Surgical access device, system, and methods of use

• US 20070010716A1
• Filed: 06/07/2006
• Published: 01/11/2007
• Est. Priority Date: 07/11/2005
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Malandain, Hugues, Edidin, Avram, Rothwell, Derek
• Granted Patent: US 8,105,236 B2
• Time in Patent Office: Days
• US Class Current: 600/224
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• 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: A61B 90/35 Supports therefor

Abstract

A surgical access device can include a plurality of retractor members that together define a lumen having a first cross-sectional dimension. Each of the plurality of retractor members can be moved radially outward to at least a second cross-sectional dimension to create a surgical access passage. The surgical access device, systems and kits comprising the surgical access device, and methods of using the surgical access device can include a mechanism for inserting an elongate member from exterior the body to the surgical site, a mechanism for moving the retractor members radially outward, a mechanism for guiding the radially outward movement of the retractor members, a mechanism for securing each of the retractor members in a range of positions, and a mechanism for illuminating the surgical site. Variations of the devices, systems, kits, and methods are useful for creating and maintaining a surgical access passage for performing minimally invasive surgery.

Claims

1. A device, comprising:

an elongate member comprising a proximal end, a distal end, and a plurality of retractor members each having an inner surface that together define a lumen of the elongate member, the lumen having a first cross-sectional dimension,

each of the plurality of retractor members being moveable radially outward to a second cross-sectional dimension for creating a surgical access passage capable of receiving instruments.

2. The device of claim 1, wherein the surgical access passage further comprises a substantially constant cross-sectional dimension between the proximal end and the distal end.

3. The device of claim 1, wherein the surgical access passage further comprises a direct access to a surgical site.

4. The device of claim 1, further comprising:

a retractor member arm extending outwardly from the proximal end of each retractor member; and

a retainer ring comprising a plurality of retractor member guide channels and configured for placement at the proximal end of and concentric to the plurality of retractor members, each retractor member arm slidable within one of the guide channels.

5. The device of claim 4, further comprising a mechanism for securing each of the plurality of retractor members in a first position comprising the first cross-sectional dimension and in a second position comprising the second cross-sectional dimension.

6. The device of claim 5, wherein the mechanism for securing each of the plurality of retractor members comprises a wheel lock threaded through a wheel lock guide in the retainer ring into each retainer member guide channel and into adjustable contact with the retainer member arm in that guide channel.

7. The device of claim 1, further comprising a stylet comprising a pointed tip and a guide wire bore extending through the stylet, the stylet insertable into the lumen for guiding the elongate member over a guide wire to a surgical site.

8. The device of claim 1, further comprising a mechanism insertable into the lumen and actuatable to apply a radially outward force to move the retractor members.

9. The device of claim 8, wherein the mechanism for moving the retractor members comprises an expandable body.

10. The device of claim 9, the plurality of retractor members having a length, wherein the expandable body comprises a length that approximates the length of the retractor members.

11. The device of claim 9, the plurality of retractor members having a length, wherein the expandable body comprises a length less than the length of the retractor members.

12. The device of claim 8, the mechanism for moving the retractor members further comprising a hydraulic mechanism.

13. The device of claim 8, the mechanism for moving the retractor members further comprising a mechanical mechanism.

14. The device of claim 4, the surgical access passage further comprising one cross-sectional dimension from a range of cross-sectional dimensions between the first cross-sectional dimension of the lumen and a cross-sectional dimension equal to an inside diameter of the retainer ring.

15. The device of claim 1, the surgical access passage having a cross-sectional dimension comprising a diameter in the range of ¾

inch to 1¼

inch.

16. The device of claim 1, the surgical access passage further comprising a non-circular cross-sectional configuration.

17. The device of claim 1, one or more of the retractor members further comprising a hollow region for transferring material to and from a surgical site.

18. The device of claim 1, further comprising a light source for illuminating a surgical site.

19. The device of claim 18, further comprising a retainer ring configured for placement at the proximal end of and concentric to the plurality of retractor members,

a rotatable arm rotatably mounted on the retainer ring, and

a curved insertion member attachable to the rotatable arm, having the light source at a distal tip of the insertion member, and being capable of percutaneous insertion of the light source to a periphery of the surgical site.

20. The device of claim 18, further comprising a retainer ring configured for placement at the proximal end of and concentric to the plurality of retractor members,

a retainer ring arm extending laterally from the retainer ring and comprising an angled guide slot, and

a straight insertion member having the light source at a distal tip of the insertion member and being capable of guided percutaneous insertion through the guide slot so that the light source is positionable at a periphery of the surgical site.

21. The device of claim 20, the straight insertion member further comprising indicia for indicating a distance the insertion member has been inserted toward the surgical site.

22. The device of claim 18, further comprising the light source at a distal end of at least one of the plurality of retractor members.

23. The device of claim 18, further comprising a stabilization ring positionable inside and near the distal end of the retractor members when the retractor members are in a position comprising the second cross-sectional dimension, wherein the stabilization ring comprises the light source.

24. The device of claim 18, further comprising a retainer ring configured for placement at the proximal end of and concentric to the plurality of retractor members, wherein the light source comprises a light source near an inside edge of the retainer ring.

25. The device of claim 1, further comprising a barrier material between at least two of the retractor members.

26. The device of claim 1, further comprising a barrier material between each pair of adjacent retractor members.

27. The device of claim 1, wherein the surgical access passage is in a human or an animal.

28. The device of claim 1, wherein the surgical access passage comprises access to a spine.

29. The device of claim 1, wherein the surgical access passage comprises access to a joint.

30. A device, comprising:

an elongate member comprising a proximal end, a distal end, and a plurality of retractor members each having an inner surface that together define a lumen of the elongate member, the lumen having a first cross-sectional dimension;

a retractor member arm extending outwardly from the proximal end of each retractor member;

a lower retainer ring comprising a plurality of retractor member guide channels and configured for placement at the proximal end of and concentric to the plurality of retractor members, each retractor member arm slidable within one of the guide channels; and

an upper retainer ring engageable with and slidingly rotatable relative to the lower retainer ring; and

each of the plurality of retractor members being moveable radially outward to a second cross-sectional dimension when the upper and lower retainer rings are rotated relative to each other for creating a surgical access passage capable of receiving instruments.

31. The device of claim 30, wherein

the lower retainer ring comprises a lower retainer ring slot located above and parallel to each guide channel;

the upper retainer ring comprises an upper retainer ring slot having a center aligned with a center of the lower retainer ring slot and angled relative to the longitudinal axis of the lower retainer ring slot; and

each retractor member arm comprises a peg extending upward through the lower and upper retainer ring slots,

such that when the upper and lower retainer rings are rotated relative to each other, the upper retainer ring slot presses against the peg, causing the retractor member to move radially.

32. The device of claim 30, further comprising a mechanism for securing the upper and lower retainer rings in a desired position relative to each other.

33. The device of claim 30, further comprising a mechanism for securing each of the plurality of retractor members in a first position comprising the first cross-sectional dimension and in a second position comprising the second cross-sectional dimension.

34. The device of claim 30, further comprising a light source for illuminating a surgical site.

35. The device of claim 30, wherein the surgical access passage further comprises a substantially constant cross-sectional dimension between the proximal end and the distal end.

36. The device of claim 30, wherein the surgical access passage further comprises a direct access to a surgical site.

37. A device, comprising:

an elongate member comprising a proximal end, a distal end, and a plurality of retractor members each having an inner surface that together define a lumen of the elongate member, the lumen having a first cross-sectional dimension;

a threaded retractor member arm rotatably connected to and extending outwardly from the proximal end of each retractor member;

a retainer ring comprising a plurality of matingly threaded retractor member guide channels and configured for placement at the proximal end of and concentric to the plurality of retractor members, each threaded retractor member arm rotatable within one of the guide channels; and

each of the plurality of retractor members being moveable radially outward to a second cross-sectional dimension when the threaded retractor member arm is rotated for creating a surgical access passage capable of receiving instruments.

38. The device of claim 37, wherein each threaded retractor member arm is fixedly inserted through a rotation wheel adjacent to the exterior of the retainer ring, and wherein rotation of the rotation wheel causes the connected retractor member to move radially.

39. The device of claim 37, further comprising a mechanism for securing each of the plurality of retractor members in a first position comprising the first cross-sectional dimension and in a second position comprising the second cross-sectional dimension.

40. The device of claim 37, further comprising a light source for illuminating a surgical site.

41. The device of claim 37, wherein the surgical access passage further comprises a substantially constant cross-sectional dimension between the proximal end and the distal end.

42. The device of claim 37, wherein the surgical access passage further comprises a direct access to a surgical site.

43. A kit, comprising:

an elongate member comprising a proximal end, a distal end, and a plurality of retractor members each having an inner surface that together define a lumen of the elongate member, the lumen having a first cross-sectional dimension, each of the plurality of retractor members being moveable radially outward to a second cross-sectional dimension for creating a surgical access passage; and

a retainer ring comprising a plurality of retractor member guide channels and configured for placement at the proximal end of and concentric to the plurality of retractor members, each retractor member slidable within one of the guide channels.

44. The kit of claim 43, wherein the surgical access passage further comprises a substantially constant cross-sectional dimension between the proximal end and the distal end.

45. The kit of claim 43, further comprising a stylet comprising a pointed tip and a guide wire bore extending through the stylet, the stylet insertable into the lumen for guiding the elongate member over a guide wire to a surgical site.

46. The kit of claim 43, further comprising a mechanism for moving the retractor members radially outward, the mechanism being insertable into the lumen and actuatable to apply a radially outward force to move the retractor members.

47. The kit of claim 43, further comprising a light source for illuminating the surgical site.

48. A system, comprising:

a plurality of inter-connected retractor members each having an inner surface that together define a lumen, the lumen having a first cross-sectional dimension, each of the plurality of retractor members being moveable radially outward to a second cross-sectional dimension for creating an access passage; and

a mechanism configured to control movements of the plurality of inter-connected retractor members.

49. The system of claim 48, wherein the access passage further comprises a proximal end and a distal end and a substantially constant cross-sectional dimension between the proximal end and the distal end.

50. The system of claim 48, wherein the mechanism to control movements of the retractor members is insertable into the lumen and actuatable to apply a force to move the retractor members radially outward.

51. The system of claim 50, wherein the mechanism to control movements of the retractor members comprises an expandable body.

52. The system of claim 51, wherein the expandable body comprises a balloon.

53. The system of claim 48, further comprising

a retractor member arm extending outwardly from a proximal end of each retractor member;

and

a retainer ring comprising a plurality of retractor member guide channels and configured for placement at the proximal end of and concentric to the plurality of retractor members, each retractor member arm slidable within one of the guide channels.

54. The system of claim 48, further comprising a mechanism for securing each of the plurality of retractor members in a first position comprising the first cross-sectional dimension and in a second position comprising the second cross-sectional dimension.

55. The system of claim 48, further comprising a stylet comprising a pointed tip and a guide wire bore extending through the stylet, the stylet insertable into the lumen for guiding the elongate member over a guide wire to a surgical site.

56. The system of claim 53, the access passage further comprising one cross-sectional dimension from a range of cross-sectional dimensions between the first cross-sectional dimension of the lumen and a cross-sectional dimension equal to an inside diameter of the retainer ring.

57. The system of claim 48, further comprising a light source for illuminating a surgical site.

58. The system of claim 48, further comprising a barrier material between at least two of the retractor members.

59. The system of claim 48, further comprising a barrier material between each pair of adjacent retractor members.

60. A method of creating a surgical access passage, comprising:

percutaneously inserting to a surgical site an elongate member comprising a proximal end, a distal end, and a plurality of retractor members each having an inner surface that together define a lumen of the elongate member, the lumen having a first cross-sectional dimension;

inserting an expandable body into the lumen of the elongate member;

expanding the expandable body to move the plurality of retractor members radially outward to a second cross-sectional dimension; and

contracting the expandable body and removing the expandable body from the surgical access passage.

61. The method of claim 60, wherein percutaneously inserting the elongate member further comprises:

providing an insertion instrument having a guide wire bore and a guide wire threaded through the guide wire bore;

percutaneously inserting the insertion instrument to provide an insertion passage to the surgical site;

removing the insertion instrument from the insertion passage, while leaving the guide wire in the insertion passage;

inserting into the lumen of the elongate member a stylet comprising a pointed tip and a stylet guide wire bore extending through the stylet;

threading the stylet guide wire bore over the guide wire to insert the stylet and the elongate member into the insertion passage to the surgical site; and

removing the stylet from the lumen of the elongate member.

62. The method of claim 60, further comprising securing the retractor members in a position comprising the first cross-sectional dimension or in a position comprising the second cross-sectional dimension.

63. The method of claim 62, a retractor member arm extending outwardly from the proximal end of each retractor member, the method further comprising

placing a retainer ring comprising a plurality of retractor member guide channels at the proximal end of and concentric to the plurality of retractor members, each retractor member arm positioned and slidable within one of the guide channels,

wherein securing the retractor members further comprises securing each of the retractor member arms with a threaded wheel lock adjustably inserted through the retainer ring into each guide channel into securing contact with the retractor member arm positioned therein.

64. The method of claim 60, further comprising

placing a retainer ring at the proximal end and concentric to the plurality of retractor members,

wherein expanding the expandable body further comprises expanding the expandable body to one cross-sectional dimension from a range of cross-sectional dimensions between the first cross-sectional dimension of the lumen and a cross-sectional dimension equal to an inside diameter of the retainer ring.

65. The method of claim 60, wherein the surgical access passage comprises a substantially constant cross-sectional dimension between the proximal end exterior a body and the distal end at the surgical site.

66. The method of claim 60, wherein the surgical access passage comprises a cross-sectional dimension having a diameter in the range of ¾

inch to 1¼

inch.

67. The method of claim 60, wherein moving the plurality of retractor members radially outward further comprises moving one of the retractor members radially outward more or less than another one of the retractor members to provide the surgical access passage having a non-circular cross-sectional configuration.

68. The method of claim 60, further comprising illuminating the surgical site with a light source positioned at a periphery of the surgical site.

69. The method of claim 60, further comprising inserting a plurality of surgical instruments into the surgical access passage.

70. The method of claim 60, further comprising performing a surgical procedure under direct visualization of the surgical site.

71. The method of claim 60, wherein the surgical site comprises a spine.

72. The method of claim 60, wherein the surgical site comprises a joint.

73. A method of creating a surgical access passage, comprising:

percutaneously inserting to a surgical site an elongate member comprising a proximal end, a distal end, and a plurality of retractor members each having an inner surface that together define a lumen of the elongate member, a retractor member arm extending outwardly from the proximal end of each retractor member, the lumen having a first cross-sectional dimension;

placing at the proximal end of and concentric to the plurality of retractor members a lower retainer ring comprising a plurality of retractor member guide channels, each retractor member arm slidable within one of the guide channels, and an upper retainer ring engageable with and slidingly rotatable relative to the lower retainer ring; and

rotating the upper and lower retainer rings relative to each other to move each of the plurality of retractor members radially outward to a second cross-sectional dimension for creating a surgical access passage capable of receiving instruments.

74. The device of claim 73, wherein

the lower retainer ring comprises a lower retainer ring slot located above and parallel to each guide channel;

the upper retainer ring comprises an upper retainer ring slot having a center aligned with a center of the lower retainer ring slot and angled relative to the longitudinal axis of the lower retainer ring slot; and

each retractor member arm comprises a peg extending upward through the lower and upper retainer ring slots,

such that when the upper and lower retainer rings are rotated relative to each other, the upper retainer ring slot presses against the peg, causing the retractor member to move radially.