CA2583906A1 - Devices and methods for tissue removal - Google Patents

Devices and methods for tissue removal Download PDF

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Publication number
CA2583906A1
CA2583906A1 CA002583906A CA2583906A CA2583906A1 CA 2583906 A1 CA2583906 A1 CA 2583906A1 CA 002583906 A CA002583906 A CA 002583906A CA 2583906 A CA2583906 A CA 2583906A CA 2583906 A1 CA2583906 A1 CA 2583906A1
Authority
CA
Canada
Prior art keywords
tissue
removal system
tissue removal
barrier
cannula
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002583906A
Other languages
French (fr)
Other versions
CA2583906C (en
Inventor
Jeffery L. Bleich
Steven A. Spisak
Edwin J. Hlavka
Vahid Saadat
David R. Miller
James Yurchenco
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxano Inc
Original Assignee
Baxano, Inc.
Jeffery L. Bleich
Steven A. Spisak
Edwin J. Hlavka
Vahid Saadat
David R. Miller
James Yurchenco
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxano, Inc., Jeffery L. Bleich, Steven A. Spisak, Edwin J. Hlavka, Vahid Saadat, David R. Miller, James Yurchenco filed Critical Baxano, Inc.
Publication of CA2583906A1 publication Critical patent/CA2583906A1/en
Application granted granted Critical
Publication of CA2583906C publication Critical patent/CA2583906C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3135—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for examination of the epidural or the spinal space
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    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
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Abstract

Methods and apparatus are provided for selective surgical removal of tissue, e.g., for enlargement of diseased spinal structures, such as impinged lateral recesses and pathologically narrowed neural foramen. In one variation, tissue may be ablated, resected, removed, or otherwise remodeled by standard small endoscopic tools delivered into the epidural space through an epidural needle.
Once the sharp tip of the needle is in the epidural space, it is converted to a blunt tipped instrument for further safe advancement. A nerve stimulator optionally may be provided to reduce a risk of inadvertent neural abrasion.
Additionally, safe epidural placement of the working barrier and epidural tissue modification tools may be further improved with the- use of electrical nerve- stimulation- capabilities within the invention that, when combined with neural stimulation monitors, provide neural localization capabilities to the surgeon.

Claims (86)

1. A surgical tissue removal system, comprising:
a flexible elongate body that is adapted to conform with the target anatomy, the body having at least one blade edge, where the blade edge is flush with a surface of the elongate body, where the flexible elongate body further comprises a profile having a width that is substantially greater than a height;
a barrier having at least one window, where the flexible body is slidably located within the barrier such that when the elongate body moves within the barrier the blade edges move across the window.
2. The tissue removal system of claim 1, where the window comprises a protective cover that is slidably located in the barrier, such that removal of the cover exposes the at least one blade edge.
3. The tissue removal system of claim 1, where the flexible elongate body comprises a low profile having a width that is substantially greater than a height of the flexible elongate body. The tissue removal system of claim 1, where the at least one blade edge comprises a plurality of blade edges that are formed by openings in the flexible elongate body.
4. The tissue removal system of claim 3, where the blade edges are formed from at least two sides of the opening to allow for bi-directional cutting of tissue.
5. The tissue removal system of claim 1, where the blade edges comprise a shape selected from the group consisting of a serrated edge, a scalloped edge and a smooth edge.
6. The tissue removal system of claim 1, where the at least one blade edge comprises a plurality of paired blade edges where each blade in the paired blade edges intersects another
7. The tissue removal system of claim 1, where the at least one blade edge is formed on at least one edge of the flexible elongate member.
8. The tissue removal system of claim 7, further comprising additional openings in the body of the flexible elongate member and where the additional openings comprise additional blade edges.
9. The tissue removal system of claim 1, where the at least one blade edge comprises a plurality of blade edges and where the plurality of blade edges are formed on at least both edges of the flexible elongate member.
10. The tissue removal system of claim 1, where the window comprises at least one window edge.
11. tissue removal system of claim 10, where the at least one window edge comprises a plurality of window edges.
12. The tissue removal system of claim 10, where the at least one window edge is sharpened.
13. The tissue removal system of claim 10, where the at least one window edge is conductive.
14. The tissue removal system of claim 13, where the at least one window edge is electrically coupled to a power supply to enable hemostasis of tissue or neural localization.
15. The tissue removal system of claim 1, where the width of the flexible elongate body varies along the length of the system.
16. The tissue removal system of claim 1, further comprising at least one rail being located within a portion of the barrier or attached to the flexible elongate body.
17. The tissue removal system of claim 1, where the barrier is coupled to at least one of a vacuum source to provide suction or an irrigation source.
18. The tissue removal system of claim 1, where at least a portion of the flexible elongate body includes a lubricious layer.
19. The tissue removal system of claim 1, where at least a portion of the barrier includes a lubricious layer.
20. The tissue removal system of claim 1, further comprising a motor coupled to at least a portion of the elongate body.
21. The tissue removal system of claim 1, further comprising at least one measuring elements coupled to the elongate body.
22. The tissue removal system of claim 21, where the at least one measuring element comprises a sensor or a sound.
23. The tissue removal system of claim 1, where the flexible elongate body is ribbon shaped.
24. The tissue removal system of claim 1, wherein the flexible elongated body further comprises at least one electrode.
25. The tissue removal system of claim 1, wherein the barrier further comprises at least one electrode.
26. A tissue removal system, comprising:
a flexible elongate body, the body having a plurality of needlette ports on a working surface of the elongate body, and a plurality of cannula conduits within the body, each conduit being fluidly coupled to at least one needlette port;
a plurality of needlettes slidably located in at least a portion of the needlette ports, such that a distal tip of the needlettes may advance and withdraw from the needeltte port.
27. The tissue removal system of claim 26, where the needlette are coupled to a power supply selected from the group consisting of electrical, ultrasound, thermal, microwave, laser, cryo, and a combination thereof.
28. A surgical tissue removal system, comprising:
a flexible elongate body, the body having at least one tissue removal element having at least one blade edge, where the tissue removal element is coupled to at least one driveshaft such that the driveshaft causes the tissue removal element to move;
a barrier having at least one window, where the flexible body is slidably located within the barrier such that when the elongate body moves within the barrier the blade edges move across the window;
a motor coupled to the driveshaft.
29. A surgical tissue removal system, comprising:
a flexible elongate body that is adapted to conform with the target anatomy, the body having at least one blade edge, where the blade edge is flush with a surface of the elongate body, where the flexible elongate body further comprises a profile having a width that is substantially greater than a height.
30. The tissue removal system of claim 29, where the flexible elongate body comprises a low profile having a width that is greater than a height of the flexible elongate body.
31. The tissue removal system of claim 29, where the at least one blade edge comprises a plurality of blade edges that are formed by openings in the flexible elongate body.
32. The tissue removal system of claim 31, where the blade edges are formed from at least two sides of the opening to allow for bi-directional cutting of tissue.
33. The tissue removal system of claim 29, where the blade edges comprise a shape selected from the group consisting of a serrated edge, a scalloped edge and a smooth edge.
34. The tissue removal system of claim 29, where the at least one blade edge comprises a plurality of paired blade edges where each blade in the paired blade edges intersects another.
35. The tissue removal system of claim 29, where the at least one blade edge is formed on at least one edge of the flexible elongate member.
36. The tissue removal system of claim 35, further comprising additional openings m the body of the flexible elongate member and where the additional openings comprise additional blade edges.
37. The tissue removal system of claim 29, where the at least one blade edge comprises a plurality of blade edges and where the plurality of blade edges are formed on at least both edges of the flexible elongate member.
38. The tissue removal system of claim 29, where the width of the flexible elongate body varies along the length of the system.
39 The tissue removal system of claim 29, where at least a portion of the flexible elongate body includes a lubricious layer.
40. The tissue removal system of claim 29, further comprising a motor coupled to at least a portion of the elongate body.
41. The tissue removal system of claim 29, further comprising at least one measuring elements coupled to the elongate body.
42. The tissue removal system of claim 41, where the at least one measuring element comprises a sensor or a sound.
43. The tissue removal system of claim 27, wherein the flexible elongated body further comprises at least one electrode.
44. The tissue removal system of claim 27, where the flexible elongate body is ribbon shaped.
45. A surgical tissue removal system, comprising:
a flexible elongate body, where the flexible elongate body comprises a low profile having a width that is substantially greater than a height of the flexible elongate body, the body having at least one blade edge, where the blade edge is flush with a surface of the elongate body, wherein the flexible elongated body further comprises at least one electrode for assessing the proximity of neural tissue to the blade edge.
46. A surgical tissue removal system, comprising:
a flexible elongate body, where the flexible elongate body comprises a low profile having a width that is substantially greater than a height of the flexible elongate body, the body having at least one blade edge, where the blade edge is flush with a surface of the elongate body, a barrier having at least one window, where the flexible body is slidably located within the barrier such that when the elongate body moves within the barrier the blade edges move across the window, wherein the barrier further comprises at least one electrode for assessing the proximity of neural tissue to the blade edge.
47. A surgical tissue modification device for use with a nerve stimulation apparatus, the tissue modification device comprising:
an elongate flexible body;
at least one tissue modification surface located on the body;
at least one electrode attached to the body; and a connector for electrically coupling the electrode to the nerve stimulation apparatus.
48. The surgical tissue modification device of claim 47, further comprising at least one barrier located over a portion of the tissue modification surface.
49. The surgical tissue modification device of claim 48, where the barrier further comprises at least one opening such that the opening forms a window for the tissue modification surface to contact tissue when the barrier is placed over the tissue modification surface.
50. The surgical tissue modification device of claim 48, where the barrier is slidable relative to the tissue modification surface.
51. The surgical tissue modification device of claim 48, where at least one electrode is located on the barrier.
52. The surgical tissue modification device of claim 48, where the at least one electrode comprises at least two electrodes, where the electrodes are located in at least one of the following combinations, one on each side of the flexible body, one on each side of the barrier, one on the tissue modification side of the flexible body and one on the opposite side of the barrier
53. The surgical tissue modification device of claim 47, where the tissue modification surface is located on a first side of the flexible body and the electrode is located on the first side of the body.
54. The surgical tissue modification device of claim 47, where the tissue modification surface comprises a plurality of grooves.
55. The surgical tissue modification device of claim 47, where the tissue modification surface comprises a plurality of perforations.
56. The surgical tissue modification device of claim 47, where the flexible body comprises a shape selected from the group consisting of a flat shape, a ribbon shape, and a tubular shape.
57. The surgical tissue modification device of claim 47, further comprising at least one medication or bioactive component for delivery to the tissue located on the tissue modification surface.
58. The surgical tissue modification device of claim 57, where the medication or bioactive component is selected from a substance from the group consisting of steroids, procoagulants, bone wax, and adhesion barriers.
59. A medical device for accessing tissue, the device comprising:
a cannula having a sharp tip at a distal end thereof, the cannula further comprising a lumen extending therethrough and exiting out of the distal end at an opening;
a second member having a distal section comprising an atraumatic protective cover, where the second member is slidably located within the cannula lumen, and where the distal section fits within the cannula lumen, and upon exiting the cannula lumen the protective cover is able to prevent the sharp tip from contacting tissue.
60. The medical device of claim 59, where the distal section is located on a distal end of the second member
61. The medical device of claim 59, where the distal section is located proximal to a distal end of the second member.
62. The medical device of claim 59, where the distal section assumes a reduced profile when located in the cannula lumen.
63. The medical device of claim 59, where the distal section changes shape such that it can cover the sharp tip of the cannula.
64. The medical device of claim 5, wherein changing the shape of the distal section is accomplished by expanding the distal section such that it can be expanded to fit over the sharp tip of the cannula.
65. The medical device of claim 59, where the distal section is expandable such that it can be expanded to fit over the sharp tip of the cannula.
66. The medical device of claim 59, where the second member comprises a fiberoptic cable extending through at least a portion of the second member
67. The medical device of claim 59, further comprising at least one anchor mechanism located on the second member.
68. The medical device of claim 59, further comprising at least one anchor mechanism located on the cannula.
69. The medical device of claim 59, where the cannula distal end is curved.
70. The medical device of claim 59, where the cannula body comprises at least a second lumen extending parallel to the first lumen.
71. The medical device of claim 59, where the cannula body comprises at least one channel located along a first side of the cannula, where the opening is located towards the distal end on the first side of the cannula, further comprising an instrument having at least one protrusion, where the protrusion is slidably located in the channel such that the instrument may be advanced relative to the cannula in fixed alignment.
72. The medical device of claim 71, where the instrument comprises an instrument selected from the group consisting of radio frequency device, lasers, rasps, ronguers, graspers, burrs, sanders, drills, shavers, visualization devices, guidewire and probes.
73. The medical device of claim 59, where the cannula body comprises at least one protrusion located along a first side of the cannula, where the protrusion is located towards the distal end on the first side of the cannula, further comprising an instrument having at least one channel, where the protrusion is slidably located in the channel such that the instrument may be advanced relative to the cannula in fixed alignment.
74. The medical device of claim 73, where the instrument comprises an instrument selected from the group consisting of radio frequency device, lasers, rasps, ronguers, graspers, burrs, sanders, drills, shavers, visualization devices, guidewire and probes.
75. The medical device of claim 74, where the instrument further comprises a flexible flat distal section, where the flexible flat distal section is configured to be advanced through the lumen of the access device body and upon exiting from the access device body can expand to form a barrier
76. The medical device of claim 59, further comprising at least one conductive element located on a distal end of the cannula.
77. A system for use in treating tissue, the system comprising:
a cannula;
a barrier device comprising an elongate member having a flexible flat distal section, where the flexible flat distal section is configured to be advanced through the lumen of the cannula and after exiting from the cannula can expand to form a shield having a cross sectional area greater than that of the lumen of the cannula;
and at least one electrode located on the barrier, the electrode adapted to be coupled to a neural locating device.
78. The system of claim 1, further comprising a second electrode on the barrier device, where the second electrode is adapted to be coupled to the neural locating device.
79. The system of claim 1, further comprising a cannula electrode located on the cannula, where the cannula electrode is adapted to be coupled to the neural locating device
80. A surgical barrier device for use with a nerve locating apparatus, the barrier device comprising:
an elongate member having a flexible flat distal section, where the flexible flat distal section is configured to be collapsible to reduce in profile, at least one electrode attached to the flat distal section, and a connector for electrically coupling the electrode to the nerve locating apparatus.
81. The surgical barrier of claim 4, where the electrode is located on at least a top or bottom surface of the flat distal section.
82. The surgical barrier of claim 4, where the at least one electrode comprises at least two electrodes, and where an electrode is located on a top and bottom surface of the flat distal section.
83. The surgical barrier of claim 4, wherein the flat distal section is steerable
84. A device for treating a spinal condition in a patient, comprising:
a cannulated device with a sharp tip adapted to penetrate tissue and enteran epidural space, an atraumatic protective cover, when placed adjacent to the sharp tip of the cannulated device, blunts the sharp tip preventing the sharp tip from penetrating tissue; and an elongate member, moveable through the cannulated device, the elongate member having a first surface and a second surface, the first surface being adapted to face a first direction in the patient and a second surface adapted to face in an opposite direction, the first surface being adapted to remove tissue and the second surface being adapted to protect tissue
85. The device of claim 84 further comprising at least one stimulating electrode coupled to at least one of the surfaces.
86. The device of claim 84, wherein said second surface is a flexible barrier.
CA2583906A 2004-10-15 2005-10-15 Devices and methods for tissue removal Expired - Fee Related CA2583906C (en)

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US61930604P 2004-10-15 2004-10-15
US60/619,306 2004-10-15
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US68171905P 2005-05-16 2005-05-16
US68186405P 2005-05-16 2005-05-16
US60/681,719 2005-05-16
US60/681,864 2005-05-16
US68519005P 2005-05-27 2005-05-27
US60/685,190 2005-05-27
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