Catheter introducer having an expandable tip

• US 7,144,386 B2
• Filed: 08/05/2003
• Issued: 12/05/2006
• Est. Priority Date: 06/29/2001
• Status: Expired due to Term

• Current Assignee: AB Korkor Medical Incorporated
• Original Assignee: AB Korkor Medical Incorporated
• Inventors: Ash, Stephen, Kruger, Robert J., Korkor, Adel B.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Ahmed, Aamer S.
• Application Number:
  US10/634,715
• Publication Number:
  US 20040030319A1
• Time in Patent Office: 1,218 Days
• Field of Search: 604/93.01, 604/104, 604/264, 60416401-16411, 604/543, 604/523, 604/173, 604/506, 606/185, 606/198, 606/108, 606190-192, 606/136, 606/167
• US Class Current: 604/164.03
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A catheter includes a body having an outer surface defining a lumen and an expandable tip on a distal end thereof. The tip includes an opening axially extending therethrough. Upon insertion of a device having a larger outer diameter than the inner diameter of the expandable tip, the opening permits passage of the device therethrough. The tip expands commensurately with a difference between the outer diameter of the device and the inner diameter of the expandable tip. The expandable tip includes a tubular wall having an axially extending weakened portion formed from (1) at least two axially aligned slit segments and (2) at least two axially aligned segments that are strengthened when compared to the slit segments. One of the strengthened segments is positioned between two of the slit segments. Another of the strengthened segments is formed between a distal-most slit segment and a distal end of the expandable tip.

Claims

1. A catheter introducer, comprising:

(a) a body including an outer surface defining a lumen and having a proximal end and a distal end; and

(b) an expandable tip on the distal end, the expandable tip including a sidewall that is continuous and non-convoluted in an unexpanded state and including an opening axially extending therethrough and configured, upon insertion of a device having a larger outer diameter than the inner diameter of the expandable tip, to permit passage of the device therethrough, the expandable tip being configured to expand commensurately with a difference between the outer diameter of the device and the inner diameter of the expandable tip,

wherein the expandable tip comprises a tubular wall having an axially extending weakened portion formed from (1) at least two axially aligned slit segments and (2) at least two segments that are axially aligned with one another and with the slit segments and that are strengthened when compared to the slit segments, one of the strengthened segments being positioned between two of the slit segments and another, distal-most strengthened segments being formed between a distal-most slit segment and a distal end of the expandable tip and being weakened when compared to portions of the tubular wall that are circumferentially adjacent to the distal-most strengthened segment.

2. The catheter introducer of claim 1, wherein at least one of the strengthened segments comprises a scored segment having a wall thickness greater than a thickness of the expandable tip wall at the slit segments but less than a thickness of the remainder of the expandable tip wall.

3. The catheter introducer of claim 2, wherein the slit segments and the scored segments are formed in an outer peripheral surface of the expandable tip wall.

4. The catheter introducer of claim 1, wherein the body is formed from a material comprising a polymeric material.

5. The catheter introducer of claim 1, wherein the weakened portion of the expandable tip comprises at least four axially aligned slit segments.

6. The catheter introducer of claim 1, wherein the tubular wall of the expandable tip has at least two axially extending weakened portions.

7. The catheter introducer of claim 6, wherein the two weakened portions are offset from one another by about 180°

.

8. The catheter introducer of claim 1, wherein the slit segments extend at least essentially through the depth of the expandable tip wall.

9. The catheter introducer of claim 1, wherein the slit segments extend through at least about 90% through the depth of expandable tip wall.

10. The catheter introducer of claim 9, wherein the slit segments extend through at least about 99% of the depth the expandable tip wall.

11. The catheter introducer of claim 1, wherein at least one of the strengthened segments comprises a scored segment extending through about 10% of the depth of the expandable tip wall.

12. The catheter introducer of claim 11, wherein the scored segment extends through about 20% of the depth of the expandable tip wall.

13. The catheter introducer of claim 1, wherein all of the strengthened segments are weakened when compared to portions of the tubular wall that are circumferentially adjacent to the strengthened segments.

14. A catheter introducer, comprising:

(a) an elongate, hollow body having a distal end and a proximal end;

(b) a hub disposed at the proximate end, the hub being configured to permit communication between the hub and the body; and

(c) a tip disposed at the distal end and including a sidewall that is continuous and non-convoluted in an unexpanded state and including an opening extending axially therethrough, the opening being selectively radially expandable to permit passage through the tip of a device having a larger outer diameter than the inner diameter of the tip, the tip being configured to expand commensurately with a difference between the outer diameter of the device and the inner diameter of the expandable tip,

wherein the expandable tip comprises a tubular wall having an axially extending weakened portion formed from (1) at least two axially aligned slit segments and (2) at least two axially aligned segments that are strengthened when compared to the slit segments, one of the strengthened segments being positioned between the slit segments and another of the strengthened segments being formed between a distal-most slit segment and a distal end of the expandable tip, a distal-most one of the strengthened segments comprising a scored segment having a wall thickness greater than a thickness of the expandable tip wall at the slit segments but less than a thickness of the remainder of the expandable tip wall.

15. The catheter introducer of claim 14, wherein the body is tapered such that the distal end is narrower than the proximal end.

16. The catheter introducer of claim 14, wherein the slit segments are formed in an outer peripheral surface of the expandable tip wall.

17. The catheter introducer of claim 16, wherein the body is formed from a material comprising a polymeric material.

18. A method of inserting a medical device having a larger outer diameter than an inner diameter of a catheter tip of a catheter introducer through an opening in the catheter tip, the method comprising:

(a) cannulating a vein or artery with a needle and the catheter introducer, the catheter introducer being disposed over the needle and the catheter introducer including an expandable tip on a distal end thereof, the expandable tip including

(i) a body including an outer surface defining a lumen and having a distal end and a proximate end; and

;

(ii) an expandable tip on the distal end, the expandable tip having a tubular wall, including an opening axially extending therethrough and an axially extending weakened portion formed from (1) at least two axially aligned slit segments and (2) at least two segments that are axially aligned with the slit segments and with one another and that are strengthened when compared to the slit segments, one of the strengthened segments being positioned between two of the slit segments and another, distal-most strengthened segment being formed between a distal-most slit segment and the distal end of the expandable tip and being weakened when compared to portions of the tubular wall that are circumferentially at to the distal-most strengthened segment,

(b) removing the needle from the catheter introducer;

(c) inserting a medical device into the body, the device having a larger outer diameter than a minimum inner diameter of the expandable tip;

(d) inserting the medical device through the lumen of the body; and

(e) inserting the medical device through the opening of the expandable tip, thereby expanding the expandable tip as a result of the insertion of the medical device through the tip; and

then

(f) removing the catheter introducer from the patient'"'"'s body while leaving the device in place.

19. The method of claim 18, wherein the device comprises a guidewire.

20. The method of claim 19, further comprising, after the removing step, inserting a peripheral or central venous or arterial device over the guidewire and into the vein or artery, and then removing the guidewire from the peripheral or central venous or arterial device.

21. The method of claim 19, wherein the peripheral or central venous or arterial device comprises a PICC line.

22. The method of claim 18, wherein the expanding step comprises splitting the distal end of the expandable tip at least one of the weakened portions and expanding a width of at least one of the slit segments.

23. The method of claim 18, wherein all of the strengthened segments are weakened when compared to portions of the tubular wall that are circumferentially adjacent to the strengthened segments.

24. A catheter introducer, comprising:

(a) a body including an outer surface defining a lumen and having a proximal end and a distal end; and

(b) an expandable tip on the distal end, the expandable tip including a sidewall that is continuous and non-convoluted in an unexpanded state and including an opening axially extending therethrough and configured, upon insertion of a device having a larger outer diameter than the inner diameter of the expandable tip, to permit passage of the device therethrough, the expandable tip being configured to expand commensurately with a difference between the outer diameter of the device and the inner diameter of the expandable tip,

wherein the expandable tip comprises a tubular wall having an axially extending weakened portion formed from (1) at least one slit segment and (2) at least first and second scored segments that are axially aligned with each other and with the slit segment, the first scored segment being positioned between a proximal-most slit segment and a proximal end of the expandable tip, and the second scored segment extending from a distal-most slit segment to a distal end of the expandable tip.

25. The catheter introducer of claim 24, wherein the slit segment and the scored segments are formed in an outer peripheral surface of the expandable tip wall.

26. The catheter introducer of claim 24, wherein the body is formed from a material comprising a polymeric material.

27. The catheter introducer of claim 24, wherein the slit segment is a first slit segment, and wherein the weakened portion of the tubular wall further comprises a second slit segment that is axially aligned with the first slit segment and the scored segments and that is located between the second scored segment and the proximal end of the tip.

28. The catheter introducer of claim 24, wherein the weakened portion of the tubular wall includes at least two slit segments and at least two scored segments which are disposed in an alternating aligned abutting relationship with one another.

29. The catheter introducer of claim 24, wherein the tubular wall has a second weakened portion and which is circumferentially offset from the first weakened portion.

30. The catheter introducer of claim 24, wherein the two weakened portions are offset from one another by about 180°

.

31. The catheter introducer of claim 24, wherein the slit segments extend at least essentially through the depth of the tubular wall.

32. The catheter introducer of claim 24, wherein the slit segments extend through at least about 99% of the depth the tubular wall.

33. The catheter introducer of claim 24, wherein the scored segments extend through about 10% of the depth of the tubular wall.

34. The catheter introducer of claim 24, wherein the scored segment extends through about 20% of the depth of the tubular wall.

35. A method of inserting a medical device having a larger outer diameter than an inner diameter of a catheter tip of a catheter introducer through an opening in the catheter tip, the method comprising:

(a) cannulating a vein or artery with a needle and the catheter introducer, the catheter introducer being disposed over the needle and the catheter introducer including an expandable tip on a distal end thereof, the expandable tip including

(i) a body including an outer surface defining a lumen and having a distal end and a proximate end; and

;

(ii) an expandable tip on the distal end, the expandable tip including an opening axially extending therethrough and an axially extending weakened portion formed from (1) at least one slit segment and (2) at least first and second scored segments that are axially aligned with each other and with the slit segment, the first scored segment being positioned between a proximal-most slit segment and a proximal end of the expandable tip, and the second scored segment extend from a distal-most slit segment to a distal end of the expandable tip;

(b) removing the needle from the catheter introducer;

(c) inserting a medical device into the body, the device having a larger outer diameter than a minimum inner diameter of the expandable tip;

(d) inserting the medical device through the lumen of the body; and

(e) inserting the medical device through the opening of the expandable tip, thereby expanding the expandable tip as a result of the insertion of the medical device through the tip; and

then

(f) removing the catheter introducer from the patient'"'"'s body while leaving the device in place.

36. The method of claim 35, wherein the device comprises a guidewire.

37. The method of claim 36, further comprising, after the removing step, inserting a peripheral or central venous or arterial device over the guidewire and into the vein or artery, and then removing the guidewire from the peripheral or central venous or arterial device.

38. The method of claim 37, wherein the peripheral or central venous or arterial device comprises a PICC line.

39. The method of claim 38, wherein the expanding step comprises splitting the distal end of the expandable tip at least one of the weakened portions and expanding a width of at least one of the slit segments.