Device for delivery of liquid and gel-like surgical materials and methods for use thereof

• US 6,607,512 B2
• Filed: 01/09/2001
• Issued: 08/19/2003
• Est. Priority Date: 01/09/2001
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: Oliver, Dana A., Travers, Lawrence F.
• Primary Examiner(s): JACYNA, J CASIMER
• Application Number:
  US09/757,278
• Publication Number:
  US 20030078912A1
• Time in Patent Office: 952 Days
• Field of Search: 604/181, 604/187, 604/191, 604/207-209, 604/223, 604/224, 604/232
• US Class Current: 604/209
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle

Abstract

The present invention provides a novel apparatus for delivering a liquid or gel-like surgical material to a target site within a body cavity. The apparatus is characterized in part by an elongated structural member adapted for engagement with a conventional syringe and cannula assembly. In preferred embodiments of the present invention, devices of the invention further comprise a highly flexible applicator tip which permits application of the surgical material at variable delivery angles and even against gravity. Methods also are disclosed for applying the surgical material to the target site using. devices of the present invention.

Claims

1. A device for delivery of a liquid or gel-like surgical material into a body cavity comprising:

a) an elongated structural member adapted for engagement with a conventional syringe;

b) a cannula assembly capable of engagement with the syringe;

c) a saddle portion in which the syringe is seated and which permits flow communication of the surgical material through the cannula assembly; and

d) a drive mechanism in communication with the elongated structural member for advancing the surgical material through the cannula assembly wherein the surgical material has a viscosity greater than about 50,000 centipoise.

2. The device of claim 1 wherein the syringe is removably connected to the cannula assembly.

3. The device of claim 1 wherein the cannula assembly is rotatably connected to the saddle.

4. The device of claim 1 wherein the cannula assembly is removably connected to the saddle.

5. The device of claim 1 wherein the cannula assembly is connected to the saddle via a pivot assembly.

6. The device of claim 1 wherein the drive mechanism is actuated by a handle thereby advancing the surgical material through the cannula assembly.

7. The device of claim 6 wherein the handle is accessible from a position external to the body cavity during delivery of the surgical material.

8. The device of claim 1 further comprising a secondary mechanism which disengages the elongated structural member upon actuation.

9. The device of claim 1 further comprising a secondary mechanism which prevents syringe plunger expansion and permits air bolus priming.

10. The device of claim 1 further comprising an applicator tip attached to the cannula assembly at its distal end.

11. The device of claim 10 wherein the applicator tip comprises a flexible material.

12. The device of claim 11 wherein the flexible material is shaped as a collapsible fan shaped member.

13. The device of claim 10 wherein the applicator tip has a fan-shaped distal end.

14. The device of claim 1 wherein the surgical material is an anti-adhesion barrier having a viscosity between about 50,000 to 90,000 centipoise.

15. A device for delivery of a liquid or gel-like surgical material into a body cavity comprising:

a) an elongated structural member adapted for engagement with a conventional syringe;

b) a cannula assembly capable of engagement with the syringe;

c) a saddle portion in which the syringe is seated and which permits flow communication of the surgical material through the cannula assembly;

d) a drive mechanism in communication with the elongated structural member for advancing the surgical material through the cannula assembly;

e) an applicator tip attached to a distal end of the cannula assembly; and

f) a secondary mechanism for air bolus priming of the syringe wherein the secondary mechanism disengages the elongated structural member upon actuation.

16. The device of claim 15 wherein the drive mechanism is advanced by actuation of a handle in communication therewith.

17. The device of claim 15 wherein the syringe is removably seated in the saddle.

18. The device of claim 15 wherein the applicator tip has a fan-shaped distal end.

19. A device for delivery of a liquid or gel-like surgical material into a body cavity comprising:

a) an elongated structural member adapted for engagement with a conventional syringe;

b) a cannula assembly capable of engagement with the syringe;

c) a saddle portion in which the syringe is seated and which permits flow communication of the surgical material through the cannula assembly;

d) one or more pivot levers in communication with the elongated structural member for advancing the surgical material through the cannula assembly;

e) an applicator tip attached to a distal end of the cannula assembly; and

f) a secondary mechanism for air bolus priming of the syringe wherein the secondary mechanism disengages the elongated structural member upon actuation.

20. The device of claim 19 wherein the elongated structural member communicates with a spring-reinforced assembly to prevent syringe plunger expansion and permit air bolus priming.

21. A device for delivery of a liquid or gel-like surgical material into a body cavity comprising:

a) an elongated structural member adapted for engagement with a conventional syringe;

b) a cannula assembly capable of engagement with the syringe;

c) a saddle portion in which the syringe is seated and which permits flow communication of the surgical material through the cannula assembly;

d) one or more pivot levers in communication with the elongated structural member for advancing the surgical material through the cannula assembly;

e) an applicator tip attached to a distal end of the cannula assembly; and

f) a secondary mechanism for air bolus priming of the syringe wherein the secondary mechanism disengages the elongated structural member upon actuation and wherein the elongated structural member communicates with a spring-reinforced assembly to prevent syringe plunger expansion and permit air bolus priming and wherein the spring-reinforced assembly comprises a cylindrical rod about which a flat or rounded coil is fitted.

22. A method of delivering a surgical material to a target site within a body cavity comprising:

providing a device comprising an elongated structural member adapted for engagement with a conventional syringe, a cannula assembly capable of engagement with the syringe, a saddle in which the syringe is seated and which permits conduit with the cannula assembly, and a mechanism in communication with the elongated structural member for advancing the surgical material through the cannula assembly;

loading the surgical material into the syringe;

engaging the syringe with the cannula assembly and seating the syringe in the saddle of the device;

inserting the cannula portion of the device into the body cavity;

positioning the distal tip of the cannula within proximity of the target site;

applying the surgical material having a viscosity greater than 50,000 centipoise directly to the target site; and

withdrawing the apparatus from the body cavity.

23. The method of claim 22 wherein applying the surgical material to the target site comprises application against gravity.

24. The method of claim 22 further comprising priming of the syringe and or cannula assembly.

25. The method of claim 22 wherein the mechanism for advancing the surgical material through the cannula assembly is a drive mechanism.

26. The method of claim 22 wherein the mechanism for advancing the surgical material through the cannula assembly comprises a spring-reinforced assembly.

27. The method of claim 22 wherein applying the surgical material to the target site comprises replacing a spent syringe with a syringe containing an additional volume of surgical material.

28. The method of claim 22 wherein the device further comprises application of the surgical material to the target site through a flexible and generally fan shaped applicator tip which is attached to the cannula assembly at its distal end.

29. A method of delivering a surgical material to a target site within a body cavity comprising:

providing a device comprising an elongated structural member adapted for engagement with a conventional syringe, a cannula assembly capable of engagement with the syringe, a saddle in which the syringe is seated and which permits conduit with the cannula assembly;

a drive mechanism in communication with the elongated structural member for advancing the surgical material through the cannula assembly, an applicator tip attached to a distal end of the cannula assembly and a secondary mechanism which permits air bolus priming of the syringe and which disengages the elongated structural member upon actuation;

loading the surgical material into the syringe;

connecting the syringe to the cannula assembly and seating the syringe in the saddle of the device;

inserting the cannula portion of the device into the body cavity;

positioning the distal tip of the cannula within proximity of the target site;

applying the surgical material to the target site wherein the surgical material has a viscosity greater than about 50,000 centipoise;

optionally replacing the syringe with the same or another syringe containing an additional volume of surgical material; and

withdrawing the apparatus from the body cavity.

30. A method of reducing adhesions between bodily tissues at a target anatomical site within a body cavity comprising:

providing a device comprising an elongated structural member adapted for engagement with a conventional syringe, a cannula assembly capable of engagement with the syringe, a surface on which the syringe is seated and which permits flow communication of the surgical material through the cannula assembly;

a mechanism in communication with the elongated structural member for advancing an adhesion barrier material through the cannula assembly, a flexible applicator tip attached to a distal end of the cannula assembly for advancing an adhesion barrier material there through and a secondary mechanism which permits priming of the syringe and which disengages the elongated structural member upon actuation;

loading the syringe with the adhesion barrier material;

connecting the syringe to the cannula assembly and seating the syringe in the device;

inserting the cannula portion of the device into the body cavity;

locating the distal tip of the cannula within proximity of the target anatomical site;

applying the adhesion barrier material to the target anatomical site; and

withdrawing the apparatus from the body cavity.

31. The method of claim 30 wherein applying the adhesion barrier material to the target anatomical site comprises replacing a spent syringe with a syringe containing an additional volume of adhesion barrier material.

32. The method of claim 30 wherein the distal tip of the cannula is formed to include a fan-shaped member and the fan-shaped member is positioned in the target anatomical site to apply the adhesion barrier material to cardiac tissue.

33. The method of claim 30 wherein the distal tip of the cannula is formed to include a fan-shaped member and the fan-shaped member is positioned in the target anatomical site to apply the adhesion barrier material to abdominal tissue.

34. A method for sealing a bodily organ or tissue at a target anatomical site within a body cavity comprising:

providing a device comprising an elongated structural member adapted for engagement with a conventional syringe, a cannula assembly capable of engagement with the syringe, a surface on which the syringe is seated and which permits flow communication of the surgical material through the cannula assembly;

a mechanism in communication with the elongated structural member for advancing an anatomical filler material through the cannula assembly, an applicator tip attached to a distal end of the cannula assembly and a secondary mechanism which permits priming of the syringe and which disengages the elongated structural member upon actuation;

loading the syringe with the anatomical filler material;

connecting the syringe to the cannula assembly and seating the syringe in the device;

inserting the cannula portion of the device into the body cavity;

locating the distal tip of the cannula within proximity of the target anatomical site;

applying the anatomical filler material to the target anatomical site wherein the anatomical filler material has a viscosity greater that 50,000 centipoise; and

withdrawing the apparatus from the body cavity.

35. The method of claim 34 wherein applying the anatomical filler material to the target anatomical site comprises replacing a spent syringe with a syringe containing an additional volume of anatomical filler material.

36. The method of claim 34 wherein the distal tip of the cannula is formed to include a fan-shaped member and the fan-shaped member is a flexible member that is positioned in the target anatomical site to apply the anatomical filler material to cardiac tissue.

37. The method of claim 34 wherein the distal tip of the cannula is formed to include a fan-shaped member and the fan-shaped member is a flexible member that is positioned in the target anatomical site to apply the anatomical filler material to abdominal tissue.