DEVICES, SYSTEMS AND METHODS FOR TREATING BENIGN PROSTATIC HYPERPLASIA AND OTHER CONDITIONS

• US 20090060977A1
• Filed: 10/17/2008
• Published: 03/05/2009
• Est. Priority Date: 05/20/2005
• Status: Abandoned Application

• Current Assignee: Teleflex Life Sciences Limited (Teleflex Incorporated)
• Original Assignee: NeoTract, Inc. (Teleflex Incorporated)
• Inventors: Welch, Jacqueline Nerney, Collinson, Michael, Vidal, Claude, Catanese, Joseph III, Redmond, Russell J., Makower, Joshua, Walke, Amrish Jayprakash, Lamson, Theodore Charles
• Application Number:
  US12/253,821
• Publication Number:
  US 20090060977A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0451 : Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 : Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00517 : Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00547 : Prostate
• CPC Class Codes: A61B 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/144 : Wire
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/041 : Bile ducts

Abstract

Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Claims

1-249. -249. (canceled)

250. A method for treating a condition in a human or animal subject wherein the prostate gland is causing undesirable constriction of the urethra, said method comprising the steps of:

A) inserting an introducer device into the subject'"'"'s body;

B) advancing a cutting device from the introducer device;

C) using the cutting device to cut at least a portion of the prostate without substantially damaging the urethra such that the constriction of the urethra is lessened; and

D) implanting at least one tissue compressing device to compresses the prostate in a manner that lessens constriction of the urethra.

251. A method according to claim 250 wherein the introducer device inserted in Step A comprises a scope lumen and a working lumen and wherein a scope is inserted into the scope lumen and the cutting device is advanced through the working lumen.

252. A method according to claim 250 further comprising the step of using the scope to view at least a portion of the performance of the method.

253. A method according to claim 250 wherein Step A comprises inserting the introducer to a position within the urethra and wherein Steps B and C comprise forming an opening in the wall of the urethra, advancing either the introducer or the cutting apparatus though the opening formed in the wall of the urethra and thereafter causing the cutting apparatus to form a cut that extends through the capsule of the prostate gland.

254. A method according to claim 250 wherein Step B comprises advancing the cutting device into the prostate gland.

255. A method according to claim 250 wherein Step B comprises advancing the cutting device to a position adjacent to the outer surface of the prostate capsule.

256. A method according to claim 250 wherein Step B comprises advancing a guide to a position within or near the prostate and advancing the cutting device over or through said guide.

257. A method according to claim 256 wherein the guide comprises a guidewire and wherein the cutting device comprises a guidewire lumen that facilitates advancement of the cutting device over the guidewire.

258. A method according to claim 256 further comprising the step of anchoring the guide.

259. A method according to claim 250 wherein Step C comprises using the cutting device to form a subcapsular cut within the prostate gland.

260. A method according to claim 250 wherein Step C comprises using the cutting device to form a cut through the capsule of the prostate gland.

261. A method according to claim 250 wherein Step C comprises forming a cut between the lobes of the prostate gland such that the lobes separate from one another.

262. A method according to claim 250 wherein the cutting device comprises an elongate shaft and a cutting element that is deployable from the shaft.

263. A method according to claim 262 wherein the cutting element comprises a cutting member that is initially in a non-cutting configuration substantially parallel to a longitudinal axis of the shaft and may be caused to bow outwardly from the shaft thereby cutting tissue as it bows outwardly.

264. A method according to claim 263 wherein the cutting device is advanced into the prostate gland with the cutting member in its non cutting configuration and, thereafter, causing the cutting member to bow outwardly thereby forming a cut in the prostate gland.

265. A method according to claim 262 wherein Step C comprises causing the cutting member to emit energy to facilitate formation of said cut.

266. A method according to claim 250 further comprising the step of maintaining separation of opposing surface of the cut for at least a period of time after formation of the cut.

267. A method according to claim 250 further comprising the step of delivering a therapeutic substance to a location within or near the prostate gland wherein the therapeutic substance is selected from the group consisting of:

hemostatic agents;

antimicrobial agents;

antibiotics;

antifungals;

antiprotozoals;

antivirals;

antimicrobial metals;

hemostatic and/or vasoconstricting agents;

pseudoephedrine;

xylometazoline;

oxymetazoline;

phenylephrine;

epinephrine;

cocaine;

local anesthetic agents;

lidocaine;

cocaine;

bupivacaine;

hormones;

anti-inflammatory agents;

corticosteroids;

non-steroidal anti-inflammatory agents;

hormonally active agents;

agents that enhance potency;

substances that dissolve, degrade, cut, break, weaken, soften, modify or remodel connective tissue or other tissue;

enzymes;

collagenase;

trypsin;

EDTA;

trypsin combined with EDTA;

hyaluronidase;

tosyllysylchloromethane (TLCM));

chemotherapeutic or antineoplastic agents;

substances that prevent adhesion formation;

hyaluronic acid gel;

space occupying substances;

substances that promote desired tissue ingrowth into an anchoring device or other implanted device;

substances that promote or facilitate epithelialization;

substances that create a coagulative lesion which is subsequently resorbed causing the tissue to shrink, substances that cause the prostate to decrease in size;

phytochemicals that cause the prostate to decrease in size;

alpha-1a-adrenergic receptor blocking agents;

5-alpha-reductase inhibitors;

smooth muscle relaxants and agents that inhibit the conversion of testosterone to dihydrotestosterone.

268. A method according to claim 267 wherein the step of delivering a therapeutic substance to a location within or near the prostate gland comprises injecting said therapeutic substance into or near the prostate gland.

269. A method according to claim 267 wherein the step of delivering a therapeutic substance to a location within or near the prostate gland comprises placing a substance eluting implant in or near the prostate gland.

270. A method according to claim 269 wherein the substance eluting implant is further operative to maintain separation of opposing surface of the cut for at least a period of time after formation of the cut.

271. A method according to claim 250 further comprising the step of:

forming a lesion within the tissue which subsequently causes shrinkage of the tissue.

272. A method according to claim 271 wherein a coagulative lesion is formed by heating the tissue.

273. A method according to claim 272 wherein the coagulative lesion subsequently becomes resorbed thereby causing the tissue to shrink.

274. A method according to claim 250 wherein the step of implanting at least one tissue compressing device to compresses the prostate in a manner that lessens constriction of the urethra comprises:

placing a first anchor at a first location on, in or adjacent to the prostate;

placing a second anchor at a second location on, in or adjacent to the prostate; and

placing a connecting member between the first and second anchors, said connecting member drawing at least one of said first and second anchors toward the other thereby compressing at least a portion of the prostate.

275. A transvesicular method for delivering a treatment to the prostate gland of a human or animal subject, said method comprising the steps of:

A) percutaneously inserting a device through the wall of the abdomen;

B) forming a first opening in the wall of the urinary bladder;

C) advancing the device inserted in Step A through the first opening and into the urinary bladder;

D) forming a second opening in the wall of the bladder;

E) advancing at least one treatment delivering device through the second opening in the wall of the urinary bladder to a position within or near the urinary bladder; and

F) using said at least one treatment delivering device to deliver the treatment to the prostate gland.

276. A method according to claim 275 wherein the treatment comprises implantation of an implant device within or near the prostate gland.

277. A method according to claim 276 wherein the prostate is causing constriction of the urethra and wherein the implant comprises a device that compresses the prostate in a manner that lessens constriction of the urethra.

278. A method according to claim 276 wherein the implant delivers a therapeutic substance to treat a condition of the prostate.

279. A method according to claim 278 wherein the implant delivers a therapeutic substance selected from the group consisting of:

hemostatic agents;

antimicrobial agents;

antibiotics;

antifungals;

antiprotozoals;

antivirals;

antimicrobial metals;

hemostatic and/or vasoconstricting agents;

pseudoephedrine;

xylometazoline;

oxymetazoline;

phenylephrine;

epinephrine;

cocaine;

local anesthetic agents;

lidocaine;

cocaine;

bupivacaine;

hormones;

anti-inflammatory agents;

corticosteroids;

non-steroidal anti-inflammatory agents;

hormonally active agents;

agents that enhance potency;

substances that dissolve, degrade, cut, break, weaken, soften, modify or remodel connective tissue or other tissue;

enzymes;

collagenase;

trypsin;

EDTA;

trypsin combined with EDTA;

hyaluronidase;

tosyllysylchloromethane (TLCM));

chemotherapeutic or antineoplastic agents;

substances that prevent adhesion formation;

hyaluronic acid gel;

space occupying substances;

substances that promote desired tissue ingrowth into an anchoring device or other implanted device;

substances that promote or facilitate epithelialization;

substances that create a coagulative lesion which is subsequently resorbed causing the tissue to shrink, substances that cause the prostate to decrease in size;

phytochemicals that cause the prostate to decrease in size;

alpha-1a-adrenergic receptor blocking agents;

5-alpha-reductase inhibitors;

smooth muscle relaxants and agents that inhibit the conversion of testosterone to dihydrotestosterone.

280. A method according to claim 275 wherein the treatment comprises forming a cut in the prostate in a manner that lessens constriction of the urethra.

281. A method according to claim 280 wherein the cut extends through the capsule of the prostate gland.

282. A method according to claim 281 wherein the cut is formed at or near the commissure of the prostate gland.

283. A method according to claim 275 wherein the treatment comprises forming a lesion in the prostate gland that subsequently causes shrinkage of the prostate gland.

284. A method according to claim 283 wherein the lesion is a coagulative lesion is formed by heating the tissue.

285. A method according to claim 284 wherein the coagulative lesion subsequently becomes resorbed thereby causing the tissue to shrink.

286. A method for compressing at least one region of the prostate in a manner that relieves constriction of the urethra, said method comprising the steps of

placing a first member in an anatomical structure outside of the urethra;

placing a second member in the lumen or wall of the urethra;

bringing the first member closer to the second member in a manner that relieves constriction of the urethra.

287. A device for compressing at least one region of the prostate comprising

a first element configured to communicate force to an anatomical structure outside of the urethra;

a second element configured to communicate force to the urethra; and

a tethering element capable of linking the first and second elements.

288. A method of relieving obstruction of the urethra by the prostate, said method comprising the steps of:

delivering at least one device through the wall of the urethra;

using said at least one device to performing at least one action on the prostate which changes the force exerted by the prostate on the urethra without removing or destroying prostatic tissue.

289. A device for relieving a urethral obstruction caused by the prostate gland, said device comprising

an implant that modifies at least one property of the tissue beyond the prostatic urethra without destroying or removing tissue.

290. A method for decompressing a compressed lumen within the body of a human or animal subject, said method comprising the steps of.

forming an opening in the wall of the lumen;

placing a first attachment element in or near the lumen,

placing a second attachment element in the subject'"'"'s body at a location farther away from the lumen than the first attachment element;

placing a tensioning element between the first attachment element and the second attachment element said tensioning element being under sufficient tension to decompress the lumen;

wherein the lumen within the body comprises the lumen of the urethra and the first attachment element, second attachment element and tensioning element are placed so as to modify forces exerted on the urethra.

291. A system for treating a condition where a prostate tissue or anatomical structure causes constriction or interferes with an adjacent tissue or anatomical structure in the body of a human or animal subject, said system comprising:

a first anchor;

a second anchor; and

a tensioning member that extends between the first and second anchors.

292. A system according to claim 291 wherein at least one of the first and second anchors comprises a crumpling anchor.

293. A system according to claim 291 wherein at least one of the first and second anchors comprises T shaped anchor.

294. A system according to claim 291 wherein at least one of the first and second anchors comprises a bow shaped anchor.

295. A system according to claim 291 wherein at least one of the first and second anchors comprises a cross shaped anchor.

296. A system according to claim 291 wherein at least one of the first and second anchors comprises a woven fabric, screen, textile, paper or other porous material.

297. A system according to claim 291 wherein at least one of the first and second anchors comprises an adhesive.

298. A system according to claim 291 wherein at least one of the first and second anchors comprises a plurality of arms extending outwardly from a central hub.

299. A system according to claim 291 wherein at least one of the first and second anchors comprises a spiral anchor.

300. A system according to claim 291 wherein at least one of the first and second anchors is configured to generally conform to the shape of an anatomical structure against which it is intended to rest.

301. A system according to claim 291 wherein at least one of the first and second anchors comprises a screw.

302. A system according to claim 291 wherein at least one of the first and second anchors comprises a plurality of splayable members.

303. A system according to claim 291 wherein at least one of the first and second anchors comprises a molly bolt anchor.

304. A system according to claim 291 wherein at least one of the first and second anchors is constructed to receive a trocar during insertion of the anchor.

316. A method for treating a prostate, comprising:

passing an anchor through a prostate in a first orientation; and

releasing the anchor to a second orientation for retention in anatomy adjacent the prostate.

317. A method for treating a prostate involving an anchor delivery device including a needle assembly and at least one anchor assembly including a connector attached to an anchor, comprising:

placing the needle assembly at an interventional site;

advancing the anchor assembly through the needle assembly by applying a force on the connector; and

deploying the anchor assembly at the interventional site.