U.S. patent application number 16/401783 was filed with the patent office on 2019-08-22 for system for delivering anchors for treating incontinence.
The applicant listed for this patent is NeoTract, Inc.. Invention is credited to Joseph Catanese, III, Floria Cheng, Michael Gearhart, Theodore C. Lamson, Matthew McLean, James W. Niederjohn, Brian Y. Tachibana.
Application Number | 20190254799 16/401783 |
Document ID | / |
Family ID | 49513066 |
Filed Date | 2019-08-22 |
View All Diagrams
United States Patent
Application |
20190254799 |
Kind Code |
A1 |
Lamson; Theodore C. ; et
al. |
August 22, 2019 |
SYSTEM FOR DELIVERING ANCHORS FOR TREATING INCONTINENCE
Abstract
A system and associated method for manipulating tissues and
anatomical or other structures in medical applications for the
purpose of treating incontinence. In one aspect, the system
includes a delivery device configured to deploy and implant anchor
devices for distracting and/or retracting the urethra or tissues
proximate thereto, or to maintain a position of a urethra in
response to intra-abdominal pressures.
Inventors: |
Lamson; Theodore C.;
(Pleasanton, CA) ; Catanese, III; Joseph; (San
Leandro, CA) ; McLean; Matthew; (San Francisco,
CA) ; Niederjohn; James W.; (San Jose, CA) ;
Cheng; Floria; (San Francisco, CA) ; Tachibana; Brian
Y.; (Oakland, CA) ; Gearhart; Michael;
(Fremont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NeoTract, Inc. |
Pleasanton |
CA |
US |
|
|
Family ID: |
49513066 |
Appl. No.: |
16/401783 |
Filed: |
May 2, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13852756 |
Mar 28, 2013 |
10292801 |
|
|
16401783 |
|
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|
61617244 |
Mar 29, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00893
20130101; A61B 17/0401 20130101; A61B 2017/0409 20130101; A61B
2017/00805 20130101; A61B 2017/00274 20130101; A61F 2/0022
20130101; A61B 17/0218 20130101; A61F 2/0036 20130101; A61B
2017/0419 20130101; A61B 2017/06052 20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61B 17/04 20060101 A61B017/04 |
Claims
1. A method for treating incontinence, comprising: passing a first
anchor through anterior periurethral fascia and implanting the
first anchor, wherein the first anchor is connected to a tensioning
connector; applying tension to the tensioning connector; and
implanting a second anchor and connecting the second anchor to the
tensioning connector, wherein the tension along the tensioning
connector lifts a portion of a urethra towards a portion of the
abdomen thereby reducing incontinence.
2. The method of claim 1, wherein the tensioning connector does not
pass through a urethral lumen when the tensioning connector is in
position to lift the portion of the urethra towards the portion of
the abdomen.
3. The method of claim 1, wherein the first anchor is implanted in
lateral tissue.
4. The method of claim 1, wherein the first anchor is implanted in
bone.
5. The method of claim 1, wherein the second anchor is implanted in
lateral tissue.
6. The method of claim 1, wherein the second anchor is implanted in
bone.
7. The method of claim 1, wherein the first anchor comprises a
tubular body portion and a tail portion.
8. The method of claim 1, wherein the second anchor comprises a
slotted portion.
9. A method for treating incontinence, comprising: passing a first
anchor through anterior periurethral fascia and implanting the
first anchor, wherein the first anchor is connected to a first
tensioning connector; passing a second anchor into a portion of the
urethral lumen and connecting the second anchor to the first
tensioning connector; passing a third anchor through anterior
periurethral fascia and implanting the third anchor, wherein the
third anchor is connected to a second tensioning connector;
applying tension to the second tensioning connector; and implanting
a fourth anchor in an area proximate the first anchor or the first
tensioning connector and connecting the fourth anchor to the second
tensioning connector, wherein the tension along the second
tensioning connector lifts a portion of a urethra towards a portion
of the abdomen thereby reducing incontinence.
10. The method of claim 9 further comprising passing a fifth anchor
through anterior periurethral fascia and implanting the fifth
anchor, wherein the fifth anchor is connected to a third tensioning
connector; applying tension to the third tensioning connector; and
implanting a sixth anchor in an area proximate the first anchor or
the first tensioning connector and connecting the sixth anchor to
the third tensioning connector, wherein the tension along the third
tensioning connector lifts a portion of a urethra towards a portion
of the abdomen thereby reducing incontinence.
11. The method of claim 9, wherein the third anchor is implanted in
lateral tissue.
12. The method of claim 9, wherein the third anchor is implanted in
bone.
13. The method of claim 10, wherein the fifth anchor is implanted
in lateral tissue.
14. The method of claim 10, wherein the fifth anchor is implanted
in bone.
15. The method of claim 9, wherein the first and third anchors
comprise a tubular body portion and a tail portion.
16. The method of claim 9, wherein the second and fourth anchors
comprise a slotted portion.
17. The method of claim 10, wherein the fifth anchor comprises a
tubular body portion and a tail portion.
18. The method of claim 10, wherein the sixth anchor comprises a
slotted portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/852,756, filed Mar. 28, 2013, entitled
"System for Delivering Anchors for Treating Incontinence," which
claims priority to and the benefit of U.S. Provisional Application
No. 61/617,244 filed Mar. 29, 2012, entitled "System for Delivering
Anchors for Treating Incontinence," each of which is incorporated
herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices
and methods, and more particularly to systems and associated
methods for manipulating or retracting tissues and anatomical or
other structures within the body of human or animal subjects for
the purpose of treating incontinence. Urinary incontinence is any
involuntary leakage of urine. It almost always results from an
underlying treatable medical condition.
[0003] Normal continence involves a balance between urethral
closure and detrusor muscle activity. The body stores urine in the
urinary bladder. The bladder connects to the urethra, the tube
through which urine leaves the body. Urethral pressure normally
exceeds bladder pressure, resulting in urine remaining in the
bladder. When sphincter muscles surrounding the urethra relax,
urine is passed out of the body. Incontinence will occur if the
bladder muscles suddenly contract or muscles surrounding the
urethra suddenly relax.
[0004] There are a number of causes of incontinence. An enlarged
prostate may be cause of incontinence, particularly urge
incontinence, in men after the age of 40. Sometimes prostate cancer
may also be associated with urinary incontinence. While urinary
incontinence affects older men more often than younger men, the
onset of incontinence can happen at any age. Recent estimates by
the National Institutes of Health (NIH) suggest that 17 percent of
men over age 60, an estimated 600,000 men, experience urinary
incontinence, with this percentage increasing with age.
Incontinence is treatable and often curable at all ages.
Incontinence in men usually occurs because of problems with muscles
that help to hold or release urine.
[0005] Incontinence in women can result from physical changes from
pregnancy and childbirth. Menopause can also contribute to stress
incontinence. Incontinence can worsen during the week before the
menstrual period. At that time, lowered estrogen levels may lead to
lower muscular pressure around the urethra, increasing chances of
leakage. The incidence of incontinence increases following
menopause, similarly because of lowered estrogen levels. As much as
35% of the total population over the age of 60 years is estimated
to be incontinent, with women twice as likely as men to experience
incontinence. One in three women over the age of 60 years are
estimated to have bladder control problems. Incontinence is
expensive to the health care system and nursing home industry as
more than 50% of nursing facility admissions are related to
incontinence. Further, disorders like multiple sclerosis, spina
bifida, Parkinson's disease, strokes and spinal cord injury can all
interfere with nerve function of the bladder.
[0006] There are also a number of different types of incontinence.
Stress incontinence, also known as effort incontinence, is due
essentially to insufficient strength of the pelvic floor muscles.
Urge incontinence is generally due to involuntary loss of urine
occurring for no apparent reason while suddenly feeling the need or
urge to urinate. Overflow incontinence refers to people finding
that they cannot stop their bladders from constantly dribbling or
continuing to dribble for some time after they have passed
urine.
[0007] Incontinence treatment options include behavior management,
medications and surgery. Some approaches address the problem
symptomatically, and can be applicable to more than one type of
incontinence. Absorbent pads and various types of urinary catheters
may be employed to help certain individuals. Men also can use an
external urine collection device that is worn around the penis.
These are traditionally referred to as condom catheters. Absorbent
products include shields, undergarments, protective underwear,
briefs, diapers, adult diapers and underpads.
[0008] 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 States, 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.
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.
[0009] 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 pressure
on 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.
[0010] 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.
[0011] 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.
Minimally invasive procedures for treating BPH symptoms include
Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle
Ablation (TUNA), Interstitial Laser Coagulation (ILC), and
Prostatic Stents.
[0012] There have been advances in developing minimally invasive
devices and methods for lifting, stabilizing and repositioning of
tissues. There remains, however, a need for the development of new
devices and methods that can be used for various procedures where
it is desired to lift, compress, support, stabilize, modify or
reposition tissues to treat incontinence. In particular, there is a
need for alternative apparatus and treatment approaches for the
purpose of manipulating the urethra and tissues surrounding the
urethra. Various structures ensuring an effective interventional
procedure have been found to be needed.
[0013] The present disclosure addresses these and other needs.
SUMMARY
[0014] Briefly and in general terms, the present invention is
directed towards an apparatus and method for deploying an anchor
assembly within a patient's body to accomplish treating
incontinence. A delivery device is provided to access the anatomy
targeted for the interventional procedure, such as a urethra. The
delivery device facilitates the implantation of the anchor assembly
in a manner accomplishing retraction or displacement of tissue. The
delivery device is configured to accomplish the assembly of the
anchor assembly in situ and can also automatically determine a
length of the anchor assembly.
[0015] In one approach, one or more anchor assemblies are
configured to reposition, stabilize or reduce the mobility of a
portion of a urethra upwardly with respect to surrounding tissue.
The anchor also can be configured to reduce a lumen size of the
urethra. A proximal portion of the anchor assembly can be placed
within anterior or lateral sections of the urethra. The anchor
assemblies can also be positioned laterally relative to the urethra
and implanted to maintain a constant position of the urethra
against increases in intra-abdominal pressure. Moreover, one or
more anchor assemblies can be configured about the prostate to lift
or maintain a position of a portion of a urethra in a male patient.
In a female patient, a portion of an anchor assembly can be passed
through anterior periurethral fascia to the exclusion of or
including the urethral lumen, and anchored to surrounding tissue to
thereby reposition, stabilize or maintain positioning of a urethra,
or reduce or modify the size of the urethra.
[0016] The delivery apparatus of the present disclosure includes
various subassemblies, which are mobilized via an actuator or other
manually accessible structure. The apparatus is sized and shaped so
that it can be placed transurethrally or it can be configured to be
inserted through a surgical incision so that access to tissue
surrounding a urethra can be accessed. The operation of the
subassemblies is coordinated and synchronized to ensure accurate
and precise implantation of an anchor assembly. In one embodiment,
the delivery device is embodied in a tissue retraction
assembly.
[0017] In one particular aspect, the present invention is directed
towards a delivery device, which accomplishes the delivery of a
first or distal anchor assembly component at a first location
within a patient's body and the delivery of a second or proximal
anchor assembly component at a second location within the patient.
The device also accomplishes imparting tension during delivery to a
connector to hold it while attaching the proximal anchor in situ.
The procedure can be viewed employing a scope inserted in the
device. Also, the delivery device can be sized and shaped to be
compatible inside a sheath up to 24 F, preferably a 19 F sheath or
smaller.
[0018] The anchor assembly can be configured to accomplish
approximating, retracting, lifting, compressing, supporting,
stabilizing, or repositioning tissue within the body of a human or
animal subject. Moreover, the apparatus configured to deploy the
anchor assembly as well as the anchor assembly itself are
configured to complement and cooperate with body anatomy. Further,
the anchor assembly can be coated or imbedded with therapeutic or
diagnostic substances, in particular Botulinum toxin, or a silver
ion coating or such substances can be introduced into or near an
interventional site by the anchor deployment device or other
structure.
[0019] In various approaches, the anchor can include a distal
anchor connected to a proximal anchor by a connector. The distal
anchor has a body with a tail. The proximal anchor can include a
pair of spaced members, which are configured to capture and deform
the connector there between and prevent the connector from
disengaging from the anchor device once engaged. The mechanism of
connector attachment and strength of the assembly is a combination
of compression of the connector between deformable structure of the
anchor as well as disruption of the connector surface by the
anchor. The deformable structure provides surface contact and
focuses the compressive forces that cause the connector to conform
about the anchor.
[0020] The anchor assembly can also be characterized by a connector
embodying multiple strands. Such strands can be spaced upon
delivery of the anchor assembly to provide a larger supporting
structure. The anchor assembly can further define a sling structure
including a woven connector connecting spaced anchor members.
[0021] Various alternative methods of use are contemplated. Thus, a
transurethral approach to anchor assembly delivery as well as an
approach through a surgical incision are contemplated. The
disclosed apparatus can be used to alter flow of a body fluid
through a body lumen, such as for the purpose of treating urinary
incontinence. Also, the disclosure has a myriad of other potential
surgical, therapeutic, cosmetic or reconstructive applications,
such as where a tissue, organ, graft or other material requires
stabilizing, retracting, lifting, repositioning, compression,
modifying or support.
[0022] In a specific application, the disclosed apparatus are
contemplated to be employed to reposition, stabilize or maintain
positioning of a portion of a urethra or can be used to alter or
reduce the size of the urethra. In one aspect, an anchoring device
housed within a delivery device is inserted into a urethra
transurethrally and the delivery device is employed to reconfigure
the urethra.
[0023] Other features and advantages of the present invention will
become apparent from the following detailed description, taken in
conjunction with the accompanying drawings, which illustrate, by
way of example, the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a cross-sectional view, depicting anatomy
surrounding a urethra in a human male subject;
[0025] FIG. 2 is an enlarged cross-sectional view, depicting
anatomy surrounding a prostate;
[0026] FIG. 3 is a cross-sectional view, depicting anatomy
surrounding a urethra in a female subject;
[0027] FIG. 4 is a perspective side view, depicting one embodiment
of an anchor assembly;
[0028] FIGS. 5A-D are side and perspective views, depicting one
embodiment of a delivery device and various features thereof;
[0029] FIG. 5A is a view of a first embodiment of a delivery
device;
[0030] FIG. 5B is a view of a second embodiment of a delivery
device;
[0031] FIG. 5C is a view of a third embodiment of a delivery
device;
[0032] FIG. 5D is a view of a fourth embodiment of a delivery
device;
[0033] FIGS. 6A-B are cross-sectional views, depicting one
incontinence treatment approach;
[0034] FIG. 6A is a view of a first treatment approach;
[0035] FIG. 6B is a view of a second treatment approach;
[0036] FIG. 7 is a cross-sectional view depicting of another
incontinence treatment approach;
[0037] FIGS. 8A-B are cross-sectional views, depicting yet further
approaches to treatment;
[0038] FIG. 8A is a view of a first further treatment approach;
[0039] FIG. 8B is a view of a second further treatment
approach;
[0040] FIGS. 9A-B are cross-sectional views, depicting still
further treatment approaches;
[0041] FIG. 9A is a view of a first further treatment approach;
[0042] FIG. 9B is a view of a second further treatment
approach;
[0043] FIG. 9C is a view of a third further treatment approach;
[0044] FIG. 10 is a side view, depicting an alternative anchor
assembly;
[0045] FIG. 11 is a cross-sectional view, depicting use of the
structure of FIG. 10 in a treatment approach;
[0046] FIG. 12 is a cross-sectional view, depicting a treatment
approach involving the prostate;
[0047] FIGS. 13A-B are cross-sectional views, depicting yet further
incontinence treatment approaches;
[0048] FIG. 13A is a view of a first further treatment
approach;
[0049] FIG. 13B is a view of a second further treatment
approach;
[0050] FIGS. 14A-B depict alternative approaches to treatment;
[0051] FIG. 14A is a view of a first alternative approach; and
[0052] FIG. 14B is a view of a second alternative approach.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0053] Turning now to the figures, which are provided by way of
example and not limitation, the present disclosure is directed to a
device configured to deliver an anchor assembly within a patient's
body for treatment purposes. The disclosed apparatus can be
employed for various medical purposes including but not limited to
treating incontinence.
[0054] In an aspect of the present invention, one portion of an
anchor assembly or implant is positioned and implanted against a
first section of anatomy. A second portion of the anchor assembly
or implant is then positioned and implanted adjacent to a second
section of anatomy for the purpose of retracting, lifting,
compressing, stabilizing, supporting or repositioning the second
section of anatomy with respect to the first section of anatomy as
well as for the purpose of retracting, lifting, compressing,
stabilizing, supporting or repositioning the first section of
anatomy with respect to the second section of anatomy. It is also
to be recognized that both a first and second portion of the anchor
assembly can be configured to accomplish the desired retracting,
lifting, compressing, stabilizing, supporting or repositioning of
anatomy due to tension supplied during delivery via a connector
assembly affixed to the first and second portions of the anchor
assembly or implant.
[0055] Turning to FIGS. 1-3, various features of urological anatomy
of a human subject are presented. With specific reference to FIGS.
1 and 2, in a male subject, the prostate gland PG is a walnut-sized
muscular gland found in a male and located adjacent the urinary
bladder UB. The urethra UT runs through the prostate gland PG. The
prostate gland PG secretes fluid that protects and nourishes sperm.
The prostate also contracts during ejaculation of sperm to expel
semen and to provide a valve to keep urine out of the semen. A
capsule C surrounds the prostate gland PG. The portion of the
urethra UT extending through the prostate PG is referred to as the
prostatic urethra PU. Distal to the prostatic urethra PU are the
membranous urethra MU and bulbous urethra BU portions of the
urethra UT. The membranous urethra MU is the most narrow, shortest
and least dilatable portion of the urethra. It extends between an
apex of the prostate PG to the bulb of the urethra UT.
[0056] The urinary bladder UB holds urine. The vasa deferentia VD
define ducts through which semen is carried and the seminal
vesicles SV secrete seminal fluid. The rectum R is the end segment
of the large intestine and through which waste is dispelled. The
urethra UT carries both urine and semen out of the body. Thus, the
urethra is connected to the urinary bladder UB and provides a
passageway to the vasa deferentia VD and seminal vesicles SV.
[0057] Further, the trigone T is a smooth triangular region of the
bladder. It is sensitive to expansion and signals the brain when
the urinary bladder UB is full. The verumontanum VM is a crest in
the wall of the urethra UT where the seminal ducts enter. The
prostatic urethra is the section of the urethra UT which extends
through the prostate.
[0058] In a female subject (FIG. 3), the urinary bladder UB also
holds urine and extending from the bladder is the urethra UT. The
pelvic floor muscle PFM supports the female urinary bladder UB and
the position of the urethra UT. The uterus US and vagina V as well
as the rectum R are positioned posteriorly of the anatomy defining
the urinary system.
[0059] In one embodiment (See FIG. 4), the anchor assembly 60 is
embodied in a tissue anchor. The tissue anchor is an implant
assembly that includes one tubular member, referred to as the
capsular anchor or, more generally, distal anchor 70. The distal
anchor 70 is preferably connected by a suture (preferably
polyester) 78 to a slotted, flattened-tubular member (preferably
comprised of stainless steel), referred to as the urethral anchor
or proximal anchor 84. In one specific, non-limiting embodiment,
the distal anchor 70 is comprised of an electro-polished Nitinol
(nickel titanium alloy SE508, 55.8% nickel) tube.
[0060] The tissue anchor is designed to be useable in physician's
clinical office environment (in contrast to requiring a hospital
environment) with a delivery tool. The delivery tool is used
through a 19 F sheath in one preferred embodiment, while in another
embodiment a sheath size of 21 F is employed. In this suture-based,
tissue technique, a needle delivery mechanism is used to implant a
nitinol distal anchor 70 and attached suture 78. Once the distal
anchor 70 and attached suture 78 have been deployed, with the
needle retracted and the suture 78 tensioned, the slotted anchor 84
is pushed by the delivery tool and captures the suture 78
transverse to the anchor axis. The flattened portion of the anchor
84 allows the anchor to be held by the tool without rotating so
that it will stay oriented properly to ensure the suture enters the
space between the prongs. In many of the illustrated embodiments,
the seating region in the slotted anchor for the suture is shown in
approximately the midpoint of the slotted anchor but it is within
the scope of the present invention to locate the seating region
closer to one end or the other of the anchor in order to prevent
the ends of the prongs of the anchor from digging into tissue after
implantation but rather sit more parallel to the tissue, if so
desired.
[0061] The nitinol tube can be attached to a USP size 0 PET (Poly
Ethylene Terephthalate) monofilament suture 78 by thermally forming
the suture to locking features on the anchor 70. Referring again to
the suture itself, the PET suture is a round monofilament
extrusion/pulltrusion composed of a grade 8816 polyethylene
terephthalate. Typically, the base material for the suture is
annealed at approximately 375 degrees Fahrenheit for approximately
5 minutes in a straight condition. In one non-limiting embodiment,
the PET suture 78 has a diameter of 0.015 inches and a tensile
strength greater than or equal to 12.7 pounds. It is preferred that
the tensile strength be about 6 pounds or greater.
[0062] In one embodiment, the proximal anchor 84 is a 316L
stainless steel flattened tube that is slotted, electro-polished,
and passivated. The anchor is depicted in the figures with a flat
surface on the top or bottom but it is within the scope of the
present invention that only one of the surfaces be flat and that
the surface(s) do not have to be true flat but rather could have a
slight dip or protrusion on the flattened surfaces. The slotted
anchor 84 includes prongs 96 that grip and deform the suture 78 in
the seating region 98 between the spaced prongs 96. It is to be
recognized that rather than defining mirrored images, in one or
more of the embodiments disclosed herein, the seating region can be
formed by staggered structure or one prong can have a longer area
defining seating structure than an opposing prong to provide an
effective engagement for a particular suture or connector design.
The prongs 96 are quite stiff and robust therefore subject to
minimal to no deflection. In particular preferred embodiments, the
prongs or overall width of the anchor adjacent the seating region
98 expands, after a connector has been seated in the seating
region, less than about 0.002 inches (i.e., less than about five
percent), more preferably less than about 0.001 inches (i.e., less
than about two and half percent). In particular preferred
embodiments, the prongs or overall width of the anchor adjacent the
ends of the prongs 96 expands, after a connector has been seated in
the seating region, less than about 0.0065 inches (i.e., less than
about seventeen percent), more preferably less than about 0.006
inches (i.e., less than about fifteen percent). Due to its
particular configuration, the slotted anchor 84 also requires less
force to deploy onto a suture 78. Being relatively stiff, the
prongs 96 of the slotted anchor 84 are significantly more resistant
to bending. The four individual edges/faces (two on each prong 96)
of the slotted anchor 84 disrupt the surface of the suture 78, both
biting into the suture 78 as well as compressing the suture 78
between the slotted prongs 96, including sometimes melting the
suture locally due to the pressure and heat created during
deployment of the slotted anchor onto the suture. The reduced area
of contact provided by this structure as well as multiple planes of
engagement of the anchor slot to the connector strengthens
connections and prevents inadvertent separation. Additionally, the
narrow width between the prongs 96 is substantially smaller than
the connector diameter, with the purpose to allow the stiffer
prongs to slightly elastically expand over the connector and
contribute to anchor retention by means of compression but not
intended to receive the connector into this relief slot, which is
positioned proximal to the seating portion 98. It is beneficial in
some circumstances however for the slotted anchor to be pushed far
enough on to the connector such that the connector becomes at least
partially seated in the slot inception relief slot so that it
becomes pinched and/or wedged. In this circumstance, a two-part
compression slot is created wherein the short, narrow part of the
slot ensures a good mechanical interlock but may compromise the
strength of the suture locally and the second wider part is ensures
a good mechanical interlock but without any compromise in the
strength of the suture. Notably, the outwardly stepped slot width
also has a dimension smaller than the connector diameter, and
receives the connector with some interference.
[0063] The prongs 96 can be formed from a wide (or flattened)
tubular structure. The wider and smoother prongs 96 of the anchor
84 assist in preventing the prongs 96 from irritating and/or
damaging tissue, which is more likely to occur with a thinner and
pointier leg structure. Further, in one embodiment, the slot in the
anchor 84 is configured to create registering and aligning surfaces
to the delivery tool (not shown). In several embodiments, the two
inner surfaces of the prongs 96 of the slotted anchor 84 are
configured as corresponding inwardly facing U-shapes. In this
configuration, the inner surfaces of the prongs 96 bite into the
suture 78. In still other embodiments, the two inner surfaces of
the prongs 96 of the slotted anchor 84 are configured to present a
notched geometry. In still other embodiments, the inner surfaces of
the prongs are configured with burrs, roughened edges, serrations,
etc. to enhance their ability to retain the connector.
[0064] Referring now to FIGS. 5A-D, there is shown one embodiment
of a delivery device 100. This device is configured to include
structure that is capable of both gaining access to an
interventional site as well as assembling and implanting one or
more anchor assemblies or implants within a patient's body. The
delivery device 100 can be configured to assemble and implant a
single anchor assembly or implant. The device is further
contemplated to be compatible for use with a 19 F sheath. The
device additionally includes structure configured to receive a
conventional remote viewing device (e.g., an endoscope) so that the
steps being performed at the interventional site can be
observed.
[0065] Prior to use of the present device 100, a patient typically
undergoes a five day regiment of antibiotics. A local anesthesia
can be employed for the interventional procedure. A combination of
an oral analgesic with a sedative or hypnotic component can be
ingested by the patient. Moreover, topical anesthesia such as
lidocaine liquids or gel can be applied to the bladder and
urethra.
[0066] The anchor delivery device 100 includes a handle assembly
102 connected to an elongate tissue access assembly 104. The
elongate tissue access assembly 104 houses components employed to
construct an anchor assembly and is sized to fit into a 19 F
cystosopic sheath for patient tolerance during a procedure in which
the patient is awake rather than under general anesthesia. The
tissue access assembly is stiff to allow manual exploration of
tissue at an interventional site by leveraging or pushing the
handle assembly 102.
[0067] The anchor delivery device 100 further includes a number of
subassemblies. A handle case assembly 106 including mating handle
parts, which form part of the handle assembly 102. The handle
assembly 102 is sized and shaped to fit comfortably within an
operator's hand and can be formed from conventional materials.
Windows can be formed in the handle case assembly 106 to provide
access to internal mechanisms of the device so that a manual
override is available to the operator in the event the
interventional procedure needs to be abandoned.
[0068] In one embodiment, the delivery device 100 is equipped with
various activatable members, which facilitate assembly and delivery
of an anchor assembly at an interventional site. A needle actuator
108 is provided and as described in detail below, effectuates the
advancement of a needle assembly (loaded with a first component of
an anchor assembly) to an interventional site. In a preferred
embodiment, the needle assembly has a needle that moves through a
curved trajectory and exits the needle housing in alignment with a
handle element, and in particular embodiments, in alignment with
the grip. In various other embodiments, the needle housing is
oriented such that the needles exits the housing at either the two
o'clock or ten o'clock positions relative to a handle grip that is
vertical. A needle retraction lever assembly 110 is also provided
and when actuated causes the needle assembly to be withdrawn and
expose the first anchor component. This action and the structure
involved is also described in detail below. Finally, the delivery
device 100 is equipped with a rear or proximal anchor actuator
assembly 112, which as fully described below, upon actuation,
accomplishes assembly of a second component to the anchor assembly
and release of the anchor assembly at the interventional site.
[0069] In one particular, non-limiting use in treating
incontinence, the elongate tissue access portion 104 of a delivery
device is placed within a urethra (UT) leading to a urinary bladder
(UB) of a patient. In one approach, the delivery device can be
placed within an introducer sheath (not shown) previously
positioned in the urethra or alternatively, the delivery device can
be inserted directly within the urethra. When employing an
introducer sheath, the sheath can be attached to a sheath mount
assembly (described below). The patient is positioned in lithotomy.
The elongate portion 104 is advanced within the patient until a
leading end thereof reaches a target tissue.
[0070] As shown in FIGS. 5A-B, the delivery device is at this stage
configured in a ready state. The needle actuator 108 and the needle
retracting lever 110 are in an inactivated position.
[0071] Upon depression of the needle actuator 108, the needle
assembly 230 is advanced from within the elongate member 104 (See
FIG. 5C). The needle assembly can be configured so that it curves
back toward the handle as it is ejected. In use, the needle
assembly is advanced through and beyond a target tissue. Spring
deployment helps to ensure the needle passes swiftly through the
tissue. In one approach, the needle is made from Nitinol tubing and
can be coated with Parylene N. Such a coating helps compensate for
frictional or environmental losses (e.g., wetness), which may
degrade effectiveness of needle penetration.
[0072] After complete depression of the needle actuator 108 and the
unlocking of the needle retraction lever 110, the needle retraction
lever 110 can be actuated. Such action results in a withdrawal of
the needle assembly 230, leaving the connector 78 of an anchor
assembly in an extended position (See FIG. 5D). In one embodiment,
the needle 230 is withdrawn further than its original position
within the device pre-deployment.
[0073] The proximal anchor actuator assembly 112 is configured at a
back end of the casing 106. Actuation of the proximal anchor
actuator 112 results in causing the proximal anchor component 84 to
engage the connector 78. It also accomplishes cutting a connector
78 to length. Within a patient's body, the anchor assembly is
configured across anatomy within the interventional site. The
urethra UT is thus stabilized, repositioned or its position is
maintained due to the anchor assembly engaging the surrounding
tissue. The urethra UT can also be modified using the anchor
assemblies, such as by decreasing its size or cross-sectional
profile.
[0074] Accordingly, an approach involving inserting a tissue
suturing or anchoring device into the prostatic urethra UT
transurethrally to displace or maintain positioning of the urethra
UT is contemplated. The delivery device can also be inserted within
the patient's body through an incision site. It is thus
contemplated that the anchor delivery device 100 can be advanced
through an incision site made in the front of the patient's body,
or in the space behind the testicles in the male or through the
vagina in a female. An approach originating through the rectum is
also contemplated.
[0075] As an initial step, sagittal views of a patient's urethra,
bladder and surrounding tissues can be taken using transabdominal
or transrectal ultrasonography. In this way, the patient's anatomy
can be assessed. In this regard, measurements can be taken to
determine the various distances and spaces involved in an approach
to treat incontinence. After assessing the anatomy, the elongate
tissue access assembly 104 of an anchor delivery device (See FIGS.
5A-B) is advanced within the urethra UT or through an incision
site.
[0076] Next, an anchor assembly can be deployed to stabilize,
reposition, modify or hold in place the target urethra UT. As
described above, the anchor delivery device accomplishes first
deploying a distal anchor 70 and then assembles and attaches a
proximal anchor component 84 onto a connector 78. The distal anchor
70 is implanted in anatomy having sufficient purchase. Although the
above described tissue anchor matter is shown in a number of
drawings relating to treating incontinence, it is to be recognized
that various other embodiment of anchors can also be utilized in
any of the treatment approaches (See for example, FIG. 10).
[0077] As stated, the present disclosure is intended to address all
forms of incontinence. In treating Stress Urinary Incontinence
(SUI), the fascia and pelvic muscles surrounding the urethra do not
adequately hold the urethra UT in position. When intra-abdominal
pressure increases, during events such as coughing or sneezing, the
urethra can move downward in position, causing urine to leak. In
one approach, an anchor assembly 60 including a distal anchor 70
attached to a second anchor 84 by a tensioned suture element 78 is
used to stabilize, reposition and hold the urethra UT in the proper
position.
[0078] As shown in FIGS. 6A-B in one treatment protocol, the distal
anchor 70 is deployed anterior of the urethra UT, the suture 78 is
tensioned, and then the proximal anchor 84 would be deployed in the
urethra UT. After deployment, the proximal anchor 84 pulls the
urethra UT upward based on the tension (FIG. 6A (before) and FIG.
6B (after)).
[0079] This approach would provide a treatment that is minimally
invasive. The anchor assembly 60 is small and can be delivered
transurethrally. The procedure may be performed in the office
setting instead of an operating room. Also, side effects and
complications from surgery, such as erosion, are reduced. In women,
using a conventional sling can result in substantial mesh
erosion.
[0080] In another approach (FIG. 7), the distal anchor 70 can also
be deployed laterally relative to the urethra UT. The anchor
assembly 60 would tension the urethra UT to stabilize it during
increases or changes in intra-abdominal pressure.
[0081] Also, as shown in FIGS. 8A-B, the delivery device 100 could
be placed in a low (posterior) position in the urethra UT
initially, but the target exterior the urethra UT would be a high
(anterior) position. Also, it is contemplated that the delivery
device 100 or other instruments can be employed to manipulate
tissue to achieve a desired, non-linear trajectory of the connector
60 through tissue defining the urethra UT (See FIG. 8B).
[0082] In women, the urethra UT is supported by pelvic floor fascia
PFM (See FIG. 3). If this support is insufficient, the urethra UT
can move downward at times of increased abdominal pressure leading
to urinary incontinence. Devices, which lift the urethra UT towards
the abdomen to improve continence, are thus contemplated. In
particular, an anchor assembly 60 can be used to treat urinary
incontinence by stabilizing, repositioning and/or lifting the
urethra UT towards the abdomen, or otherwise stabilize or modify
the urethra UT. This can be achieved through several
approaches.
[0083] In a first approach (FIG. 9A), the connector 78 of an anchor
assembly 60 is passed laterally through the anterior periurethral
fascia APF and is anchored to lateral tissue or bone. Applying
tension along the suture connector 78 would serve to lift the
urethra UT towards the abdomen thus reducing incontinence in women
in this approach. The suture would not enter the urethral
lumen.
[0084] In an alternate approach (FIG. 9B), the connector 78 of an
anchor assembly is passed laterally through the anterior
periurethral fascia APF and anchored to lateral tissue or bone.
Here, the suture connector 78 would pass through the urethral lumen
UT. Applying tension along the suture 78 would serve to lift the
urethra UT towards the abdomen thus reducing incontinence in
women.
[0085] In yet another approach (FIG. 9C), the connector 78 of an
anchor assembly 60 is anchored into anterior urethral fascia AUF.
Another anchor assembly 60 would serve as a direct link from the
fascia to the urethral lumen UT. Applying lateral tension to the
sutures lifts the fascia towards the abdomen, which would, in turn,
pull the suture connecting the fascia to the urethral lumen UT. As
a result, the urethra UT would be pulled towards the abdomen thus
reducing incontinence in women. Accordingly, a minimally invasive
transurethral or laparoscopic approach is described, one where
additional lift or purchase by passing the suture through the
urethral lumen UT is suggested or alternatively, in men, the
additional lift or purchase is achieved by passing through the
prostate capsule.
[0086] It is also contemplated that incontinence can be treated
using a sling device 560 (See FIG. 10). The sling device can
include a mid-section defined by an elongate mesh structure 578. At
each end of the mesh structure 578 there are extensions including
barbs or anchors 584. The sling assembly 560 can be deployed into
the prostate PG with both sling ends 584 on the prostate capsule C
and with the exposed sling in urethra UT providing tissue
stabilizing or repositioning (See FIG. 11). The sling 560 could be
initially placed inside a hollow needle or other element and
delivered into the tissue via a trocar. The sling assembly 560
could also be deployed through the prostate, with one sling end on
the capsule C and the other sling end residing on the urethra UT to
provide tissue repositioning or stabilizing. In a related treatment
approach (See FIG. 12), an anchor assembly 60 can be configured
across the prostate PG to aid in repositioning or stabilizing of
the urethra UT to treat SUI. These approaches to treating urinary
incontinence allow for minimally invasive surgical approaches and
would be a cost effective, simple way to urinary incontinence.
[0087] Further, it is contemplated that the sling assembly 560 or
anchor assembly 60 can include an anchor having a multi or staged
barb component (See 590; FIG. 11) that could provide means for
adjustment and custom tissue stabilizing or repositioning. Staged
barbs 590 would allow tightening or length adjustment of the sling
or anchor assemblies. Also, a wire or similar element could reside
in the sling assembly 560 to provide increased column strength. An
expandable balloon or other element could reside against the
urethra UT to provide adjustable tissue compression. Alternatively,
a urethral element can also be used which can twist or rotate to
adjust implant length and provide adjustable tissue repositioning
or stabilizing.
[0088] As shown in FIG. 12, one or more anchor assemblies 60 can be
positioned across the prostate PG to treat incontinence. In this
approach, the urethra UT is repositioned or stabilized by anchors
providing forces on the prostate PG without physical contact with
the urethra.
[0089] With reference now to FIGS. 13A-B, another approach involves
deploying two anchor assemblies 60 in cross-pattern below the
prostate PG to hold urethra UT upward in a correct or desired
position. Another configuration would be to deploy anchor assembly
60 underneath the prostate PG to hold the urethra UT upward in the
desired position (FIG. 13B). Multiple anchor assemblies 60 could
also be used along length of urethra UT (FIG. 14A). Alternately,
the anchor assembly 660 could be modified from a single
monofilament to a multi-strand, splayable suture 678 with shared
end connections (FIG. 14B).
[0090] It is to be recognized that the approaches depicted in at
least FIGS. 6-9 and 13A-B can be utilized in the male treatment of
the membranous urethra MU and the bulbous urethra BU (See also FIG.
2). That is, one or more anchor assemblies can be configured
through and/or about the membranous and bulbous sections of the
urethra UT to reconfigure, stabilize or change the size or shape of
these sections of the urethra UT. By so specifically addressing the
membranous urethra and bulbous urethra BU, in continence in males
can be minimized.
[0091] Moreover, it is contemplated that the anchor assembly
connector 78 could be replaced with a wider material, such as a
biocompatible tape. The connector 78 could also be placed in a
diagonal pattern, to provide greater area for the connector to
interface with the urethra (See FIG. 14A).
[0092] Accordingly, the present invention contemplates both pushing
directly on anchor portions of an anchor assembly as well as
pushing directly upon the connector of the anchor assembly.
Moreover, as presented above, the distal or first anchor component
is advanced and deployed through a needle assembly and at least one
component of the proximal or second anchor component is advanced
and deployed from a housing portion of the anchor deployment
device. Further, either a single anchor assembly or multiple anchor
assemblies can be delivered and deployed at an intervention site by
the deployment device. Additionally, a single anchor assembly
component can for example, be placed on one side of a prostate or
urethra while multiple anchor assembly components can be positioned
along an opposite or displaced position of such anatomy. The number
and locations of the anchor assemblies can thus be equal and/or
symmetrical, different in number and asymmetrical, or simply
asymmetrically placed. Moreover, drug delivery is both contemplated
and described as a further remedy in BPH and over active bladder
treatment as well as treating prostate cancer and prostatitis.
[0093] Once implanted, the anchor assembly of the present invention
accomplishes desired tissue manipulation, approximation,
compression or retraction as well as cooperates with the target
anatomy to provide an atraumatic support structure.
[0094] Furthermore, in addition to an intention to cooperate with
natural tissue anatomy, the present invention also contemplates
approaches to accelerate healing or induce scarring. Manners in
which healing can be promoted can include employing abrasive
materials, textured connectors, biologics and drugs.
[0095] Additionally, it is contemplated that the components of the
anchor assembly or selected portions thereof (of any of the anchor
assemblies described or contemplated), can be coated or embedded
with therapeutic or diagnostic substances (e.g. drugs or
therapeutic agents). Again, in the context of treating a prostate
gland, the anchor assembly can be coated or imbedded with
substances such as 5-alpha-reductase inhibitors, which cause the
prostate to decrease in size. Other substances contemplated include
but are not limited to phytochemicals generally,
alpha-la-adrenergic receptor blocking agents, smooth muscle
relaxants, and agents that inhibit the conversion of testosterone
to dihydrotestosterone. In one particular approach, the connector
can for example, be coated with a polymer matrix or gel coating,
which retains the therapeutic or diagnostic substance and
facilitates accomplishing the timed release thereof. Additionally,
it is contemplated that bacteriostatic coatings as well as
analgesics and antibiotics for prostatitis and other chemical
coatings for cancer treatment, can be applied to various portions
of the anchor assemblies described herein. Such coatings can have
various thicknesses or a specific thickness such that it along with
the connector itself matches the profile of a cylindrical portion
of an anchor member affixed to the connector. Moreover, the
co-delivery of a therapeutic or diagnostic gel or other substances
through the implant deployment device or another medical device
(i.e. catheter), and moreover an anchor assembly including the
same, is within the scope of the present invention as is
radio-loading devices (such as a capsular or distal ends of
implants for cancer or other treatment modalities). In one such
approach, the deployment device includes a reservoir holding the
gel substance and through which an anchor device can be advance to
pick up a desired quantity of therapeutic or diagnostic gel
substance.
[0096] It is to be recognized that the timing of the dual
advancement of the needle and connector assemblies and subsequent
relative motion between the assemblies is coordinated. That is, the
needle assembly first provides access to an interventional site and
then the connector assembly is left extending beyond a terminal end
of the needle assembly through the relative motion of the needle
and connector assemblies.
[0097] It is further contemplated that in certain embodiments, the
anchor delivery device can include the ability to detect forces
being applied thereby or other environmental conditions. Various
sections of the device can include such devices and in one
contemplated approach sensors can be placed along the needle
assembly. In this way, an operator can detect for example, whether
the needle has breached the target anatomical structure at the
interventional site and the extent to which such breaching has
occurred. Other sensors, which can detect particular environmental
features, can also be employed such as blood or other chemical or
constituent sensors. Moreover, one or more pressure sensors or
sensors providing feedback on the state of deployment of the anchor
assembly during delivery or after implantation are contemplated.
For example, tension or depth feedback can be monitored by these
sensors. Further, such sensors can be incorporated into the anchor
assembly itself, other structure of the deployment device or in the
anatomy.
[0098] Moreover, it is to be recognized that the foregoing
procedure is reversible. In one approach, the connection of an
anchor assembly can be severed and a proximal (or second) anchor
component removed from the patient's body. For example, the
physician can cut the connector and subsequently remove the one or
both anchors previously implanted for example, in the patient's
urethra.
[0099] An aspect that the various embodiments of the present
invention provide is the ability to deliver an anchor assembly
having a customizable length, each anchor assembly being implanted
at a different location without having to remove the device from
the patient. Other aspects of the various embodiments of the
present invention are load-based delivery, of an anchor assembly,
anchor assembly delivery with a device having integrated connector,
(e.g. suture), cutting, and anchor assembly delivery with an
endoscope in the device. The delivery device is uniquely configured
to hold the suture with tension during delivery to help ensure that
the first anchor component sits firmly against a tissue plane
(e.g., the outer capsule of the prostate) and is held relatively
firm as the second anchor component is attached to the connector
and the delivery device. In this aspect, the needle assembly acting
as a penetrating member is cooperatively connected to a mechanism,
which pulls on the anchor while the needle assembly is
retracted.
[0100] It is to be recognized that various materials are within the
scope of the present invention for manufacturing the disclosed
devices. Moreover, one or more components such as distal anchor,
proximal anchor, and connector, of the one or more anchor devices
disclosed herein can be completely or partially biodegradable or
biofragmentable.
[0101] Further, as stated, the devices and methods disclosed herein
can be used to treat a variety of pathologies in a variety of
lumens or organs comprising a cavity or a wall. Examples of such
lumens or organs include, but are not limited to urethra, bowel,
stomach, esophagus, trachea, bronchii, bronchial passageways, veins
(e.g. for treating varicose veins or valvular insufficiency),
arteries, lymphatic vessels, ureters, bladder, cardiac atria or
ventricles, uterus, fallopian tubes, etc.
[0102] Finally, it is to be appreciated that the invention has been
described herein with reference to certain examples or embodiments
of the invention but that 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
unpatentable or unsuitable for its intended use. Also, for example,
where the steps of a method are described or listed in a particular
order, the order of such steps may be changed unless to do so would
render the method unpatentable 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.
[0103] Thus, it will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without parting from
the spirit and scope of the invention.
* * * * *