METHODS AND DEVICES FOR THE PREVENTION OF INCISIONAL SURGICAL SITE INFECTIONS

• US 20140316210A1
• Filed: 03/13/2014
• Published: 10/23/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Prescient Surgical, Inc., Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Prescient Surgical, Inc., Leland Stanford Junior University (Stanford University)
• Inventors: Suh, Insoo, Koehler, Jeremy, Coe, Jonathan
• Granted Patent: US 9,402,612 B2
• Time in Patent Office: Days
• 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 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/3429 having a unitary compressible body, e.g. made of silicone or foam
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• 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 device for facilitating access through an incision to a surgical site in a patient'"'"'s body has a pliable membrane which is configured to engage and expand the incision. The pliable membrane includes a base layer, a permeable membrane attached to the base layer, and a fluid channel disposed between the layers. The fluid channel is fluidly coupled to a fluid source. The fluid is delivered to the surgical site via the permeable membrane. The surgical access device may also have a locking mechanism for holding the device in a desired configuration.

Claims

1. A surgical access device for facilitating access through an incision to a surgical site in a patient'"'"'s body, said device comprising:

a pliable membrane having a superior end and an inferior end, the pliable membrane configured to engage and expand the incision, the pliable membrane comprising;

a base layer;

a permeable membrane attached to the base layer; and

a fluid channel disposed between the base layer and the permeable membrane, wherein the fluid channel is fluidly coupled to a fluid source and fluid from the fluid source is delivered to the surgical site via the permeable membrane.

2. The device of claim 1, further comprising an intermediate layer of material disposed between the base layer and the permeable membrane.

3. The device of claim 2, further comprising a manifold seal layer of material disposed between the base layer and the permeable membrane, the manifold seal layer of material capturing the intermediate layer of material between the manifold seal layer and the base layer.

4. The device of claim 2, wherein the intermediate layer of material comprises foam.

5. The device of claim 1, wherein the base layer is impermeable.

6. The device of claim 1, wherein the permeable membrane comprises a plurality of holes disposed therethrough.

7. The device of claim 1, further comprising a superior retention member coupled to the superior end of the pliable membrane.

8. The device of claim 7, wherein the superior retention member is radially expandable and radially collapsible.

9. The device of claim 7, wherein the superior retention member forms a closed ring.

10. The device of claim 1, further comprising an inferior retention member coupled to the inferior end of the pliable membrane, and wherein the inferior retention member is resilient.

11. The device of claim 10, wherein the inferior retention member forms a closed ring.

12. The device of claim 1, wherein the superior end of the pliable membrane comprises a plurality of tabs each having a hole disposed therethrough, the hole configured to be coupled with an engagement element on the superior retention member.

13. The device of claim 1, wherein the pliable membrane forms a substantially frustoconical shape.

14. The device of claim 1, wherein the pliable membrane comprises a fixed length.

15. The device of claim 1, further comprising a suction channel disposed between the base layer and the permeable membrane, wherein the suction channel is configured to be coupled to a vacuum source, and vacuum from the vacuum source draws fluid from the surgical site into the suction channel via the permeable membrane.

16. The device of claim 15, wherein the permeable membrane comprises a plurality of holes disposed therethrough, and wherein the plurality of holes comprise a first plurality of holes and a second plurality of holes, the first plurality of holes through which the vacuum is applied, and the second plurality of holes through which the fluid passes.

17. The device of claim 16, wherein the second plurality of holes are smaller than the first plurality of holes.

18. The device of claim 15, wherein the suction channel and the fluid channel comprise a plurality of channels, and wherein the plurality of channels are positioned along the pliable membrane so as to substantially minimize fluidic resistance at a respective exit point.

19. The device of claim 18, wherein the plurality of channels comprise a plurality of inner suction channels and a plurality of outer suction channels.

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

providing a pliable membrane having a superior end, an inferior end, a base layer and a permeable membrane coupled to the base layer;

inserting the pliable membrane through the incision into the surgical site;

radially expanding the pliable membrane thereby expanding the incision; and

irrigating the surgical site with fluid delivered from a fluid channel disposed between the base layer and the permeable membrane, the fluid exiting a first plurality of holes disposed in the permeable membrane.

21. The method of claim 20, wherein a resilient inferior retention member is coupled to the inferior end of the pliable member, and wherein inserting the pliable membrane comprises inserting the resilient inferior retention member through the incision into the surgical site.

22. The method of claim 20, wherein radially expanding the pliable membrane comprises forming the pliable membrane into a substantially frustoconical shape.

23. The method of claim 20, wherein radially expanding the pliable membrane comprises radially expanding a superior retention member coupled to the superior end of the pliable membrane.

24. The method of claim 20, further comprising maintaining a fixed length of the pliable membrane.

25. The method of claim 20, further comprising suctioning fluid from the surgical site, the suctioned fluid entering a second plurality of holes disposed in the permeable membrane and passing through a suction channel disposed between the base layer and the permeable membrane.

26. A method for fabricating a pliable membrane for a surgical access device configured to facilitate access through an incision to a surgical site in a patient'"'"'s body, said method comprising:

providing a base layer, and a permeable membrane;

sealing the base layer to the permeable membrane;

forming a first plurality of holes in the permeable membrane; and

forming a fluid channel disposed between the base layer and the permeable membrane, wherein the fluid channel is configured to deliver a fluid from a fluid source through the fluid channel and to the surgical site via the first plurality of holes.

27. The method of claim 26, wherein sealing the base layer to the permeable membrane comprises thermally welding the base layer to the permeable membrane.

28. The method of claim 26, wherein forming the first plurality of holes comprises laser drilling the first plurality of holes into the permeable membrane.

29. The method of claim 26, further comprising coupling an expandable superior retention member to a superior end of the pliable membrane.

30. The method of claim 29, wherein the superior end of the pliable membrane comprises a plurality of tabs, and wherein coupling the expandable superior retention member comprises coupling the plurality of tabs with pins disposed on the superior retention member.

31. The method of claim 29, further comprising coupling a locking mechanism to the superior retention member, the locking mechanism comprising a ratchet and pawl having a locked configuration and an unlocked configuration, the locked configuration adapted to hold the superior retention member in a desired size, and the unlocked configuration adapted to allow expansion or collapsing of the superior retention member.

32. The method of claim 26, further comprising coupling a resilient inferior retention member to an inferior end of the pliable membrane.

33. The method of claim 26, wherein a second plurality of holes are disposed in the permeable membrane, and the method further comprises forming a suction channel disposed between the base layer and the permeable membrane, wherein the suction channel is configured to transmit a vacuum from a vacuum source through the suction channel to the surgical site via the second plurality of holes.

34. The method of claim 26, further comprising providing an intermediate layer of material and disposing the intermediate layer of material between the base layer and the permeable membrane.

35. The method of claim 34, further comprising:

providing a manifold seal layer of material;

disposing the manifold seal layer of material over the intermediate layer of material;

sealing the manifold seal layer of material to the base layer; and

sealing the permeable membrane to the manifold seal layer of material.

36. A surgical access device for facilitating access through an incision to a surgical site in a patient'"'"'s body, said device comprising:

a radially expandable and collapsible retention ring having a collapsed configuration, an expanded configuration, and a plurality of configurations therebetween, the retention ring comprising;

a plurality of links pivotably coupled to one another; and

a locking mechanism having a locked position and an unlocked position, the locked position configured to hold the retention ring in a desired configuration, and the unlocked position configured to allow radial expansion or radial collapsing of the retention ring,

wherein the locking mechanism comprises a ratchet and a pawl, and engagement of the ratchet and pawl prevent pivoting of adjacent links amongst the plurality of links relative to one another, and disengagement of the ratchet from the pawl allow pivoting of the adjacent links relative to one another, and

wherein the locking mechanism maintains a distance between any two points on any two links in the plurality of links when the locking mechanism is in the locked position, or

wherein the locking mechanism maintains an angle between any two links in the plurality of links when the locking mechanism is in the locked position.

37. The device of claim 36, wherein the retention ring forms a closed ring having a desired size in between the collapsed configuration and the expanded configuration, and wherein the locking mechanism holds the closed ring in the desired size.

38. The device of claim 36, wherein the plurality of configurations comprises between 2 and 20 configurations.

39. The device of claim 36, wherein the plurality of configurations comprises an infinite number of configurations.

40. The device of claim 36, wherein adjacent links in the plurality of links are pivotably coupled together with a pin.

41. The device of claim 40, wherein a distance between two adjacent pins is minimized in the collapsed configuration, and wherein the distance is maximized in the expanded configuration.

42. The device of claim 40, wherein an angle between the adjacent links is minimized in the collapsed configuration, and wherein the angle is maximized in the expanded configuration.

43. The device of claim 36, wherein the ratchet comprises one or more teeth and the pawl comprises one or more teeth, the one or more teeth of the ratchet engaging the one or more teeth of the pawl in the locked configuration.

44. The device of claim 43, wherein the one or more teeth of the ratchet or the one or more teeth of the pawl are angled relative to one another so as to bias engagement therebetween when a collapsing force is applied to the adjustable ring.

45. The device of claim 36, further comprising a torsion spring coupled to the pawl and configured to provide a torque in a direction that biases the pawl to engage the ratchet.

46. The device of claim 36, further comprising an interface surface coupled to the pawl, the interface surface configured to allow a user to apply a torque thereto thereby disengaging the pawl from the ratchet and allowing the retention member to expand or collapse.

47. The device of claim 36, wherein ratchet comprises a continuous curved element frictionally engaged with the pawl, and

wherein frictional engagement of the continuous curved element and pawl prevent pivoting of the adjacent links relative to one another, and

wherein disengagement of the continuous curved element from the pawl allows pivoting of the adjacent links relative to one another to form an infinite number of configurations sized between the expanded and the collapsed configurations.

48. The device of claim 47, further comprising a torsion spring coupled to the pawl and configured to provide a torque in a direction that biases the pawl to frictionally engage the continuous curved element.

49. The device of claim 47, further comprising a cam surface coupled to the pawl, the cam surface configured to control rotation of the pawl by engagement with a portion of the adjustable ring.

50. The device of claim 36, further comprising a pliable membrane coupled to the retention ring.

51. The device of claim 50, further comprising an inferior resilient retention ring coupled to the pliable membrane opposite of the retention ring.

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

providing an access device having an adjustable superior retention member, an inferior resilient retention member and a pliable membrane coupled therebetween;

inserting the resilient retention member through the incision into the surgical site;

inserting the pliable membrane through the incision into the surgical site;

expanding or contracting the adjustable superior retention member outside the body to a desired expanded size; and

locking the adjustable superior retention member into the desired size with a ratchet and pawl locking mechanism.

53. The method of claim 52, further comprising unlocking the adjustable superior retention member by disengaging the pawl from the ratchet and collapsing the adjustable superior retention member to a collapsed size smaller than the desired expanded size.

54. The method of claim 52, further comprising irrigating the surgical site with fluid delivered from the pliable membrane.

55. The method of claim 52, further comprising suctioning fluid from the surgical site with a vacuum provided by the pliable membrane.