# US 11,076,893 B2 · Methods for treating a patient's spine > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,076,893 B2 - Document ID: US11076893B2 - Status: Granted - Kind: B2 - Application number: 16/116,735 - Filed: 2018-08-29 - Published: 2019-03-28 - Granted: 2021-08-03 - Earliest claimed: 2006-10-18 - Assignees: VertiFlex, Inc. - Applicants: VertiFlex, Inc. - Inventors: Moti Altarac; Robert Gutierrez; Shawn Tebbe; Daniel H. Kim; J. Christopher Flaherty - Web page: https://patentgrep.com/patent/US11076893B2 ## CPC - A61B 17/7065: {Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor} - A61B 17/0206: {with antagonistic arms as supports for retractor elements} - A61B 17/025: {Joint distractors} - A61B 17/1671: {for the spine} - A61B 17/1697: {specially adapted for wire insertion} - A61B 17/1757: {for the spine} - A61B 17/3421: {Cannulas} - A61B 17/7067: {Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor} - A61B 17/8866: {for gripping or pushing bones, e.g. approximators (joint distractors A61B17/025)} - A61B 17/7062: {Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs (rib fixation devices A61B17/8076); Tools for such devices} - A61B 17/848: {Kirschner wires, i.e. thin, long nails} - A61B 17/8897: {Guide wires or guide pins} - A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive} - A61B 2017/0023: {disposable} - A61B 2017/00261: {Discectomy} - A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)} - A61B 2017/0256: {for the spine} - A61B 2090/033: {Abutting means, stops, e.g. abutting on tissue or skin} - A61B 2090/034: {abutting on parts of the device itself} - A61B 2090/062: {penetration depth} - A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract A plurality of individual tools is provided where each tool is uniquely configured to perform a step or a portion of a step in a novel procedure associated with the implantation of a stabilizing device (e.g., an interspinous spacer) for stabilizing at least one spinal motion segment. The tools are usable individually, or more preferably as a tooling system in which the tools are collectively employed to implant an interspinous spacer, generally in a minimally invasive manner. For example, each of the tools is arranged with coordinated markings and/or other features to ensure consistent depths of insertion, proper orientation of the tools with respect to each other or an anatomical feature of the patient, and precise delivery of the spacer to maintain safe positioning throughout the implantation procedure. ## Claims ### Claim 1 A treatment system for insertion between first and second spinous processes of a subject, the treatment system comprising: a first instrument assembly configured to be positioned between the first and second spinous processes and including a target needle having a distal portion, a proximal portion, and a lumen, and a puncher with a needle portion configured to extend through the lumen such that the needle portion protrudes from the distal portion of the target needle; a second instrument assembly configured to be positioned along an opening in the subject formed by the first instrument assembly, wherein the second instrument assembly includes a first dilator having a first dilator distal end, a first dilator proximal end, and a first dilator elongate body, and a second dilator configured to receive the first dilator such that the second dilator is movable over the first dilator; and a cannula configured to be moved over the second dilator, the cannula comprising a distal end and a pair of opposing spinous process channels disposed along the distal end of the cannula and positioned to engage the first and second spinous processes while the cannula is advanced into the subject with the distal end of the cannula between the first and second spinous processes. ### Claim 2 (depends on 1) The treatment system of claim 1, wherein the second dilator has a second dilator distal end, a second dilator proximal end, and a second dilator lumen, and wherein the second dilator distal end is movable toward the first dilator distal end while the first dilator extends along the second dilator lumen and the first dilator proximal end is positioned outside of the second dilator. ### Claim 3 (depends on 1) The treatment system of claim 1, wherein the cannula has a longitudinal length shorter than a longitudinal length of the second dilator. ### Claim 4 (depends on 1) The treatment system of claim 1, further comprising a holder device configured to releasably clamp onto the cannula to hold the cannula relative to the subject. ### Claim 5 (depends on 1) The treatment system of claim 1, wherein the distal end of the cannula is tapered. ### Claim 6 (depends on 1) The treatment system of claim 1, further comprising: a tissue-removal instrument movable through the cannula to remove bone and/or tissue from the subject while the cannula is located in an opening in a supraspinous ligament of the subject. ### Claim 7 (depends on 6) The treatment system of claim 6 wherein the tissue-removal instrument is a reamer. ### Claim 8 (depends on 1) The treatment system of claim 1, wherein the distal end of the cannula is configured to distract the first and second spinous processes. ### Claim 9 (depends on 1) The treatment system of claim 1, further comprising an interspinous knife movable through the cannula to cut tissue of the subject. ### Claim 10 (depends on 1) The treatment system of claim 1, further comprising a wire movable through the target needle such that a distal end of the wire is moved out of a distal end portion of the target needle. ### Claim 11 (depends on 1) The treatment system of claim 1, further comprising an interspinous gauge configured to determine a distance between the first and second spinous processes. ### Claim 12 (depends on 1) A method for treating a subject using the treatment system of claim 1, the method comprising: moving the first instrument assembly into the subject such that a distal portion of the first instrument assembly is positioned between first and second spinous processes to provide a delivery path; removing the puncher from the target needle; and after removing the puncher from the target needle, moving the first dilator along the delivery path to dilate an opening formed by the first instrument assembly, moving the second dilator over the first dilator; and moving the cannula over the second dilator to position the distal end of the cannula between the first and second spinous processes. ### Claim 13 (depends on 12) The method of claim 12, further comprising determining a distance between the first and second spinous processes using an interspinous gauge positioned within the cannula. ### Claim 14 (depends on 12) The method of claim 12, wherein the method further comprises removing the puncher from the target needle while the target needle is positioned in an opening in a supraspinous ligament. ### Claim 15 (depends on 12) The method of claim 12, further comprising moving a wire through the target needle such that a distal end of the wire is moved out of a distal portion of the target needle. ### Claim 16 (depends on 12) The method of claim 12, further comprising: delivering at least one instrument through the cannula, which is positioned between the first and second spinous processes, to cut and/or remove tissue. ### Claim 17 (depends on 12) The method of claim 12, further comprising: delivering an interspinous knife through the cannula to cut tissue; and delivering a reamer through the cannula to remove tissue. ### Claim 18 (depends on 12) The method of claim 12, further comprising: using a holder device to hold the first dilator, the second dilator, and/or the cannula at a fixed position relative to the subject. ### Claim 19 (depends on 18) The method of claim 18 wherein the holder device is configured to releasably clamp onto the first dilator, the second dilator, and/or the cannula. ### Claim 20 (depends on 12) The method of claim 12 wherein the method further includes holding the second dilator using a holder device such that an end portion of the first dilator is positioned generally between the first and second spinous processes; moving the cannula over the second dilator; removing the second dilator from the cannula; and holding the cannula using the holder device such that the distal end of the cannula is positioned generally between the first and second spinous processes. ### Claim 21 (depends on 12) The method of claim 12, further comprising: positioning the cannula in a holder device; and moving the holder device from an open configuration for releasing the cannula to a closed configuration for clamping onto the cannula. ### Claim 22 (depends on 21) The method of claim 21 wherein the holder device is configured to hold the cannula at a fixed position relative to the subject. ### Claim 23 (depends on 12) The method of claim 12, further comprising advancing the cannula into the subject to move the first and second spinous processes along the pair of the opposing spinous process channels of the cannula. ### Claim 24 (depends on 12) The method of claim 12, further comprising moving the cannula into the subject such that the cannula distracts the first and second spinous processes. ### Claim 25 (depends on 12) The method of claim 12, further comprising: moving a spacer through the cannula to position the spacer within the subject; operating an insertion instrument extending through the cannula to deploy the spacer at an interspinous space between the first and second spinous processes; and after deploying the spacer, releasing the spacer from the insertion instrument positioned in the cannula. ### Claim 26 (depends on 12) The method of claim 12, further comprising: delivering one or more instruments through the cannula to remove bone and/or soft tissue; after removing the bone and/or soft tissue, delivering a spacer device through the cannula and to an interspinous space; and implanting the spacer device at the interspinous space. ### Claim 27 (depends on 12) The method of claim 12, further comprising: delivering an interspinous spacer device through the cannula while a longitudinal axis of the cannula is generally parallel to an anterior-to-posterior direction relative to a spine of the subject; and deploying the interspinous spacer device at an interspinous space between the first and second spinous processes.