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

• US 20090192439A1
• Filed: 08/13/2007
• Published: 07/30/2009
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Exploramed Nc2, Inc., 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
• Granted Patent: US 7,914,542 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• 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

1-84. -84. (canceled)

85. 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; and

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.

86. A method according to claim 85 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.

87. A method according to claim 86 further comprising the step of using the scope to view at least a portion of the performance of the method.

88. A method according to claim 85 wherein the introducer inserted in Step A comprises a scope and a working lumen and wherein the cutting device is advanced through the working lumen and the scope is used to view at least a portion of the performance of the method.

89. A method according to claim 85 wherein Step A comprises inserting the introducer percutaneously through the abdominal wall.

90. A method according to claim 85 wherein Step A comprises inserting the introducer percutaneously through the perineum.

91. A method according to claim 85 wherein Step A comprises inserting the introducer percutaneously through the abdominal wall, through the wall of the urinary bladder and to a position within the urinary bladder.

92. A method according to claim 85 wherein Step A comprises inserting the introducer into the urethra and advancing it to a position within the urethra where the urethra is substantially surrounded by the prostate gland.

93. A method according to claim 85 wherein Step A comprises inserting the introducer into the urethra and advancing the introducer to a position within the urethra distal to the prostate gland.

96. A method according to claim 85 wherein Step A comprises inserting the introducer into the rectum and wherein the method further comprises advancing either the introducer or the cutting device through an opening formed in the rectal wall.

97. A method according to claim 96 wherein the method further comprises closing the opening formed in the rectal wall.

98. A method according to claim 85 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.

99. A method according to claim 98 wherein the opening formed in the wall of the urethra is no greater than 2 mm in its greatest cross-dimension.

100. A method according to claim 98 further comprising the step of closing the opening formed in the urethra.

101. A method according to claim 85 wherein Step B comprises advancing the cutting device into the prostate gland.

102. A method according to claim 85 wherein Step B comprises advancing the cutting device through the prostate gland.

103. A method according to claim 85 wherein Step B comprises advancing the cutting device to a position adjacent to the outer surface of the prostate capsule.

104. A method according to claim 85 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.

105. A method according to claim 104 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.

106. A method according to claim 104 further comprising the step of anchoring the guide.

107. A method according to claim 106 wherein the step of anchoring the guide comprises anchoring a distal portion of the guide.

108. A method according to claim 106 wherein the guide is advanced through the prostate into the urinary bladder and wherein the guide is anchored in a way that deters a distal portion of the guide from being pulled out of the urinary bladder.

109. A method according to claim 85 wherein Step C comprises using the cutting device to form a subcapsular cut within the prostate gland.

110. A method according to claim 85 wherein Step C comprises using the cutting device to form a cut through the capsule of the prostate gland.

111. A method according to claim 85 wherein Step C comprises using the cutting device to form a cut that extends through subcapsular prostate tissue and through the capsule of the prostate gland.

112. A method according to claim 85 wherein Step C comprises forming a cut between the lobes of the prostate gland such that the lobes separate from one another.

113. A method according to claim 85 further comprising administering a local, regional or general anesthetic to the subject.

114. A method according to claim 113 wherein a local anesthetic is injected into the prostate before performance of Step C.

115. A method according to claim 85 wherein the cutting device comprises an elongate shaft and a cutting element that is deployable from the shaft.

116. A method according to claim 115 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.

117. A method according to claim 116 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.

118. A method according to claim 117 wherein:

Step A comprises inserting the introducer into the urethra;

Step B comprises advancing the cutting device through the wall of the urethra while the cutting member in its non cutting configuration; and

Step C comprises causing the cutting member to bow outwardly thereby forming a cut in the prostate gland.

119. A method according to claim 118 wherein Step B further comprises advancing a guide from the introducer, through the wall of the urethra and into the prostate gland and thereafter advancing the cutting member in its non cutting configuration.

120. A method according to claim 115 wherein Step C comprises causing the cutting member to emit energy to facilitate formation of said cut.

121. A method according to claim 120 wherein the cutting member is caused to emit radiofrequency energy.

122. A method according to claim 85 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.

123. A method according to claim 122 wherein the step of maintaining separation of opposing surface of the cut for at least a period of time after formation of the cut comprises implanting space occupying matter within the cut.

124. A method according to claim 123 wherein the space occupying matter is substantially resorbable.

125. A method according to claim 124 wherein the space occupying matter comprises is not substantially resorbable.

126. A method according to claim 122 wherein the step of maintaining separation of opposing surface of the cut for at least a period of time after formation of the cut comprises implanting a device within the cut.

127. A method according to claim 123 wherein the device implanted within the cut is substantially resorbable.

128. A method according to claim 124 wherein the device implanted within the cut is not substantially resorbable.

129. A method according to claim 85 further comprising the step of delivering a therapeutic substance to a location within or near the prostate gland.

130. A method according to claim 129 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.

131. A method according to claim 129 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.

132. A method according to claim 129 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.

133. A method according to claim 132 wherein the substance eluting implant comprises a substance eluting device.

134. A method according to claim 132 wherein the substance eluting implant comprises a substance eluting material.

135. A method according to claim 132 wherein the substance eluting implant is positioned within the cut.

136. A method according to claim 135 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.

137. A method according to claim 85 further comprising the step of:

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

138. A method according to claim 137 wherein a coagulative lesion is formed by heating the tissue.

139. A method according to claim 138 wherein the coagulative lesion subsequently becomes resorbed thereby causing the tissue to shrink.

140. A method according to claim 85 further comprising the step of implanting at least one tissue compressing device to compresses the prostate in a manner that lessens constriction of the urethra.

141. A method according to claim 140 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.

248. A method according to claim 85 wherein Step C comprises using the cutting device to form a cut within the capsule of the prostate gland.

94. A method according to 85 wherein Step A comprises inserting the introducer into the urethra and advancing the introducer into the urinary bladder.

95. A method according to 85 wherein Step A comprises percutaneously inserting the introducer through the abdominal wall and though an opening formed in a bone of the pelvis.

142-244. -244. (canceled)

245. A device for forming a cut in the prostate gland of a human or animal subject, said device comprising:

an elongate shaft that is positionable within or near the prostate gland;

a cutting member disposed on or in the shaft;

said cutting member being initially disposable in a non-cutting position wherein it is substantially parallel to a longitudinal axis of the shaft and, thereafter, said cutting member being bowable outwardly from the shaft such that it advances through prostate tissue thereby cutting the prostate tissue.

246. A device according to claim 245 wherein the cutting member emits energy to facilitate formation of said cut.

247. A device according to claim 246 wherein the cutting member emits radiofrequency energy.