Surgical access apparatus and method

• US 8,672,839 B2
• Filed: 09/13/2011
• Issued: 03/18/2014
• Est. Priority Date: 10/19/2000
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Ewers, Richard C., Brustad, John R., Pingleton, Edward D., Hilal, Nabil, Dulak, Gary R., Adlparvar, Payam, Bowes, Robert R.
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US13/231,348
• Publication Number:
  US 20120004510A1
• Time in Patent Office: 917 Days
• Field of Search: 606/108, 606/191, 606/213, 606205-207, 60416401-16411, 604/165, 604/166, 604/167, 604/246, 604/247, 604/250, 604/264, 600/206, 600/208
• US Class Current: 600/208
• 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 17/3474 Insufflating needles, e.g. Veress needles
• 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 2017/00265 Hand assisted surgery, i.e. minimally invasive surgery with at least part of an assisting hand inside the body
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61M 13/003 Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing

Abstract

An access system comprises an access device. The access device is adapted to be disposed within an opening in a body wall. The access device has an external flange adapted to be disposed external to the body wall and an internal flange adapted to be disposed internal to the body wall. Holes extend through the access device between an external surface and an internal surface of the access device. The holes span the thickness of the body wall between a location external to the body wall and a location internal to the body wall. The access device is formed of an elastomeric material adapted to conform to surfaces of instruments inserted through the holes to form instrument seals along at least a portion of a length spanning the thickness of the body wall. The elastomeric material is compressible and adapted to form a seal with the body wall.

Claims

1. A method of using an access system, the method comprising:

disposing a non-inflatable access device within an opening in a body wall of a patient to provide access to a body cavity of the patient, wherein the access device has an external flange, an internal flange, and at least one hole through the access device between an external surface and an internal surface of the access device, the access device with flanges being monolithically formed of an elastomeric material, wherein the external flange is disposed external to the body wall in an operative position, the internal flange is disposed internal to the body wall in the operative position, and the hole spans the thickness of the body wall between a location external to the body wall and a location internal to the body wall in the operative position, wherein disposing the access device within the opening provides pressure between the access device and the opening when in use in the operative position;

positioning a trocar through the hole, wherein the trocar is an instrument having a valve structure configured to inhibit the escape of gas through the trocar when in use in an operative position, wherein at least a portion of the access device between the external flange and the internal flange and within the opening between an external surface of the body wall and an internal surface of the body wall contacts a surface of the instrument positioned through the hole along at least a portion of a length spanning the thickness of the body wall; and

introducing gas into the body cavity of the patient to pressurize the body cavity.

2. The method of claim 1, wherein the access device comprises a plurality of holes, and further comprising providing a plurality of instruments configured for placement through the plurality of holes.

3. The method of claim 1, wherein introducing gas into the body cavity comprises positioning an insufflation device into an abdominal cavity to pressurize the abdominal cavity with the insufflation gas.

4. The method of claim 1, wherein the elastomeric material of the access device comprises a thermoplastic elastomer.

5. The method of claim 4, wherein the elastomeric material comprises a triblock copolymer.

6. The method of claim 5, wherein the triblock copolymer comprises Styrene-Ethylene/Butylene-Styrene.

7. The method of claim 4, wherein the elastomeric material comprises an oil.

8. The method of claim 7, wherein the elastomeric material comprises a foaming agent.

9. A method of using an access system, the method comprising:

positioning a non-inflatable monolithic access device within an opening in a patient, the access device having an external flange, an internal flange, and a path extending through the access device between an external surface and an internal surface of the access device, the access device being formed of an elastomeric material comprising a thermoplastic elastomer, wherein the access device is positioned within the opening such that the external flange is disposed external to the patient, the internal flange is disposed internal to the patient, and the path spans a thickness of the access device between a location external to patient and a location internal to the patient, wherein locating the access device within the opening provides an outward force between the access device and the opening such that the elastomeric material presses against the patient;

positioning an instrument along the path through the access device, wherein the instrument is a trocar with a valve to inhibit the escape of gas through the trocar when in use, wherein at least a portion of the access device between the external flange and the internal flange and within the opening contacts the instrument, and wherein the elastomeric material presses against a surface of the instrument positioned through the access device along at least a portion of a length spanning the thickness of the access device; and

positioning a gas delivery device into the patient for delivery of gas into the patient.

10. The method of claim 9, further comprising placing a plurality of instruments through a plurality of paths in the access device.

11. The method of claim 9, wherein at least a portion of the external surface of the access device is concave.

12. The method of claim 9, wherein the thermoplastic elastomer comprises a triblock copolymer.

13. The method of claim 12, wherein the triblock copolymer comprises Styrene-Ethylene/Butylene-Styrene.

14. The method of claim 12, wherein the thermoplastic elastomer comprises an oil.

15. The method of claim 14, wherein the elastomeric material comprises a foaming agent.

16. A method of using an access system to perform laparoscopic surgery, the method comprising:

positioning a non-inflatable access port within an incision in an abdominal wall of a patient, wherein the non-inflatable access port spans a thickness of the abdominal wall of the patient and permits access of a surgical instrument through the incision in the abdominal wall of the patient and into an abdominal cavity, wherein the access port comprises a proximal flange, a distal flange, and an intermediate portion between the proximal flange and the distal flange, wherein an opening extends through the access port between the proximal flange and the distal flange, wherein the proximal flange, the distal flange, and the intermediate portion are monolithically formed of an elastomeric material comprising a triblock copolymer, wherein the intermediate portion comprises an outer surface and an inner surface, the inner surface at least partially defines the opening, and wherein positioning the access port within the incision maintains the access port in an operative position with the proximal flange disposed exteriorly of the abdominal wall, the distal flange disposed interiorly of the abdominal wall, and the intermediate portion disposed within the incision and exerting an outward force against the incision;

positioning a surgical instrument through the access port, wherein the surgical instrument is a trocar having a valve structure configured to inhibit the escape of gas through the trocar when in use in an operative position, wherein the intermediate portion contacts a surface of the surgical instrument positioned through the access port along a length spanning a thickness of the intermediate portion; and

positioning an insufflation device into the patient to deliver insufflation gas to the abdominal cavity to pressurize the abdominal cavity with the insufflation gas.

17. The method of claim 16, wherein the opening is configured to self seal in the absence of any instrument extending through the opening.

18. The method of claim 16, wherein the access port comprises a plurality of openings and further comprising positioning a plurality of instruments through the access device.

19. The method of claim 18, further comprising maintaining a sealing relationship with the plurality of instruments while accommodating relative movement between the plurality of instruments.

20. The method of claim 16, wherein the triblock copolymer comprises Styrene-Ethylene/Butylene-Styrene.

21. The method of claim 20, wherein the elastomeric material comprises an oil.