Surgical apparatus

• US 5,813,409 A
• Filed: 03/29/1995
• Issued: 09/29/1998
• Est. Priority Date: 09/02/1994
• Status: Expired due to Term

• Current Assignee: MCT II, LLC
• Original Assignee: vMedical Creative Technologies, Inc.
• Inventors: Leahy, Patrick F., Rambo, Robert D., Crook, Berwyn M.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/410,316
• Time in Patent Office: 1,280 Days
• Field of Search: 600/21-22, 128/897, 128/846, 128/850-56, 604/167, 604/174, 604/178, 604/237, 604/256, 606/213, 606/215
• US Class Current: 128/897
• 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 17/0293 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 46/00 Surgical drapes
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

An improved surgical apparatus for hand-assisted minimum invasive surgery with isolation at the site of a wound from ambient conditions. A sleeve of gas-impermeable material includes entry and exit openings for access to the wound, and ports for introducing surgical instruments into the sleeve within easy reach of a surgeon'"'"'s hand.

Claims

1. An improved surgical apparatus for hand-assisted minimum invasive surgery with isolation at the site of a wound from ambient conditions, said apparatus including a sleeve of gas-impermeable supple material having an entry opening at a proximal end thereof and an exit opening at a distal end thereof, first sealing means adapted to seal the exit opening around the wound, and second sealing means adapted to seal the entry opening around a surgeon'"'"'s forearm to create a gastight chamber in said sleeve, the improvement comprising:

at least one port means in said sleeve proximal to said exit opening formed to maintain effective isolation of the wound while passing surgical instruments through said port means into said chamber.

2. The improvement according to claim 1 wherein:

said port means includes a first aperture disposed in said sleeve oppositely from said exit opening, and a first duckbill check valve connected to said sleeve for communicating between said first aperture and said chamber.

3. The improvement according to claim 2 further comprising:

a snap-on cap means connected to said port means for manually closing said first aperture.

4. The improvement according to claim 2 wherein:

said first check valve is formed to pass lengthwise slender surgical instruments, including trocars and lumens.

5. The improvement according to claim 2 wherein:

said port means includes an elongate second aperture disposed in said sleeve near the distal end and athwart the length thereof, and a second duckbill check valve connected to said sleeve for communicating between said second aperture and said chamber.

6. The improvement according to claim 5 further comprising:

grommet means lining said second aperture for providing stiffness and tear resistance thereto, and

a peelable strip adhesively secured to an exposed surface of said grommet for manually closing said second aperture to the ambient conditions.

7. Apparatus according to claim 5 wherein:

said second check valve is formed to pass lengthwise wide instruments, including forceps and clamps.

8. The improvement according to claim 5 wherein:

said first and second check valves each comprise two flexible panels with opposite congruent side edges respectively joined together, and one end of said panels joined to said sleeve around respective ones of said apertures.

9. The improvement according to claim 1 wherein:

said port means includes a plurality of apertures in said sleeve disposed in close proximity to said exit opening, and a duckbill check valve at each of said apertures connected to said sleeve and communicating between each of said apertures and said chamber.

10. The improvement according to claim 1 further comprising:

an adhesive coating secured to the first sealing means for adhering around the wound comprises an acrylate polymer of about 0.002 in. thickness, approximate physical properties of peel adhesion 8 to 10 lb/in², shear resistance of 1.2 hrs. at 1 kg/in², and tack 1250 g/cm².

11. Apparatus for enabling surgery with two hands with isolation at the site of a wound from ambient conditions comprising, in combination:

a dome-shaped gas-impermeable enclosure having a centrally disposed exit opening adapted to seal around the wound; and

at least two gas-impermeable sleeves, each sleeve communicating at a distal end thereof through an opening with the interior of said enclosure, and an entry opening at a proximal end thereof adapted to seal about the forearm of a hand extended therein forming thereby a gas-tight chamber with said enclosure.

12. Apparatus according to claim 11 further comprising:

at least one port means formed in said enclosure proximal to said exit opening for effectively maintaining isolation while passing surgical instruments through said port means into said chamber.

13. Apparatus according to claim 12 wherein:

said port means includes an aperture disposed in said enclosure, and a check valve connected to said enclosure for communicating between said aperture and said chamber.

14. Apparatus according to claim 13 wherein:

said check valve is formed to pass surgical instruments through.

15. Apparatus according to claim 13 further comprising:

a snap-on cap connected to said port means for manually closing said aperture.

16. An improved surgical apparatus for hand-assisted surgery with isolation at the site of a wound from ambient conditions, said apparatus including a sleeve of gas-impermeable supple material having an entry opening at a proximal end thereof and an exit opening at a distal end thereof, first sealing means adapted to seal the exit opening around the wound, and second sealing means adapted to seal the entry opening around a surgeon'"'"'s forearm to create a gastight chamber in said sleeve, the improvement comprising:

a wound protector including a flexible tube adapted to line the wound, said tube having resilient rings at respective ends thereof, for stretching the ends of said tube around the internal and external surfaces of the wound; and

an annular lip formed at the distal end of said sleeve having an interference fit formed to snap onto said ring at the external end of said tube.

17. The improvement according to claim 16 further comprising:

a flexible flange recessed around said lip and having an exposed face for adapted to attach around the site of the wound.

18. The improvement according to claim 16 further comprising:

at least one port means formed in said sleeve proximal to said exit opening for effectively maintaining isolation while passing surgical instruments through said port means into said chamber near the site of the wound.

19. The improvement according to claim 18 wherein:

said port means includes an aperture disposed in said sleeve oppositely from said exit opening, and a duckbill check valve connected to said sleeve for communicating between said aperture and said chamber.

20. The improvement according to claim 18 further comprising:

a snap-on cap means connected to said port means for manually closing said aperture.

21. The improvement according to claim 19 wherein:

said check valve is formed to pass lengthwise slender surgical instruments, including trocars and lumens.

22. A method for hand-assisted minimum invasive surgery with isolation at the site of a wound from ambient conditions, the method comprising:

providing a gas-impermeable sleeve having an entry opening at a proximal end adapted to seal around a surgeon'"'"'s forearm, an exit opening at a distal end for fenestration with the wound, and at least one surgical instrument access port near the distal end;

adhering the sleeve at the exit opening around the wound;

inserting a hand in the sleeve through the entry and exit openings to the wound; and

introducing surgical instruments into the sleeve through the access port to the surgeon.

23. A method according to claim 22 further comprising:

insufflating a cavity at the wound before inserting the hand or instruments into the sleeve.

24. An improved surgical apparatus for hand-assisted surgery with isolation at the site of a wound from ambient conditions, comprising:

a sleeve of gas-impermeable supple material having an entry opening at a proximal end thereof and an exit at a distal end thereof;

first sealing means formed to seal the exit opening around the wound, said first sealing means including a first resilient ring formed to be externally secured around the site of the wound, and a second resilient ring around the distal end of said sleeve having an interference fit formed to snap together with said first ring; and

second sealing means formed to seal the entry opening around the surgeon'"'"'s forearm to create a gastight chamber in said sleeve.

25. An apparatus according to claim 24 wherein:

said first ring includes an continuous rib; and

said second ring includes a continuous groove complementary to said rib.

26. Apparatus according to claim 24 further comprising:

a flexible tube secured around one end thereof to said first ring for lining the wound; and

a resilient internal ring fixed to said tube around the other end thereof for stretching said tube around the internal surface of the wound.

27. Apparatus for use on a patient undergoing endoscopic surgery, said apparatus comprising:

a flexible envelope providing a chamber surrounding an incision in the patient, said envelope having a port affording access into said chamber from outside said envelope;

a normally-closed check valve in communication with said port to afford passage of instrumentarium into said enclosure;

a first ring gastightly secured to the patient around the incision;

a second ring gastightly carried on the enclosure; and

complementary matingly engageable means on said first and second rings for effecting a releasable connection of said rings and hence the enclosure to the patient;

whereby the enclosure may be readily mounted to and dismounted from the patient.

28. Apparatus according to claim 27 wherein said check valve opens laterally into said enclosure upon admission of an instrument.

29. Apparatus according to claim 27 wherein said check valve is of the duckbill type which closes upon pressure in said chamber greater than pressure outside said chamber.

30. Apparatus according to claim 27 including a tethered cap on the outside of said envelope providing a closure for said check valve.

31. Apparatus according to claim 27 wherein said envelope has a normally open proximal end for receiving a surgeon'"'"'s hand.

32. Apparatus for use on a patient undergoing endoscopic surgery, said apparatus comprising:

a flexible enclosure having a distal end with a large opening disposable adjacent to the patient for surrounding an incision therein, said flexible enclosure having a plurality of at least three other openings spaced from said large opening, at least one of said other openings being larger than the others of said other openings;

means for gastightly securing said envelope distal end to said patient around the outside of said incision; and

means carried by said enclosure for operatively closing said other openings to maintain insufflation gas within the enclosure during surgery.

33. Apparatus according to claim 32 wherein said envelope securing means includes:

a first ring gastightly secured to the patient around the incision;

a second ring gastightly carried on the distal end of the enclosure; and

complementary matingly engageable means on said first and second rings for effecting a releasable connection of said rings and hence the enclosure to the patient;

whereby the enclosure may be readily mounted to and dismounted from the patient.

34. Apparatus according to claim 32 wherein at least one of said other openings includes a normally-closed duckbill check valve operable upon insertion of an instrument into the enclosure to provide a slidable seal relative to the instrument.

35. Apparatus for use in endoscopic surgery to provide a chamber above an incision in a patient, comprising:

a flexible hemispheric enclosure having a distal end opening and at least one lateral opening spaced from said distal end opening,

means for releasably gastightly adhesively securing said enclosure distal end outside of the patient around the incision, and

a duckbill check valve normally closing said lateral opening while affording sliding sealed engagement with a surgical instrument.

36. Apparatus for use in minimally invasive surgery through a wound into an insufflated patient cavity, comprising:

an outer sleeve having a distal end adapted to be positioned adjacent the patient;

an annular ring operatively connected to said sleeve distal end for extending around the wound and effecting a sealed gastight connection of said outer sleeve onto said patient;

an inner glove extending interiorly of said outer sleeve and connected thereto remote from said distal end for receiving a surgeon'"'"'s fingers and creating a gastight chamber in said outer sleeve;

whereby the outer sleeve cooperates with the glove to afford a range of movement during surgery under insufflation conditions of the patient'"'"'s cavity.

37. Apparatus according to claim 36 wherein said inner glove has a hand receiving portion and an elongate gauntlet with an open end, and said gauntlet is connected to said sleeve.

38. Apparatus according to claim 37 wherein said gauntlet has a sealing flange around its open end for sealingly engaging said outer sleeve thereat.

39. Apparatus according to claim 36 wherein said annular ring has an adhesive layer for effecting said gastight sealed connection onto said patient.

40. Apparatus according to claim 39 wherein said adhesive is an acrylate polymer having a thickness of about 0.002 in., a peel adhesion of between about 8 to about 10 psi., a shear resistance of 1.2 hrs. at 1 kg/sq. in., and a tack of 1250 g/sq. cm.