Anastomotic device

• US 20030120292A1
• Filed: 11/06/2002
• Published: 06/26/2003
• Est. Priority Date: 06/20/2001
• Status: Active Grant

• Current Assignee: Park Media LLC
• Original Assignee: Park Media LLC
• Inventors: Park, Adrian Edward, Knapp, Charles Francis
• Granted Patent: US 7,115,136 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

The present invention is directed to gastrointestinal or enteric (including biliary) anastomosis and the like. The anastomotic device of the invention is a three dimensional woven tube of wire. The outer loops or ends of the tube fold or loop back on deployment in a manner which holds the luminal interface of the anastomotic site into apposition at the deployment site. The woven tube is deployed using a protective sleeve and nose assembly. Adjustment of the wire diameter and/or material properties of the wire can cause the anastomotic device to remain in place permanently or, for example, in the case of the intestine to slough through the two apposing walls of the lumen resulting in the device safely passing through the intestine leaving a naturally healed, properly functioning anastomosis.

Claims

1. An anastomotic device, comprising a woven tube of wire, the tube being constructed from a thermal, shape memory alloy, a spring wire or a compressible wire having outer loops or ends which thermally or mechanically deform and evert when inserted into walls of two adjacent lumens at a luminal interface of an anastomotic site, the ends of the tube thermally or mechanically deforming and everting to form petals in a manner which holds the luminal interface of the anastomotic site into apposition, the wire diameter and/or material properties of the tube being selected such that the mechanical force of the deployed tube causes the deployed tube to remain temporarily in place until sufficient healing occurs at which time the deployed tube sloughs leaving a properly function anastomosis.

2. The device of claim 1, wherein the thermal, shape memory alloy is a titanium-nickel alloy.

3. The device of claim 1, wherein the opposed petals are interdigitated.

4. An anastomotic delivery device, comprising a woven tube of wire, a protective sleeve to encapsulate the tube, a ram to push the tube from an end of the protective sleeve, a nose assembly including a streamlined nose providing a smooth surface for inserting into a vessel or lumen in the body, a first alignment mechanism to place tissues from the protective sleeve onto the tube during deployment, a second alignment mechanism to assist in placement of tissues during closure of the tube, a compression device incorporated in the nose assembly to insure closure of the deployed tube, the tube being constructed from a thermal shape memory alloy, a spring wire or a compressible wire such that the tube contracts longitudinally to produce the anastomosis when deployed.

5. The device of claim 4, wherein the device further comprises a knife blade, initially retracted in the center of the streamlined nose, adapted to be exposed at the tip in order to assist a surgeon when passing the delivery device through walls of the vessel or lumen.

6. The device of claim 4, wherein the first alignment mechanism is an alignment sleeve surrounding the protective sleeve.

7. The device of claim 4, wherein the second alignment mechanism is alignment struts or an alignment buttress mechanism.

8. The device of claim 4, wherein the compression device is a hollow rubber or plastic cylinder.

9. The device of claim 4, wherein the thermal, shape memory alloy is a titanium-nickel alloy.

10. The device of claim 4, wherein the tube contracts longitudinally to cause ends of the tube to deform and evert to form petals to produce the anastomosis.

11. The device of claim 10, wherein the opposed petals are interdigitated.

12. An anastomotic delivery device, comprising a woven tube of wire, a protective sleeve to encapsulate the tube, an alignment sleeve surrounding the protective sleeve to push tissues from the protective sleeve onto the tube during deployment, a hollow ram housed in the protective sleeve to push the tube from an end of the protective sleeve, a nose assembly including a hollow shaft adapted to be housed in the hollow ram and a streamlined nose providing a smooth surface for inserting into a vessel or lumen in the body, an alignment mechanism to assist in placement of tissues during deployment of the tube, and a compression device incorporated in the nose assembly to insure closure of the deployed tube, the tube being constructed from a thermal shape memory alloy, a spring wire or a compressible wire such that the tube contracts longitudinally to produce the anastomosis when deployed.

13. The device of claim 12, wherein the device further comprises a knife blade, initially retracted in the center of the streamlined nose, adapted to be exposed at the tip in order to assist a surgeon when passing the delivery device through walls of the vessel or lumen.

14. The device of claim 12, wherein the alignment mechanism is an alignment strut or an alignment buttress mechanism.

15. The device of claim 12, wherein the compression device is a hollow rubber or plastic cylinder.

16. A method of deploying an anastomosis device, comprising mounting a woven tube of wire inside a protective sleeve, inserting the device into a body cavity through a trochar or tube to a predetermined puncture site of a first segment either proximal or distal to a desired anastomotic site, advancing the device intraluminally to the anastomotic site either manually or with the aid of a guide wire, bringing a second tissue segment into close apposition to the first segment at the anastomotic site, piercing a wall of the first segment and a wall of the second segment and into a lumen of the second segment, deploying the tube from the protective sleeve at a juncture of apposing puncture holes created by the device, the ends of the tube forming a petal configuration at the anastomotic site to hold the two segments in apposition.

17. The method of claim 16, wherein the first and second segments are intestinal segments.

18. The method of claim 16, wherein one of the first and second segments is a bile duct and the other of the first and second segments is the jejunum.

19. The method of claim 16, wherein the anastomosis is a side-to-side anastomosis.

20. The method of claim 16, wherein the mechanical force of the woven tube to hold the two segments in apposition is selected such that the deployed tube remains temporarily in place until sufficient healing of the segments occurs at which time the tube sloughs from the segments leaving a properly functioning anastomosis.

21. The method of claim 16, wherein the device is advanced to the anastomotic site with the aid of a previously positioned guide wire.

22. The method of claim 16, wherein the tube is deployed from the protective sleeve by a ram housed in the protective sleeve.

23. The method of claim 16, wherein tissues are pushed from the protective sleeve onto the tube during deployment by an alignment sleeve associated with the protective sleeve.

24. The method of claim 16, wherein the tissues are properly placed during deployment of the tube by an alignment mechanism.

25. The method of claim 16, wherein the closure of the deployed tube is ensured by compression of the tube distal from the protective sleeve.