Sutureless anastomotic technique using a bioadhesive and device therefor

• US 6,245,083 B1
• Filed: 11/19/1999
• Issued: 06/12/2001
• Est. Priority Date: 09/25/1998
• Status: Expired due to Fees

• Current Assignee: Cryolife Incorporated
• Original Assignee: Cryolife Incorporated
• Inventors: Gundry, Steve, Black, Kirby S., Yüksel, Ümit
• Primary Examiner(s): Chaudhuri, Olik
• Assistant Examiner(s): Trinh, Hoa B.
• Application Number:
  US09/443,588
• Time in Patent Office: 571 Days
• Field of Search: 606/213, 606/159, 606/151, 606/153, 606/152, 606/155, 606/108, 604/22, 604/27, 604/28
• US Class Current: 606/153
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

A method of anastomosing two hollow bodily organs using a bioadhesive. The method involves apposing apertures in the organs to be joined and applying the bioadhesive, thereby joining the apertures in the organs and allowing movement of fluid or semi-solid material from one of the two organs to the second organ. The invention also relates to a device for anastomosing two hollow organs. The device has two inflatable balloons, one of which is placed into the lumen each of the two organs to be joined. Inflation of the balloons holds the apertures together while the bioadhesive is applied. The device allows anastomosis of blood vessels through endoscopic means.

Claims

1. A device for joining a first hollow bodily organ to a second hollow bodily organ, comprising:

(a) a first flexible elongated structure extending from a first proximal end to a first distal end, wherein a first longitudinal lumen extends within the first elongated structure from the first proximal end to the first distal end;

(b) a distal annular inflatable balloon disposed around a distal portion of the first elongated structure;

(c) a proximal annular inflatable balloon disposed around the first elongated structure proximal to the distal inflatable balloon;

(d) a second flexible, elongated structure slidably received within the first longitudinal lumen, wherein the second elongated structure extends from a second proximal end to a second distal end, the second distal end forming a tissue piercing tip;

wherein, the device, when in an operative position, is capable of having the distal balloon positioned within the second organ and the proximal balloon positioned within the first organ, and, when in a piercing position, the tissue piercing tip extends distally beyond the first distal end, and when in a retracted position, the tissue piercing tip is retracted within the first elongated structure.

2. The device of claim 1, further comprising:

a third longitudinal lumen extending within the first elongated structure from the distal inflatable balloon to the first proximal end; and

a fourth longitudinal lumen extending within the first elongated structure from the proximal inflatable balloon to the first proximal end.

3. The device of claim 1, further comprising:

a second longitudinal lumen extending within the second elongated structure extending from the second proximal end to the distal end of the tissue piercing tip; and

a guide wire slidably received within the second longitudinal lumen, the guide wire extending from a third proximal end to a third distal end;

wherein, when in a guiding position, the third distal end is extended distally beyond the distal end of the piercing tip, and when in a non-guiding position, the third distal end does not extend beyond the distal end of the piercing tip.

4. The device of claim 1, wherein the piercing tip comprises a needle having a longitudinal lumen.

5. The device of claim 1, further comprising a piercing tip locking mechanism capable of reversibly locking the second elongated structure in at least one of the piercing position and the retracted position.

6. The device of claim 3, further comprising a guiding locking mechanism capable of reversibly locking the guide wire in at least one of the guiding position and the non-guiding position.

7. The device of claim 1, wherein the distance between the proximal inflatable balloon and the distal inflatable balloon is from about 1 to about 2 millimeters.

8. The device of claim 1, wherein the external diameter of the device is sufficiently small to allow use of the device through a surgical endoscope.

9. The device of claim 1, wherein the first distal end further comprises a tapered contour having a distal diameter that is smaller than a proximal diameter.

10. A device for joining a first hollow bodily organ to a second hollow bodily organ comprising:

(a) a first flexible elongated structure extending from a first proximal end to a first distal end;

(b) a proximal annular inflatable balloon disposed around a first distal portion of the first elongated structure;

(c) a first longitudinal lumen extending within the first elongated structure from the first proximal end to the first distal end;

(d) a second flexible elongated structure slidably received within the first longitudinal lumen, the second elongated structure extending from a second proximal end to a second distal end;

(e) a distal annular inflatable balloon provided around a second distal portion of the second elongated structure;

wherein, when the device is in an operative position, the distal balloon is received within the second organ, the proximal balloon is received within the first organ.

11. The device of claim 10, further comprising:

a second longitudinal lumen extending within the second elongated structure from the second proximal end to the second distal end; and

a third flexible elongated structure, slidably received within the second longitudinal lumen, wherein the third elongated structure extends from a third proximal end to a third distal end, the third distal end forming a tissue piercing tip;

wherein, when in a piercing position, the tissue piercing tip extends distally beyond the second distal end and when in a retracted position, the tissue piercing tip retracts within the second elongated structure.

12. The device of claim 11, further comprising:

a third longitudinal lumen extending within the third elongated structure from the third proximal end to the tissue piercing tip;

a guide wire slidably received within the third longitudinal lumen, the guide wire extending from a fourth proximal end to a fourth distal end;

wherein, when in a guiding position, the fourth distal end extends distally beyond the distal end of the piercing tip, and when in a non-guiding position, the fourth distal end does not extend beyond the distal end of the piercing tip.

13. The device of claim 10, further comprising:

a fourth longitudinal lumen extending within the first elongated structure from the proximal inflatable balloon to the first proximal end; and

a fifth longitudinal lumen extending within the second elongated structure from the distal inflatable balloon to the second proximal end.

14. The device of claim 10, wherein the proximal annular inflatable balloon is an obturator.

15. The device of claim 10, wherein the proximal annular inflatable balloon is replaced by an O-ring.

16. A method of anastomosing a first hollow bodily organ having a first aperture to a second hollow bodily organ having a second aperture, comprising the steps of:

A. inserting into the first hollow bodily organ a device comprising;

(a) a first flexible, elongated structure extending from a first proximal end to a first distal end, wherein a first longitudinal lumen extends within the first elongated structure from the first proximal end to the first distal end;

(b) a distal annular inflatable balloon disposed around a distal portion of the first elongated structure;

(c) a proximal annular inflatable balloon disposed around the first elongated structure proximal to the distal inflatable balloon;

B. apposing the first and second apertures to form an anastomosis site;

C. advancing the first elongated structure and the second elongated structure through the first aperture and second apertures into the second organ to a position wherein the distal inflatable balloon is received within the second organ and the proximal inflatable balloon is received within the first organ;

D. inflating the proximal and distal balloons to stabilize the first and second organs in an apposed position with the first and second apertures adjacent to one another; and

E. applying a bioadhesive to the anastomosis site thereby joining the first aperture to the second aperture.

21. The method of claims 16 or 17, wherein the proximal and distal inflatable balloons are inflated with a fluid.

17. A method of anastomosing a first hollow bodily organ to a second hollow bodily organ comprising the steps of:

A. inserting into the first hollow bodily organ a device comprising;

(a) a first flexible, elongated structure extending from a first proximal end to a first distal end, wherein a first longitudinal lumen extends within the first elongated structure from the first proximal end to the first distal end;

(b) a distal annular inflatable balloon disposed around a distal portion of the first elongated structure;

(c) a proximal annular inflatable balloon disposed around the first elongated structure proximal to the distal inflatable balloon;

(d) a second flexible, elongated structure slidably received within the first longitudinal lumen, wherein the second elongated structure extends from a second proximal end to a second distal end, the second distal end forming a tissue piercing tip;

wherein, when in a piercing position, the tissue piercing tip extends distally beyond the first distal end, and when in a retracted position, the tissue piercing tip retracts within the first elongated structure;

B. apposing a first wall of the first organ to a second wall of the second organ to form an anastomosis site;

C. extending the second elongated structure to the tissue piercing position;

D. piercing the first and second walls to form first and second apertures in the first and second walls respectively;

E. retracting the second elongated structure to the retracted position;

F. advancing the first elongated structure and the second elongated structure through the first aperture and second apertures into the second organ to a position wherein the distal inflatable balloon is received within the second organ and the proximal inflatable balloon is received within the first organ;

G. inflating the proximal and distal balloons to stabilize the first and second organs in an apposed position with the first and second apertures adjacent to one another; and

H. applying a bioadhesive to the anastomosis site to join the first aperture to the second aperture while maintaining fluid communication between the first organ and the second organ.

18. The method of claim 17, wherein the device further comprises:

a second longitudinal lumen extending within the second elongated structure extending from the second proximal end to the distal end of the tissue piercing tip; and

a guide wire slidably received within the second longitudinal lumen, the guide wire extending from a third proximal end to a third distal end;

wherein, when in a guiding position, the third distal end extends distally beyond the distal end of the piercing tip, and when in a non-guiding position, the third distal end does not extend beyond the distal end of the piercing tip.

19. The method of claim 18, wherein step F further comprises the step of:

extending the guide wire to the guiding position, wherein the third distal end is received within the second organ prior to advancing the first elongated structure and the second elongated structure through the first aperture and second apertures into the second organ to a position wherein the distal inflatable balloon is received within the second organ and the proximal inflatable balloon is received within the first organ.

20. The method of claim 19, further comprising the step of retracting the guide wire into the non-guiding position after inflating the distal inflatable balloon.

22. The method of claim 17, wherein the first and second hollow bodily organs are arteries.

23. The method of claim 17, wherein the first organ is the internal mammary artery and the second organ is the left anterior descending coronary artery.

24. A method of anastomosing a first hollow bodily organ having a first aperture to a second hollow bodily organ having a second aperture comprising the step of:

A. inserting into the first hollow bodily organ a device comprising;

(a) a first flexible elongated structure extending from a first proximal end to a first distal end;

(b) a proximal annular inflatable balloon disposed around a first distal portion of the first elongated structure;

(c) a first longitudinal lumen extending within the first elongated structure from the first proximal end to the first distal end;

(d) a second flexible elongated structure slidably received within the first longitudinal lumen, the second elongated structure extending from a second proximal end to a second distal end;

(e) a distal annular inflatable balloon provided around a second distal portion of the second elongated structure;

B. apposing the first and second apertures to form an anastomosis site;

C. extending the second elongated structure to the second position;

D. advancing the second elongated structure through the first and second apertures into the second organ to a position wherein the distal inflatable balloon is received within the second organ;

E. inflating the distal inflatable balloon, thereby stabilizing the distal balloon within the second organ;

F. inflating the proximal inflatable balloon, thereby stabilizing the distal balloon within the first organ;

G. retracting the second elongated structure into the first position, thereby apposing the first and second apertures between the proximal and distal inflatable balloons; and

H. applying a bioadhesive to the anastomosis site to join the first aperture to the second aperture to provide fluid communication between the first organ and the second organ.

28. The method of claims 24 or 25, wherein the proximal inflatable balloon is an obturator.

25. A method of anastomosing a first hollow bodily organ to a second hollow bodily organ, comprising the steps of:

A. inserting into the first hollow bodily organ a device comprising;

(a) a first flexible elongated structure extending from a first proximal end to a first distal end;

(b) a proximal annular inflatable balloon disposed around a first distal portion of the first elongated structure;

(c) a first longitudinal lumen extending within the first elongated structure from the first proximal end to the first distal end;

(d) a second flexible elongated structure slidably received within the first longitudinal lumen, the second elongated structure extending from a second proximal end to a second distal end;

(e) a distal annular inflatable balloon provided around a second distal portion of the second elongated structure;

(f) a second longitudinal lumen extending within the second elongated structure from the second proximal end to the second distal end;

(g) a third flexible elongated structure, slidably received within the second longitudinal lumen, wherein the third elongated structure extends from a third proximal end to a third distal end, the third distal end forming a tissue piercing tip;

wherein, when in a piercing position, the tissue piercing tip extends distally beyond the second distal end and when in a retracted position, the tissue piercing tip retracts within the second elongated structure;

B. apposing, at the site of anastomosis, a first wall of the first organ to a second wall of the second organ;

C. extending the third elongated structure to the piercing position;

D. piercing the first and second walls to form first and second apertures in the first and second walls respectively;

E. retracting the third elongated structure to the retracted position;

F. extending the second elongated structure to the second position;

G. advancing the second elongated structure through the first and second apertures into the second organ to a position wherein the distal inflatable balloon is received within the second organ;

H. inflating the distal inflatable balloon, thereby stabilizing the distal balloon within the second organ;

I. inflating the proximal inflatable balloon, thereby stabilizing the distal balloon within the first organ;

J. retracting the second elongated structure into the first position, thereby apposing the first and second apertures between the proximal and distal inflatable balloons; and

K. applying a bioadhesive to the anastomosis site to join the first aperture to the second aperture to provide fluid communication between the first organ and the second organ.

26. The method of claim 25, wherein the device further comprises:

a third longitudinal lumen extending within the third elongated structure from the third proximal end to the tissue piercing tip;

a guide wire slidably received within the third longitudinal lumen, the guide wire extending from a fourth proximal end to a fourth distal end;

wherein, when in a guiding position, the fourth distal end extends distally beyond the distal end of the piercing tip, and when in a non-guiding position, the fourth distal end does not extend beyond the distal end of the piercing tip.

27. The method of claim 26, wherein step G further comprises the step of:

extending the guide wire to the guiding position, wherein the fourth distal end is received within the second organ prior to advancing the second elongated structure through the first and second apertures into the second organ to a position wherein the distal inflatable balloon is received within the second organ.

29. The method of claim 26 wherein the first and second hollow bodily organs are arteries.

30. A method of performing a sutureless side-to-side anastomosis of two blood vessels comprising the steps of:

A. isolating a first vessel;

B. creating a first aperture in a wall of the first vessel;

C. isolating a second vessel;

D. creating a second aperture in a wall of the second vessel;

E. positioning a multiple balloon catheter such that a first balloon is received within the first vessel and a second balloon is received within the second vessel;

F. expanding the first and second balloons to stabilize said first and second apertures in apposition to form an anastomosis site; and

G. applying bioadhesive to the anastomosis site to join the first and second apertures such that blood can flow between the first vessel and the second vessel.

31. The method of claim 30, wherein the first vessel is an internal mammary artery and the second vessel is a branch of the left coronary artery.

32. The method of claim 31, wherein between steps D and E, the method further comprises the steps of:

extending a guide wire from the first artery through the first and second apertures and into the second artery; and

introducing the multiple balloon catheter through the first and second apertures along the guide wire.

33. The method of claim 30, wherein the distance between the first and second balloons can be slidably increased or decreased, and wherein the method further comprises the steps of:

expanding the first balloon in the first vessel;

expanding the second balloon within the second vessel; and

sliding the first and second expanded balloons toward one another thereby bringing said apertures into direct apposition.

34. The method of claim 33, wherein the multiple balloon device comprises a lock mechanism adapted to lock the first and second balloons set distances from one another and wherein the method further comprises the step of locking the first and second balloons a set distance from one another before applying the bioadhesive.