Over-the-wire apparatus and method for open surgery making of fluid connection between two neighboring vessels

• US 6,685,716 B1
• Filed: 01/04/2000
• Issued: 02/03/2004
• Est. Priority Date: 01/04/2000
• Status: Expired due to Term

• Current Assignee: TransVascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Flaherty, J. Christopher, Evard, Philip C.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Davis, D. Jacob
• Application Number:
  US09/478,109
• Time in Patent Office: 1,491 Days
• Field of Search: 606/52, 606/53, 606/153, 606/154, 606/159, 606/184, 606/185, 606/174, 606/205, 606/207, 606/170, 606/151, 606/156-158, 606/209
• US Class Current: 606/159
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

The invention provides a wire guided aperture creating apparatus, an over-the-wire kit, and a method for creating a hole in adjacent portions of first and second anatomical conduits during a surgical procedure. The apparatus includes an elongated element having a guidewire lumen and an aperture creating assembly disposed near the distal end of the elongated element. In a further embodiment the device may include first and second elongated elements coupled via a coupler and an aperture creating assembly disposed between the elements. At least one of the elements includes a passage-defining element permitting passage therethrough of a first guidewire. In addition to the devices identified above, the kit includes a first guidewire for insertion into a lumen of the first vessel to an initial cutpoint and then through adjacent portions of sidewalls of the first and second vessels into a lumen of the second vessel. The method involves inserting a first guidewire into a lumen of a first vessel to an initial cutpoint and then though adjacent portions of sidewalls of the first vessel and a second vessel into a lumen of the second vessel. The method further involves providing a wire guided aperture creating apparatus as identified above, and inserting the device over the first guidewire such that the passage-defining element passes over the first guidewire.

Claims

1. An over-the-wire kit for simultaneously cutting a slit in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure comprising:

A. a first guidewire for insertion into a lumen of the first vessel through adjacent portions of sidewalls of the first vessel and the second vessel into a lumen of the second vessel; and

B. a wire-guided cutting assembly including;

i. a first elongated element extending along a first axis between a proximal end and a distal end,

ii. a second elongated element extending along a second axis between a proximal end and a distal end,

iii. a coupler for coupling said first elongated element to said second elongated element whereby said first axis substantially intersects said second axis, and whereby said distal end of said first elongated element is movable with respect to said distal end of said second elongated element about an axis orthogonal to said first axis and said second axis, and

iv. a tissue cutting assembly disposed between said first and second elongated elements,

wherein at least one of said first and second elongated elements includes a passage-defining element permitting passage therethrough of said first guidewire,

wherein at least one of said first and second elongated elements is flexible at least near said distal end, and

wherein said tissue cutting assembly includes;

a blade at a point of coupling of said first and second elongated elements, wherein said blade faces away from said point of coupling.

2. A kit according to claim 1 wherein both of said first and second elongated elements are flexible at least near said distal ends.

3. An over-the-wire kit for simultaneously cutting a slit in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure comprising:

A. a first guidewire for insertion into a lumen of the first vessel through adjacent portions of sidewalls of the first vessel and the second vessel into a lumen of the second vessel; and

B. a wire-guided cutting assembly including;

i. a first elongated element extending along a first axis between a proximal end and a distal end,

ii. a second elongated element extending along a second axis between a proximal end and a distal end,

iii. a coupler for coupling said first elongated element to said second elongated element whereby said first axis substantially intersects said second axis, and whereby said distal end of said first elongated element is movable with respect to said distal end of said second elongated element about an axis orthogonal to said first axis and said second axis, and

iv. a tissue cutting assembly disposed between said first and second elongated elements

wherein at least one of said first and second elongated elements includes a passage-defining element permitting passage therethrough of said first guidewire, the kit farther comprising a second guidewire for insertion into a lumen of the first vessel, and wherein each of said first and second elongated elements includes a passage-defining element permitting passage therethrough of an associated one of said first and second guidewires.

4. A kit according to claim 3 wherein said first and second elongated elements are rigid and said coupling is a pivotal coupling about said orthogonal axis.

5. A kit according to claim 4, wherein said wire-guided cutting assembly is a scissors wherein each of said first and second elongated elements extends in a first direction from said intermediate point and has a handle cutting control element extending from said intermediate point in a direction at least in part opposite to the said direction,

wherein said pivotal coupling is at said intermediate point on said first and second elongated elements to form a pair of opposed cutting elements.

6. A kit according to claim 5 wherein a bisector of an angle formed by said first and second axes of said opposing cutting elements is angularly offset with respect to a bisector of an angle formed by said first and second axes of said handle cutting control elements.

7. A kit according to claim 3 wherein at least one of said first and second elongated elements is flexible at least near said distal end.

8. A kit according to claim 7 wherein said tissue cutting assembly includes:

a blade at a point of coupling of said first and second elongated elements, wherein said blade faces away from said point of coupling.

9. A kit according to claim 3 wherein said tissue cutting assembly includes:

a blade at a point of coupling of said first and second elongated elements, wherein said blade faces away from said point of coupling.

10. A kit according to claim 3 wherein said tissue cutting assembly includes

a hole punch on one said first and second elongated elements, said hole punch facing the other of said first and second elongated elements, and an anvil on said elongated element not having said hole punch, said anvil being opposite said hole punch.

11. A wire guided cutting apparatus for simultaneously cutting a slit in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure comprising:

A. a first elongated element extending along a first axis between a proximal end and a distal end;

B. a second elongated element extending along a second axis between a proximal end and a distal end;

C. a coupler for coupling said first elongated element to said second elongated element whereby said first axis substantially intersects said second axis, and whereby said distal end of said first elongated element is movable with respect to said distal end of said second elongated element about an axis orthogonal to said first and second axes; and

D. a tissue cutting assembly disposed between said first and second elongated elements, said tissue cutting assembly including a hole punch on one said first and second elongated elements, said hole punch facing the other of said first and second elongated elements, and an anvil on said elongated element not having said hole punch, said anvil being opposite said hole punch;

wherein each of said first and second elongated elements includes a passage-defining element permitting passage therethrough of an associated one of said first guidewire and a second guidewire.

12. A method for creating a hole in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure, comprising the steps of:

A. introducing a lead end of a first guidewire into a lumen of the first vessel and advancing said lead end through adjacent portions of sidewalls of the first vessel and the second vessel and into a lumen of the second vessel;

B. providing a wire guided cutting apparatus including;

i. a first elongated element extending along a first axis between a proximal end and a distal end,

ii. a second elongated element extending along a second axis between a proximal end and a distal end,

iii. a coupler for coupling said first element to said second element whereby said first axis substantially intersects said second axis, and whereby said distal end of said first element is movable with respect to said distal end of said second element about an axis orthogonal to said first axis and said second axis at said intersection of said first axis and said second axis, and

iv. a tissue cutting assembly disposed between said first and second elongated elements,

wherein a least one of said first and second elongated elements includes a passage-defining element permitting passage therethrough of said first guidewire; and

C. positioning said wire guided cutting apparatus over said first guidewire such that said passage-defining element passes over said first guidewire,

D. advancing said first and second elongated elements into said lumen of said first vessel and along said lumen whereby said first elongated element follows said first guidewire along said lumen of said first vessel and through said sidewalls of said first and second vessels and into said lumen of said second vessel which said second elongated element remains in said lumen of said first vessel, and

E. causing said tissue cutting assembly to cut tissue between said first and second elongated elements.

13. A method according to claim 12 further comprising the step of introducing a lead end of a second guidewire into said lumen of said first vessel and advancing said lead end in said lumen beyond said initial cutpoint,

wherein said providing step comprises providing said wire guided cutting apparatus wherein each of said first and second elongated elements has a passage-defining element permitting passage therethrough of an associated one of said first and second guidewires; and

wherein said positioning step comprises positioning said wire guided cutting apparatus over said first guidewire and said second guidewire such that said passage-defining element of one of said first and second elongated elements passes over one of said first and second guidewires, and said passage-defining element of the other of said first and second elongated elements passes over the other of said first and second guidewires.

14. An over-the-wire kit for simultaneously cutting a slit in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure, comprising:

a first guidewire for insertion into a lumen of the first vessel and through a sidewall of the first vessel into a lumen of the second vessel; and

a wire-guided cutting assembly including;

a first elongated element extending along a first axis between a proximal end and a distal end;

a second elongated element extending along a second axis between a proximal end and a distal end, the second elongated element being pivotably coupled to the first elongated element; and

a tissue cutting assembly disposed between the first and second elongated elements;

wherein each of the first and second elongated elements includes a tubular element permitting passage therethrough of the first guidewire and a second guidewire, respectively.

15. A kit according to claim 14, wherein the first and second elongated elements are rigid.

16. A kit according to claim 14, wherein the wire-guided cutting assembly is a pair of opposing cutting elements extending in a fist direction from a pivotal coupling point, arid a pair of handle cutting control elements extending from the pivotal coupling point in a direction at least in part opposite to the first direction.

17. A kit according to claim 14, wherein at least one of the first and second elongated elements is flexible at least near said distal end.

18. A kit according to claim 17, wherein the tissue cutting assembly includes a blade at the pivotal coupling point of the first and second elongated elements, the blade facing away from a coupling point where the second elongated element is pivotably coupled to the first elongated element.

19. A kit according to claim 17, wherein both of the first and second elongated elements are flexible at least near their distal ends.

20. A kit according to claim 14, wherein the tissue cutting assembly comprises a cooperating blade and anvil on the first and second elongated elements.

21. An over-the-wire kit for simultaneously cutting a slit in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure, comprising:

a first guidewire for insertion into a lumen of the first vessel and through a sidewall of the first vessel into a lumen of the second vessel; and

a wire-guided cutting assembly including;

a first elongated element extending along a first axis between a proximal end and a distal end;

a second elongated element extending along a second axis between a proximal end and a distal end, the second elongated element being pivotably coupled to the first elongated element;

a tissue cutting assembly disposed between the first and second elongated elements; and

a second guidewire for insertion into a lumen of the first vessel, and wherein each of the first and second elongated elements comprises a tubular element permitting passage therethrough of one of the first and second guidewires.

22. A wire-guided cutting apparatus for simultaneously cutting a slit in adjacent portions of a first blood vessel and a second blood vessel during a surgical procedure comprising:

a first elongated element comprising a proximal end, a distal end insertable into a first blood vessel, and a first axis therebetween, the first elongated element comprising a first tubular element comprising proximal and distal ends on the distal end of the first elongated element and comprising coaxial proximal and distal openings in the proximal and distal ends of the first tubular element for permitting passage therethrough of a first guidewire;

a second elongated element comprising a proximal end, a distal end insertable into a second blood vessel, and a second axis therebetween, the second elongated element being pivotably coupled to the first elongated element, the second elongated element comprising a second tubular element comprising proximal and distal ends on the distal end of the second elongated element and comprising coaxial proximal and distal openings in the proximal and distal ends of the second tubular element for permitting passage therethrough of a second guidewire; and

a tissue cutting assembly disposed between the first and second elongated elements.

23. A wire-guided cutting apparatus according to claim 22, wherein each of the passage-defining elements comprises a pair of ring-like guides.

24. A wire-guided cutting apparatus according to claim 22, wherein the passage-defining elements comprise channels extending through the first and second elongate elements, respectively.

25. A wire-guided cutting apparatus according to claim 22, wherein the first and second elongated elements are substantially rigid.

26. A wire-guided cutting apparatus according to claim 25, wherein the wire-guided cutting apparatus comprises opposing cutting elements extending in a first direction from an intermediate point, and a handle cutting control element extending from the intermediate point in a direction opposite to the first direction, the second elongated element being pivotably coupled to the first elongated element at the intermediate point.

27. A wire-guided cutting apparatus according to claim 26, wherein a bisector of an angle formed by the first and second axes of the opposed cutting elements is angularly offset with respect to a bisector of an angle formed by the first and second axes of the handle cutting control element.

28. A wire-guided cutting apparatus according to claim 22, wherein at least one of the first and second elongated elements is flexible at least near their distal ends.

29. A wire-guided cutting apparatus according to claim 22, wherein both of the first and second elongated elements are flexible at least near their distal ends.

30. A wire-guided cutting apparatus according to claim 22, wherein the tissue cutting assembly includes a blade at a point of coupling of the first and second elongated elements, the blade facing away from the point of coupling.

31. A wire-guided cutting apparatus according to claim 22, wherein the tissue cutting assembly comprises a cooperating blade and anvil on the first and second elongated elements.

32. An over-the-wire kit for simultaneously cutting a slit in adjacent portions of a first blood vessel ad a second blood vessel during a surgical procedure, comprising:

a first guidewire for insertion into a lumen of the first vessel and through a sidewall of the first vessel into a lumen of the second vessel; and

a wire-guided cutting assembly including;

a first elongated element extending along a first axis between a proximal end and a distal end, the first elongated element comprising a passage-defining element permitting passage therethrough of the firs guidewire;

a second elongated element extending along a second axis between a proximal end and a distal end, the second elongated element being pivotably coupled to the firs elongated element, the second elongated element comprising a passage-defining element permitting passage therethrough of a second guidewire; and

a tissue cutting assembly disposed between the first and second elongated elements; and

a second guidewire for insertion into a lumen of the first vessel, the second guidewire being insertable through the passage-defining element of the second elongated element.