U.S. patent application number 12/253821 was filed with the patent office on 2009-03-05 for devices, systems and methods for treating benign prostatic hyperplasia and other conditions.
This patent application is currently assigned to Neotract, INC.. Invention is credited to Joseph Catanese, III, Michael Collinson, Theodore Charles Lamson, Joshua Makower, Russell J. Redmond, Claude Vidal, Amrish Jayprakash Walke, Jacqueline Nerney Welch.
Application Number | 20090060977 12/253821 |
Document ID | / |
Family ID | 37449345 |
Filed Date | 2009-03-05 |
United States Patent
Application |
20090060977 |
Kind Code |
A1 |
Lamson; Theodore Charles ;
et al. |
March 5, 2009 |
DEVICES, SYSTEMS AND METHODS FOR TREATING BENIGN PROSTATIC
HYPERPLASIA AND OTHER CONDITIONS
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).
Inventors: |
Lamson; Theodore Charles;
(Pleasanton, CA) ; Makower; Joshua; (Los Altos,
CA) ; Catanese, III; Joseph; (San Leandro, CA)
; Welch; Jacqueline Nerney; (Pacifica, CA) ;
Walke; Amrish Jayprakash; (Santa Clara, CA) ; Vidal;
Claude; (Santa Barbara, CA) ; Redmond; Russell
J.; (Goleta, CA) ; Collinson; Michael;
(Goleta, CA) |
Correspondence
Address: |
STEPTOE & JOHNSON - NEOTRACT
2121 AVENUE OF THE STARS, SUITE 2800
LOS ANGELES
CA
90067
US
|
Assignee: |
Neotract, INC.
Pleasanton
CA
|
Family ID: |
37449345 |
Appl. No.: |
12/253821 |
Filed: |
October 17, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11134870 |
May 20, 2005 |
|
|
|
12253821 |
|
|
|
|
Current U.S.
Class: |
424/423 ;
128/898; 424/94.64; 424/94.67; 514/304; 514/330; 514/396; 514/54;
514/626; 514/646; 514/653; 604/22; 606/191; 606/49 |
Current CPC
Class: |
A61B 17/0487 20130101;
A61B 17/00234 20130101; A61B 2017/0456 20130101; A61B 2017/0458
20130101; A61B 17/0467 20130101; A61B 2017/0417 20130101; A61B
17/42 20130101; A61B 2017/0451 20130101; A61B 2017/00805 20130101;
A61B 2017/00022 20130101; A61B 2017/00796 20130101; A61B 2017/0464
20130101; A61B 17/0401 20130101; A61B 2017/00274 20130101; A61B
17/0482 20130101; A61B 2017/0462 20130101; A61B 17/3468 20130101;
A61B 17/3478 20130101; A61B 2017/0419 20130101; A61B 2017/0409
20130101; A61B 2017/06176 20130101; A61B 2018/00547 20130101; A61B
17/0469 20130101; A61B 2017/0454 20130101; A61F 2/82 20130101; A61B
17/0218 20130101; A61B 17/06109 20130101; A61B 2017/00792 20130101;
A61B 2017/0488 20130101; A61B 2017/06052 20130101; A61B 2017/0404
20130101; A61F 2002/041 20130101 |
Class at
Publication: |
424/423 ;
514/646; 514/396; 514/653; 514/304; 514/626; 514/330; 424/94.67;
424/94.64; 514/54; 128/898; 604/22; 606/191; 606/49 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61K 31/137 20060101 A61K031/137; A61K 31/4164 20060101
A61K031/4164; A61K 31/46 20060101 A61K031/46; A61K 31/167 20060101
A61K031/167; A61K 31/445 20060101 A61K031/445; A61K 38/48 20060101
A61K038/48; A61K 31/728 20060101 A61K031/728; A61M 37/00 20060101
A61M037/00; A61M 29/00 20060101 A61M029/00; A61B 18/14 20060101
A61B018/14 |
Claims
1-249. (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.
305. A system according to claim 191 wherein at least one of the
first and second anchors comprises a device that is a) implantable
in tissue before it is connected to the tensioning member and b) is
configured to facilitate connection of the tensioning member
thereto after it has been implanted in tissue.
306. A system according to claim 191 wherein at least one of the
first and second anchors comprises a spring.
307. A system according to claim 191 wherein at least one of the
first and second anchors comprises a screw.
308. A system according to claim 191 wherein the tensioning member
comprises an elongate member having at least one toothed
surface.
309. A system according to claim 191 wherein the tensioning member
comprises a helical member.
310. A system according to claim 191 wherein the tensioning member
comprises a telescoping member.
311. A system according to claim 191 wherein the tensioning member
comprises a first elongate portion, a second elongate portion and a
connecting body, the first elongate portion being connected to and
extending from the connecting body in a first direction and the
second elongate portion being connected to and extending from the
connecting body in a second direction.
312. A system according to claim 191 wherein the tensioning member
is capable of being shortened after at least one of the anchors has
been implanted.
313. A system according to claim 191 further comprising apparatus
for placing the tensioning member under a desired amount of
tension.
314. A system according to claim 191 further comprising a delivery
device for delivering the system into the subject's body wherein
the delivery device comprises an elongate member having a lumen and
wherein the system is initially disposed within the lumen of the
elongate member and wherein the system is expellable out of the
lumen of the elongate member.
315. A system according to claim 314 wherein the delivery device is
attached to at least one of said first anchor, second anchor and
tensioning member and wherein the system further comprises
apparatus for severing that attachment.
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.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to medical devices
and methods and more particularly to devices, systems and methods
for treating conditions wherein a tissue (e.g., the prostate gland)
has a) become enlarged and/or b) undergone a change in form,
position, structure, rigidity or force exertion with respect to
another anatomical structure and/or c) has begun to impinge upon or
compress an adjacent anatomical structure (e.g., the urethra).
BACKGROUND OF THE INVENTION
[0002] There are numerous pathological and nonpathological
conditions in which a tissue (e.g., a gland, tumor, cyst, muscle,
fascia, skin, adipose, mucous membrane, etc.) becomes enlarged,
changed form or position and/or causes unwanted impingement,
obstruction, occlusion, stretching, sagging, caving, expulsion
and/or collapse of an adjacent body lumen or anatomical structure
(e.g., the urethra). Examples of specific conditions which
illustrate these medical problems include tissue relaxation or
collapse (loose skin, fat or muscle folds, vaginal, rectal, or
bladder prolapse, incontinence, etc.), tissue remodeling (scar
formation, bladder stiffness secondary to chronic overexertion,
infiltrative lung disease), traumatic injury, surgical manipulation
(i.e. removal of supportive tissues, removal of tumors,
reattachment of ligaments, etc.), tissue growth or enlargement
(i.e. benign growths, cancers, angiomas, bone spurs, etc.), luminal
obstruction or occlusion (coronary artery disease, peripheral
vascular disease, stroke, non-communicating hydrocephalus,
infertility secondary to non-patent fallopian tubes, urinary tract
obstruction, etc.), tissue impingement (slipped spinal disks,
degenerative joint disease, etc.), and ptosis.
[0003] In particular, Benign Prostatic Hyperplasia (BPH) is one of
the most common medical conditions that affect men, especially
elderly men. It has been reported that, in the United Sates, more
than half of all men have histopathologic evidence of BPH by age 60
and, by age 85, approximately 9 out of 10 men suffer from the
condition. Moreover, the incidence and prevalence of BPH are
expected to increase as the average age of the population in
developed countries increases.
[0004] The prostate gland enlarges throughout a man's life. In some
men, the prostatic capsule around the prostate gland may prevent
the prostate gland from enlarging further. This causes the inner
region of the prostate gland to squeeze the urethra. This
compression of the urethra increases resistance to urine flow
through the region of the urethra enclosed by the prostate. Thus
the urinary bladder has to exert more pressure to force urine
through the increased resistance of the urethra. Chronic
over-exertion causes the muscular walls of the urinary bladder to
remodel and become stiffer. This combination of increased urethral
resistance to urine flow and stiffness and hypertrophy of urinary
bladder walls leads to a variety of lower urinary tract symptoms
(LUTS) that may severely reduce the patient's quality of life.
These symptoms include weak or intermittent urine flow while
urinating, straining when urinating, hesitation before urine flow
starts, feeling that the bladder has not emptied completely even
after urination, dribbling at the end of urination or leakage
afterward, increased frequency of urination particularly at night,
urgent need to urinate etc.
[0005] In addition to patients with BPH, LUTS may also be present
in patients with prostate cancer, prostate infections, and chronic
use of certain medications (e.g. ephedrine, pseudoephedrine,
phenylpropanolamine, antihistamines such as diphenhydramine,
chlorpheniramine etc.) that cause urinary retention especially in
men with prostate enlargement.
[0006] Although BPH is rarely life threatening, it can lead to
numerous clinical conditions including urinary retention, renal
insufficiency, recurrent urinary tract infection, incontinence,
hematuria, and bladder stones.
[0007] In developed countries, a large percentage of the patient
population undergoes treatment for BPH symptoms. It has been
estimated that by the age of 80 years, approximately 25% of the
male population of the United States will have undergone some form
of BPH treatment. At present, the available treatment options for
BPH include watchful waiting, medications (phytotherapy and
prescription medications), surgery and minimally invasive
procedures.
[0008] For patients who choose the watchful waiting option, no
immediate treatment is provided to the patient, but the patient
undergoes regular exams to monitor progression of the disease. This
is usually done on patients that have minimal symptoms that are not
especially bothersome.
[0009] Medications for treating BPH symptoms include phytotherapy
and prescription medications. In phytotherapy, plant products such
as Saw Palmetto, African Pygeum, Serenoa repens (sago palm) and
South African star grass are administered to the patient.
Prescription medications are prescribed as first line therapy in
patients with symptoms that are interfering with their daily
activities. Two main classes of prescription medications are
alpha-1a-adrenergic receptors blockers and 5-alpha-reductase
inhibitors. Alpha-1a-adrenergic receptors blockers block that
activity of alpha-1a-adrenergic receptors that are responsible for
causing constriction of smooth muscle cells in the prostate. Thus,
blocking the activity of alpha-1a-adrenergic receptors causes
prostatic smooth muscle relaxation. This in turn reduces urethral
resistance thereby reducing the severity of the symptoms.
5-alpha-reductase inhibitors block the conversion of testosterone
to dihydrotestosterone. Dihydrotestosterone causes growth of
epithelial cells in the prostate gland. Thus 5-alpha-reductase
inhibitors cause regression of epithelial cells in the prostate
gland and hence reduce the volume of the prostate gland which in
turn reduces the severity of the symptoms.
[0010] Surgical procedures for treating BPH symptoms include
Transurethal Resection of Prostate (TURP), Transurethral
Electrovaporization of Prostate (TVP), Transurethral Incision of
the Prostate (TUIP), Laser Prostatectomy and Open
Prostatectomy.
[0011] Transurethal Resection of Prostate (TURP) is the most
commonly practiced surgical procedure implemented for the treatment
of BPH. In this procedure, prostatic urethral obstruction is
reduced by removing most of the prostatic urethra and a sizeable
volume of the surrounding prostate gland. This is carried out under
general or spinal anesthesia. In this procedure, a urologist
visualizes the urethra by inserting a resectoscope, that houses an
optical lens in communication with a video camera, into the urethra
such that the distal region of the resectoscope is in the region of
the urethra surrounded by the prostate gland. The distal region of
the resectoscope consists of an electric cutting loop that can cut
prostatic tissue when an electric current is applied to the device.
An electric return pad is placed on the patient to close the
cutting circuit. The electric cutting loop is used to scrape away
tissue from the inside of the prostate gland. The tissue that is
scraped away is flushed out of the urinary system using an
irrigation fluid. Using a coagulation energy setting, the loop is
also used to cauterize transected vessels during the operation.
[0012] Another example of a surgical procedure for treating BPH
symptoms is Transurethral Electrovaporization of the Prostate
(TVP). In this procedure, a part of prostatic tissue squeezing the
urethra is desiccated or vaporized. This is carried out under
general or spinal anesthesia. In this procedure, a resectoscope is
inserted transurethrally such that the distal region of the
resectoscope is in the region of the urethra surrounded by the
prostate gland. The distal region of the resectoscope consists of a
rollerball or a grooved roller electrode. A controlled amount of
electric current is passed through the electrode. The surrounding
tissue is rapidly heated up and vaporized to create a vaporized
space. Thus the region of urethra that is blocked by the
surrounding prostate gland is opened up.
[0013] Another example of a surgical procedure for treating BPH
symptoms is Transurethral Incision of the Prostate (TUIP). In this
procedure, the resistance to urine flow is reduced by making one or
more incisions in the prostrate gland in the region where the
urethra meets the urinary bladder. This procedure is performed
under general or spinal anesthesia. In this procedure, one or more
incisions are made in the muscle of the bladder neck, which is the
region where the urethra meets the urinary bladder. The incisions
are in most cases are deep enough to cut the surrounding prostate
gland tissue including the prostatic capsule. This releases any
compression on the bladder neck and causes the bladder neck to
spring apart. The incisions can be made using a resectoscope, laser
beam etc.
[0014] Another example of a surgical procedure for treating BPH
symptoms is Laser Prostatectomy. Two common techniques used for
Laser Prostatectomy are Visual Laser Ablation of the Prostate
(VLAP) and the Holmium Laser Resection/Enucleation of the Prostate
(HoLEP). In VLAP, a neodymium:yttrium-aluminum-garnet (Nd:YAG)
laser is used to ablate tissue by causing coagulation necrosis. The
procedure is performed under visual guidance. In HoLEP, a holmium:
Yttrium-aluminum-garnet laser is used for direct contact ablation
of tissue. Both these techniques are used to remove tissue
obstructing the urethral passage to reduce the severity of BPH
symptoms.
[0015] Another example of a surgical procedure for treating BPH
symptoms is Photoselective Vaporization of the Prostate (PVP). In
this procedure, laser energy is used to vaporize prostatic tissue
to relieve obstruction to urine flow in the urethra. The type of
laser used is the Potassium-Titanyl-Phosphate (KTP) laser. The
wavelength of this laser is highly absorbed by oxyhemoglobin. This
laser vaporizes cellular water and hence is used to remove tissue
that is obstructing the urethra.
[0016] Another example of a surgical procedure for treating BPH
symptoms is Open Prostatectomy. In this procedure, the prostate
gland is surgically removed by an open surgery. This is done under
general anesthesia. The prostate gland is removed through an
incision in the lower abdomen or the perineum. The procedure is
used mostly in patients that have a large (greater than
approximately 100 grams) prostate gland.
[0017] Minimally invasive procedures for treating BPH symptoms
include Transurethral Microwave Thermotherapy (TUMT), Transurethral
Needle Ablation (TUNA), Interstitial Laser Coagulation (ILC), and
Prostatic Stents.
[0018] In Transurethral Microwave Thermotherapy (TUMT), microwave
energy is used to generate heat that destroys hyperplastic prostate
tissue. This procedure is performed under local anesthesia. In this
procedure, a microwave antenna is inserted in the urethra. A rectal
thermosensing unit is inserted into the rectum to measure rectal
temperature. Rectal temperature measurements are used to prevent
overheating of the anatomical region. The microwave antenna is then
used to deliver microwaves to lateral lobes of the prostate gland.
The microwaves are absorbed as they pass through prostate tissue.
This generates heat which in turn destroys the prostate tissue. The
destruction of prostate tissue reduces the degree of squeezing of
the urethra by the prostate gland thus reducing the severity of BPH
symptoms.
[0019] Another example of a minimally invasive procedure for
treating BPH symptoms is Transurethral Needle Ablation (TUNA). In
this procedure, heat induced coagulation necrosis of prostate
tissue regions causes the prostate gland to shrink. It is performed
using local anesthetic and intravenous or oral sedation. In this
procedure, a delivery catheter is inserted into the urethra. The
delivery catheter comprises two radiofrequency needles that emerge
at an angle of 90 degrees from the delivery catheter. The two
radiofrequency needles are aligned are at an angle of 40 degrees to
each other so that they penetrate the lateral lobes of the
prostate. A radiofrequency current is delivered through the
radiofrequency needles to heat the tissue of the lateral lobes to
70-100 degree Celsius at a radiofrequency power of approximately
456 KHz for approximately 4 minutes per lesion. This creates
coagulation defects in the lateral lobes. The coagulation defects
cause shrinkage of prostatic tissue which in turn reduces the
degree of squeezing of the urethra by the prostate gland thus
reducing the severity of BPH symptoms.
[0020] Another example of a minimally invasive procedure for
treating BPH symptoms is Interstitial Laser Coagulation (ILC). In
this procedure, laser induced necrosis of prostate tissue regions
causes the prostate gland to shrink. It is performed using regional
anesthesia, spinal or epidural anesthesia or local anesthesia
(periprostatic block). In this procedure, a cystoscope sheath is
inserted into the urethra and the region of the urethra surrounded
by the prostate gland is inspected. A laser fiber is inserted into
the urethra. The laser fiber has a sharp distal tip to facilitate
the penetration of the laser scope into prostatic tissue. The
distal tip of the laser fiber has a distal-diffusing region that
distributes laser energy 360.degree. along the terminal 3 mm of the
laser fiber. The distal tip is inserted into the middle lobe of the
prostate gland and laser energy is delivered through the distal tip
for a desired time. This heats the middle lobe and causes laser
induced necrosis of the tissue around the distal tip. Thereafter,
the distal tip is withdrawn from the middle lobe. The same
procedure of inserting the distal tip into a lobe and delivering
laser energy is repeated with the lateral lobes. This causes tissue
necrosis in several regions of the prostate gland which in turn
causes the prostate gland to shrink. Shrinkage of the prostate
gland reduces the degree of squeezing of the urethra by the
prostate thus reducing the severity of BPH symptoms.
[0021] Another example of a minimally invasive procedure for
treating BPH symptoms is implanting Prostatic Stents. In this
procedure, the region of urethra surrounded by the prostate is
mechanically supported to reduce the constriction caused by an
enlarged prostate. Prostatic stents are flexible devices that are
expanded after their insertion in the urethra. They mechanically
support the urethra by pushing the obstructing prostatic tissue
away from the urethra. This reduces the constriction of the urethra
and improves urine flow past the prostate gland thereby reducing
the severity of BPH symptoms.
[0022] Although existing treatments provide some relief to the
patient from symptoms of BPH, they have significant disadvantages.
Alpha-1a-adrenergic receptors blockers have side effects such as
dizziness, postural hypotension, lightheadedness, asthenia and
nasal stuffiness. Retrograde ejaculation can also occur.
5-alpha-reductase inhibitors have minimal side effects, but only a
modest effect on BPH symptoms and the flow rate of urine. In
addition, anti-androgens, such as 5-alpha-reductase, require months
of therapy before LUTS improvements are observed. Surgical
treatments of BPH carry a risk of complications including erectile
dysfunction; retrograde ejaculation; urinary incontinence;
complications related to anesthesia; damage to the penis or
urethra, need for a repeat surgery etc. Even TURP, which is the
gold standard in treatment of BPH, carries a high risk of
complications. Adverse events associated with this procedure are
reported to include retrograde ejaculation (65% of patients),
post-operative irritation (15%), erectile dysfunction (10%), need
for transfusion (8%), bladder neck constriction (7%), infection
(6%), significant hematuria (6%), acute urinary retention (5%),
need for secondary procedure (5%), and incontinence (3%) Typical
recovery from TURP involves several days of inpatient hospital
treatment with an indwelling urethral catheter, followed by several
weeks in which obstructive symptoms are relieved but there is pain
or discomfort during micturition.
[0023] The reduction in the symptom score after minimally invasive
procedures is not as large as the reduction in symptom score after
TURP. Up to 25% of patients who receive these minimally invasive
procedures ultimately undergo a TURP within 2 years. The
improvement in the symptom score generally does not occur
immediately after the procedure. For example, it takes an average
of one month for a patient to notice improvement in symptoms after
TUMT and 1.5 months to notice improvement after ILC. In fact,
symptoms are typically worse for these therapies that heat or cook
tissue, because of the swelling and necrosis that occurs in the
initial weeks following the procedures. Prostatic stents often
offer more immediate relief from obstruction but are now rarely
used because of high adverse effect rates. Stents have the risk of
migration from the original implant site (up to 12.5% of patients),
encrustation (up to 27.5%), incontinence (up to 3%), and recurrent
pain and discomfort. In published studies, these adverse effects
necessitated 8% to 47% of stents to be explanted. Overgrowth of
tissue through the stent and complex stent geometries have made
their removal quite difficult and invasive.
[0024] Thus the most effective current methods of treating BPH
carry a high risk of adverse effects. These methods and devices
either require general or spinal anesthesia or have potential
adverse effects that dictate that the procedures be performed in a
surgical operating room, followed by a hospital stay for the
patient. The methods of treating BPH that carry a lower risk of
adverse effects are also associated with a lower reduction in the
symptom score. While several of these procedures can be conducted
with local analgesia in an office setting, the patient does not
experience immediate relief and in fact often experiences worse
symptoms for weeks after the procedure until the body begins to
heal. Additionally all device approaches require a urethral
catheter placed in the bladder, in some cases for weeks. In some
cases catheterization is indicated because the therapy actually
causes obstruction during a period of time post operatively, and in
other cases it is indicated because of post-operative bleeding and
potentially occlusive clot formation. While drug therapies are easy
to administer, the results are suboptimal, take significant time to
take effect, and often entail undesired side effects.
[0025] Thus there remains a need for the development of new
devices, systems and methods for treating BPH as well as other
conditions in which one tissue or anatomical structure impinges
upon or compresses another tissue or anatomical structure.
SUMMARY OF THE INVENTION
[0026] The present invention provides 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
improve patency or fluid flow through a body lumen or cavity.
Examples of body lumens through which flow may be facilitated using
the present invention include the urethra, ureter, trachea,
bronchus, bronchiole, other respiratory passageway, stomach,
duodenum, small intestine, jejunum, illium, colon, cystic duct,
hepatic duct, common bile duct, pancreatic duct, the alimentary
canal, an endocrine passageway, a lymphatic, etc. Examples of
tissues and anatomical structures that may be compressed, cut,
incised, reconfigured, remodeled, attached, repositioned,
supported, dislocated or compositionally altered by the present
invention include the prostate gland, other glands and organs,
neoplasms, benign growths, cancerous growths, tumors, cysts, other
masses, congenital deformities, structures that have become
enlarged due to hypertrophy, hyperplasia, edema, fluid build up,
fluid retention, excess fluid production, impeded fluid outflow,
etc.
[0027] In accordance with the invention there are provided devices,
systems and methods for implanting devices within the body to
compress tissue in a manner that relieves pressure exerted on or
interference with an adjacent anatomical structure. The implantable
devices useable for this purpose generally comprising anchoring
elements and tensioning elements that extend between the anchoring
elements. The anchoring elements are implanted at selected
locations and the tensioning elements then draw or pull the
anchoring elements toward one another, thereby compressing tissue
between the anchoring elements. In applications where these devices
are implanted to treat prostatic enlargement, anchoring and
tensioning element(s) are implanted and tensioned to compress or
reposition prostatic tissue thereby lessening prostate induced
constriction of the urethra. In at least some applications, this
invention may be used to treat prostatic enlargement without
causing substantial damage to the urethra (e.g., forming an opening
in the urethra no larger than about 2 mm in its greatest
cross-dimension). As used herein, the term "compress" includes not
only actual compression of the tissue but also any application of
pressure or force upon the tissue that causes the intended
therapeutic effect by reconfiguring, remodeling, repositioning or
altering the tissue.
[0028] Still further in accordance with the invention there are
provided devices, systems and methods for cutting tissue(s) of the
body in a manner that relieves pressure exerted on or interference
with an adjacent anatomical structure. In some applications of the
invention, one or more working devices may be inserted into the
body and used to incise the capsule of an encapsulated organ,
tumor, mass or other structure, thereby relieving the capsule's
constraint of the encapsulated organ, tumor, mass or other
structure and allowing the encapsulated organ, tumor, mass or other
structure to expand, herniate, evulse, splay, spread apart,
reconfigure or move in a way that results in decreased pressure on,
or decreased interference with, the adjacent anatomical structure.
In applications where the invention is used to treat prostatic
enlargement, a cutting device may be anchoring and tensioning
element(s) are implanted and tensioned to compress or reposition
prostatic tissue thereby lessening prostate induced constriction of
the urethra.
[0029] Additional and more specific aspects, elements, steps,
applications, embodiments and examples of the invention will be
understood by those of skill in the art upon reading of the
detailed description and claims set forth herebelow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1A is a sagittal sectional view of a male human body
through the lower abdomen showing the male urinary tract.
[0031] FIG. 1B is a coronal sectional view through the lower
abdomen of a human male showing a region of the male urogenital
system.
[0032] FIG. 2A is a coronal sectional view through the prostate
gland and adjacent structures showing a first trans-urethral
approach that may be used to implant tissue compression devices(s)
(e.g., clips, compression elements, anchoring elements, etc.) to
compress or modify the shape of the prostate gland.
[0033] FIG. 2B is a coronal sectional view through the prostate
gland and adjacent structures showing a second trans-urethral
approach that may be used to implant tissue compression devices(s)
(e.g., clips, compression elements, anchoring elements, etc.) to
compress or modify the shape of the prostate gland.
[0034] FIG. 2C is a coronal sectional view through the prostate
gland and adjacent structures showing a third trans-urethral
approach that may be used to implant tissue compression devices(s)
(e.g., clips, compression elements, anchoring elements, etc.) to
compress or modify the shape of the prostate gland.
[0035] FIG. 2D is a coronal sectional view through the prostate
gland and adjacent structures showing a transperineal approach that
may be used to implant tissue compression devices(s) (e.g., clips,
compression elements, anchoring elements, etc.) to compress or
modify the shape of the prostate gland.
[0036] FIG. 2E is a coronal sectional view through the prostate
gland and adjacent structures showing a percutaneous approach that
may be used to implant tissue compression devices(s) (e.g., clips,
compression elements, anchoring elements, etc.) to compress or
modify the shape of the prostate gland.
[0037] FIG. 2F is a coronal sectional view through the prostate
gland and adjacent structures showing a percutaneous trans-osseus
approach that may be used to implant tissue compression devices(s)
(e.g., clips, compression elements, anchoring elements, etc.) to
compress or modify the shape of the prostate gland.
[0038] FIG. 2G is a coronal sectional view through the prostate
gland and adjacent structures showing a percutaneous suprapubic
approach that may be used to implant tissue compression devices(s)
(e.g., clips, compression elements, anchoring elements, etc.) to
compress or modify the shape of the prostate gland.
[0039] FIG. 2H is a sagittal sectional view through the prostate
gland and adjacent structures showing a percutaneous infrapubic
approach that may be used to implant tissue compression devices(s)
(e.g., clips, compression elements, anchoring elements, etc.) to
compress or modify the shape of the prostate gland.
[0040] FIG. 2I is a sagittal sectional view through the prostate
gland and adjacent structures showing a trans-rectal approach that
may be used to implant tissue compression devices(s) (e.g., clips,
compression elements, anchoring elements, etc.) to compress or
modify the shape of the prostate gland.
[0041] FIGS. 3A to 3H show various components of a system for
treating prostate gland disorders by compressing a region of the
prostate gland.
[0042] FIG. 3A shows the perspective view of an introducer
device.
[0043] FIG. 3B shows a perspective view of an injecting needle that
may be used for injecting one or more diagnostic or therapeutic
agents in the anatomy.
[0044] FIG. 3C shows a perspective view of an introducing
sheath.
[0045] FIG. 3D shows a perspective view of a trocar.
[0046] FIG. 3E shows a perspective view of an anchor delivery
device.
[0047] FIG. 3F shows an enlarged view of the distal region of the
device in FIG. 3E.
[0048] FIG. 3G shows a perspective view of deployed anchors showing
radially expanded splayable arms of proximal anchor and distal
anchor.
[0049] FIG. 3H shows a perspective view from the proximal direction
of a particular embodiment of the attachment mechanism of FIG.
99E.
[0050] FIGS. 4A through 4H show a coronal section through the
prostate gland showing the various steps of a method of treating
prostate gland disorders by compressing a region of the prostate
gland using the kit shown in FIGS. 3A through 3H.
[0051] FIGS. 4G' through 4H' show the final steps of an embodiment
of method of treating prostate gland disorders by deploying a
proximal anchor in the urethra.
[0052] FIG. 4H'' shows a coronal section through the prostate gland
showing a final deployed configuration of an embodiment of bone
anchoring devices for treating prostate gland disorders by
compressing a region of the prostate gland.
[0053] FIGS. 4I and 4J is a crossectional view through the
prostatic urethra (i.e., the portion of the urethra that passes
through the prostate gland) showing the appearance of the urethral
lumen before and after performing the method shown in FIGS. 4A
through 4H.
[0054] FIGS. 5A through 5I show perspective views of some designs
of the tension elements that can be used in the embodiments
disclosed elsewhere in this patent application.
[0055] FIG. 5A shows a perspective view of a tension element
comprising a single strand of an untwisted material.
[0056] FIG. 5B shows a perspective view of a tension element
comprising one or more serrations or notches.
[0057] FIG. 5C shows a perspective view of a tension element
comprising multiple filaments of a material twisted together.
[0058] FIG. 5D shows a perspective view of a tension element
comprising a flexible, elastic, spiral or spring element.
[0059] FIG. 5E shows a perspective view of a tension element
comprising a screw threading on the outer surface of tension
element.
[0060] FIG. 5F shows a perspective view of a tension element
comprising a hollow shaft comprising one or more collapsible
regions.
[0061] FIG. 5G shows a perspective view of an anchoring device 522
comprising a tension element and two anchors.
[0062] FIG. 5H shows a perspective view of a tensioning element
device comprising a detachable region.
[0063] FIG. 5I shows a perspective view of a tensioning element
comprising telescoping tubes.
[0064] FIGS. 6A through 11B show various examples of anchor designs
and/or anchoring device designs.
[0065] FIGS. 6A and 6B show perspective views of two states of a
crumpling anchor.
[0066] FIGS. 7A and 7B show sectional views of an undeployed
configuration and a deployed configuration respectively of a
deployable anchor.
[0067] FIGS. 8A and 8B show sectional views of an undeployed
configuration and a deployed configuration respectively of a "T"
shaped deployable anchor.
[0068] FIGS. 9A through 9D show various alternate configurations of
the anchoring arms in FIGS. 7A and 7B.
[0069] FIGS. 10A and 10A' show a distal view and a perspective view
respectively of an anchor comprising a spiral element having a
three dimensional shape.
[0070] FIGS. 10B and 10B' show a distal view and a side view
respectively of an anchor comprising a spiral element having a two
dimensional shape.
[0071] FIGS. 10C and 10C' show a distal view and a perspective view
respectively of an anchor comprising one or more circular
elements.
[0072] FIG. 10D shows a perspective view of an embodiment of an
anchoring device comprising an outer ring.
[0073] FIG. 10E shows a partial perspective view of an anchoring
device comprising a hemostatic element.
[0074] FIG. 11A shows a perspective view of a device having a set
of anchors comprising a curved sheet.
[0075] FIG. 11B shows a perspective view of a device having a
detachable region located on a tensioning element.
[0076] FIGS. 12A through 17I show further examples of anchor
designs and/or anchoring device designs. FIG. 12A shows a
perspective view of an anchor comprising an arrowhead.
[0077] FIG. 12B shows a crossectional view of an anchor comprising
a cup-shaped element that encloses a cavity.
[0078] FIG. 12C shows a perspective view of an anchor comprising a
screw.
[0079] FIGS. 13A and 13B show perspective views of an uncollapsed
state and a collapsed state respectively of an anchor comprising a
collapsible region.
[0080] FIGS. 13C and 13D show perspective views of an undeployed
state and a deployed state respectively of an anchor comprising
radially spreading arms.
[0081] FIG. 13E shows perspective views of an alternate embodiment
of an undeployed state of an anchor comprising radially spreading
arms.
[0082] FIGS. 14A and 14B show perspective views of anchoring
devices comprising an adhesive delivering element.
[0083] FIGS. 15A and 15B show two configurations of an anchoring
device comprising a ratcheted tension element.
[0084] FIG. 16 shows a perspective view of an anchor comprising a
trocar lumen.
[0085] FIG. 17A shows a perspective view in the undeployed state of
an anchor comprising a rigid or partially flexible T element and a
crumpling element.
[0086] FIGS. 17B and 17C show various steps of a method to deploy
the anchoring device shown in FIG. 17A.
[0087] FIGS. 17D and 17E show perspective views of an undeployed
and deployed configuration of an anchor comprising a rigid or
partially flexible T element with one or more openings or
perforations.
[0088] FIGS. 17F and 17G show perspective views of an undeployed
and deployed configuration of an anchor comprising a stent.
[0089] FIGS. 17H and 17I show perspective views of an undeployed
and deployed configuration of an anchor comprising a spring.
[0090] FIGS. 18A through 22E show various embodiments of mechanisms
to deploy one or more anchors. FIGS. 18A and 18B show a crossection
of an anchor deploying mechanism comprising a screw system.
[0091] FIGS. 19A and 19B show a crossectional view of an anchor
deploying system comprising an electrolytic detachment element.
[0092] FIG. 20 shows a perspective view of an anchor deploying
system comprising a looped ribbon.
[0093] FIG. 21A shows a crossectional view of an anchor deploying
system comprising a locked ball.
[0094] FIGS. 21B and 21C show a method of deploying an anchor
comprising a locked ball.
[0095] FIGS. 22A through 22C show various views of an anchor
deploying system comprising two interlocking cylinders.
[0096] FIGS. 22D and 22E show the steps of a method of unlocking
the two interlocking cylinders from the anchor deploying systems of
FIGS. 22A through 22C.
[0097] FIG. 23A shows a perspective view of a distal end of an
anchoring device that has an imaging modality.
[0098] FIGS. 23B through 23G show various steps of a method for
compressing an anatomical region using the anchoring device of FIG.
23A.
[0099] FIGS. 24A through 24C' show the device and various steps of
a method of compressing an anatomical region using a device with
deploying arms deployed through a trocar.
[0100] FIG. 24D shows a crossection through the deployed anchoring
device of FIG. 24A.
[0101] FIG. 25A shows a perspective view of a spring clip that can
be used to spread the anatomy.
[0102] FIGS. 25B through 25F show various steps of a method of
spreading an anatomical region or regions using the spring clip of
FIG. 25A.
[0103] FIGS. 26A and 26B show a crossectional view and a
perspective view respectively of a mechanism of cinching a tension
element or tether to an anchor.
[0104] FIGS. 26C and 26D show a partial section through a cinching
mechanism comprising a cam element.
[0105] FIG. 26E shows a sectional view of an embodiment of a
cinching mechanism comprising a locking ball.
[0106] FIG. 26F shows a side view of an embodiment of a cinching
mechanism comprising multiple locking flanges.
[0107] FIG. 26G shows an end view of body of FIG. 26F.
[0108] FIG. 26H shows a side view of an embodiment of a cinching
mechanism comprising a single locking flange.
[0109] FIG. 26I shows an end view of body of FIG. 26H.
[0110] FIG. 26J shows an end view of a cinching mechanism
comprising a crimping lumen.
[0111] FIGS. 26K and 26L show crossections of an embodiment of a
cinching mechanism comprising a crimping anchor in the undeployed
and deployed configurations respectively.
[0112] FIG. 26M shows a perspective view of an embodiment of a
cinching mechanism comprising an element providing a tortuous path
to a tension element.
[0113] FIG. 26N shows a crossectional view of an embodiment of a
locking mechanism comprising a space occupying anchor securely
attached to a tension element.
[0114] FIGS. 26O and 26P shows a partial sectional view and a
perspective view of an embodiment of a cinching mechanism
comprising a punched disk.
[0115] FIGS. 26Q and 26R show a perspective view of a first
embodiment of a cutting device before and after cutting an elongate
element.
[0116] FIG. 26S show a crossectional view of a second embodiment of
a cutting device for cutting an elongate element.
[0117] FIGS. 27A through 27D show axial sections through the
prostate gland showing various configurations of anchoring devices
comprising distal anchors and a tension element.
[0118] FIGS. 28 and 28A show perspective views of an embodiment of
an anchoring device comprising an elongate element comprising
multiple barbs or anchors.
[0119] FIGS. 28B through 28E show a coronal section through the
prostate gland showing various steps of a method of treating the
prostate gland using the device of FIG. 28.
[0120] FIG. 29A shows an axial section of the prostate gland
showing a pair of implanted magnetic anchors.
[0121] FIGS. 29B through 29D show a coronal section through the
prostate gland showing the steps of a method of implanting magnetic
anchors of FIG. 29A.
[0122] FIG. 30A is a coronal sectional view of a portion of the
male urogenital system showing a transurethral approach that may be
used to perform a prostate cutting procedure of the present
invention.
[0123] FIG. 30B is a coronal sectional view of a portion of the
male urogenital system showing another transurethral approach that
may be used to perform a prostate cutting procedure of the present
invention.
[0124] FIG. 30C is a coronal sectional view of a portion of the
male urogenital system showing a transurethral/transvesicular
approach that may be used to perform a prostate cutting procedure
of the present invention.
[0125] FIG. 30D is a coronal sectional view of a portion of the
male urogenital system showing another transurethral approach that
may be used to perform a prostate cutting procedure of the present
invention, wherein a device advances from the urethra, through the
prostate gland, and thereafter accesses the prostate capsule from
its outer surface.
[0126] FIG. 31 is a coronal sectional view of a portion of the male
urogenital system showing a percutaneous/infrapubic approach that
may be used to perform a prostate cutting procedure of the present
invention.
[0127] FIG. 32 is a coronal sectional view of a portion of the male
urogenital system showing a percutaneous/transvesicular approach
that may be used to perform a prostate cutting procedure of the
present invention.
[0128] FIGS. 33A-33E shows perspective views of various devices
that may be included in a system for performing a prostate cutting
procedure in accordance with the present invention.
[0129] FIG. 33A shows a perspective view of an introducer device
comprising a first tubular element having a working device
lumen.
[0130] FIG. 33B shows a perspective view of an injecting needle
that may be used for injecting one or more diagnostic or
therapeutic substances.
[0131] FIG. 33C shows a perspective view of a guiding device
comprising an elongate body comprising a sharp distal tip.
[0132] FIG. 33D shows a perspective view of a RF cutting device
[0133] FIG. 33E shows a perspective view of an embodiment of a
plugging device to plug an opening created during a procedure.
[0134] FIGS. 33F through 33N show various alternate embodiments of
the electrosurgical cutting device in FIG. 33D.
[0135] FIGS. 33F and 33G show perspective views of the distal
region of a first alternate embodiment of an electrosurgical
cutting device in the undeployed and deployed states
respectively.
[0136] FIGS. 33H and 33I show perspective views of the distal
region of a second alternate embodiment of an electrosurgical
cutting device in the undeployed and deployed states
respectively.
[0137] FIGS. 33J through 33L show perspective views of the distal
region of a second alternate embodiment of an electrosurgical
cutting device showing the steps of deploying the electrosurgical
cutting device.
[0138] FIGS. 33M through 33N show perspective views of the distal
region of a third alternate embodiment of an electrosurgical
cutting device showing the steps of deploying the electrosurgical
cutting device.
[0139] FIG. 34 shows a perspective view of the distal region of a
balloon catheter comprising a balloon with cutting blades.
[0140] FIG. 35 shows a perspective view of the distal region of a
balloon catheter comprising a balloon with cutting wires.
[0141] FIGS. 36A and 36B series show perspective views of an
undeployed state and a deployed state respectively of a tissue
displacement device.
[0142] FIGS. 36C and 36D show a coronal view and a lateral view
respectively of a pair of deployed tissue displacement devices of
FIGS. 36A and 36B implanted in the prostate gland.
[0143] FIGS. 36E through 36H show an axial section through a
prostate gland showing the various steps of a method of cutting or
puncturing the prostate gland and lining or plugging the cut or
puncture.
[0144] FIGS. 37A through 37K show an embodiment of a method of
treating prostate gland disorders by cutting a region of the
prostate gland using the devices described in FIGS. 33A through
33E.
[0145] FIGS. 38A to 38D show various components of a kit for
treating prostate gland disorders by compressing a region of the
prostate gland.
[0146] FIG. 38A shows the perspective view of an introducer
device.
[0147] FIG. 38B shows a perspective view of a bridge device
[0148] FIG. 38C shows a perspective view of a distal anchor
deployment device
[0149] FIG. 38D shows the proximal anchor delivery tool
[0150] FIG. 38E shows a close-up perspective view of proximal
anchor 3833 mounted on proximal anchor delivery tool of FIG.
38D.
DETAILED DESCRIPTION
[0151] The following detailed description and the accompanying
drawings are intended to describe some, but not necessarily all,
examples or embodiments of the invention only and does not limit
the scope of the invention in any way.
[0152] The following detailed description and the accompanying
drawings are intended to describe some, but not necessarily all,
examples or embodiments of the invention only and does not limit
the scope of the invention in any way.
[0153] A number of the drawings in this patent application show
anatomical structures of the male reproductive and/or urinary
system. In general, these anatomical structures are labeled with
the following reference letters: [0154] Urethra UT [0155] Urethral
Lumen UL [0156] Urethral Opening UO [0157] Urinary Bladder UB
[0158] Ureters UR [0159] Prostate Gland PG [0160] Capsule of
Prostate Gland CP [0161] Testis TS [0162] Vas Deferens VD
[0163] FIG. 1A shows a sagittal section of a male human body
through the lower abdomen showing the male urinary tract. The male
urinary tract comprises a pair of tubular organs called ureters
(UR) that conduct urine produced by the kidneys. The ureters empty
into the urinary bladder. The urinary bladder is a hollow muscular
organ that temporarily stores urine. It is situated posterior to
the pubic bone. The inferior region of the urinary bladder has a
narrow muscular opening called the bladder neck which opens into a
soft, flexible, tubular organ called the urethra. The muscles
around the bladder neck are called the internal urethral sphincter.
The internal urethral sphincter is normally contracted to prevent
urine leakage. The urinary bladder gradually fills with urine until
full capacity is reached, at which point the sphincter relaxes.
This causes the bladder neck to open, thereby releasing the urine
stored in the urinary bladder into the urethra. The urethra begins
at the bladder neck, terminates at the end of the penis, and allows
for urine to exit the body.
[0164] The region of the urethra just inferior to the urinary
bladder is completely surrounded by the prostate gland. The
prostate gland is part of the male reproductive system and is
usually walnut shaped. Clinically, the prostate is divided into
lobes. The lateral lobes are located lateral to the urethra; the
middle lobe is located on the dorsal aspect of the urethra, near
the bladder neck. Most commonly in BPH, the lateral lobes become
enlarged and act like curtains to close the urethral conduit. Less
commonly, the middle lobe grows in size and becomes problematic.
Because of its superior location near the bladder neck with respect
to the urethra, an enlarged middle lobe acts like a ball valve and
occludes fluid passage.
[0165] FIG. 1B shows a coronal section through the lower abdomen of
a human male showing a region of the male urinary system. The
prostate gland (PG) is located around the urethra at the union of
the urethra and the urinary bladder.
[0166] FIGS. 2A through 2H show various alternate approaches to
deploy implantable tissue compression device(s) (e.g., one or more
clips, anchoring elements, tensioning members, etc.) to compress
the prostate gland PG, thereby relieving constriction of the
urethra. Specific examples of implantable tissue compression
device(s) (e.g., one or more clips, anchoring elements, tensioning
members, etc.) useable in this invention are shown in other figures
of this patent application and are described more fully
herebelow.
[0167] FIG. 2A shows a first trans-urethral approach that may be
used to implant tissue compression devices(s) to compress the
prostate gland PG. In FIG. 2A, an introducing device 200 is
introduced in the urethra through the urethral opening of the
penis. Introducing device 200 comprises an elongate body 202
comprising a lumen that terminates distally in a distal opening
204. One or more working device(s) 206 is/are then introduced
through distal opening 204 into the urethra. The working device(s)
206 penetrate the urethral wall and thereafter one or more lobes of
the prostate gland. In some applications of the method, working
device(s) 206 may further penetrate the prostate capsule and enters
the pelvic cavity. Working device(s) 206 are also used to deploy
and implant implantable tissue compression device(s) (e.g., one or
more clips, anchoring elements, tensioning members, etc.) to
compress the prostate gland PG, thereby relieving constriction of
the urethra.
[0168] FIG. 2B shows a second trans-urethral approach that may be
used to implant tissue compression devices(s) to compress the
prostate gland PG. In FIG. 2B, an introducing device 210 is
introduced in the urethra through the urethral opening UO of the
penis. Introducing device 210 comprises an elongate body 212
comprising a lumen that terminates distally in a distal opening
214. One or more working device(s) 216 is/are insertable through
distal opening 214 into the urethra. Working device(s) 216
penetrate(s) the urethral wall inferior to the prostate gland and
enters the pelvic cavity. Thereafter, working device(s) 216
penetrate(s) the prostate capsule CP and thereafter one or more
lobes of the prostate gland. In some applications of the method the
working device(s) 216 may further penetrate the urethral wall
enclosed by the prostate gland EG and enters the urethral lumen.
Working device(s) 216 may then be used to deploy and implant
implantable tissue compression device(s) (e.g., one or more clips,
anchoring elements, tensioning members, etc.) to compress the
prostate gland PG, thereby relieving constriction of the
urethra.
[0169] FIG. 2C shows a third trans-urethral approach that may be
used to implant tissue compression devices(s) to compress the
prostate gland PG. In FIG. 2C, an introducing device 220 is
introduced in the urethra through the urethral opening UO of the
penis. Introducing device 220 comprises an elongate body 222
comprising a lumen that terminates distally in a distal opening
224. Introducing device 220 is positioned such that distal opening
224 is located in the urinary bladder UB. Thereafter, a one or more
working device(s) 226 is/are introduced through distal opening 224
into the urinary bladder UB. Working device(s) 226 penetrate(s) the
wall of the urinary bladder UB and thereafter penetrate(s) one or
more lobes of the prostate gland PG. In some applications of the
method, the working device(s) 226 may further penetrate the
prostate capsule and enter the pelvic cavity. Working device(s) 226
may then be used to deploy and implant implantable tissue
compression device(s) (e.g., one or more clips, anchoring elements,
tensioning members, etc.) to compress the prostate gland PG,
thereby relieving constriction of the urethra.
[0170] FIG. 2D shows a transperineal approach that may be used to
implant tissue compression devices(s) to compress the prostate
gland PG. In FIG. 2D, an introducing device 230 is introduced in
the pelvic cavity percutaneously through the perineum. Introducing
device 230 comprises an elongate body 232 comprising a lumen that
terminates distally in a distal opening 234. Introducing device 230
is positioned such that distal opening 234 is located in the pelvic
cavity adjacent to prostate gland. Thereafter, one or more working
device(s) 236 is/are introduced through distal opening 234 into the
prostate gland PG. Working device(s) 236 penetrate(s) the prostate
capsule CP and thereafter penetrate(s) one or more lobes of the
prostate gland PG. In some applications of the method, the working
device(s) 236 may further penetrate the urethral wall surrounded by
the prostate gland PG and enter the urethral lumen. Working device
236 may then be used to deploy and implant implantable tissue
compression device(s) (e.g., one or more clips, anchoring elements,
tensioning members, etc.) to compress the prostate gland PG,
thereby relieving constriction of the urethra.
[0171] FIG. 2E shows a percutaneous/transvesicular approach that
may be used to implant tissue compression devices(s) to compress
the prostate gland PG. In FIG. 2E, an introducing device 240 is
introduced percutaneously through the abdominal wall. Introducing
device 240 comprises an elongate body 242 comprising a lumen that
terminates distally in a distal opening 244. After passing through
the abdominal wall, introducing device 240 is advanced through the
wall of the urinary bladder UB such that distal opening 244 is
located in the urinary bladder UB. Thereafter, one or more working
device(s) 246 is/are introduced through distal opening 244 into the
urinary bladder UB. One or more working device(s) 246 are advanced
through the wall of the urinary bladder UB and into the prostate
gland PG. In some applications of the method, working device(s) 246
may further penetrate through the prostate gland capsule and enter
the pelvic cavity. Working device(s) 246 is/are then used to deploy
and implant implantable tissue compression device(s) (e.g., one or
more clips, anchoring elements, tensioning members, etc.) to
compress the prostate gland PG, thereby relieving constriction of
the urethra.
[0172] FIG. 2F shows a percutaneous trans-osseus approach that may
be used to implant tissue compression devices(s) to compress the
prostate gland PG. In FIG. 2F, an introducing device 250 is
introduced percutaneously through the abdominal wall. Introducing
device 250 comprises an elongate body 252 comprising a lumen that
terminates distally in a distal opening 254. Introducing device 250
is used to penetrate a pelvic bone (e.g. the pubic bone PB).
Thereafter, introducing device 250 is positioned such that distal
opening 254 is located adjacent to the prostate gland PG.
Thereafter, one or more working device(s) 256 is/are introduced
through distal opening 254 into the prostate gland PG. Working
device(s) 256 penetrate the prostate capsule and thereafter
penetrate one or more lobes of the prostate gland PG. In some
applications of the method, working device(s) 256 may further
penetrate the urethral wall surrounded by the prostate gland and
enter the urethral lumen. Working device(s) 256 is/are then used to
deploy and implant implantable tissue compression device(s) (e.g.,
one or more clips, anchoring elements, tensioning members, etc.) to
compress the prostate gland PG, thereby relieving constriction of
the urethra.
[0173] FIG. 2G shows a percutaneous suprapubic approach that may be
used to implant tissue compression devices(s) to compress the
prostate gland PG. In FIG. 2G, an introducing device 260 is
introduced in the pelvic cavity percutaneously in a trajectory that
passes superior to the pubis bone. Introducing device 260 comprises
an elongate body 262 comprising a lumen that terminates distally in
a distal opening 264. Introducing device 260 is then positioned
such that distal opening 264 is located in the pelvic cavity
adjacent to prostate gland. Thereafter, one or more working
device(s) 266 is/are introduced through distal opening 264 into the
prostate gland PG. Working device(s) 266 penetrate the prostate
capsule CP and thereafter penetrate one or more lobes of the
prostate gland PG. In some applications of the method, working
device(s) 266 may further penetrate the urethral wall surrounded by
the prostate gland and enter the urethral lumen. Working device(s)
266 is/are then used to deploy and implant implantable tissue
compression device(s) (e.g., one or more clips, anchoring elements,
tensioning members, etc.) to compress the prostate gland PG,
thereby relieving constriction of the urethra. FIG. 2H shows a
percutaneous infrapubic approach that may be used to implant tissue
compression devices(s) to compress the prostate gland. In FIG. 2H,
an introducing device 270 is introduced in the pelvic cavity
percutaneously in a trajectory that passes inferior to the pubis
bone. Introducing device 270 comprises an elongate body 272
comprising a lumen that terminates distally in a distal opening
274. Introducing device 270 is introduced percutaneously in the
pelvic cavity in a trajectory that passes inferior to the pubic
bone. Introducing device 270 is then positioned such that distal
opening 274 is located in the pelvic cavity adjacent to prostate
gland. Thereafter, one or more working device(s) 276 is/are
introduced through distal opening 274 into the prostate gland PG.
Working device(s) 276 penetrate the prostate capsule CP and
thereafter penetrate one or more lobes of the prostate gland PG. In
some applications of the method, working device(s) 276 may further
penetrate the urethral wall surrounded by the prostate gland PG and
enter the urethral lumen. Working device(s) 276 is/are then used to
deploy and implant implantable tissue compression device(s) (e.g.,
one or more clips, anchoring elements, tensioning members, etc.) to
compress the prostate gland PG, thereby relieving constriction of
the urethra.
[0174] FIG. 2I shows a trans-rectal approach that may be used to
implant tissue compression devices(s) to compress the prostate
gland PG. In FIG. 2I, an introducing device 280 is introduced in
the rectum. Introducing device 280 comprises an elongate body 282
comprising a lumen that terminates distally in a distal opening
284. Introducing device is then advanced such that it penetrates
the rectal wall and enters the pelvic cavity. Introducing device
280 is then positioned such that distal opening 284 is located in
the pelvic cavity adjacent to prostate gland. Thereafter, one or
more working device(s) 286 is/are introduced through distal opening
284 into the prostate gland PG. Working device(s) 286 penetrate the
prostate capsule CP and thereafter penetrate one or more lobes of
the prostate gland. In some applications of the method, working
device(s) 286 may further penetrate the urethral wall surrounded by
the prostate gland and enter the urethral lumen. Working device(s)
286 is/are then used to deploy and implant implantable tissue
compression device(s) (e.g., one or more clips, anchoring elements,
tensioning members, etc.) to compress the prostate gland PG,
thereby relieving constriction of the urethra.
[0175] FIGS. 3A to 3F show various examples of devices and systems
that are useable to treat conditions where the prostate gland PG is
compressing a region of the urethra such that the urethra does not
expand normally during micturition and urine outflow is
impeded.
[0176] FIG. 3A shows the perspective view of an introducer device
300. Introducer device 300 comprises an outer body 301 constructed
from suitable biocompatible materials including, but not limited to
Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC,
Hytrel, HDPE, PEEK, metals like stainless steel and fluoropolymers
like PTFE, PFA, FEP, EPTFE etc. Body 301 comprises a working device
lumen 302. Distal end of working device lumen 302 emerges out of
the distal end of body 301. In one embodiment, distal end of
working device lumen 302 has a bent or curved region. Proximal end
of working device lumen 302 emerges out of a first flexible tube
304. The proximal end of first flexible tube 304 comprises a stasis
valve 306. Body 301 further comprises a cystoscope lumen 308.
Distal end of cystoscope lumen 308 emerges out of the distal end of
body 301. Proximal end of cystoscope lumen 308 emerges out of a
second flexible tube 310. The proximal end of second flexible tube
310 comprises a stasis valve 312. Cystoscope lumen 308 may comprise
one or more side ports e.g. a first side port 318 for the
introduction or removal of one or more fluids. Working device lumen
302 may comprise one or more side ports e.g. a second side port 320
for the introduction or removal of one or more fluids.
[0177] FIG. 3B shows a perspective view of an injecting needle.
Injecting needle 330 is used for injecting one or more diagnostic
or therapeutic substances. In some applications of the invention,
the injecting needle 330 may be used to inject local anesthetic in
the urethra, prostate gland and/or tissues near the prostate gland.
Specific examples of target areas for injecting local anesthetics
are the neurovascular bundles, the genitourinary diaphragm, the
region between the rectal wall and prostate, etc. Examples of local
anesthetics that can be injected by injecting needle 330 are
anesthetic solutions e.g. 1% lidocaine solution; anesthetic gels
e.g. lidocaine gels; combination of anesthetic agents e.g.
combination of lidocaine and bupivacaine; etc. Injecting needle 330
comprises a hollow shaft 332 made of suitable biocompatible
materials including, but not limited to stainless steel 304,
stainless steel 306, Nickel-Titanium alloys, titanium etc. In this
example, the distal end of hollow shaft 332 comprises a sharp tip
334. The proximal end of hollow shaft 332 has a needle hub 336 made
of suitable biocompatible materials including, but not limited to
metals e.g. stainless steel 304, stainless steel 306,
Nickel-Titanium alloys, titanium etc.; polymers e.g. polypropylene,
Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC,
Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc. In one embodiment,
needle hub 336 comprises a luer lock.
[0178] FIG. 3C shows an example of an introducing device or
introducing sheath 340. Introducing sheath 340 comprises a hollow,
tubular body 342 made of suitable biocompatible materials
including, but not limited to metals e.g. stainless steel 304,
stainless steel 306, Nickel-Titanium alloys, titanium etc. or
polymers e.g. Pebax, Polyimide, Braided Polyimide, Polyurethane,
Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc. Tubular
body 342 further comprises two marker bands: a proximal marker band
344 and a distal marker band 346. The marker bands can be seen by a
cystoscope. In one embodiment, proximal marker band 344 and distal
marker band 346 are radiopaque. The position of proximal marker
band 344 and distal marker band 346 is such that after introducing
sheath 340 is placed in an optimum location in the anatomy,
proximal marker band 344 is located in the urethra where it can be
seen by a cystoscope and distal marker band 346 is located in the
prostrate gland or in the wall of the urethra where it cannot be
seen by a cystoscope. Tubular body 342 further comprises a series
of distance markers 348 on the outer surface of tubular body 342.
The proximal end of tubular body 342 further comprises a hub 350
made of suitable biocompatible materials including, but not limited
to metals e.g. stainless steel 304, stainless steel 306,
Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax,
Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel,
HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc. In one embodiment, hub 350
comprises a luer lock.
[0179] FIG. 3D shows a perspective view of a trocar. Trocar 360
comprises a tubular trocar body 362. The proximal end of trocar
body 362 comprises a hub 364. Trocar body 362 and hub can be
constructed from suitable biocompatible materials including, but
not limited to metals e.g. stainless steel 304, stainless steel
306, Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax,
Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel,
HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc. Distal end of trocar body
362 ends in a sharp trocar tip 366.
[0180] FIG. 3E shows a perspective view of an anchor delivery
device. Anchor delivery device 370 comprises a body 372 having a
distal opening 373. A section of the distal region of body 372 has
been removed to show a view of the anchor assembly. Body 372
encloses a distal anchor 374 and a proximal anchor 376. Proximal
anchor 376 and distal anchor 374 can have a variety of designs
including, but not limited to the designs disclosed elsewhere in
this patent application. Proximal anchor 376 and distal anchor 374
can be constructed from suitable biocompatible materials including,
but not limited to metals e.g. stainless steel 304, stainless steel
306, Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax,
Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel,
HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc. In one embodiment, shown in
FIGS. 3F and 3G, proximal anchor 9976 and distal anchor 9974
comprise splayable elements that expand in a radially outward
direction when a radial compression force, as enacted by body lumen
9972, on proximal anchor 9976 and distal anchor 9974 is removed.
The splayable elements can be made of suitable super-elastic
materials such as Nickel-Titanium alloys etc. Proximal anchor 9976
and distal anchor 9974 are connected to each other by a tension
element 9978. Tension element 9978 can be made of suitable elastic
or non-elastic materials including, but not limited to metals e.g.
stainless steel 304, stainless steel 306, Nickel-Titanium alloys,
suture materials, titanium etc. or polymers such as silicone,
nylon, polyamide, polyglycolic acid, polypropylene, Pebax, PTFE,
ePTFE, silk, gut, or any other braided or mono-filament material.
Tension element 9978 can have a variety of designs including the
designs shown in FIGS. 5A through 5F. As shown in FIG. 3E, the
proximal end of proximal anchor 9976 is connected by an attachment
mechanism 9980 to a torquable shaft 9982. The proximal end of
torquable shaft 9982 is attached to a control button 9984. Control
button 9984 can be used to deploy proximal anchor 9976 by sliding
control button 9984 along groove 9985 in the distal direction.
Control button 9984 is then used to deploy distal anchor 9974 by
turning control button 9984 in the circumferential direction along
groove 9985.
[0181] FIG. 3H shows a perspective view from the proximal direction
of a particular embodiment of the attachment mechanism of FIG. 3E.
Attachment mechanism 380 comprises a circular plate 386 made from
suitable biocompatible materials including, but not limited to
metals e.g. stainless steel 304, stainless steel 306,
Nickel-Titanium alloys, titanium etc. or polymers e.g.
Polycarbonate, PVC, Pebax, Polyimide, Polyurethane, Nylon, Hytrel,
HDPE, PEEK, PTFE, PFA, FEP etc. The proximal face of circular plate
386 is connected to torquable shaft 382. Circular plate 386 further
comprises a semicircular groove 388. One end of semicircular groove
388 comprises an enlarged region 390. A knob 392 located on the
proximal portion of proximal anchor 376 slides on semicircular
groove 388. The size of knob 322 is larger than the size of
semicircular groove 388 but smaller than size of enlarged region
390. This keeps proximal anchor 376 attached to circular plate 386.
When control button 384 is turned in the circumferential direction
along groove 385, torquable shaft 382 is turned. This turns
circular plate 386 causing knob 392 to slide on the groove 388.
Ultimately, knob 392 reaches enlarged region 390. This releases
knob 392 from circular plate 386 thereby releasing proximal anchor
376 from anchor delivery device 370.
[0182] FIGS. 4A through 4H show a coronal section through the
prostate gland showing the various steps of a method of treating
prostate gland disorders by compressing a region of the prostate
gland using the kit shown in FIGS. 3A through 3F. In FIG. 4A,
introducer device 300 is introduced in the urethra through the
urethral opening at the tip if the penis. A cystoscope is inserted
in introducer device 300 through cystoscope lumen 308 such that the
lens of the cystoscope is located in the distal opening of
cystoscope lumen. The cystoscope is used to navigate introducer
device 300 through the urethra such that the distal region of
introducer device 300 is located in a target region in the
prostatic urethra. Thereafter in FIG. 4B, injecting needle 330 is
advanced through working device lumen 302 such that the distal tip
of injecting needle 330 penetrates into a region of the urethral
wall or the prostate gland. Injecting needle 330 is then used to
inject one or more diagnostic or therapeutic agents into the
urethral wall or the prostate gland. This step may be repeated one
or more times to inject one or more diagnostic or therapeutic
agents in one or more regions of the urethral wall and/or the
prostate gland. In one method embodiment, injecting needle 330 is
used to inject an anesthetic in one or more regions of the urethral
wall and/or the prostate gland. In another embodiment, injecting
needle 330 is used to deliver energy in the form of radiofrequency
energy, resistive heating, laser energy, microwave energy etc. In
another embodiment, injecting needle 330 is used to deliver alpha
antagonist agents, such as phenoxybenzamine, prazosin, doxazosin,
terazosin, tamsulosin, alfuzosin etc. In another embodiment,
injecting needle 330 is used to deliver anti-androgen, such as
flutamide or 5-alpha reductase inhibitors, such as finasteride,
dutasteride, 3-oxosteroid compounds, 4-aza-3-oxosteroid derivatives
of testosterone etc. In another embodiment, injecting needle 330 is
used to deliver anti-inflammatory agents, such as rapamycin,
paclitaxel, ABT-578, everolimus, taxol etc. In another embodiment,
injecting needle 330 is used to deliver ablative agents such as
methyl alcohol etc.
[0183] In another embodiment, injecting needle 330 is used to
deliver energy in the form of radiofrequency energy, resistive
heating, laser energy, microwave energy etc. In another embodiment,
injecting needle 330 is used to deliver alpha antagonist agents,
such as phenoxybenzamine, prazosin, doxazosin, terazosin,
tamsulosin, alfuzosin etc. In another embodiment, injecting needle
330 is used to deliver anti-androgen, such as flutamide or 5-alpha
reductase inhibitors, such as finasteride, dutasteride,
3-oxosteroid compounds, 4-aza-3-oxosteroid derivatives of
testosterone etc. In another embodiment, injecting needle 330 is
used to deliver anti-inflammatory agents, such as rapamycin,
paclitaxel, ABT-578, everolimus, taxol etc. In another embodiment,
injecting needle 330 is used to deliver ablative agents such as
methyl alcohol etc.
[0184] In step 4C, injecting needle 330 is withdrawn from
introducer device 300. Thereafter, introducer sheath 340 and trocar
360 are advanced through working device lumen 302. In the example
shown, introducer sheath 340 and trocar 360 are advanced till the
distal tip of trocar 360 penetrates the capsule of the prostate
gland and the distal end of introducer sheath 340 is located
outside the prostate gland in the pelvic cavity. Thereafter, trocar
360 is withdrawn from working device lumen 302 leaving introducer
sheath 340 in place. In FIG. 4D, anchor delivery device 370 is
introduced through the lumen of introducer sheath 340 till the
distal end of body 372 protrudes through the distal tip of
introducer sheath 340. In step 4E, distal anchor 374 is deployed.
It should be noted that the anchor may be carried to the site and
deployed from within an introducer, on the outside of an
introducer, or it may be the distal tip of the introducer itself.
Thereafter, anchor deliver device 370 is pulled in the proximal
direction along with introducer sheath 340 so that distal anchor
374 is anchored on the outer surface of the prostate capsule. This
step may be used to create tension in the tension element 378. In
one method embodiment, anchor deliver device 370 is pulled in the
proximal direction along with introducer sheath 340 such that the
distal end of anchor delivery device 370 is located in the prostate
gland. In another method embodiment, anchor deliver device 370 is
pulled in the proximal direction along with introducer sheath 340
till the distal end of anchor delivery device 370 is located in the
urethral wall or the urethral lumen. In step 4F, proximal anchor
376 is deployed. Proximal anchor 376 may be deployed in the
prostate gland, in the urethral wall or in the urethral lumen.
Proximal anchor 376 is still attached by attachment mechanism 380
to anchor delivery device 370. The proximal anchor may be
pre-loaded on the tension element, or may subsequently be loaded by
the operator on the tension element. FIGS. 4G through 4H show the
steps of deploying proximal anchor 376 in the prostate gland. In
FIG. 4G, proximal anchor 376 is separated from anchor delivery
device 370. This separation may be achieved via numerous means
including cutting, melting, un-locking a link, or breaking the
tensioning element at a desired location. Ideally this residual end
of the tensioning element will not protrude substantially into the
lumen of the urethra. Thus proximal anchor 376 and distal anchor
374 are anchored in the anatomy. Thereafter, anchor delivery device
370 and introducer sheath 340 are both pulled in the proximal
direction and are withdrawn into introducer device 300. Thereafter,
introducer device 300 is pulled in the proximal direction to pull
it out of the urethra. In FIG. 4H, the steps from FIGS. 4A through
4G are repeated in a second region of the prostate gland if desired
to implant two or more sets of anchoring devices.
[0185] Alternatively, FIGS. 4G' through 4H' show the steps of
deploying proximal anchor 376 in the urethra. After the step in
FIG. 4F, in FIG. 4G', proximal anchor 376 is separated from anchor
delivery device 370 in the urethra. Thus proximal anchor 376 and
distal anchor 374 are anchored in the urethra and the prostate
capsule respectively. Thereafter, anchor delivery device 370 and
introducer sheath 340 are both pulled in the proximal direction and
are withdrawn into introducer device 300. Thereafter, introducer
device 300 is pulled in the proximal direction to pull it out of
the urethra. In FIG. 4H', the steps from FIGS. 4A through 4G' are
repeated optionally in a second region of the prostate gland to
implant two or more sets of anchoring devices. It should be
understood that this method and devices may be applied to any lobe
(middle or lateral lobes) of the prostate and further more may be
used multiple times in the same lobe to achieve the desired
effect.
[0186] FIG. 4H'' shows a coronal section through the prostate gland
showing the final deployed configuration of an embodiment of bone
anchoring devices for treating prostate gland disorders by
compressing a region of the prostate gland. In the method of
deploying this device, introducer sheath 340 and trocar 360 are
advanced till the distal tip of trocar 360 penetrates a bone in the
abdomen (e.g. the pelvic bone, etc.) and the distal end of
introducer sheath 340 is located outside the bone. Thereafter,
trocar 360 is withdrawn from working device lumen 302 leaving
introducer sheath 340 in place. Thereafter, anchor delivery device
370 is introduced through the lumen of introducer sheath 340 until
the distal end of body 372 touches the bone through the distal tip
of introducer sheath 340. Thereafter, distal anchor 374 is
implanted in the bone. Distal anchor 374 may comprise a variety of
designs including, but not limited to designs of distal tips of
Kirschner wires. Examples of such Kirschner wire distal tips are
spiral drill tips, lancer tips, threaded trocar tips, lengthwise
knurled tips, 3-sided trocar tips, 4-sided trocar tips, Thereafter,
anchor deliver device 370 is pulled in the proximal direction along
with introducer sheath 340. This step creates tension in the
tension element 378. In another method embodiment, anchor deliver
device 370 is pulled in the proximal direction along with
introducer sheath 340 till the distal end of anchor delivery device
370 is located in the urethral wall or the urethral lumen. The
remaining method steps are similar to steps 4F through 4H.
[0187] One or more anchors disclosed in this patent application may
be implanted in anatomical locations that include, but are not
limited to: [0188] a location within prostatic lobe; [0189] a
location within peripheral zone of prostate; [0190] a location
within prostatic capsule; [0191] a location between prostatic
capsule and pubic fascia; [0192] a location within the pubic
fascia; [0193] a location within the levator ani muscle [0194] a
location within the obturator internus muscle; [0195] a location
within the pelvic bone; [0196] a location within the periostium of
pelvic bone; [0197] a location within the pubic bone; [0198] a
location within the periostium of pubic bone; [0199] a location
within the symphysis pubica; [0200] a location within the urinary
bladder wall; [0201] a location within the ischiorectal fossa;
[0202] a location within the urogenital diaphragm; and [0203] a
location within the abdominal fascia.
[0204] FIGS. 4I and 4J show a crossection of the urethra through
the prostate gland PG showing the appearance of the urethral lumen
before and after performing the method shown in FIGS. 4A through
4H. FIG. 4I shows a crossection of the urethra through the prostate
gland showing the appearance of the urethral lumen in a patient
with BPH. FIG. 4J shows a crossection of the urethra through the
prostate gland PG showing the appearance of the urethral lumen
after performing the procedure shown in FIGS. 4A through 4H. The
urethral lumen shown in FIG. 4I is larger than the urethral lumen
in FIG. 4J.
[0205] FIGS. 5A through 5F show perspective views of some designs
of the tension elements that can be used in the embodiments
disclosed elsewhere in this patent application. FIG. 5A shows a
perspective view of a tension element 500 comprising a single
strand of an untwisted material. Examples of materials that can be
used to manufacture tension element 500 include but are not limited
to synthetic fibers e.g. various grades of Nylon, polyethylene,
polypropylene, polyester, Aramid etc.; metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; natural fibers e.g. cotton,
silk etc.; rubber materials e.g. various grades of silicone rubber
etc. FIG. 5B shows a perspective view of a tension element 502
comprising one or more serrations 504 or notches. Serrations 504
may be aligned in a particular direction to allow relatively easy
movement of an outer body along tension element 502 in one
direction and offer significant resistance to movement of the outer
body along the tension element in the other direction. FIG. 5C
shows a perspective view of a tension element 506 comprising
multiple filaments 507 of a material twisted together. Examples of
materials that can be used include to manufacture multiple
filaments 507 include but are not limited to synthetic fibers e.g.
various grades of Nylon, polyethylene, polypropylene, polyester,
Aramid etc.; metals e.g. various grades of stainless steel,
titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum
etc.; natural fibers e.g. cotton, silk etc.; rubber materials e.g.
various grades of silicone rubber etc. multiple filaments 507 may
be coated with a coating 508 including, but not limited to a
lubricious coating, antibiotic coating, etc. It is also possible
for the tension element to comprise a composite braided structure
in a plastic/metal or plastic/plastic configuration to reduce
profile and increase strength. Such materials could have preset
levels of elasticity and non-elasticity. FIG. 5D shows a
perspective view of a tension element 509 comprising a flexible,
elastic, spiral or spring element. Examples of materials that can
be used include to manufacture tension element 509 include but are
not limited to metals e.g. various grades of stainless steel,
titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum
etc. FIG. 5E shows a perspective view of a tension element 510
comprising a screw threading 511 on the outer surface of tension
element 510. Screw threading 511 enables tension element 510 to be
screwed through an outer element to advance or withdraw tension
element through the outer element. FIG. 5F shows a perspective view
of a tension element 512 comprising a hollow shaft 514 comprising
one or more collapsible regions 516. A collapsible region 516
comprises one or more windows 518. Windows 518 are cut in hollow
shaft 514 in such a way that several thin, collapsible struts 520
are created between adjacent windows 518. When tension element 512
is compresses along its length, collapsible struts 520 are deformed
in the radially outward direction to create one or more anchoring
regions.
[0206] FIG. 5G shows a perspective view of an anchoring device 522
comprising a tension element and two anchors. Distal end of a
tension element 524 is attached to a distal anchor 526. Proximal
end of tension element 524 is attached to a proximal anchor
528.
[0207] FIG. 5H shows a perspective view of a tensioning element
device comprising a detachable region. Anchoring device 530
comprises a first anchor 532 and a second anchor 534. First anchor
532 and second anchor 534 may comprise a variety of anchor designs
disclosed elsewhere in this patent application. In one embodiment,
one or both of first anchor 532 and second anchor 534 comprise a
substantially flat plate. The substantially flat plate may be made
from various materials including, but not limited to metals e.g.
various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc.; synthetic fibers e.g. various grades of
Nylon, polyethylene, polypropylene, polyester, Aramid etc.; natural
fibers e.g. cotton, silk etc.; rubber materials e.g. various grades
of silicone rubber etc. First anchor 532 and second anchor 534 are
connected to a tensioning element. The tensioning element comprises
two flexible members: a first tensioning member 536 and a second
tensioning member 538. The distal end of first tensioning member
536 is connected to first anchor 532 and the proximal end of second
tensioning member 538 is connected to second anchor 534. Proximal
end of first tensioning member 536 and distal end of second
tensioning member 538 are connected to a releasable member 540.
Releasable member 540 can be releasably connected to a deploying
device. In one embodiment of a method using anchoring device 530,
first anchor 532 is deployed out of an anatomical tissue (e.g. the
prostate gland) into a first anatomical cavity (e.g. the pelvic
cavity). Thereafter, second anchor 534 is deployed into a second
anatomical cavity (e.g. the urethral lumen). Thereafter, releasable
member 540 is released from the deploying device to deliver
anchoring device 530 in a target region.
[0208] FIG. 5I shows a perspective view of a tensioning element
comprising telescoping tubes. Tensioning element 544 may comprise
two or more telescoping tubes. In this example, tensioning element
544 comprises three telescoping tubes: a first telescoping tube
546, a second telescoping tube 548 and a third telescoping tube
550. Second telescoping tube 548 slidably fits into a lumen of
first telescoping tube 546. Similarly third telescoping tube 550
slidably fits into a lumen of second telescoping tube 548. The
telescoping tubes have a locking mechanism to prevent a telescoping
tube from completely disengaging from another telescoping tube. The
telescoping tubes may be made from a variety of biocompatible
materials including, but not limited to plastics, metals etc.
[0209] All the components of the systems disclosed herein
(including but not limited to the tensioning elements, inner and
outer anchor members) may be coated or embedded with therapeutic or
diagnostic substances (e.g., drugs or therapeutic agents) or such
therapeutic or diagnostic substances may be introduced into or near
the prostate or adjacent tissue through a catheter, cannula
needles, etc. Examples of therapeutic and diagnostic substances
that may be introduced or eluted include but are not limited to:
hemostatic agents; antimicrobial agents (antibacterials,
antibiotics, antifungals, antiprotozoals; antivirals; antimicrobial
metals (e.g., silver, gold, etc.); hemostatic and/or
vasoconstricting agents (e.g., pseudoephedrine, xylometazoline,
oxymetazoline, phenylephrine, epinephrine, cocaine, etc.); local
anesthetic agents (lidocaine, cocaine, bupivacaine,); hormones;
anti-inflammatory agents (steroidal and non-steroidal); hormonally
active agents; agents to enhance potency; substances to dissolve,
degrade, cut, break, weaken, soften, modify or remodel connective
tissue or other tissues; (e.g., enzymes or other agents such as
collagenase (CGN), trypsin, trypsin/EDTA, hyaluronidase, and
tosyllysylchloromethane (TLCM)); chemotherapeutic or antineoplastic
agents; substances that prevent adhesion formation (e.g.,
hyaluronic acid gel); substances that promote desired tissue
ingrowth into an anchoring device or other implanted device;
substances that promote or facilitate epithelialization of the
urethra or other areas; 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; agents that inhibit the
conversion of testosterone to dihydrotestosterone, etc. Specific
examples of antitumor agents (e.g., cancer chemotherapeutic agents,
biological response modifiers, vascularization inhibitors, hormone
receptor blockers, cryotherapeutic agents or other agents that
destroy or inhibit neoplasia or tumorigenesis) that may be
delivered in accordance with the present invention include but are
not limited to; alkylating agents or other agents which directly
kill cancer cells by attacking their DNA (e.g., cyclophosphamide,
isophosphamide), nitrosoureas or other agents which kill cancer
cells by inhibiting changes necessary for cellular DNA repair
(e.g., carmustine (BCNU) and lomustine (CCNU)), antimetabolites and
other agents that block cancer cell growth by interfering with
certain cell functions, usually DNA synthesis (e.g., 6
mercaptopurine and 5-fluorouracil (5FU), antitumor antibiotics and
other compounds that act by binding or intercalating DNA and
preventing RNA synthesis (e.g., doxorubicin, daunorubicin,
epirubicin, idarubicin, mitomycin-C and bleomycin) plant (vinca)
alkaloids and other anti-tumor agents derived from plants (e.g.,
vincristine and vinblastine), steroid hormones, hormone inhibitors,
hormone receptor antagonists and other agents which affect the
growth of hormone-responsive cancers (e.g., tamoxifen, herceptin,
aromatase inhibitors such as aminoglutethamide and formestane,
triazole inhibitors such as letrozole and anastrazole, steroidal
inhibitors such as exemestane), antiangiogenic proteins, small
molecules, gene therapies and/or other agents that inhibit
angiogenesis or vascularization of tumors (e.g., meth-1, meth-2,
thalidomide), bevacizumab (Avastin), squalamine, endostatin,
angiostatin, Angiozyme, AE-941 (Neovastat), CC-5013 (Revimid),
medi-522 (Vitaxin), 2-methoxyestradiol (2ME2, Panzem),
carboxyamidotriazole (CAI), combretastatin A4 prodrug (CA4P),
SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11, IM862,
TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon alpha,
interleukin-12 (IL-12) or any of the compounds identified in
Science Vol. 289, Pages 1197-1201 (Aug. 17, 2000) which is
expressly incorporated herein by reference, biological response
modifiers (e.g., interferon, bacillus calmette-guerin (BCG),
monoclonal antibodies, interluken 2, granulocyte colony stimulating
factor (GCSF), etc.), PGDF receptor antagonists, herceptin,
asparaginase, busulphan, carboplatin, cisplatin, carmustine,
chlorambucil, cytarabine, dacarbazine, etoposide, flucarbazine,
fluorouracil, gemcitabine, hydroxyurea, ifosphamide, irinotecan,
lomustine, melphalan, mercaptopurine, methotrexate, thioguanine,
thiotepa, tomudex, topotecan, treosulfan, vinblastine, vincristine,
mitoazitrone, oxaliplatin, procarbazine, streptocin, taxol,
taxotere, analogs/congeners and derivatives of such compounds as
well as other antitumor agents not listed here.
[0210] Additionally or alternatively, in some applications such as
those where it is desired to grow new cells or to modify existing
cells, the substances delivered in this invention may include cells
(mucosal cells, fibroblasts, stem cells or genetically engineered
cells) as well as genes and gene delivery vehicles like plasmids,
adenoviral vectors or naked DNA, mRNA, etc. injected with genes
that code for anti-inflammatory substances, etc., and, as mentioned
above, macrophages or giant cells that modify or soften tissue when
so desired, cells that participate in or effect the growth of
tissue.
[0211] FIGS. 6A through 11B show various examples of anchor designs
and/or anchoring device designs. FIGS. 6A and 6B show examples of a
crumpling anchor 600. In FIG. 6A, crumpling anchor 600 comprises a
substantially flattened body 602. Body 602 can be made of a variety
of materials including, but not limited to synthetic fibers e.g.
various grades of Nylon, polyethylene, polypropylene, polyester,
Aramid etc.; metals e.g. various grades of stainless steel,
titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum
etc.; natural fibers e.g. cotton, silk etc.; rubber materials e.g.
various grades of silicone rubber etc. Further, in any of the
implantable tissue compression devices, any or all of the anchors,
the tensioning element(s) and any other components may be coated,
impregnated, embedded or otherwise provided with substance(s)
(e.g., drugs, biologics, cells, etc.) to reduce the likelihood of
infection, inflammation, treat the prostatic adenoma directly or
enhance the likelihood of endothelialization, deter adhesion
formation, promote healing or otherwise improve the likelihood or
degree of success of the procedure. Such substance(s) may be
released primarily at the time of delivery or may be released over
a sustained period. Examples of such substances are listed above
and include but are not limited to certain metals with
bacteriostatic action (i.e. silver, gold, etc.), antibiotics,
antifungals, hemostatic agents (i.e. collagen, hyaluronic acid,
gelfoam, cyano-acrylate, etc.), anti-inflammatory agents (steroidal
and non-steroidal), hormonally active agents, stem cells,
endothelial cells, genes, vectors containing genes, etc. Body 602
may be non-woven or woven. Body 602 may have a variety of shapes
including, but not limited to square, rectangular, triangular,
other regular polygonal, irregular polygonal, circular etc. Body
602 may have a substantially one dimensional, two dimensional or
three dimensional shape. The material chosen for this device may
have hemostatic properties to reduce bleeding from the implantation
tract or site. Distal end of body 602 is connected to the distal
end of tension element 604. Body 602 further comprises one or more
attachment means 606. Attachment means are used to create a channel
in the body 602 through which tension element 604 passes. Crumpling
anchor 600 is introduced through a region of tissue (e.g. through
prostate gland tissue) into a cavity or lumen e.g. pelvic cavity,
urethral lumen etc. In FIG. 6B, tension element 604 is pulled in
the proximal direction. The causes crumpling (e.g., collapsing) of
the crumpling anchor 600 between the tissue and the distal end of
tension element 604. This process prevents tension element 604 in
the tissue and prevents further movement of tension element 604 in
the proximal direction.
[0212] FIGS. 7A and 7B show an example of a deployable anchor 700
in an undeployed configuration and a deployed configuration,
respectively. This deployable anchor 700 comprises one or more
anchoring arms 702. Anchoring arms 702 may be made from a variety
of elastic, super-elastic or shape memory materials etc. Typical
examples of such materials include but are not limited to metals
e.g. stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc. Anchoring arms 702 are
connected to a central hub 704. Central hub in turn is connected to
the distal end of a tension element 706. In FIG. 7A, anchoring arms
702 are folded inside a hollow deploying sheath 708. This reduces
the undeployed diameter of anchoring arms 702 and also prevents
unwanted anchoring of anchoring arms 702. In FIG. 7B, deploying
sheath 708 is pulled in the proximal direction. This releases
anchoring arms 702 from the distal end of deploying sheath 702.
This causes anchoring arms 702 to open in the radially outward
direction. Anchor 700 can then anchor to tissue and resist movement
of tension element 706 in the proximal direction.
[0213] FIGS. 8A and 8B show sectional views of an undeployed
configuration and a deployed configuration respectively of a "T"
shaped deployable anchor. Anchor 8110 comprises an elongate region
802. Elongate region 802 may be made from a variety of elastic,
super-elastic or shape memory materials etc. Typical examples of
such materials include but are not limited to metals e.g. stainless
steel, titanium, nickel-titanium alloys, cobalt-chromium alloys,
tantalum etc; polymers e.g. polypropylene, Teflon etc. Middle
section of elongate region 802 is connected to the distal end of a
tension element 804 to form a "T" shaped anchor. In one embodiment,
middle section of elongate region 802 is connected to the distal
end of a tension element 804 by a hinge. In FIG. 8A, elongate
region 802 is folded inside a hollow deploying sheath 806. This
reduces the undeployed diameter of the distal region of anchor 8110
and also prevents unwanted anchoring of elongate region 802 to
tissue. In FIG. 8B, deploying sheath 806 is pulled in the proximal
direction. This releases elongate region 802 from the distal end of
deploying sheath 806. This in turn causes elongate region 802 to
twist and orient itself perpendicular to the distal end of a
tension element 804. Anchor 800 can then anchor to tissue and
resist movement of tension element 804 in the proximal
direction.
[0214] Anchoring arms 702 in FIGS. 7A and 7B can have a variety of
configurations including, but not limited to configurations shown
in FIGS. 9A through 9D. FIG. 9A shows a distal end view of an
embodiment of an anchor comprising two triangular arms. Anchor 900
comprises two anchor arms 902. Anchor arms 902 can be made of a
variety of materials including, but not limited to metals e.g.
stainless steel, titanium, nickel-titanium alloys, cobalt-chromium
alloys, tantalum etc; polymers e.g. polypropylene, Teflon etc.
Anchor arms 902 are connected to a tension element 904. In one
embodiment, anchor arms 902 are connected to a central hub, which
in turn is connected to tension element 904. The arms in each of
these devices may be folded or contained prior to deployment
through the use of a sheath or grasping or mounting device. FIG. 9B
shows a distal end view of an embodiment of an anchor comprising
four rectangular arms. Anchor 906 comprises four anchor arms 908.
Anchor arms 908 can be made of a variety of materials including,
but not limited to metals e.g. stainless steel, titanium,
nickel-titanium alloys, cobalt-chromium alloys, tantalum etc;
polymers e.g. polypropylene, Teflon etc. Anchor arms 908 are
connected to a tension element 910. In one embodiment, anchor arms
908 are connected to a central hub, which in turn is connected to
tension element 910. FIG. 9C shows a distal end view of an
embodiment of an anchor comprising a mesh or a woven material.
Anchor 912 comprises four anchor arms 914. Anchor arms 914 can be
made of a variety of materials including, but not limited to metals
e.g. stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc; polymers e.g. polypropylene,
Teflon etc. Anchor arms 914 are connected to a tension element 916.
In one embodiment, anchor arms 914 are connected to a central hub,
which in turn is connected to tension element 916. A layer of
porous material 918 is located between anchor arms 914. Porous
material 918 comprises a plurality of pores that allow for tissue
ingrowth. Porous material 918 may also help to distribute the
pressure on anchor arms 914 over a wider area. Porous material 918
can be made of variety of materials including, but not limited to
synthetic fibers e.g. various grades of Nylon, polyethylene,
polypropylene, polyester, Aramid etc.; metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; natural fibers e.g. cotton,
silk etc.; rubber materials e.g. various grades of silicone rubber
etc. Porous material 918 may be non-woven or woven. Any of the arms
or struts in one or more anchoring devices may comprise bent or
curved regions. For example, FIG. 9D shows a distal end view of an
embodiment of an anchor comprising four curved arms. Anchor 920
comprises four curved anchor arms 922. Curved anchor arms 922 can
be made of a variety of materials including, but not limited to
metals e.g. stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc; polymers e.g. polypropylene,
Teflon etc. Curved anchor arms 922 are connected to a tension
element 924. In one embodiment, curved anchor arms 922 are
connected to a central hub which in turn is connected to tension
element 924.
[0215] FIG. 10A shows a distal end view of an anchor comprising a
spiral element having a three dimensional shape. Anchor 1000
comprises a three dimensional spiral element 1002. Diameter of
spiral element 1002 may be substantially constant or may
substantially vary along the length of spiral element 1002. Spiral
element 1002 may be made of an elastic, super-elastic or shape
memory materials. Spiral element 1002 may be made of a variety of
materials including, but not limited to metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,
Teflon etc.; synthetic fibers e.g. various grades of Nylon,
polyethylene, polypropylene, polyester, Aramid etc.; natural fibers
e.g. cotton, silk etc.; rubber materials e.g. various grades of
silicone rubber etc. Spiral element 1002 is connected to a central
hub 1004, which in turn is connected to a tension element. In one
embodiment, spiral element 1002 is directly connected to a tension
element without using central hub 1004. FIG. 10A' shows a side view
of the anchor in FIG. 10A. FIG. 10A' shows anchor 1000 comprising
spiral element 1002 connected to central hub 1004 which in turn is
connected to a tension element 1006. FIG. 10B shows a distal end
view of an anchor comprising a spiral element having a two
dimensional shape. Anchor 1000 comprises a two dimensional spiral
element 1010. Spiral element 1010 may be made of an elastic,
super-elastic or shape memory materials. Spiral element 1010 may be
made of a variety of materials including, but not limited to metals
e.g. various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc.; synthetic fibers e.g. various grades of
Nylon, polyethylene, polypropylene, polyester, Aramid etc.; natural
fibers e.g. cotton, silk etc.; rubber materials e.g. various grades
of silicone rubber etc. Spiral element 1010 is connected to a
central hub 1012 which in turn is connected to a tension element.
In one embodiment, spiral element 1010 is directly connected to a
tension element without using central hub 1012. FIG. 10B' shows a
side view of the anchor in FIG. 10B. FIG. 10B' shows anchor 1008
comprising spiral element 1010 connected to central hub 1012 which
in turn is connected to a tension element 1014. FIG. 10C shows a
distal end view of an anchor comprising one or more circular
elements. In FIG. 10C, anchor 1016 comprises an inner circular
element 1018 and an outer circular element 1020. A series of radial
arms or struts 1022 connect inner circular element 1018 to outer
circular element 1020 and to a central hub 1024. Central hub 1024
may have a lumen 1026. Anchor 1016 may be substantially two
dimensional or three dimensional. FIG. 10C' shows a perspective
view of the anchor in FIG. 10C. FIG. 10C' shows an anchor 1016
comprising an inner circular element 1018, an outer circular
element 1020 and series of radial arms or struts 1022 connecting
inner circular element 1018 to outer circular element 1020 and to a
central hub 1024. Central hub 1024 is connected to a tension
element.
[0216] FIG. 10D shows a perspective view of an embodiment of an
anchoring device comprising an outer ring. Anchor 1040 comprises a
central hub 1042 and an outer ring 1044. In one embodiment, central
hub 1042 acts as a plug to plug an opening in the anatomy to reduce
or prevent bleeding or leakage of fluids. Central hub 1042 is
connected to outer ring 1044 by one or more bars or struts 1046. In
one embodiment, central hub 1042 is connected to an inner ring 1048
which in turn is connected to outer ring 1044 by one or more bars
or struts 1046. Central hub 1042 further comprises a locking
element 1050. Locking element 1050 comprises a lumen 1052 through
which a tension element can slide. After positioning anchor 1040 in
a desired position with respect to the tension element, locking
element 1050 is used to securely attach anchor 1040 on the tension
element. Locking element 1050 may comprise a design disclosed
including various locking designs disclosed elsewhere in this
patent application. Anchor 1040 may be made from a variety of
materials including, but not limited to synthetic fibers e.g.
various grades of Nylon, polyethylene, polypropylene, polyester,
Aramid etc.; metals e.g. various grades of stainless steel,
titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum
etc.; natural fibers e.g. cotton, silk etc.; rubber materials e.g.
various grades of silicone rubber etc.
[0217] FIG. 10E shows a partial perspective view of an anchoring
device comprising a hemostatic element. Anchor 1060 comprises a
central hub 1062. In one embodiment, central hub 1062 acts as a
plug to plug an opening in the anatomy to reduce or prevent
bleeding or leakage of fluids. Central hub 1062 comprises a
cinching mechanism to allow central hub 1062 to cinch on to a
tension element 1064 passing through central hub 1062. The free end
1066 of tension element 1064 is severed to minimize the presence of
tension element 1064 in the anatomy. Anchor 1060 further comprises
an outer ring 1068. Central hub 1062 is connected to outer ring
1068 by one or more struts 1070. Anchor 1060 further comprises a
mesh or porous element 1072 between outer ring 1068 and struts
1070. The mesh or porous element 1072 may be concave shaped as
shown in FIG. 10E. Mesh or porous element 1072 allows for tissue
ingrowth over a period of time thus providing additional securing
of anchor 1060 to tissue.
[0218] FIG. 11A shows a perspective view of a device having a set
of anchors comprising a curved sheet. Anchoring device 1100 may
comprise one or more anchors comprising a curved sheet. In this
example, anchoring device 1100 comprises a first anchor 1102 and a
second anchor 1104. First anchor 1102 and second anchor 1104 may
comprise elastic, super elastic or shape memory materials. First
anchor 1102 and second anchor 1104 may be made from various
materials including, but not limited to metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,
Teflon etc.; synthetic fibers e.g. various grades of Nylon,
polyethylene, polypropylene, polyester, Aramid etc.; natural fibers
e.g. cotton, silk etc.; rubber materials e.g. various grades of
silicone rubber etc. The concave surface of first anchor 1102 is
connected to a first end of a tension element 1106. Second end of
tension element 1106 is connected to the convex surface of second
anchor 1104. In one embodiment of a method to deploy anchoring
device 1106, first anchor 1102 is deployed out of an anatomical
tissue (e.g. the prostate gland) into a first anatomical cavity
(e.g. the pelvic cavity). Thereafter, second anchor 1104 is
deployed into a second anatomical cavity (e.g. the urethral lumen).
This method embodiment has the advantage of using the natural
curvature of first anchor 1102 and second anchor 1104 to distribute
pressure on first anchor 1102 and second anchor 1104 over a large
area.
[0219] FIGS. 12A through 17I show further examples of anchor
designs and/or anchoring device designs. FIG. 12A shows a
perspective view of an anchor comprising an arrowhead. Anchor 1200
comprises an arrowhead 1202. Arrowhead 1202 may be made from
various materials including, but not limited to metals e.g. various
grades of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,
Teflon etc.; rubber materials e.g. various grades of silicone
rubber etc. Arrowhead 1202 may comprise a sharp distal tip.
Arrowhead 1202 may have a three dimensional or a substantially two
dimensional design. Proximal region of arrowhead 1202 is wider that
the distal region of arrowhead 1202 to resist motion of arrowhead
1202 along the proximal direction after it is deployed in a tissue.
Proximal region of arrowhead 1202 is connected to a tension element
1204. FIG. 12B shows a crossectional view of an anchor comprising a
cup-shaped element that encloses a cavity. Anchor 1208 comprises a
cup-shaped element 1210. Proximal, concave surface of cup-shaped
element 1210 encloses a cavity. Cup-shaped element 1210 may be made
from various materials including, but not limited to metals e.g.
various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc.; rubber materials e.g. various grades of
silicone rubber etc. Proximal region of cup-shaped element 1210 is
connected to a tension element 1212. FIG. 12C shows a perspective
view of an anchor comprising a screw. Anchor 1216 comprises a screw
1218. Screw 1218 may be made from various materials including, but
not limited to metals e.g. various grades of stainless steel,
titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum
etc.; polymers e.g. polypropylene, Teflon etc. Screw 1218 may
comprise a sharp distal tip. Proximal region of screw 1218 may be
wider that the distal region of screw 1218 to resist motion of
screw 1218 along the proximal direction after it is deployed in a
tissue. Screw 1218 comprises a thread rolled thread including, but
not limited to wood screw style thread, double lead thread, tapping
style thread, tapered wood thread etc. Proximal region of arrowhead
1202 is connected to a tension element 1204.
[0220] FIGS. 13A and 13B show perspective views of an uncollapsed
state and a collapsed state respectively of an anchor comprising a
collapsible region. In FIG. 13A, anchor element 1300 is in an
uncollapsed state. Anchor element 1300 comprises a hollow shaft
1302 comprising one or more collapsible regions. A collapsible
region comprises one or more windows 1304. Windows 1304 are cut in
hollow shaft 1302 in such a way that several thin, collapsible
struts 1306 are created between adjacent windows 1304. In FIG. 13B,
anchor element 1300 is in a collapsed state. When anchor element
1300 is compresses along its length, collapsible struts 1306 are
deformed in the radially outward direction to create one or more
anchoring regions.
[0221] FIGS. 13C and 13D show perspective views of an undeployed
state and a deployed state respectively of an anchor comprising
radially spreading arms. In FIG. 13C, anchor 1312 comprises a
hollow tube 1314. Hollow tube 1314 is made from suitable elastic,
super-elastic or shape memory materials such as metals including,
but not limited to titanium, stainless steel, Nitinol etc.;
suitable elastic polymers etc. U-shaped slots 1316 are cut in
hollow tube 1314 in such a way that arms 1318 are created within
U-shaped slots 1316. In this embodiment, U-shaped slots are
substantially parallel to the axis of hollow tube 1314. In absence
of an external force, arms 1318 tend to spread in a radially
outward direction. Anchor 1312 is kept in an undeployed state by
enclosing anchor 1312 in a sheath. Anchor 1312 is deployed by
removing the sheath to allow arms 1318 to spread in a radially
outward direction as shown in FIG. 13D.
[0222] Hollow tube 1314 may comprise one or more cinching elements.
Cinching elements may be located on the proximal region, distal
region or a middle region of hollow tube 1314. The cinching element
or elements may comprise cinching mechanisms including, but not
limited to cinching mechanisms disclosed in FIGS. 26A through
29P.
[0223] FIG. 13E shows perspective views of an alternate embodiment
of an undeployed state of an anchor comprising radially spreading
arms. In FIG. 13C, anchor 1320 comprises a hollow tube 1322. Hollow
tube 1322 is made from suitable elastic, super-elastic or shape
memory materials such as metals including, but not limited to
titanium, stainless steel, Nitinol etc.; suitable elastic polymers
etc. U-shaped slots 1324 are cut in hollow tube 1322 in such a way
that arms 1326 are created within U-shaped slots 1324. In this
embodiment, U-shaped slots are at an angle to the axis of hollow
tube 1322 as shown in FIG. 13E.
[0224] FIGS. 14A and 14B show perspective views of anchoring
devices comprising an adhesive delivering element. FIG. 14A shows a
perspective view of an anchoring device 1400 comprising a hollow
shaft 1402 with a shaft lumen. Hollow shaft 1402 can be made of
suitable biocompatible materials including, but not limited to
Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC,
Hytrel, HDPE, PEEK, metals like stainless steel and fluoropolymers
like PTFE, PFA, FEP and EPTFE etc. Distal end of shaft lumen ends
in a delivery opening 1404. When an adhesive is injected through
the shaft lumen, it emerges out of anchoring device 1400 through
delivery opening 1404. Hollow shaft 1402 may also comprise an
attachment element 1406 such as a porous woven or non-woven
circular sleeve securely attached to hollow shaft 1402. The
circular sleeve may be made of a variety of materials including,
but not limited to metals e.g. various grades of stainless steel,
titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum
etc.; polymers e.g. polypropylene, Teflon etc.; synthetic fibers
e.g. various grades of Nylon, polyethylene, polypropylene,
polyester, Aramid etc.; natural fibers e.g. cotton, silk etc.;
rubber materials e.g. various grades of silicone rubber etc. The
adhesive flowing out through delivery opening comes into contact
with attachment element 1406 and securely attaches attachment
element 1406 to surrounding tissue. FIG. 14B shows a perspective
view of an anchoring device 1408 comprising a hollow shaft 1410
with a shaft lumen. Hollow shaft 1410 can be made of suitable
biocompatible materials including, but not limited to Pebax,
Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel,
HDPE, PEEK, metals like stainless steel and fluoropolymers like
PTFE, PFA, FEP and EPTFE etc. Distal end of shaft lumen ends in a
delivery opening 1412. When an adhesive is injected through the
shaft lumen, it emerges out of anchoring device 1408 through
delivery opening 1412. Hollow shaft 1410 may also comprise an
attachment element 1414 such as porous foam securely attached to
hollow shaft 1410. The porous foam may be made of a variety of
materials including, but not limited to polymers e.g.
polypropylene, Teflon etc.; synthetic fibers e.g. various grades of
Nylon, polyethylene, polypropylene, polyester, Aramid etc.; rubber
materials e.g. various grades of silicone rubber etc. The adhesive
flowing out through delivery opening comes into contact with
attachment element 1414 and securely attaches attachment element
1414 to surrounding tissue. Typical examples of adhesives that can
be used with anchoring device 1400 and anchoring device 1408
include but are not limited to cyanoacrylates, marine adhesive
proteins, fibrin-based sealants etc.
[0225] FIGS. 15A and 15B show two configurations of an anchoring
device comprising a ratcheted tension element. Anchoring device
1500 comprises a distal anchor. Distal anchor may comprise a design
selected from the variety of designs disclosed elsewhere in this
document. In this particular example, distal anchor comprises a
series of radial arms 1502 connected to a central hub 1504. The
proximal end of central hub is attached to a ratcheted tension
element 1506. A proximal anchor is located on ratcheted tension
element 1506 proximal to the distal anchor. Proximal anchor may
comprise a design selected from the variety designs disclosed
elsewhere in this document. In this particular example, distal
anchor comprises a series of radial arms 1508 connected to a
central hub 1510. Central hub 8368 has a central lumen through
which ratcheted tension element 1506 can slide. Ratcheted tension
element 1506 has ratchets arranged such that proximal anchor can
slide easily over ratcheted tension element 1506 in the distal
direction but cannot slide easily in the proximal direction. In
FIG. 15B, proximal anchor slides over ratcheted tension element
1506 in the distal direction. This causes a compression of tissue
between distal anchor and proximal anchor. The compression of
tissue can be maintained since proximal anchor cannot slide easily
in the proximal direction. In one embodiment of a method using
anchoring device 1500, distal anchor is introduced via an
anatomical lumen (e.g. the urethral lumen) and through a tissue
(e.g. the prostate gland) into an anatomical cavity (e.g. the
pelvic cavity). Thereafter, proximal anchor is advanced along
ratcheted tension element 1506 till it encounters a wall (e.g. the
urethral wall) of the anatomical lumen. Anchoring device 1500 may
be made from various materials including, but not limited to metals
e.g. various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc.
[0226] FIG. 16 shows a perspective view of an anchor comprising a
trocar lumen. Anchor 1600 comprises a hollow shaft 1602 comprising
a lumen. A trocar 1604 or a penetrating device can pass through
hollow shaft 1602 such that the distal tip of trocar 1604 emerges
out through the distal end of hollow shaft 1602. Distal end of
hollow shaft 1602 comprises a tapering region 1606 with a smaller
distal diameter and a larger proximal diameter. Tapering region
1606 further comprises a series of sharp projections 1608 located
on the proximal end of tapering region 1606. Projections 1608 may
be projecting in the proximal direction, radially outward direction
etc. Projections 1608 prevent the movement of anchor 1600 in the
proximal direction after it has penetrated through a tissue. Anchor
1600 may also comprise a sleeve 1610 located proximal to tapering
region 1606. Sleeve 1610 is made of a porous material that has a
plurality of pores that allow for tissue ingrowth thus anchoring
sleeve 1610 firmly in tissue. Sleeve 1610 may also help to
distribute the pressure on tapering region 1606 over a wider area.
Sleeve 1610 may be non-woven or woven. Sleeve 1610 can be made of
variety of materials including, but not limited to synthetic fibers
e.g. various grades of Nylon, polyethylene, polypropylene,
polyester, Aramid etc.; metals e.g. various grades of stainless
steel, titanium, nickel-titanium alloys, cobalt-chromium alloys,
tantalum etc.; natural fibers e.g. cotton, silk etc.; rubber
materials e.g. various grades of silicone rubber etc.
[0227] FIG. 17A shows a perspective view in the undeployed state of
an anchor comprising a rigid or partially flexible T element and a
crumpling element. In FIG. 17A, anchoring device 1700 comprises a
distal, T element 1702. The T element 1702 may be made of a variety
of materials including, but not limited to metals e.g. various
grades of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,
Teflon etc.; rubber materials e.g. various grades of silicone
rubber etc. Further it may be a composite material or have cut out
sections to allow it to be flexible in certain dimensions but rigid
in other dimensions. In this example, T element 1702 is in the form
of a hollow cylinder. The proximal end of T element 1702 is in
contact with the distal end of a delivery rod 1704. Delivery rod
1704 is hollow and is used to deliver T element 8266 in a target
anatomical region. A trocar 1705 can pass through delivery rod 1704
and through T element 1702 such that the distal tip of trocar
emerges through the distal end of rigid element 1702. The T-element
could also be contained within a lumen of the trocar or may be the
trocar itself. of the T element 1702 is connected to the distal end
of a flexible tension element 1706. Various connection means are
possible such as the tension element being tied or crimped to the T
element, or passing through a loop in the T element, or being
adhered by adhesive or weld, or by being made of a continuous
material which becomes the T element. Although the T element is
shown as a T, any shape which is larger in at least one dimension
compared to its other dimensions could appropriately be released
and cause to change it's orientation to produce an anchoring
effect. Examples of materials that can be used to manufacture
tension element 1706 include but are not limited to synthetic
fibers e.g. various grades of Nylon, polyethylene, polypropylene,
polyester, Aramid etc.; metals e.g. various grades of stainless
steel, titanium, nickel-titanium alloys, cobalt-chromium alloys,
tantalum etc.; natural fibers e.g. cotton, silk etc.; rubber
materials e.g. various grades of silicone rubber etc. A
substantially flattened body 1708 is located on the distal region
of tension element 1706. Tension element 1706 is threaded through
body 1708 in such a way that tension element 1706 can slide through
body 1708. Body 1708 may be non-woven or woven. Body 1708 can be
made of a variety of materials including, but not limited to
synthetic fibers e.g. various grades of Nylon, polyethylene,
polypropylene, polyester, Aramid etc.; metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; natural fibers e.g. cotton,
silk etc.; rubber materials e.g. various grades of silicone rubber
etc. Body 1708 may have a variety of shapes including, but not
limited to square, rectangular, triangular, other regular
polygonal, irregular polygonal, circular etc. Body 1708 may have a
substantially one dimensional, two dimensional or three dimensional
shape. FIGS. 17B and 17C show various steps of a method to deploy
the anchoring device shown in FIG. 17A. In FIG. 17B, anchoring
device 1700 is introduced in an anatomical cavity (e.g. the pelvic
cavity) through a tissue (e.g. the prostate gland). Thereafter,
trocar 1705 is withdrawn by pulling trocar 1705 in the proximal
direction. Thereafter, delivery rod 1704 is withdrawn by pulling
delivery rod 1704 in the proximal direction. Thereafter, tension
element 1706 is pulled in the proximal direction. Tension element
1706 in turn pulls T element 1702 in the proximal direction. In
FIG. 17C, rigid element 1702 is pulled against a wall of the tissue
(e.g. the prostate gland) but is unable to penetrate the tissue
because of its size. This causes body 1708 to crumple because of
compression of body 1708 between the wall of the tissue and rigid
element 1702. Crumpled body 1708 may be designed to cause tissue
ingrowth or epithelialization in body 1708 as well as healing,
hemostasis or a more even force distribution.
[0228] FIGS. 17D and 17E show perspective views of an undeployed
and deployed configuration of an anchor comprising a rigid or
partially flexible T element with one or more openings or
perforations. FIG. 17D shows a perspective view of an anchoring
device 1720 comprising an anchor 1722. Anchor 1722 comprises a
tubular body. The tubular body may comprise one or more openings or
perforations 1724 in the tubular body. Openings or perforations
1724 increase the flexibility of anchor 1722. This makes it easier
to navigate anchoring device 1720 through the anatomy before
reaching its target location. Further it enables anchoring device
1720 to be passed through a tight bend in the anatomy or through a
delivery device. Within tubular body of anchor 1722 is trocar tip
1727 that is fixedly attached to tensioning element 1728. In the
embodiment shown in FIG. 17D, anchor 1722 comprises a lumen. A
length of the distal end of deployment element 1726 passes through
the proximal end of the lumen and abuts trocar tip 1727 that
enables anchor 1722 to puncture tissue. In an alternate embodiment
trocar tip is fixedly attached to elongate deployment element 1726
and is retracted fully into element 1729 upon anchor deployment. In
an alternate embodiment, distal tip of deployment device 1726 is
not exposed through the distal end of anchor 1722. Distal end of
anchor 1722 comprises a sharp tip to enable anchor 1722 to puncture
tissue. Anchoring element 1720 further comprises a tension element
1728 attached to tubular body 1722. In this embodiment, distal end
of tension element 1728 attached to the inner surface of the trocar
tip 1727. Proximal region of tension element 1728 passes through
deployment element 1726. Anchor 1722 is deployed by pushing in a
distal direction one elongate deployment element 1726, that runs
within lumen of anchor 1722 abutting trocar tip 1727 distally, in
tandem with another elongate deployment element 1729 that abuts the
proximal end of anchor 1722. Anchoring device 1720 punctures tissue
to transport anchor 1722 through a first anatomical location (e.g.
a prostate gland) to a second anatomical location (e.g. the pelvic
cavity, urethra etc.). Thereafter, deployment element 1726 is
withdrawn by pulling deployment element 1726 in the proximal
direction. Thereafter, tension element 1728 is pulled in the
proximal direction. This causes anchor 1722 to anchor in tissue as
shown in FIG. 17E. Proximal portion of tension element 1728 emerges
out of anchor 1722 through a lengthwise groove in anchor 1722 to
create a T shaped anchor as shown in FIG. 17E. Tension on
tensioning element 1728 causes trocar tip 1727 to retract into
lumen 1722. In the example shown, the first anatomical location is
the prostate gland PG and the second anatomical location is the
pelvic cavity. Anchoring device 1720 can be made from a variety of
materials including, but not limited to metals such as synthetic
fibers e.g. various grades of Nylon, polyethylene, polypropylene,
polyester, Aramid etc.; metals e.g. various grades of stainless
steel, titanium, nickel-titanium alloys, cobalt-chromium alloys,
tantalum etc.; natural fibers e.g. cotton, silk etc.; rubber
materials e.g. various grades of silicone rubber etc. Tension
element 1728 may then be connected to any one of the other
anchoring elements such as anchor 10D.
[0229] FIGS. 17F and 17G show perspective views of an undeployed
and deployed configuration of an anchor comprising a stent. Anchor
1730 comprises a self-expanding stent 1732 and a tension element
1734. Distal end of tension element 1734 is attached to stent 1732.
In one embodiment, distal end of tension element 1734 is attached
on the mid section of stent 1732. Stent 1732 may comprise various
designs including, but not limited to metallic tube designs,
polymeric tube designs, spiral designs, chain-linked designs,
rolled sheet designs, single wire designs etc. Stent 1732 may have
an open celled or closed celled structure. A variety of fabrication
methods can be used for fabricating stent 1732 including but not
limited to laser cutting a metal or polymer element, welding metal
elements etc. A variety of materials can be used for fabricating
stent 1732 including but not limited to metals, polymers, foam type
materials, super elastic materials etc. A variety of features can
be added to stent 1732 including but not limited to radiopaque
coatings, drug elution mechanisms etc. Anchor 1730 is introduced
through a sheath 1736 into a target anatomy. Thereafter, sheath
1736 is withdrawn. This causes stent 1732 to revert to its natural
shape as shown in FIG. 17G and act as an anchor.
[0230] FIGS. 17H and 17I show perspective views of an undeployed
and deployed configuration of an anchor comprising a spring. Anchor
1740 comprises an elastic spring 1742 and a tension element 1744.
Distal end of tension element 1744 is attached to spring 1742. In
one embodiment, distal end of tension element 1744 is attached on
the mid section of spring 1742. A variety of materials can be used
for fabricating spring 1742 including but not limited to metals,
polymers, foam type materials, super elastic materials etc. A
variety of features can be added to spring 1742 including but not
limited to radiopaque coatings, drug elution mechanisms etc. Anchor
1740 is introduced through a sheath 1746 into a target anatomy to
reduce the profile of spring 1742. Thereafter, sheath 1746 is
withdrawn. This causes spring 1742 to revert to its natural shape
as shown in FIG. 171 and act as an anchor.
[0231] FIGS. 18A through 22E show various embodiments of mechanisms
to deploy one or more anchors. FIG. 18A shows a crossection of an
anchor deploying mechanism comprising a screw system. FIG. 18A
shows an anchor deploying mechanism comprising an anchor 1800
comprising an anchor body 1802 and anchoring elements 1804 attached
to anchor body 1802. Anchor body 1802 comprises an inner lumen.
Inner lumen of anchor body 1802 comprises screw threading.
Anchoring elements 1804 may have various designs including, but not
limited to anchor designs disclosed elsewhere in this document.
Anchor body 1802 and anchoring elements 1804 may be made of a
variety of materials including, but not limited to metals e.g.
various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc.; rubber materials e.g. various grades of
silicone rubber etc. The anchor deploying mechanism further
comprises a deploying shaft 1806. Distal region of deploying shaft
1806 comprises a screw threading such that deploying shaft 1806 can
be screwed into anchor body 1802. FIG. 18B shows the method of
deploying an anchor comprising a screw mechanism. Deploying shaft
1806 is rotated to release the distal region of deploying shaft
1806 from anchor body 1802 after positioning anchor 1800 in a
desired location. Such a mechanism can be used to deploy one or
more anchors. In one embodiment, more than one anchors are located
on deploying shaft 1806. The anchors can be sequentially deployed
by rotating deploying shaft 1806. Deploying shaft 1806 may be made
of a variety of materials including, but not limited to metals e.g.
various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc. In one embodiment, the anchor deploying
mechanism is located inside an outer sheath.
[0232] FIGS. 19A and 19B show a crossectional view of an anchor
deploying system comprising an electrolytic detachment element.
FIG. 19A shows a crossection of an anchor deploying mechanism
comprising a deployable anchor 1900. Deployable anchor 1900
comprises an anchor body 1902 and anchoring elements 1904 attached
to anchor body 1902. Anchoring elements 1904 may have various
designs including, but not limited to anchor designs disclosed
elsewhere in this document. Anchor body 8402 and anchoring elements
8404 may be made of a variety of materials including, but not
limited to metals e.g. various grades of stainless steel, titanium,
nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;
polymers e.g. polypropylene, Teflon etc.; rubber materials e.g.
various grades of silicone rubber etc. Proximal region of
deployable anchor 1900 further comprises an electrolyzable element
1906. Electrolyzable element 1906 is made of a length of metallic
wire e.g. steel wire. Proximal region of electrolyzable element
1906 is electrically connected to a deploying shaft 1908. Proximal
region of deploying shaft 1908 is further connected to a first
electrode. The anchor deploying system further comprises a second
electrode 1910 connected to a bodily region of the patient to be
treated. In FIG. 19B, the first electrode is connected to a
positive terminal of a power supply and the second electrode is
connected to the negative terminal of the power supply to form an
electrical circuit. Electrical current flowing between
electrolyzable element 1906 and second electrode 1910 causes
metallic ions from electrolyzable element 1906 to dissolve into
surrounding anatomy. This causes electrolyzable element 1906 to
detach from deploying shaft 1908.
[0233] FIG. 20 shows a perspective view of an anchor deploying
system comprising a looped ribbon. The anchor deploying system
comprises a deployable anchor 2000. Deployable anchor 2000
comprises an anchor body 2002 and anchoring elements 2004 attached
to anchor body 2002. Anchoring elements 2004 may have various
designs including, but not limited to anchor designs disclosed
elsewhere in this document. Anchor body 2002 and anchoring elements
2004 may be made of a variety of materials including, but not
limited to metals e.g. various grades of stainless steel, titanium,
nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;
polymers e.g. polypropylene, Teflon etc.; rubber materials e.g.
various grades of silicone rubber etc. Proximal region of
deployable anchor 2000 further comprises a looping lumen 2006. A
looped ribbon 2008 is looped through looping lumen 2006. Looped
ribbon 2008 may be made of a variety of materials including, but
not limited to synthetic fibers e.g. various grades of Nylon,
polyethylene, polypropylene, polyester, Aramid etc.; metals e.g.
various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; natural fibers e.g.
cotton, silk etc.; rubber materials e.g. various grades of silicone
rubber etc. looped ribbon 2008 extends to a proximal region where
it can be cut by a user. In a method of deploying deployable anchor
2000, a single cut is made in looped ribbon 2008 at a proximal
region. This turns looped ribbon 2008 into a straight ribbon. The
straight ribbon can then be pulled in the proximal direction to
remove it from deployable anchor 2000. Looped ribbon 2008 may also
be in the form of a looped monofilament or multifilament wire or
suture.
[0234] FIG. 21A shows a crossectional view of an anchor deploying
system comprising a locked ball. The anchor deploying system
comprises a deployable anchor 2100. Deployable anchor 2100
comprises an anchor body 2102. Deployable anchor 2100 may have
various designs including, but not limited to anchor designs
disclosed elsewhere in this document. Proximal end of anchor body
2102 is connected to a thin shaft 2104. Proximal end of thin shaft
2104 comprises a locking ball 2106. Anchor body 8428, thin shaft
2104 and locking ball 2106 may be made of a variety of materials
including, but not limited to metals e.g. various grades of
stainless steel, titanium, nickel-titanium alloys, cobalt-chromium
alloys, tantalum etc.; polymers e.g. polypropylene, Teflon etc.;
rubber materials e.g. various grades of silicone rubber etc. The
anchor deploying system further comprises an outer locking sheath
2108. Distal end of locking sheath 2108 comprises an opening 2110.
Diameter of opening 2110 is greater than the diameter of thin shaft
2104 but greater than diameter of locking ball 2106. Thus, locking
ball 2106 is locked in locking sheath 2108. The anchor deploying
system further comprises a deploying shaft 2112 located within
locking sheath 2108. Deploying shaft 2112 can be pushed in the
distal direction within locking sheath 2108 by a user. Locking
sheath 2108 and deploying shaft 2112 may be made of a variety of
materials including, but not limited to metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,
Teflon etc. In one embodiment, distal region of locking sheath 2108
comprises one or more longitudinal grooves or windows to allow
distal region of locking sheath 2108 to expand easily in the radial
direction. FIGS. 21B and 21C show a method of deploying an anchor
comprising a locked ball. In FIG. 21B, deploying shaft 2112 is
pushed in the distal direction by a user. This causes distal end of
deploying shaft 2112 to push locking ball 2106 in the distal
direction. This in turn causes locking ball 2106 to exert a force
on the distal end of locking sheath 2108. This force causes opening
2110 to enlarge and release locking ball 2106. In FIG. 21C, locking
ball 2106 is released by locking sheath 2108 thus releasing
deployable anchor 2100.
[0235] FIGS. 22A through 22C show various views of an anchor
deploying system comprising two interlocking cylinders. The anchor
deploying system comprises a proximal interlocking cylinder and a
distal interlocking cylinder. The distal interlocking cylinder is
located on an anchor to be deployed. FIG. 22A shows a perspective
view of a proximal interlocking cylinder 2200 comprising a locking
element 2202 located on the distal end of proximal interlocking
cylinder 2200. In this example, locking element 2202 comprises a
solid cylinder with a ninety degree bend. Proximal interlocking
cylinder 2200 and locking element 2202 may be made of a variety of
materials including, but not limited to metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys,
cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,
Teflon etc. FIG. 22B shows a crossectional view of the anchor
deploying system comprising proximal interlocking cylinder 2200
interlocked with a distal interlocking cylinder 2204. Distal
interlocking cylinder 2204 comprises a groove 2206 which locks
locking element 2202. Locking element 2202 can be unlocked from
distal interlocking cylinder 2204 by turning proximal interlocking
cylinder 2200. distal interlocking cylinder 2204 may be made of a
variety of materials including, but not limited to metals e.g.
various grades of stainless steel, titanium, nickel-titanium
alloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.
polypropylene, Teflon etc.; rubber materials e.g. various grades of
silicone rubber etc. FIG. 22C shows a crossectional view through
plane A-A in FIG. 22B. FIG. 22C shows distal interlocking cylinder
comprising groove 2206. Also shown is locking element 2202 located
in groove 2206. Turning proximal interlocking cylinder 2200 turns
locking element 2202. At a particular orientation, distal region of
locking element 2202 can pass easily through groove 2206 unlocking
proximal interlocking cylinder 2200 from distal interlocking
cylinder 2204.
[0236] FIGS. 22D and 22E show the steps of a method of unlocking
the two interlocking cylinders from the anchor deploying systems of
FIGS. 22A through 22C. In FIG. 22D, locking element 2202 of
proximal interlocking cylinder 2200 is locked in groove 2206 of
distal interlocking cylinder 2204. In FIG. 22E, proximal
interlocking cylinder 2200 is turned in a clockwise or
counterclockwise direction to unlock locking element 2202 from
groove 2206. Thereafter, proximal interlocking cylinder 2200 is
pulled in the proximal direction to separate proximal interlocking
cylinder 2200 from distal interlocking cylinder 2204.
[0237] FIG. 23A shows a perspective view of a distal end of an
anchoring device that has an imaging modality. Anchoring device
2300 comprises an elongate shaft 2302 comprising a lumen. Elongate
shaft 2302 can be made of suitable biocompatible materials such as
metals, polymers etc. The lumen of shaft 2302 terminates in a
window 2304 located on the distal region of shaft 2302. Anchoring
device further comprises an imaging modality such as a cystoscope,
an ultrasound imaging system etc. In this example, the imaging
modality is a cystoscope 2306. Distal end of cystoscope 2306 is
located in window 2304 to allow visualization of the anatomy
adjacent to window 2304. In one embodiment, cystoscope 2306 is
permanently fixed to anchoring device 2300. In another embodiment,
cystoscope 2306 can be introduced through the proximal region of
anchoring device 2300. Anchoring device 2300 further comprises a
puncturing device 2308. Puncturing device 2308 comprises a sharp
distal tip and a lumen that holds an anchor. Anchoring device 2300
further comprises an anchor deployment device 2310. Distal end of
anchor deployment device 2310 is detachably attached to the
anchor.
[0238] FIGS. 23B through 23G show various steps of a method for
compressing an anatomical region using the anchoring device of FIG.
23A. In FIG. 23B, Anchoring device 2300 is introduced in an
anatomical region such that distal end of anchoring device 2300 is
located adjacent to a target anatomical region to be treated. In
one method embodiment, anchoring device 2300 is introduced
transurethrally into the prostatic urethra. Thereafter, puncturing
device 2308 is advanced to puncture the anatomical region. In this
example, puncturing device 2308 punctures the prostate gland PG
such that distal end of puncturing device 2308 is located in the
pelvic cavity. Puncturing device comprises an anchor located in the
lumen of puncturing device 2308. The anchor comprises a distal
anchor 2312, a tension element 2314 connected at one end to distal
anchor 2312 and a proximal anchor 2316 that can slide over tension
element 2314. Puncturing device 2308 comprises a groove at the
distal end such that tension element exits puncturing device 2308
through the groove. Puncturing device 2308 further comprises a
pusher 2318 that can push distal anchor 2312 out of puncturing
device 2308. Proximal anchor 2316 is detachably attached to the
distal region of anchor deployment device 2310. Proximal anchor
2312, distal anchor 2316 and tension element 2314 may comprise
designs including, but not limited to the designs disclosed
elsewhere in this patent application. The imaging modality may be
used to verify the accurate placement and working of anchoring
device 2300. In FIG. 23C, pusher 2318 is pushed in the distal
direction to push distal anchor 2312 out of puncturing device 2308.
Distal anchor 2312 is thus deployed in the anatomy e.g. in the
pelvic cavity surrounding the prostate gland PG. Thereafter, in
step 23D, Puncturing device 2308 is withdrawn by pulling it in the
proximal direction. In step 23E, tension element 2314 is pulled in
the proximal direction through anchor deployment device 2310.
Thereafter, in step 23F, tension element 2314 is pulled further in
the proximal direction such that the anatomical region between
proximal anchor 2316 and distal anchor 2312 is compressed.
Thereafter, in step 23G, proximal anchor 2316 is securely locked on
to tension element 2314. Further in step 23G, proximal anchor 2316
is detached from anchor deployment device 2310. The detachment can
be performed by a variety of mechanisms including, but not limited
to the anchor detachment mechanisms disclosed elsewhere in this
patent application. Further in step 23G, excess length of tension
element 2314 is removed. This removal can be done using a variety
of methods including, but not limited to the methods disclosed
elsewhere in this patent application such as cutting, delinking,
melting, and breaking. Thereafter, anchoring device 2300 is
withdrawn from the anatomy. It should be understood that these
deployment steps may be repeated in the same, opposing or
neighboring tissues to essentially tack up the encroaching tissue
(i.e. prostatic tissue, tumor, relaxed tissue, expanded tissue or
growth). It may be desired that over time both anchors become
completely embedded within the tissue and covered to prevent
encrustation, clotting or other tissue or body-fluid
interaction--this may be facilitated by the processes, therapeutic
agents and coatings described elsewhere in the application.
Although these anchors are shown on either side of the tissue, it
may be possible to deploy either or both of them within the body of
the tissue itself to help bury them and eliminate the possibility
that they may interact with other parts of the body. It should
further be noted that in the case of application to the prostate,
that this technique may be used on any of the lateral or middle
lobes to compress or hold the prostate gland PG away from the lumen
of the urethra.
[0239] If removal of the intra or para luminal anchor is required,
it may be possible to resect that region completely, capturing the
anchor embedded within the tissue and removing it en-bloc, severing
the tether in the process. In the case of prostate applications,
such removal may be accomplished with a standard resectoscope
system. In other regions, and energized RF or sharp curette or
blade may be used to resect the anchor minimally invasively.
Alternatively if engagement with the locking mechanism is still
achievable, it may be possible to simply unlock the tether,
releasing the anchor. Lastly, if applying additional tension at
some point after the procedure is required, it may be possible to
engage and grasp the tether as it exits the locking device in the
anchor and apply additional tension.
[0240] FIGS. 24A through 24C' show various steps of a method of
compressing an anatomical region using a device with deploying arms
deployed through a trocar. In FIG. 24A, an anchoring device 2400 is
introduced in an anatomical region. Anchoring device 2400
comprising a distal anchor 2402 is introduced in the anatomy.
Distal anchor 2402 comprises a hollow shaft. Distal end of distal
anchor 2402 comprises one or more outwardly curling or spreading
arms 2404. Curling or spreading arms 2404 are made of an elastic,
springy, super-elastic or shape memory material such that they tend
to curl or spread in a radially outward direction in absence of an
external force. Anchoring device 2400 further comprises a proximal
anchor comprising a variety of designs including, but not limited
to the designs disclosed elsewhere in this patent application. In
this example, proximal anchor is designed similar to anchor 1040 in
FIG. 10D. Anchor 1040 can slide along proximal region of distal
anchor 2402. Anchor 1040 can also be attached to distal anchor 2402
after a desired positioning between anchor 1040 and distal anchor
2402 is achieved. Anchoring device 2400 is delivered through a
trocar 2406. Trocar 2406 comprises a sharp distal tip 2408 that can
penetrate through tissue. The proximal region of distal tip 2408
comprises one or more grooves or notches such that distal ends of
curling or spreading arms 2404 can be temporarily held together by
distal tip 2408 to allow for easy introduction into a target
anatomy. Anchoring device 2400 is introduced into a target tissue
to be compressed such that curling or spreading arms 2404 are
distal to the target tissue and anchor 1040 is proximal to the
target tissue. FIG. 24A' shows the distal end view of the anchoring
device 2400. In FIG. 24B, trocar 2406 is pushed in the distal
direction relative to proximal anchor 2402. This releases the
distal ends of curling or spreading arms 2404 causing them to curl
or spread outwards. FIG. 24A' shows the distal end view of the
anchoring device 2400 with released curling or spreading arms 2404.
In FIG. 24C, anchor 1040 is pushed in the distal direction over
distal anchor 2402 to compress tissue between anchor 1040 and
distal anchor 2402. Thereafter, anchor 1040 is attached to the
hollow shaft of distal anchor 2402. Thereafter trocar 2406 is
withdrawn from the anatomy. In the above embodiment, the tethering
function is performed by the shaft of the distal anchor, and the
force is created by the curling arms. This tension may be pre-set
into the arms through heat forming. It should be noted that any
mechanism capable of expanding from within a tubular shape and
capable of applying retrograde forces on the tissue are within the
scope of this invention such as expandable flanges, balloons,
cages, molly-bolt-like structures, stent-like structures and
springs.
[0241] FIG. 24D shows a crossection through the deployed anchoring
device 2400 of FIG. 24A.
[0242] In one anchoring device embodiment, anchoring device 2400
comprises a distal anchor such as the distal anchor described in
FIG. 17A instead of distal anchor 2412.
[0243] FIG. 25A shows a perspective view of a spring clip that can
be used to spread the anatomy. Clip 2500 comprises two or more
spreading arms 2502. Spreading arms 2502 may be curved or straight.
Distal ends of spreading arms 2502 may comprise a flattened region.
The proximal ends or curved arms 2502 are connected to each other
by a heel region 2504. Heel region 2504 may be made from the same
material as curved arms 2502. In an undeployed configuration,
spreading arms 2502 are held close to each other. When clip 2500 is
deployed, spreading arms 2502 tend to expand away from each other
thus spreading the anatomical region or regions between spreading
arms 2502. Clip 2500 can be made of suitable elastic, super-elastic
or shape memory biocompatible materials including, but not limited
to synthetic fibers e.g. various grades of Nylon, polyethylene,
polypropylene, polyester, Aramid etc.; metals e.g. various grades
of stainless steel, titanium, nickel-titanium alloys, etc.
[0244] FIGS. 25B through 25F show various steps of a method of
spreading an anatomical region or regions using the spring clip of
FIG. 25A. In FIG. 25B, a delivery tool 2506 comprising a clip 2500
is introduced in the anatomy and positioned near the target anatomy
to be spread. Delivery tool 2506 comprises an elongate hollow body
2508 comprising a lumen. Distal end of body 2508 may comprise a
blunt, atraumatic end. Distal region of body 2508 comprises a slot
2510 that is in fluid communication with the lumen of body 2508.
Delivery tool may further comprise an outer sheath 2512 and an
imaging modality 2514. Imaging modality 2514 may be permanently
attached to delivery tool 2506 or may be introduced into delivery
tool 2506 by a user. In this example, imaging modality 2514 is a
cystoscope. In FIG. 25C, clip 2500 is introduced into the anatomy
by pushing clip 2500 out of slot 2510 such that the distal ends of
spreading arms 2502 emerge first. Slot 2510 is designed such that
spreading arms 2504 are biased towards each other as they emerge
out of slot 2510. In FIG. 25D, clip 2500 is further advanced such
that distal tips of spreading arms 2502 penetrate into the tissue
to be spread. In FIG. 25E, clip 2500 is advanced further such that
the biasing forces on spreading arms 2502 are removed. Spreading
arms 2502 tend to spread away from each other thus spreading the
tissue between them. Clip 2500 is detachably attached to delivery
tool 2506 by a detaching mechanism 2516 including, but not limited
to the several detaching mechanisms disclosed elsewhere in this
patent application. In FIG. 25F, detaching mechanism 2516 is used
to detach clip 2500 from delivery tool 2506 or deploy clip 2500 in
the target anatomy. In this example, distal region of delivery tool
2506 is inserted transurethrally into the prostatic urethra. Clip
2500 is then delivered into the anterior commissure to spread the
two lateral lobes of the prostate gland PG apart. In one method
embodiment, an opening in the commissure is made prior to the
method of FIGS. 25B through 25G. In another embodiment, the
spreading force exerted by spreading arms 2502 cause cutting of the
anterior commissure. Clip 2500 may be placed completely
sub-urethrally or a small amount of heel region 2504 remains in the
urethra.
[0245] The embodiments of anchoring devices wherein a sliding
anchor is slid over a tension element may comprise one or more
cinching elements. These cinching elements may be present on the
sliding anchors, on the tension elements etc. A cinching element
may be a separate device that cinches to a tension element. In
doing so, it increases the effective diameter of that region of the
tension element and prevents the tension element from sliding
through a sliding anchor. Cinching elements may allow only
unidirectional motion of the sliding anchor over the tension
element or may prevent any substantial motion of the sliding anchor
over the tension element. Typical examples of such cinching
mechanisms include, but are not limited to mechanisms described in
the FIG. 26 series. For example, FIGS. 26A and 26B show a
crossectional view and a perspective view respectively of a
mechanism of cinching a tension element or tether to an anchor. In
FIG. 26A, cinching mechanism 2600 comprises an outer base 2602.
Outer base 2602 comprises one or more grooves created by the
presence of two or more leaflets 2604. Leaflets 2604 are biased
along a first axial direction as shown in FIG. 26A. When a tension
element 2606 is located in the one or more grooves, cinching
mechanism 2600 allows motion of tension element 2606 only along the
first axial direction and prevents substantial movement of tension
element 2606 in the opposite direction.
[0246] FIGS. 26C and 26D show a partial section through a cinching
mechanism comprising a cam element. In FIG. 26C, cinching mechanism
2610 comprises an outer body 2612 made of suitable biocompatible
metals, polymers etc. Body 2162 comprises a cam 2614 located on a
pivot 2616. Cam 2614 may comprise a series of teeth to grip a
tension element 2618 passing through body 2612. In one embodiment,
body 2162 comprises an opening 2620 located proximal to cam 2614.
Proximal region of tension element 2618 passes out of body 2612
through opening 2620. Cinching mechanism 2610 allows movement of
body 2162 over tension element 2618 in the proximal direction. In
FIG. 26D, body 2162 is moved over tension element 2618 in the
distal direction. Motion of tension element 2618 over cam 2614
causes cam 2614 to turn in the anti-clockwise direction. This
causes tension element 2618 to be pinched between cam 2614 and body
2612. This in turn prevents further motion of body 2162 over
tension element 2618.
[0247] FIG. 26E shows a sectional view of an embodiment of a
cinching mechanism comprising a locking ball. Cinching mechanism
2630 comprises an outer body 2632 comprising a lumen. A tension
element 2634 passes through the lumen of outer body 2632. The lumen
of outer body gradually reduces in the proximal direction as shown
in FIG. 26E. A locking ball 2636 is present in the lumen. Motion of
outer body 2632 over tension element 2634 in the distal direction
pushes locking ball 2636 in the proximal region of outer body 2632.
A proximal end region 2638 of a small diameter prevents locking
ball 2636 from falling out of outer body 2632. The large lumen
diameter in the proximal region of outer body 2632 allows free
motion of locking ball 2636. Thus, presence of locking ball 2636
does not hinder the motion of outer body 2632 over tension element
2634 in the proximal direction. When outer body 2632 is moved over
tension element 2634 in the proximal direction, locking ball 2636
is pushed in the distal region of outer body 2632. The small lumen
diameter in the proximal region of outer body 2632 constricts
motion of locking ball 2636. This causes a region of tension
element 2634 to be pinched between anchoring ball 2636 and outer
body 2632. This in turn prevents further motion of outer body 2632
over tension element 2634 in the proximal direction. This mechanism
thus allows unidirectional motion of outer body 2632 is over
tension element.
[0248] FIG. 26F shows a side view of an embodiment of a cinching
mechanism comprising multiple locking flanges. In this embodiment,
cinching mechanism 2644 comprises a body 2646 comprising a lumen
lined by a first locking flange 2648 and a second locking flange
2650. First locking flange 2648 and second locking flange 2650 are
biased in the proximal direction as shown. A tension element 2652
passes through the lumen of body 2646. First locking flange 2648
and second locking flange 2650 together allow the movement of body
2646 over tension element 2652 in the distal direction, but prevent
movement of body 2646 over tension element 2652 in the proximal
direction. Similar cinching mechanisms may be designed comprising
more than two locking flanges. FIG. 26G shows an end view of body
2646 comprising a lumen lined by first locking flange 2648 and
second locking flange 2650. Body 2646 may be made of suitable
biocompatible metals, polymers etc.
[0249] FIG. 26H shows a side view of an embodiment of a cinching
mechanism comprising a single locking flange. In this embodiment,
cinching mechanism 2656 comprises a body 2658 comprising a lumen
lined by a locking flange 2660. Locking flange 2660 is biased in
the proximal direction as shown. A tension element 2662 passes
through the lumen of body 2658. Locking flange 2660 allows the
movement of body 2658 over tension element 2662 in the distal
direction, but prevents movement of body 2658 over tension element
2662 in the proximal direction. FIG. 26I shows an end view of body
2658 comprising a lumen 2662 lined by locking flange 2660. Body
2658 may be made of suitable biocompatible metals, polymers
etc.
[0250] FIG. 26J shows an end view of a cinching mechanism
comprising a crimping lumen. Cinching mechanism 2670 comprises a
body 2672 comprising a crimping lumen 2674. Crimping lumen 2674 is
in the form of an arc with a gradually reducing size as shown in
FIG. 26J. A tension element 2676 passes through crimping lumen
2674. In FIG. 26J, tension element 2676 is locked in a region of
crimping lumen 2674 of a diameter smaller than the diameter of
tension element 2676. Tension element 2676 can be unlocked from
crimping lumen 2674 by rotating body 2672 in the anti-clockwise
direction. Similarly, rotating body 2672 in the clockwise direction
causes an unlocked tension element 2676 to be locked into crimping
lumen 2674.
[0251] In an alternate embodiment, cinching mechanism comprises a
disk shaped body comprising a central lumen. Central lumen is large
enough to allow a tension element to slide easily through the
central lumen. One or more radially oriented slits emerge from the
central lumen. The radially oriented slits have a diameter that is
of the same size or is slightly smaller than the diameter of the
tension element. To lock cinching mechanism to the tension element,
the tension element is forced through one of the radially oriented
slits. The friction between the disk shaped body and the tension
element prevents or resists sliding of tension element through the
disk shaped body. To unlock cinching mechanism from the tension
element, the tension element is moved back to the central
lumen.
[0252] In another alternate embodiment, cinching mechanism
comprises a disk shaped body comprising a small central lumen. The
central region of the body comprises three or more triangular flaps
biased together out of the plane of the body. The ends of the
triangular flaps together form the central lumen that is of the
same size or is slightly smaller than the diameter of the tension
element. Tension element can pass easily through the central lumen
in the direction of the bias of the triangular flaps. But, tension
element cannot pass or encounters substantial resistance when the
tension element is pulled through the central lumen in the opposite
direction.
[0253] FIGS. 26K and 26L show crossections of an embodiment of a
cinching mechanism comprising a crimping anchor in the undeployed
and deployed configurations respectively. Cinching mechanism 2680
comprises a crimping anchor 2680 comprising a lumen. Crimping
anchor 2680 can be made of a variety of biocompatible materials
including, but not limited to metals e.g. various grades of
stainless steel, titanium, nickel-titanium alloys, cobalt-chromium
alloys, tantalum etc., polymers, etc. A tension element 2684 passes
through the lumen of crimping anchor 2680. The lumen of an
undeployed crimping anchor 2680 is larger than the diameter of
tension element 2684. In FIG. 26L, crimping anchor 2680 is deployed
by compressing the middle section of crimping anchor 2680 such that
crimping anchor 2680 compresses tension element 2684. Friction
between crimping anchor 2680 and tension element 2684 prevents
relative motion between crimping anchor 2680 and tension element
2684. Crimping anchor 2680 may be a component of a sliding anchor
or may be a stand-alone device used to prevent or restrict motion
of a sliding anchor over a tension element.
[0254] FIG. 26M shows a perspective view of an embodiment of a
cinching mechanism comprising an element providing a tortuous path
to a tension element. In this example, cinching mechanism 2686
comprises a spring 2688. A tension element 2690 is passed through
spring 2688 such that the path of tension element 2690 through
spring 2688 is tortuous. When spring 2688 is moved over tension
element, motion of tension element 2690 through the tortuous path
generates high frictional forces that prevent or reduce motion of
spring 2688 over tension element 2690. The frictional forces are
strong enough to resist motion of spring 2688 over tension element
2690 after deploying cinching mechanism 2686 in the anatomy. A user
can move spring 2688 over tension element 2690 by applying a force
that overcomes the resistive frictional forces that prevent
movement of spring 2688 over tension element 2690. Similarly, other
cinching mechanisms comprising a tortuous path can be used instead
of spring 2688. Examples of such mechanisms are solid elements
comprising tortuous lumens, elements comprising multiple struts or
bars that provide a tortuous path etc. In another embodiment the
cinching mechanism comprises a knot on one or more tensioning
element. Said knot can be advanced fully tightened or can be loose
when advanced and tightened in situ.
[0255] FIG. 26N shows a crossectional view of an embodiment of a
locking mechanism comprising a space occupying anchor securely
attached to a tension element. Locking mechanism 2692 comprises a
hollow element 2694 comprising a lumen. Hollow element 2694 is a
component of a sliding anchor that slides over tension element
2696. Tension element 2696 comprises a space occupying anchor 2698
comprising a tapering distal end 2699. Anchor 2698 is securely
attached to tension element 2696. Diameter of anchor 2698 is larger
than the diameter of the lumen of hollow element. Due to this,
anchor 2698 cannot pass through hollow element 2694 effectively
locking the position of tension element 2696 with respect to the
position of hollow element 2694.
[0256] FIGS. 26O and 26P shows a partial sectional view and a
perspective view of an embodiment of a cinching mechanism
comprising a punched disk. Cinching mechanism 2602' comprises a
disk 2604' comprising a punched hole 2606'. Punched hole 2606' is
made by punching disk 2604' along the proximal direction such that
the punching action leaves an edge that is biased along the
proximal direction as shown in FIG. 26O. Disk 2604' can slide over
a tension element 2608' along the distal direction. However, motion
of disk 2604' over tension element 2608' along the proximal
direction is substantially resisted by the proximally biased edges
of punched hole 2606'.
[0257] Excess lengths of tension elements or other severable
regions of one or more devices disclosed in this patent application
may be cut, severed or trimmed using one or more cutting devices.
For example, FIGS. 26Q and 26R show a perspective view of a first
embodiment of a cutting device before and after cutting an elongate
element. In FIG. 26Q, cutting device 2610' comprises an outer
sheath 2612' comprising a sharp distal edge 2614'. Outer sheath
2612' encloses an inner sheath 2616'. Inner diameter of outer
sheath 2612' is slightly larger than outer diameter of inner sheath
2616' such that inner sheath 2616' can slide easily through outer
sheath 2612'. Inner sheath 2616' comprises a lumen that terminates
distally in an opening 2618'. An elongate severable device passes
through the lumen and emerges out of opening 2618'. An example of
an elongate severable device is a tension element 2620'. In the
method of cutting or trimming tension element 2620' the desired
area of tension element 2620' to be cut or severed is positioned
near opening 2618' by advancing or withdrawing cutting device 2610'
over tension element 2620'. Thereafter, outer sheath 2612' is
advanced over inner sheath 2616' to cut tension element 2620'
between sharp distal edge 2614' and an edge of opening 2618'. Inner
sheath 2616' and outer sheath 2612' may be substantially rigid or
flexible. They may be made of suitable materials including, but not
limited to Pebax, Polyimide, Braided Polyimide, Polyurethane,
Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainless steel and
fluoropolymers like PTFE, PFA, FEP and EPTFE etc.
[0258] FIG. 26S show a crossectional view of a second embodiment of
a cutting device for cutting an elongate element. Cutting device
2622' comprises an outer sheath 2624' comprising a lumen that opens
in an opening 2626' in outer sheath 2624'. Outer sheath 2624'
encloses an inner sheath 2628' that comprises a lumen and a sharp
distal edge 2630'. Inner diameter of outer sheath 2624' is slightly
larger than outer diameter of inner sheath 2628' such that inner
sheath 2628' can slide easily through outer sheath 2624'. An
elongate severable device passes through the lumen of inner sheath
2628' and emerges out of distal end of inner sheath 2628' and out
of outer sheath 2624' through opening 2626'. An example of an
elongate severable device is a tension element 2632'. In the method
of cutting or trimming tension element 2632' the desired area of
tension element 2632' to be cut or severed is positioned near
opening 2626' by advancing or withdrawing cutting device 2622' over
tension element 2632'. Thereafter, inner sheath 2628' is advanced
through outer sheath 2624' to cut tension element 2632' between
sharp distal edge 2630' and an edge of opening 2626'. Inner sheath
2628' and outer sheath 2624 may be substantially rigid or flexible.
They may be made of suitable materials including, but not limited
to Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC,
Hytrel, HDPE, PEEK, metals like stainless steel and fluoropolymers
like PTFE, PFA, FEP and EPTFE etc.
[0259] In a third embodiment of a cutting device for cutting an
elongate element, the cutting device comprises an outer hollow
sheath. Outer hollow sheath has a distal end plate comprising a
window. An elongate severable device passes through the window. An
example of an elongate severable device is a tension element. An
inner shaft can slide and rotate within outer hollow sheath. Distal
end of inner shaft comprises a blade that is usually located away
from the window and adjacent to the distal end plate of the outer
hollow sheath. In the method of cutting or trimming tension element
the elongate severable device, the desired area of the elongate
severable device to be cut or severed is positioned near the
window. This is done by advancing or withdrawing the cutting device
over the elongate severable device. Thereafter, the inner shaft is
rotated within outer hollow sheath such that the blade cuts the
elongate severable device between a sharp edge of the blade and an
edge of the window. Inner shaft and outer hollow sheath may be
substantially rigid or flexible. They may be made of suitable
materials including, but not limited to Pebax, Polyimide, Braided
Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals
like stainless steel and fluoropolymers like PTFE, PFA, FEP and
EPTFE etc. The end plate and the blade are preferentially rigid.
They may be made of suitable materials including, but not limited
to metals like stainless steel, polymers like Polycarbonate,
Polyimide, PVC, Hytrel, HDPE, PEEK and fluoropolymers like PTFE,
PFA, FEP etc.
[0260] The anchoring devices disclosed herein may be used in a
variety of configurations depending on the location of the disease
process, ease of procedure etc. FIGS. 27A through 27D show axial
sections through the prostate gland PG showing various
configurations of anchoring devices comprising distal anchors 2700
and a tension element 2702 that is anchored at a suitable location
such that a sufficient tension exists in tension element 2702.
[0261] FIGS. 28 and 28A show perspective views of an embodiment of
an anchoring device comprising an elongate element comprising
multiple barbs or anchors. FIG. 28 shows a perspective view of
anchoring device 2800 comprising an elongate element 2802. Elongate
element 2802 can be made of several biocompatible materials
including, but not limited to synthetic fibers e.g. various grades
of Nylon, polyethylene, polypropylene, polyester, Aramid etc.;
metals e.g. various grades of stainless steel, titanium,
nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;
natural fibers e.g. cotton, silk etc.; rubber materials e.g.
various grades of silicone rubber etc. Elongate element 2802 may
comprise natural or artificial suture materials. Examples of such
materials include but are not limited to Polyamide (Nylon),
Polypropylene, Polyglycolic Acid (PGA), polylactic acid (PLA) and
copolymers of polylactic acid, polyglycolic acid and copolymers of
polyglycolic acid, copolymers of PLA and PGA, Silk, Polyester,
silicone, collagen, Polymers of Glycolide and Lactide. A particular
example of a suture is the Nordstrom suture which is a highly
elastic silicone suture. In one embodiment, the suture material is
bioabsorbable. Elongate element 2802 comprises two sets of
projections such as barbs, anchors or hooks. In the example shown,
elongate element 2802 comprises a set of distal barbs 2804 and a
set of proximal barbs 2806. Distal barbs 2804 are oriented in the
proximal direction and proximal barbs 2806 are oriented in the
distal direction as shown in FIG. 25. FIG. 28A shows a magnified
view of the region 28A of anchoring device 2800 showing proximal
barbs 2806.
[0262] FIGS. 28B through 28E show a coronal section through the
prostate gland PG showing various steps of a method of treating the
prostate gland PG using the device of FIG. 28. In FIG. 28B,
introducer device 300 of FIG. 3A comprising a working device lumen
and a cystoscope lumen 308 is introduced into the urethra such that
the distal end of introducer device 300 is located in the prostatic
urethra. Thereafter, a hollow puncturing device 2808 is inserted in
the working device lumen of introducer device. Puncturing device
2808 is advanced such that distal end of puncturing device 2808
penetrates the prostate gland PG. In FIG. 28C, anchoring device
2800 is introduced through puncturing device 2808 into the prostate
gland PG. Thereafter, puncturing device 2808 is pulled in the
proximal direction. Simultaneously, anchoring device 2800 is pulled
in the proximal direction to anchor distal barbs 2804 in the
anatomy. In FIG. 28D, puncturing device 2808 is pulled further in
the proximal direction to expose the entire anchoring device 2800.
Thereafter, in step 28E, the proximal end of anchoring device 2800
is detached to deploy anchoring device 2800 in the anatomy. Thus,
tissue between distal barbs 2804 and proximal barbs 2806 is
anchored to anchoring device 2800.
[0263] FIG. 29A shows an axial section of the prostate gland PG
showing a pair of implanted magnetic anchors. In FIG. 29A, a first
magnetic anchor 2900 and a second magnetic anchor 2902 are
implanted in the prostate gland PG on either side of the urethra.
Like poles of first magnetic anchor 2900 and second magnetic anchor
2902 face each other such that there is magnetic repulsion between
first magnetic anchor 2900 and second magnetic anchor 2902. This
causes the urethral lumen to widen potentially reducing the
severity of BPH symptoms.
[0264] FIGS. 29B through 29D show a coronal section through the
prostate gland PG showing the steps of a method of implanting
magnetic anchors of FIG. 29A. In FIG. 29B, a deployment device 2904
is advanced trans-urethrally. Deployment device 2904 comprises a
sharp distal tip 2906 and first magnetic anchor 2900. Distal tip
2906 of deployment device 2904 penetrates prostatic tissue and
implants first magnetic anchor 2900 in the prostate gland PG.
Similarly, another deployment device 2908 comprising a sharp distal
tip 2920 is used to implant second magnetic anchor 2902 in the
prostate gland PG. First magnetic anchor 2900 and second magnetic
anchor 2902 are implanted on opposite sides of the urethra such
that like poles of first magnetic anchor 2900 and second magnetic
anchor 2902 face each other. This causes magnetic repulsion between
first magnetic anchor 2900 and second magnetic anchor 2902. This
causes the urethral lumen to widen potentially reducing the
severity of BPH symptoms. In one embodiment, deployment device 2904
can be used to deploy multiple magnetic anchors.
[0265] FIG. 30A shows a coronal section of a region of the male
urinary system showing the general working environment of a method
of treating prostate disorders by cutting prostrate tissue using a
device inserted into the prostate gland PG from the urethra.
Cutting device 3000 comprises an outer body 3002 comprising a side
port 3004. Outer body 3002 can be made of suitable biocompatible
materials including, but not limited to metals e.g. stainless
steel, Nickel-Titanium alloys, titanium etc.; polymers e.g. etc.
Cutting device 3000 further comprises an access device 3006 that
can be deployed out of side port 3004. Access device 3006 can be
retracted back into side port 3004. Typical examples of elements
that can be used as access device 3006 are needles, trocars etc.
Access device 3006 may be made from suitable biocompatible
materials including, but not limited to metals e.g. stainless
steel, Nickel-Titanium alloys, titanium etc.; polymers e.g. etc.
Access device 3006 penetrates the walls of the urethra and enters
the prostate gland PG by creating an access channel in the prostate
gland PG. Cutting device 3000 further comprises a cutting element
3008 that is introduced into the prostate gland PG through the
access channel in the prostate gland PG. In one embodiment, cutting
element 3008 enters the prostate gland PG through access device
3006. Cutting element 3008 comprises one or more cutting modalities
such as electrosurgical cutter, Laser cutter, mechanical cutter
e.g. a knife edge etc. Cutting element 3008 may be moved through
prostate tissue by several mechanisms including one or more
deflecting or bending elements located on cutting element 3008; one
or more articulating elements located on cutting element 3008;
motion of cutting device 3000 along the urethra etc. Cutting
element 3008 is used to cut one or more regions of the prostate
gland PG including peripheral zone, transition zone, central zone
or prostatic capsule. After the desired region or regions of the
prostate gland PG are cut, cutting element 3008 and access device
3006 are withdrawn into cutting device 3000. Thereafter, cutting
device 3000 is withdrawn from the urethra. In one device
embodiment, cutting device 3000 comprises an endoscope or means for
inserting an endoscope.
[0266] FIG. 30B shows a coronal section of a region of the male
urinary system showing the general working environment of a method
of treating prostate disorders by cutting prostrate tissue using a
device that accesses outer surface of the prostate gland PG by
passing through the walls of the urethra distal to the prostate
gland PG. Cutting device 3020 comprises an outer body 3022
comprising a side port 3024. Outer body 3022 can be made of
suitable biocompatible materials including, but not limited to
metals e.g. stainless steel, Nickel-Titanium alloys, titanium etc.;
polymers e.g. etc. Cutting device 3020 is advanced into the urethra
such that side port 3024 is located distal to the prostate gland
PG. Cutting device 3020 further comprises an access device 3026
that can be deployed out of side port 3024. Access device 3026 can
be retracted back into side port 3024. Typical examples of elements
that can be used as access device 3026 are needles, trocars etc.
Access device 3026 may be made from suitable biocompatible
materials including, but not limited to metals e.g. stainless
steel, Nickel-Titanium alloys, titanium etc.; polymers e.g. etc.
Access device 3026 is deployed from side port 3024 in a desired
orientation such that access device 3026 penetrates the wall of the
urethra. Access device 3026 is advanced further such that distal
end of access device 3026 is located near the prostate gland PG.
Thereafter, a cutting element 3028 is introduced through access
device 3026 to the outer surface of the prostate gland PG. Cutting
element 3028 comprises one or more cutting modalities such as
electrosurgical cutter, Laser cutter, mechanical cutter e.g. a
knife edge etc. Cutting element 3028 is used to cut one or more
regions of the prostate gland PG including prostatic capsule,
peripheral zone, transition zone or central zone. Cutting element
3028 may be moved relative to prostate tissue by several mechanisms
including one or more deflecting or bending elements located on
cutting element 3028; motion of cutting element 3028 along access
device 3026 etc. In one method embodiment, cutting element 3028
cuts prostatic capsule while being withdrawn into access device
3026. After the desired region or regions of the prostate gland PG
are cut, cutting element 3028 and access device 3026 are withdrawn
into cutting device 3020. Thereafter, cutting device 3020 is
withdrawn from the urethra. In one device embodiment, cutting
device 3020 further comprises an endoscope or means for inserting
an endoscope.
[0267] FIG. 30C shows a coronal section of a region of the male
urinary system showing the general working environment of a method
of treating prostate disorders by cutting prostrate tissue using a
device that accesses outer surface of the prostate gland PG by
passing through the wall of the urinary bladder. Cutting device
3040 comprises an outer body 3042 comprising a side port 3044.
Outer body 3042 can be made of suitable biocompatible materials
including, but not limited to metals e.g. stainless steel,
Nickel-Titanium alloys, titanium etc.; polymers e.g. etc. Cutting
device 3040 is advanced into the urethra such that side port 3044
is located inside the urinary bladder. Cutting device 3040 further
comprises an access device 3046 that can be deployed out of side
port 3044. Access device 3046 can be retracted back into side port
3044. Typical examples of elements that can be used as access
device 3046 are needles, trocars etc. Access device 3046 may be
made from suitable biocompatible materials including, but not
limited to metals e.g. stainless steel, Nickel-Titanium alloys,
titanium etc.; polymers e.g. etc. Access device 3046 is deployed
from side port 3044 in a desired orientation such that access
device 3046 penetrates the wall of the urinary bladder. Access
device 3046 is advanced further such that distal end of access
device 3046 is located near the prostate gland PG. Thereafter, a
cutting element 3048 is introduced through access device 3046 to
the outer surface of the prostate gland PG. Cutting element 3048
comprises one or more cutting modalities such as electrosurgical
cutter, Laser cutter, mechanical cutter e.g. a knife edge etc.
Cutting element 3048 is used to cut one or more regions of the
prostate gland PG including prostatic capsule, peripheral zone,
transition zone or central zone. Cutting element 3048 may be moved
relative to prostate tissue by several mechanisms including one or
more deflecting or bending elements located on cutting element
3048; motion of cutting element 3048 along access device 3046 etc.
In one method embodiment, cutting element 3048 cuts prostatic
capsule while being withdrawn into access device 3046. After the
desired region or regions of the prostate gland PG are cut, cutting
element 3048 and access device 3046 are withdrawn into cutting
device 3040. Thereafter, cutting device 3040 is withdrawn from the
urethra. In one device embodiment, cutting device 3040 further
comprises an endoscope or means for inserting an endoscope.
[0268] FIG. 30D shows a coronal section of a region of the male
urinary system showing the general working environment of a method
of treating prostate disorders by cutting prostrate tissue using a
device that accesses outer surface of the prostate gland PG by
passing through the walls of the urethra enclosed to the prostate
gland PG. Cutting device 3060 comprises an outer body 3062
comprising a side port 3064. Outer body 3062 can be made of
suitable biocompatible materials including, but not limited to
metals e.g. stainless steel, Nickel-Titanium alloys, titanium etc.;
polymers e.g. etc. Cutting device 3060 is advanced into the urethra
such that side port 3064 is located in the region of the urethra
enclosed by the prostate gland PG. Cutting device 3060 further
comprises an access device 3066 that can be deployed out of side
port 3064. Access device 3066 can be retracted back into side port
3064. Typical examples of elements that can be used as access
device 3066 are needles, trocars etc. Access device 3066 may be
made from suitable biocompatible materials including, but not
limited to metals e.g. stainless steel, Nickel-Titanium alloys,
titanium etc.; polymers e.g. etc. Access device 3066 is deployed
from side port 3064 in a desired orientation such that access
device 3066 penetrates the prostate. Thereafter, a cutting element
3068 is introduced through access device 3066 such that the distal
region of cutting element can access the outer surface of the
prostate gland PG. Cutting element 3068 comprises one or more
cutting modalities such as electrosurgical cutter, Laser cutter,
mechanical cutter e.g. a knife edge etc. Cutting element 3068 is
used to cut one or more regions of the prostate gland PG including
prostatic capsule, peripheral zone, transition zone or central
zone. Cutting element 3068 may be moved relative to prostate tissue
by several mechanisms including one or more deflecting or bending
elements located on cutting element 3068; motion of cutting element
3068 along access device 3066 etc. In one method embodiment,
cutting element 3068 cuts prostatic capsule while being withdrawn
into access device 3066. After the desired region or regions of the
prostate gland PG are cut, cutting element 3068 and access device
3066 are withdrawn into cutting device 3060. Thereafter, cutting
device 3060 is withdrawn from the urethra. In one device
embodiment, cutting device 3060 further comprises an endoscope or
means for inserting an endoscope.
[0269] FIG. 31 shows a coronal section of a region of the male
urinary system showing the general working environment of a method
of treating prostate disorders by cutting prostrate tissue by a
percutaneous device that accesses the prostate gland PG through an
incision in the abdomen. In this method, a cannula 3100 is
introduced percutaneously into the lower abdomen. Cannula 3100 can
be made of suitable biocompatible materials including, but not
limited to metals e.g. stainless steel, Nickel-Titanium alloys,
titanium etc.; polymers etc. Cannula 3100 is advanced into the
abdomen such that it passes below the pubic bone. The distal end of
cannula 3100 is positioned near the prostate gland PG. Thereafter,
a cutting device 3102 is advanced through distal end of cannula
3100 to the outer surface of the prostate gland PG. Cutting device
3102 can be retracted back into cannula 3100. Cutting device 3102
comprises one or more cutting modalities such as electrosurgical
cutter, Laser cutter, mechanical cutter e.g. a knife edge etc.
Cutting device 3102 is used to cut one or more regions of the
prostate gland PG including prostatic capsule, peripheral zone,
transition zone or central zone. Cutting device 3102 may be moved
relative to prostate tissue by several mechanisms including one or
more deflecting or bending elements located on cutting device 3102;
motion of cutting device 3102 along cannula 3100 etc. In one method
embodiment, cutting device 3102 cuts prostatic capsule while being
withdrawn into cannula 3100. After the desired region or regions of
the prostate gland PG are cut, cutting device 3102 is withdrawn
into cannula 3100. Thereafter, cannula 3100 is withdrawn from the
urethra. In one device embodiment, cannula 3100 further comprises
an endoscope or means for inserting an endoscope.
[0270] FIG. 32 shows a coronal section of a region of the male
urinary system showing the general working environment of a method
of treating prostate disorders by cutting prostrate tissue by a
percutaneous device that penetrates the urinary bladder and
accesses the outer surface of the prostate gland PG through an
incision in the urinary bladder. In this method, a cannula 3200 is
introduced percutaneously into the lower abdomen. Cannula 3200 can
be made of suitable biocompatible materials including, but not
limited to metals e.g. stainless steel, Nickel-Titanium alloys,
titanium etc.; polymers etc. Cannula 3200 is advanced into the
abdomen such that it passes above the pubic bone. The distal end of
cannula 3200 enters the urinary bladder. Thereafter, an access
device 3202 is advanced through cannula 3200 such that access
device 3202 penetrates the urinary bladder wall as shown in FIG. 4.
Thereafter, a cutting device 3204 is advanced through distal end of
access device 3202 to the outer surface of the prostate gland PG.
Cutting device 3202 can be retracted back into access device 3202.
Cutting device 3202 comprises one or more cutting modalities such
as electrosurgical cutter, Laser cutter, mechanical cutter e.g. a
knife edge etc. Cutting device 3202 is used to cut one or more
regions of the prostate gland PG including prostatic capsule,
peripheral zone, transition zone or central zone. Cutting device
3202 may be moved relative to prostate tissue by several mechanisms
including one or more deflecting or bending elements located on
cutting device 3202 or access device 3202; motion of cutting device
3202 along access device 3202 etc. In one method embodiment,
cutting device 3202 cuts prostatic capsule while being withdrawn
into access device 3202. After the desired region or regions of the
prostate gland PG are cut, cutting device 3202 is withdrawn into
access device 3202. Access device 3202 is then withdrawn into
cannula 3200. Thereafter, cannula 3200 is withdrawn from the
urinary bladder. In one device embodiment, cannula 3200 further
comprises an endoscope or means for inserting an endoscope.
[0271] FIG. 33 series shows a perspective view of a prostate
treatment kit to cut prostate tissue. FIG. 33A shows a perspective
view of an introducer device. Introducer device 3300 comprises a
first tubular element 3302 enclosing a working device lumen 3304.
First tubular element 3302 can be made of suitable biocompatible
materials such as Pebax, Polyimide, Braided Polyimide,
Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainless
steel and fluoropolymers like PTFE, PFA, FEP and EPTFE etc. The
proximal end of working device lumen 3304 comprises a first stasis
valve 3306. The distal end of working device lumen 3304 comprises a
deflection mechanism. The deflection mechanism is used to bend the
distal region of working device lumen 3304. One example of
deflection mechanism is a pull wire and a deflection dial 3310 to
adjust the magnitude and/or the direction of deflection caused by
the pull wire. Similarly, other deflection mechanisms can be used
in the introducer device instead of a pull wire. Introducer device
3300 further comprises a second tubular element 3312 which encloses
a cystoscope lumen 3314. A cystoscope can be introduced through
cystoscope lumen 3314 into the urethra. Typical examples of
cystoscopes that can be used with introducer device are those
manufactured by Olympus, Pentax, Storz, Wolf, Circon-ACMI, etc.
These may have pre-set angles (i.e. 0, 30, 70, 120 degrees) or may
be flexible scopes where in the tip may be deflectable. The
proximal end of cystoscope lumen 3314 comprises a second stasis
valve 3316. The cystoscope is inserted through the proximal end of
cystoscope lumen 3314 and emerges out into the urethra from the
distal end of cystoscope lumen 3314. The cystoscope can then be
used to visualize the anatomy and various instruments during a
procedure. Working device lumen 3314 may comprise one or more side
ports e.g. a first side port 3318 for the introduction or removal
of one or more fluids. Cystoscope lumen 3314 may comprise one or
more side ports e.g. a second side port 3320 for the introduction
or removal of one or more fluids.
[0272] FIG. 33B shows a perspective view of an injecting needle.
Injecting needle 3330 is used for injecting one or more diagnostic
or therapeutic agents in the anatomy. In one method embodiment,
injecting needle 3330 is used to inject local anesthetic in the
urethra and/or prostate gland PG. Specific examples of target areas
for injecting local anesthetics are the neurovascular bundles, the
genitourinary diaphragm, the region between the rectal wall and
prostate, etc. Examples of local anesthetics that can be injected
by injecting needle 3330 are anesthetic solutions e.g. 1% lidocaine
solution; anesthetic gels e.g. lidocaine gels; combination of
anesthetic agents e.g. combination of lidocaine and bupivacaine;
etc. Injecting needle 3330 comprises a hollow shaft 3332 made of
suitable biocompatible materials including, but not limited to
stainless steel 304, stainless steel 306, Nickel-Titanium alloys,
titanium etc. The length of hollow shaft 3332 can range from to
centimeters. The distal end of hollow shaft 3332 comprises a sharp
tip 3334. The proximal end of hollow shaft 3332 has a needle hub
3336 made of suitable biocompatible materials including, but not
limited to metals e.g. like stainless steel 304, stainless steel
306, Nickel-Titanium alloys, titanium etc.; polymers e.g.
polypropylene etc. In one embodiment, needle hub 3336 comprises a
luer lock.
[0273] FIG. 33C shows a perspective view of a guiding device.
Guiding device 3338 comprises an elongate body 3340 comprising a
sharp distal tip 3342. In one embodiment, guiding device 3338 is a
guidewire. Distal end of elongate body 3340 may comprise an
anchoring element to reversibly anchor guiding device 3338 into
tissue. Examples of suitable anchoring elements are barbs,
multipronged arrowheads, balloons, other mechanically actuable
members (e.g. bendable struts), screw tips, shape memory elements,
or other suitable anchor designs disclosed elsewhere in this patent
application.
[0274] FIG. 33D shows a perspective view of a RF cutting device.
Cutting device 3343 comprises an inner sheath 3344 and an outer
sheath 3346. Inner sheath 3344 comprises a lumen of a suitable
dimension such that cutting device 3343 can be advanced over
guiding device 538. Outer sheath 3346 can slide on inner sheath
3344. Outer sheath 3346 also comprises two marker bands: a proximal
marker band 3348 and a distal marker band 3350. The marker bands
can be seen by a cystoscope. In one embodiment, proximal marker
band 3348 and distal marker band 3350 are radiopaque. The position
of proximal marker band 3348 and distal marker band 3350 is such
that after cutting device 3343 is placed in an optimum location in
the anatomy, proximal marker band 3348 is located in the urethra
where it can be seen by a cystoscope and distal marker band 3350 is
located in the prostrate gland PG or in the wall of the urethra
where it cannot be seen by the cystoscope. Cutting device 3343
further comprises a cutting wire 3352 that is capable of delivering
electrical energy to the surrounding tissue. The distal end of
cutting wire 3352 is fixed to the distal region of outer sheath
3344. The proximal end of cutting wire 3352 is connected to a
distal region of outer sheath 3346 and is further connected to a
source of electrical energy. In FIG. 33D, cutting wire 3352 is in
an undeployed configuration. FIG. 33D' shows the distal region of
cutting device 3343 when cutting wire 3352 is in a deployed
configuration. To deploy cutting wire 3352, inner sheath 3344 is
moved in the proximal direction with respect to outer sheath 546.
This causes cutting wire 3352 to bend axially outward thus
deploying cutting wire 3352 in the surrounding anatomy.
[0275] FIG. 33E shows a perspective view of an embodiment of a
plugging device to plug an opening created during a procedure.
Plugging device 3354 comprises a tubular shaft 3356 comprising a
distal opening 3358. Distal opening 3358 is used to deliver one or
more plugging materials 3360 in the adjacent anatomy. Plugging
material 3360 may comprise a porous or non-porous matrix formed of
a biodegradable or non-biodegradable material such as a flexible or
rigid polymer foam, cotton wadding, gauze, hydrogels, etc. Examples
of biodegradable polymers that may be foamed or otherwise rendered
porous include but are not restricted to polyglycolide,
poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone,
polycaprolactone, polygluconate, polylactic acid-polyethylene oxide
copolymers, modified cellulose, collagen, polyorthoesters,
polyhydroxybutyrate, polyanhydride, polyphosphoester,
poly(alpha-hydroxy acid) and combinations thereof. In one
embodiment, plugging material 3360 comprises biocompatible sealants
including but not limited to fibrin sealants, combination of
natural proteins (e.g. collagen, albumin etc.) with aldehyde
cross-linking agents (e.g. glutaraldehyde, formaldehyde) or other
polymeric, biological or non-polymeric materials capable of being
implanted with the body, etc. Plugging device 3354 may be
introduced in the anatomy by various approaches including the
approaches disclosed elsewhere in this patent application. Plugging
device 3354 may be introduced in the anatomy through a cannula,
over a guiding device such as a guidewire etc. In the embodiment
shown in FIG. 33E, plugging material 3360 is preloaded in plugging
device 3354. Plugging material 3360 is introduced through distal
opening 3358 by pushing plunger 3362 in the distal direction. In
another embodiment, plugging device 3354 comprises a lumen that
extends from the proximal end to distal opening 3358. Plugging
material 3360 may be injected through the proximal end of the lumen
such that it emerges out through distal opening 3358.
[0276] FIGS. 33F through 33N show various alternate embodiments of
the electrosurgical cutting device in FIG. 33D. FIGS. 33F and 33G
show perspective views of the distal region of a first alternate
embodiment of an electrosurgical cutting device in the undeployed
and deployed states respectively. FIG. 33F show an electrosurgical
cutting device 570 comprising an elongate shaft 3372. Shaft 3372 is
made of an electrically insulating material. Electrosurgical
cutting device 3370 further comprises an electrosurgical cutting
wire 3374. Electrosurgical cutting wire 3374 can be made of a
variety of materials including, but not limited to tungsten,
stainless steel, etc. Distal end of cutting wire 3374 is attached
to distal region of shaft 3372. The proximal region of cutting wire
3374 can be pulled in the proximal direction by an operator. In one
embodiment, electrosurgical cutting device 3370 is introduced in
the target anatomy through a sheath 3376. In FIG. 33F,
electrosurgical cutting device 3370 is deployed by pulling cutting
wire 3374 in the proximal direction. This causes distal region of
shaft 3372 to bend. Thereafter, electrical energy is delivered
through cutting wire 3374 to cut tissue. This may be accompanied by
motion of electrosurgical cutting device 3370 along the proximal or
distal direction.
[0277] FIGS. 33H and 33I show perspective views of the distal
region of a second alternate embodiment of an electrosurgical
cutting device in the undeployed and deployed states respectively.
Electrosurgical cutting device 3380 comprises an elongate sheath
3382 comprising a lumen. Distal region of sheath 3382 has a window
3384. Electrosurgical cutting device 3380 further comprises an
electrosurgical cutting wire 3386 located in the lumen. Distal end
of cutting wire 3386 is fixed to the distal end of sheath 3384.
Proximal end of cutting wire 3386 can be pushed in the distal
direction by a user. In FIG. 331, cutting wire 3386 is deployed by
pushing cutting wire 3386 in the distal direction. This causes a
region of cutting wire 3386 to bend in the radially outward
direction and thus emerge out of window 3384. Thereafter,
electrical energy is delivered through cutting wire 3386 to cut
tissue. This may be accompanied by motion of electrosurgical
cutting device 3380 along the proximal or distal direction.
[0278] FIGS. 33J through 33L show perspective views of the distal
region of a second alternate embodiment of an electrosurgical
cutting device showing the steps of deploying the electrosurgical
cutting device. Electrosurgical cutting device 3390 comprises an
elongate sheath 3391 comprising a lumen 3392. In FIG. 33J, an
electrosurgical cutting wire 3394 is introduced through lumen 3392
such that it emerges out through the distal opening of lumen 3392.
In FIG. 33K, cutting wire 3394 is further advanced in the distal
direction. Distal end of cutting wire 3394 has a curved region so
that cutting wire 3394 starts to bend as it emerges out of lumen
3392. IN FIG. 33L, cutting wire 3394 is further advanced in the
distal direction to fully deploy cutting wire 3394. Thereafter,
electrical energy is delivered through cutting wire 3394 to cut
tissue. This may be accompanied by motion of electrosurgical
cutting device 3390 along the proximal or distal direction.
[0279] FIGS. 33M through 33N show perspective views of the distal
region of a third alternate embodiment of an electrosurgical
cutting device showing the steps of deploying the electrosurgical
cutting device. Electrosurgical cutting device 3395 comprises an
elongate sheath 3396 comprising a lumen. Cutting device 3395
further comprises a cutting wire 3398 located in the lumen of
elongate sheath 3396. The proximal end of cutting wire 3398 is
connected to a source of electrical energy. Distal end of cutting
wire 3398 is connected to the inner surface of the distal region of
elongate sheath 3396. Cutting wire 3398 may be made from suitable
elastic, super-elastic or shape memory materials including but not
limited to Nitinol, titanium, stainless steel etc. In FIG. 33N,
Electrosurgical cutting device 3395 is deployed by pushing the
proximal region of cutting wire 3398 in the distal direction. This
causes a distal region of cutting wire 3398 to emerge from the
distal end of elongate sheath 3396 as a loop. Thereafter,
electrical energy is delivered through cutting wire 3398 to cut
tissue. This may be accompanied by motion of electrosurgical
cutting device 3395 along the proximal or distal direction.
Electrosurgical cutting device 3395 can be used to cut multiple
planes of tissue by withdrawing cutting wire 3398 in elongate
sheath 3396, rotating elongate sheath 3396 to a new orientation,
redeploying cutting wire 3398 and delivering electrical energy
through cutting wire 3398. The devices 33H through 33N may be
introduced by one or more access devices such as guidewires,
sheaths etc.
[0280] FIG. 34 shows a perspective view of the distal region of a
balloon catheter comprising a balloon with cutting blades. Balloon
catheter 3400 can be introduced into a lumen or in the tissue of an
organ to be treated using one or more of the introducing methods
disclosed elsewhere in this patent application. Balloon catheter
3400 comprises a shaft 3402. Shaft 3402 may comprise a lumen to
allow balloon catheter 3400 to be introduced over a guidewire. In
one embodiment, shaft 3402 is torquable. Shaft 3402 comprises a
balloon 3404 located on the distal end of shaft 3402. Balloon 3404
can be fabricated from materials including, but not limited to
polyethylene terephthalate, Nylon, polyurethane, polyvinyl
chloride, crosslinked polyethylene, polyolefins, HPTFE, HPE, HDPE,
LDPE, EPTFE, block copolymers, latex and silicone. Balloon 3404
further comprises one or more cutter blades 3406. Balloon catheter
3400 is advanced with balloon 3404 deflated, into a natural or
surgically created passageway and positioned adjacent to tissue or
matter that is to be cut, dilated, or expanded. Thereafter, balloon
3404 is inflated to cause cutter blades 3406 to make one or more
cuts in the adjacent tissue or matter. Thereafter balloon 3404 is
deflated and balloon catheter 3400 is removed. Cutter blades 3406
may be energized with mono or bi-polar RF energy. Balloon catheter
3400 may comprise one or more navigation markers including, but not
limited to radio-opaque markers, ultrasound markers, light source
that can be detected visually etc.
[0281] FIG. 35 shows a perspective view of the distal region of a
balloon catheter comprising a balloon with cutting wires. Balloon
catheter 3500 can be introduced into a lumen or in the tissue of an
organ to be treated using one or more of the introducing methods
disclosed elsewhere in this patent application. Balloon catheter
3500 comprises a shaft 3502. Shaft 3502 may comprise a lumen to
allow balloon catheter 3500 to be introduced over a guidewire. In
one embodiment, shaft 3502 is torquable. Shaft 3502 comprises a
balloon 3504 located on the distal end of shaft 3502. Balloon 3504
can be fabricated from materials including, but not limited to
polyethylene terephthalate, Nylon, polyurethane, polyvinyl
chloride, crosslinked polyethylene, polyolefins, HPTFE, HPE, HDPE,
LDPE, EPTFE, block copolymers, latex and silicone. Balloon 3504
further comprises one or more radiofrequency wires 3506. Balloon
catheter 3500 is advanced with balloon 3504 deflated, into a
natural or surgically created passageway and positioned adjacent to
tissue or matter that is to be cut, dilated, or expanded.
Thereafter, balloon 3504 is inflated and an electrical current is
delivered through radiofrequency wires 3506 to make one or more
cuts in the adjacent tissue or matter. Thereafter the electrical
current is stopped, balloon 3504 is deflated and balloon catheter
3500 is removed. Radiofrequency wires 3504 may be energized with
mono or bi-polar RF energy. Balloon catheter 3500 may comprise one
or more navigation markers including, but not limited to
radio-opaque markers, ultrasound markers, light source that can be
detected visually etc.
[0282] FIGS. 36A and 36B series show perspective views of an
undeployed state and a deployed state respectively of a tissue
displacement device. FIG. 36A shows a tissue anchoring device 3600
in the undeployed state. Anchoring device 3600 comprises an
elongate body having a proximal end 3602 and a distal end 3604.
Anchoring device 3600 may be made of a variety of elastic or
super-elastic materials including, but not limited to Nitinol,
stainless steel, titanium etc. Anchoring device 3600 is
substantially straight in the undeployed state and has a tendency
to become substantially curved in the deployed state. Anchoring
device 3600 is maintained in the undeployed state by a variety of
means including, but not limited to enclosing anchoring device 3600
in a cannula or sheath, etc. FIG. 36B shows tissue anchoring device
3600 in the deployed state. Anchoring device 3600 comprises a
curved region. When anchoring device 3600 changes from an
undeployed state to a deployed state, the anatomical tissue
adjacent to the central region of anchoring device 3600 is
displaced along the direction of motion of the central region.
Anchoring device 3600 can be deployed by a variety of methods
including, but not limited to removing anchoring device 3600 from a
sheath or cannula, etc. In one embodiment, anchoring device 3600 is
made from a shape memory material such as Nitinol. In this
embodiment, anchoring device 3600 is maintained in the undeployed
state by maintaining anchor device 3600 in a temperature lower than
the transition temperature of the super-elastic material. Anchoring
device 3600 is converted to the deployed state by implanting
anchoring device 3600 in a patient such that the device is warmed
to the body temperature which is above the transition temperature
of the super-elastic material.
[0283] FIGS. 36C and 36D show a coronal view and a lateral view
respectively of a pair of deployed tissue displacement devices of
FIGS. 36A and 36B implanted in the prostate gland PG. In FIG. 36C,
two anchoring devices are implanted in the prostate gland PG near
the prostatic urethra in a patient with BPH. A first anchoring
device 3600 is introduced on a first side of the urethra and is
deployed there as shown. Similarly, a second anchoring device 3606
comprising a proximal end 3608 and a distal end 3610 is introduced
on the other side of the urethra and is deployed there as shown.
First anchoring device 3600 and second anchoring device 3606 change
into the deployed curved configuration. This causes prostate gland
PG tissue near the central regions of first anchoring device 3600
and second anchoring device 3606 to be displaced radially away from
the urethra. This displacement of prostate gland PG tissue can be
used to eliminate or reduce the compression of the urethra by an
enlarged prostate gland PG. FIG. 36D shows a lateral view of the
urethra enclosed by the prostate gland PG showing deployed first
anchoring device 3600 and second anchoring device 3606.
[0284] The various cuts or punctures made by one or more cutting
devices disclosed in this patent application may be plugged or
lined by a plugging or space filling substance. FIGS. 36E through
36H show an axial section through a prostate gland showing the
various steps of a method of cutting or puncturing the prostate
gland and lining or plugging the cut or puncture. FIG. 36E shows a
section of the prostate gland showing the urethra, the lateral
lobes and the middle lobe surrounded by the prostatic
pseudocapsule. In FIG. 36F, one or more cuts are made in a region
of the prostatic pseudocapsule. In addition, one or more cuts may
be made in a region of between two lobes of the prostate gland. In
FIG. 36G, a plugging material 3619 is introduced in the one or more
regions of the prostate gland that are cut or punctured. Plugging
material 3619 may be delivered through one or more delivery devices
including, but not limited to the device disclosed in FIG. 33E.
Plugging material 3619 may comprises a material such as plugging
material 3360.
[0285] The various cuts or punctures made by one or more cutting
devices disclosed in this patent application may be spread open by
a clipping device. For example, FIG. 36H shows an axial section
through a prostate gland showing a clip for spreading open a cut or
punctured region of the prostate gland. Spreading device 3620
comprises a body having a central region and two distal arms.
Spreading device 3620 may be made of a variety of elastic or
super-elastic materials including, but not limited to Nitinol,
stainless steel, titanium etc. Spreading device 3620 has a reduced
profile in the undeployed state by maintaining distal arms close to
each other. Spreading device 5000 is maintained in the undeployed
state by a variety of means including, but not limited to enclosing
spreading device 3620 in a cannula or sheath, etc. When spreading
device 3620 changes from an undeployed state to a deployed state,
the distance between the two distal arms increases. This causes any
anatomical tissue between two distal arms to spread along the
straight line between two distal arms Spreading device 3620 can be
deployed by a variety of methods including, but not limited to
removing spreading device 3620 from a sheath or cannula, etc. In
one embodiment, spreading device 3620 is made from a shape memory
material such as Nitinol. In this embodiment, spreading device 3620
is maintained in the undeployed state by maintaining anchor device
3620 in a temperature lower than the transition temperature of the
super-elastic material. Spreading device 3620 is converted to the
deployed state by implanting spreading device 3620 in a patient
such that the device is warmed to the body temperature which is
above the transition temperature of the super-elastic material.
Stretching of prostate gland tissue can be used to eliminate or
reduce the compression of the urethra by an enlarged prostate gland
or to prevent cut edges of a cut from rejoining.
[0286] More than one spreading device 3620 may be used to treat the
effects of an enlarged prostate or to eliminate or reduce the
compression of the urethra by an enlarged prostate gland or to
prevent cut edges of a cut from rejoining.
[0287] FIGS. 37A through 37K show an embodiment of a method of
treating prostate gland disorders by cutting a region of the
prostate gland using the devices described in FIGS. 33A through
33E. In FIG. 37A, introducer device 3300 is introduced in the
urethra. It is advanced through the urethra such that the distal
tip of introducer device 3300 is located in the prostatic urethra.
Thereafter, injecting needle 3330 is introduced through introducer
device 3300. The distal tip of injecting needle 3330 is advanced
such that injecting needle 3330 penetrates the prostate gland.
Injecting needle 3330 is then used to inject a substance such as an
anesthetic in the prostate gland. Thereafter, in FIG. 37B,
injecting needle 3330 is withdrawn from the anatomy. The distal
region of introducer device 3300 is positioned near a region of the
prostate gland to be punctured. Thereafter, in FIG. 37C, first
tubular element 3302 is bent or deflected with a bending or
deflecting mechanism such as the bending mechanism in FIGS. 37C''
and 37C''' to align the distal region of first tubular element 3302
along a desired trajectory of puncturing the prostate gland.
[0288] FIG. 37C' shows the proximal region of introducer device
3300. A cystoscope 3700 is introduced through second stasis valve
3316 such that the distal end of cystoscope 3700 emerges through
the distal end of introducer device 3300. Cystoscope 3700 is then
used to visualize the anatomy to facilitate the method of treating
prostate gland disorders.
[0289] FIG. 37C'' shows a perspective view of the distal region of
an embodiment of introducer device 3300 comprising a bending or
deflecting mechanism. In this embodiment, first tubular element
3302 comprises a spiral cut distal end and a pull wire. In FIG.
37C''', the pull wire is pulled by deflection dial 3310. This
deflects the distal tip of first tubular element 3302 as shown.
[0290] After the step in FIG. 37C, guiding device 3338 is
introduced through first tubular element 3302. Guiding device 3338
is advanced through first tubular element 3302 such that the distal
tip of guiding device 3338 penetrates into the prostate gland. In
one method embodiment, guiding device 3338 is further advanced such
that the distal tip of guiding device 3338 penetrates through the
prostate gland and enters the urinary bladder. In one embodiment,
distal region of guiding device 3338 comprises an anchoring element
3702. Anchoring element 3702 is deployed as shown in FIG. 37E.
Thereafter, guiding device 3338 is pulled in the proximal direction
till anchoring element 3702 is snug against the wall of the urinary
bladder. Cystoscope 3700 can be used to visualize the steps of
penetrating the prostate gland by guiding device 3338 and deploying
anchoring element 3702. If guiding device 3338 is not positioned in
a satisfactory position, guiding device 3338 is pulled back in
introducer device 3300. The deflection angle of distal end of first
tubular lumen 3302 is changed and guiding device 3338 is
re-advanced into the urinary bladder. FIG. 37E' shows a perspective
view of an embodiment of anchoring element 3702. Anchoring element
comprises a hollow sheath 3704. Distal region of hollow sheath 3704
is attached to distal region of guiding device 3338. A number of
windows are cut in the distal region of hollow sheath 3704 such
that several thin, splayable strips are formed between adjacent
windows. Pushing hollow sheath 3704 in the distal direction causes
splayable strips to splay in the radially outward direction to form
an anchoring element. In FIG. 37F, cutting device 3343 is advanced
over guiding device 3338 into the prostate gland. In FIG. 37G,
cutting device 3343 is positioned in the prostate gland such that
proximal marker band 3348 can be seen by cystoscope 3700 but distal
marker band 3350 cannot be seen.
[0291] Thereafter, in FIG. 37H, relative motion between outer
sheath 3343 and inner sheath 3344 causes cutting wire 3352 to
deploy outward in the axial direction. In one embodiment, this step
is carried out by moving outer sheath 3343 in the distal direction
while the inner sheath 3344 is stationary. In another embodiment,
this step is carried out by moving inner sheath 3344 in the
proximal direction while outer sheath 3343 is kept stationary. Also
during step, electrical energy is delivered through cutting wire
3352 to cut tissue. In FIG. 37I, cutting device 3343 is pulled in
the proximal direction such that the deployed cutting wire 3352
slices through tissue. Thereafter, cutting wire 3352 is withdrawn
again in cutting device 3343. Cutting device 3343 is then removed
from the anatomy.
[0292] In FIG. 37J, plugging device 3354 is introduced over guiding
device 3338 through the puncture or opening in the prostate gland.
Thereafter, in FIG. 37K, anchoring element 3702 is undeployed and
guiding device 3343 is withdrawn from the anatomy. Thereafter,
plugging device 3354 is used to deliver one or more plugging
materials in the adjacent anatomy. The plugging materials can be
used to plug or line some or all of the cuts or punctures created
during the method.
[0293] FIGS. 38A to 38D show various components of a kit for
treating prostate gland disorders by compressing a region of the
prostate gland. FIG. 38A shows the perspective view of an
introducer device 3800. Introducer device 3800 comprises an outer
body 3801 constructed from suitable biocompatible materials
including, but not limited to metals like stainless steel, Nichol
plated brass, polymers like Pebax, Polyimide, Braided Polyimide,
Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK and fluoropolymers
like PTFE, PFA, FEP, EPTFE etc. Body 3801 comprises a working
device lumen 3802. Distal end of working device lumen 3802 emerges
out of the distal end of body 3801. Proximal end of working device
lumen 3802 incorporates lock thread 3803 such that introducer
device may join with other devices. Device lumen 3802 may comprise
one or more side ports e.g. a first side port 3804 and a second
side port 3805 for the introduction or removal of one or more
fluids.
[0294] FIG. 38B shows a perspective view of a bridge device 3806
constructed from suitable biocompatible materials including, but
not limited to metals like stainless steel, Nichol plated brass,
polymers like Pebax, Polyimide, Braided Polyimide, Polyurethane,
Nylon, PVC, Hytrel, HDPE, PEEK and fluoropolymers like PTFE, PFA,
FEP, EPTFE etc. Bridge device may insert into introducer lumen 3802
and lock into place by threadably mating thread lock 3807 with
thread 3803. Bridge may incorporate port 3808 for cystoscope with
locking means 3809 that joins to cystoscope when inserted. Bridge
device may incorporate one or more working lumens. Working lumen
3810 emerges out of the distal end of body 3806. In one embodiment,
distal end of working device lumen 3810 has a bent or curved
region. Proximal end of lumen 3810 emerges from port 3811 that may
incorporate fluid stasis valve 3812 and a luer lock. Working lumen
3813 emerges distally in straight fashion through blunt obturator
3814 at distal end of body 3806 and emerges proximally through
second port that may incorporate fluid stasis valve and luer
lock.
[0295] FIG. 38C shows a perspective view of a distal anchor
deployment device 3815 constructed from suitable biocompatible
materials including, but not limited to polymers like
Polycarbonate, PVC, Pebax, Polyimide, Braided Pebax, Polyurethane,
Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainless steel, Nichol
plated brass, and fluoropolymers like PTFE, PFA, FEP, EPTFE etc.
Deployment device 3815 comprises handle 3816, which incorporates
movable thumb ring pusher 3817 and anchor deployment latch 3818;
and distal shaft 3819 which has trocar point 3820 at distal end.
Mounted on distal shaft 3819 is distal anchor 3821 that
incorporates tether 3822. Tether 3822 can be made of suitable
elastic or non-elastic materials including, but not limited to
metals e.g. stainless steel 304, stainless steel 306,
Nickel-Titanium alloys, suture materials, titanium etc. or polymers
such as silicone, nylon, polyamide, polyglycolic acid,
polypropylene, Pebax, PTFE, ePTFE, silk, gut, or any other
monofilament or any braided or mono-filament material. Proximal end
of tether 3822 may incorporate hypotube 3823. Distal anchor 3821 is
constructed from suitable biocompatible materials including, but
not limited to metals e.g. stainless steel 304, stainless steel
306, Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax,
Braided Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon,
PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc. Deployment
device 3815 is inserted into bridge working lumen 3810. Advancement
of thumb ring 3817 extends distal shaft 3819 through distal end of
working lumen 3810, preferably into tissue for deployment of distal
anchor 3821. Depth of distal shaft deployment can be monitored on
cystoscope by visualizing depth markers 3824. Once distal shaft
3819 is deployed to desired depth, anchor deployment latch 3818 is
rotated to release distal anchor 3821. Retraction of thumb ring
3817 then retracts distal shaft 3819 while leaving distal anchor
3821 in tissue. Bridge 3806 is then disconnected from introducer
device 3800 and removed.
[0296] FIG. 38D shows the proximal anchor delivery tool 3825
constructed from suitable biocompatible materials including, but
not limited to polymers like Polycarbonate, PVC, Pebax, Polyimide,
Braided Pebax, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals
like stainless steel, Nichol plated brass, and fluoropolymers like
PTFE, PFA, FEP, EPTFE etc. Proximal anchor delivery tool 3825
comprises handle 3826, which incorporates anchor deployment switch
3827 in slot 3828 and tether cut switch 3829; and distal shaft 3830
which houses hypotube 3831. Lumen of hypotube 3831 emerges
proximally at port 3832 which may incorporate a luer lock. Mounted
on the hypotube and distal shaft is the proximal anchor 3833 with
cinching hub 3834. Proximal anchor 3833 is constructed from
suitable biocompatible materials including, but not limited to
metals e.g. stainless steel 304, stainless steel 306,
Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax,
Braided Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon,
PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE or biodegradable
polymers e.g. polyglycolic acid, poly(dioxanone), poly(trimethylene
carbonate) copolymers, and poly (.epsilon.-caprolactone)
homopolymers and copolymers etc. FIG. 38E shows a close-up
perspective view of proximal anchor 3833 mounted on hypotube 3831
and distal shaft 3830 of proximal anchor delivery tool 3825.
Hypotube 3831 biases open the cinching lock 3835 of cinching hub
3834. In order to deploy proximal anchor 3833, hypotube 3823 is
loaded into hypotube 3831 until it exits proximal port 3832.
Hypotube 3823 is then stabilized while proximal anchor delivery
tool 3825 is advanced into introducer device lumen 3802 and
advanced to tissue target. Because hypotube 3831 biases open
cinching lock 3835, the proximal anchor delivery tool travels
freely along tether 3822. Once proximal anchor 3833 is adequately
apposed to urethral wall of prostate, anchor deployment switch 3827
is retracted. During retraction of switch 3827, hypotube 3831 is
retracted proximal to cinching hub 3834 and tether 3822 is
tightened. When switch 3827 is fully retracted or desired tension
is accomplished, tether 3822 is cut within cinching hub 3834 by
advancing cutting switch 3829.
[0297] Any of the anchoring devices disclosed herein may comprise
one or more sharp distal tips, barbs, hooks etc. to attach to
tissue.
[0298] Various types of endoscopes can be used in conjunction with
the devices disclosed herein such as flexible scopes that are thin,
flexible, fibre-optic endoscopes and rigid scopes that are thin,
solid, straight endoscopes. The scopes may have one or more side
channels for insertion of various instruments. Further they may be
used with in conjunction with standard and modified sheaths
intended for endoscopic and transurethral use.
[0299] Local or general anesthesia may be used while performing the
procedures disclosed herein. Examples of local anesthetics that can
be used are anesthetic gels e.g. lidocaine gels in the urethra;
combination of anesthetic agents e.g. combination of lidocaine and
bupivacaine in the urethra; spinal anesthetics e.g. ropivacaine,
fentanyl etc.; injectable anesthetics e.g. 1% lidocaine solution
injected into the neurovascular bundles, the genitourinary
diaphragm, and between the rectal wall and prostate; etc.
[0300] An optional trans-rectal ultrasound exam may be performed
before and/or during the procedures disclosed herein. In this exam,
a device called ultrasound transducer is inserted into the rectum.
The ultrasound transducer is then used to image the prostate gland
PG using ultrasound waves. The devices may be modified so that they
are more visible under ultrasound such as etched surfaces. Other
imaging devices may also be optionally used such as MRI, RF,
electromagnetic and fluoroscopic or X-ray guidance. The anchoring
devices or delivery devices may contain sensors or transmitters so
that certain elements may be tracked and located within the body.
The tethering devices may be used as cables to temporarily transmit
energy to the distal and/or proximal anchors during deployment.
[0301] The invention has been described hereabove with reference to
certain examples or embodiments of the invention but various
additions, deletions, alterations and modifications may be made to
those examples and embodiments without departing from the intended
spirit and scope of the invention. For example, any element or
attribute of one embodiment or example may be incorporated into or
used with another embodiment or example, unless to do so would
render the embodiment or example unsuitable for its intended use.
Also, where the steps of a method or process are described, listed
or claimed in a particular order, such steps may be performed in
any other order unless to do so would render the embodiment or
example un-novel, obvious to a person of ordinary skill in the
relevant art or unsuitable for its intended use. All reasonable
additions, deletions, modifications and alterations are to be
considered equivalents of the described examples and embodiments
and are to be included within the scope of the following
claims.
* * * * *