Apparatus and method for placing bifurcated stents

• US 20020077692A1
• Filed: 07/18/2001
• Published: 06/20/2002
• Est. Priority Date: 11/18/1999
• Status: Active Grant

• Current Assignee: Petrus Besselink
• Original Assignee: Petrus Besselink
• Inventors: Besselink, Petrus
• Granted Patent: US 6,669,718 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end

Abstract

An apparatus and method to place a bifurcated stent into a body lumen by using a delivery device requiring only one incision. Relative axial movements between a catheter and a sheath in the delivery device permit the insertion and expansion of the stent. During placement into and removal from the patient'"'"'s body, the branch sections of the bifurcated stent are held in substantially parallel arrangement. Opposing tendencies between a self-expanding stent and leg portions within the delivery device can be tailored such that, during deployment, the bifurcation bias due to the elastic spring forces in the stent overcome the parallel bias within the delivery device. In situations where a balloon-expandable stent is used, the delivery device obviates the need for balloon change during stent placement. Such catheters can also be used for angioplasty, eventually in combination with stenting, and are also equally applicable to both multibranch and side branch body lumens, which are difficult to reach with conventional devices and techniques.

Claims

1. A catheter configured for the placement of a bifurcated surgical device in a body lumen such that only a single surgical incision is necessary, said catheter comprising:

an elongate body of substantially tubular construction, said elongate body comprising;

a proximal end;

a distal end sufficiently enlarged relative to said proximal end so as to sheath engaging end portions of said bifurcating surgical device; and

a hollow core extending from said proximal end to said distal end; and

a central catheter wire disposed substantially within and translatable relative to said hollow core of said elongate body such that said central catheter wire can deploy said bifurcated surgical device relative to said catheter, said central catheter wire comprising;

a first leg portion with a user-engageable proximal end and a distal end, said first leg portion configured to engage a first branch section of said bifurcated surgical device;

a second leg portion with a distal end coupled to said distal end of said first leg portion at a bifurcation point;

said second leg portion configured to engage a second branch section of said bifurcated surgical device; and

a trunk portion with a proximal end coupled to said first leg portion and said second leg portion at said bifurcation point, said trunk portion configured to engage a trunk section of said bifurcated surgical device.

2. A catheter according to claim 1, wherein said central catheter wire is biased such that said first leg portion, said second leg portion and said trunk are substantially parallel.

3. A catheter according to claim 1, further comprising:

a first marker disposed at said proximal end of said elongate body; and

a second marker disposed at said user engageable proximal end of said first leg portion such that the relative axial and angular positions between said first and second leg portions provide indicia of the translational and angular orientations of said surgical device relative to said body lumen.

4. A catheter according to claim 1, further comprising:

a plurality of travelling sheaths, each configured to restrain a portion of said bifurcated surgical device encased therein; and

a travelling sheath deployment wire disposed adjacent said central catheter wire, said travelling sheath deployment wire coupled to at least one of said plurality of travelling sheaths.

5. A catheter according to claim 4, wherein said central catheter wire further includes at least one mechanical stop disposed thereon.

6. A catheter according to claim 4, wherein said plurality of travelling sheaths are configured to be decoupled from one another.

7. A catheter configured for the placement of a self-expanding bifurcated surgical device in a body lumen such that only a single surgical incision is necessary, said catheter comprising:

an elongate body of substantially tubular construction, said elongate body comprising;

a proximal end;

a distal end sufficiently enlarged relative to said proximal end so as to sheath engaging end portions of said bifurcating surgical device; and

a hollow core extending from said proximal end to said distal end;

a central catheter wire disposed substantially within and translatable relative to said hollow core of said elongate body such that said central catheter wire can deploy said bifurcated surgical device relative to said catheter, said central catheter wire comprising;

a first leg portion with a user-engageable proximal end and a distal end, said first leg portion configured to engage a first branch section of said bifurcated surgical device;

a second leg portion with a distal end coupled to said distal end of said first leg portion at a bifurcation point;

said second leg portion configured to engage a second branch section of said bifurcated surgical device; and

a trunk portion with a proximal end coupled to said first leg portion and said second leg portion at said bifurcation point, said trunk portion configured to engage a trunk section of said bifurcated surgical device;

a plurality of travelling sheaths, each configured to restrain a portion of said bifurcated surgical device encased therein;

a biasing sleeve that is configured to apply a contracting force to at least one of said plurality of travelling sheaths; and

a travelling sheath deployment wire disposed adjacent said central catheter wire, said travelling sheath deployment wire coupled to at least one of said plurality of travelling sheaths.

8. A stent delivery catheter for the placement of a stent in a body lumen side branch, said stent delivery catheter comprising:

a core wire, said core wire including;

a main body portion with a user-graspable proximal end and a distal end; and

a leg portion joined to said distal end of said main body portion to form a hinged relationship therebetween;

a sheath configured to restrain said main body portion and said leg portion in a substantially parallel relationship; and

a sheath deploying wire disposed adjacent said core wire, said sheath deploying wire comprising;

a user-graspable proximal end; and

a distal end coupled to said sheath to permit rotational and translational motion of said sheath upon user-defined movement imparted at said user-graspable proximal end of said sheath deploying wire.

9. A stent delivery catheter according to claim 8, further comprising:

a first marker disposed at said user-graspable proximal end of said main body portion of said core wire; and

a second marker disposed at said user-graspable proximal end of said sheath deploying wire such that the relative axial and angular positions between said first and second markers provide indicia of the translational and angular orientations of said stent relative to said body lumen.

10. A stent delivery catheter comprising:

an elongate body of substantially tubular construction, said elongate body comprising;

a proximal end;

a distal end sufficiently enlarged relative to said proximal end so as to sheath an engaging end portion of said stent; and

a hollow core extending from said proximal end to said distal end;

a central catheter core wire disposed within and positionable relative to said hollow core of said elongate body, said central catheter core wire comprising;

a main body portion with a user-graspable proximal end and a distal end; and

a leg portion comprising;

a distal end joined to said distal end of said main body portion to form a hinged relationship therebetween; and

a remote end engageable with said stent; and

a stent release wire disposed within and positionable relative to said hollow core of said elongate body, said stent release wire comprising;

a main body portion with a user-graspable proximal end; and

a distal end configured to engage said stent and said remote end of said leg portion.

11. A method for implanting a bifurcated surgical device having first and second branch sections connected to a trunk in such a way that said branch sections are resiliently biased to open to a preferred angle between them, said method comprising the steps of:

defining a delivery catheter to include;

an elongate body of substantially tubular construction, said elongate body comprising;

a proximal end;

a substantially hollow distal end sufficiently enlarged relative to said proximal end so as to define a restraining means; and

a hollow core extending from said proximal end to said distal end; and

a central catheter core wire disposed within and positionable relative to said hollow core of said elongate body, said central catheter wire comprising;

a first leg portion with a proximal end and a distal end;

a second leg portion with a distal end coupled to said distal end of said first leg portion at a wire bifurcation point;

a trunk portion with a proximal end coupled to said first leg portion and said second leg portion at said wire bifurcation point;

attaching said bifurcated surgical device to at least a portion of said delivery catheter;

placing at least an end of said branch sections of said bifurcated surgical device in said restraining means such that said branch sections and trunk are substantially parallel;

routing said surgical device and said distal end of said catheter into a body lumen bifurcating point in such a position that both of said branch sections of said surgical device are positioned entirely beyond said body lumen bifurcation point, where said body lumen bifurcation point includes a trunk section and branch sections;

releasing said branch sections of said bifurcated surgical device from said restraining means to enable them to occupy said preferred angle relative to one another;

seating said bifurcated surgical device adjacent said body lumen bifurcation point such that each of said trunk and branch sections of said bifurcated surgical device are in operative cooperation with respective said trunk and branch sections of said body lumen;

causing said branch and trunk sections of said bifurcated surgical device to expand until they come in the desired final size in their respective said trunk and branch sections of said body lumen;

reducing contact between said delivery catheter and said bifurcated surgical device, thereby effecting return of said delivery catheter to a substantially as-inserted dimension;

moving said delivery catheter without said bifurcated surgical device to a position where said leg portions of said delivery catheter can elastically return to a preferable, substantially parallel state;

moving said restraining means over at least a portion of said first and second leg portions to secure said delivery catheter in said substantially parallel state; and

removing said delivery catheter from the patient'"'"'s body.

12. The method according to claim 11 wherein the bias between said branch sections of said bifurcated surgical device is sufficient to overcome a contrariwise tendency to return to said substantially parallel state for said leg portions of said delivery catheter.

13. The method according to claim 11, wherein said bias between said branch sections of said bifurcated surgical device is caused by elastic energy which is stored in at least one of said bifurcated surgical device, an additional elastic backbone element defining at least a part of said surgical device, or an attached graft material.

14. The method according to claim 11, wherein said step of causing said trunk and branch sections of said bifurcated surgical device to expand is performed by inflating bifurcated balloon sections that are mounted on said central catheter wire, and inside said respective trunk and branch sections.

15. The method according to claim 14, said method including the step of deflating said balloon sections after placement of said bifurcated surgical device in said body lumen.

16. The method according to claim 15, wherein said inflation and deflation of said balloon sections is performed by moving a fluid through said hollow core of said elongate body.

17. The method according to claim 16, wherein the time of deflation and the final diameter for said balloon sections are minimized by surrounding said balloon sections with an elastic biasing sleeve that squeezes said fluid out of said balloon, while helping to maintain the concentric, circular cross section of said deflating balloon sections.

18. The method according to claim 11, wherein the step of causing said trunk and branch sections of said bifurcated surgical device to expand is performed by axial release of a plurality of travelling sheaths, each of said plurality of travelling sheaths configured to hold respective said trunk and branch sections in their compressed state.

19. The method according to claim 18, wherein a travelling sheath deployment wire is connected to the free end of at least one of said plurality of travelling sheaths, and is used to push or pull said at least one travelling sheath from its respective bifurcated surgical device trunk or leg portion.

20. The method according to claim 19, wherein the release of said bifurcated surgical device portions from said traveling sheaths is caused by a series of axial movements of said travelling sheath deployment the wire in proximal and distal direction while said bifurcated surgical device is in a constant axial position relative to the body lumen.

21. The method according to claim 20, wherein said travelling sheath deployment wire includes a mechanical stop at its proximal end, and said central catheter wire includes at least one mechanical stop such that it can apply an axial force to one of said plurality of travelling sheaths in response to user-applied force.

22. The method according to claim 18, wherein the step of minimizing the dimensions of the delivery catheter after expansion of said bifurcated surgical device sections is performed by the use of an elastic biasing sleeve, surrounding at least one of said plurality of travelling sheaths.

23. The method according to claim 11, wherein said elongate body includes enhanced flexibility to facilitate movement through said body lumen.

24. The method according to claim 23, wherein said elongate body is made of a polymer, a metal or a combination thereof.

25. The method according to claim 11, wherein said delivery catheter is made from the group of materials consisting of polymers, metals, memory materials with superelastic or temperature-dependent behavior, organic materials, ceramics, or combinations thereof.

26. The method according to claim 11, wherein at least one marker disposed on a proximal end of said central catheter wire provides angular position indicia of said bifurcated surgical device as well as relative axial position of said components within said delivery catheter.

27. The method according to claim 11, wherein said bifurcated surgical device is an angioplasty balloon.

28. The method according to claim 11, wherein said bifurcated surgical device is a stent comprising a graft.

30. The method according to claim 29, wherein said restraining means is used to minimize said angle between said trunk and branch sections, while removal of said restraining means causes an increase of said angle.

31. The method according to claim 30, further including a sliding ring that engages at least a part of said trunk and branch sections, said sliding ring being moved axially by a proximally actuated element.

32. The method according to claim 31, wherein removal of said sliding ring from between said trunk and branch sections causes a decrease of said angle.

33. The method according to claim 31, wherein said sliding ring is pushed between at least a part of said trunk and branch sections to increase the angle therebetween.

34. The method according to claim 30, wherein said deployment wire is attached to said remote end of said core wire, said deployment wire configured to pull said remote end of said core wire toward a substantially parallel relationship with said trunk section.

35. The method according to claim 29, wherein said components of said catheter are made from materials from the group consisting of polymers, metals, memory materials with superelastic or temperature-dependent behavior, organic materials, ceramics, or combinations thereof.

36. The method according to claim 29, comprising the additional step of manipulating at least one marker disposed at a proximal end of said catheter to provide angular and translational position indicia of said catheter when placed in said body lumen.

37. The method according to claim 29, wherein said surgical device is placed together with a graft.

38. The method according to claim 29, wherein said surgical device is an angioplasty balloon.

39. The method according to claim 29, wherein said surgical device is a stent.

40. The method according to claim 29, wherein said restraining means is disposed over at least a portion of said distal end of said core wire.

41. The method according to claim 29, wherein said restraining means is disposed over at least a portion of said proximal end of said core wire.

29. A method for bringing a surgical device into a side branch of a body lumen by means of a bifurcating delivery catheter, said method comprising the steps of:

defining said bifurcating delivery catheter to comprise;

a substantially elongate restraining means with at least one hollow portion;

a core wire engageable with said restraining means, said core wire defining a proximal end, a distal end and a remote end, said core wire configured to translate and rotate a surgical device inside a body lumen, said core wire comprising;

a trunk section extending from said proximal end to said distal end; and

a branch section extending from said distal end to said remote end, said branch section hingedly connected to said trunk section at said distal end such that an angle formed between said trunk and branch sections can be varied by axial manipulation of said restraining means; and

a deployment wire to provide movement to either said restraining means or said surgical device;

attaching said surgical device in its unexpanded state to said catheter;

minimizing said angle between said trunk and branch sections through axial displacement of said restraining means;

routing said surgical device and said distal portion of said catheter into said body lumen near a lumen bifurcating point such that said remote end of said branch section is adjacent said side branch of said body lumen;

releasing said remote end of said branch section from said restraining means to enable said branch section to hingedly deploy away from said trunk section, thereby increasing said angle between said trunk and branch sections;

bringing said catheter with said surgical device in its said unexpanded state into operative engagement with said side branch of said body lumen;

expanding said surgical device to a preferred expanded state in said side branch of said body lumen;

returning said catheter to its as-inserted dimension, thereby facilitating removal from said surgical device;

moving said catheter without said surgical device to a position where said trunk and branch sections of said core wire can return to a preferable, substantially parallel state;

moving said restraining means in axial direction such that said trunk and branch sections of said core wire are brought back into said substantially parallel state; and

removing said catheter from said body.