Medical grafting methods and apparatus

• US 6,602,263 B1
• Filed: 10/20/2000
• Issued: 08/05/2003
• Est. Priority Date: 11/30/1999
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Inventors: Galdonik, Jason A., Boldenow, Gregory A., Bonilla, Luis, Cornelius, Rick, Swanson, William J., Berg, Todd A., Hindrichs, Paul J.
• Primary Examiner(s): Calvert, John J.
• Assistant Examiner(s): Hurley, Shaun R
• Application Number:
  US09/693,578
• Time in Patent Office: 1,019 Days
• Field of Search: 606/139, 606/142, 606/151, 606/153-158
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 46/17 closed at the distal end

Abstract

Methods and apparatus for making an anastomotic connection between a first conduit and a second conduit. A connector structure having a first end portion and a second end portion is positioned about a balloon catheter, which when pressurized, expands to a significant extent at the distal end thereof. The balloon enlarges the connector structure when positioned at the distal end portion of the balloon to create the anastomosis, and at the same time reduces the axial length of the connector, thereby compressing the first conduit to the second conduit, creating a hemodynamic seal and a firm attachment of the two conduits. After enlargement, the connector structure remains in place and adds structure to the anastomosis. During introduction, the second end portion of the connector is covered by a nosecone assembly to prevent trauma to the second conduit while the apparatus is being introduced. The nosecone assembly has a flexible structure which may change configuration to expose the second set of members after insertion into the second conduit and to allow removal of the nosecone after deployment.

Claims

1. Method for making an anastomotic connection between a first opening in a side wall of a first vessel and a second opening in a side wall of a second vessel, comprising:

providing a connector structure having a first end portion configured to engage the first vessel and a second end portion configured to engage the second vessel, the connector structure being plastically deformable from a first configuration to a second configuration having an enlarged annular dimension;

providing a balloon having an expanded configuration defining a substantially large diameter adjacent the distal end thereof;

making the first opening in the side wall of the first vessel;

attaching the first vessel to the connector structure;

making the second aperture in the side wall of the second vessel;

providing an introduction structure for the connector structure comprising a first introduction configuration and a second removal configuration having smooth proximal surface;

inserting the introduction structure along with the second end portion of the connector structure into the second opening; and

attaching the first vessel to the second vessel adjacent the first and second openings to form a fluid-tight anastomotic connection therebetween by annularly enlarging the connector structure to the second configuration with the distal end portion of the balloon.

2. Method as defined in claim 1, wherein making the opening in the side wall of one of the first and the second vessels comprises:

making an incision in the side wall of the vessel; and

dilating the incision to a dimension substantially equal to an internal diameter of the connector structure.

3. Method as defined in claim 1, wherein making the first opening in the side wall of the first vessel comprises making an incision in the side wall of the first vessel having a dimension substantially equal to an internal diameter of the second vessel.

4. Method as defined in claim 1, wherein providing the connector structure further comprises providing a first plurality of members at said first end portion having free ends configured to penetrate the side wall of the first vessel at locations that are annularly spaced about the first opening.

5. Method as defined in claim 4, wherein attaching the first vessel to the connector structure further comprises penetrating the side wall of the first vessel at locations that are annularly spaced about the first aperture with the free ends of the plurality of second members.

6. Method as defined in claim 1, further comprising:

providing a ring structure having a body portion defining a substantially toroidal shape configured for placement about the first opening in the side wall of the first vessel, the ring structure having an inner diameter which is sized to cover the periphery of the first opening and an outer diameter which is sized to substantially inhibit insertion thereof into the second aperture of the second vessel during the inserting.

7. Method as defined in claim 6, further comprising:

after attaching the connector structure in the first configuration to the first vessel, positioning the ring structure about the aperture in the side wall of the first vessel.

8. Method as defined in claim 1, wherein inserting the second end portion of the connector structure into the second opening comprises inserting the connector structure substantially parallel to an internal lumen of the second conduit.

9. Method as defined in claim 1, which further comprises:

after inserting the second end portion of the connector structure into the second opening substantially parallel to the internal lumen of the second conduit, moving to the connector structure to a configuration substantially perpendicular to the internal lumen of the second conduit.

10. Method as defined in claim 1, wherein the introduction structure further comprises a first configuration with a tapered portion configured to surround the second end portion of the connector structure,

wherein inserting the second end portion of the connector structure into the second opening comprises inserting the tapered portion into the aperture of the second vessel while in a surrounding configuration with respect to the connector structure, and unfolding the introduction structure to a second configuration to expose the second end portion of the connector structure.

11. Method as defined in claim 1, wherein the introduction structure further comprises a first configuration with a tapered portion configured to surround the second end portion of the connector structure,

wherein inserting the second end portion of the connector structure into the second opening comprises inserting the tapered portion into the aperture of the second vessel while in a surrounding configuration with respect to the connector structure, and advancing the tapered portion distally to a position spaced apart from the connector structure.

12. Method as defined in claim 11, wherein providing the introduction structure further comprises providing an intermediate portion proximal of the tapered structure that is flexible between a folded first configuration, defining a recess for receiving the second portion of the connector structure, and an unfolded second configuration, and an elongated tubular structure proximal of the intermediate structure configured to extend proximally within an internal lumen of the first conduit,

wherein the inserting the tapered portion into the aperture of the second vessel comprises positioning the elongated tubular structure within the internal lumen of the first conduit and positioning the second end portion of the connector in the recess of the intermediate portion, and

wherein the advancing the tapered portion comprises advancing the tapered portion such that the elongated tubular portion remains substantially stationary and the intermediate portion is unfolded from the folded first configuration to the unfolded second configuration.

13. Method as defined in claim 12, wherein the tapered structure, the intermediate portion, and the elongated tubular structure are in fluid communication,

wherein advancing the tapered portion comprises introducing fluid into the tapered structure and the intermediate portion through the elongated tubular structure.

14. Method as defined in claim 1, further comprising:

providing a balloon structure having a balloon configured for expansion within the connector structure,

wherein attaching the first vessel to the second vessel by annularly enlarging the connector structure comprises inflating the balloon disposed inside the connector structure.

15. Method as defined in claim 14, wherein inflating the balloon disposed inside the connector structure comprises inflating the balloon such that the connector structure is positioned adjacent the distal end of the balloon at a distance less than an internal diameter of the second vessel.

16. Method as defined in claim 14, wherein the balloon has an expanded configuration defining a substantially large diameter adjacent a distal end thereof, and

wherein inflating the balloon disposed inside the connector structure comprises inflating the balloon such that the connector structure is positioned at about 2.5 mm from the distal end of the balloon.

17. Method as defined in claim 1, wherein providing the connector structure further comprises providing a second plurality of members at said second end portion having free ends configured to engage the side wall of the second vessel at locations that are annularly spaced about the second opening.

18. Method as defined in claim 17, wherein attaching the first vessel to the second vessel further comprises engaging the side wall of the second vessel at locations that are annularly spaced about the second aperture with the free ends of the plurality of second members.

19. Method as defined in claim 1, wherein providing a connector structure comprises providing the first and second end portions that are annularly enlargeable to a greater extent than the remainder of the connector structure,

wherein attaching the first vessel and the second vessel by annularly enlarging the connector structure comprises annularly enlarging the first and second end portions to a greater extent than the remainder of the connector structure, wherein the first and second end portions are approximated.

20. Method as defined in claim 1, further comprising:

after attaching the first and second vessels, closing the end portion of the first vessel.

21. System for making an anastomotic connection between a first opening in a side wall of a first vessel and a second opening in a side wall of a second vessel, comprising:

a connector structure having a first end portion configured for attachment to the first vessel and a second end portion configured to engage the second vessel, the connector being plastically deformable from a first configuration to a second configuration having an enlarged annular dimension substantially equivalent to an internal diameter of the second vessel;

a balloon structure having a balloon configured for positioning within the connector structure to enlarge the connector structure from the first configuration to the second configuration, the balloon structure configured to define a substantially large diameter adjacent to the distal end thereof; and

an introduction structure comprising a first configuration having a tapered portion for introduction into the second opening and defining a recess for surrounding the second end portion of the connector structure during said introduction into the second opening, and a second configuration having a smaller dimension and a smooth proximal surface, wherein the introduction structure is configured to move to the second configuration to expose the second end portion of the connector structure.

22. System as defined in claim 21, wherein the connector structure further comprises a first plurality of members at said first end portion having free ends configured to penetrate the side wall of the first vessel at locations that are annularly spaced about the first opening.

23. System as defined in claim 21, further comprising:

a ring structure having a body portion configured for placement about the first opening, the ring structure having an inner diameter which is sized to cover the side wall of the first vessel about the periphery of the first opening, and an outer diameter which is sized to substantially inhibit passage of the first vessel into the second opening.

24. System as defined in claim 21, further comprising:

a ring structure having a body portion configured for placement about the first opening, which provides a visual indication of the first opening.

25. System as defined in claim 21, wherein a portion of the introduction structure is flexible between a substantially straight configuration and a configuration defining an angle of about 90 degrees.

26. System as defined in claim 21, wherein the introduction structure further comprises an intermediate portion proximal of the tapered portion, the intermediate portion defining the recess for receiving the second end portion of the connector structure in the first configuration and capable of being unfolded in the second configuration, and an elongated tubular structure proximal of the intermediate structure configured to extend proximally within an internal lumen of the first conduit.

27. System as defined in claim 26, wherein the tapered portion is configured for advancement such that the elongated tubular portion remains substantially stationary and the intermediate portion is unfolded from the folded configuration to the unfolded configuration.

28. System as defined in claim 27, wherein the tapered structure, the intermediate portion, and the elongated tubular structure define a common internal space in fluid communication.

29. System as defined in claim 28, wherein introduction structure is configured such that introduction of fluid into the common internal space causes distal advancement of the tapered structure.

30. System as defined in claim 28, wherein introduction structure is configured such that introduction of fluid into the common internal space causes simultaneous movement of the intermediate portion from the folded configuration to the unfolded configuration and distal advancement of the tapered structure.

31. System as defined in claim 21, wherein the balloon has an expanded configuration defining a substantially large diameter adjacent a distal end thereof, and

wherein inflating the balloon disposed inside the connector structure comprises inflating the balloon such that the connector structure is positioned adjacent the distal end of the balloon.

32. System as defined in claim 21, wherein the first and second end portions of the connector structure are configured for annular enlargement to a greater extent than the remainder of the connector structure.

33. System as defined in claim 21, wherein the connector structure comprises a first axial length in the first configuration and a second, shorter axial length in the second configuration.

34. System as defined in claim 21, wherein the connector structure further comprises a second plurality of members at said second end portion having free ends configured to penetrate the side wall of the second vessel at locations that are annularly spaced about the second opening.

35. The method of making a hollow annular anastomotic connection between a portion of a side wall of a tubular graft conduit and a side wall of a tubular body tissue conduit in a patient so that body fluid can flow through the connection between a lumen of the graft conduit and a lumen of the tubular body tissue conduit, the graft conduit having first and second portions that extend axially along the graft conduit in respective opposite directions away from the portion of the side wall of the graft conduit, the first portion being used for body fluid flow after the connection has been made, and the second portion having a severed end spaced from the portion of the side wall of the graft conduit, comprising:

inserting instrumentation for making the connection into the lumen of the second portion so that the instrumentation extends between the severed end and the portion of the side wall of the graft conduit.

36. The method defined in claim 35 further comprising:

causing a portion of the instrumentation to extend through the portion of the side wall of the graft conduit.

37. The method defined in claim 36 further comprising:

further causing the portion of the instrumentation to pass through the side wall of the body tissue conduit.

38. The method defined in claim 37 further comprising:

providing the portion of the instrumentation with a hollow annular connector.

39. The method defined in claim 38 further comprising:

engaging with a first portion of the connector the portion of the side wall of the graft conduit, the engaging being in a first hollow annular pattern that is substantially concentric with the connector.

40. The method defined in claim 39 further comprising:

using the instrumentation to position the connector so that a second portion of the connector can engage the side wall of the body tissue conduit in a second hollow annular pattern that is substantially concentric with the connector.

41. The method defined in claim 40 further comprising:

further using the instrumentation to cause the second portion of the connector to engage the side wall of the body tissue conduit in the second hollow annular pattern.

42. The method defined in claim 41 wherein the further using comprises:

employing the instrumentation to change in shape at least some parts of the connector.

43. The method defined in claim 42 wherein the employing comprises:

annularly enlarging the connector.

44. The method defined in claim 42 wherein the employing comprises:

deflecting first parts of the connector radially out relative to second parts of the connector.

45. The method defined in claim 42 wherein the employing comprises:

causing the first and second portions of the connector to move toward one another substantially parallel to an axis about which the connector is annular.

46. The method defined in claim 42 wherein the employing comprises:

causing the first and second portions of the connector to press together hollow annular portions of the portion of the side wall of the graft conduit and the side wall of the body tissue conduit.

47. The method defined in claim 41 further comprising:

after the further using, withdrawing the instrumentation from the connector and from the patient via the severed end.

48. The method defined in claim 47 further comprising:

after the withdrawing, closing the lumen of the second portion of the graft conduit.

49. The method defined in claim 42 wherein the instrumentation comprises an inflatable balloon around which the connector is annularly disposed, and wherein the employing comprises:

inflating the balloon.

50. The method defined in claim 49 further comprising:

after the inflating, deflating the balloon; and

after the deflating, withdrawing the instrumentation from the connector and from the patient via the severed end.

51. The method defined in claim 50 further comprising:

after the withdrawing, closing the lumen of the second portion of the graft conduit.

52. The method defined in claim 40 wherein the instrumentation includes a substructure configured to selectively cover the second portion of the connector, and wherein the using comprises:

employing the substructure to cover the second portion of the connector until the second portion of the connector is positioned where it can be made to engage the side wall of the body tissue conduit in the second hollow annular pattern; and

operating the substructure to uncover the second portion of the connector.

53. The method defined in claim 52 wherein the substructure comprises an inflatable balloon configured to cover the second portion of the connector prior to inflation, and wherein the operating comprises:

inflating the balloon.

54. A method of making a graft connection between first, second, and third portions of a patient'"'"'s body tissue conduit system, the first portion supplying body fluid to the graft, and the second and third portions receiving body fluid from the graft comprising:

supplying a graft conduit;

forming a first hollow annular anastomotic connection between a first location along the graft conduit and the first portion of the body tissue conduit system so that body fluid can flow from the first portion into the graft conduit at the first location via the first connection;

using a first hollow annular connector to form a second hollow annular anastomotic connection between apertures in a side wall of the graft conduit at a second location along the graft conduit and in a side wall of the second portion of the body tissue conduit system so that body fluid can flow from the graft conduit into the second portion via the second connection; and

using a second hollow annular connector to form a third hollow annular anastomotic connection between apertures in the side wall of the graft conduit at a third location along the graft conduit and in a side wall of the third portion of the body tissue conduit system so that body fluid can flow from the graft conduit into the third portion via the third connection.

55. The method defined in claim 54 wherein the graft conduit has a severed end;

wherein the first location, the second location, the third location, and the severed end are in that order along the graft conduit; and

wherein the using a second hollow annular connector comprises;

introducing the second connector into the graft conduit via the severed end.

56. The method defined in claim 55 wherein the using a second hollow annular connector further comprises:

passing the second connector inside the graft conduit from the severed end to the third location until a first portion of the second connector extends through the aperture at the third location, while a second portion of the second connector remains inside the graft conduit adjacent the aperture at the third location.

57. The method defined in claim 56 wherein the using the second connector further comprises:

engaging the second portion of the second connector with the side wall of the graft conduit annularly around the aperture at the third location.

58. The method defined in claim 57 wherein the using the second connector further comprises:

approximating the aperture at the third location with the aperture in the third portion of the body tissue conduit system; and

inserting the first portion of the second connector into the aperture in the third portion of the body tissue conduit system.

59. The method defined in claim 58 wherein the using the second connector further comprises:

engaging the first portion of the second connector with the side wall of third portion of the body tissue conduit system annularly around the aperture in that portion of the body tissue conduit system.

60. The method defined in claim 59 wherein the using the second connector further comprises:

deforming at least parts of the second connector after the inserting.

61. The method defined in claim 60 wherein the deforming comprises:

causing parts of the second connector to increase in radial outward extension.

62. The method defined in claim 60 wherein the deforming comprises:

annularly expanding the second connector.