Minimally invasive tooling for delivery of interspinous spacer

• US 20070276370A1
• Filed: 10/18/2006
• Published: 11/29/2007
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation), Vetiflex, Inc.
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Kim, Daniel, Altarac, Moti, Tebbe, Shawn, Gutierrez, Robert, Flaherty, J.
• Granted Patent: US 8,128,662 B2
• Time in Patent Office: Days
• US Class Current: 606/86.A
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/0077 : Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

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

1-207. -207. (canceled)

208. An insertion instrument for implanting an interspinous spacer in a patient, the insertion instrument comprising:

a barrel assembly with a proximal end and a distal end, the barrel assembly comprising an elongated outer tube, an inner shaft slidably received by the outer tube, and a handle assembly fixedly attached to the proximal end of the barrel assembly,

wherein the barrel assembly is configured to engage with an interspinous spacer, insert the interspinous spacer into the body of the patient, expand the interspinous spacer, and disengage from the interspinous spacer.

209. The insertion instrument of claim 208 wherein the barrel assembly is further configured to unexpand and explant the interspinous spacer.

211. The insertion instrument of claim 208 wherein the barrel assembly is further configured to re-engage with an implanted interspinous spacer device.

212. The insertion instrument of claim 208 wherein the barrel assembly is configured to be inserted through a cannula.

213. The insertion instrument of claim 212 wherein the barrel assembly includes a mechanical feature that mates with the cannula to determine depth of insertion and/or orientation of insertion.

214. The insertion instrument of claim 213 wherein the mechanical feature is a flat surface which mates with a flat surface of the cannula.

215. The insertion instrument of claim 213 wherein the barrel assembly distal end includes a spacer attachment mechanism.

216. The insertion instrument of claim 215 wherein the spacer attachment mechanism includes at least two prongs, the at least two prongs configured to be releasably engaged with an interspinous spacer device.

217. The insertion instrument of claim 216 wherein a first prong is longer than a second prong.

218. The insertion instrument of claim 215 wherein the at least two prongs engage with an outer surface of the interspinous spacer.

219. The insertion instrument of claim 215 wherein the spacer attachment mechanism includes a projection, the projection configured to releasably engage with an interspinous spacer device.

220. The insertion instrument of claim 219 wherein the projection comprises a threaded rod.

221. The insertion instrument of claim 219 wherein the projection engages with an actuator mechanism of the interspinous spacer device.

222. The insertion instrument of claim 215 wherein the spacer attachment mechanism further includes an attached interspinous spacer device.

223. The insertion instrument of claim 215 wherein the barrel assembly further comprises a second spacer attachment mechanism.

224. The insertion instrument of claim 208 wherein the handle further comprises a control operatively connected to the inner shaft and configured to translate and/or rotate the inner shaft.

227. The insertion instrument of claim 208 wherein the handle further includes a control, the control configured to operatively expand and/or contract an interspinous spacer device.

228. The insertion instrument of claim 208 wherein the handle further includes a control, the control configured to engage and/or disengage the barrel assembly with an interspinous spacer device.

229. The insertion instrument of claim 208 wherein the handle further includes at least two controls, the at least two controls configured to collectively engage, re-engage, expand, contract and/or disengage the distal end of the barrel assembly with an interspinous spacer device.

230. The insertion instrument of claim 208 wherein the handle further includes a control, the control configured to operatively distract a first spinous process and a second spinous process.

231. The insertion instrument of claim 208 further comprising a deployment status indicator.

234. The insertion instrument of claim 231 wherein the deployment status indicator provides quantitative deployment information.

235. The insertion instrument of claim 231 wherein the deployment status indicator provides a confirmation of successful expansion of an interspinous spacer device.

236. The insertion instrument of claim 208 further including an engagement status indicator.

239. The insertion instrument of claim 236 wherein the engagement status indicator provides quantitative engagement information.

240. The insertion instrument of claim 236 wherein the engagement status indicator provides a confirmation of successful disengagement from an interspinous spacer device.

241. The insertion instrument of claim 236 wherein the engagement status indicator provides a confirmation of successful re-engagement with an interspinous spacer device.

248. The insertion instrument of claim 208 further comprising an interspinous spacer device.

249. The insertion instrument of claim 208 further including an interspinous gauge assembly, the interspinous gauge assembly configured to measure the distance between a first spinous process and a second spinous process of the patient.

252. The insertion instrument of claim 249 wherein the interspinous gauge assembly includes a sensor which provides a signal correlating to the measured distance.

254. The insertion instrument of claim 252 wherein the interspinous gauge assembly further includes an expandable assembly disposed proximate to the distal end of the elongated barrel and configured for expansion between two spinous processes, wherein the sensor provides a signal indicating the state of expansion of the expandable assembly.

259. The insertion instrument of claim 208 further including a size indicator configured to provide interspinous spacer size information.

263. The insertion instrument of claim 208 further including a force measurement assembly configured to provide information to an operator, the information correlating to the magnitude of force required to distract two spinous processes a fixed distance.

267. The insertion instrument of claim 208 further including a spinous process thickness measurement assembly configured to provide information to an operator, the information correlating to a thickness of one or more spinous processes of the patient.

268. The tool of claim 267 wherein the provided thickness information includes acceptability of the measured force.

271. The insertion instrument of claim 208 further including an osteophyte treatment assembly configured to remove, smooth and/or otherwise treat an osteophyte.

274. The insertion instrument of claim 208 further including a spinous process distraction assembly.

275. The insertion instrument of claim 274 wherein the handle further comprises a control for operatively engaging the distraction assembly.

276. The insertion instrument of claim 274 wherein the distraction assembly is configured to not exceed a pre-determined distraction force.

277. The insertion instrument of claim 274 wherein the distraction assembly is configured to not exceed a pre-determined distraction distance.

210. (canceled)

225-226. -226. (canceled)

232-233. -233. (canceled)

237-238. -238. (canceled)

242-247. -247. (canceled)

250-251. -251. (canceled)

253. (canceled)

255-258. -258. (canceled)

260-262. -262. (canceled)

264-266. -266. (canceled)

269-270. -270. (canceled)

272-273. -273. (canceled)

278. A method for performing a procedure on a patient'"'"'s spine, the method comprising the steps of:

inserting a guidewire comprising a flexible filament through skin of the patient to a location proximate to the patient'"'"'s spine;

inserting a cannula comprising a rigid elongated tube with a proximal end, a distal end, and a lumen therethrough proximate to the patient'"'"'s supraspinous ligament;

placing a mounting bracket comprising a receiving tube and an attachment port over the cannula so that the cannula is received in the receiving tube;

attaching the attachment port to a stabilizing device;

orienting the cannula relative to the stabilizing device; and

delivering an interspinous spacer through the cannula to an interspinous process space.

279. The method of claim 278 further including the step of inserting the cannula through the supraspinous ligament.

280. The method of claim 278 further including the step of inserting the cannula into the patient laterally and proximate to the supraspinous ligament.

281. The method of claim 278 further including the step of inserting the cannula into the patient laterally to the supraspinous ligament.

288. The method of claim 278 including a further step of penetrating the supraspinous ligament using a target needle, the target needle comprising a hollow needle comprising a proximal end, a distal end, and a lumen therethrough and an inner core slidably received by the hollow needle.

289. The method of claim 288 including a further step of removing the inner core from the hollow needle after penetrating the supraspinous ligament.

293. The method of claim 278 including a further step of oscillating the cannula in partial rotations in clockwise and counterclockwise direction to separate filamentous strands of the supraspinous ligament.

295. The method of claim 278 including a further step of making one or more plunge cuts using an interspinous knife, the interspinous knife comprising an elongated outer tube with a proximal end and a distal end, an inner tube with a proximal end and a distal end, the inner tube slidably received by the elongated outer tube and the distal end of the inner tube including a cutting element.

296. The method of claim 295 in which a first of the one or more plunge cuts comprises an “

X”

shaped cut that is oriented approximately 45 degrees from a second one of the one or more plunge cuts comprising an “

X”

shaped cut.

298. The method of claim 295 in which the interspinous knife is inserted into the cannula so that a surface feature of the interspinous knife comes in contact with a counterbore feature of the cannula to thereby provide a fixed orientation of the interspinous knife with respect to the cannula.

299. The method of claim 278 including a further step of using an interspinous reamer to remove tissue, the interspinous reamer comprising an elongated tube with a proximal end and a distal end, the distal end comprising an axial cutting element configured to cut tissue of the patient, and a flat end drill, the drill configured to remove the tissue from the elongated tube.

300. The method of claim 299 in which the interspinous reamer is inserted into the cannula until a depth-limiting element disposed in the interspinous reamer mates with the cannula to thereby limit insertion of the elongated tube and/or flat-end drill into the cannula.

303. The method of claim 278 including a further step of treating an osteophyte using an interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

304. The method of claim 303 in which the treatment includes mechanically abrading the osteophyte using a back and forth motion.

306. The method of claim 278 including a further step of applying a distraction force between a first spinous process and a second spinous process using an interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

307. The method of claim 278 including a further step of inserting an interspinous gauge through the cannula, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

308. The method of claim 307 in which the interspinous gauge is inserted into the cannula until a flat surface on the interspinous gauge mates with a counterbore of the cannula to thereby provide a fixed orientation of the interspinous gauge with respect to the cannula.

309. The method of claim 278 including a further step of measuring a magnitude of force required to distract two spinous processes a fixed distance using an interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

310. The method of claim 278 including a further step of measuring a thickness of one or more spinous processes using an interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

311. The method of claim 278 including a further step of implanting an interspinous spacer using a interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel, and an implant insertion assembly that is configured to engage and re-engage with an interspinous spacer.

312. The method of claim 278 including a further step of creating an opening in the supraspinous ligament.

313. The method of claim 312 wherein the step of creating an opening in the supraspinous ligament includes creating an opening using a first ligament separating tool and delivering energy to the distal end of the ligament separating tool to thereby cut tissue and/or coagulate blood.

314. The method of claim 312 including a further step of using a first ligament separating tool comprising an elongated tube with a proximal end, a distal end, and a lumen therebetween and a ligament separating assembly disposed proximate to the distal end of the elongated tube.

282-287. -287. (canceled)

290. (canceled)

291. The method of 278 including a further step of inserting at least one dilator over the guidewire to thereby dilate the patient'"'"'s tissue, the at least one dilator comprising an elongated tube with a proximal end, a distal end, and a lumen therethrough, the lumen configured to allow placement of the at least one dilator over the guidewire, and the distal end including a taper configured to dilate tissue.

292. The method of claim 291 in which the at least one dilator is used to separate filamentous strands of the supraspinous ligament.

294. (canceled)

297. (canceled)

301. (canceled)

302. The method of 278 including a further step of measuring a distance between a first spinous process and a second spinous process of the patient using an interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

305. (canceled)

315. A method of implanting an interspinous spacer in a patient, the method comprising the steps of:

providing an interspinous spacer;

providing an insertion instrument;

operating the insertion instrument to thereby engage with the interspinous spacer, the insertion instrument comprising a barrel assembly with a proximal end and a distal end, the barrel assembly comprising an elongated outer tube, an inner shaft slidably received by the outer tube, and a handle assembly fixedly attached to the proximal end of the barrel assembly;

inserting the insertion instrument proximate to the patient'"'"'s supraspinous ligament;

expanding the interspinous spacer by operation of the handle assembly; and

disengaging the insertion instrument from the interspinous spacer.

316. The method of claim 315 in which the barrel assembly is inserted into the cannula until a mechanical feature mates with the cannula to thereby set depth of insertion and/or orientation of the insertion instrument.

317. The method of claim 315 including a further step of reading a deployment status indicator to receive quantitative deployment information.

318. The method of claim 315 including a further step of delivering energy to the distal end of the barrel to thereby cut tissue, coagulate blood and/or treat osteophytes.

319. The method of claim 315 including a further step of measuring a distance between a first and a second spinous process using the insertion instrument configured with an interspinous gauge assembly.

320. The method of claim 315 including a further step of measuring a force required to distract two spinous processes a fixed distance using the insertion instrument configured with a force measurement assembly.

321. The method of claim 315 including a further step of measuring a thickness of one or more spinous processes using the insertion instrument configured with a thickness measurement assembly.

322. The method of claim 315 including a further step of inserting the insertion instrument through the superspinous ligament.

323. A system of tools used in a surgical procedure on a patient'"'"'s spine, the system comprising:

an spacer insertion instrument;

a stabilizing device comprising at least a first attachment element; and

a mounting tower comprising a receiving tube, an attachment port, and at least one spinous process gripper, the receiving tube configured to receive a spacer insertion instrument, the attachment port configured to attach to the at least first attachment element of the stabilizing device, and the at least one spinous process gripper configured to mount to a spinous process, the spinous process being one of superior spinous process or inferior spinous process.

324. The system of claim 323 in which the at least one spinous process gripper comprises a pair of spinous process grippers.

325. The system of claim 324 in which a first pair of the pair of spinous process grippers is arranged to clamp to the superior spinous process and a second pair of the pair of spinous process grippers is arranged to clamp to the inferior spinous process.

326. The system of claim 323 in which the at least one spinous process gripper comprises a pair of legs, a proximal end of at least one of the legs being pivotally mounted to the mounting tower and a distal end of at least one of the legs configured to interface with a surface of the spinous process.

327. The system of claim 326 in which the at least one spinous process gripper is coupled to a control interface.

328. The system of claim 327 in which the control interface includes a first control interface and a second control interface.

329. The system of claim 328 in which operation of the first control interface causes each leg in the pair of legs to pivot outward in a lateral direction with respect to the other leg.

330. The system of claim 329 in which operation of the first control interface further causes each spinous process gripper in the pair of spinous process grippers to pivot inward in an axial direction with respect to the other spinous process gripper.

331. The system of claim 330 in which the mounting bracket includes a direction indicator.

332. The system of claim 328 in which operation of the second control interface causes each leg in the pair of legs to pivot inward in a lateral direction with respect to the other leg to thereby impose a clamping force on the spinous process.

333. The system of claim 327 in which the control interface is rotatably disposed along a longitudinal axis of the mounting tower.

334. The system of claim 328 in which the first control interface and second control interface are co-axially disposed.

335. A method for performing a procedure on a patient'"'"'s spine, the method comprising the steps of:

inserting a cannula through the skin of the patient to a location proximate to the patient'"'"'s spine, the cannula comprising a rigid elongated tube with a proximal end, a distal end, and a lumen therethrough; and

delivering an interspinous spacer through the cannula using one or more tools from a tool set comprising a plurality of individual tools, the individual tools selected from one of interspinous knife, ligament separating tool, interspinous reamer and interspinous gauge,

wherein the interspinous knife comprises an elongated outer tube with a proximal end and a distal end;

an inner tube with a proximal end and a distal end, the inner tube slidably received by the elongated outer tube and the distal end of the inner tube including a cutting element having two blades substantially arranged in an X pattern, the interspinous knife further including a depth control element configured to allow an operator to select from a plurality of pre-set cutting depths, and

wherein the ligament separating tool comprises an elongated tube with a proximal end, a distal end, and a lumen therebetween, and a ligament separating assembly disposed proximate to the distal end of the elongated tube, and

wherein the interspinous reamer comprises an elongated tube with a proximal end and a distal end, the distal end comprising an axial cutting element configured to cut tissue of the patient, and a flat end drill, the drill configured to remove tissue from the elongated tube, and

wherein the interspinous gauge comprises an elongated barrel with a proximal end and a distal end, and at least one control attached to the proximal end of the elongated barrel

wherein the interspinous gauge is configured to measure the distance between a first spinous process and a second spinous process of the patient through operation of the at least one control.

336. The method of claim 335 in which the cannula has an lumen diameter that is less than approximately 20 millimeters, less than approximately 15 millimeters, or in a range of approximately 8 to 10 millimeters.

339. The method of claim 335 in which the inserting is performed through the superspinous ligament using a single insertion point that is substantially aligned with a midline of a supraspinous ligament.

337-338. -338. (canceled)

340-345. -345. (canceled)