Endovascular delivery system

• US 5,968,068 A
• Filed: 09/12/1996
• Issued: 10/19/1999
• Est. Priority Date: 09/12/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation, W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Baxter International Inc.
• Inventors: Yu, Weiyun, White, Geoffrey H., Dehdashtian, Mark, Saravia, Maria Lilian
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/713,070
• Time in Patent Office: 1,132 Days
• Field of Search: 606/108, 606/192, 606/195, 606/194, 604/51, 604/96, 604/103, 604/104, 604/280
• US Class Current: 606/192
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body. Thereafter, the dilator may be removed from the introducer sheath and the delivery catheter/loader assembly may be attached to the introducer, such that the delivery catheter having the prosthesis mounted thereon may advanced through the introducer, to a desired location within the body. Thereafter, the radial expandable endoluminal prosthesis mounted on the delivery catheter is deployed and implanted by an expansion device (e.g., balloon) formed on the delivery catheter. The delivery catheter may incorporate one or more outflow apertures at specific location(s) to facilitate injection of radiographic contrast medium in a manner which will check for leakage around the endoluminal prosthesis, after the endoluminal prosthesis has been radially expanded and implanted.

Claims

1. A delivery catheter system for implanting a tubular endoluminal prosthesis within a body lumen of a mammal, said delivery catheter system comprising:

a) an elongate catheter body having a longitudinal axis projectable therethrough, said catheter body comprising;

i) an outer tube having a proximal end, a distal end and a hollow lumen extending longitudinally therethrough;

ii) an elongate inner member having a proximal end and a distal end, said inner member extending longitudinally through the lumen of said outer tube such that a distal portion of said inner member protrudes out of and extends beyond the distal end of said outer tube;

b) an annular balloon for radially expanding said endoluminal prosthesis, said balloon having a proximal end and a distal end, the proximal end of said balloon being affixed to said outer tube and distal end of said balloon being operatively connected to the distal portion of said inner member;

c) a balloon inflation fluid passageway which extends longitudinally through said catheter body to permit balloon inflation fluid to be infused into and withdrawn from said balloon;

d) at least one of said outer tube and said inner member being moveable relative to the other so as to reduce the radial profile of the balloon when the balloon is deflated; and

e) a tubular endoluminal prosthesis mounted upon said balloon such that said endoluminal prosthesis will become radially expanded by inflation of said balloon.

2. The system of claim 1 wherein said balloon, when inflated, comprises:

a substantially cylindrical sidewall disposed coaxially about said longitudinal axis, said sidewall having a proximal end and a distal end;

a proximal end wall extending from the proximal end of the cylindrical sidewall to the outer surface of said outer tube; and

,

a distal end wall extending from the distal end of the cylindrical sidewall to the outer surface of said inner member;

said proximal end wall and said distal end wall being disposed at angles which are no more than ten degrees from an axis which is perpendicular to the longitudinal axis of the catheter body.

3. The system of claim 1 further comprising a proximal connector assembly attached to said catheter body for facilitating the longitudinal movement of said outer tube and said inner member relative to each other.

4. The system of claim 3 wherein said proximal connector assembly includes a spacer clip releasably attached thereto for preventing the inadvertent longitudinal movement of the outer tube and inner member relative to each other.

5. The system of claim 1 further comprising an elongate pusher body having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough, said outer tube extending longitudinally through the lumen of said pusher body such that the balloon protrudes from the distal end of the pusher body.

6. The system of claim 5 wherein said pusher body includes an enlarged distal portion for receiving the proximal end of the balloon and a proximal portion of the endoluminal prosthesis.

7. The system of claim 5 further comprising a loader slidably advancable along the pusher body and adapted to receive the balloon and the endoluminal prosthesis.

8. The system of claim 1 further comprising at least one radiopaque marker attached to said catheter body to facilitate the precise positioning of the endoluminal prosthesis within a desired region of the body lumen.

9. The system of claim 8 comprising:

a first radiopaque marker attached to the outer tube of the catheter body adjacent the proximal end of the balloon; and

a second radiopaque marker attached to the inner member of the catheter body adjacent the distal end of the balloon;

said first and second radiopaque markers being positioned adjacent respective ones of the opposed ends of the endoluminal prosthesis mounted to the balloon to facilitate the precise positioning of the endoluminal prosthesis within a desired region of the body lumen.

10. The system of claim 2 wherein the proximal and distal end walls are disposed at angles of no more than 10°

from an axis which is perpendicular to the longitudinal axis of the catheter body.

11. The system of claim 2 wherein the proximal and distal end walls are disposed at angles of no more than 5°

from an axis which is perpendicular to the longitudinal axis of the catheter body.

12. The system of claim 1 wherein the prosthesis is pressure-expandable.

13. The system of claim 2 wherein said endoluminal prosthesis has a length which is substantially the same as the length of the cylindrical side wall of said balloon.

14. The system of claim 1 wherein at least one of said outer tube and said inner tube are longitudinally moveable relative to the other so as to cause tightening of the balloon by longitudinal extension thereof, when the balloon is deflated.

15. The system of claim 1 wherein at least one of said outer tube and said inner tube is rotatably moveable relative to the other so as to cause tightening by twisting of the balloon, when the balloon is deflated.

16. A delivery catheter for implanting a tubular endoluminal prosthesis within a body lumen of a mammal, said delivery catheter comprising:

a) an elongate, pliable catheter body having a longitudinal axis projectable therethrough, a proximal end and a distal end;

b) an annular balloon for radially expanding said endoluminal prosthesis, said balloon having, in its un-inflated state;

i) a substantially cylindrical sidewall which is disposed coaxially about the longitudinal axis of said catheter body, said sidewall having a proximal end and a distal end;

ii) a proximal end wall which extends from the proximal end of said cylindrical sidewall to the catheter body; and

iii) a distal end wall which extends from the distal end of said cylindrical sidewall to the catheter body;

iv) said proximal end wall and said distal end wall being disposed at angles which are no more than ten degrees from an axis which is perpendicular to the longitudinal axis of the catheter body.

17. The delivery catheter of claim 16 wherein at least one of said proximal and distal end walls of said balloon forms an internal angle of 80°

-90°

relative to the longitudinal axis of said catheter body.

18. The delivery catheter of claim 16 wherein at least one of said proximal and distal end walls of said balloon forms an internal angle of 85°

-90°

relative to the longitudinal axis of said catheter body.

19. The delivery catheter of claim 16 wherein said catheter body comprises:

an outer tube having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough; and

an elongate inner member having a proximal end and a distal end, said inner member extending longitudinally through the lumen of said outer tube such that the distal portion of said inner member protrudes out of and extends beyond the distal end of said outer tube;

the proximal end wall being affixed to said outer tube and said distal end wall being affixed to said inner member, with at least one of said outer tube and said inner member being moveable relative to the other so as to cause tightening of the balloon when the balloon is deflated.

20. The delivery catheter of claim 19 further comprising an elongate pusher body having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough, said outer tube extending longitudinally through the lumen of said pusher body such that the balloon protrudes from the distal end of the pusher body.

21. The delivery catheter of claim 20 wherein said pusher body includes an enlarged distal portion for receiving the proximal end of the balloon and a proximal portion of the endoluminal prosthesis.

22. The delivery catheter of claim 20 further comprising a loader slidably advancable along the pusher body and adapted to receive the balloon and the endoluminal prosthesis.

23. The delivery catheter of claim 19 further comprising at least one radiopaque marker attached to said catheter body to facilitate the precise positioning of the endoluminal prosthesis within a desired region of the body lumen.

24. The delivery catheter of claim 23 comprising:

a first radiopaque marker attached to the outer tube of the catheter body adjacent the proximal end of the balloon; and

a second radiopaque marker attached to the inner member of the catheter body adjacent the distal end of the balloon;

said first and second radiopaque markers being positioned adjacent respective ones of the opposed ends of the endoluminal prosthesis mounted to the balloon to facilitate the precise positioning of the endoluminal prosthesis within a desired region of the body lumen.

25. A system for implanting a radially expandable endoluminal prosthesis within a body lumen of a mammal and for checking for endoleaks whereby endogenous fluid flowing through the body lumen may leak outside of the radially expanded and implanted endoluminal prosthesis, said system comprising:

a) an elongate catheter having a longitudinal axis projectable therethrough, a proximal end, and a distal end;

b) a radially expandable endoluminal prosthesis secured to said catheter such that said catheter may be advanced longitudinally to an implantation position whereat said endoluminal prosthesis may be released from said catheter and radially expanded such that the endoluminal prosthesis will be in abutting contact with the body lumen and will remain substantially stationary therewith following removal of the catheter;

c) at least one radiographic contrast medium outflow aperture comprising a side port formed in said delivery catheter at a location which is upstream of said endoluminal prosthesis when said delivery catheter is in said implantation position; and

,

d) a radiographic contrast medium lumen extending longitudinally through the catheter to said at least one outflow aperture, such that radiographic contrast medium may be injected through said lumen and out of said outflow aperture when said catheter is in said implantation position, and following radial expansion and implantation of said tubular endoluminal prosthesis, to radiographically determine whether any of said endoleaks are present.

26. The system of claim 25 wherein delivery catheter is intended to be advanced in retrograde fashion into the body lumen wherein the endoluminal prosthesis is to be implanted, and wherein in said at least one radiographic contrast outflow aperture is located in a portion of the catheter which is distal to the endoluminal prosthesis such that radiographic contrast medium will flow out of said outflow aperture(s) upstream of the radially expanded and implanted endoluminal prosthesis.

27. The system of claim 25 wherein said catheter is intended to be advanced in the same direction as a flow of endogenous fluid through said body lumen, and wherein said at least one radiographic contrast medium outflow aperture is formed in said catheter at a location which is proximal to the location of the endoluminal prosthesis, such that radiographic contrast medium flowing out of said outflow aperture(s) will be introduced upstream of the radially expanded and implanted endoluminal prosthesis.

28. A tubular cannula which is insertable into a mammalian body, said cannula comprising:

a tubular cannula body having a proximal end, a distal end and a hollow lumen extending longitudinally therethrough; and

,

a radiopaque marker embedded within said tubular cannula body at a location which will be within the mammalian body when the tubular cannula is inserted thereinto.

29. The cannula of claim 28, wherein said radiopaque marker is located adjacent the distal end of said cannula body to permit the positioning of the distal end of the cannula body to be radiologically visualized within the body.

30. The cannula of claim 28 wherein said radiopaque marker is a ring formed of radiopaque material.

31. A delivery catheter for implanting a tubular endoluminal prosthesis within a body lumen of a mammal, said delivery catheter comprising:

a) an elongate, pliable catheter body, comprising;

i) a longitudinal axis projectable therethrough, a proximal end and a distal end;

ii) an outer tube having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough;

iii) an elongate inner member having a proximal end and a distal end, said inner member extending longitudinally through the lumen of said outer tube such that the distal portion of said inner member protrudes out of and extends beyond the distal end of said outer tube; and

iv) the proximal end wall being affixed to said outer tube and said distal end wall being affixed to said inner member, with at least one of said outer tube and said inner member being moveable relative to the other so as to cause tightening of the balloon when the balloon is deflated;

b) an annular balloon for radially expanding said endoluminal prosthesis, said balloon having;

c) a substantially cylindrical sidewall which is disposed coaxially about the longitudinal axis of said catheter body, said sidewall having a proximal end and a distal end;

d) a proximal end wall which extends from the proximal end of said cylindrical sidewall to the catheter body; and

e) a distal end wall which extends from the distal end of said cylindrical sidewall to the catheter body;

f) said proximal end wall and said distal end wall being disposed at angles which are no more than ten degrees from an axis which is perpendicular to the longitudinal axis of the catheter body.

32. The delivery catheter of claim 31 further comprising an elongate pusher body having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough, said outer tube extending longitudinally through the lumen of said pusher body such that the balloon protrudes from the distal end of the pusher body.

33. The delivery catheter of claim 32 wherein said pusher body includes an enlarged distal portion for receiving the proximal end of the balloon and a proximal portion of the endoluminal prosthesis.

34. The delivery catheter of claim 32 further comprising a loader slidably advancable along the pusher body and adapted to receive the balloon and the endoluminal prosthesis.

35. The delivery catheter of claim 31 further comprising at least one radiopaque marker attached to said catheter body to facilitate the precise positioning of the endoluminal prosthesis within a desired region of the body lumen.

36. The delivery catheter of claim 35 comprising:

a) a first radiopaque marker attached to the outer tube of the catheter body adjacent the proximal end of the balloon; and

b) a second radiopaque marker attached to the inner member of the catheter body adjacent the distal end of the balloon;

c) said first and second radiopaque markers being positioned adjacent respective ones of the opposed ends of the endoluminal prosthesis mounted to the balloon to facilitate the precise positioning of the endoluminal prosthesis within a desired region of the body lumen.

37. A system for implanting a radially expandable endoluminal prosthesis within a body lumen of a mammal and for checking for endoleaks whereby endogenous fluid flowing through the body lumen may leak outside of the radially expanded and implanted endoluminal prosthesis, said system comprising:

a) an elongate catheter having a longitudinal axis projectable therethrough, a proximal end, and a distal end;

b) a radially expandable endoluminal prosthesis secured to said catheter such that said catheter may be advanced longitudinally to an implantation position whereat said endoluminal prosthesis may be released from said catheter and radially expanded such that the endoluminal prosthesis will be in abutting contact with the body lumen and will remain substantially stationary therewith following removal of the catheter;

c) a hollow tubular member extending from the proximal end of the catheter through the endoluminal prosthesis and having a distal radiographic contrast medium outflow aperture formed at a location distal with respect to said endoluminal prosthesis, such that radiographic contrast medium may be injected through said hollow tubular member and out of said outflow aperture when said catheter is in said implantation position, and following radial expansion and implantation of said tubular endoluminal prosthesis, to radiographically determine whether any of said endoleaks are present.

38. The system of claim 37, wherein said distal radiographic contrast medium outflow aperture comprises a side port formed in said hollow tubular member.

39. A tubular cannula which is insertable into a mammalian body, said cannula comprising:

a) a tubular cannula body having a proximal end, a distal end and a hollow lumen extending longitudinally therethrough; and

,

b) a radiopaque marker embedded within said tubular cannula body at a location which will be within the mammalian body when the tubular cannula is inserted thereinto, wherein said radiopaque marker is embedded within said tubular cannula body by a process which comprises the steps of;

i) initially positioning the radiopaque marker on the outer surface of said cannula;

ii) causing a portion of said cannula body adjacent said radiopaque marker to become melted, such that molten cannula material will flowably surround said radiopaque marker; and

,

iii) allowing the molten cannula material to re-solidify with said radiopaque marker embedded therewithin.

40. The cannula of claim 39, wherein said radiopaque marker is located adjacent the distal end of said cannula body to permit the positioning of the distal end of the cannula body to be radiologically visualized within the body.

41. The cannula of claim 39 wherein said radiopaque marker is a ring formed of radiopaque material.

42. The cannula of claim 39 wherein said cannula has an outer surface of an outer diameter, and wherein said marker is a ring having an outer diameter which is no larger than the outer diameter of said cannula, and wherein step a comprises:

a) initially removing a portion of the outer surface of the cannula adjacent the distal end thereof to create a reduced diameter region of said cannula; and

,

b) advancing said ring onto the reduced diameter region of the cannula.

43. The cannula of claim 39 wherein the melting of said cannula in step b is accomplished by applying radio frequency energy to the cannula.

44. A delivery catheter for implanting a tubular endoluminal prosthesis within a body lumen of a mammal, said delivery catheter comprising:

a) an elongate catheter body having a longitudinal axis projectable therethrough, said catheter body comprising;

b) an outer tube having a proximal end, a distal end and a hollow lumen extending longitudinally therethrough;

c) an elongate inner member having a proximal end and a distal end, said inner member extending longitudinally through the lumen of said outer tube such that a distal portion of said inner member protrudes out of and extends beyond the distal end of said outer tube;

d) an annular balloon for radially expanding said endoluminal prosthesis, said balloon having a proximal end and a distal end, the proximal end of said balloon being affixed to said outer tube at a location proximal to the distal end of the outer tube so that a distal portion of the outer tube extends within the balloon, and distal end of said balloon being affixed to the distal portion of said inner member;

e) a radiopaque marker provided on the distal portion of the outer tube and within the balloon;

f) a balloon inflation fluid passageway which extends longitudinally through said catheter body to permit balloon inflation fluid to be infused into and withdrawn from said balloon; and

,

at least one of said outer tube and said inner member being moveable relative to the other so as to cause tightening of the balloon when the balloon is deflated.

45. The catheter of claim 44 further including a radiopaque marker provided on the distal portion of the inner member and within the balloon.