Methods and apparatus for making anastomotic connections larger than the graft conduit

• US 20040267290A1
• Filed: 03/29/2004
• Published: 12/30/2004
• Est. Priority Date: 03/28/2003
• Status: Active Grant

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Baker, Matthew, Krinke, Todd A., Logan, John, Costello, David, Brenzel, Michael P., Peterson, Alex A.
• Granted Patent: US 8,790,358 B2
• Time in Patent Office: Days
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065

Abstract

Methods and apparatus for making an anastomotic connection between an opening at an end of a graft conduit and an aperture in a side wall of a body tissue conduit using a hollow connector assembly are provided, wherein the cross-sectional area of the anastomotic connection is larger than that of the graft conduit. The tissue about the opening is introduced about and retained by first members of a distal portion of the connector assembly held by a loading tool. A delivery tool then collapses a proximal portion defined by second members of the connector assembly and delivers the second members into the lumen of the body tissue conduit via the aperture. Upon inserting the second members into the body tissue conduit, the delivery tool is disemployed and the second members expand such that they press against the interior wall of the body tissue conduit and such that the first members are held within the aperture against a medial wall of the body tissue conduit.

Claims

1. A connector assembly for use in making an anastomotic connection between an opening prepared at an end of a graft tissue conduit and an aperture in a side wall of a body tissue conduit in a patient comprising:

a body disposed annularly about a longitudinal axis and having axially spaced distal and proximal portions, the distal portion having a graft retention component to secure the tissue of the graft tissue conduit about the opening to the connector assembly, and the proximal portion having a plurality of annularly spaced body fingers that expand radially out to engage the interior surface of the side wall of the body tissue conduit about the aperture.

2. The connector assembly defined in claim 1, wherein the graft retention component comprises an annular inside-retention element configured to engage the interior surface of the graft tissue conduit about the opening.

3. The connector assembly defined in claim 2, wherein the annular inside-retention element has a cross-sectional area larger than the cross-sectional area of the graft tissue conduit.

4. The connector assembly defined in claim 2, wherein the annular inside-retention element is unitary with the distal portion of the body.

5. The connector assembly defined in claim 2, wherein the annular inside-retention element is coupled to the distal portion of the body.

6. The connector assembly defined in claim 2, wherein the annular inside-retention element includes a plurality of annularly spaced inside-retention members that have free ends configured to engage the interior surface of the graft tissue conduit about the opening.

7. The connector assembly defined in claim 2, wherein the connector assembly further comprises an outside-retention element configured to annularly engage the exterior surface of the graft tissue conduit about the opening.

8. The connector assembly defined in claim 7, wherein the outside-retention element comprises a plurality of annularly spaced outside-retention members.

9. The connector assembly defined in claim 7, wherein the outside-retention element is hingedly coupled to the distal portion of the body.

10. The connector assembly defined in claim 7, wherein the outside-retention element is rigidly connected to the distal portion of the body.

11. The connector assembly defined in claim 7, wherein the outside-retention element is slidably coupled to the distal portion of the body.

12. The connector assembly defined in claim 7, wherein the outside-retention element is further configured to engage the exterior surface of the body tissue conduit about the opening.

13. The connector assembly defined in claim 7, wherein the outside-retention element is configured to be at least partially proximal to the plurality of inside-retention members.

14. The connector assembly defined in claim 7, wherein the outside-retention element is configured to be at least partially in the same plane as the inside-retention element.

15. The connector assembly defined in claim 7, wherein the outside-retention element is a substantially annular expandable band configured to pass annularly about the plurality of inside-retention members from a first position distal to the plurality of inside-retention members to a second position at least partially proximal to the plurality of inside-retention members.

16. The connector assembly defined in claim 15, wherein the connector assembly further comprises a collar configured to prevent the band from expanding when in said second position.

17. The connector assembly defined in claim 1, wherein the radially outward expansion of the plurality of annularly spaced body fingers is an elastic bending.

18. The connector assembly defined in claim 1, wherein the body has a medial portion between the proximal portion and the distal portion, wherein the medial portion includes at least one torsional element.

19. The connector assembly defined in claim 1, wherein the opening is prepared by a length-wise axial incision from a toe point at the end of the graft tissue conduit to a heel point along the length of the graft tissue conduit.

20. The connector assembly defined in claim 1, wherein the opening is prepared by an incision oblique to the longitudinal axis of the graft tissue conduit from a toe point at the end of the graft tissue conduit to a first point along the length of the graft tissue conduit followed by a length-wise axial incision from the first point to a heel point further along the length of the graft tissue conduit.

21. Apparatus for producing an anastomotic connection between an opening prepared at an end of a graft tissue conduit and an aperture in a side wall of a body tissue conduit in a patient comprising:

a connector assembly having a body that is disposed annularly about a longitudinal axis and that has axially spaced distal and proximal portions, the distal portion having a graft retention component to secure the tissue of the graft tissue conduit about the opening to the connector assembly, and the proximal portion having a plurality of annularly spaced body fingers that expand radially out to engage the interior surface of the side wall of the body tissue conduit about the aperture; and

a delivery tool having a first configuration and a second configuration, wherein the first configuration is configured for deforming the proximal portion of the connector assembly from an expanded configuration to a deformed configuration and to advance the deformed proximal portion of the connector assembly into the lumen of the body tissue conduit via the aperture, and wherein the second configuration is configured for un-deforming the proximal portion of the connector assembly in the lumen of the body tissue conduit.

22. The apparatus defined in claim 21, wherein the loading tool is external to the cannulation of the connector assembly.

23. The apparatus defined in claim 21 further comprising a loading tool having a body portion, wherein the body portion is configured to support the distal portion of the connector assembly and to define the resulting shape of the anastomotic connection external to the body tissue conduit.

24. The apparatus defined in claim 23, wherein the loading tool further comprises at least one tissue holder configured to engage the exterior surface of the graft tissue conduit about the opening and to hold the graft tissue conduit about the graft retention component of the connector assembly.

25. The apparatus defined in claim 21, wherein the graft retention component comprises an annular inside-retention element configured to engage the interior surface of the graft tissue conduit about the opening.

26. The apparatus defined in claim 23, wherein the annular inside-retention element has a cross-sectional area larger than the cross-sectional area of the graft tissue conduit.

33. The method of claim 26, wherein the cross-sectional area of the ostium of the connection is larger than the cross-sectional area of the graft tissue conduit.

27. A method of producing an anastomotic connection between an opening prepared at an end of a graft tissue conduit and an aperture in a side wall of a body tissue conduit in a patient comprising:

securing the tissue of the graft tissue conduit about the opening to a graft retaining component of a distal axial portion of a hollow annular connector assembly;

deforming a proximal axial portion of the connector assembly, wherein the proximal axial portion includes a plurality of annularly spaced body fingers;

approximating the opening and the aperture so that the proximal axial portion of the connector assembly extends into the body tissue conduit via the aperture;

un-deforming the proximal axial portion so that the body fingers expand radially out to engage the interior surface of the side wall of the body tissue conduit about the aperture.

28. The method defined in claim 27, wherein the securing comprises:

positioning the graft tissue conduit so that the interior surface of the graft tissue about the opening engages a plurality of annularly spaced inside-retention members of the graft retention component; and

positioning an outside-retention element of the connector assembly to engage the exterior surface of the graft tissue about the opening at least partially proximal to the plurality of annularly spaced inside-retention members.

29. The method defined in claim 28, wherein the securing further comprises:

before the positioning the graft tissue conduit, providing a loading tool having a body portion configured to hold the distal portion of the connector assembly to define the resulting shape of the anastomotic connection external to the body tissue conduit.

30. The method of claim 27, wherein the deforming comprises:

providing a delivery tool with a noose threaded through an eyelet provided by each of the body fingers; and

tightening the noose so that each body finger is variably constrained radially from a fully un-deformed configuration to a fully deformed configuration.

31. The method of claim 30, wherein the approximating comprises:

advancing the delivery tool so that the plurality of body fingers extend into the body tissue conduit via the aperture.

32. The method of claim 30, wherein the un-deforming comprises:

releasing the noose.

34. The method of claim 30, wherein the delivery tool does not cannulate the connector assembly or the graft tissue conduit.