Method of making a hand access laparoscopic device

• US 7,749,415 B2
• Filed: 10/12/2006
• Issued: 07/06/2010
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Johnson, Gary M, Brustad, John R., Hilal, Nabil, Albrecht, Jeremy J, Hart, Charles C.
• Primary Examiner(s): Michener; Jennifer K
• Assistant Examiner(s): SLAWSKI, MAGALI P
• Application Number:
  US11/548,746
• Publication Number:
  US 20070085232A1
• Time in Patent Office: 1,363 Days
• Field of Search: 600201-209, 264/102, 264/268, 264/313, 264/317, 264/341, 264/343, 264/273, 264/274
• US Class Current: 264/102
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/0287 with elastic retracting members connectable to a frame, e.g. hooked elastic wires
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2050/005 with a lid or cover
• CPC Class Codes: A61B 2050/0051 closable by rotation
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

The invention relates to a hand access laparoscopy device having a gelcap, a retainer, a sleeve and a retention ring. The gelcap includes gel that is bonded to a cap. The cap includes an inner cylindrical wall to which the gel in bonded, thereby providing a sealing area between the device and the wound in a body wall. By securing the gel to the inner cylindrical wall, the thickness of the gel and corresponding cap is minimized along with the overall footprint of the device. With the gel thickness reduced and able to be substantially flush, the “doming” phenomenon produced by insufflation of a patient'"'"'s abdomen is reduced.

Claims

1. A method of making a gelcap, comprising:

providing a cap having a wall comprising a plurality of apertures, wherein the wall defines an opening through the cap;

providing a casting mold having a mold cavity;

providing an oil;

providing a triblock copolymer;

mixing the oil and the triblock copolymer to form a slurry;

degassing the slurry;

filling the mold cavity with slurry;

heating the slurry and the mold until the slurry attains a temperature within a range between about 130°

C. and about 250°

C. and maintaining the mold and slurry within the range until the slurry transforms into gel;

cooling the gel to about ambient room temperature; and

removing the cured gel from the mold.

2. The method of claim 1, the providing an oil including providing mineral oil.

3. The method of claim 1, the degassing step including stirring the slurry while degassing the slurry.

4. The method of claim 1, further comprising degassing the slurry while the slurry is in the mold.

5. The method of claim 1, further comprising preheating the slurry prior to filling the mold cavity with slurry.

6. The method of claim 1, the cooling step including immersing the gel in water.

7. The method of claim 1, the cooling step including air cooling the gel.

8. The method of claim 1, further comprising inserting a plurality of gas-filled balloons into the slurry in the mold cavity.

9. The method of claim 8, the inserting step including inserting the balloons into the slurry substantially around the center of the mold cavity.

10. The method of claim 8, the inserting step including dispersing the balloons in the slurry randomly about the mold cavity throughout the region beyond the center of the mold cavity.

11. The method of claim 1, further comprising:

inserting a plurality of solid objects into the slurry in the mold cavity; and

removing the plurality of solid objects after the gel is cured.

12. The method of claim 11, the inserting step including inserting at least one sphere into the slurry around the center of the mold cavity.

13. The method of claim 11, the inserting step including inserting the solid objects in the slurry substantially around the center of the mold cavity.

14. The method of claim 11, the inserting step including, dispersing the solid objects in the slurry randomly about the mold cavity throughout the region beyond the center of the mold cavity.

15. The method of claim 1, further comprising sterilizing the gelcap with gamma sterilization.

16. The method of claim 1, further comprising mixing the slurry in a centrifuge while heating the slurry and the mold.

17. The method of claim 1, further comprising coupling the gel to the cap.

18. The method of claim 17, the coupling step including bonding the gel to the cap with an adhesive.

19. The method of claim 17, the providing a cap step including providing a cap made of a plastic material.

20. The method of claim 19, the coupling step including:

applying a solvent to the gel to melt polystyrene in the gel;

applying a solvent to the cap to melt the plastic of the cap; and

placing the gel in contact with the cap to allow a bond to form between the gel and the cap.

21. The method of claim 17, wherein:

the providing a cap having a wall step including providing a cap having an inner wall, the cap being made of a polymeric material; and

the coupling step including coupling the cured gel to the inner wall of the cap.

22. The method of claim 21, the providing a casting mold step including providing a mold configured to produce a gel slug having a smaller periphery than the inner wall of the cap and a height higher than a height of the inner wall of the cap.

23. The method of claim 22, further comprising placing the gel slug within the inner wall of the cap.

24. The method of claim 23, the coupling step including compression molding the gel slug to the inner wall of the cap.

25. The method of claim 23, the coupling step including heating the gel slug and the cap to a temperature sufficient for polystyrene of the gel and the polymer of the cap to form bonds.

26. The method of claim 1, further comprising:

placing the cap into the mold cavity,

wherein the filling step including filling the mold cavity having the cap with slurry such that the slurry is in contact with the cap,

the heating step including heating the slurry, the cap and the mold until the slurry transforms into gel, the gel being coupled to the cap, thereby forming a gelcap,

the cooling step including cooling the gelcap, and

the removing step including removing the gelcap from the mold.

27. The method of claim 26, wherein:

the providing a cap step including providing a cap including styrene-ethylene/butylene-styrene; and

the heating step including heating the slurry, cap and mold to above about 130°

C. and maintaining the temperature above about 130°

C. until a bond is formed between the cap and gel.

28. The method of claim 26, wherein:

the providing a cap step including providing a cap including polycarbonate; and

the heating step including heating the slurry, cap and mold to about 150°

C. and maintaining that temperature until a bond is formed between the cap and gel.

39. The method of claim 1, the degassing step including applying a vacuum of about one atmosphere to the slurry.

29. A method of making a gelcap, comprising:

providing a cap having an opening;

providing a casting mold having a mold cavity;

providing mineral oil;

providing a triblock copolymer;

mixing the mineral oil and the triblock copolymer to form a slurry;

degassing the slurry in a vacuum chamber by stirring the slurry and applying a vacuum of about one atmosphere to the slurry;

preheating the slurry prior to filling the mold cavity with slurry;

filling the mold cavity with slurry;

heating the slurry and the mold until the slurry attains a temperature within a range between about 130°

C. and about 250°

C. and maintaining the mold and slurry within the range until the slurry transforms into gel;

degassing the slurry further while the slurry is in the mold;

cooling the gel to about ambient room temperature;

removing the cured gel from the mold; and

coupling the gel to the cap, thereby forming the gelcap.

30. The method of claim 29, the coupling step including bonding the gel to the cap with an adhesive.

31. The method of claim 29, wherein:

the providing a cap step including providing a cap made of a plastic material; and

the coupling step including applying a solvent to the gel to melt polystyrene in the gel, applying a solvent to the cap to melt the plastic of the cap, and placing the gel in contact with the cap to allow a bond to form between the gel and the cap.

32. The method of claim 29, wherein:

the providing a cap step including providing a cap having an inner wall, the opening of the cap being defined by the inner wall, the cap being made of a polymeric material;

the providing a casting mold step including providing a mold configured to produce a gel slug having a smaller periphery than the inner wall of the cap and a height higher than the height of the inner wall of the cap; and

the coupling step including coupling the cured gel to the inner wall of the cap.

33. The method of claim 32, further comprising placing the gel slug within the inner wall of the cap.

34. The method of claim 33, the coupling step including compression molding the gel slug to the inner wall of the cap.

35. The method of claim 33, the coupling step including heating the gel slug and the cap to a temperature sufficient for polystyrene of the gel and the polymer of the cap to form bonds.

36. A method of making a gelcap, comprising:

providing a cap having an opening therethrough;

providing a casting mold having a mold cavity;

providing mineral oil;

providing a triblock copolymer;

mixing the mineral oil and the triblock copolymer to form a slurry;

degassing the slurry in a vacuum chamber by stirring the slurry and applying a vacuum of about one atmosphere to the slurry;

preheating the slurry prior to filling the mold cavity with slurry;

placing the cap into the mold cavity;

filling the mold cavity having the cap with slurry such that the slurry is in contact with the cap;

heating the slurry, the cap, and the mold until the slurry attains a temperature within a range between about 130°

C. and about 250°

C. and maintaining the mold and slurry within the range until the slurry transforms into gel, the gel being coupled to the cap and forming a gelcap;

degassing the slurry further while the slurry and the cap are in the mold;

cooling the gelcap to about ambient room temperature; and

removing the gelcap from the mold.

37. The method of claim 36, wherein:

the providing a cap step including providing a cap including styrene-ethylene/butylene-styrene; and

the heating step including heating the slurry, cap and mold to above about 130°

C. and maintaining the temperature above about 130°

C. until a bond is formed between the cap and gel.

38. The method of claim 36, wherein:

the providing a cap step including providing a cap including polycarbonate; and

the heating step including heating the slurry, cap and mold to about 150°

C. and maintaining that temperature until a bond is formed between the cap and gel.