Apparatus and method for use in surgery

• US 5,640,977 A
• Filed: 09/02/1994
• Issued: 06/24/1997
• Est. Priority Date: 04/08/1994
• Status: Expired due to Fees

• Current Assignee: MCT II, LLC
• Original Assignee: vMedical Creative Technologies, Inc.
• Inventors: Rambo, Robert D., Crook, Berwyn M., Leahy, Patrick F.
• Primary Examiner(s): DEMILLE, DANTON D
• Application Number:
  US08/300,346
• Time in Patent Office: 1,026 Days
• Field of Search: 600/21-22, 128/897, 128/846, 128/850-856, 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• 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
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Apparatus and method for hand-assisted minimally invasive laparoscopic surgery which allows for palpation and biophysical feedback within a sterile environment. A sleeve provides a sealed chamber communicating with a wound accessible to an surgeon'"'"'s hand through entry and exit openings. The entry opening is sealed around the surgeon'"'"'s wrist or forearm by a cuff.

Claims

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

an outer 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 gastightly around the wound in a patient; and

second sealing means adapted to seal the entry opening gastightly around a surgeon'"'"'s arm received therein and create thereby a gastight chamber in said outer sleeve when a surgeon'"'"'s arm is operatively received in said sleeve;

whereby the sleeve cooperates with the first and second sealing means to enable the surgery to be performed under insufflatable conditions.

2. Apparatus according to claim 1 further comprising:

third sealing means interposed in said sleeve between said first and second sealing means adapted to maintain the gastight chamber with the wound when said second sealing means is breached.

3. Apparatus according to claim 2 wherein:

said third sealing means includes an inner sleeve having a proximal end sealingly joined at facing portions to said outer sleeve and a distal end forming a normally closed aperture which opens automatically in response to movement of an object from proximal to distal locations therethrough.

4. Apparatus according to claim 3 wherein:

said third sealing means further includes a resilient means connecting the proximal end of said inner sleeve to said outer sleeve for biasing said aperture to a normally closed gastight position.

5. Apparatus according to claim 1 wherein:

said first sealing means includes a flexible flange secured around said exit opening and having an exposed face adapted to attach around the wound.

6. Apparatus according to claim 5 further comprising:

an adhesive coating on said exposed face adapted to adhere to said flange around the wound.

7. Apparatus according to claim 6 further comprising:

a peel-off strip covering said adhesive coating.

8. Apparatus according to claim 1 wherein:

said entry and exit openings are formed to accommodate a surgeon'"'"'s hand and forearm.

9. Apparatus according to claim 1 wherein:

said entry and exit openings are formed to accommodate instrumentarium.

10. Apparatus according to claim 1 wherein:

said material is sufficiently flexible for effecting a wide range of arm movement at said entry opening relative to said exit opening.

11. Apparatus according to claim 1 further comprising:

a wound protector means adapted to be inserted in the wound for simultaneously lining said exit opening and the wound, said protector including a pair of generally coaxial resilient rings contiguously connected to respective ends of a flexible tube, one of said rings being formed to compress said tube within said outer sleeve around said exit opening, and the other of said rings adapted to compress said tube around the internal side of the wound.

12. Apparatus according to claim 11 wherein said tube is made of a supple material effectively impermeable to gases and microorganism-bearing fluids.

13. Apparatus according to claim 12 wherein:

said tube is adapted to be in contiguous contact with the wound.

14. Apparatus according to claim 1 wherein said second sealing means comprises:

an inflatable tube fixed around the proximal end of said outer sleeve; and

an elastic inflator operatively connected to said tube adapted to inflate said tube in compression around the surgeon'"'"'s arm or instrument.

15. Apparatus according to claim 1 wherein said second sealing means comprises:

a track formed around the proximal end of said outer sleeve;

a clamp tie having a U-shape strip adapted to slide in said track with an exposed finger grip at one end and an exposed latch at the other end, and a sawtooth leader adapted to slide in said strip extending from said grip for engaging said latch.

16. Apparatus according to claim 15 wherein said clamp tie further comprises:

an elastic pad interposed between said strip and said outer sleeve adapted to enhance contiguity of engagement between said outer sleeve and the surgeon'"'"'s arm.

17. Apparatus according to claim 1 wherein:

said second sealing means includes a pair of flanges interconnected on a common axis by a supple tube, said flanges being relatively adjustable about said axis for twisting said tube into a constricting position around an object.

18. Apparatus according to claim 17 wherein;

said flanges include means for locking said flanges together in the constricting position.

19. Apparatus according to claim 1 wherein:

said second sealing means includes a first flange secured around said entry opening, a surgical glove for inserting into said outer sleeve through said first flange, and a second flange secured around the opening of said glove for sealing attachment to said first flange.

20. Apparatus for use in hand-assisted minimally-invasive surgery in a sufflatable body cavity having an outer surface, comprising:

an elongate flexible sleeve having an end portion adapted to be positioned adjacent the body cavity and a proximal end portion adapted to be positioned away from the body;

means defining an exit opening laterally of said flexible sleeve adjacent to said distal end portion;

means defining an entry opening co-axially of said flexible sleeve at said proximal end portion;

first sealing means carried by said sleeve and surrounding said exit opening and adapted to engage said body outer surface;

second sealing means carried by said sleeve and surrounding said proximal end portion adapted to seal gastightly a surgeon'"'"'s arm; and

means in said sleeve between its distal and proximal end portions providing a normally-closed flexible valve adapted to open upon insertion of the surgeon'"'"'s hand toward the distal end portion of the sleeve and automatically close gastightly upon withdrawal of the surgeon'"'"'s hand, said valve providing a third sealing means co-operable with said first sealing means to define a substantially gastight chamber in communication with said exit opening;

whereby the surgeon can readily insert and withdraw the hand from the body cavity in the course of surgery without significant loss of pressure in the body cavity when sufflated.

21. Apparatus according to claim 20 wherein said normally closed valve is of the duckbill type formed by at least one flexible panel secured to said sleeve and providing an aperture at a location adjacent to said exit opening.

22. Apparatus according to claim 21 including resilient means carried by said sleeve for biasing said at least one panel in a direction to close said aperture.

23. Apparatus according to claim 22 wherein said valve includes another panel like said first mentioned panel and juxtaposed in said sleeve therewith for cooperating therewith defining an elongate slot in said aperture.

24. Apparatus according to claim 20 wherein said means defining an exit opening includes an annular flange having an adhesive coating adapted to secure the sleeve to the body outer surface with the sleeve extending alongside the body.

25. Apparatus according to claim 20 including a flexible, tubular wound protector depending from said means providing said exit opening adapted to be inserted into a wound formed in said outer surface, said wound protector including a flexible membrane mounting annular elastic rings at opposite ends.

26. Apparatus according to claim 20 wherein said proximal end second sealing means is adapted to engage gastightly the periphery of the surgeon'"'"'s arm when the hand is inserted in the sleeve.

27. Apparatus for use in hand-assisted minimally invasive surgery in a gas sufflatable body, comprising:

an elongate flexible sleeve having a lateral exit opening at one location and an axial entry opening at another location;

first means adapted to seal gastightly said sleeve around said exit opening to a body surface undergoing minimally invasive surgery;

second means adapted to seal gastightly said sleeve around a surgeon'"'"'s arm adjacent to said entry opening; and

means providing a duckbill check valve in said sleeve for preventing gas flow from said exit opening to said entry opening when said second sealing means is unsealed;

whereby a surgeon may insert and withdraw the hand through the exit opening without significantly affecting gas pressure in the sufflated body.

28. Surgical apparatus for use in minimally invasive surgery for introducing a hand or instrument through a wound into an insufflated cavity comprising:

protective sleeve means of gas-impermeable material having a distal end adapted to be inserted through the wound for overlapping the lower edge thereof, and a proximal end formed to extend out of the wound;

an inside sealing ring, operatively connected to said sleeve means in proximity to the distal end, adapted to self-seal gastightly around the inside of the wound;

an outside sealing ring, operatively connected to said protective sleeve means in proximity to the proximal end thereof and forming with said first sealing means a gastight chamber in said protective sleeve means and adapted to seal gastightly around the outside of the wound;

an elongate gas-impermeable supple sleeve extending laterally of said outside sealing ring; and

means providing a gastight-seal on said elongate sleeve at an end thereof remote from said outside sealing ring;

whereby the wound is protected by the protective sleeve while insufflation gas is contained within the elongate sleeve.

29. Surgical apparatus according to claim 28 wherein:

said sleeve means includes a tubular portion closely conforming to the wound surface.

30. Surgical apparatus according to claim 28 wherein:

said first sealing means includes a normally closed resilient member formed to prevent gas flow from the cavity into the chamber.

31. Surgical apparatus according to claim 28 further comprising:

a resilent ring affixed around the distal end and adapted to expand beyond the edge of the wound when the distal end is fully inserted in the wound.