Devices and methods for tissue access

• US 9,463,041 B2
• Filed: 12/15/2015
• Issued: 10/11/2016
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Amendia, Inc. (Spinal Elements, Inc.)
• Inventors: Bleich, Jeffery L., Hlavka, Edwin J., Saadat, Vahid, Miller, David J., Yurchenco, James R.
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): Ku, Si Ming
• Application Number:
  US14/969,691
• Publication Number:
  US 20160135834A1
• Time in Patent Office: 301 Days
• Field of Search: 606/79, 606/82, 606/84, 606/85, 606/167, 606/176, 606/177
• US Class Current: 1/1
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/320004 : abrasive
• CPC Class Codes: A61B 2017/320044 : Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/32006 : with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3447 : Linked multiple cannulas
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00595 : Cauterization
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2034/2063 : Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61B 2090/374 : NMR or MRI
• CPC Class Codes: A61B 2090/376 : using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3762 : using computed tomography systems [CT]
• CPC Class Codes: A61B 5/4893 : Nerves
• CPC Class Codes: A61B 90/04 : Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61F 2/0045 : Support slings
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

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 some embodiments, a surgical tissue removal device includes a flexible elongate body that is adapted to conform with the target anatomy and a guidewire connector at the distal end region of the flexible elongate body configured to removably connect to the end of a guidewire so that the guidewire and flexible elongate body can be pulled distally. The body may have at least one blade edge, and the flexible elongate body may be a thin, flat, ribbon shaped flexible body that comprises a profile having a width that is substantially greater than a height.

Claims

1. A surgical tissue removal device comprising:

a flexible elongate body that is adapted to conform with a target anatomy, the body having a working surface for separating and removing impinging tissue, the working surface defined by at least one blade edge, where the flexible elongate body is a thin, flat, ribbon shaped flexible body that comprises a profile having a width that is substantially greater than a height;

a guidewire connector at a distal end region of the flexible elongate body configured to removably connect to an end of a guidewire so that the guidewire and the flexible elongate body can be pulled distally, wherein the at least one blade edge is a v-shaped blade edge; and

wherein a portion of the flexible elongate body removed from the working surface includes a lubricious layer not on the working surface for removing tissue.

2. The tissue removal device of claim 1, further comprising:

a distal handle configured to couple to the distal end of the flexible elongate body; and

a proximal handle configured to couple to a proximal end region of the flexible elongate body, wherein the distal handle and the proximal handle are configured to allow the body to be reciprocated proximally and distally to cut tissue.

3. The tissue removal device of claim 2, wherein the distal handle is configured to connect to the guidewire while a proximal end of the guidewire is connected to the distal end of the flexible elongate body.

4. The tissue removal device of claim 1, wherein a guidewire connector region is configured to hook the flexible elongate body to an end region of the guidewire.

5. The tissue removal device of claim 1, wherein the at least one blade edge comprises a plurality of discrete sharpened blade edges for cutting through tissue and bone.

6. The tissue removal device of claim 1, wherein the at least one blade edge is flush with a surface of the elongate body.

7. A surgical tissue removal device, comprising:

a flexible elongate body that is adapted to conform with a target anatomy, the body having a working surface for separating and removing impinging tissue, the working surface defined by at least one blade edge extending from one surface of the flexible elongate body, where the flexible elongate body is a thin, flat, ribbon shaped flexible body that further comprises a profile having a width that is substantially greater than a height;

a guidewire connector on the flexible elongate body configured to connect to an end of a guidewire so that the end of the guidewire connects into the guidewire connector at a distal end region of the flexible elongate body so that the guidewire and the flexible elongate body can be pulled distally to draw the at least one blade edge distally across the target anatomy, wherein the at least one blade edge is a v-shaped blade edge; and

wherein a portion of the flexible elongate body removed from the working surface includes a lubricious layer not on the working surface for removing tissue.

8. The tissue removal device of claim 7, where the flexible elongate body is configured to pass through a subject'"'"'s spinal foramen.

9. The tissue removal device of claim 7, where the at least one blade edge comprises a plurality of blade edges located on the surface of the flexible elongate body near an end of the flexible elongate body comprising the guidewire connector so that the end of the flexible elongate body opposite of the guidewire connector does not include a blade edge.

10. The tissue removal device of claim 7, where the at least one blade edge comprises a plurality of blade edges and where the plurality of blade edges comprise a plurality of blade edges located on the surface of the flexible elongate body near a center of the flexible elongate body so that ends of the flexible elongate body do not include any blade edges.

11. The tissue removal device of claim 7, further comprising:

a distal handle configured to couple to the distal end of the flexible elongate body; and

a proximal handle configured to couple to the proximal end region of the flexible elongate body, wherein the distal handle and the proximal handle are configured to allow the body to be reciprocated proximally and distally to cut tissue.

12. The tissue removal device of claim 11, wherein the distal handle is configured to connect to the guidewire while a proximal end of the guidewire is connected to the distal end of the flexible elongate body.

13. The tissue removal device of claim 7, wherein a guidewire connector region is configured to hook the flexible elongate body to an end region of the guidewire.

14. The tissue removal device of claim 7, wherein the at least one blade edge comprises a plurality of discrete sharpened blade edges for cutting through tissue and bone.

15. The tissue removal device of claim 7, the body having an axial length and a plurality of blade edges arranged in rows extending from one surface of the flexible elongate body, wherein the rows are disposed transverse to the axial length of the elongate body and the rows are separated by gaps that extend transverse to the axial length of the elongate body.