Apparatus and methods for occluding a hollow anatomical structure

• US 20050277959A1
• Filed: 05/26/2004
• Published: 12/15/2005
• Est. Priority Date: 05/26/2004
• Status: Active Grant

• Current Assignee: Atricure, Inc.
• Original Assignee: I D X Medical Ltd
• Inventors: Williamson, Warren P. IV, Berky, Craig B., Cosgrove, Delos M.
• Granted Patent: US 7,645,285 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/2825 Inserts of different material in jaws

Abstract

A device for occluding a hollow anatomical structure includes a clamp having at least first and second clamping portions adapted to be placed on opposite sides of the anatomical structure. At least one of the first and second clamping portions is movable toward the other from an open position to a clamping or closed position to occlude the anatomical structure. The clamp has an annular shape configured to surround the hollow anatomical structure in the open position and a flattened shape in the clamping position configured to occlude the hollow interior of the anatomical structure. The clamp is preferably covered with fabric to promote tissue ingrowth. A clamp delivery and actuation device is provided for allowing the clamp to be applied in either an open surgical procedure or a minimally invasive procedure.

Claims

1. A device for occluding a hollow anatomical structure, the device comprising:

a clamp having at least first and second clamping portions adapted to be placed on opposite sides of the hollow anatomical structure, at least one of said first and second clamping portions being movable toward the other of said first and second clamping portions from an open position into a clamping position to occlude the hollow anatomical structure,

said clamp comprising an annular shape configured to surround the hollow anatomical structure in the open position and a flattened shape in the clamping position configured to occlude the hollow interior of the hollow anatomical structure.

2. The device of claim 1, wherein said first and second clamping portions further comprise concave portions curved in opposite directions to form said clamp into a generally oval shape.

3. The device of claim 1, wherein at least one of said first and second clamping portions is spring biased toward the other of said first and second clamping portions in the clamping position.

4. The device of claim 3, wherein said one of said first and second clamping portions is normally spring biased toward the other of said first and second clamping portions when said first and second clamping portions are in the open position.

5. The device of claim 3, wherein said one of said first and second clamping portions is movable toward the other of said first and second clamping portions to an over-center position at which said one of said first and second clamping portions is spring biased toward the other of said first and second clamping portions.

6. The device of claim 1, wherein said first and second clamping portions have tissue engaging surfaces for engaging the hollow anatomical structure in the clamping position, at least one of said tissue engaging surfaces adapted to promote tissue ingrowth.

7. The device of claim 6, wherein said at least one tissue engaging surface includes pores sized from about 200 to about 400 microns.

8. The device of claim 1, further comprising a fabric covering on at least one of said first and second clamping portions.

9. The device of claim 1, wherein at least one of said first and second clamping portions includes a resilient polymeric surface for preventing the clamp from slipping on the hollow anatomical structure.

10. The device of claim 1, wherein said first and second clamping portions have complementary shapes in cross section such that said complementary shapes fit together in the clamping position.

11. The device of claim 1, wherein at least one of said first and second clamping portions is convexly curved toward the other of said first and second clamping portions in cross section.

12. The device of claim 1, further comprising projections on at least one of said first and second clamping portions configured to engage the hollow anatomical structure when said clamp is in the clamping position.

13. The device of claim 12, further comprising receiving elements configured to engage and lock with said projections when said clamp is in the clamping position.

14. The device of claim 1, further comprising at least one locking element engageable with at least one of said first and second clamping portions to lock said first and second clamping portions in the clamping position.

15. The device of claim 14, wherein said locking elements further comprise ratchet elements.

16. The device of claim 1, further comprising an actuating element associated with at least one of said first and second clamping portions and configured to move said one of said first and second clamping portions toward the other of said first and second clamping portions.

17. The device of claim 16, wherein said actuating element further comprises a magnetic element.

18. The device of claim 16, wherein said actuating element is movable to force said one of said first and second clamping portions toward the other of said first and second clamping portions.

19. The device of claim 18, wherein said actuating element further comprises a cam element.

20. The device of claim 19, wherein said cam element is rotatable to move said one of said first and second clamping portions toward the other of said first and second clamping portions.

21. The device of claim 19, wherein said cam element is slidable to move said one of said first and second clamping portions toward the other of said first and second clamping portions.

22. A device for occluding a hollow anatomical structure, the device comprising:

a clamp having at least first and second concave clamping portions adapted to be placed on opposite sides of the hollow anatomical structure to form a generally oval shape, at least one of said first and second clamping portions being movable under spring bias toward the other of said first and second clamping portions from an open position into a clamping position and locked in place in the clamping position to occlude the hollow anatomical structure,

said clamp configured to surround the hollow anatomical structure in the open position and assume a flattened shape in the clamping position to occlude the hollow interior of the hollow anatomical structure, and

a fabric covering on at least one of said first and second clamping portions, wherein said fabric prevents the clamp from slipping on the hollow anatomical structure.

23. The device of claim 22, wherein said first and second clamping portions have complementary shapes in cross section such that said complementary shapes fit together in the clamping position.

24. The device of claim 22, wherein at least one of said first and second clamping portions is convexly curved toward the other of said first and second clamping portions in cross section.

25. The device of claim 22, further comprising projections on at least one of said first and second clamping portions configured to engage the hollow anatomical structure when said clamp is in the clamping position.

26. The device of claim 25, further comprising receiving elements configured to engage and lock with said projections when said clamp is in the clamping position.

27. The device of claim 22, further comprising at least one locking element engageable with at least one of said first and second clamping portions to lock said first and second clamping portions in the clamping position.

28. The device of claim 22, wherein said fabric covering is adapted to promote tissue ingrowth.

29. The device of claim 28, wherein said fabric covering includes pores sized from about 200 to about 400 microns.

30. A device for occluding a hollow anatomical structure, the device comprising:

a clamp having at least first and second concave clamping portions adapted to be placed on opposite sides of the hollow anatomical structure to form a generally oval shape, at least one of said first and second clamping portions being movable toward the other of said first and second clamping portions from an open position into a clamping position and locked in place in the clamping position to occlude the hollow anatomical structure,

said clamp configured to surround the hollow anatomical structure in the open position and assume a flattened shape in the clamping position to occlude the hollow anatomical structure, and said one of said first and second clamping portions being movable toward the other of said first and second clamping portions to an over-center position at which said one of said first and second clamping portions is spring biased toward the other of said first and second clamping portions, and

a fabric covering on at least one of said first and second clamping portions to prevent the clamp from slipping on the hollow anatomical structure.

31. Apparatus for occluding a hollow anatomical structure, the device comprising:

a clamp delivery and actuation device including first and second jaws, and an actuator configured to move at least one of said first and second jaws toward the other of said first and second jaws, and

a clamp having at least first and second clamping portions releasably secured between said first and second jaws and adapted to be placed on opposite sides of the hollow anatomical structure, at least one of said first and second clamping portions being movable toward the other of said first and second clamping portions from an open position into a clamping position by said one of said first and second jaws to occlude the hollow anatomical structure,

said clamp comprising an annular shape configured to surround the hollow anatomical structure in the open position and a flattened shape in the clamping position configured to occlude the hollow interior of the hollow anatomical structure.

32. The apparatus of claim 31, wherein said first and second jaws and said clamp are configured to enable repeated movement of the clamp between the open and closed positions.

33. The apparatus of claim 31, wherein said clamp is releasably held to said first and second jaws by suture.

34. The apparatus of claim 32, wherein said clamp delivery and actuation device includes a movable blade configured to cut said suture to release said clamp from said first and second jaws.

35. The apparatus of claim 33, wherein said suture is tied to said clamp and is configured to be pulled to untie said suture and release said clamp from said first and second jaws.

36. The apparatus of claim 31, wherein said clamp is held to said first and second jaws by a gripping element, and said clamp delivery and actuation device further includes a tension member coupled with said gripping element, said tension member configured to be pulled to release said gripping element from said clamp thereby releasing said clamp from said first and second jaws.

37. The apparatus of claim 36, wherein said clamp has a length and said clamp is coupled to said first and second jaws so as to pivot about an axis generally transverse to said length.

38. The apparatus of claim 37, wherein said clamp pivots freely about said axis.

39. The apparatus of claim 37, wherein said clamp delivery and actuation device includes a pivoting mechanism coupled to said clamp and configured to pivot said clamp in opposite directions about said axis.

40. The apparatus of claim 31, wherein said clamp delivery and actuation device further comprises:

an elongate jaw support member extending along an axis and having a handle at a proximal end thereof and said first and second jaws at a distal end thereof, said first and second jaws lying generally in a plane oriented at an acute angle relative to said axis.

41. The apparatus of claim 40, wherein said axis is between about 20°

and about 30°

.

42. The apparatus of claim 31, wherein said clamp delivery and actuation device further includes a pistol grip with an actuating member configured to be manually depressed to move said one of said first and second jaws toward the other of said first and second jaws.

43. A method of occluding a hollow anatomical structure with an annular clamp having at least first and second clamping portions, the method comprising:

surrounding the hollow anatomical structure with the annular clamp, and

moving at least one of the first and second clamping portions toward the other of the first and second clamping portions to occlude the hollow anatomical structure.

44. The method of claim 43, wherein the hollow anatomical structure is the left atrial appendage of a heart.

45. The method of claim 44, wherein the method further comprises:

accessing the left atrial appendage of the heart through an intercostal space.

46. The method of claim 43, wherein at least one of said clamping portions further includes a fabric covering, and the method further comprises engaging the fabric covering with the hollow anatomical structure.

47. The method of claim 43, further comprising:

moving at least one of the first and second clamp portions away from the other of the first and second clamping portions;

repositioning the annular clamp on the pedunculated, hollow anatomical structure; and

moving at least one of the first and second clamping portions toward the other of the first and second clamping portions to occlude the hollow anatomical structure.

48. The method of claim 43, further comprising:

delivering the clamp in proximity to the pedunculated, hollow anatomical structure with a delivery device, and

pivoting the clamp with respect to the delivery device prior to the step of moving at least one of the first and second clamping portions toward the other of the first and second clamping portions to occlude the pedunculated, hollow anatomical structure.

49. The method of claim 43, wherein the step of moving at least one of the first and second clamping portions toward the other of the first and second clamping portions further comprises:

spring biasing one of the first and second clamping portions toward the other of the first and second clamping portions.

50. The method of claim 49, wherein the step of spring biasing one of the first and second clamping portions toward the other of the first and second clamping portions further comprises:

moving said one of the first and second clamping portions to an over center position relative to the other of the first and second clamping portions.

51. The method of claim 43, wherein the step of moving at least one of the first and second clamping portions toward the other of the first and second clamping portions further comprises:

changing the shape of the clamp from a generally oval shape to a flattened curved shape.

52. The method of claim 43, further comprising:

delivering the clamp in proximity to the hollow anatomical structure with a delivery device, and

squeezing an actuating member on a pistol grip of the delivery device to move at least one of the first and second clamping portions toward the other of the first and second clamping portions.

53. The method of claim 52, further comprising:

releasing the clamp from the delivery device by cutting a suture connection between the delivery device and the clamp.

54. The method of claim 52, further comprising:

releasing the clamp from the delivery device by untying a suture connection between the delivery device and the clamp.

55. The method of claim 52, further comprising:

releasing the clamp from the delivery device by spreading apart a pair of gripping elements engaged with the clamp.

56. The method of claim 55, wherein spreading apart the pair of gripping elements further comprises:

using a spring bias to move at least one of the gripping elements away from the other.

57. The method of claim 43, further comprising:

engaging a plurality of projections on the clamp with the hollow anatomical structure.

58. The method of claim 57, wherein the projections extend from the first clamping portion and the second clamping portion includes corresponding receiving elements, and the method further comprises:

engaging the projections in the receiving elements while moving at least one of the first and second clamping portions toward the other of the first and second clamping portions.

59. The method of claim 58, wherein at least one of said clamping portions further includes a fabric covering, and the method further comprises engaging the fabric covering with the hollow anatomical structure.

60. The method of claim 43, further comprising:

pulling the hollow anatomical structure through the annular clamp using flat, paddle-shaped gripper elements.

61. The method of claim 43, further comprising:

initially containing the annular clamp in a hollow structure with the first and second clamping portions in a closed position;

inserting the hollow structure into a patient;

deploying the annular clamp from within the hollow structure; and

moving at least one of the first and second clamping portions away from the other of the first and second clamping portions into an open position.

62. Apparatus for occluding a hollow anatomical structure, the device comprising:

a clamp delivery and actuation device including a hollow structure containing a clamp deploying member; and

a clamp having at least first and second clamping portions adapted to be placed on opposite sides of the hollow anatomical structure, at least one of said first and second clamping portions being movable toward and away from the other of said first and second clamping portions between a closed position and an open position in which said clamp assumes an annular shape, said clamp being carried within said hollow structure in said closed position and extendable out of said hollow structure by said deploying member whereupon said clamp may be actuated to said open position and clamped onto the hollow anatomical structure.

63. The apparatus of claim 62, wherein said clamp is actuated into said open position during deployment of said clamp from said hollow structure.

64. The apparatus of claim 63, wherein said clamp is actuated into said closed position during retraction of said clamp into said hollow structure.

65. The apparatus of claim 62, wherein said hollow structure further comprises a tube adapted for minimally invasive surgery and having a maximum outer diameter of about 8 mm.