Applicator for laparoscopic or endoscopic surgery

• US 6,494,896 B1
• Filed: 11/30/1999
• Issued: 12/17/2002
• Est. Priority Date: 11/30/1999
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Closure Medical Corporation (Johnson & Johnson)
• Inventors: DʼAlessio, Keith R., Mainwaring, Lawrence H.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/450,686
• Time in Patent Office: 1,113 Days
• Field of Search: 606/213, 604/19, 604/36, 604/38
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

A hand-held applicator delivers liquid or semi-liquid compositions, such as adhesives, to an internal tissue or organ in an even and controlled manner. The applicator includes a pump, a tubular extension that is thin enough to pass through an endoscopic pathway or trocar, a proximal end of the tubular extension being sealingly connected to the pump, and an applicator tip that attaches to the distal end of the tubular extension. The tip includes the liquid and the pump pumps the liquid to the internal tissue in an even and controlled manner without contact of the liquid by the pump. The pump is preferably a micropipetter that includes a hand-held portion having a hand-actuatable plunger that does not come in direct, physical contact with the liquid to be dispensed. The composition may be an adhesive such as an alpha-cyanoacrylate. The device may further include a wound closure device including at least two closure pins extending from the distal end of the tubular extension. The wound closure device retracts from the applicator device and orients and aligns a wound or incision target tissue site immediately prior to application of the medical composition. The device provides improved control, ergonomics, and convenience. The device is particularly useful in the field of surgery, especially in the field of laparoscopic or endoscopic surgery, where an even and controlled amount of a medically-acceptable adhesive is to be applied to a target site on an internal tissue or organ.

Claims

1. A hand-held applicator for laparoscopic or endoscopic surgery, comprising:

a base grippable by a hand of an operator;

a pump;

a tubular extension connected at a proximal end to the base, the tubular extension having an outer diameter small enough to fit within a laparoscopic pathway or trocar, an inner bore in fluid communication with the pump, and a length sufficient to extend beyond the laparoscopic pathway or trocar; and

a tip attachable to a distal end of the tubular extension, the tip when attached being in fluid communication with the inner bore and containing a predetermined amount of a liquid or semi-liquid composition to be dispensed,

wherein the pump allows for precise delivery of the composition without physically contacting the composition by acting on the inner bore to transfer pressure from the pump to the liquid or semi-liquid composition to be dispersed.

2. The hand-held applicator of claim 1, wherein the hand-held applicator is a pipetter.

3. The hand-held applicator of claim 2, wherein the pipetter is a digital pipetter.

4. The hand-held applicator of claim 1, wherein the hand-held applicator is a repeat pipetter.

5. The hand-held applicator of claim 2, wherein the tip contains a volume of between 1 and 10000 μ

L of the composition.

6. The hand-held applicator of claim 2, wherein the tip contains a volume of between 200 and 2000 μ

L of the composition.

7. The hand-held applicator of claim 1, wherein the composition is an adhesive.

8. The hand-held applicator of claim 7, wherein the adhesive is a 1,1-disubstituted ethylene adhesive.

9. The hand-held applicator of claim 7, wherein the adhesive is an α

-cyanoacrylate.

10. The hand-held applicator of claim 1, wherein the hand-held applicator is resterilizable.

11. The hand-held applicator of claim 1, wherein the pump comprises a plunger located within the base and an actuator element that moves the plunger, the actuator element extending from the base and actuatable by a finger or thumb of the hand of the operator gripping the base.

12. The hand-held applicator of claim 1, wherein the tip is formed from polyethylene.

13. The hand-held applicator of claim 1, wherein the tip has a distal opening with a broad width so as to apply a bead of several mm of the composition.

14. The hand-held applicator of claim 1, wherein the tip has a distal opening with a fine width so as to apply a fine bead of up to about 0.5 mm of the composition.

15. The hand-held applicator of claim 1, wherein the tip is shaped to provide delivery of the composition in a fine spray.

16. The hand-held applicator of claim 1, wherein the tip has a distal opening containing a porous body impregnated with a polymerization initiator or rate modifier.

17. The hand-held applicator of claim 1, wherein the tip has a length of between 1.27 to 7.62 cm.

18. The hand-held applicator of claim 1, wherein the tubular delivery element is sized to fit into a 5 mm diameter trocar.

19. The hand-held applicator of claim 1, wherein the tubular extension has a length of between 15 to 61 cm.

20. The hand-held applicator of claim 1, wherein the tubular extension is removably attached to the base by a luer lock fitting.

21. The hand-held applicator of claim 1, wherein the tip is removably attached to the distal end of the tubular assembly by a friction fit.

22. The hand-held applicator of claim 1, wherein the hand-held applicator is sterile.

23. The hand-held applicator of claim 1, further comprising a wound closure device including at least two wound closure pins operable at a distal end of said tubular extension and a manipulation element mechanically coupled to the at least two wound closure pins through a connecting element, the manipulation element being operable by the hand of the operator.

24. The hand-held applicator of claim 23, further comprising a second tubular extension arranged substantially parallel to and adjacent the first tubular extension, the wound closure pins and connecting element being provided closely adjacent the first tubular extension.

25. The hand-held applicator of claim 24, wherein the second tubular extension is coaxially arranged relative to the tubular extension and the wound closure pins and the connecting element are provided in a space between the tubular extension and the second tubular extension.

26. A method of applying a composition to tissue within a body during laparoscopic or endoscopic surgery, comprising the steps of:

inserting the tubular extension and tip of the hand-held applicator of claim 1 into the body through a laparoscopic pathway or trocar;

positioning the tip adjacent target tissue within the body;

actuating the pump to controllably dispense the composition onto the tissue through the tip; and

removing the tubular extension and tip from the laparoscopic pathway or trocar.

27. The method of claim 26, further comprising the steps of:

removing and discarding the removably attachable tip from the tubular assembly after use; and

attaching a new tip onto the tubular assembly.

28. The method of claim 26, further comprising the step of:

discarding the hand-held applicator after a single use.

29. The method of claim 26, wherein the composition being dispensed is an adhesive.

30. The method of claim 29, wherein the adhesive is a 1,1-disubstituted ethylene adhesive.

31. The method of claim 29, wherein the adhesive is an alpha-cyanoacrylate.

32. A kit comprising a saleable package containing the hand-held applicator of claim 1.

33. The kit of claim 32, wherein said package contains a plurality of said tips.

34. The kit of claim 33, wherein said plurality of said tips are of more than one size.

35. The kit of claim 32, wherein said kit further contains a trocar.

36. The kit of claim 32, wherein the contents of the kit are sterile.

37. The kit of claim 32, wherein the composition in the tip is an adhesive.

38. The kit of claim 37, wherein the adhesive is a 1,1-disubstituted ethylene adhesive.

39. The kit of claim 37, wherein the adhesive is an alpha-cyanoacrylate adhesive.

40. The kit of claim 37, wherein the tip has a distal opening containing a porous body having on or in it a polymerization initiator or rate modifier.

41. A method of applying a composition to tissue within a body during laparoscopic or endoscopic surgery, comprising the steps of:

inserting the tubular extension and tip of the hand-held applicator of claim 23 into the body through a laparoscopic pathway or trocar;

positioning the tip adjacent target tissue within the body;

engaging the wound closure pins with target tissue adjacent a wound or incision;

aligning and closing the wound or incision by manipulating the wound closure pins with the manipulation element;

actuating the pump to controllably dispense the composition onto the tissue through the tip; and

removing the tubular extension and tip from the laparoscopic pathway or trocar.

42. The method of claim 41, further comprising the step of disengaging the wound closure pins from the target tissue and fully retracting the wound closure pins.

43. The method of claim 41, wherein the pump is actuated to controllably dispense the composition onto the tissue through the tip before engaging the wound closure pins with the target tissue.

44. The method of claim 41, wherein the pump is actuated to controllably dispense the composition onto the tissue through the tip after engaging the wound closure pins with the target tissue.

45. A hand-held applicator and wound closure device for laparoscopic or endoscopic surgery, comprising:

a base grippable by a hand of an operator;

a pump;

a tubular extension connected at a proximal end to the base and in fluid communication with the pump, the tubular extension having an outer diameter small enough to fit within a laparoscopic pathway or trocar and a length sufficient to extend beyond the laparoscopic pathway or trocar,

a tip attachable to a distal end of the tubular extension, the tip containing a predetermined amount of a liquid or semi-liquid composition to be dispensed; and

a wound closure device including at least two wound closure pins operable at a distal end of said tubular extension and a manipulation element mechanically coupled to the at least two wound closure pins through a connecting element, the manipulation element being operable by the hand of the operator.