Method and apparatus for delivering a prosthetic fabric into a patient

• US 20050277942A1
• Filed: 05/27/2004
• Published: 12/15/2005
• Est. Priority Date: 05/27/2004
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Kullas, Karen E., Coffey, Dennis J., Calabrese, David C., Capuzziello, Thomas J., Hass, Daniel E.
• Granted Patent: US 7,846,171 B2
• Time in Patent Office: Days
• US Class Current: 606/99
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor

Abstract

An introducer and method for delivering a prosthetic fabric into a patient. The introducer includes a delivery tube having a distal end adapted to be inserted into the patient and a lumen that receives the prosthetic fabric. A loader may be provided to reconfigure the prosthetic fabric from a first configuration to a collapsed configuration and/or to insert the collapsed fabric into the lumen of the delivery tube. A plunger may be provided to push the prosthetic fabric through the delivery tube and into the patient. The loader and plunger may be combined in a dual-purpose component that is reversible to either load the fabric into the delivery tube or push the fabric through the delivery tube.

Claims

1. A method of delivering a prosthetic fabric into a patient, the method comprising acts of:

(a) collapsing the prosthetic fabric from a first configuration to a collapsed configuration;

(b) loading the prosthetic fabric in the collapsed configuration into a delivery tube using a dual-purpose component in a first orientation;

(c) reversing the dual-purpose component from the first orientation to a second orientation; and

(d) expelling the prosthetic fabric in the collapsed configuration from a distal end of the delivery tube using the dual-purpose component in the second orientation.

2. The method according to claim 1, wherein act (a) includes collapsing the prosthetic fabric using the dual-purpose component in the first orientation.

3. The method according to claim 2, wherein act (a) includes rolling the prosthetic fabric about the dual-purpose component in the first orientation.

4. The method according to claim 1, wherein act (b) includes loading the prosthetic fabric through an aperture at a proximal end of the delivery tube.

5. The method according to claim 1, wherein act (d) includes limiting travel of the dual-purpose component through the delivery tube in the second configuration.

6. The method according to claim 1, wherein act (c) includes maintaining the prosthetic fabric in the delivery tube.

7. The method according to claim 1, further comprising an act of:

(e) prior to act (d), inserting the delivery tube into the patient to a predetermined depth.

8. The method of claim 7, wherein act (e) includes adjusting the predetermined depth.

9. An introducer for delivering a prosthetic fabric into a patient, the introducer comprising:

a delivery tube having a distal end adapted to be inserted into the patient and a lumen extending therethrough that is adapted to receive the prosthetic fabric; and

a dual-purpose component including a first portion to load the prosthetic fabric into the delivery tube and a second portion to push the prosthetic fabric through the lumen, the first portion and the second portion having different configurations, the dual-purpose component being reversibly insertable into the lumen in one of a first orientation to load the prosthetic fabric into the delivery tube with the first portion and a second orientation to push the prosthetic fabric through the delivery tube with the second portion.

10. The introducer according to claim 9, wherein the dual-purpose component includes an elongate member, the first portion being disposed at a first end of the elongate member and the second portion being disposed at a second end of the elongate member.

11. The introducer according to claim 9, wherein the first portion is disposed within the lumen between the second portion and the distal end of the delivery tube when the dual-purpose component is inserted in the first orientation, and wherein the second portion is disposed within the lumen between the first portion and the distal end of the delivery tube when the dual-purpose component is inserted in the second orientation.

12. The introducer according to claim 9, wherein the first portion extends from an end of the second portion in a longitudinal direction.

13. The introducer according to claim 12, wherein the first portion includes an elongate rod that is constructed and arranged to receive a portion of the prosthetic fabric.

14. The introducer according to claim 13, wherein the elongate rod includes a pair of opposed tines that are constructed and arranged to receive the prosthetic fabric therebetween.

15. The introducer according to claim 14, wherein the dual-purpose component is constructed and arranged to roll the prosthetic fabric about the elongate rod in the first configuration.

16. The introducer according to claim 13, wherein the second portion includes a body having an outer periphery shaped to conform to an inner wall of the delivery tube.

17. The introducer according to claim 12, wherein the first portion has a first cross section dimension perpendicular to the longitudinal direction and the second portion has a second cross sectional dimension perpendicular to the longitudinal direction that is larger than the first cross section dimension.

18. The introducer according to claim 17, wherein the first portion is longer than the second portion in the longitudinal direction.

19. The introducer according to claim 9, further comprising:

a closure disposed on the delivery tube, the closure being operable between a closed position to at least partially obstruct the lumen and an open position to allow passage of the prosthetic fabric from the delivery tube through the lumen.

20. The introducer according to claim 19, wherein the closure includes a plurality of flaps that are movable between the closed position and the open position.

21. The introducer according to claim 9, wherein the introducer further comprises:

a stop constructed and arranged to limit movement of the dual-purpose component through the lumen.

22. The introducer according to claim 21, wherein the stop is disposed on the first portion to contact the delivery tube when the dual-purpose component is inserted a predetermined distance through the lumen in the second configuration to prevent the second portion from traveling beyond a predetermined position relative to the distal end.

23. The introducer according to claim 9, further comprising:

a stop constructed and arranged to limit insertion depth of the delivery tube into the patient.

24. The introducer according to claim 23, wherein the stop is positionable at each of a plurality of different locations relative to the distal end of the delivery tube.

25. The introducer according to claim 24, wherein the stop includes a flange located on the delivery tube.

26. The introducer according to claim 9, wherein the delivery tube includes a textured internal surface that is constructed and arranged to reduce contact area between the prosthetic fabric and the delivery tube.

27. The introducer according to claim 9, wherein the textured internal surface includes a plurality of protrusions.

28. The introducer according to claim 9, wherein the plurality of protrusions includes a plurality of ribs extending in an end-to-end direction.

29. The introducer according to claim 9, in combination with the prosthetic fabric.

30. The combination according to claim 29, wherein the prosthetic fabric is loaded in the delivery tube.

31. An introducer for delivering a prosthetic fabric into a patient, the introducer comprising:

a delivery tube having a distal end adapted to be inserted into the patient and a lumen extending therethrough that is adapted to receive the prosthetic fabric therein;

a closure disposed on the delivery tube, the closure being operable between a closed position to at least partially obstruct the lumen and an open position to allow passage of the prosthetic fabric from the delivery tube through the lumen; and

a loader to reconfigure the prosthetic fabric to a collapsed configuration that is movable along the lumen.

32. The introducer according to claim 31, wherein the closure includes a plurality of flaps that are movable between the closed position and the open position.

33. The introducer according to claim 32, wherein the plurality of flaps includes a plurality of flexible flaps.

34. The introducer according to claim 31, wherein the closure is constructed and arranged to be actuated to the open position when pressure is applied thereto by the prosthetic fabric in the lumen.

35. The introducer according to claim 31, wherein the closure forms a hemispherical tip on the distal end of the delivery tube to facilitate insertion of the introducer through an incision and into the patient.

36. The introducer according to claim 31, wherein the loader includes an elongate rod that is constructed and arranged to receive a portion of the prosthetic fabric.

37. The introducer according to claim 36, wherein the elongate rod includes a pair of opposed tines that are constructed and arranged to receive the prosthetic fabric therebetween.

38. The introducer according to claim 36, wherein the loader includes a handle, the elongate rod extending from an end of the handle.

39. The introducer according to claim 31, further comprising:

a plunger to push the prosthetic fabric through the lumen.

40. The introducer according to claim 39, wherein the loader and the plunger are provided by a reversible dual-purpose component.

41. The introducer according to claim 40, wherein the dual-purpose component is insertable into the lumen in a first configuration to load the prosthetic fabric into the lumen and a second configuration to push the prosthetic fabric through the lumen.

42. The introducer according to claim 39, further comprising:

a stop constructed and arranged to limit travel of the plunger through the lumen.

43. The introducer according to claim 42, further comprising:

a handle that is removably attachable to the plunger.

44. The introducer according to claim 43, wherein the stop is disposed on the handle to contact a proximal portion of the delivery tube to limit travel of the plunger.

45. The introducer according to claim 31, further comprising:

a stop constructed and arranged to limit insertion depth of the delivery tube into the patient.

46. The introducer according to claim 45, wherein the stop includes a flange located on the delivery tube.

47. The introducer according to claim 46, wherein the flange is positionable at a plurality of different locations relative to the distal end of the delivery tube.

48. The introducer according to claim 46, wherein the flange has a non-circular shape.

49. The introducer according to claim 31, wherein the delivery tube has an opening at a proximal end thereof that is adapted to receive the collapsed prosthetic fabric.

50. The introducer according to claim 31, wherein the delivery tube includes a textured internal surface that is constructed and arranged to present a contact area between the prosthetic fabric and the delivery tube.

51. The introducer according to claim 50, wherein the textured internal surface includes a plurality of protrusions.

52. The introducer according to claim 51, wherein the plurality of protrusions includes a plurality of ribs extending in an end-to-end direction.

53. The introducer according to claim 31, in combination with the prosthetic fabric.

54. The combination according to claim 53, wherein the prosthetic fabric is loaded in the delivery tube in the collapsed configuration.

55. An introducer for delivering a prosthetic fabric into a patient, the introducer comprising:

a delivery tube having a distal end adapted to be inserted into the patient and a textured internal surface adapted to contact the prosthetic fabric as the prosthetic fabric is advanced through the delivery tube, the textured internal surface constructed and arranged to present a contact area between the prosthetic fabric and the delivery tube that is less than a contact area between the prosthetic fabric and a smooth internal surface; and

a plunger to push the prosthetic fabric through the lumen of the delivery tube.

56. The introducer according to claim 55, wherein the textured internal surface includes a plurality of protrusions.

57. The introducer according to claim 56, wherein the plurality of protrusions includes a plurality of ribs extending in an end-to-end direction.

58. The introducer according to claim 55, further comprising:

a loader constructed and arranged to reconfigure the prosthetic fabric from a first configuration to a collapsed configuration for insertion into the lumen.

59. The introducer according to claim 58, wherein the loader and the plunger are provided with a reversible dual-purpose component.

60. The introducer according to claim 59, wherein the dual-purpose component is insertable into the lumen in one of a first orientation to load the prosthetic fabric into the lumen and a second orientation to push the prosthetic fabric through the lumen.

61. The introducer according to claim 58, wherein the loader includes an elongate rod that is constructed and arranged to receive a portion of the prosthetic fabric.

62. The introducer according to claim 61, wherein the loader includes a handle and the elongate rod includes a pair of opposed tines that extend from the handle.

63. The introducer according to claim 55, further comprising:

a closure disposed on the delivery tube, the closure being operable between a closed position to at least partially obstruct the lumen and an open position to allow passage of the prosthetic fabric from the delivery tube through the lumen.

64. The introducer according to claim 55, further comprising:

a stop constructed and arranged to limit travel of the plunger through the lumen.

65. The introducer according to claim 55, further comprising:

a stop constructed and arranged to limit insertion of the delivery tube into the patient.

66. The introducer according to claim 65, wherein the stop is positionable at each of a plurality of different locations relative to the distal end of the delivery tube.

67. The introducer according to claim 55, in combination with the prosthetic fabric.

68. The introducer according to claim 67, wherein the prosthetic fabric is loaded in the delivery tube.

69. An introducer for delivering a prosthetic fabric into a patient, the introducer comprising:

a delivery tube having a distal end adapted to be inserted into the patient and a lumen extending therethrough that is adapted to receive the prosthetic fabric;

a dual-purpose component including a pair of opposed tines to load the prosthetic fabric into the delivery tube and a body portion to push the prosthetic fabric through the lumen, the body portion having an outer periphery constructed and arranged to conform to an inner wall of the delivery tube and the pair of opposed tines extending from an end of the body portion in a longitudinal direction, the dual-purpose component being reversibly insertable into the lumen in one of a first orientation to load the prosthetic fabric into the delivery tube with the pair of opposed tines and a second orientation to push the prosthetic fabric through the delivery tube with the body portion; and

a closure disposed at the distal end of the delivery tube, the closure being operable between a closed position to at least partially obstruct the lumen and an open position to allow passage of the prosthetic fabric from the delivery tube through the lumen.

70. The introducer according to claim 69, wherein the dual-purpose component is constructed and arranged to roll the prosthetic fabric about the pair of opposed tines into a collapsed configuration for insertion into the delivery tube.

71. The introducer according to claim 69, wherein the pair of opposed tines has a first cross section dimension perpendicular to the longitudinal direction and the body portion has a second cross sectional dimension perpendicular to the longitudinal direction that is larger than the first cross section dimension.

72. The introducer according to claim 71, wherein the pair of opposed tines is longer than the body portion in the longitudinal direction.

73. The introducer according to claim 69, wherein the closure includes a plurality of flaps that are movable between the closed position and the open position.

74. The introducer according to claim 69, further comprising a handle that is removably attachable to the pair of opposed tines to push the prosthetic fabric through the delivery tube with the body portion when the dual-purpose component is inserted into the lumen in the second orientation.

75. The introducer according to claim 69, further comprising an adjustable stop, disposed on the delivery tube, that is constructed and arranged to limit insertion depth of the delivery tube into the patient.

76. The introducer according to claim 69, wherein the delivery tube includes a textured internal surface that is constructed and arranged to present a contact area between the prosthetic fabric and the delivery tube.

77. The introducer according to claim 76, wherein the textured internal surface includes a plurality of ribs extending in an end-to-end direction.

78. The introducer according to claim 69, in combination with the prosthetic fabric.

79. The combination according to claim 78, wherein the prosthetic fabric is loaded in the delivery tube.

80. A method of delivering a prosthetic fabric into a patient, the method comprising acts of:

(a) collapsing the prosthetic fabric external to a delivery tube using a loader to form a collapsed prosthetic fabric;

(b) placing the collapsed prosthetic fabric into the delivery tube with the loader; and

(c) removing the loader from the delivery tube while maintaining the collapsed prosthetic fabric in the delivery tube.

81. The method according to claim 80, further comprising an act of:

(d) inserting a plunger into the delivery tube subsequent to act (c).

82. The method according to claim 81, further comprising an act of:

(e) pushing the collapsed prosthetic fabric through the delivery tube and into the patient using the plunger.

83. The method according to claim 82, further comprising an act of:

(f) limiting travel of the plunger through the delivery tube.

84. The method according to claim 82, wherein act (e) includes opening a closure at the distal end of the delivery tube to allow delivery of the prosthetic fabric into the patient.

85. The method according to claim 80, wherein act (a) includes rolling the prosthetic fabric about the loader to form the collapsed prosthetic fabric.

86. The method according to claim 85, wherein the loader includes a pair of opposed tines, and wherein act (a) includes placing a portion of the prosthetic fabric between the pair of opposed tines.

87. A method of replacing a first laparoscopic instrument in an incision with a second laparoscopic instrument, the method comprising acts of:

(a) inserting a switching stick into the incision through a lumen of the first laparoscopic instrument;

(b) removing the first instrument from the incision while maintaining the switching stick in the incision; and

(c) guiding an external surface of the second laparoscopic instrument along the switching stick and into the incision.

88. The method according to claim 87, further comprising acts of:

(d) removing the second laparoscopic instrument from the incision while maintaining the switching stick in the incision; and

(e) reinserting the first laparoscopic instrument into the incision.

89. The method according to claim 88, wherein act (e) includes receiving the switching stick through the lumen of the first laparoscopic instrument.

90. The method according to claim 87, wherein the second laparoscopic instrument includes a prosthetic fabric introducer, and wherein act (c) includes guiding the external surface of the prosthetic fabric introducer along the switching stick and into the incision.

91. The method according to claim 90, further comprising an act of:

(f) delivering a prosthetic fabric into a patient using the prosthetic fabric introducer subsequent to act (c).

92. The method according to claim 87, wherein the switching stick includes a curved surface, and wherein act (c) includes guiding the external surface of the second laparoscopic instrument along the curved surface of the switching stick and into the incision.

93. The method according to claim 92, wherein the curved surface of the switching stick is concave.

94. The method according to claim 87, wherein act (c) includes flexing a proximal portion of the switching stick while guiding the external surface of the second laparoscopic instrument along a distal portion the switching stick and into the incision.