Percutaneous Tissue Excision Devices and Methods

• US 20070055215A1
• Filed: 07/31/2006
• Published: 03/08/2007
• Est. Priority Date: 07/29/2005
• Status: Active Grant

• Current Assignee: Vertos Medical, Inc.
• Original Assignee: X-Sten Incorporated
• Inventors: Way, Bryce, Tran, Minh
• Granted Patent: US 8,696,671 B2
• Time in Patent Office: Days
• US Class Current: 604/540
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/1608 the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/2911 rings
• CPC Class Codes: A61B 2017/2925 Pistol grips
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

A device for percutaneously excising tissue. In an embodiments the device comprises an outer tubular. In addition, the device comprises an inner tubular slidingly received within the outer tubular, wherein the inner tubular has a distal end including an upper member and a lower member. Further, the device includes an open position with the distal end fully extended from the outer tubular, and a closed position with the distal end disposed within the outer tubular, wherein the upper member is biased away from the lower member and is disposed at an open angle θ_O relative to the lower member when the device is in the opened position.

Claims

1. A tissue excision device comprising:

an outer tubular member; and

an inner tubular member slidingly received within the outer tubular member;

wherein the inner tubular member has a distal end including an upper member and a lower member;

wherein the device has an open position in which the distal end is fully extended from the outer tubular member, and a closed position in which the distal end is disposed within the outer tubular; and

wherein the upper member is biased away from the lower member and is disposed at an open angle θ

_O relative to the lower member when the device is in the opened position.

2. The device of claim 1 wherein the open angle θ

_O is between 5° and

30°

.

3. The device of claim 2 wherein open angle θ

_O is between 8° and

20°

.

4. The device of claim 1 wherein the upper member has a fixed end integral with the inner tubular member and a cutting end adapted to cut tissue.

5. The device of claim 1 wherein the length of the upper member between the fixed end and the cutting end is between 0.5 and 1.0 inches.

6. The device of claim 1 wherein the upper member is disposed at a closed angle θ

_C relative to the lower member when the device is in the closed position, wherein closed angle θ

_C is between 0° and

5°

.

7. The device of claim 4 wherein the upper member includes a flexing region between the cutting end and the fixed end, wherein the upper member is adapted to flex about the flexing region.

8. The device of claim 4 wherein the cutting end of the upper member extends toward the central axis of the inner tubular member at a bent region to form a tooth.

9. The device of claim 8 wherein the bent region has a curved outer surface.

10. The device of claim 1 wherein the lower member includes a fixed end integral with the inner tubular member and a cutting end adapted to cut tissue.

11. The device of claim 10 wherein the cutting end of the lower member has a cutting tip with a beveled edge defined by an acute angle λ

between 15° and

45°

.

12. The device of claim 1 wherein the lower member is coaxial with the outer tubular member.

13. The device of claim 1 wherein the outer tubular member includes an annular cutting edge adapted to cut tissue.

14. The device of claim 1, further comprising a plunger slidingly received within the inner tubular member.

15. A method for treating stenosis in a spine of a patient having a median plane, the spine including a spinal canal having a posterior surface, a dural sac and an epidural space between the posterior surface and dural sac, the location of the stenosis determining a region of interest in the spine, comprising the steps of:

a) positioning a tissue excision device adjacent the region of interest, wherein the tissue excision device comprises;

an outer tubular member;

an inner tubular member slidably received within the outer tubular member, wherein the inner tubular member has a distal end including an upper member and a lower member;

wherein the tissue excision device has an open position in which the distal end is fully extended from the outer tubular member and the upper and lower member define angle θ

_O therebetween and a closed position in which the distal end is disposed within the outer tubular;

b) opening the tissue excision device by extending the distal end of the inner tubular from the outer tubular;

c) inserting the tissue excision device into tissue in the region of interest;

d) closing the tissue excision device by sliding the outer tubular over the distal end of the inner tubular; and

e) retracting the tissue excision device from the tissue in the region of interest.

16. The method of claim 15 wherein a portion of the patient'"'"'s ligamentum flavum occupies the region of interest, and wherein step c) comprises inserting the tissue excision device into the ligamentum flavum in the region of interest, step d) comprises cutting at least a portion of the ligamentum flavum in the region of interest, and step e) comprises removing at least a portion of the cut ligamentum flavum.

17. The method of claim 15 further comprising the steps of compressing the dural sac in the region of interest by injecting a fluid to form a safety zone and establish a working zone in the region of interest, the safety zone lying between the working zone and the dural sac.

18. The method of claim 15 further comprising the step of emptying the cut tissue from the tissue excision device.

19. A kit for performing a procedure on a spine, the spine including an epidural space containing a dural sac, the kit comprising:

an insertion member for accessing the epidural space;

a volume of a contrast medium adapted to be inserted into the epidural space by the insertion member and expanded so as to compress a portion of the thecal sac and provide a safety zone within the epidural space; and

a tissue excision device comprising;

an outer tubular member; and

an inner tubular member slidably received within the outer tubular member;

wherein the inner tubular member has a distal end including an upper member and a lower member;

wherein the device has an open position in which the distal end is fully extended from the outer tubular member, and a closed position in which the distal end is disposed within the outer tubular; and

wherein the upper member is biased away from the lower member and is disposed at an open angle θ

_O relative to the lower member when the device is in the opened position.