Methods and apparatus for reducing the risk of surgical site infections

• US 10,327,751 B2
• Filed: 03/20/2014
• Issued: 06/25/2019
• Est. Priority Date: 03/20/2013
• Status: Active Grant

• Current Assignee: Prescient Surgical, Inc.
• Original Assignee: Prescient Surgical, Inc.
• Inventors: Coe, Jonathan, Suh, Insoo, Koehler, Jeremy
• Primary Examiner(s): Yabut, Diane D
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/220,928
• Publication Number:
  US 20140343366A1
• Time in Patent Office: 1,923 Days
• Field of Search: 600205-208, 604540, 604541, 604 26, 60410301, 222187, 222175, 222152, 222192, 2241481, 2241482
• 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 17/3462 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 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 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61F 7/034 Flameless
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means

Abstract

A surgical access system that facilitates access to a surgical site through an incision in the patient'"'"'s body includes a surgical retractor and a fluid delivery or fluid evacuation device. The fluid delivery or fluid evacuation device is coupled to the surgical retractor and is adapted to deliver fluid to the surgical site or evacuate fluid from the surgical site.

Claims

1. A surgical access system adapted to facilitate access to a surgical site through an incision in a patient'"'"'s body, said system comprising:

a surgical retractor comprising an upper retention member, a lower retention member and a membrane disposed therebetween; and

a first fluid delivery or fluid evacuation device coupled with the surgical retractor, the first fluid delivery or fluid evacuation device configured to deliver fluid to the surgical site or configured to evacuate fluid from the surgical site, wherein the first fluid delivery or fluid evacuation device forms a ring coupled to an outer surface of the membrane, the ring having a width d1 and the ring being disposed a distance d2 from the lower retention member,

wherein d1 is greater than d2,

and wherein d2 is non-zero.

2. The system of claim 1, wherein the upper retention member comprises an expandable and collapsible ring, and wherein the lower retention member comprises a resilient ring.

3. The system of claim 1, wherein the first fluid delivery or fluid evacuation device further comprises a fluid delivery or fluid removal tube fluidly coupled thereto and configured to deliver fluid from a fluid source to the device, or configured to deliver a vacuum from a vacuum source to the device.

4. The system of claim 3, wherein the membrane comprises a dual layer membrane with a channel disposed therebetween, and wherein the channel is fluidly coupled with the fluid delivery or fluid removal tube.

5. The system of claim 1, wherein the first fluid delivery or fluid evacuation device is configured to deliver fluid to the surgical site and configured to evacuate fluid from the surgical site.

6. The system of claim 1, wherein the ring comprises an inner layer of material, an outer layer of material and a support member disposed therebetween, the support member providing support to prevent collapse of the inner and outer layers toward one another.

7. The system of claim 1, wherein the ring comprises an inner layer of material, an outer layer of material and a fluid dispersion member disposed therebetween and configured to distribute the fluid about a perimeter of the ring.

8. The system of claim 1, wherein the first fluid delivery or fluid evacuation device is discrete and releasably coupled with the surgical retractor.

9. The system of claim 1, wherein the first fluid delivery or fluid evacuation device is integrally formed with the surgical retractor.

10. The system of claim 1, wherein the first fluid delivery or fluid evacuation device comprises a permeable outer layer of material fixedly attached to the surgical retractor thereby forming a channel disposed therebetween, and wherein fluid or vacuum is delivered through the channel and through the permeable outer layer of material to the surgical site.

11. The system of claim 10, further comprising an intermediate layer of material disposed in the channel, the intermediate layer of material configured to support the channel and help prevent collapse of the permeable outer layer of material and the surgical retractor toward one another.

12. The system of claim 11, wherein the intermediate layer of material comprises foam.

13. The system of claim 1, wherein the first fluid delivery or fluid evacuation device is a first fluid delivery device, and wherein a fluid is stored in the first fluid delivery device, and wherein the fluid is delivered to the surgical site without requiring fluid coupling between the first fluid delivery device and an external fluid source.

14. The system of claim 13, wherein the fluid is stored in an absorbable material coupled to the first fluid delivery device.

15. The system of claim 1, wherein the first fluid delivery or fluid evacuation device comprises a layer of absorbent material, the layer of absorbent material holding the fluid and configured to deliver the fluid to the surgical site.

16. The system of claim 15, wherein the first fluid delivery or fluid evacuation device comprises a second layer of absorbent material, the second layer of absorbent material positioned to absorb excess fluid from the surgical site.

17. The system of claim 1, wherein the first fluid delivery or fluid evacuation device comprises an inner layer of material and an outer permeable layer of material, and wherein the layers of material are sealed to one another in a quilted pattern.

18. The system of claim 1, wherein the first fluid delivery or fluid evacuation device is a fluid delivery device comprising a gutter for collecting the fluid.

19. The system of claim 1, further comprising a second fluid delivery or fluid evacuation device coupled with the surgical retractor, the second fluid delivery or fluid evacuation device configured to deliver fluid to the surgical site or configured to evacuate fluid from the surgical site.

20. The system of claim 19, wherein the first fluid delivery or fluid evacuation device is a fluid delivery device that delivers a fluid to the surgical site, and wherein the second fluid delivery or fluid evacuation device is a fluid evacuation device that delivers a vacuum to the surgical site to evacuate fluid from the surgical site.

21. The system of claim 19, wherein the second fluid delivery or fluid evacuation device comprises a ring disposed around an outer surface of the surgical retractor.

22. The system of claim 1, further comprising the fluid, and wherein the fluid comprises saline or an antibiotic.

23. The system of claim 1, further comprising an exothermic reagent for generating heat and warming the surgical site.

24. The system of claim 1, further comprising a circulating system for collecting the fluid from the surgical site and redelivering the fluid to the surgical site.

25. The system of claim 1, further comprising a sealing element disposed between a patient'"'"'s skin and the surgical retractor or the first fluid delivery or fluid evacuation device, the sealing element configured to prevent leakage of the fluid from the surgical site.

26. The system of claim 1, further comprising a surgical access port having a resilient access membrane biased to collapse into a relaxed configuration thereby substantially closing any punctures formed by a hand or a surgical instrument passing through the resilient access membrane.

27. The system of claim 1, further comprising an illumination element for illuminating the surgical site.

28. The system of claim 27, wherein the illumination element provides visible light or ultraviolet light.

29. The system of claim 1, wherein the ring is integrally formed with the membrane.

30. The system of claim 1, wherein the ring completely encircles a circumference of the membrane.

31. The system of claim 1, wherein the ring comprises a plurality of holes disposed therein, the holes allowing fluid or suction to pass therethrough.

32. The system of claim 1, further comprising a fluid source fluidly coupled with the ring.

33. The system of claim 1, wherein the ring is slidably disposed on the membrane.

34. The system of claim 1, comprising both the first fluid delivery and fluid evacuation device.

35. A method for accessing a surgical site through an incision in a patient'"'"'s body, said method comprising:

providing a surgical retractor and a first fluid delivery or fluid evacuation device, wherein the surgical retractor comprises an upper retention member, a lower retention member and a membrane disposed therebetween, and wherein the first fluid delivery or fluid evacuation device forms a ring coupled to an outer surface of the membrane, the ring having a width d1 and the ring being disposed a distance d2 from the lower retention member, wherein d1 is greater than d2, and wherein d2 is non-zero;

inserting the surgical retractor through the incision;

retracting tissue in the surgical site with the surgical retractor; and

delivering fluid to the surgical site from the first fluid delivery device, or evacuating fluid from the surgical site to the first fluid evacuation device.

36. The method of claim 35, wherein retracting the tissue comprises radially expanding or collapsing an expandable or collapsible upper retention ring coupled to the surgical retractor.

37. The method of claim 35, further comprising coupling a fluid delivery tube or a fluid removal tube to the first fluid delivery or fluid evacuation device, the fluid delivery tube or the fluid removal tube allowing a fluid connection between the first fluid delivery or fluid evacuation device and a source of the fluid, or a source of vacuum.

38. The method of claim 35, wherein the first fluid delivery or fluid evacuation device is a fluid delivery device having a fluid stored therein, and delivering the fluid comprises releasing the stored fluid.

39. The method of claim 38, wherein the fluid is delivered without requiring coupling of the fluid delivery device with an external source of fluid.

40. The method of claim 38, wherein the stored fluid is stored in an absorbent material.

41. The method of claim 35, wherein delivering the fluid comprises delivering saline or an antibiotic to the surgical site.

42. The method of claim 35, wherein the first fluid delivery or fluid evacuation device further comprise an inner layer of material and an outer permeable layer, the method further comprising providing a support element disposed between the inner layer and the outer layer of material, the support element providing support to prevent collapse of the layers inward toward one another.

43. The method of claim 35, further comprising providing a second fluid delivery or fluid evacuation device, the method further comprising:

coupling the second fluid delivery or fluid evacuation device with the surgical retractor;

delivering fluid to the surgical site from the first fluid delivery device; and

evacuating fluid from the surgical site with the second fluid evacuation device.

44. The method of claim 35, further comprising heating the surgical site.

45. The method of claim 35, further comprising illuminating the surgical site with light.

46. The method of claim 45, wherein the illuminating comprises illuminating the surgical site with visible light or ultraviolet light.

47. The method of claim 35, wherein the ring is integrally formed with the membrane.

48. The method of claim 35, wherein the ring completely encircles a circumference of the membrane.

49. The method of claim 35, wherein the ring comprises a plurality of holes disposed therein, the method comprising passing fluid or suction through the plurality of holes.

50. The method of claim 35, further comprising fluidly coupling a fluid source with the ring.

51. The method of claim 35, further comprising slidably disposing the ring on the membrane.

52. The method of claim 35, wherein providing comprises providing both the first fluid delivery and the fluid evacuation device.