U.S. patent application number 13/489793 was filed with the patent office on 2012-09-27 for anchor delivery system with replaceable cartridge.
This patent application is currently assigned to NEOTRACT, INC.. Invention is credited to Mitchell C. Barham, Joseph Catanese, III, Floria Cheng, Michael Gearhart, Andrew L. Johnston, Theodore C. Lamson, Joshua Makower, Matthew McLean, Michael Wei.
Application Number | 20120245600 13/489793 |
Document ID | / |
Family ID | 41137066 |
Filed Date | 2012-09-27 |
United States Patent
Application |
20120245600 |
Kind Code |
A1 |
McLean; Matthew ; et
al. |
September 27, 2012 |
ANCHOR DELIVERY SYSTEM WITH REPLACEABLE CARTRIDGE
Abstract
A system and associated method for manipulating tissues and
anatomical or other structures in medical applications for the
purpose of treating diseases or disorders or other purposes. In one
aspect, the system includes a delivery device configured to deploy
and implant anchor devices for such purposes.
Inventors: |
McLean; Matthew; (San
Francisco, CA) ; Barham; Mitchell C.; (San Mateo,
CA) ; Wei; Michael; (Redwood City, CA) ;
Cheng; Floria; (San Francisco, CA) ; Johnston; Andrew
L.; (Redwood City, CA) ; Gearhart; Michael;
(Fremont, CA) ; Catanese, III; Joseph; (San
Leandro, CA) ; Lamson; Theodore C.; (Pleasanton,
CA) ; Makower; Joshua; (Los Altos, CA) |
Assignee: |
NEOTRACT, INC.
Pleasanton
CA
|
Family ID: |
41137066 |
Appl. No.: |
13/489793 |
Filed: |
June 6, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12512674 |
Jul 30, 2009 |
8216254 |
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13489793 |
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11775162 |
Jul 9, 2007 |
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12512674 |
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11671914 |
Feb 6, 2007 |
8157815 |
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11775162 |
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11492690 |
Jul 24, 2006 |
7896891 |
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11671914 |
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11318246 |
Dec 22, 2005 |
7645286 |
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11492690 |
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11134870 |
May 20, 2005 |
7758594 |
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11318246 |
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61084937 |
Jul 30, 2008 |
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Current U.S.
Class: |
606/146 |
Current CPC
Class: |
A61B 2017/00022
20130101; A61B 2017/00792 20130101; A61B 2017/2923 20130101; A61B
17/00234 20130101; A61B 17/0469 20130101; A61B 2017/0417 20130101;
A61B 2017/00805 20130101; A61B 2017/0488 20130101; A61B 2017/0419
20130101; A61B 17/3468 20130101; A61B 17/42 20130101; A61B
2017/00796 20130101; A61B 2017/06095 20130101; A61B 17/3478
20130101; A61B 2017/0479 20130101; A61B 2017/06052 20130101; A61B
17/32 20130101; A61B 2017/0409 20130101; A61B 2018/00547 20130101;
A61B 2017/00274 20130101; A61B 2017/0464 20130101; A61B 17/0401
20130101; A61B 2017/0046 20130101 |
Class at
Publication: |
606/146 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A system for treatment of body tissue, comprising: an anchor
assembly, the anchor assembly including a first component and a
second component; and a delivery device, the delivery device
including a needle assembly, a needle deploy actuator and a retract
lever; wherein the actuator accomplishes automated deployment of
the needle assembly along a curved trajectory and the lever
accomplishes manual withdrawal of the needle assembly.
2. The system of claim 1, wherein the delivery device includes a
needle deployment spring and actuation of the actuator results in
the needle deployment spring automatically advancing the needle
assembly with a force sufficient to penetrate through and beyond a
prostate and outer capsule of the prostate.
3. The system of claim 2, wherein the delivery device includes a
spool assembly controlling the position of the needle assembly.
4. The system of claim 3, wherein the spool assembly includes the
needle deployment spring.
5. The system of claim 4, wherein the delivery device includes a
cartridge assembly, the cartridge assembly housing one anchor
component.
6. The system of claim 5, wherein the cartridge assembly is
configured to releasably engage the spool assembly.
7. The system of claim 6, wherein the cartridge assembly is
configured to feed the one anchor component within the needle
assembly.
8. The system of claim 7, wherein the cartridge assembly includes a
spring.
9. The system of claim 8, wherein a clutch is provided to
disassociate the cartridge assembly from at least a portion of the
spool assembly.
10. The system of claim 9, wherein the spring is configured to
apply a tension on the one anchor component.
11. The system of claim 10, wherein the delivery device includes a
trigger assembly.
12. The system of claim 11, wherein the trigger assembly is
configured to effect assembly of the anchor assembly.
13. The system of claim 12, wherein the trigger assembly controls
severing of a third component of the anchor assembly.
14. The system of claim 13, wherein the delivery device includes a
bail-out assembly configured to sever the third component of the
anchor assembly.
15. The system of claim 14, wherein the delivery device includes a
first reset lever configured to reset the needle spool
assembly.
16. The system of claim 15, wherein the delivery device includes a
second reset lever configured to reset the trigger assembly.
17. A system for treatment of body tissue, comprising: an anchor
assembly; and a delivery device including a needle assembly, a
spool assembly, a trigger assembly, a first actuator, a second
actuator and a third actuator; wherein actuation of the first
actuator advances the needle assembly and a portion of the anchor
assembly along a curved trajectory, actuation of the second
actuator withdraws the needle assembly and actuation of the third
actuator accomplishes assembly of the anchor assembly.
18. The system of claim 17, wherein the delivery device includes a
first reset lever and a second reset lever, wherein the first reset
lever resets the spool assembly and the second reset lever resets
the trigger assembly.
19. The system of claim 18, wherein the delivery device includes a
bail-out assembly and actuation of the bail-out assembly
accomplishes severing a component of the anchor assembly.
20. The system of claim 17, wherein the delivery device includes a
lock-out assembly which locks the lever until after depression of
the first actuator.
21. The system of claim 17, wherein the delivery device includes a
locking mechanism which locks the lever in a depressed
condition.
22. The system of claim 17, wherein the delivery device includes
structure to avoid premature deployment of the third actuator until
the second actuator is fully depressed.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of copending U.S.
patent application Ser. No. 11/775,162 entitled Multi-Actuating
Trigger Anchor Delivery System, filed Jul. 9, 2007, which is a
continuation-in-part of copending U.S. patent application Ser. No.
11/671,914, entitled Integrated Handle Assembly For Anchor Delivery
System, filed Feb. 6, 2007, which is a continuation-in-part of
copending U.S. patent application Ser. No. 11/492,690, entitled
Apparatus and Method for Manipulating or Retracting Tissue and
Anatomical Structure, filed on Jul. 24, 2006, which is a
continuation-in-part of copending U.S. patent application Ser. No.
11/318,246, entitled Devices, Systems and Methods for Retracting,
Lifting, Compressing, Supporting or Repositioning Tissues or
Anatomical Structures, filed on Dec. 22, 2005, which is a
continuation-in-part of copending U.S. patent application Ser. No.
11/134,870 entitled Devices, Systems and Methods for Treating
Benign Prostatic Hyperplasia and Other Conditions, filed on May 20,
2005, the entire disclosures of which are expressly incorporated
herein by reference and claims the benefit of Provisional
Application Ser. No. 61/084,937.
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 diseases or disorders and/or for cosmetic
or reconstructive or other purposes.
BACKGROUND OF THE INVENTION
[0003] There are a wide variety of situations in which it is
desirable to lift, compress or otherwise reposition normal or
aberrant tissues or anatomical structures (e.g., organs, ligaments,
tendons, muscles, tumors, cysts, fat pads, etc.) within the body of
a human or animal subject. Such procedures are often carried out
for the purpose of treating or palliating the effects of diseases
or disorders (e.g., hyperplasic conditions, hypertrophic
conditions, neoplasias, prolapses, herniations, stenoses,
constrictions, compressions, transpositions, congenital
malformations, etc.) and/or for cosmetic purposes (e.g., face
lifts, breast lifts, brow lifts, etc.) and/or for research and
development purposes (e.g., to create animal models that mimic
various pathological conditions). In many of these procedures,
surgical incisions are made in the body and laborious surgical
dissection is performed to access and expose the affected tissues
or anatomical structures. Thereafter, in some cases, the affected
tissues or anatomical structures are removed or excised. In other
cases, various natural or man made materials are used to lift,
sling, reposition or compress the affected tissues.
Benign Prostatic Hyperplasia (BPH)
[0004] One example of a condition where it is desirable to lift,
compress or otherwise remove a pathologically enlarged tissue is
Benign Prostatic Hyperplasia (BPH). 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[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] Minimally invasive procedures for treating BPH symptoms
include Transurethral Microwave Thermotherapy (TUMT), Transurethral
Needle Ablation (TUNA), Interstitial Laser Coagulation (ILC), and
Prostatic Stents.
[0012] 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.
Urinary Incontinence (UI)
[0013] Many women experience loss of bladder control following
childbirth or in old age. This condition is broadly referred to as
urinary incontinence (UI). The severity of UI varies and, in severe
cases, the disorder can be totally debilitating, keeping the
patient largely homebound. It is usually associated with a
cystocele, which results from sagging of the neck of the urinary
bladder into or even outside the vagina
[0014] The treatments for UI include behavioral therapy, muscle
strengthening exercises (e.g., Kegel exercises), drug therapy,
electrical stimulation of the pelvic nerves, use of intravaginal
devices and surgery.
[0015] In severe cases of UI, surgery is generally the best
treatment option. In general, the surgical procedures used to treat
UI attempt to lift and support the bladder so that the bladder and
urethra are returned to their normal positions within the pelvic
cavity. The two most common ways of performing these surgeries is
through incisions formed in the abdominal wall or though the wall
of the vagina.
[0016] A number of different surgical procedures have been used to
treat UI. The names for these procedures include the Birch
Procedure, Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling,
Trans-Vaginal Tape Procedure, Urethral Suspension, Vesicourethral
Suspension. These procedures generally fall into two categories,
namely a) retropubic suspension procedures and b) sling
procedures.
[0017] In retropubic suspension procedures, an incision is
typically made in the abdominal wall a few inches below the navel
and a network of connectors are placed to support the bladder neck.
The connectors are anchored to the pubic bone and to other
structures within the pelvis, essentially forming a cradle which
supports the urinary bladder.
[0018] In sling procedures, an incision is typically made in the
wall of the vagina and a sling is crafted of either natural tissue
or synthetic (man-made) material to support the bladder neck. Both
ends of the sling may be attached to the pubic bone or tied in
front of the abdomen just above the pubic bone. In some sling
procedures a synthetic tape is used to form the sling and the ends
of the synthetic tape are not tied but rather pulled up above the
pubic bone.
[0019] The surgeries used to treat UI are generally associated with
significant discomfort as the incisions heal and may require a
Foley or supra-pubic urinary catheter to remain in place for at
least several days following the surgery. Thus, there exists a need
in the art for the development of minimally invasive (e.g.,
non-incisional) procedures for the treatment of UI with less
postoperative discomfort and less requirement for post-surgical
urinary catheterization.
Cosmetic or Reconstructive Tissue Lifting and Repositioning
[0020] Many cosmetic or reconstructive surgical procedures involve
lifting, compressing or repositioning of natural tissue, natural
tissue or artificial grafts or aberrant tissue. For example,
surgical procedures such as face lifts, brow lifts, neck lifts,
tummy tucks, etc. have become commonplace. In many cases, these
procedures are performed by creating incisions through the skin,
dissecting to a plane beneath muscles and fascia, freeing the
muscles, fascia and overlying skin from underlying structures
(e.g., bone or other muscles), lifting or repositioning the freed
muscles, fascia and overlying skin and then attaching the
repositioned tissues to underlying or nearby structures (e.g.,
bone, periostium, other muscles) to hold the repositioned tissues
in their new (e.g., lifted) position. In some cases excess skin may
also be removed during the procedure.
[0021] There have been attempts to develop minimally invasive
devices and methods for cosmetic lifting and repositioning of
tissues. For example, connector suspension lifts have been
developed where one end of a standard or modified connector thread
is attached to muscle and the other end is anchored to bone,
periostium or another structure to lift and reposition the tissues
as desired. Some of these connector suspension techniques have been
performed through cannulas or needles inserted though relatively
small incisions of puncture wounds.
[0022] There remains a need for the development of new devices and
methods that may be used for various procedures where it is desired
to lift, compress, support or reposition tissues or organs within
the body with less intraoperative trauma, less post-operative
discomfort and/or shorter recovery times. Further, there is a need
for an apparatus and related method which is easy and convenient to
repeatedly employ in an interventional procedure. In particular,
there is an apparatus which can accomplish accessing an
interventional site as well as be reused after reloading. Moreover,
there is a need for a device including manual as well as automatic
features so that successful use is facilitated.
[0023] The present invention addresses these and other needs.
SUMMARY OF THE INVENTION
[0024] 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. The apparatus of the present
invention includes various subassemblies which are mobilized via a
trigger or other manually accessible structure. The operation of
the subassemblies is coordinated and synchronized to ensure
accurate and precise implantation of an anchor assembly. Structure
for re-loading of the device is also described.
[0025] In one embodiment, the delivery device is embodied in a
tissue approximation assembly. The tool includes a case assembly
enclosing a trigger assembly, a needle spool assembly and a
replaceable cartridge assembly. Extending from the case assembly
and attached to the trigger assembly and needle spool assembly is a
shaft assembly. Also, extending through the shaft assembly and
connected to the trigger assembly are a pusher assembly, needle,
and a cutter assembly. Operatively associated with the needle spool
and cartridge assemblies are a needle actuator and a needle
retraction actuator (e.g., a lever assembly). A rear actuator is
operatively associated with the trigger assembly. This actuator can
be positioned on a side of the instrument and can also be
incorporated into the lever. It is also contemplated that each of
the actuators can be incorporated into a single structure for
creating movement of internal mechanisms of the device. Activation
of the needle actuator accomplishes the advancement of a needle
assembly and a first component of an anchor assembly attached to a
connector member, to an interventional site. Activation of the
needle retraction actuator withdraws the needle assembly leaving
the first component of the anchor assembly at the interventional
site. Thereafter, manipulation of the rear actuator results in
lockingly engaging a second anchor component with the connector
member and cutting the connector member to a desired length.
[0026] 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 a tension during delivery
and a tension between implanted anchor components as well as
cutting the anchor assembly to a desired length and assembling 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 with a sheath in the range of 18
to 24 F, preferably a 19 F sheath.
[0027] Additionally, in a contemplated embodiment of an anchor
delivery system, actuating a needle deploy actuator results in a
needle assembly being advanced within a patient to an
interventional site. Activating a needle retraction lever
accomplishes the withdrawal of the needle and deployment of a first
anchor component of an anchor assembly at the interventional site.
Depression of a second actuator facilitates the incorporation of a
second component into the anchor assembly and its release at the
interventional site. A reset assembly is further provided to reset
aspects of the delivery system as is a bail out assembly configured
to release anchor structure from the delivery device. Moreover,
various locking mechanisms are provided for both operational as
well as safety reasons.
[0028] The present invention also contemplates a reversible
procedure as well as an anchor assembly with sufficient visibility
when viewed ultrasonically, by xray, MRI or other imaging
modalities. In one aspect, the implant procedure is reversible by
severing a connector of an anchor assembly and removing an anchor
of the anchor assembly such as by removing a proximally placed
anchor previously implanted in an urethra. Moreover, the anchor
assemblies can be formed of structures such as that having
increased density to thereby facilitate ultrasound viewing or other
imaging modalities.
[0029] The anchor assembly can be configured to accomplish
retracting, lifting, compressing, supporting 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 may 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.
[0030] In one embodiment, the anchor delivery device includes a
handle assembly with a actuator attached thereto. The actuator is
associated with a body of the handle assembly and is operatively
attached to the needle assembly and structure that advances the
first anchor member. A second actuator is operatively associated
with structure that accomplishes assembling the second anchor
member to the connector member. Additionally, the handle assembly
is equipped with structure that is configured in one contemplated
embodiment, to effect the cutting of the anchor assembly to a
desired length and deployment of the structure at an interventional
site.
[0031] In a specific embodiment, the anchor delivery device
includes a generally elongate tubular housing assembly member
extending distally from a handle assembly including an actuator.
The proximal end of the handle assembly is equipped with mounting
structure configured to receive a telescope or other endoscopic
viewing instrument. A bore sized to receive the telescope extends
distally through a body of the handle assembly and continues
through an outer tubular cover member forming the generally
elongate member. Housed within the tubular housing assembly are a
telescope tube having an interior defining a distal section of the
bore sized to receive the telescope, an upper tubular member
assembly sized to receive at least one component of the implant
assembly through a needle housing configured to receive the needle
assembly, and a lower tubular member assembly sized to receive at
least one second component of the implant assembly through a cutter
member.
[0032] Additionally, in a preferred embodiment the first anchor
member includes a tubular portion, a mid-section and a tail
portion. The tail portion of the member further includes a
connector section which acts as a resilient member. A terminal end
portion of the tail is further contemplated to have a surface area
larger than the connector section to provide a platform for
engaging tissue.
[0033] Further, in the preferred embodiment, one component of the
second anchor member is embodied in a pin having a first end
equipped with a pair of spaced arms and a second end defining a
flattened tube.
[0034] Moreover, various alternative methods of use are also
contemplated. That is, in some applications of the invention, the
invention may be used to facilitate volitional or non-volitional
flow of a body fluid through a body lumen, modify the size or shape
of a body lumen or cavity, treat prostate enlargement, treat
urinary incontinence, support or maintain positioning of a tissue,
organ or graft, perform a cosmetic lifting or repositioning
procedure, form anastomotic connections, and/or treat various other
disorders where a natural or pathologic tissue or organ is pressing
on or interfering with an adjacent anatomical structure. Also, the
invention has a myriad of other potential surgical, therapeutic,
cosmetic or reconstructive applications, such as where a tissue,
organ, graft or other material requires retracting, lifting,
repositioning, compression or support.
[0035] In one or more embodiments, the disclosed device can have a
compact shaft profile which, for example, can fit into a 19 F
cystoscopic sheath for patient tolerant access during an awake
procedure. The device has a stiff distal shaft to allow manual
compression of tissue at an interventional site by means of
leveraging the tool handle. In a specific application, a
spring-driven needle can be deployed to a single depth, and sized
to pierce through a predominate population of urethral-prostatic
distances. An automated deployment of the needle through anatomy is
contemplated to pierce reliably with sufficient force and speed.
Moreover, the device can be provided with structure providing
manual retraction of the needle to provide tactile feedback to the
user to confirm completion of needle retraction. This also
simplifies the mechanics to provide the option to retract the
needle at any time and results in depositing the first and second
anchor components in the tissue after needle refraction.
[0036] Further, the device can be configured with suture guides
which provide centering of the suture and/or a stop to hold the
suture stable while an anchor is placed on it to ensure a reliable
assembly of an anchor assembly. Additionally, an automated
tensioning spring is provided for actuation during the lever
retraction, thus providing consistent suture tension during the
anchor deployment and making the anchor seating more reliable, as
well as minimizing the distance between the two anchors and holding
the target tissue approximated. Also, a delivery tool shaft lumen
that has at least one flat registration surface to align the
anchors to be registered with the tensioned suture as well as a
spring-like obstructive tab are used to maintain the most distal
anchor in position prior to deployment. Actuation of a final
trigger can then translate a pusher element to advance the anchor
onto the suture with sufficient speed and force to seat with
reliable retention force.
[0037] 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
[0038] FIG. 1 is a left side view, depicting one embodiment of an
anchor delivery system;
[0039] FIG. 2 is a perspective view, depicting the anchor delivery
system of FIG. 1;
[0040] FIG. 3 is a right side view, depicting the anchor delivery
system of FIG. 1;
[0041] FIG. 4 is a side view, depicting the anchor delivery system
of FIG. 3 with a portion of the casing removed;
[0042] FIG. 5 is a left side view, depicting the anchor delivery
device of FIG. 1 with a portion of the casing removed;
[0043] FIG. 6 is an exploded view, depicting the device of FIG.
1;
[0044] FIG. 7 is a perspective view, depicting a needle drive spool
assembly;
[0045] FIG. 8 is another perspective view, depicting the needle
drive spool assembly of FIG. 7;
[0046] FIG. 9 is an exploded view, depicting the needle drive spool
assembly of FIG. 7;
[0047] FIG. 10 is an enlarged view, depicting a portion of the
needle drive spool assembly;
[0048] FIG. 11 is an enlarged view, depicting a portion of the
needle assembly attached to the needle drive spool assembly;
[0049] FIG. 12 is a perspective view, depicting a cartridge
assembly of the delivery device;
[0050] FIG. 13 is a rotated perspective view, depicting the
cartridge assembly of FIG. 12;
[0051] FIG. 14 is an exploded view, depicting components of the
cartridge assembly;
[0052] FIG. 15 is a side view, depicting a first component of an
anchor and anchoring delivery system;
[0053] FIG. 16 is a perspective view, depicting components for
attaching components of FIG. 15 to a cartridge assembly;
[0054] FIG. 17 is a perspective view, depicting replacing a
cartridge assembly within an anchor delivery device;
[0055] FIG. 18 is a perspective view, depicting attachment of a
cartridge assembly to other components of anchor delivery
system;
[0056] FIG. 19 is a perspective view, depicting loading a portion
of an anchor assembly emerging from a cartridge to pass through a
needle assembly within a delivery device;
[0057] FIG. 20 is a perspective view, depicting a further step
involving loading of a cartridge assembly;
[0058] FIG. 21 is a perspective view, depicting yet another step in
loading of a cartridge assembly involving advancing a portion of
the anchor assembly to a distal end of the delivery device;
[0059] FIG. 22 is a cross-sectional view, depicting a first step
involving an interventional procedure;
[0060] FIG. 23 is a partial cross-sectional view, depicting a
delivery device in a non-actuated configuration;
[0061] FIG. 24 is a perspective view partially in cross-section,
depicting a distal terminal end of a delivery device;
[0062] FIG. 25 is a partial cross-sectional view, depicting
depression of an actuator of a delivery device;
[0063] FIG. 26 is a partial cross-sectional view, depicting
disengagement of an actuator of a delivery device;
[0064] FIG. 27 is a perspective view in partial cross-section,
depicting partial ejection of a needle assembly;
[0065] FIG. 28 is a perspective view in partial cross-section
depicting complete ejection of a needle assembly ejection;
[0066] FIG. 29 is a cross-sectional view, depicting advancement of
a needle assembly at an interventional site;
[0067] FIG. 30 is a partial cross-sectional view, depicting a
delivery device in a ready state;
[0068] FIG. 31 is a partial cross-sectional view, depicting
depression of an actuator of a delivery device;
[0069] FIG. 32 is a partial cross-sectional view, depicting action
of components of a delivery device upon depression of an
actuator;
[0070] FIG. 33 is a partial cross-sectional view, depicting
complete depression of a lever of a delivery system;
[0071] FIG. 34 is a perspective partial cross-sectional view,
depicting withdrawal of a needle assembly leaving a connector
element;
[0072] FIG. 35 is a cross-sectional view, depicting delivery of a
first component of an anchor assembly at an interventional
site;
[0073] FIG. 36 is a partial cross-sectional view, depicting
positional relationships of internal components of the delivery
system upon actuation of an actuator;
[0074] FIG. 37 is a partial cross-sectional view, depicting further
action of internal components of the delivery device;
[0075] FIG. 38 is a partial cross-sectional view, depicting yet
further action of internal components of the delivery device;
[0076] FIG. 39 is a side view, depicting components of a needle
drive spool assembly;
[0077] FIG. 40 is a cross-sectional view, depicting components of a
needle drive spool assembly;
[0078] FIG. 41 is a side view, depicting action of components of a
spool assembly;
[0079] FIG. 42 is a cross-sectional view, depicting the structure
of FIG. 41 after actuation;
[0080] FIG. 43 is a perspective view, depicting components of a
cartridge assembly in conjunction with components of a needle drive
assembly;
[0081] FIG. 44 is a perspective view, depicting the components of
FIG. 43 subsequent to action of an actuator;
[0082] FIG. 45 is a perspective view, depicting further action of
the components of FIG. 43 subsequent to action of a retraction
lever;
[0083] FIG. 46 is a perspective view, depicting yet further action
of the components of FIG. 43;
[0084] FIG. 47 is a perspective view, depicting a shaft assembly of
the delivery device;
[0085] FIG. 48 is a perspective view, depicting structure defining
a scope mount;
[0086] FIG. 49 is a perspective view and partial cross-sectional
view, depicting a sheath mount assembly;
[0087] FIG. 50 is a perspective view, depicting a cutter assembly
of the delivery device;
[0088] FIG. 51 is a perspective view, depicting a terminal end of
the cutter assembly of FIG. 50;
[0089] FIG. 52 is a perspective view, depicting a pusher assembly
of the delivery device;
[0090] FIG. 53 is a perspective view, depicting a trigger assembly
of the delivery device;
[0091] FIG. 54 is an exploded view, depicting the components of the
trigger assembly of FIG. 53;
[0092] FIG. 55 is a partial cross-sectional view, depicting the
delivery device prior to depression of the retraction lever;
[0093] FIG. 56 is a partial cross-sectional view, depicting the
device of FIG. 55 after depression of the retraction lever;
[0094] FIG. 57 is a partial cross-sectional view, depicting further
action of components of the device depicted in FIG. 56;
[0095] FIG. 58 is a partial cross-sectional (inferior) view,
depicting action of the trigger assembly;
[0096] FIG. 59 is a partial cross-sectional view, depicting a
delivery device readied for depression of the proximal anchor
actuator;
[0097] FIG. 60 is a partial cross-sectional view, depicting a
depression of the proximal anchor actuator of the device shown in
FIG. 59;
[0098] FIG. 61 is a partial cross-sectional view, depicting action
of internal components of a delivery device after depression of the
proximal anchor actuator;
[0099] FIG. 62 is a perspective view, depicting advancement of a
second anchor component into engagement with a connector;
[0100] FIG. 63 is a cross-sectional view, depicting release of a
second anchor component within an interventional site;
[0101] FIG. 64 is a partial cross-sectional view, depicting yet
further action of components internal to the delivery device;
[0102] FIG. 65 is a perspective view, depicting cutting of a
connector;
[0103] FIG. 66 is a cross-sectional view, depicting release of an
assembled anchor assembly within an interventional site;
[0104] FIG. 67 is a cross-sectional view, depicting an untreated
interventional site;
[0105] FIG. 68 is a cross-sectional view, depicting implantation of
two anchor assemblies at an interventional site; and
[0106] FIG. 69 is an enlarged view of a portion of FIG. 68.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0107] 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 anchor assemblies within a patient's
body. As stated, the disclosed apparatus can be employed for
various medical purposes including but not limited to retracting,
lifting, compressing, approximating, supporting or repositioning
tissues, organs, anatomical structures, grafts or other material
found within a patient's body. Such tissue manipulation is intended
to facilitate the treatment of diseases or disorders. Moreover, the
disclosed invention has applications in cosmetic or reconstruction
purposes or in areas relating the development or research of
medical treatments.
[0108] In one particular aspect, the anchor assembly of the present
disclosure is contemplated to be formed of a structure which is
visible by ultrasound. Accordingly, the anchor assembly can be
viewed during ultrasonic body scans such as during normal
trans-rectal ultrasound when a medical professional is conducting
diagnoses or treatment associated with conditions like prostate
cancer.
[0109] 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 a second
section of anatomy for the purpose of retracting, lifting,
compressing, approximating, 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,
approximating, 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, approximating, supporting or repositioning of
anatomy due to tension supplied thereto via a connector assembly
affixed to the first and second portions of the anchor assembly or
implant.
[0110] Referring now to FIGS. 1-3, there is shown one embodiment of
a 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. In one aspect, the device 100 is
configured to assemble and implant a single anchor assembly or
implant with a replaceable cartridge. If the user replaces the
cartridge another anchor assembly or implant can be assembled and
implanted. 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.
[0111] 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 compression of
tissue at an interventional site by leveraging the handle assembly
102.
[0112] The anchor delivery device 100 further includes a number of
subassemblies. A handle case assembly 106 including mating handle
parts encase 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.
[0113] 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 assembly in alignment with
the handle element, 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.
[0114] Turning now to FIGS. 4-6, a number of the subassemblies of
the delivery device 100 are introduced, the function and structure
of each of which are addressed in detail below. In the embodiment
depicted, the case assembly 106 has three mating parts, a left top
case 114, a left bottom case 116, and a right case 118. It is
within the scope of the present invention that the case assembly be
made of a variety of numbers of parts. In addition to mating to
enclose subassemblies, the case parts also include structural
features for providing rigidity and support for the enclosed
components.
[0115] Housed within the case assembly 106 are a needle retract
spool assembly 120 and a cartridge assembly 122. The rotational
axes of the needle spool assembly and cartridge assembly are the
same. A shaft assembly 124 includes a portion residing within the
case assembly 106 and a portion extending from a forward end of the
case assembly. Attached to and operatively associated with the
shaft assembly 124 is a trigger assembly 126. The trigger assembly
126 is also housed within the case assembly 106. FIGS. 4 and 5
illustrate the juxtapositional relationships of the various
subassemblies and FIG. 6 is an exploded view depicting the
subassemblies.
[0116] With reference to FIGS. 7-9, details concerning this
embodiment of the structure of the needle spool assembly 120 are
presented. As described further below, the needle retract spool
assembly 120 cooperates with the needle actuator and needle
retraction lever to advance and then withdraw a needle assembly at
an interventional site.
[0117] The needle retract spool assembly 120 is a compact structure
including a number of moving pieces. A needle spring housing 202
forms one side of the assembly 120 and is placed adjacent to a
needle spool housing 204. An outer side of the needle spring
housing 202 forms a generally flat surface and formed on the
opposite side of the needle spring housing 202 is a circular
recess. When the needle retract spool assembly 120 is in its
assembled form, the circular recess of the needle spring housing
202 faces the needle spool housing 204. Formed in opposite sides of
the needle spool housing 204 are two additional generally circular
recesses.
[0118] Between the needle spring housing 202 and the needle spool
housing 204 and within the facing circular recesses formed therein,
are a needle deploy spring 206 configured within and adjacent a
needle deploy spring arbor 208, which is adjacent to a needle
clutch plate 210. The needle clutch plate 210, in turn, is adjacent
and received within a circular recess formed in a needle clutch cup
212. Received in the needle spool housing 204 recess opposite of
the needle spring housing 202 is a needle spool 214. The needle
deploy spring 206 functions to rotate the needle spool 214 and to
project a tip of the needle through tissue with force and speed. In
one approach, it is contemplated that the device 100 be configured
so that the needle is deployed to a single depth to pierce through
a predominant population of urethral-prostatic distances.
[0119] Each of the generally circular profiled needle deploy spring
206 and needle deploy spring arbor 208 include a center through
hole. Further, a clutch push rod 216 extends through such aligned
holes of a completed assembly from the outer side of the needle
spring housing 202 and through the needle deploy spring 206 and
needle deploy spring arbor 208. A pivotable clutch actuator 218
configured on the outside surface of the needle spring housing 202,
as described in further detail below through its interaction with
the needle retraction lever, causes lateral movement of the push
rod 216 so that it engages the needle clutch plate 210 separating
it from the spring arbor 208. The spring arbor 206 is rotationally
biased by the needle deploy spring 206, which can be formed of a
helically arranged motor spring. A needle spring reset lever 220 is
further provided, the same being accessible to reset the spring
arbor 208 after an initial use.
[0120] As stated, the clutch plate 210 is received within the
needle clutch cup 212. The interior of the clutch cup 212 includes
bosses (not shown) sized to mate with corresponding recesses formed
in the clutch plate 210. Further, a center hole formed in the
clutch plate 210 is sized to receive a center post extending from
an adjacent face of the clutch plate. Such structure facilitates
complementary rotation of the clutch plate 210 and clutch cup 212.
Complementary rotational motion of the clutch cup 212 and the
needle spool 214 is also accomplished through an interconnection of
these pieces through a center hole form in the needle spool housing
204.
[0121] The assembly further includes a needle deploy pawl 222 which
is operatively associated with the needle actuator. As shown and
described below, the needle actuator pivots the needle deploy pawl
222 away from engagement with the spring arbor 208, thereby
permitting rotation of the same.
[0122] An unsheathing pawl 224 is also provided and configured at
one end to engage the needle retraction lever. At another end of
the unsheathing pawl 224 there is structure configured to engage a
capsular cartridge spool (described below) to thereby fix its
rotational position while the needle spool 214 rotates.
[0123] As shown in FIGS. 10 and 11, a proximal end 230 of a needle
assembly can be sized and shaped for connecting with other
structure. In one approach, the proximal end of the needle assembly
includes a shoulder sized and shaped for receipt within a
corresponding recess formed near a periphery of the needle spool
214. Other approaches to effecting a connection are also
contemplated such as using a shear wire (not shown) to engage a
recess formed in the end of the needle assembly and hold the needle
assembly in place relative to the needle spool. Through such
connections, rotation of the needle spool 214 can result in
advancing and withdrawing lengths of a needle assembly. In this
regard, as shown in FIGS. 10-11, a peripheral recess formed in the
needle spool 214 is provided to take up lengths of a needle
assembly.
[0124] Details of the cartridge assembly 122 are depicted in FIGS.
12-14. A generally circular profiled suture spool sleeve 302 forms
an outer structure of the cartridge assembly 122. Between a
generally disk shaped suture spool track 304 and a primary knob 306
and within the suture spool sleeve of an assembled cartridge 122,
are a tensioning spring 308 and a suture spool 310. As is developed
below, the tensioning spring 300 functions to provide a tension on
a connector member (e.g., a suture) of an anchor assembly. Various
different cartridges can be provided which embody springs having
varying tensions associated therewith. Moreover, the system can be
configured to provide a different tension when advancing the
connector member from that generated subsequent to placement of the
anchor assembly at an interventional site. The suture spool 310 is
configured to releasably engage the unsheathing pawl 224. Also
provided, the function of which is described below, are a knob
follower 312 and wire clip 314.
[0125] One form of a distal anchor 350 and connector member 352 of
an anchor assembly is shown in FIG. 15. At a proximal end of the
anchor assembly there can be configured a pusher (e.g., a PTFE
coated stainless steel wire) 354 attached to the connector member
352 (e.g., a PET monofilament suture) by a sleeve (e.g., polyimide
sleeve) 356. It is a proximal terminal end of the pusher 354 which
is fixed to the suture spool 304 by the wire clip 314 (See FIG.
16). An annular space formed about the suture spool 304 is provided
to receive a length of the pusher 354.
[0126] Referring now to FIGS. 17-21, a particular advantage of this
embodiment is that the cartridge assembly 122 is removable and
replaceable. In the preferred embodiment, a door on the case can be
opened or an open window can be in the case to provide access to
the interior of the delivery device. Alternatively, the left top
case 114 can be removed providing access to an interior of the
delivery device. When replacing, the cartridge assembly 122 can be
placed within an outside recess of the spool housing 204 and into
engagement with the needle spool 214. The center post extending
from the needle spool 214 helps guide the cartridge assembly 122
perpendicularly to the needle spool 214. Shoulders 360, 362 formed
on the needle spool 214 and the cartridge assembly 122,
respectively, ensure proper alignment between the pieces. As shown
best in FIG. 19, a leading terminal end 364 of an anchor assembly
protrudes from a cartridge shoulder 362, a length of the assembly
previously being configured about the suture spool. The terminal
end 364 of the assembly aligns with and is insertable within a hole
366 formed in a shoulder 360 of the needle spool.
[0127] Once inserted, the primary knob 306 of the cartridge
assembly 122 is rotated (FIGS. 20-21) to advance the leading
terminal end and connector portion of the anchor assembly through
the hole 366 then through the length of the needle assembly (See
FIGS. 10-11). The primary knob 306 is continued to be rotated until
the knob follower 312 registers at a completion point to thereby
signal that the anchor assembly is fully loaded within the needle
assembly and in one embodiment the leading end of the anchor
assembly is just proximal the distal opening of the needle.
[0128] In one particular, non-limiting use in treating a prostate
(See FIG. 22), 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. The elongate portion 104 is advanced within the
patient until a leading end 400 thereof reaches a prostate gland
(PG).
[0129] As shown in FIG. 23, the delivery device 100 is at this
stage configured in a ready state. The needle actuator 108 and the
needle retracting lever 110 are in an inactivated position. The
needle actuator 108 is spring biased by a rotating biasing assembly
402. A needle actuator safety (not shown) can be included to lock
the needle trigger 108 in an inactive position. Upon depression of
the needle actuator 108, a lock-out cam assembly 404 is rotated
ninety degrees thereby permitting subsequent actuation of the
needle retracting lever 110. The assembly further includes a lever
lock 406 configured to hold the depressed needle retracting lever
after retraction of the lever 110. It is at this stage also that
the terminal end 400 of the elongate portion 104 of the delivery
device houses a completely withdrawn needle assembly 410 and
further includes a second anchor assembly component 450 registered
for later deployment (See FIG. 24).
[0130] Initial depression of the needle actuator 108 causes
components of the biasing assembly 402 to pivot (See FIG. 25).
Releasing the needle actuator 108 facilitates it returning to an
undepressed condition and permits the lock-out cam assembly 404 to
rotate ninety degrees (See FIG. 26). In this position, the lock-out
cam assembly 404 is positioned to permit actuation of the needle
retraction lever 110.
[0131] At the leading end 400 of the delivery device, as shown in
FIGS. 27 and 28, such action results in the needle assembly being
advanced from within the elongate member 104. As is to be
appreciated, the needle is ejected by the needle deploy spring 206
in this embodiment in a direction commensurate with the direction
the handle assembly extends. Moreover, the needle assembly can be
configured so that it curves back toward the handle as it is
ejected. In use in a prostate intervention (See FIG. 29), the
needle assembly 410 is advanced through and beyond a prostate gland
(PG). The spring deployment helps to ensure the needle tip passes
swiftly through the tough outer capsule of the prostate without
"tenting" the capsule or failing to pierce the capsule. In an
alternate embodiment, the needle could be manually deployed by the
user. In one approach, the needle 410 is made from Nitinol tubing
and can be coated with Parylene N. Such a coating helps compensate
for frictional or environmental losses (i.e. wetness) which may
degrade effectiveness of needle penetration.
[0132] Referring to FIGS. 30-32, the actions of internal
sub-components of the delivery device 100 upon actuation of the
needle actuator 108 are described. FIG. 30 shows the needle
actuator 108 in an unactuated state. As the needle actuator 108 is
depressed (FIG. 31), it rotates and an extension thereof engages
the needle deploy pawl 222. Continual depression of the needle
actuator (FIG. 32) causes the needle pawl 222 to rotate from its
engagement with the needle deploy spring arbor 208. This
disengagement then permits the needle deploy spring 206 to rotate
the needle deploy arbor 208, clutch plate 210, needle clutch cup
212 and needle spool 214 (See FIG. 9). Rotational motion of the
needle deploy spring arbor 208 can be observed by noting the change
in position of the needle spring reset lever 220. Again, through
its connection with a needle assembly, rotation of the needle spool
214 causes the needle assembly to be advanced a desired
distance.
[0133] Next, after complete depression of the needle actuator 108
and the unlocking of the needle retraction lever 110, the needle
retraction lever 110 can be completely actuated (See FIG. 33). When
so actuated, the lever lock 406 engages and locks the lever 110 in
place. The lever lock 406 can be later manipulated to unlock the
lever 110. Such action results in a withdrawal of the needle
assembly 410, leaving the connector 352 of an anchor assembly in an
extended position (See FIG. 34). When extended, the connector 352
extends through the needle window and is centered by suture guide
structure. As shown in FIG. 35, in a prostatic interventional
procedure, the same results in configuring a first or distal anchor
component beyond an outer surface of a prostate gland (PG) with the
connector 352 extending toward the terminal end 400 of a delivery
device.
[0134] Internal to the delivery device 100, actuation of the needle
retraction lever 110 causes the rotation of the pivotable clutch
actuator 218 (See FIGS. 31-38). As shown in FIG. 36, the clutch
actuator 218 is in a home position. Upon actuation of the lever
110, the clutch actuator 218 rotates (See FIG. 37).
[0135] As best seen in FIGS. 39-42, rotation of the pivotable
clutch actuator causes an inclined lever surface thereof to engage
the push rod 216. This in turn causes lateral translation of the
push rod 216 against the clutch plate 210 as well as a
disengagement thereof from the spring arbor 208. This disengagement
consequently results in configuring needle spool 214 to allow
manual retraction of the needle assembly by manipulating the needle
retraction lever 110 and to provide a tension on a connector of an
anchor assembly. Manual retraction of the needle provides a
simplified approach as well as tactile feedback to the operator to
confirm completion of needle retraction. It is to be recognized
that such unclutching of the needle deploy spring allows
manipulation of the needle retraction lever 110 to be tolerable by
the patient and with little to no delivery device tool movement.
The tensioning spring 308 provides the tension forces which helps
to ensure the distal anchor is pulled back into firm contact with a
desired tissue plane such as, for example, the outer capsular
surface of the prostate gland. Notably, the spring in a preferred
embodiment provides a desired force such as up to 1-2 pounds or
more of tension. In another embodiment, a spring can be used to
automatically retract the needle assembly.
[0136] The timing of the needle retraction and tensioning is
accomplished through the interaction of the unsheathing pawl 224
and the needle spool 214. As shown in FIGS. 43 and 44, the
unsheathing pawl 224 is configured to permit a clockwise rotation
of the needle spool which occurs during needle actuator depression
until the unsheathing pawl 224 registers within grooves formed in
the needle spool. Actuation of the needle retraction lever 110
causes a deflection of the unsheathing pawl 224 (See also FIG. 38)
which disengages the unsheathing pawl 224 from the needle spool
214. Since the needle spool 214 is at this point disengaged from
the operation of the spring arbor as described above, the needle
spool 214 is permitted to rotate in a counterclockwise direction as
illustrated in FIG. 46. This counterclockwise rotation continues
until the unsheathing pawl 224 again registers in recesses 516
formed in the needle spool 214 (FIG. 46). Such recesses can be
spaced to provide desired corresponding needle depths. Also, this
structure can be equipped with a roller-clutch (not shown) which
would provide a continuous process of longitudinal movement. The
tensioning spring of the cartridge assembly 122 (See FIG. 14) is
then left to automatically provide a consistent tensioning force on
a connector of an anchor assembly. It is at this juncture that the
connector gets pulled into suture guide structure 411 (see FIG. 34)
to center the connector and ready it for engagement with a second
anchor component. Such tensioning results in seating a distal or
first anchor component 350 as desired within an interventional site
such as shown in FIG. 35 as well as to minimize a distance between
two anchor members of an implanted anchor assembly. Again, the
tension generated after seating the anchor component 350 can be
different from that during delivery of the connector of the anchor
assembly.
[0137] A more detailed description of the shaft assembly and
trigger assembly now follow as does a description of the operation
of the trigger assembly to achieve assembly of a second or proximal
anchor component to a connector of an anchor assembly and release
of a complete anchor assembly at the interventional site.
[0138] With reference to FIG. 47, there is shown an embodiment of a
shaft assembly 124. As previously disclosed, a trigger assembly
(described below) is mounted to the shaft assembly 124 and the
shaft assembly 124 includes components residing within the device
case assembly 106 as well as structure extending therefrom. A
terminal end portion 400 of the shaft assembly 124 includes an
atraumatic tip sleeve 502. Proximally located to the tip sleeve 502
is a tubular shaft assembly 504 which is sized and shaped to
slidably receive the needle assembly. A distal end portion of the
tubular shaft assembly 504 is curved so that a needle projecting
therefrom extends in a direction generally corresponding to that of
the handle of the delivery device. Configured longitudinally
adjacent the tubular shaft assembly is a scope tube 506 which is
sized and shaped to receive a scope. Configured below and
longitudinally adjacent the scope tube 506 is an elongate cover 507
which is sized to receive elongate portions of the cutter and
pusher assemblies.
[0139] At a proximal end of the shaft assembly 124 is a scope mount
lock screw assembly 508. A sheath mount assembly 510 including a
screw lock 512 is spaced distal and longitudinally from the scope
mount assembly 508. Configured between these assemblies are
components of a cutter assembly 514 and a pusher assembly 516. It
is to be recognized, however, that both the cutter and pusher
assemblies include elongate portions extending toward a distal end
400 of the shaft assembly 124.
[0140] As shown in FIG. 48, the scope mount lock screw assembly 508
includes a screw lock 520 rotatably positioned adjacent a scope
mount receiver 522. The scope mount assembly further includes a
handle pusher support snap fit 524. As best seen in previously
presented FIGS. 3-5, the scope mount lockingly engages a scope 550
which has a longitudinal dimension sufficient to extend
longitudinally substantially a length of the scope tube 506.
[0141] The sheath mount 510 can be screwed to elongate portions of
the shaft assembly (See FIG. 49). The sheath mount 510 can include
a seal 530 which functions to seal and minimize fluid ingress into
the handle portion of a delivery device.
[0142] As best shown in FIGS. 50 and 51, an embodiment of the
cutter assembly 514 includes a cutter plate 560 supporting a
distally directed, elongate cutter tube 562 and a guide 564. A pair
of spring extensions 566 are also provided and are each configured
to be attached to a cutter spring. A distal end 568 of the cutter
tube 562 is configured with a blade so that once cutter springs are
permitted to withdraw the cutter assembly 514, the blade can sever
as desired a connector of an anchor assembly.
[0143] With reference to FIG. 52, an embodiment of the pusher
assembly 516 of the shaft assembly 124 is described. The pusher
assembly 516 includes an elongate pusher member 580 extending from
a pusher block 582 to a pusher extension 584. As described in more
detail below, the pusher extension 584 engages a proximal end of a
second or proximal anchor component. The pusher block 582 further
includes a plurality of recesses 586 sized and shaped to receive
corresponding structure of the trigger assembly.
[0144] Details of an embodiment of the trigger assembly 126 are
depicted in FIGS. 53 and 54. The assembly 126 includes a base 602
and a frame 604 to which other components are affixed or supported.
A lever pivot 606 is rotatably attached to a proximal anchor
actuator assembly 608. As described below, the lever pivot 606 is
rotated through action of the lever from a first position where it
locks the rear or proximal anchor actuator 608 against actuation to
a second position where actuation of the proximal anchor actuator
is possible. Eventual actuation of the proximal anchor actuator
assembly 608 causes a deflection of a trigger 610 which releases a
tripper 612 having cammed surfaces. A first pawl 614 is further
provided and placed against both the camming surfaces of the
tripper 612 and into recesses formed in the pusher block of the
above disclosed pusher assembly. As described below, a second pawl
616 follows the action of the first pawl 614 to engage as desired
the pusher block. A cutter pawl 618 is also placed into engagement
with camming surfaces of the tripper 612, the cutter pawl
cooperating to actuate the cutter assembly. Furthermore, the
trigger assembly 126 also includes a reset lever 620 and a cutter
bailout assembly 622 including a biasing spring 624, operation of
which will be described below. It is to be recognized, however,
that the system can be configured such that manipulation of the
needle retract lever, for example, can accomplish resetting the
device as well as the bailout function.
[0145] With reference now to FIGS. 55-58, an embodiment of the
anchor delivery is shown in cross-section to illustrate locked and
unlocked configurations of the trigger assembly 126. In FIG. 55,
the needle actuator 108 and needle refractor lever 110 are in a
non-actuated position and the lever pivot 606 is in a first
position locking the button pad assembly 608 against actuation.
Upon depression of the needle actuator 108 and subsequent actuation
of the retraction lever 110 (See FIG. 56), the lever pivot 606 is
rotated out of engagement with the proximal anchor actuator
assembly 608. It is at this stage that the proximal anchor actuator
608 is unlocked and can be depressed (See FIG. 57). Once depressed,
the proximal anchor actuator assembly 608 translates longitudinally
to rotate the trigger 610 out of locking engagement with the
tripper 612. This, in turn, initiates the action of the trigger
assembly 126.
[0146] Turning now to FIG. 59, the trigger assembly 126 is shown
prior to actuation. As shown, the proximal anchor actuator 608 is
readied for depression and the trigger 612 is in its longitudinally
distal position. Also, the first pawl 614 is in a first position in
locking engagement with the pusher 582 of the pusher assembly (See
Also FIG. 58).
[0147] Pressing the proximal anchor actuator assembly 608, as above
stated, releases the tripper 612. Being biased by a spring assembly
650, upon release the tripper 612 moves proximally relative to an
operator (See FIG. 60). As it moves proximally, camming surfaces on
the tripper 612 rotate the first pawl out of engagement with the
pusher 582. This action results in the release of the pusher
assembly (See also FIG. 52) to move longitudinally in the distal
direction. Control of the longitudinal translation of the pusher
assembly is maintained by the second pawl 616 which follows
movement of the first pawl, and which rotates to again lock the
pusher 662.
[0148] Accordingly, release of the pusher assembly accomplishes
advancing the pusher thereof distally resulting in advancing a
second component 450 of an anchor assembly into locking engagement
with a connector of an anchor assembly (See FIG. 62). Such action
causes the pusher 582 to advance an anchor component 450 onto a
connector (e.g., a suture) with sufficient speed and force to seat
the anchor 450 with reliable retention force. Within a patient's
body, as shown in FIG. 63, the anchor assembly is configured across
anatomy within the interventional site. Longitudinally displaced
cutter cam surfaces formed on the tripper 612 then subsequently
engage the cutter pawl 618 to rotate it out of engagement with the
cutter assembly (See FIGS. 50-55) to thereby allow it to be
withdrawn by action of springs 660 biasing the cutter assembly (See
FIG. 64). Upon withdrawal of the cutter assembly, the blade portion
570 (See FIGS. 51 and 65) thereof is brought across the connector
352 thereby severing it close to the second anchor component 450.
The resultant implanted anchor assembly 700 is shown in FIGS. 65,
68 and 69. FIG. 68 depicts a partial cross-sectional view of the
urethra (UT) widened due to the anchor assembly compressing the
surrounding enlarged prostate tissue due to the fact that the outer
capsular tissue is rather strong, non-compressible and
non-displaceable and the adenoma of the prostate gland and the
urethral wall are compressible and displaceable. By way of
comparison, FIG. 67 depicts a partial cross-sectional view of an
untreated interventional site of the urethra (UT) narrowed by the
surrounding enlarged prostate tissue.
[0149] As shown in FIGS. 62 and 65, the delivery device 100 can be
configured to retain and deploy multiple second anchor components
450. The anchor components 450 are placed in-line and arranged such
that a single anchor component is advanced one deployed anchor
length with each trigger actuation. Upon reset of the trigger
assembly a next sequential anchor component is readied for
deployment. In this regard, the cover 507 can be configured with a
spring-like distal tab 710 which engages a slot formed in the
second to most distally positioned anchor component and which
facilitates maintaining proper positioning of the most distal
anchor prior to deployment. The cover 507 can further be equipped
with a proximal suture slot (not shown) and include an interior
arranged to include at least one flat registration surface to align
anchor components 450 with connector members 352 (See FIG. 62).
Furthermore, the distal end of the delivery device can be equipped
with a flexible/elastomer cover. This cover shields the anchor
deployment space to ensure reliable anchor seating on connector and
to allow for ejection of an implant from a delivery tool. In FIG.
65, the distal end of the delivery device is shown within
cystoscopic sheath 712.
[0150] The second anchor component can be embodied in a slotted
anchor configured to secure to a connector. The slotted proximal
anchor can include a flattened-tubular back end that resembles a
flattened tube in shape, with a width in lateral cross-section that
is greater than its thickness. The slotted proximal anchor also
includes a pair of spaced apart prongs extending from the back end
of the slotted proximal anchor to the front end of the slotted
proximal anchor. The spaced prongs join together at a slot
inception. The prongs are shaped and sized of a configuration and
of a rigidity to substantially prevent deflection of the prongs.
The prongs can include inwardly facing protrusions that are
configured to capture and deform the connector between the
protrusions and prevent the connector from disengaging from the
slotted anchor device once engaged. The mechanism of suture
attachment and strength of the assembly is a combination of
compression of the suture between the stiff slotted prongs of the
anchor as well as disruption of the suture surface by the discreet
edges of the slotted, flattened-tubular anchor. The discreet edges
provide a lower contact surface area between anchor prongs and
suture and focuses the compressive forces in focal points that
cause the suture to conform around both internal recesses and
external faces. It is also to be recognized that various further
embodiments of slotted anchors or anchors forming a clip are also
contemplated. In particular, various embodiments of structures
which accordingly provide alternative approaches to attach to a
connector can be employed. That is, the anchors can be deformable,
deflectable, latching, nested, meltable and/or coiled in
structure.
[0151] 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, both a single anchor assembly or multiple anchor
assemblies can be delivered and deployed at an intervention site by
the deployment device. Consequently, in the context of prostate
treatment, the present invention is used for the compression of the
prostate gland and the opening of the prostatic urethra, the
delivering of an implant at the interventional site, and applying
tension between ends of the implant. 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.
[0152] Once implanted, the anchor assembly of the present invention
accomplishes desired tissue manipulation, compression or retraction
as well as cooperates with the target anatomy to provide an
atraumatic support structure. In one preferred embodiment, the
shape and contour of the anchor assembly 700 is configured so that
the assembly invaginates within target tissue, such as within
natural folds formed in the urethra by the opening of the urethra
lumen by the anchor assembly (See FIGS. 68-69). In fact, in
situations where the anchor assembly is properly placed, wispy or
pillowy tissue in the area collapses around the anchor structure.
Eventually, the natural tissue can grow over the anchor assembly
700 and new cell growth occurs over time (see FIG. 69). Such
cooperation with target tissue facilitates healing and avoids
unwanted side effects such as calcification or infection at the
interventional site.
[0153] The disclosed anchor delivery device can be configured for
multiple or single use. In this regard, multiple or a single first
anchor component can be loaded within the delivery device via a
cartridge assembly, which is a removable and replaceable assembly.
Further, multiple or a single second anchor component can be
configured within the shaft assembly such as shown in FIG. 34. In
this regard, the second anchor components can be lined up end to
end within the shaft assembly with a proximal most second anchor
component being placed into engagement with a lead end of the
pusher assembly.
[0154] Additionally, after a first use, the spool assembly of the
delivery device can be reset for further use through the
manipulating of the reset lever 220 (See FIGS. 30-32, 36-38). An
initial step in resetting the device would involve releasing the
needle retraction lever 110 from its engagement with the locking
mechanism 406 (See FIG. 33). Further, the trigger assembly can be
reset through the actuator of the trigger reset lever 620.
[0155] It has also been observed that in certain situations there
may be a need for a cutter bailout assembly 622 (See FIGS. 54, 58
and 59) after the first anchor component has been delivered within
an interventional site (FIG. 35). Depression of the cutter bailout
assembly 622, when needed, results in tripping the cutter pawl
thereby releasing the cutter assembly and subsequently cutting a
connector of an anchor assembly prior to completing assembly of the
anchor. It is contemplated within the present invention the ability
to retract the needle at any time including arresting a moving
needle and retracting an incompletely deployed needle.
[0156] 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.
[0157] It has been observed that placing the anchors at various
desired positions within anatomy can extract the best results. For
example, when treating a prostate, one portion of an anchor
assembly can be placed within an urethra and a second component
beyond the outer surface of the prostate. It has been found that
implanting the anchor assemblies by using the distal end of the
device to displace the prostate lobe on either side (while the
tension spring is taking up slack in the connector after the
delivery needle has been refracted) while deploying the second
anchor component so that the ten o'clock and two o'clock positions
(when looking along the axis of the urethra) are supported or
retained, effectively holds the anatomy open and also facilitates
invagination of the anchor portion within natural tissue. This is
particularly true in the regions of anatomy near the bladder and
the juncture at which the ejaculatory duct connects to the
urethra.
[0158] Additionally, it is contemplated that all components of the
anchor assembly or selected portions thereof (of any of the anchor
assemblies described or contemplated), may 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 which cause the prostate to
decrease in size. Other substances contemplated include but are not
limited to phytochemicals generally, alpha-1a-adrenergic receptor
blocking agents, smooth muscle relaxants, and agents that inhibit
the conversion of testosterone to dihydrotestosterone. In one
particular approach, the connector 95 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.
[0159] 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.
[0160] 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.
[0161] 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 simply cut the connector and simultaneously remove
the second anchor previously implanted for example, in the
patient's urethra using electrosurgical, surgical or laser surgical
devices used in performing transurethral prostate resection.
[0162] An aspect that the various embodiments of the present
invention provide is the ability to deliver multiple, anchor
assemblies having a customizable length and distal anchor
components, each anchor assembly being implanted at a different
location without having to remove the device from the patient. The
various embodiments provide for variable needle depth and variable
connector length for each of the multiple anchor assemblies
delivered. Other aspects of the various embodiments of the present
invention are load-based delivery, preferably 1 pound, 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 place such a load (half pound to five pounds) between
spaced first anchor members as well as between or on an implanted
first anchor 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 can
be cooperatively connected to a mechanism which produces a desired
tension between the various anchor members while the needle
assembly is retracted. Moreover, this load can be accomplished
between first and second implanted anchor members.
[0163] 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, connector, of the one or more anchor devices
disclosed herein may be designed to be completely or partially
biodegradable or biofragmentable.
[0164] Further, as stated, the devices and methods disclosed herein
may 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.
[0165] Finally, it is to be appreciated that the invention has been
described hereabove 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.
[0166] 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.
* * * * *