Medical grafting apparatus and methods

• US 6,699,256 B1
• Filed: 06/02/2000
• Issued: 03/02/2004
• Est. Priority Date: 06/04/1999
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Inventors: Logan, John, Peterson, Alex, Thome, Scott, Berg, Todd A.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Baxter, Jessica R
• Application Number:
  US09/587,112
• Time in Patent Office: 1,369 Days
• Field of Search: 606/151-155, 606/184, 606/185, 606/186
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• 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 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• 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 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections

Abstract

Instrumentation for facilitating cutting an opening in a side wall of a body conduit in a patient. A tubular structure defines a lumen and has a sharpened distal end portion configured to cut a section of the body conduit to create the opening. A tissue holding structure is provided which is axially movable within the lumen of the tubular structure. The tissue holding structure includes a piercing portion to permit passage of the tissue holding structure through the body conduit from an entrance side to an exit side thereof. The tissue holding structure also includes a retention member to secure the section of the body conduit to the tissue holding structure during movement of the tissue holding structure to approximate the entrance side of the body conduit with the sharpened distal portion of the tubular structure to enable the sharpened distal structure to cut the body conduit. A connector is also provided for attaching a new length of tubing to the body conduit at the opening made by the cutting.

Claims

1. Instrumentation for facilitating cutting an opening in a side wall of a body conduit comprising:

a tubular structure defining a lumen and having a sharpened distal end portion configured to cut a section of the body conduit to create the opening; and

a tissue holding structure axially movable within the lumen of the tubular structure, the tissue holding structure comprising a piercing portion to permit passage of the tissue holding structure through the body conduit from an entrance side adjacent the tubular structure to an exit side thereof, and a retention member to secure the section of the body conduit to the tissue holding structure during movement of the tissue holding structure to approximate the entrance side of the section of the body conduit and the sharpened distal portion of the tubular structure which cuts the section of body conduit, wherein the retention member is a barb that is resiliently biased radially outwardly in order to secure the section of body conduit, wherein the barb is deflected radially inwardly during the distal passage of the tissue holding structure through the section of the body conduit, and wherein the piercing portion comprises a needle catheter having a sharpened distal end portion to permit passage of the tissue holding structure through the section of body conduit.

2. The instrumentation as defined in claim 1, wherein the tissue holding structure further comprises a barb support member which supports the barb thereon and is axially movable within an internal lumen of the needle catheter.

3. The instrumentation as defined in claim 2, wherein the needle catheter is sized to deflect the barb radially inwardly during distal movement of the barb support member through the internal lumen of the needle catheter, and which allows the barb to return to an outwardly extending orientation after passage through the internal lumen.

4. The instrumentation as defined in claim 2, wherein the barb support member has an atraumatic distal tip portion.

5. The instrumentation as defined in claim 2, wherein the barb support member extends distally from a flexible catheter.

6. Instrumentation for facilitating cutting an opening in a side wall of a body conduit comprising:

a tubular structure defining a lumen and having a sharpened distal end portion configured to cut a section of the body conduit to create the opening;

a tissue holding structure axially movable within the lumen of the tubular structure, the tissue holding structure comprising a piercing portion to permit passage of the tissue holding structure through the body conduit from an entrance side adjacent the tubular structure to an exit side thereof, and a retention member to secure the section of the body conduit to the tissue holding structure during movement of the tissue holding structure to approximate the entrance side of the section of the body conduit and the sharpened distal portion of the tubular structure which cuts the section of body conduit, wherein the retention member is a barb that is resiliently biased radially outwardly in order to secure the section of body conduit; and

a connector for providing an anastomosis between the body conduit and a new length of body tubing comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing the new length of body tubing to the connector.

7. The instrumentation as defined in claim 6, wherein the first plurality of fingers, the second plurality of fingers, and the engagement members are resiliently disposed radially outward.

8. The instrumentation as defined in claim 7, further comprising:

a connector support defining a longitudinal axis and having a first retention structure to retain the first plurality of fingers towards parallelism with the longitudinal axis and a second retention structure to retain the second plurality of fingers towards parallelism with the longitudinal axis, such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto by piercing the new length of tubing.

9. The instrumentation as defined in claim 8, wherein the connector support defines an interior lumen for receiving the tubular structure and tissue holding structure therethrough.

10. The instrumentation as defined in claim 8, wherein the first retention structure is an annular sleeve for retaining the first plurality of fingers distally towards parallelism with the longitudinal axis.

11. The instrumentation as defined in claim 10, wherein the first retention structure retains the first plurality of fingers in a configuration having a dimension smaller than the opening in the body conduit.

12. The instrumentation as defined in claim 8, wherein the second retention structure is an annular sleeve to retain the second plurality of fingers towards parallelism with the longitudinal axis.

13. Instrumentation for facilitating cutting an opening in a side wall of a body conduit comprising:

a tubular structure defining a lumen and having a sharpened distal end portion configured to cut a section of the body conduit to create the opening;

a tissue holding structure axially movable within the lumen of the tubular structure, the tissue holding structure comprising a piercing portion to permit passage of the tissue holding structure through the body conduit from an entrance side adjacent the tubular structure to an exit side thereof, and a retention member to secure the section of the body conduit to the tissue holding structure during movement of the tissue holding structure to approximate the entrance side of the section of the body conduit and the sharpened distal portion of the tubular structure which cuts the section of body conduit;

a connector for providing an anastomosis between the body conduit and a new length of body tubing comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing the new length of body tubing to the connector, wherein the first plurality of fingers, the second plurality of fingers, and the engagement members are resiliently disposed radially outward; and

a connector support defining a longitudinal axis and having a first retention structure to retain the first plurality of fingers towards parallelism with the longitudinal axis and a second retention structure to retain the second plurality of fingers towards parallelism with the longitudinal axis, such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto by piercing the new length of tubing, wherein the second retention structure is a member having a projection received in a corresponding opening in each of the second plurality of fingers to retain the second plurality of fingers towards parallelism with the longitudinal axis.

14. Instrumentation for facilitating cutting an opening in a side wall of a body conduit comprising:

a tubular structure defining a lumen and having a sharpened distal end portion configured to cut a section of the body conduit to create the opening;

a tissue holding structure axially movable within the lumen of the tubular structure, the tissue holding structure comprising a piercing portion to permit passage of the tissue holding structure through the body conduit from an entrance side adjacent the tubular structure to an exit side thereof, and a retention member to secure the section of the body conduit to the tissue holding structure during movement of the tissue holding structure to approximate the entrance side of the section of the body conduit and the sharpened distal portion of the tubular structure which cuts the section of body conduit;

a connector for providing an anastomosis between the body conduit and a new length of body tubing comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing the new length of body tubing to the connector, wherein the new length of tubing has a direction of natural fluid flow; and

a sleeve sized for passage within the new length of tubing having a tapered tip portion to provide a visual indication of the direction of natural fluid flow.

15. Instrumentation for facilitating cutting an opening in a side wall of a body conduit comprising:

a tubular structure defining a lumen and having a sharpened distal end portion configured to cut a section of the body conduit to create the opening;

a tissue holding structure axially movable within the lumen of the tubular structure, the tissue holding structure comprising a piercing portion to permit passage of the tissue holding structure through the body conduit from an entrance side adjacent the tubular structure to an exit side thereof, and a retention member to secure the section of the body conduit to the tissue holding structure during movement of the tissue holding structure to approximate the entrance side of the section of the body conduit and the sharpened distal portion of the tubular structure which cuts the section of body conduit;

a connector for providing an anastomosis between the body conduit and a new length of body tubing comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing the new length of body tubing to the connector, wherein the first plurality of fingers, the second plurality of fingers, and the engagement members are resiliently disposed radially outward;

a connector support defining a longitudinal axis and having a first retention structure to retain the first plurality of fingers towards parallelism with the longitudinal axis and a second retention structure to retain the second plurality of fingers towards parallelism with the longitudinal axis, such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto by piercing the new length of tubing; and

a pressure-application tool for facilitating the piercing of the new length of tubing by individual ones of the engagement members to secure the new length of tubing to the, connector, the pressure-application tool having a distal sleeve portion with an internal lumen sized such that individual ones of the engagement members may be received therein, the sleeve providing substantially uniform pressure to the new length of tubing about the engagement member to pierce the new length of tubing by the engagement member.

16. A method for cutting an opening in a body conduit comprising:

providing a tissue holding structure having a retention member to secure a section of the body conduit to the tissue holding structure;

securing the retention member to the section of the body conduit by at least partially inserting the tissue holding structure into the body conduit;

providing a tubular structure having a sharpened distal portion;

approximating the body conduit and the sharpened distal portion of the tubular structure by relative movement of the tissue holding structure towards the tubular structure; and

cutting the section of the body conduit with the sharpened distal portion of the tubular structure to provide the opening in the body conduit, wherein the tissue holding structure further comprises a piercing portion, wherein securing the retention member to the body conduit comprises piercing the body conduit with the piercing portion of the tissue holding structure, wherein the piercing portion comprises a needle catheter having a sharpened distal end portion, and wherein piercing the body conduit comprises piercing the body conduit from an entrance side to an exit side with the needle catheter.

17. A method for cutting an opening in a body conduit comprising:

providing a tissue holding structure having a retention member to secure a section of the body conduit to the tissue holding structure;

securing the retention member to the section of the body conduit by at least partially inserting the tissue holding structure into the body conduit;

providing a tubular structure having a sharpened distal portion;

approximating the body conduit and the sharpened distal portion of the tubular structure by relative movement of the tissue holding structure towards the tubular structure; and

cutting the section of the body conduit with the sharpened distal portion of the tubular structure to provide the opening in the body conduit, wherein the tissue holding structure further comprises a piercing portion, wherein securing the retention member to the body conduit comprises piercing the body conduit with the piercing portion of the tissue holding structure, wherein the piercing portion comprises a needle catheter having a sharpened distal end portion, wherein piercing the body conduit comprises piercing the body conduit from an entrance side to an exit side with the needle catheter, wherein the tissue holding structure further comprises a barb support member which supports a barb thereon and is axially movable within an internal lumen of the needle catheter, and wherein the securing further comprises passing the barb support member and the barb through the internal lumen of the needle catheter from the entrance side to the exit side.

18. The method as defined in claim 17, wherein the needle catheter is sized to deflect the barb radially inwardly during distal movement of the barb support member through the internal lumen of the needle catheter.

19. The method as defined in claim 18, wherein the securing the retention member to the body conduit further comprises allowing the barb to return to a configuration wherein the retention member is positioned radially outwardly in order to secure the body conduit thereby.

20. The method as defined in claim 17, wherein the barb support member extends distally from a flexible catheter and

wherein securing the tissue holding member to the body conduit further comprises advancing the catheter towards the body conduit.

21. The method as defined in claim 20, wherein the approximating the body conduit and the sharpened portion of the tubular structure comprises withdrawing the catheter away from the body conduit.

22. A method for performing an anastomosis between a body conduit and a new length of tubing comprising:

providing a tissue holding structure having a retention member to secure a section of the body conduit to the tissue holding structure;

securing the retention member to the section of the body conduit by at least partially inserting the tissue holding structure into the body conduit;

providing a tubular structure having a sharpened distal portion;

approximating the body conduit and the sharpened distal portion of the tubular structure by relative movement of the tissue holding structure towards the tubular structure;

cutting the section of the body conduit with the sharpened distal portion of the tubular body structure to provide an opening in the body conduit; and

attaching the new length of tubing to the body conduit adjacent the opening made by the cutting.

23. The method as defined in claim 22, further comprising:

providing a connector defining a central opening and comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing a portion of the new length of body tubing to the connector, wherein attaching the new length of tubing to the body conduit adjacent the opening comprises securing a portion of the new length of body tubing to the connector with the plurality of engagement members, engaging the inner wall of the body conduit with the first plurality of fingers, and engaging the outer wall of the body conduit with the second plurality of fingers.

24. The method as defined in claim 23, further comprising:

providing a connector support defining a longitudinal axis and having a first retention structure for retaining at least one finger of the first plurality of fingers towards parallelism with the longitudinal axis; and

prior to securing the portion of the new length of tubing to the connector, mounting the connector coaxially about the connector support and retaining the at least one finger of the first plurality of fingers with the retention structure.

25. The method as defined in claim 24, wherein the connector support further comprises a second retention structure such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto.

26. The method as defined in claim 25, wherein mounting the connector coaxially about the connector support further comprises retaining the first plurality of fingers towards parallelism with the longitudinal axis and retaining the second plurality of fingers towards parallelism with the longitudinal axis such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto.

27. The method as defined in claim 26, wherein the first retention structure is an annular sleeve, and wherein mounting the connector coaxially about the connector support further comprises retaining the first plurality of fingers distally towards parallelism with the longitudinal axis.

28. The method as defined in claim 26, wherein the mounting the connector coaxially about the connector support further comprises retaining the first plurality of fingers in a configuration having a diameter smaller than the opening in the body conduit.

29. A method for performing an anastomosis between a body conduit and a new length of tubing comprising:

providing a tissue holding structure having a retention member to secure a section of the body conduit to the tissue holding structure;

securing the retention member to the section of the body conduit by at least partially inserting the tissue holding structure into the body conduit;

providing a tubular structure having a sharpened distal portion;

approximating the body conduit and the sharpened distal portion of the tubular structure by relative movement of the tissue holding structure towards the tubular structure;

cutting the section of the body conduit with the sharpened distal portion of the tubular body structure to provide an opening in the body conduit;

attaching the new length of tubing to the body conduit adjacent the opening made by the cutting;

providing a connector defining a central opening and comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing a portion of the new length of body tubing to the connector, wherein attaching the new length of tubing to the body conduit adjacent the opening comprises securing a portion of the new length of body tubing to the connector with the plurality of engagement members, engaging the inner wall of the body conduit with the first plurality of fingers, and engaging the outer wall of the body conduit with the second plurality of fingers;

providing a connector support defining a longitudinal axis and having a first retention structure for retaining at least one finger of the first plurality of fingers towards parallelism with the longitudinal axis; and

prior to securing the portion of the new length of tubing to the connector, mounting the connector coaxially about the connector support and retaining the at least one finger of the first plurality of fingers with the retention structure, wherein the connector support further comprises a second retention structure such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto, wherein mounting the connector coaxially about the connector support further comprises retaining the first plurality of fingers towards parallelism with the longitudinal axis and retaining the second plurality of fingers towards parallelism with the longitudinal axis such that the engagement members are disposed radially outwardly to facilitate attachment of the new length of tubing thereto, and wherein the second retention structure is a member having a tab received in a corresponding opening in each of the second plurality of fingers.

30. The method as defined in claim 29, wherein the member is a tubular sheath, the method further comprising:

after securing the new length of tubing to the connector, releasing the second plurality of fingers from the tabs and advancing the tubular sheath such that the second plurality of fingers are deflected towards parallelism with the longitudinal axis in a substantially opposite direction than prior to the releasing.

31. The method as defined in claim 30, wherein attaching the new length to tubing to the body conduit adjacent the opening further comprises:

inserting the first plurality of fingers into the opening;

releasing the first retention structure to allow the first plurality of fingers to engage the inner wall of the body conduit; and

releasing the second retention structure to allow the second plurality of fingers to engage the outer wall of the body conduit.

32. A method for performing an anastomosis between a body conduit and a new length of tubing comprising:

providing a tissue holding structure having a retention member to secure a section of the body conduit to the tissue holding structure;

securing the retention member to the section of the body conduit by at least partially inserting the tissue holding structure into the body conduit;

providing a tubular structure having a sharpened distal portion;

approximating the body conduit and the sharpened distal portion of the tubular structure by relative movement of the tissue holding structure towards the tubular structure;

cutting the section of the body conduit with the sharpened distal portion of the tubular body structure to provide an opening in the body conduit;

attaching the new length of tubing to the body conduit adjacent the opening made by the cutting;

providing a connector defining a central opening and comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing a portion of the new length of body tubing to the connector, wherein attaching the new length of tubing to the body conduit adjacent the opening comprises securing a portion of the new length of body tubing to the connector with the plurality of engagement members, engaging the inner wall of the body conduit with the first plurality of fingers, and engaging the outer wall of the body conduit with the second plurality of fingers, wherein the new length of tubing has a direction of natural fluid flow;

providing a sleeve sized for passage within the new length of tubing having a tapered tip portion to provide a visual indication of the direction of natural fluid flow; and

before securing the portion of the new length of tubing to the connector, advancing the new length of tubing over the sleeve such that new length of tubing may be attached to the connector based on the direction of natural fluid flow.

33. A method for performing an anastomosis between a body conduit and a new length of tubing comprising:

providing a tissue holding structure having a retention member to secure a section of the body conduit to the tissue holding structure;

securing the retention member to the section of the body conduit by at least partially inserting the tissue holding structure into the body conduit;

providing a tubular structure having a sharpened distal portion;

approximating the body conduit and the sharpened distal portion of the tubular structure by relative movement of the tissue holding structure towards the tubular structure;

cutting the section of the body conduit with the sharpened distal portion of the tubular body structure to provide an opening in the body conduit;

attaching the new length of tubing to the body conduit adjacent the opening made by the cutting;

providing a connector defining a central opening and comprising a first plurality of fingers for engaging an inner wall of the body conduit, a second plurality of fingers for engaging an outer wall of the body conduit, and a plurality of engagement members for securing a portion of the new length of body tubing to the connector, wherein attaching the new length of tubing to the body conduit adjacent the opening comprises securing a portion of the new length of body tubing to the connector with the plurality of engagement members, engaging the inner wall of the body conduit with the first plurality of fingers, and engaging the outer wall of the body conduit with the second plurality of fingers; and

providing a pressure-application tool having a distal sleeve portion with an internal lumen sized such that individual ones of the engagement members may be received therein, wherein securing the portion of the new length of tubing to the connector comprises providing substantially uniform pressure by the sleeve portion to the new length of tubing about the engagement member to facilitate piercing of the new length of tubing by the engagement member.