheter with said stem received therein is positioned within εaid passageway of said compression sleeve; and

(c) an opposing set of radially displacable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

66. A catheter connection system as defined in Claim 63, wherein said attachment means compriseε: (a) an engagement barb radially, outwardly extending on said exterior surface of said stem and encircling said stem; and

(b) a locking barb radially, outwardly extending on said exterior εurface of εaid εtem and encircling εaid stem between said engagement barb and the medical device .

67. A catheter connection system as defined in Claim 66, wherein said engagement barb has a maximum outer diameter, said locking barb has a maximum outer diameter, and said maximum outer diameter of said locking barb is larger than said maximum outer diameter of said engagement barb.

68. A catheter connection εystem for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a polyurethane catheter, the polyurethane catheter having a body wall with an exterior εurface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection system comprising: 151

(a) a rigid, tubular εtem attached at a proximal end thereof in fluid communication to the medical device, said εtem having a free diεtal end opposite said proximal end and an exterior surface extending therebetween;

(b) an engagement barb radially, outwardly extending on said exterior surface of said stem and encircling said stem, said engagement barb having a maximum outer diameter so sized as to fit within the lumen of the polyurethane catheter when said distal end of said stem is received in the lumen of the polyurethane catheter;

(c) a locking barb radially, outwardly extending on said exterior εurface of εaid stem and encircling said stem between said engagement barb and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of εaid engagement barb; and

(d) a fastening assembly comprising: (i) a locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway extending therebetween;

(ii) a pliable compresεion sleeve longitudinally dispoεed within εaid passageway of said locking sleeve and having an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve radially, inwardly compresεing a portion of the body wall of the polyurethane catheter againεt εaid engagement barb on εaid εtem when εaid εtem is received in the lumen of the polyurethane catheter and the polyurethane catheter with said stem received therein is positioned within said passageway of said compressive sleeve; and 152

(iii) an oppoεing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve to grasp said locking barb.

69. A catheter connection system as defined in Claim 68, wherein said locking sleeve further compriseε an annular bracing ring extending inwardly from said interior surface of said locking sleeve.

70. A catheter connection system as defined in Claim 69, wherein said compression sleeve comprises:

(a) a head portion having an exterior surface and a first outer diameter; and (b) a tail portion having a second outer diameter smaller than εaid first outer diameter of said head portion.

71. A catheter connection system as defined in Claim 70, wherein said exterior surface of said head portion is biased against said interior surface of said locking sleeve between said C-shaped clamps and said bracing ring.

72. A catheter connection syεtem as defined in

Claim 68, wherein said locking barb is longitudinally positioned on said stem so that said C-εhaped clampε are positioned between said locking barb and the medical device when said stem is received in the lumen of the polyurethane catheter and the polyurethane catheter with said stem received therein is positioned within said passageway of said compression sleeve.

73. A catheter connection system for effecting a mechanical joinder between a medical device and a selected catheter chosen from among three or more catheters, each of 153 the catheterε having a combination of size and material composition distinct from the otherε of the catheterε, the εelected catheter having a body wall with an exterior εurface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection system comprising:

(a) a rigid stem attached at a proximal end thereof to the medical device, εaid stem having a free distal end opposite said proximal end and an exterior surface extending therebetween;

(b) anchoring means on said exterior surface of said εtem for engaging the interior εurface of the εelected catheter when εaid distal end of said stem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem; and

(c) clinching means operative when said distal end of εaid stem is received in the lumen of the selected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said anchoring means on said stem, and for interacting with said anchoring means to preclude unintentional disengagement of the selected catheter from said stem.

74. A catheter connection system as recited in Claim 73, wherein said anchoring means compriseε:

(a) a firεt engagement barb radially, outwardly extending on said exterior surface of said stem and encircling said stem on said diεtal end of εaid stem, said first engagement barb having a maximum outer diameter so sized aε to fit within the lumen of the εelected catheter when εaid distal end of said εtem iε received in the lumen of the selected catheter; (b) a second engagement barb radially, outwardly extending on said exterior surface of said stem and 154 encircling said stem proximal of said first engagement barb, said second engagement barb having a maximum outer diameter larger than said first engagement barb; and (c) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said εecond engagement barb and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said second engagement barb.

75. A catheter connection system as recited in Claim 73, wherein said anchoring means comprises:

(a) a first set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said εtem on said distal end of said stem, said first set of engagement barbs having a maximum outer diameter so sized as to fit within the lumen of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter;

(b) a second set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem proximal of said first set of engagement barbs, said second set of engagement barbs having a maximum outer diameter larger than said first set of engagement barbs; and

(c) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said second set of engagement barbs and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said second set of engagement barbs. 155

76. A catheter connection εyεtem as recited in Claim 75, wherein each consecutive one of said first εet of engagement barbε and εaid εecond εet of engagement barbε have a maximum outer diameter that decreaεeε in size toward εaid diεtal end of εaid εtem.

77. A catheter connection εyεtem aε recited in Claim 75, wherein said first εet of engagement barbε and εaid second set of engagement barbs are separated by a portion of said εtem.

78. A catheter connection system as recited in Claim 75, further comprising a second locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said first set of engagement barbs and said second set of engagement barbs.

79. A catheter connection system as recited in Claim 75, wherein said first set of engagement barbs compriεeε two or more engagement barbε, each consecutive one of said engagement barbs having a maximum outer diameter that decreases in size toward said distal end of said stem.

80. A catheter connection syεtem aε recited in Claim 73, wherein said anchoring means comprises:

(a) a engagement bulb radially, outwardly extending on said exterior surface of εaid εtem and encircling said stem at said distal end of said stem, εaid engagement bulb having a maximum outer diameter εo εized aε to fit within the lumen of the selected catheter when said distal end of εaid stem is received in the lumen of the selected catheter; (b) a firεt εet of engagement barbs radially, outwardly extending on said exterior surface of said 156 εtem proximal of said engagement bulb, said first set of engagement barbs having a maximum outer diameter at leaεt as large as said maximum outer diameter of said engagement bulb and being separated from said engagement bulb by a first portion of said stem; and

(c) a second set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem proximal of said first set of engagement barbs, said second set of engagement barbs having a maximum outer diameter larger than said first set of engagement barbs and being εeparated from said first set of engagement barbs by a second portion of said stem.

81. A catheter connection syεtem aε recited in

Claim 73, wherein εaid εtem and εaid anchoring meanε are made of metal.

82. A catheter connection system as recited in Claim 73, wherein said stem and said anchoring means are made of plastic.

83. A catheter connection syεtem as defined in Claim 73, wherein said clinching means comprises a first fastening aεsembly, said first fastening assembly compriεing:

(a) a first locking εleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said stem when said stem is received in the lumen of the selected catheter and the selected catheter with said 157 stem received therein is poεitioned within εaid paεεageway of εaid firεt locking εleeve; and

(b) an annular compreεsion ring extending inwardly from said interior surface of said first locking sleeve.

84. A catheter connection system as defined in Claim 73, wherein εaid clinching meanε compriεes a second fastening asεembly corresponding to the selected catheter εaid εecond faεtening aεεembly comprising:

(a) a second locking εleeve having a distal end, a proximal end, and an interior surface defining a pasεageway extending therebetween;

(b) a pliable compression sleeve longitudinally dispoεed within εaid paεεageway of said second locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compresεion εleeve radially, inwardly co preεεing a portion of the body wall of the εelected catheter againεt εaid portion of said anchoring means on said εtem when εaid εtem iε received in the lumen of the εelected catheter and the selected catheter with said stem received therein is positioned within said pasεageway of said compression sleeve; and

(c) an opposing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve .

85. A catheter connection system as recited in

Claim 84 , wherein said interior surface of said compression sleeve compriseε:

(a) an annular firεt portion poεitioned at εaid distal end and having an inner diameter; and 158

(b) an annular second portion positioned at said proximal end and having an inner diameter larger than said inner diameter of said first portion.

86. A catheter connection syεtem aε defined in

Claim 73, wherein the selected catheter is made of silicone.

87. A catheter connection syεtem as defined in Claim 73, wherein the selected catheter is made of polyurethane .

88. A catheter connection system as defined in Claim 73, wherein the selected catheter is a composite catheter.

89. A catheter connection syεtem as defined in Claim 73 , wherein the medical device is an access port .

90. A catheter connection syεtem aε defined in

Claim 73, wherein the medical device iε an leaflet port.

91. A catheter connection εyεtem as defined in Claim 73 , wherein the medical device is a catheter termination hub.

92. A catheter connection system as defined in Claim 73, wherein the medical device is a catheter repair and extension assembly.

93. A catheter connection system /as defined in Claim 73, wherein the medical device is an access port.

94. A catheter connection system aε defined in Claim 73, wherein εaid clinching meanε and εaid anchoring meanε are εo configured that εubstantially no fluid leaking 159 occurs between the selected catheter and said stem when a fluid is pressurized within the selected catheter up to 2.81 kilograms per square centimeter (40 pounds per square inch) .

95. A catheter connection syεtem aε defined in Claim 73, wherein εaid clinching means and said anchoring means are so configured that εubεtantially no fluid leaking occurs between the selected catheter and said stem when a fluid is pressurized within the selected catheter up to 4.22 kilograms per square centimeter (60 pounds per square inch) .

96. A catheter connection syεtem aε defined in Claim 73, wherein said clinching means and εaid anchoring meanε are εo configured that εubεtantially no fluid leaking occurs between the selected catheter and said stem when a fluid is pressurized within the selected catheter up to 5.62 kilograms per εquare centimeter (80 pounds per square inch) .

97. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a selected catheter chosen from among three or more catheterε, each of the catheterε having a combination of εize and material composition distinct from the other of the catheterε, the εelected catheter having a body wall with an exterior εurface and with an interior εurface defining a longitudinally extending, fluid flow lumen, εaid connection εyεtem compriεing:

(a) a rigid, tubular εtem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween; 160

(b) anchoring means on εaid exterior εurface of said εtem for engaging the interior εurface of the selected catheter when said distal end of εaid εtem iε received within the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem, said anchoring means comprising:

(i) a first set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem on said distal end of said stem, said first set of engagement barbs having a maximum outer diameter so sized as to fit within the lumen of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter;

(ii) a second set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem proximal of said first set of engagement barbs, said second set of engagement barbs having a maximum outer diameter larger than εaid firεt set of engagement barbs ; and

(iii) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said second set of engagement barbs and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said second set of engagement barbs; and (c) clinching means operative when said distal end of said stem is received in the lumen of the selected catheter for radially, inwardly compreεεing a portion of the body wall of the selected catheter against a portion of said anchoring meanε on said stem, and for interacting with said anchoring means to 161 preclude unintentional disengagement of the selected catheter from said stem.

98. A catheter connection system as recited in Claim 97, wherein said first set of engagement barb and εaid second set of engagement barbs each comprise two or more engagement barbs .

99. A catheter connection system as recited in Claim 97, wherein said first set of engagement barbs and said second set of engagement barbs are adjacently dispoεed.

100. A catheter connection εystem as recited in Claim 97, wherein said locking barb further comprises:

(a) a proximal side wall encircling said stem and radially extending outward therefrom to an outside corner; and

(b) a fruεtoconical top surface encircling said stem and extending between said first outside corner and εaid εtem.

101. A catheter connection εyεtem aε defined in Claim 100, wherein εaid proximal εide wall extends from said exterior surface of said stem to said second outside corner at an angle greater than 90° as measured between said proximal εide wall and the longitudinal axis of said stem proximal of said proximal εide wall .

102. A catheter connection εyεtem aε defined in

Claim 97, wherein εaid clinching meanε compriεeε a firεt faεtening aεεembly, εaid firεt faεtening assembly comprising :

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a pasεageway longitudinally extending through said first 162 locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said εtem when εaid εtem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and

(b) an annular compression ring extending inwardly from said interior surface of said first locking sleeve .

103. A catheter connection system as defined in Claim 102, wherein said compression ring has an inner diameter larger than said maximum outer diameter of said locking barb.

104. A catheter connection system as defined in Claim 97, wherein said clinching means comprises a second fastening assembly corresponding to the selected catheter, said second fastening asεembly compriεing:

(a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway extending therebetween; (b) a pliable compresεion εleeve longitudinally diεposed within said passageway of said second locking sleeve and having a distal end, a proximal end, and an interior surface defining a pasεageway longitudinally extending therethrough, said interior surface of εaid compression sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on εaid stem when said stem is received in the lumen of the εelected catheter and the selected catheter with said stem received therein is positioned within said passageway of said compression sleeve; and 163

(c) an opposing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

105. A catheter connection εyεtem aε recited in

Claim 104, wherein said C-shaped clamps have an inner diameter slightly smaller than said maximum outer diameter of said locking barb.

106. A catheter connection system as defined in

Claim 97, wherein said clinching means compriseε a third faεtening aεεembly corresponding to the selected catheter, εaid third faεtening assembly comprising:

(a) a third locking sleeve having a distal end, a proximal end, and an interior surface defining a pasεageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said passageway of said third locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve comprising:

(i) an annular first portion having an inner diameter positioned at said distal end so as to encircle and radially, inwardly compress a portion of the body wall of the selected catheter against at least a portion of said first set of engagement barbs when εaid εtem iε received within εaid paεsageway of said compression sleeve; and

(ii) an annular second portion having an inner diameter larger than said inner diameter of said first portion, said second portion being positioned at said proximal end so as to encircle at least a portion of said second set of engagement barbε when εaid stem is received 164 within said passageway of said compression sleeve; and

(c) an opposing set of radially displaceable, resilient C-shaped clamps poεitioned at εaid proximal end of said second locking sleeve.

107. A catheter connection εyεtem aε recited in Claim 97, wherein εaid stem comprises.-

(a) a distal portion having an outer diameter on which said first set of engagement barbs are positioned; and

(b) a proximal portion having an outer diameter larger than said outer diameter of said distal section, said second set of engagement barbs being positioned on εaid proximal εection.

108. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a selected catheter chosen from among three or more catheters, each of the catheters having a combination of size and material composition distinct from the other of the catheters, the εelected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection εystem compriεing:

(a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end oppoεite εaid proximal end and an exterior surface extending therebetween;

(b) anchoring means on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter, and 165 for enabling locking of the selected catheter on said stem, εaid anchoring means comprising:

(i) a first set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem on said distal end of said stem, said first set of engagement barbs having a maximum outer diameter so sized as to fit within the lumen of the εelected catheter when said distal end of said stem is received in the lumen of the selected catheter;

(ii) a second set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem proximal of said first set of engagement barbs, said second set of engagement barbs having a maximum outer diameter larger than said first set of engagement barbs;

(iii) a first locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said firεt εet of engagement barbε and said second set of engagement barbε, εaid firεt locking barb having a maximum outer diameter larger than εaid maximum outer diameter of εaid firεt εet of engagement barbε; and

(iv) a εecond locking barb radially, outwardly extending on εaid exterior surface of said stem and encircling εaid stem between said second set of engagement barbs and the medical device, said second locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said second set of engagement barbs; and (c) clinching meanε operative when εaid diεtal end of εaid εtem iε received in the lumen of the 166 selected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said anchoring means on said stem, and for interacting with said anchoring means to preclude unintentional disengagement of the selected catheter from εaid εtem.

109. A catheter connection εyεtem as recited in Claim 108, wherein said stem compriεes: (a) a distal portion having an outer diameter on which said first set of engagement barbs are positioned, and

(b) a proximal portion having an outer diameter larger than said outer diameter of said distal εection, εaid εecond set of engagement barbs being positioned on said proximal section.

110. A catheter connection system as defined in Claim 108, wherein said clinching means comprises a first fastening assembly, said first fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said firεt locking εleeve, said interior surface of said firεt locking εleeve radially, inwardly compressing a portion of the body wall of the selected catheter againεt εaid portion of said anchoring means on said stem when said stem is received m the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said pasεageway of said firεt locking sleeve; and

(b) an annular compresεion ring extending inwardly from εaid interior surface of said first locking sleeve. 167

111. A catheter connection syεtem aε defined in Claim 110, wherein εaid annular compression ring is poεitioned at said proximal end of said first locking sleeve .

112. A catheter connection system as defined in Claim 110, wherein said interior surface of said first locking sleeve is configured to radially, inwardly compress a portion of the body wall of the selected catheter against said firεt locking barb.

113. A catheter connection εystem aε defined in Claim 108, wherein εaid clinching meanε compriεeε a εecond fastening assembly corresponding to the selected catheter said second fastening asεembly compriεing:

(a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a pasεageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said pasεageway of εaid second locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said stem when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of εaid compreεεion sleeve; and

(c) an opposing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

114. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a 168 medical device that accommodates a fluid flow and a selected catheter chosen from among three or more catheters, each of the catheters having a combination of size and material composition distinct from the other of the catheters, the selected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, said connection system comprising:

(a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free diεtal end opposite said proximal end and an exterior surface extending therebetween;

(b) anchoring meanε on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said εtem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem, said anchoring means comprising: (i) a plurality of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem on said distal end of said stem, each consecutive one of said plurality of engagement barbs having a maximum outer diameter that decreases in size toward said distal end of said εtem; and

(ii) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said plurality of engagement barbs and the medical device, said locking barb having a maximum outer diameter that is larger than εaid maximum outer diameter of said plurality of engagement barbε; and

(c) clinching means operative when said distal end of εaid εtem is received in the lumen of the selected catheter for radially, inwardly compressing 169 a portion of the body wall of the selected catheter against a portion of said anchoring means on said stem, and for interacting with said anchoring means to preclude unintentional disengagement of the selected catheter from said stem.

115. A catheter connection εyεtem as defined in Claim 114, wherein said plurality of engagement barbs compriεeε at least three engagement barbs.

116. A catheter connection system aε recited in Claim 114, wherein εaid locking barb further compriεes:

(a) a proximal side wall encircling said stem and radially extending outward therefrom to an outside corner; and

(b) a frustoconical top surface encircling εaid stem and extending between said first outside corner and stem.

117. A catheter connection syεtem aε defined in

Claim 114, wherein said clinching means comprises a first fastening assembly, said first fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a pasεageway longitudinally extending through said first locking sleeve, said interior surface of said first locking εleeve radially, inwardly compreεεing a portion of the body wall of the selected catheter against said portion of said anchoring means on said stem when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and 170

(b) an annular compression ring extending inwardly from said interior surface of said first locking sleeve .

118. A catheter connection system as defined in

Claim 114, wherein said clinching meanε compriεeε a second fastening assembly corresponding to the selected catheter said second fastening assembly comprising:

(a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a pasεageway extending therebetween;

(b) a pliable compreεsion sleeve longitudinally disposed within said pasεageway of εaid εecond locking sleeve and having a diεtal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compreεsion sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of εaid anchoring meanε on εaid stem when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within εaid passageway of said compression sleeve; and

(c) an opposing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

119. A catheter connection syεtem for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodateε a fluid flow and a εelected catheter chosen from among three or more catheters, each of the catheters having a combination of size and material composition distinct from the other of the catheterε the selected catheter having a body wall with an exterior εurface and with an interior surface defining 171 a longitudinally extending, fluid flow lumen, said connection system comprising:

(a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween;

(b) anchoring means on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter, and for enabling locking of the selected catheter on said stem, said anchoring means compriεing:

(i) a first set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem on said diεtal end of said stem, each one of said first set of engagement barbs having a maximum outer diameter that decreases in size towards said diεtal end of εaid stem;

(ii) a second set of engagement barbs radially, outwardly extending on εaid exterior εurface of εaid εtem and encircling εaid εtem proximal of εaid firεt set of engagement barbs, each one of said second set of engagement barbs having a maximum outer diameter that decreases in size towards said distal end of said stem, each one of said second set of engagement barbs having a maximum outer diameter larger than said maximum outer diameter of each of said first set of engagement barbs, said firεt set of engagement barbs and said second set of engagement barbε being separated by a portion of said stem; and

(iii) a locking barb radially, outwardly extending on said exterior surface of εaid εtem and encircling εaid stem between said εecond εet 172 of engagement barbε and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of each of εaid second set of engagement barbs; and (c) clinching means operative when said distal end of said stem is received in the lumen of the selected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter againεt a portion of said anchoring means on said εtem, and for interacting with εaid anchoring meanε to preclude unintentional diεengagement of the εelected catheter from said stem.

120. A catheter connection system as defined in Claim 119, wherein said clinching means comprises a first fastening assembly, said first faεtening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said εtem when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and

(b) an annular compression ring extending inwardly from said interior surface of εaid firεt locking εleeve .

121. A catheter connection system as defined in

Claim 120, wherein said annular compression ring is positioned at said proximal end of εaid first locking sleeve so aε to compreεε a portion of the body wall of the 173 εelected catheter againεt said locking barb when said εtem iε received in the lumen of the selected catheter and the selected catheter with εaid εtem received therein iε positioned within εaid passageway of said first locking sleeve.

122. A catheter connection system as defined in Claim 120, wherein said annular compression ring is positioned on said interior surface of said firεt locking sleeve so aε to compreεε a portion of the body wall of the selected catheter between said firεt εet of engagement barbε and said second set of engagement barbs when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said first locking sleeve.

123. A catheter connection system as defined in Claim 119, wherein said clinching means comprises a second fastening asεembly corresponding to the selected catheter said second fastening assembly comprising:

(a) a second locking εleeve having a distal end, a proximal end, and an interior εurface defining a paεεageway extending therebetween; (b) a pliable compression sleeve longitudinally disposed within said passageway of said εecond locking εleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said stem when said stem iε received in the lumen of the εelected catheter and the εelected catheter with εaid εtem received therein iε positioned within said pasεageway of εaid compreεεion sleeve; and 174

(c) an opposing set of radially displaceable, reεilient C-εhaped clampε positioned at said proximal end of said second locking sleeve.

124. A catheter connection system for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates a fluid flow and a εelected catheter chosen from among three or more catheterε, each of the catheterε having a combination of size and material composition distinct from the others of the catheters, the selected catheter having a body wall with an exterior surface and with an interior surface defining a longitudinally extending, fluid flow lumen, εaid connection εyεtem comprising: (a) a rigid, tubular stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween; (b) anchoring means on said exterior surface of said stem for engaging the interior surface of the selected catheter when said distal end of said εtem is received in the lumen of the selected catheter, and for enabling locking of the εelected catheter on εaid stem, said anchoring means comprising: d) a engagement bulb radially, outwardly extending on said exterior surface of εaid εtem and encircling εaid εtem at εaid distal end of said stem, εaid engagement bulb having a maximum outer diameter εo sized as to fit within the lumen of the selected catheter when said distal end of said stem is received in the lumen of the selected catheter;

(ii) a first set of engagement barbs radially, outwardly extending on said exterior surface of said stem proximal of said engagement 175 bulb, said first set of engagement barbs having a maximum outer diameter larger than said maximum outer diameter of said engagement bulb, said firεt εet of engagement barbε being separated from said engagement bulb by a portion of εaid εtem; and

(iii) a second set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said εtem proximal of εaid first set of engagement barbs, said second set of engagement barbs having a maximum outer diameter larger than said first set of engagement barbs and being separated from said firεt εet of engagement barbε by a portion of said stem; and

(c) clinching means operative when said distal end of said stem is received in the lumen of the selected catheter for radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said anchoring means on said stem, and for interacting with said anchoring means to preclude unintentional disengagement of the selected catheter from said stem.

125. A catheter connection system as defined in

Claim 124, wherein each one of said first set of engagement barbs and said εecond εet of engagement barbε have a maximum outer diameter that decreases toward said distal end of said stem.

126. A catheter connection system as defined in Claim 124, wherein said clinching means compriεeε a firεt faεtening assembly, said first fastening assembly comprising: (a) a first locking sleeve having a proximal end, a diεtal end, and an interior εurface defining a 176 pasεageway longitudinally extending through εaid firεt locking sleeve, εaid interior εurface of εaid firεt locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said stem when said stem iε received in the lumen of the selected catheter and the εelected catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and (b) an annular compression ring extending inwardly from said interior surface of εaid firεt locking sleeve.

127. A catheter connection system as defined in Claim 126, wherein said annular compresεion ring iε poεitioned on said interior surface of said first locking sleeve εo as to compress a portion of the body wall of the selected catheter against said engagement bulb when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said first locking sleeve.

128. A catheter connection syεtem for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodateε for the flow of fluid therethrough in two distinct fluid flow pathways and a selected dual lumen catheter chosen from either a first dual lumen catheter or a second dual lumen catheter, the first dual lumen catheter being made from a first material and the second dual lumen catheter being made from a second material, the second material being leεs pliant than the first material, the selected dual lumen catheter having a body wall with an exterior εurface and an interior surface, a catheter partition wall extends between spaced locations on the interior surface to define two distinct 177 longitudinally extending, fluid flow lumens within the body wall, said connection system comprising:

(a) a stem attached at a proximal end thereof in fluid communication to the medical device, said stem having a pair of adjacent prongs separated by a gap and each terminating at a free distal end, each of εaid prongε having an exposed exterior εurface and an interior εurface defining a paεsageway extending therethrough; (b) retaining means on said exposed exterior surface of each of εaid prongε for engaging the interior surface of each of the lumens of the selected dual lumen catheter when said distal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter, and for enabling locking of the selected dual lumen catheter on said stem, said retaining means comprising:

(i) an engagement barb spanning across and radially, outwardly extending on said exposed exterior surface of each of εaid prongε, said engagement barb having a maximum outer radius so sized aε to fit within each of the lumens of the εelected dual lumen catheter when said distal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter; and

(ii) a locking barb spanning across and radially, outwardly extending on said exposed exterior surface of each of said prongs between said engagement barb and the medical device, said locking barb having a maximum outer radius that iε larger than εaid maximum outer radiuε of εaid engagement barb; and (c) claεping means operative when said distal end of each of said prongs is individually received in 178

individual of the lu enε of the selected dual lumen catheter for radially, inwardly compressing a portion of the body wall of the selected dual lumen catheter against a portion of said attachment means on each of said prongs, and for interacting with said attachment means to preclude unintentional disengagement of the selected catheter from said stem.

129. A catheter connection syεtem aε defined in Claim 128, wherein said retaining means further compriseε a plurality of engagement barbε radially, outwardly extending on εaid exposed exterior surface of each of said prongs.

130. A catheter connection syεtem as defined in

Claim 128, wherein said clasping means comprises a first fastening assembly, said first fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said anchoring means on said stem when said distal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter and the selected dual lumen catheter with said stem received therein is poεitioned within said passageway of said first locking sleeve ; and

(b) an annular compression ring extending inwardly from said interior surface of said first locking sleeve. 179

131. A catheter connection system as defined in

Claim 130, wherein said interior surface of said first locking εleeve radially, inwardly compresses a portion of the body wall of the selected catheter against each of said adjacent prongs to compresε at least a portion of the partition wall of the selected catheter between said adjacent prongs.

132. A catheter connection system as defined in Claim 128, wherein said clasping means comprises a second fastening asεembly corresponding to the selected catheter said second fastening assembly comprising:

(a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a passageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said passageway of said second locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the selected catheter againεt said portion of said anchoring means on said stem when said distal end of each of said prongε is individually received in individual of the lumens of the εelected dual lumen catheter and the εelected dual lumen catheter with εaid εtem received therein is positioned within said passageway of said compression sleeve; and (c) an opposing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

133. A catheter connection system as defined in Claim 132, wherein εaid interior εurface of εaid pliable compreεsion sleeve radially, inwardly compresses a portion 180 of the body wall of the selected catheter against each of said adjacent prongs to compress at least a portion of the partition wall between said adjacent prongs.

134. A catheter connection system as defined m

Claim 128, wherein the first material of the first dual lumen catheter is silicone.

135. A catheter connection system as defined in Claim 128, wherein the second material of the second dual lumen catheter is polyurethane.

136. A catheter connection εyεtem for effecting a fluid tight coupling and a mechanical joinder between a medical device that accommodates for the flow of fluid therethrough in two distinct fluid flow pathways and a selected dual lumen catheter chosen from among three or more catheters, each of the catheters having a combination of size and material composition distinct from the others of the catheters, the selected dual lumen catheter having a body wall with an exterior surface and an interior surface, dual lumen catheter further having a partition wall extending between spaced locationε or the interior surface to define two distinct longitudinally extending, fluid flow lumens withm the body wall, said connection εyεtem compriεing:

(a) a εtem attached at a proximal end thereof in fluid communication to the medical device, said stem having a pair of adjacent prongs εeparated by a gap and each terminating at a free distal end, each of said prongs having an exposed exterior εurface and an interior εurface defining a passageway extending therethrough;

(b) gripping meanε on εaid expoεed exterior εurface of each of εaid prongs for engaging the interior surface of each of the lumens of the εelected 181 dual lumen catheter when said diεtal end of each of said prongs is individually received in individual of the lumenε of the selected dual lumen catheter, and for enabling locking of the selected dual lumen catheter on said stem; and

(c) holding means operative when said distal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter for radially, inwardly compressing a portion of the body wall of the selected dual lumen catheter against a portion of said gripping means on each of said prongs, and for interacting with said gripping means to preclude unintentional diεengagement of the selected catheter from said stem.

137. A catheter connection εyεtem aε defined in Claim 136, wherein εaid gripping means comprises:

(a) a plurality of engagement barbs spanning acrosε and radially, outwardly extending on εaid exposed exterior εurface of each of εaid prongε, εaid engagement barbs each having a maximum outer radius that decreases in size towards said distal end of said stem, said engagement barbs being sized so that a least a portion of said engagement barbs fit within each of the lumens of the selected dual lumen catheter when said distal end of each of said prongs is individually received in individual of the lumenε of the selected dual lumen catheter; and

(b) a locking barb spanning acrosε and radially, outwardly extending on εaid exposed exterior εurface of each of εaid prongε between said engagement barbs and the medical device, said locking barb having a maximum outer radius that iε larger than said maximum outer radius of each of said engagement barbs . 182

138. A catheter connection εystem as defined in

Claim 136, wherein said holding means compriseε a firεt fastening assembly, said first faεtening aεsembly compriεing: (a) a firεt locking εleeve having a proximal end, a diεtal end, and an interior εurface defining a paεsageway longitudinally extending through said first locking sleeve, said interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against a portion of said gripping means on said stem when said diεtal end of each of εaid prongs is individually received in individual of the lumens of the εelected dual lumen catheter and the selected dual lumen catheter with said stem received therein is positioned within said pasεageway of εaid firεt locking sleeve; and

(b) an annular compression ring extending inwardly from said interior surface of said first locking sleeve.

139. A catheter connection system as defined in Claim 137, wherein said holding means comprises a second fastening asεembly correεponding to the εelected catheter said second faεtening aεsembly comprising:

(a) a second locking sleeve having a distal end, a proximal end, and an interior εurface defining a paεsageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said passageway of said second locking εleeve and having a diεtal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior εurface of εaid compression sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said gripping means on said 183 εtem when εaid distal end of each of said prongs is individually received in individual of the lumenε of the selected dual lumen catheter and the selected dual lumen catheter with εaid εtem received therein iε poεitioned within εaid paεsageway of εaid compression sleeve; and

(c) an opposing set of radially displaceable, resilient C-εhaped clampε poεitioned at εaid proximal end of εaid second locking sleeve.

140. A catheter connection syεtem aε defined in Claim 139, wherein εaid interior εurface of εaid pliable compreεεion εleeve radially, inwardly compresseε a portion of the body wall of the selected catheter against each of said adjacent prongs to compress at least a portion of the partition wall between said adjacent prongs.

141. A catheter conversion system for effecting a fluid tight coupling and a mechanical joinder between a selected dual lumen catheter and two separate selected single lumen catheters, the selected dual lumen catheter being chosen from among two or more dual lumen catheters each having a unique combination of size and material composition distinct from the others of the catheters, the selected dual lumen catheter having a body wall with an exterior surface and an interior surface, the dual lumen catheter further having a partition wall extending between spaced locations on the interior surface to define two distinct longitudinally extending, fluid flow lumens within the body wall, each of the selected single lumen catheters being chosen from among two or more catheterε each having a combination of size and material composition distinct from the other of the catheters, the selected εingle lumen catheter having a body wall with an exterior εurface and with an interior εurface defining a longitudinally 184 extending, fluid flow lumen, said catheter conversion εystem compriεing:

(a) an adapter having a first end and an opposing second end; (b) a dual lumen catheter connection system positioned at said first end of said adapter, said dual lumen catheter connection syεtem compriεing:

(i) a εtem attached at said first end in fluid communication with said adapter, εaid εtem having a pair of adjacent prongε εeparated by a gap and each terminating at a free distal end, each of said prongs having an exposed exterior surface and an interior surface defining a passageway extending therethrough; (ii) gripping means on εaid expoεed exterior surface of each of said prongs for engaging the interior surface of each of the lumens of the selected dual lumen catheter when said distal end of each of said prongs is individually received in individual of the lumenε of the selected dual lumen catheter, and for enabling locking of the selected dual lumen catheter on said stem; and

(iii) holding meanε operative when εaid diεtal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter for radially, inwardly compressing a portion of the body wall of the selected dual lumen catheter against a portion of said gripping meanε on each of εaid prongε, and for interacting with εaid gripping means to preclude unintentional diεengagement of the εelected catheter from εaid εtem; and

(c) a pair of single lumen catheter connection syεtems positioned at εaid εecond end of said adapter, individual of said single lumen catheter connection 185 syεtemε being in fluid communication with εaid passageways of said dual lumen catheter connection syεtem, each of said single lumen catheter connection systems comprising: (i) a rigid stem attached at a proximal end to said second end of said adapter, said stem having a free distal end opposite said proximal end and an exterior surface extending therebetween; (ii) anchoring means on said exterior surface of said stem for engaging the interior surface of the selected single lumen catheter when said distal end of said stem is received in the lumen of the selected single lumen catheter, and for enabling locking of the selected εingle lumen catheter on said stem; and

(iii) clinching means operative when εaid diεtal end of said stem is received in the lumen of the selected single lumen catheter for radially, inwardly compressing a portion of the body wall of the selected single lumen catheter against a portion of said anchoring means on said stem, and for interacting with εaid anchoring means to preclude unintentional disengagement of the selected single lumen catheter from said stem.

142. A catheter connection εyεtem as defined in Claim 141, wherein said gripping means compriseε: (a) a plurality of engagement barbε εpanning across and radially, outwardly extending on said exposed exterior surface of each of said prongs, said engagement barbs each having a maximum outer radius that decreases in size towards said distal end of said stem, said engagement barbs being sized so that a least a portion of said engagement barbs fit within 186 each of the lumens of the selected dual lumen catheter when said distal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter; and (b) a locking barb spanning across and radially, outwardly extending on said exposed exterior surface of each of said prongs between said engagement barbs and the medical device, said locking barb having a maximum outer radius that iε larger than εaid maximum outer radiuε of each of said engagement barbs.

143. A catheter connection system as defined in Claim 141, wherein said holding means comprises a first fastening asεembly, εaid firεt fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking εleeve, said interior surface of said first locking εleeve radially, inwardly compreεsing a portion of the body wall of the εelected catheter againεt a portion of εaid gripping means on said stem when said distal end of each of said prongs is individually received in individual of the lumens of the selected dual lumen catheter and the εelected dual lumen catheter with εaid εtem received therein iε poεitioned within εaid passageway of said first locking sleeve; and

(b) an annular compresεion ring extending inwardly from εaid interior εurface of said first locking sleeve .

144. A catheter connection syεtem aε defined in Claim 141, wherein εaid holding means compriεes a second fastening assembly corresponding to the selected catheter said second fastening assembly comprising: 187

(a) a εecond locking sleeve having a diεtal end, a proximal end, and an interior εurface defining a passageway extending therebetween;

(b) a pliable compression sleeve longitudinally disposed within said passageway of said second locking sleeve and having a distal end, a proximal end, and an interior εurface defining a passageway longitudinally extending therethrough, said interior surface of said compression sleeve radially, inwardly compressing a portion of the body wall of the selected catheter againεt said portion of said gripping means on said stem when said diεtal end of each of εaid prongs iε individually received in individual of the lumens of the selected dual lumen catheter and the selected dual lumen catheter with εaid stem received therein is positioned within said passageway of said compresεion εleeve; and

(c) an oppoεing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of εaid εecond locking εleeve.

145. A catheter connection εyεtem as defined in Claim 144, wherein said interior surface of said pliable compreεεion sleeve radially, inwardly compresεes a portion of the body wall of the selected catheter against each of said adjacent prongs to compress at least a portion of the partition wall between said adjacent prongε.

146. A catheter connection εyεtem as defined in Claim 141, wherein the anchoring means comprises:

(a) a first set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling said stem on said distal end of εaid stem, said first set of engagement barbs having a maximum outer diameter so sized aε to fit within the lumen of the εelected catheter when said distal end of 188 said stem is received in the lumen of the selected catheter;

(b) a second set of engagement barbs radially, outwardly extending on said exterior surface of said stem and encircling εaid εtem proximal of said first set of engagement barbs, said second εet of engagement barbε having a maximum outer diameter larger than said first set of engagement barbs; and

(c) a locking barb radially, outwardly extending on said exterior surface of said stem and encircling said stem between said second set of engagement barbs and the medical device, said locking barb having a maximum outer diameter that is larger than said maximum outer diameter of said second set of engagement barbs.

147. A catheter connection system as defined in Claim 141, wherein said clinching meanε compriεeε a firεt fastening assembly, said first fastening assembly comprising:

(a) a first locking sleeve having a proximal end, a distal end, and an interior surface defining a passageway longitudinally extending through said first locking εleeve, εaid interior surface of said first locking sleeve radially, inwardly compressing a portion of the body wall of the selected catheter against said portion of said anchoring means on said stem when said stem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said first locking sleeve; and

(b) an annular compreεεion ring extending inwardly from εaid interior εurface of εaid firεt locking εleeve . 189

148. A catheter connection system as defined in Claim 141, wherein said clinching means comprises a second fastening asεembly corresponding to the selected catheter, said second faεtening assembly comprising: (a) a second locking sleeve having a distal end, a proximal end, and an interior surface defining a pasεageway extending therebetween;

(b) a pliable compresεion εleeve longitudinally diεpoεed within εaid passageway of said εecond locking εleeve and having a diεtal end, a proximal end, and an interior εurface defining a pasεageway longitudinally extending therethrough, εaid interior surface of said compresεion εleeve radially, inwardly compreεεing a portion of the body wall of the εelected catheter againεt εaid portion of εaid anchoring meanε on εaid εtem when εaid εtem is received in the lumen of the selected catheter and the selected catheter with said stem received therein is positioned within said passageway of said compreεεion εleeve; and (c) an oppoεing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve.

149. A catheter connection system as defined in Claim 141, wherein said clinching means comprises a third fastening assembly corresponding to the selected catheter, said third fastening asεembly compriεing:

(a) a third locking εleeve having a distal end, a proximal end, and an interior surface defining a passageway extending therebetween;

(b) a pliable compresεion sleeve longitudinally disposed within said pasεageway of said third locking sleeve and having a distal end, a proximal end, and an interior surface defining a passageway longitudinally extending therethrough, said interior surface of εaid compreεεion εleeve compriεing: 190

(i) an annular first portion having an inner diameter positioned at said distal end so as to encircle and radially, inwardly compress a portion of the body wall of the selected catheter against at least a portion of said first set of engagement barbs when εaid stem is received within said passageway of said compresεion sleeve; and

(ii) an annular second portion having an inner diameter larger than said inner diameter of said first portion, εaid εecond portion being poεitioned at said proximal end so as to encircle at least a portion of said second set of engagement barbs when said stem is received within said passageway of said compression sleeve; and

(c) an opposing set of radially displaceable, resilient C-shaped clamps positioned at said proximal end of said second locking sleeve .

150. A catheter connection syεtem as recited in Claim 141, wherein said stem comprises:

(a) a distal portion having an outer diameter on which said first set of engagement barbs are poεitioned; and

(b) a proximal portion having an outer diameter larger than εaid outer diameter of εaid distal εection, εaid εecond set of engagement barbs being positioned on said proximal section.