SYSTEM FOR PROVIDING SURGICAL ACCESS

• US 20120078270A1
• Filed: 08/19/2011
• Published: 03/29/2012
• Est. Priority Date: 09/20/2010
• Status: Active Grant

• Current Assignee: Entourage Medical Technologies, Inc.
• Original Assignee: Entourage Medical Technologies, Inc.
• Inventors: Shanley, John F., Diaz, Stephen H., Shluzas, Alan E., Litvack, Frank
• Granted Patent: US 9,782,168 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• 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 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06023 : Multiple eyelets
• CPC Class Codes: A61B 2017/06042 : located close to needle tip
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3409 : including needle or instrument drives
• CPC Class Codes: A61B 2017/3413 : guided by ultrasound
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/0807 : Indication means
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3735 : Optical coherence tomography [OCT]
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/08 : Accessories or related features not otherwise provided for
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

One embodiment is directed to a system for providing surgical access across a wall of a tissue structure, comprising: a delivery member having proximal and distal ends; a first helical member having proximal and distal ends and a helical shape, the proximal end coupled to the delivery member distal end, the distal end extending distally of the delivery member distal end; an anchor member removably coupled to the helical member distal end; and a suture member coupled distally to a portion of the anchor member and extending proximally to a position wherein at least a portion of it may be freely manipulated by an operator; wherein the proximal end of the suture member extends proximally beyond the deployed suture pattern into a local suture length storage reservoir coupled to the delivery member, the reservoir containing an additional length of suture and being configured such that upon rotation of the delivery member in the first direction, the anchor member pulls along the distal portion of the suture member causing at least a portion of the additional length of suture to be extended out from the local suture length storage reservoir, and causing the distal portion of the suture member to form a deployed suture pattern which remains coupled to the anchor member.

Claims

1. A system for providing surgical access across a wall of a tissue structure, comprising:

a. a delivery member having proximal and distal ends;

b. a first helical member having proximal and distal ends and a helical shape, the proximal end coupled to the delivery member distal end, the distal end extending distally of the delivery member distal end;

c. an anchor member removably coupled to the helical member distal end; and

d. a suture member coupled distally to a portion of the anchor member and extending proximally to a position wherein at least a portion of it may be freely manipulated by an operator;

wherein the proximal end of the suture member extends proximally beyond the deployed suture pattern into a local suture length storage reservoir coupled to the delivery member, the reservoir containing an additional length of suture and being configured such that upon rotation of the delivery member in the first direction, the anchor member pulls along the distal portion of the suture member causing at least a portion of the additional length of suture to be extended out from the local suture length storage reservoir, and causing the distal portion of the suture member to form a deployed suture pattern which remains coupled to the anchor member.

2. The system of claim 1, wherein upon rotation of the delivery member in a second direction opposite to the first direction, a reverse load is applied to the delivery member and coupled first helical member which causes the anchor member to become decoupled from the first helical member, such that further rotation in the second direction causes removal of the first helical member and delivery member while the anchor member and suture member distal portion remain positioned across the portion of the wall of the tissue structure.

3. The system of claim 1, wherein the deployed suture pattern is characterized in that it is substantially helical and represents a number of helical loops encapsulated by the wall of the tissue structure that is greater than about one helical loop, and is less than about three helical loops.

4. The system of claim 1, wherein the anchor member has at least one shape feature that is configured to slide past nearby tissue structures during inward insertion loading associated with rotation of the first helical member in the first direction, and to resist movement relative to the nearby tissue structures upon application of outward extraction loading associated with rotation of the first helical member in the second direction.

5. The system of claim 1, wherein at least a portion of the anchor member is configured to rotate relative to wall of the tissue structure upon application of a tensioning load to the suture member.

6. The system of claim 1, wherein the first helical member and coupled anchor member are advanced in a substantially helical pathway.

7. The system of claim 1, wherein the local suture length storage reservoir is coupled to the delivery member in a configuration wherein advancement of the first helical member does not substantially advance the reservoir relative to the wall of the tissue structure.

8. The system of claim 7, further comprising a sleeve member movably coupled to the delivery member such that the deliver member is threaded through a lumen defined by the sleeve member, wherein the sleeve member is coupled to the local suture length storage reservoir.

9. The system of claim 1, wherein the first helical member defines an inner helix diameter that is substantially constant across the length of the helical member.

10. The system of claim 1, wherein the first helical member defines an inner helix diameter that varies across the length of the helical member.

11. The system of claim 9, wherein the inner helix diameter is between about 5 mm and about 60 mm.

12. The system of claim 11, wherein the inner helix diameter is between about 10 mm and about 20 mm.

13. The system of claim 1, wherein the first helical member is comprised of an elongate member formed into the helical shape, the elongate member having an outer diameter.

14. The system of claim 13, wherein the elongate member has a cross sectional shape selected from the group consisting of:

a circular cross section, an elliptical cross section, a square cross section, and a rectangular cross section.

15. The system of claim 13, wherein the outer diameter is between about 0.5 mm and about 3 mm.

16. The system of claim 13, wherein the helical shape comprises a number of helical turns advanceable into tissue that is between about 1 and about 3.

17. The system of claim 9, wherein the helical shape has a substantially constant helix pitch along the length of the helical shape.

18. The system of claim 9, wherein the helical shape has a substantially variable helix pitch along the length of the helical shape.

19. The system of claim 10, wherein the helical shape has a substantially constant helix pitch along the length of the helical shape.

20. The system of claim 10, wherein the helical shape has a substantially variable helix pitch along the length of the helical shape.

21. The system of claim 17, wherein the helix pitch is between about 5 mm and about 20 mm.

22. The system of claim 21, wherein the helix pitch is between about 7 mm and about 13 mm.

23. The system of claim 1, wherein the distal end of the first helical member comprises a sharpened tip configured to easily dive into and cross portions of the wall of the tissue structure.

24. The system of claim 13, wherein the distal end of the first helical member comprises an anchor coupling portion wherein the outer diameter of the elongate member is decreased to accommodate slidable coupling of the anchor member.

25. The system of claim 24, wherein the outer diameter of anchor member is substantially similar to that of the portions of the elongate member proximal to the anchor coupling portion.

26. The system of claim 3, wherein the helical shape is defined by a helix pitch, the helix pitch being selected based upon a targeted depth of traversal through the wall of the tissue structure that will result in the deployed suture pattern.

27. The system of claim 26, wherein the targeted depth of traversal is configured to entirely cross the wall of the tissue structure, leaving the anchor member on an opposite side of the wall.

28. The system of claim 26, wherein the targeted depth of traversal is configured to only partially cross the wall of the tissue structure, leaving the anchor member in a midsubstance location within the wall.

29. The system of claim 13, wherein the elongate member comprises a solid cross-sectional construct.

30. The system of claim 13, wherein the elongate member comprises a tubular construct having an inner diameter and as well as the outer diameter.

31. The system of claim 29, wherein the elongate member comprises a material selected from the group consisting of:

stainless steel, nitinol alloy, titanium, cobalt chrome, and polymer composite.

32. The system of claim 30, wherein the elongate member comprises a material selected from the group consisting of:

stainless steel, nitinol alloy, titanium, cobalt chrome, and polymer composite.

33. The system of claim 4, wherein the anchor member comprises a main body portion comprising a solid or tubular construct.

34. The system of claim 33, wherein the shape feature configured to slide past nearby tissue structures during inward insertion loading comprises a tapered distal tip.

35. The system of claim 33, wherein the shape feature configured to resist movement relative to the nearby tissue structures upon application of outward extraction loading comprises a projecting portion configured to extend to a projecting position beyond an outer diameter of the rest of the anchor member when tension is applied to the intercoupled suture member.

36. The system of claim 35, wherein the projecting portion comprises a portion of the anchor member that has been deformed out into the projecting position.

37. The system of claim 35, wherein the projecting portion comprises a piece of material that has been coupled to the anchor member to assume the projecting position.

38. The system of claim 35, further comprising two or more projecting portions.

39. The system of claim 35, wherein the projecting portion comprises a superelastic alloy that is shape set to the projecting position and configured to be deliverable in an elastically compressed form within a superelastic thermal range for the alloy.

40. The system of claim 1, wherein the suture member is coupled to an eyelet coupled to the anchor member.

41. The system of claim 40, wherein the eyelet is positioned such that tension on the suture member urges the anchor into rotational movement relative to surrounding portions of the wall of the tissue structure when the suture member is pulled in tension relative to the anchor member.

42. The system of claim 41, wherein anchor has a longitudinal axis, and wherein the eyelet is placed at a position spaced apart from the longitudinal axis.

43. The system of claim 40, wherein the eyelet is coupled to a ring member defining a ring aperture through which at least a portion of the anchor is positioned.

44. The system of claim 43, wherein the ring member is coupled to the anchor using a coupling selected from the group consisting of:

an adhesive coupling, a press-fit coupling, and a tack-welding coupling.

45. The system of claim 1, wherein the anchor comprises a metal selected from the group consisting of:

titanium, nickel, stainless steel, cobalt chrome, and alloys thereof.

46. The system of claim 1, wherein the anchor comprises a durable polymer selected from the group consisting of:

polyethylene terepthalate, polyethylene, high density polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, poly (ethylene-co-vinyl acetate), poly(butyl methacrylate), and co-polymers thereof.

47. The system of claim 1, wherein the anchor comprises a bioresorbable polymer selected from the group consisting of:

polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, polylactic acid-co-caprolactone, poly (block-ethylene oxide-block-lactide-co-glycolide), polyethylene glycol, polyethylene oxide, poly (block-ethylene oxide-block-propylene oxide-block-ethylene oxide), polyvinyl pyrrolidone, polyorthoester, polyanhydride, polyhydroxy valerate, polyhydroxy butyrate, and co-polymers thereof.

48. The system of claim 1, wherein the anchor comprises a biological graft material.

49. The system of claim 48, wherein the biological graft material has an origin selected from the group consisting of:

another human, the particular human, a non-human animal.

50. The system of claim 1, wherein the anchor comprises a bioresorbable material selected from the group consisting of:

porcine collagen matrix, human collagen matrix, equine collagen fleece, gelatin, polyhyaluronic acid, heparin, poly (glucose), poly(alginic acid), chitin, chitosan, cellulose, methyl cellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose;

polylysine, polyglutamic acid, albumin, hydroxy apatite, cortical bone, cancellous bone, trabecular bone, bioceramic, ligament tissue, tendon tissue, dura tissue, fascia tissue, pericardium tissue, thrombin, and fibrin.

51. The system of claim 1, wherein the local suture length storage reservoir comprises an enclosure for storing one or more loops of suture member length.

52. The system of claim 1, wherein the additional length of suture is between about 50 millimeters and about 200 millimeters.

53. The system of claim 51, wherein the enclosure comprises a membrane configured to partially encapsulate the one or more loops of suture member length, and allow the one or more loops to be pulled out of the enclosure when under tensile loading from the anchor and helical members.

54. The system of claim 1, further comprising a suture tensioning member coupled to the suture member between a proximal end of the suture member and a distal end of the suture member, the suture tensioning member configured to apply a compressive load to an exposed proximal aspect of the wall of the tissue structure when a distal end of the suture tensioning member is placed against the exposed proximal aspect of the wall and the suture member is tensioned proximally of the suture tensioning member.

55. The system of claim 54, wherein the suture tensioning member comprises an elongate tubular member defining a lumen therethrough, the suture member being threaded through the lumen.

56. The system of claim 55, further comprising a temporary suture member clamp coupleable to a proximal portion of the suture member and configured to retain tension upon a portion of suture member distal to the suture member clamp that is threaded through the lumen of the elongate tubular member.

57. The system of claim 1, wherein the suture tensioning member has two modes of operation, a first mode wherein the suture tensioning member may be moved bidirectionally relative to the suture member, and a second mode wherein the suture tensioning member may only be moved unidirectionally relative to the suture member, and wherein the suture tensioning member comprises a manually-operated mode-switching member configured to controllably switch the suture tensioning member from the first mode to the second mode.

58. The system of claim 1, further comprising a tissue interface indentor member coupled to the delivery member and operatively coupled to the first helical member, the tissue interface indentor member comprising a distally protruding shape feature configured to contact one or more portions of the tissue structure adjacent to the distal end of the helical member and change an available angle of penetration between such portions and the distal tip of the first helical member as the distal tip is inserted into the tissue structure.

59. The system of claim 58, wherein the distally protruding shape feature is configured to concentrate interfacial stresses upon the tissue structure such that the portions of the tissue structure adjacent the distal end of the first helical member become locally strained about the distally protruding shape feature as the distally protruding shape feature is advanced into contact with the adjacent tissue structure portions;

and wherein the contact between the adjacent tissue structure portions and the distally protruding shape feature locally increases the available angle of penetration defined between the first helical member and a surface of the adjacent tissue structure portions.

60. The system of claim 59, wherein at least one surface of the distally protruding shape feature comprises a surface configuration selected from the group consisting of:

a portion of a spherical surface, a linear ramp surface, an arcuate ramp surface, a multi-stepped ramp surface, and a single-stepped ramp surface.

61. The system of claim 60, wherein the surface configuration is helically wrapped about a longitudinal axis of the first helical member.

62. The system of claim 59, wherein at least one surface of the distally protruding shape feature comprises a substantially perpendicular leading surface.

63. The system of claim 59, wherein the distally protruding shape feature has a cross sectional profile comprising a cross sectional shape selected from the list consisting of:

a rectangle, a square, a half circle, a triangle, a polygon, a rounded rectangular shape, a rounded square shape, and a multi-arcuate shape.

64. The system of claim 58, wherein the distally protruding shape feature and distal tip of the helical member are operatively coupled such that the distal tip is movably coupled through a portion of the distally protruding shape feature.

65. The system of claim 64, wherein the distal tip substantially bisects the portion of the distally protruding shape feature.

66. The system of claim 58, wherein the distally protruding shape feature and distal tip of the helical member are operatively coupled such that the distal tip is movably coupled adjacent a portion of the distally protruding shape feature.

67. The system of claim 60, wherein the distal tip of the helical member is configured to follow a path substantially parallel to the surface configuration of the distally protruding shape feature.

68. The system of claim 59, wherein the distally protruding shape feature comprises one or more tissue traction features configured to prevent relative motion between the distally protruding shape feature and portions of the tissue structure with which it may be directly interfaced.

69. The system of claim 68, wherein at least one of the one of the one or more tissue traction features comprises a barb.

70. The system of claim 1, further comprising a helical member guiding member having proximal and distal ends and being coupled to the first helical member, wherein the distal end of the helical member guiding member is substantially straight and defines a longitudinal axis that is substantially coincident with a longitudinal axis defined through the first helical member.

71. The system of claim 70, wherein the helical member guiding member is coupled to the delivery member, which is coupled to the helical member.

72. The system of claim 70, wherein the helical member guiding member is immediately coupled to the helical member.

73. The system of claim 70, wherein the distal end of the helical member guiding member comprises an aperture fluidly coupled to a lumen defined through the helical member guiding member and leading proximally to a detection position wherein an operator may visually detect fluid which may be present at the aperture.

74. The system of claim 71, wherein the aperture is positioned along the longitudinal axis of the helical member guiding member that is keyed to mark a distal protrusion position of a structure portion selected from the group consisting of:

the distal end of the helical member;

the distal end of the anchor member; and

the proximal end of the anchor member.

75. The system of claim 70, further comprising a second aperture fluidly coupled to a second lumen defined through the helical member guiding member and leading proximally to a second detection position wherein an operator may visually detect fluid which may be present at the second aperture.

76. The system of claim 70, wherein the helical member guiding member comprises a sensor selected from the group consisting of:

an OCT sensor, an ultrasound sensor, an RF impedance sensor, a partial pressure of oxygen sensor, and a pressure sensor.

77. The system of claim 1, further comprising a second helical member having proximal and distal ends, the proximal end coupled to the delivery member distal end, the distal end extending distally of the delivery member distal end.

78. The system of claim 77, wherein the second helical member defines an inner helix diameter that is substantially constant across the length of the helical member.

79. The system of claim 77, wherein the second helical member defines an inner helix diameter that varies across the length of the helical member.

80. The system of claim 77, wherein the inner helix diameters of the first and second helical members are substantially equal.

81. The system of claim 77, wherein the inner helix diameters of the first and second helical members are substantially unequal.

82. The system of claim 77, wherein the first and second helical members define longitudinal axes that are substantially coaxial.

83. The system of claim 77, further comprising a second anchor member removably coupled to the distal end of the second helical member.

84. The system of claim 83, further comprising a second suture member coupled to the second helical member.