U.S. patent application number 11/435339 was filed with the patent office on 2006-10-19 for tissue anchor system.
Invention is credited to Christopher J. Walshe.
Application Number | 20060235447 11/435339 |
Document ID | / |
Family ID | 22197542 |
Filed Date | 2006-10-19 |
United States Patent
Application |
20060235447 |
Kind Code |
A1 |
Walshe; Christopher J. |
October 19, 2006 |
Tissue anchor system
Abstract
The invention disclosed herein is a tissue-anchoring system,
including a tissue-anchoring device and tissue anchors. The
tissue-anchoring device includes a housing and a tissue anchor
positioned on the tissue-anchoring device that will be inserted
into a tissue or secured onto a tissue. The device may optionally
have a plunger assembly slidably positioned in the housing to
assist advancing anchor into a tissue. The tissue anchor has a barb
end and a shaft. The barb end is adapted to resist removal from a
tissue after the anchor has been inserted. The tissue anchor shaft
and the barb end may be hollow. The anchor shaft has an attachment
member distal from the barb end for direct attachment to a tissue
or for attachment of sutures or slings. The tissue anchors may
include an adjustment mechanism for intra- or post-operative
adjustments.
Inventors: |
Walshe; Christopher J.;
(Sioux Falls, SD) |
Correspondence
Address: |
Jones, Walker, Waechter, Poitevent, Carrere &Denegre, L.L.P.
4th Floor
8555 United Plaza Blvd.
Baton Rouge
LA
70809
US
|
Family ID: |
22197542 |
Appl. No.: |
11/435339 |
Filed: |
May 16, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10324392 |
Dec 18, 2002 |
7056333 |
|
|
11435339 |
May 16, 2006 |
|
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|
09716851 |
Nov 17, 2000 |
6506190 |
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10324392 |
Dec 18, 2002 |
|
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PCT/US99/11225 |
May 21, 1999 |
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09716851 |
Nov 17, 2000 |
|
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60086284 |
May 21, 1998 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/0435 20130101;
A61B 2017/044 20130101; A61B 17/0401 20130101; A61B 2017/0412
20130101; A61B 2017/0414 20130101; A61B 2017/0409 20130101; A61B
2017/0437 20130101; A61B 2017/00805 20130101; A61B 2017/2911
20130101; A61B 2017/0417 20130101; A61B 2017/2905 20130101; A61B
2017/0427 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1-12. (canceled)
13. A device for securing an anchor in tissue comprising: a. a
housing comprising a hollow barrel with finger grips and a tissue
penetrating tip formed thereon; b. an anchor positioned in said
housing, said anchor comprising a shaft with at least one barb
positioned thereon; and c. said barb configured to remain in a
collapsed position folded toward said shaft when said shaft is
positioned in said housing and to expand when said shaft exits said
housing.
14. The anchor securing device of claim 13, wherein said barrel is
flexible.
15. The anchor securing device of claim 14, wherein said barrel
comprises plastic.
16. The anchor securing device of claim 15, wherein said anchor
comprises metal.
17. The anchor securing device of claim 13, further comprising a
plurality of barbs, wherein said barbs comprise a series of
fingers.
18. The anchor securing device of claim 13, wherein said anchor has
an end ill-suited to penetrate tissue.
19. The anchor securing device of claim 13, wherein said anchor
comprises plastic.
20. The anchor securing device of claim 15, wherein said anchor is
over six inches long.
21. The anchor securing device of claim 13, wherein said anchor has
a suture attachment member.
22. The anchor securing device of claim 13, wherein a plunger
engages said hollow barrel to expel said anchor therefrom.
23. The anchor securing device of claim 22, wherein said plunger is
flexible.
24. The anchor securing device of claim 13, wherein said barb
comprises a conical umbrella.
25. A method of placing an anchor in the tissue of an individual,
said method comprising the steps of: a. providing a tissue anchor
delivery device comprising: i. a housing comprising a hollow barrel
with finger grips and a tissue penetrating tip formed thereon; ii.
an anchor positioned in said housing, said anchor comprising a
shaft with at least one barb positioned thereon; and iii. said barb
configured to remain in a collapsed position folded toward said
shaft when said shaft is positioned in said housing and to expand
when said shaft exits said housing; b. advancing said hollow barrel
through a tissue of said individual; and c. advancing said anchor
from said hollow barrel such that said barb deploys within a tissue
of said individual.
26. The anchor placement method of claim 25, wherein said barrel is
flexible.
27. The anchor placement method of claim 26, wherein said barrel
comprises plastic.
28. The anchor placement method of claim 27, wherein said anchor
comprises metal.
29. The anchor placement method of claim 25, further comprising a
plurality of barbs, wherein said barbs comprise a series of
fingers.
30. The anchor placement method of claim 25, wherein said anchor
has an end ill-suited to penetrate tissue.
31. The anchor placement method of claim 25, wherein said anchor
comprises plastic.
32. The anchor placement method of claim 25, wherein said anchor is
over six inches long.
Description
[0001] This application is a divisional of 10/324,392, filed on
Dec. 18, 2002, which is a continuation of U.S. patent application
Ser. No. 09/716,851, which was filed on Nov. 17, 2000, and which
claims priority to International Application number PCT/US99/11225,
which was filed on May 21, 1999 and which claims priority to U.S.
Provisional Application No. 60/086,284, filed on May 21, 1998, all
of which are incorporated by reference herein in their
entirety.
TECHNICAL FIELD
[0002] Certain embodiments of this invention relates to a tissue
anchor and applicator for supporting a suture, sling member, or
other device for use in a surgical procedure. In particular,
certain embodiments relate to tissue anchors for use in surgical
treatment of urinary incontinence.
BACKGROUND ART
[0003] One problem this invention intends to address is urinary
incontinence, but the invention is applicable to a broader range of
problems. The background, however, will discuss urinary
incontinence as an example.
[0004] Urinary incontinence is an involuntary release of urine when
increases in abdominal pressure, caused by sneezing, coughing, or
exercising, are not uniformly transmitted to the proximal urethra,
resulting in urine "leakage." Moderate stress urinary incontinence
("SUI") is inconvenient and can be a social and hygienic problem,
while severe SUI can be disabling. SUI occurs in women and is
caused by either hypermobility of the bladder neck and proximal
urethra (excessive downward and rotational movement of the bladder
neck) or intrinsic sphincter deficiency.
[0005] Several defects can result in loss of support of the bladder
neck. Examples of these defects are: (a) breakage or abnormal
stretching of the passive supports of the bladder and urethra
(those connective tissues supporting these structures); or (b) loss
of the active support of the bladder neck, vagina, and rectum
provided by the levator ani muscle. For instance, one example of
passive support failure is paravaginal "defects" caused by
separation of the vaginal wall from the pelvis caused by breakage
or stretching of connective tissue (pelvic organ prolapse). Such
separation results in downward rotation of the vaginal wall, which
in turn results in downward rotation of the bladder neck because
the bladder is partially supported by the vagina. An example of
loss of active support is loss of muscle tone in the levator ani
muscle. This muscle operates as a floor, or platform, supporting
the bladder during standing and normal activity. Normal muscle tone
of the levator ani relieves the passive support of the pressures
caused by overlaid abdominal viscera. Loss of muscle tone may
result in downward rotation of the bladder.
[0006] Treatment of SUI caused by hypermobility of the bladder and
proximal urethra requires supporting the bladder neck, generally at
the urethrovesical junction ("UVJ"). Correction requires support of
the UVJ area, which helps balance increased abdominal pressures and
which allows the bladder neck to properly compress and close in
response to increased pressures, thus preventing urine leakage.
Support may be provided in various surgical procedures, including
anterior colporrhaphy, retropubic urethropexy, vaginal needle
urethropexy, and suburethral sling procedures. One particular type
of surgery is briefly discussed-retropubic urethropexy ("RU"). In
RU, a series of sutures are used to support the UVJ. The ends of
the sutures attach at various points in the body cavity depending
upon the type of failure (loss of active support, failure of a
portion of passive connective tissue, etc.). The sutures support
and properly elevate the bladder neck at the UVJ to maintain the
compressibility and pliability of the urethra and to avoid
compromising the urethral sphincteric mechanism.
[0007] In various RU procedures, different anchoring tissues are
used to support the sutures. These anchoring tissues include, but
are not limited to, soft tissues such as pubocervical fascia,
pubourethral ligaments, Cooper's ligaments, and rectus fascia. One
RU procedure, generally known as the Marshall-Marchetti-Kantz
procedure, uses several sutures, with the one end of each suture
being attached to the vaginal wall adjacent to the urethra
straddling the UVJ bilaterally. The opposite suture end passes
through the retropubic periosteum.
[0008] In another RU procedure, known as the Burch procedure, the
first end of a series of sutures is positioned in both sides of the
vagina wall (straddling the urethra) below Cooper's Ligament 602,
and the other end of the sutures is positioned in Cooper's Ligament
602, thereby supporting the vaginal wall and the UVJ.
[0009] RU procedures generally support an area by using sutures,
and additional support is provided by using slings (either man-made
materials or tissue grafted material) placed under the area to be
supported and sutured into an anchoring tissue, such as in
suburethral sling procedures (e.g. a Goebell-Stoeckel
procedure).
[0010] Problems associated with surgical correction of the failed
support mechanisms include under- or over-correction of the UVJ.
The surgeon must determine the degree of support necessary to
properly elevate and support the UVJ to properly address the SUI
problem. This determination must be made both pre- and
intra-operatively. Too little elevation causes SUI to remain,
although the degree of SUI may be reduced. Too much elevation can
result in voiding dysfunction (reduced capacity or inability to
void), prolonged catheterization, and the need for postoperative
correction.
[0011] The incidence of postoperative urinary retention can be as
high as 30% at two weeks after surgery, and 5% of patients have
postoperative urinary retention that persists. Many patients with
less severe cases of postoperative obstructive symptoms also
benefit greatly. Symptomatic detrusor instability represents the
bladder's response to increased outlet resistance caused by an
improperly tensioned sling. The incidence of postoperative
irritative symptoms secondary to detrusor instability can be as
high as 20%. Appropriate tensioning of the sling minimizes
persistent incontinence and voiding dysfunction.
[0012] Generally, all of the above procedures require placement of
sutures into an anchoring tissue or tissues and may also require
placement of sutures into supporting devices, such as slings.
Placement is provided through suturing needles, either straight or
arcuate, or the use of needle suturing devices, such as push and
catch systems, or non-adjustable fascial attachment systems. The
suture placement in the tissue can be completely through the tissue
or partially through the tissue.
SUMMARY OF THE INVENTION
[0013] Accordingly, the invention is a tissue anchoring system,
including a tissue anchoring device and tissue anchors. At least
one embodiment of the tissue anchoring system will be used in soft
tissue. The tissue-anchoring device includes housing and a tissue
anchor. The tissue anchor is placed on the tissue-anchoring device
that is advanced into a tissue. The device may optionally have a
plunger assembly slidably positioned in the housing to assist
advancing the anchor into a tissue. The tissue anchor has a barb
end and a shaft. The barb end is adapted to resist removal from a
tissue after it is inserted. The tissue anchor shaft and the barb
end may be hollow. The shaft of the anchor has an attachment member
distal from the barb end so that the attachment member may attach
directly to tissue or attach to tissue using sutures or a sling.
The tissue anchors may be adjustable.
DISCLOSURE OF THE INVENTION
[0014] It is an object of the invention to provide a
tissue-anchoring device that does not require suturing to attach to
tissue.
[0015] It is an object of the invention to provide a
tissue-anchoring device that may be repeatedly reloaded with
anchors.
[0016] It is an object of the invention to provide a
tissue-anchoring device that may insert completely through a tissue
or partially through a tissue.
[0017] It is an object of the invention to provide an alternative
to sutures in relatively inaccessible areas.
[0018] It is an object of the invention to provide a
tissue-anchoring device that can be hand-held or used with
endoscopic surgery techniques and devices, especially flexible
endoscopes.
[0019] It is an object of the invention to provide an adjustable
tissue-anchoring device to adjust the placement of devices or
tissues attached to the anchor postoperatively without further
invasive surgery.
[0020] It is an object of the invention to provide an adjustable
tissue-anchor device attachable to tissue using sutures or staples
when a surgeon deems it more suitable.
DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 illustrates an embodiment of a tissue-anchor delivery
device.
[0022] FIG. 1a illustrates another embodiment of a tissue-anchor
delivery device.
[0023] FIG. 2 illustrates another embodiment of a tissue-anchor
delivery device having a plunger with the delivery device shown as
a cross-section.
[0024] FIG. 3a illustrates a thimble-like embodiment of a
tissue-anchor delivery device.
[0025] FIG. 3b illustrates another embodiment of a tissue-anchor
delivery device that may be used in connection with an endoscope
wherein the delivery device is shown in cross-section to illustrate
the plunger positioned therein.
[0026] FIG. 3c illustrates the configuration of the tip used in
connection with the tissue-anchor delivery device shown in FIG.
3b.
[0027] FIG. 4a illustrates an anchor having a ringed attachment
member and finger projections for a barb.
[0028] FIG. 4b illustrates an anchor having an umbrella-like
barb.
[0029] FIG. 4c illustrates an anchor having an attachment member a
disk barb and an attachment member comprising holes.
[0030] FIG. 4d illustrates an anchor having an arrow shaped barb
and finger-like barbs.
[0031] FIG. 4e illustrates an anchor having a T-shaped barb having
holes in the attachment member.
[0032] FIG. 4f illustrates an anchor having a star-shaped barb.
[0033] FIG. 4g illustrates the anchor shown in FIG. 4b having a
barb retaining device in the form of a collar positioned over the
umbrella-shaped barb.
[0034] FIG. 4h illustrates another barb retaining device, namely a
sleeve positioned over the barb.
[0035] FIG. 5a illustrates an embodiment of an anchor having a
ratcheting device configured therein as a groove.
[0036] FIG. 5b illustrates an embodiment of an anchor having a
shaft positioned therein, wherein ratcheting devices are positioned
on only one side of the anchor and a corresponding side of the
shaft.
[0037] FIG. 5c illustrates the embodiment of the anchor shown in
FIG. 5a shown with a shaft inserted therethrough, illustrating
first and second ratcheting devices engaged.
[0038] FIG. 6a illustrates an embodiment of an attachment member
having holes extending therethrough.
[0039] FIG. 6b illustrates another embodiment of an attachment
member wherein holes are configured with a tab near the bottom of
the shaft.
[0040] FIG. 6c illustrates another embodiment incorporating a
ring-shaped attachment member.
[0041] FIG. 6d illustrates another embodiment of an attachment
member in the form of a clamp.
[0042] FIG. 6e illustrates another embodiment of an attachment
member comprising finger-like projections and holes.
[0043] FIG. 6f illustrates another embodiment of an attachment
member having annular projections positioned on the shaft.
[0044] FIG. 6g illustrates another embodiment of an attachment
member having indentations configured in the shaft.
[0045] FIG. 7a illustrates an embodiment of the delivery device
having a plunger and using a T-shaped anchor.
[0046] FIG. 7b illustrates another embodiment of the delivery
device having a plunger with a disc-like end designed to engage the
shaft of the anchor and anchor head.
[0047] FIG. 8a illustrates an embodiment of an adjustable
tissue-anchoring device.
[0048] FIG. 8b illustrates another embodiment of an adjustable
tissue-anchoring device.
[0049] FIG. 8c illustrates another embodiment of an anchor body
with the barbs removed and having annular projections thereon to
engage a retaining device.
[0050] FIG. 9a illustrates an embodiment of a tissue-anchor
retaining device shown as a disk.
[0051] FIG. 9b illustrates another embodiment of a tissue-anchor
retaining device shown as disk having suture apertures therein.
[0052] FIG. 10a illustrates an embodiment of a shaft having annular
projections as ratcheting devices wherein the attachment member is
rotatably attached.
[0053] FIG. 10b illustrates an embodiment of a shaft similar to the
embodiment shown in FIG. 10a wherein the ratcheting devices are
finger-like projections.
[0054] FIG. 11a illustrates an embodiment of a thimble-shaped
delivery device wherein sutures are attached near the barb.
[0055] FIG. 11b illustrates another embodiment of a delivery
device.
[0056] FIG. 11c illustrates another embodiment of a delivery device
having a pen-shaped housing.
[0057] FIG. 12 illustrates an embodiment of a delivery device
wherein the anchor slides onto the housing and the shaft slides
through the housing and the anchor.
[0058] FIG. 13 illustrates an embodiment of a delivery device
comprising two plungers.
[0059] FIG. 14 illustrates an embodiment of an adjuster
cylinder.
[0060] FIG. 15 illustrates an exploded view of an embodiment of the
invention incorporating an adjuster cylinder.
[0061] FIGS. 16a-16g illustrate the steps of placement of an
adjustable anchor and shaft within a tissue. In each FIG. 16a-16g,
the plunger, anchor body, the sleeve, and the adjuster cylinder are
shown as cross-sections. The shaft and interleaving members are
shown in full view against those cross-sections.
[0062] FIG. 17 illustrates a cross-sectional view of an embodiment
of an adjustable anchor using threads to allow adjustment of the
shaft wherein the shaft is shown in full view.
[0063] FIG. 18a illustrates an adjustable anchor attached to
Cooper's Ligament 602.
[0064] FIG. 18b illustrates a close-up view of the embodiment in
FIG. 18a.
[0065] FIG. 18c illustrates a close-up view of the embodiment in
FIG. 18a wherein corresponding threads are configured on the shaft
and housing to allow the shaft to be adjustable.
[0066] FIG. 18d illustrates an adjustable anchor having a body that
accommodates multiple shafts.
[0067] FIG. 19a illustrates a cross-sectional view of another
embodiment of the invention wherein the shaft and attachment member
are not connected, and wherein the ratcheting device comprises
corresponding threads positioned on the housing and on the shaft.
FIG. 19a also illustrates the attachment member as rotatable about
the housing. The shaft is shown in full view, and an attachment
member is shown operatively attached to the housing.
[0068] FIG. 19b illustrates an embodiment similar to that shown in
FIG. 19a wherein the ratcheting device on the shaft comprises
annular projections. The shaft is shown in full view.
[0069] FIG. 20 illustrates a schematic view of an anchor deployed
within a flexible delivery device that also incorporates a
micro-video camera and video screen.
BEST MODE FOR CARRYING OUT THE INVENTION
[0070] Illustrations of construction, design, and methods of
operation of the invention are set forth below with specific
references to the Figures. However, it is not the intention of the
inventor that the scope of his invention be limited to these
embodiments.
[0071] FIG. 1 illustrates one embodiment of the tissue-anchor
delivery device 1. Delivery device 1 comprises a housing 2 and one
or more finger grips 3, which comprise flats 4 on opposing sides of
housing 2 designed to enable a surgeon to hold device 1. Finger
grips 3 may be rings 6 (see FIG. 3b) through which the surgeon
inserts fingers, a thimble (see FIG. 3a), a handgrip, or any other
shape that enables a surgeon to hold delivery device 1. Finger
grips 3 are unnecessary if housing 2 is adapted to be hand-held,
such as a pen-shaped housing 11 shown in FIG. 1a.
[0072] FIGS. 1a and 3a illustrate an anchor stay 50. Anchor stay 50
comprises a portion of housing 2 adapted to retain an anchor 20
(not shown) thereto, as described below. In the embodiment shown in
FIG. 3a, anchor 20 (not shown) will slip over anchor stay 50, while
in the embodiment shown in FIG. 1, anchor 20 will clip onto stay 50
using clip member 12.
[0073] Anchor stay 50 is a rigid projection extending away from the
plane of the finger grip flats 4. Anchor stay 50 may have a clip
member 12 positioned near tip 57 to removably couple anchor 20 to
stay 50. Clip member 12 may include a compression-fit C-type ring
for gripping the shaft of an anchor 20. Anchor stay tip 57 may also
be designed to reversibly mate with an anchor 20 that is positioned
on or against tip 57.
[0074] Alternatively, as shown in FIG. 2, delivery device 1 may
include a plunger 5 slidably positioned in hollow barrel portion 7
of housing 2 and operated by a surgeon. Plunger 5 has an anchor end
10 adapted to engage an anchor 20. Anchor end 10 may be a flat end
to push anchor 20, a pointed end adapted to engage a hollow shaft
portion of an anchor 20 (see FIGS. 3a and 11c), a clip member 12
(see FIG. 1) positioned on end 10 designed to couple to anchor 20.
Though not shown, clip member 12 may alternatively be positioned on
anchor shaft 120 (seen in FIGS. 4a-4h). Anchor end 10 can have any
structure engaging anchor 20 that allows plunger 5 to advance
anchor 20 into a tissue and uncouple therefrom, leaving anchor 20
in tissue.
[0075] Other embodiments of delivery device 1 are shown in FIGS. 3a
and 3b. These embodiments also comprise a housing 2 and finger
grip(s) 3. As shown in FIG. 3a, housing 2 and finger grips 3
comprise a thimble 3a, while FIG. 3b shows finger grips 3 as rings
6. Viewing FIG. 3b, housing 2 has a flexible hollow barrel portion
7. A flexible plunger 5a is slidably positioned in hollow barrel
portion 7, which comprises a sleeve within which flexible plunger
5a slides. This embodiment is suitable where the invention will be
used in conjunction with an endoscope or in anatomic areas that are
hard to reach manually with a rigid device. Hollow barrel portion 7
may be rigid, but is preferable flexible so that it may be used in
conjunction with an endoscope. The hollow barrel portion 7 length
may range from 1/4-inch to one or more feet, depending upon the
particular application, and the length of flexible plunger 5a is
constructed accordingly.
[0076] Viewing FIG. 3b, hollow barrel portion 7 has a detachable
tip 8. Tip 8 screws onto hollow barrel portion 7 using
corresponding threads 8b, 8c which allows a surgeon to change tips
8. Viewing FIG. 3c, tip 8 has a knife-edge 13 to penetrate tissue.
Tip 8 may have a slot 9 starting at the edge 8a of tip 8 and
extending down tip 8, substantially along the longitudinal axis
.alpha. shown in FIG. 3c.
[0077] Viewing FIG. 1a, delivery device 1 may also comprise a stop
60, shown as an outwardly projecting ridge 60a, that is shown
located on the external walls 7a of the hollow barrel portion 7 in
FIG. 1a. Ridge 60a controls the extent of insertion of hollow
barrel portion 7. Alternatively, viewing FIG. 1, finger grips 3 can
act as stop 60. The need for a separate delivery device 1 may be
eliminated if anchor 20, later described, is itself constructed to
guide the placement of anchor 20 into tissue by hand.
[0078] As shown in FIG. 4a-f, anchor 20 can have a wide variety of
shapes depending upon the application. Anchor 20 has a barb end 21
and a shaft 120 and may also comprise an attachment member 23 (see
FIGS. 4a, 4c, and 4e) positioned on shaft 120 distal from barb end
21. Inclusion of shaft 120 is optional. Please note that in later
embodiments, the anchor shaft is also referred to as shaft 120
(e.g. FIGS. 16a-16g). Viewing FIG. 11a, if anchor 20 lacks shaft
120, attachment member 23, later described, should be placed on
barb end 21 (not shown), or the sutures 450 should directly attach
to barb 102. Shaft 120 may be from 1/4 inch to a foot or more in
length, depending upon the application.
[0079] Viewing FIG. 4a, barb end 21 is adapted to resist removal of
anchor 20 after anchor 20 has been inserted in or through a tissue
and anchored by barb 40. For example, barb 40 may comprise: a
series of downwardly-pointing fingers 30 (also referred to as
wing-like projections 30) (see FIG. 4a); a downwardly-pointing
conical umbrella 31 (see FIG. 4b); a flat area 32, such as a disk
32a (see FIG. 4c) or an arrow end 32b (see FIG. 4d); a T-shaped
head 33 (see FIG. 4e); a star-shaped head 34 (see FIG. 4f); or any
other head shape that will resist removal of anchor 20 from tissue.
Barb 40 may be flexible or collapsible, such as the umbrella 31
shown in FIG. 4b. Preferably, umbrella 31 is collapsible.
[0080] Viewing FIGS. 4g and 4h, when barbs 40 are collapsible
(generally, foldable inward toward anchor shaft 120), a barb
retaining device 94, such as a ring 95 (see FIG. 4g), or a sleeve
96 (see FIG. 4h and FIG. 15), may slide over shaft 120 to collapse
barbs 40. Retaining device 94 is retractable down shaft 120, and
may be placed over a collapsed barb 40 to hold barb 40 in a
collapsed position. When barb end 21 is inserted into tissue,
barb-retaining device 94 move down shaft 120 as barb 40 slides
through barb-retaining device 94 and deploys into the tissue. Barb
40 stays collapsed, however, as long as the barb sidewalls contact
tissue. After penetration of tissue, barb 40 expands, and resists
removal from the tissue. Barb 40 also creates resistance by the
counter-traction that occurs when barb 40 is imbedded within the
tissue.
[0081] Materials of construction for anchor 20 are preferably
biologically-inert plastics, thin stainless steel, or other
non-reactive materials that can co-exist within a tissue with
little or no adverse patient reaction. Portions of anchors 20,
however, should be sufficiently rigid to insure that anchor 20
cleanly and precisely penetrates the tissue at the desired location
and that a deployed barb 40 will resist removal from tissue.
Generally, the portion of shaft 120 attached to plunger 5 or
attached to anchor stay 50 should be fairly rigid.
[0082] Barb end 21 may also be shaped to penetrate a tissue, such
as is shown in FIGS. 4a, 4b, 4f, and 4h. When anchor 20 has a barb
end 21 that is ill-suited to penetrate a tissue (see FIGS. 4c and
4e), anchor 20 is preferably used with delivery device 1 having
hollow barrel portion 7 that is shaped to penetrate a tissue. For
example, see sharp end 125a shown in FIG. 7a.
[0083] Viewing FIG. 7a, if barb 40 comprises a T-shaped head 33,
anchor 20 may be loaded into delivery device 1 using forceps. Shaft
120 is a flexible material that allows placement of T-shaped head
33 as shown. Sharp end 125a of hollow barrel portion 7 is adapted
to penetrate a tissue. A portion of shaft 120 extends through slot
9 configured in housing sidewalls 9a. Preferably, barb end 21 has a
larger cross-section than shaft 120, and prevents removal of barb
end 21 through slot 9. Plunger 5 engages anchor 20. Though not
shown, anchor end 10 of plunger 5 may comprise a clip member 12
designed to partially encircle shaft 120 (see FIG. 1a for
example).
[0084] Viewing FIG. 7b, anchor end 10 of plunger 5 may comprise
circular-shaped disk 43 with a slot 41 into which shaft 120 is
slidably inserted. Shaft 120 passes adjacent to plunger 5 and exits
the bottom of delivery device 1, eliminating the need for slot 9.
Alternatively, but not shown, anchor end 10 may have slot 41 that
works in conjunction with slot 9 located on sidewalls 9a. In such
an embodiment, slot 41 aligns with slot 9, enabling shaft 120 to
exit hollow barrel portion 7 below anchor end 10.
[0085] Viewing FIGS. 6a-6g, attachment member 23 is a structure
generally located on shaft 120 for engaging a material, such as a
suture or tissue sample, a second barb end, or a tissue-retaining
device 27 (shown in FIGS. 9a and 9b). Tissue-retaining device 27
may comprise a disk-like washer or button 62 (see FIGS. 9a and 9b)
or simply a lip that operates in conjunction with attachment member
23 and reversibly mates with attachment member 23. Viewing FIGS.
6a-h, attachment member 23 comprises one or more openings 50a in
shaft 120 (or a tabbed portion 23c thereof) (see FIGS. 6a and 6b);
a ring 51 (see FIG. 6c), a tissue clamp 52 (see FIG. 6d),
ratcheting devices, such as series of projection fingers 55 (see
FIG. 6e) or annular projections 56 (see FIG. 6f) extending radially
from shaft 120, or a series of indentations 58 in shaft 120 (see
FIG. 6g), all of which comprise attachment members.
[0086] Alternatively, viewing FIG. 6e, attachment member 23 may
comprise a combination of the above, such as openings 50 and
fingers 55. Viewing FIG. 6d, clamp 52 has first and second
reversibly interlocking surfaces 53, 54 that may clamp onto tissue.
As shown in FIGS. 6e and 6f, fingers 55 or projections 56 may
attach a tissue-retaining device 27 (not shown, see FIG. 16f) onto
shaft 120, thereby allowing retaining device 27 to compress and
retain a tissue between barb end 21 (or tip 130) of the anchor
shaft 120 and retaining device 27. This embodiment is well-adapted
to support organs whose connective supportive tissues have weakened
or failed, such as the transvaginal sacral or sacrospinous
colpopexy later described.
[0087] Viewing FIGS. 9a and 9b, tissue-retaining device 27 is an
annular disk-like structure, sometimes referred to herein as a
"porcupine" button 62. Button 62 has a center hole 404 sized for
positioning around shaft 120 and attachment member 23. The top
surface 27a of button 62 may be arcuate-shaped, and have a series
of projections 29 extending outwardly from top surface 27a.
Projections 29 grasp tissue to prevent button 62 from migrating.
Viewing FIG. 9b, to resist migration of button 62 relative to
tissue, button 62 may have a series of holes 61 extending
therethrough around the periphery for suturing button 62 to tissue.
Alternatively, button 62 may be constructed of a mesh material,
allowing sutures to extend therethrough. A surgeon must ensure
contact between button 62 and shaft 120 does not interrupt blood
supply to that area in contact with tissue-retaining device 27.
[0088] If attachment member 23 is as a ratcheting device, such as
fingers 55 projecting from the exterior sidewalls of shaft 120 as
shown in FIG. 6e, or a series of indentations 58 (see FIG. 6g), and
tissue-retaining device 27 is button 62, button 62 may slide up or
down shaft 120. However, button 62 is retained in a given position
on shaft 120 by the inter-mating of the ratcheting devices on shaft
120 and within button center hole 404. Center hole 404 may have a
series of fingers 402, or other projections, extending outwardly to
interact with the interleaving members or ratcheting devices on
shaft 120 to accomplish the same function. Generally, button 62 has
a first interleaving member (fingers 402) on the interior walls of
hole 404, while anchor 20 will have a second interleaving member
(such as projections 701 in FIG. 8c) positioned thereon. The first
and second interleaving members cooperate to resist movement of
button 62 relative to anchor 20. Alternatively, a C-clip or other
clip member 12 on delivery device 1 may be used as a retaining
device 27 to keep anchor 20 properly positioned relative to the
tissue.
[0089] Viewing FIGS. 4a, 4c, and 4e, if sutures are placed through
attachment member 23, they are preferably installed when anchor 20
is loaded into delivery device 1 so that: (a) the surgeon does not
have to position sutures through openings 50a after anchor 20 is
attached, and (b) if the sutures are sufficiently long to reach
back to the surgeon during placement of anchor 20, the surgeon will
not fish for the sutures in the body cavity. To assist a surgeon in
tailoring anchor 20 to a particular application, attachment member
23 may be detachable from anchor 20 (e.g., threaded onto shaft 120,
or clipped onto shaft 120 or the base of barb end 21, etc). Shaft
120 has a small cross section at tip 130, much like a needle tip,
such as 1-3 mm, to allow easy penetration into tissue.
[0090] Viewing FIG. 19a, anchor 20 and attachment member 23 may
comprise separate elements. Anchor 20 has a barb 102 positioned on
a shaft 120. Attachment member 23 comprises a housing 1000, and
shaft 120 is movably inserted through housing 1000. Housing 1000
comprises an upper portion 1005 and a lower portion 1006 rotatably
engaged using interlocking lips 1007, 1007a. Interlocking lips
1007, 1007a are slidably engaged, and to assist rotation, a bearing
1009 or other suitable device may be included. Shaft 120 is movably
positioned within housing 1000 via corresponding threads 1004,
1004a.
[0091] An alternate embodiment is shown in FIG. 19b. Housing 1000
and shaft 120 engage each other with interleaving members, or
ratcheting devices 140, 150, such as grooves 1001 in housing 1000
and corresponding projections 1001a positioned on shaft 120.
Interleaving members 1001, 1001a allow the position of shaft 120 to
be fixed relative to housing 1000. Shown on shaft 120 is an
attachment member 23 and holes 50a for attaching sutures or other
suitable items.
[0092] The embodiment shown in FIGS. 19a and 19b, allows a surgeon
to adjust the position of shaft 120 relative to attachment member
23 and items attached to attachment member 23 during placement of
the tissue-anchoring system. The embodiment in FIG. 19b can be
adjusted using an adjuster cylinder 90, and the embodiment in FIG.
19a can be adjusted by rotating shaft 120, causing shaft 120 to
move up or down.
Examples of Use of the Anchoring System
[0093] Viewing FIG. 7a, to set anchor 20 in tissue, a surgeon
positions a loaded delivery device 1 against the tissue to be
penetrated for insertion of anchor 20. If the delivery device 1 has
a hollow barrel portion 7 designed to penetrate tissue, then hollow
barrel portion 7 is placed against the tissue, and delivery device
1 is advanced with hollow barrel portion 7 penetrating tissue. When
hollow barrel portion 7 has advanced so that sharp end 125a clears
the tissue or is embedded therein, plunger 5 is advanced, releasing
anchor 20. Hollow barrel portion 7 is withdrawn from the tissue,
leaving anchor 20 supported within the tissue or by a tissue
surface 601 (not shown). If delivery device 1 has a hollow barrel
portion 7 that will not penetrate tissue, then anchor 20 should be
equipped with a sharp end 125 (not shown, see FIG. 8a) designed to
penetrate a tissue. In this embodiment, hollow barrel portion 7 is
placed against the tissue, and plunger 5 advanced, forcing anchor
20 into tissue. When anchor 20 has advanced sufficiently into
tissue or through tissue, delivery device 1 is withdrawn, leaving
barb 40 embedded into tissue, or inserted through tissue.
[0094] Viewing FIGS. 11a-11c, if delivery device 1 has no hollow
barrel portion 7, (for example, the anchoring system as shown in
FIG. 1a) then barb 102 of anchor 20 is adapted to penetrate a
tissue. In such an embodiment, anchor 20 is placed against the
tissue to be penetrated, the delivery device 1 advanced (or if it
is plunger-equipped, plunger 5 is advanced), until anchor 20 has
advanced sufficiently into tissue or through tissue, at which time
the delivery device 1 is withdrawn.
[0095] This anchoring system may also be used in less surgically
technical operations for surgeons who are not comfortable with
transvaginal approaches in laproscopically-assisted sacral
colpopexy operations. The surgeon may place anchor 20 into the
anterior longitudinal ligament of the sacrum laproscopically or
endoscopically and secure the vaginal vault to the sacrum
transvaginally in a laproscopically assisted sacral colpopexy.
Alternatively, the system may be used with a microscopic video
camera 65 located near tip 8 of delivery device 1 as seen in FIG.
20. The anchoring system would be placed into and or through the
apex of the vaginal vault using a rigid or flexible delivery device
1, either endoscopically or transvaginally, to fix anchor 20 to
suspend the vault to the sacrum. The anchoring system can also be
used endoscopically with an operative single port laparoscope
thereby obviating the need for multiple puncture sites in the
abdomen when performing this procedure. The anchoring system
obviates the need for other bulkier surgical instruments currently
used for retropubic bladder neck suspension, retropubic
Goebell-Stoeckel sling procedures, and multiple abdominal scope
port sites. This anchoring system also obviates the need for using
bone anchors and obviates the associated well-known complications.
In addition, by using the tissue anchoring system and an
intervening connector to attach to a sling of harvested tissue, the
size of the material harvested or used in the sling can be
decreased in size, thereby minimizing the amount of graft tissue or
donor tissue needed to be used. In turn, this minimizes the amount
of graft tissue and operative harvesting technique, thereby
minimizing complications, such as hematoma formation, pain,
infection and decreased strength of the upper leg. In addition, the
retropubic Goebell-Stoeckel sling could be used using a smaller
fascia sling graft or donor graft using an umbrella shaped anchor
head 31 with an extended anchor shaft 120 armed at both ends
creating a u-shaped anchor that seats into the rectus fascia 603
via an exclusively transvaginal approach.
[0096] As indicated, the system can be used with a tissue clamp 52
as attachment member 23 (see FIG. 6d). Clamps 52 fix the ends of a
fascia sling for the Goebell-Stoeckel fascia sling procedure and
obviate the need for sutures. A general outline of the
transvaginal-endoscopic-sacralcolpolexy procedure using an
endoscope-adapted tissue anchor system follows. The patient is
placed into the dorsal lithotomy position and undergoes general or
spinal anesthesia. The vaginal cuff is visualized using angled
surgical retractors. A transverse incision is made just inside the
hymenal ring on the posterior wall and extended down the mid-line
of the posterior vaginal wall, sharply and bluntly dissecting the
vaginal mucosa from the underlying supportive tissue of the vagina
to the apex of the vault. The retroperitoneal space would be
accessed using sharp and blunt dissection revealing the sacral
promontory to the S2 and S3 areas of the sacrum and the anterior
longitudinal spinal ligament.
[0097] The vaginal cone speculum is inserted up to the anterior
longitudinal spinal ligament. The middle sacral vessels are
visualized and isolated to the exterior of the cone using blunt
retraction. If this is impossible and there is a significant risk
for damage to these vessels, the vessels may be ligated using a
hemoclip-extended applicator transvaginally through the vaginal
cone superior and inferior to the operative sites. If bleeders are
encountered in the retroperitoneal space while dissecting the
anterior longitudinal spinal ligament, they could be fulgurated
using a Klepinger electrocautery device or hemoclip. The surgeon
secures the tip and rim of the vaginal cone against the sacrum
maintaining isolation of the operative site while inserting a
flexible fiberoptic endoscope into the vaginal cone at the sacrum
loaded with the flexible tissue-anchor applicator. The tissue
anchor 20 is loaded onto a delivery device 1. The shaft of the
anchor is advanced into and parallel to the under surface of the
anterior longitudinal spinal ligament for approximately one
centimeter. The appropriate angle of insertion is facilitated by
the manipulation of the flexible tip of the anchor/anchor
applicator and/or endoscope by the surgeon at the operator end of
the endoscope. The delivery device 1 is advanced through the
operative port of the endoscope thereby advancing the anchor with
barb end through the anterior longitudinal spinal ligament to the
desired depth. Plunger 5 is depressed and advances anchor 20 into
the space anterior to the sacrum but just beneath the anterior
longitudinal spinal ligament. Delivery device 1 is withdrawn into
the endoscope.
[0098] The surgeon visualizes anchor 20 in the anterior
longitudinal spinal ligament. The endoscope is withdrawn trailing
the sutures which are attached to anchor 20 back into the vaginal
cone speculum and towards the surgeon at which time they are
grasped in a clamp for later attachment to a synthetic mesh, fascia
lata or rectus fascia 603 graft for later suspension of the vaginal
vault to the sacrum. If necessary, several anchors 20 may be placed
into the anterior longitudinal spinal ligaments in this
fashion.
[0099] An extended suction device is used to enhance visualization
of the space at the operative site. A suction irrigator device is
preferred. The synthetic graft is attached to the trailing sutures
from the anchor(s) 20 and then advanced up the vaginal cone
speculum, applied to the sacrum and tied in a fashion similar to
that done during an endoscopic procedure with an extended knot
pusher. This secures the proximal portion of the graft at the
anterior longitudinal spinal ligament. The distal portion of the
graft is secured to the vaginal vault apex using: (a) the standard
transvaginal surgical instruments that one would use during a
vaginal hysterectomy, or (b) the adjustable tissue anchor clasp and
adjustable suture connector for attachment and adjustment of the
vaginal cuff. The graft application is performed entirely in the
retroperitoneal space. Before placing the sutures at the vaginal
vault apex, the surgeon ensures that the sutures are placed into
the graft at a site that allows appropriate length between the
vaginal apex and the sacrum minimizing any excessive tension on the
mesh or fascial graft. The vaginal cuff is then closed in a manner
used in the standard posterior-colporhaphy procedure,
well-described in the gynecologic surgical literature. Because this
procedure is carried out endoscopically (or manually) in the
retroperitoneal space, there is no need for abdominal entrance
and/or closure of the parietal peritoneum over the mesh or fascial
graft. This ensures that there are no internal hernias
postoperatively, and the operation is totally extra-peritoneal
thereby minimizing ileus. The surgeon should be careful and
concerned about hemostasis and ensuring that the colon and ureter
are not damaged during the procedure. The vaginal cone at its apex
should be padded with a soft silicone gasket to ensure that tissues
are not unduly traumatized.
[0100] Tissue anchor 20 can also be used in the post-operatively
adjustable transvaginal-sacrospinous-colpopexy procedure as
follows. The patient is placed in a dorsal lithotomy position after
undergoing general or spinal anesthesia. This procedure may be
performed using local anesthesia for patients who have medical
conditions that may be complicated by either spinal or general
anesthesia. A weighted speculum is placed in the posterior vault. A
Sims retractor is placed anteriorly. The cuff apex is visualized if
the uterus and cervix have been removed. In the lateral vaginal
fornices, a 0.5-1.0 centimeter (cm) vaginal mucosa incision is
made, and a 1-2 cm.sup.2 area of vaginal mucosa undermined at these
sites. This reveals the underlying submucosal vaginal-supportive
tissue. Tissue-anchor delivery device 1 is placed into the
surgeon's hand and advanced into the vagina. The tissue-anchor
delivery device 1 with a loaded tissue anchor 20 is advanced up the
vagina and punctures the vaginal tissue through the lateral
fornices of the vagina on the patient's right side directly through
the area which was previously undermined. Tissue-anchor delivery
device 1 places anchor 20 into the sacrospinous ligament as
follows. The sacrospinous ligament is located after the surgeon
palpates the ischial spine, and anchor 20 is placed approximately 2
cm medial to the ischial spine through the sacrospinous ligament
mid-portion. Tissue-anchor 20 deploys into and/or through the
sacrospinous ligament, and delivery device 1 is withdrawn from the
vagina leaving anchor 20 in position transfixing the vagina vault
apex to the sacrospinous ligament. The chosen anchor 20 depends on
the surgeon's desires.
[0101] Anchor 20 may be adjustable or non-adjustable. Viewing the
embodiments shown in FIGS. 16a-16h or FIG. 17, adjustable tissue
anchors 20 are used as follows. Anchor 20 is positioned as
previously described, transfixing the lateral vaginal cuff apex to
the sacrospinous ligament. Delivery device 1 is then removed. This
leaves the adjustable shaft 120 in anchor 20 trailing from the
lateral vaginal apex into the vaginal canal. A 1-1.5 cm.sup.2
"porcupine" button 62 is then advanced onto shaft 120 and ratcheted
into place using the interleaving members 303,304 or ratcheting
devices 140, 150 positioned on shaft 120 and in some instances
using the interleaving members (fingers 402) positioned in center
hole 404, thereby opposing the lateral vaginal cuff apex to the
sacrospinous ligament. The vaginal cuff apex may be clasped or
sutured alternatively to anchor 20. The same procedure is carried
out on the opposite side. This suspends the vaginal cuff apex to
the sacrospinous ligament either unilaterally or bilaterally. The
trailing end of shaft 120 may be used for adjusting the vaginal
cuff tension postoperatively and then trimmed flush with anchor
body 99 when the appropriate tension is achieved. If the surgeon
does not want a foreign body in the vagina, a standard adjustable
tissue anchor 20 could be used, the vaginal cuff apex sutured to
anchor 20, and vaginal suspension tension adjusted postoperatively
to ensure patient comfort.
[0102] The vaginal mucosa is closed using either running- or
interrupted-absorbable sutures over button 62 at the lateral
vaginal cuff apices. In addition, button 62 may be sutured to the
submucosal vaginal tissue along its circular perimeter before
closure of the vaginal mucosa to ensure its appropriate fixation in
the tissues. The lateral circular rim of button 62 may be composed
of a mesh-like synthetic material, to facilitate penetration of
fibroblasts and granulation tissue to ensure fixation of the button
in the subvaginal mucosal tissue.
[0103] The procedure is preceded by the appropriate preparation of
the surgical site with an antiseptic solution such as iodine or
other antiseptic and appropriate draping to ensure sterile
technique. The patient should also receive pre-operative
prophylactic antibiotics, approximately one to two doses, and one
to two doses postoperatively after closure of the vaginal mucosa to
prevent postoperative infection from a foreign body.
[0104] This procedure obviates the need for extensive vaginal
dissection as described in other techniques used in vaginal vault
suspension such as sacrospinous ligament fixation using the tendon
sheath punch, or the hook-like suture carriers. Other vaginal vault
suspension procedures require a more extensive dissection of the
posterior vaginal vault and submucosal tissue. This more extensive
dissection can result in serious hemorrhage. The procedure is done
with a minimal amount of vaginal dissection--approximately 4
cm.sup.2 divided at two locations.
[0105] There is also minimal manipulation of the sacrospinous
ligaments and surrounding tissue. This procedure requires only a
single puncture of the sacrospinous ligament. The operative time
would be substantially decreased as a result of the simplicity of
operative dissection insertion of the tissue anchor system and the
ability to adjust vaginal suspension tension postoperatively, as
later described. This procedure could be used on an outpatient
basis.
Adjustable Tissue Anchor
[0106] An embodiment of an adjustable anchoring system is shown in
FIGS. 8a-8c. FIG. 8a illustrates an anchor 20 comprising a body 99
having a hollow chamber 100 therein and a shaft 120 insertable
within body 99. Shaft 120 is sized to be at least partially
insertable into hollow chamber 100 and moveable relative to hollow
chamber 100. Hollow chamber 100 may pass completely or partially
through body 99. Viewing FIG. 8b, if hollow chamber 100 extends
partially through body 99, body 99 preferably has a slot 89 that
allows shaft 120 to exit hollow chamber 100 through sidewall 89a.
Shaft 120 has a tip 130 adapted to penetrate a tissue. Tip 130
should be fairly rigid to ease tissue penetration, although a
flexible tip 130 is preferred for certain procedures, such as
transvaginal sacral colpopexy. Viewing FIGS. 16a-16g and FIG. 18b,
shaft 120 may have indicia markings 80 thereon (e.g. millimeter
(mm) markings or color change markings) as indicators that allow a
surgeon to determine the extent of tension adjustments. Shaft 120
may have a cross-section that is round, flat, rectangular, or any
other suitable shape.
[0107] The end of shaft 120 opposite tip 130 has an attachment
member 23 attached thereto or constructed as part thereof. Hollow
chamber 100 has a barb end 101 with at least one barb 102
positioned thereon. Barb 102 resists removal of anchor 20 from a
tissue after anchor 20 has been inserted into or through tissue.
Barb end 101 may be a variety of shapes but is easily insertable
into tissue, generally having a sharp end 125 and a collapsible
barb 102 for use in conjunction with a barb retainer 94, as
previously described.
[0108] Viewing FIG. 8c, body 99 may also have a ratcheting device
701 positioned on body outer walls 703 distal from barb end 101.
Ratcheting devices 701 may comprise a series of fingers, annular
projections 702, indentations, or threads to adjustably and
matingly engage tissue-retaining device 27, such as button 62.
Alternatively, tissue-retaining device 27 may comprise a
washer-like structure that snaps or clips onto shaft 120 where
desired. Though not shown, body 99 may also have a stop 70
projecting away from body walls on the end distal from barb end 101
to prevent the body 99 from inserting completely through the
desired anchoring tissue.
[0109] Viewing FIGS. 5a-5c, the interior walls 121 of hollow
chamber 100 may have a first ratcheting device 140. First
ratcheting device 140 may be a series of annular ridges, threads,
projections, indentations or other shapes designed to interlock or
interleave with a second ratcheting device 150 located on exterior
of shaft 120 (such as interlocking male and female threads,
indentations and corresponding projections (see FIG. 5b),
interleaving sidewall fingers 303 shown in FIGS. 16a-16h,
interleaving annular projections 1001a shown in FIG. 19b, and FIG.
5c). Variation in the number or type of interleaving members or
ratcheting devices or their materials of construction will vary the
load-support capability of a particular anchor 20. Ratcheting
devices 140, 150 create a two-way ratcheting-type mechanism that
positions shaft 120 relative to body 99. Shaft 120 may be adjusted
in steps by pulling or pushing shaft 120 relative to body 99 (or
turning, in the case of interlocking threads). If ratcheting
devices 140, 150 comprise male and female threads, it is desirable
that shaft 120 have a ball bearing 15 or other pivotally rotatable
mechanism 14 located in attachment member 23 as shown in FIGS. 10a
and 10b.
[0110] Mechanism 14 allows shaft 120 to turn independently of the
bottom of shaft 120 where attachment member 23 is located.
Mechanism 14 prevents twisting of sutures, slings, or other devices
attached to attachment member 23. This twisting may occur during
later tension adjustments, either intra- or post-operative.
[0111] Anchor 20 is set by first setting outer hollow chamber 100
and then shaft 120 with the surgeon's hand or with a delivery
device 1. A delivery device 1 is preferred because anchor 20 may be
relatively small. Viewing FIG. 12, delivery device 1 may comprise a
housing 2 and finger grips 3, but other previously-described
embodiments may also work.
[0112] Alternatively, anchor delivery device 1 may include a hollow
barrel portion 7 wherein at least a portion of shaft 120 is
positionable therein. Hollow barrel portion 7 has a lip section or
edge 300, sized to fit within hollow chamber 100. Though not shown,
a stop member may be positioned on body 99 to prevent body 99 from
being deployed completely through tissue. Though not shown,
delivery device 1 may optionally include a plunger 5 slidably
positioned in hollow barrel portion 7. Inclusion of a plunger 5 in
the embodiment of FIG. 12 requires that plunger 5 adapt to allow
shaft 120 to pass through or by plunger 5 (e.g., plunger 5 as shown
in FIG. 7b). In such an embodiment, plunger 5 alone activates shaft
120.
[0113] Alternatively, as shown in FIG. 13, housing 2 may have a
hollow barrel portion 7 that is adapted to have anchor 120
positioned at least partially therein. Hollow barrel portion 7
should have a sharp end 125a adapted to penetrate a tissue. This
embodiment is appropriate when barbs 102 are ill-suited to
penetrate a tissue. Delivery device 1 may further comprise one, two
or no plungers. In a two-plunger embodiment, a first plunger 301
activates body 99 after hollow barrel portion 7 has penetrated a
tissue, and second plunger 302 activates shaft 120 after barbs 102
deploy. FIG. 13 illustrates a two-plunger embodiment comprising
concentric first and second plungers 301, 302. A single-plunger
embodiment may be used if either plunger 301 or 302 activates
either body 99 or shaft 120. However, if a single plunger is
adapted to activate shaft 120, the surgeon should rely on the
friction between first and second ratcheting devices 140, 150 on
body 99 and shaft 120 to cause deployment of body 99 when the
plunger is depressed. After barbs 102 deploy, shaft 120 may be
accessed through the skin surface 601 (see FIG. 16f) by a surface
incision as will be later described. Though not shown, housing 2
may also have a projecting ridge 60a located on the external side
of hollow barrel portion 7 to act as a stop 60.
[0114] Shaft 120 is adjustable upwardly or downwardly, with or
without the aid of adjuster cylinder 90 shown in FIG. 14. As used
herein, upward and downward shall indicate movement substantially
along the central axis a of anchor 20 or housing 2 as shown in the
Figures. FIG. 15 illustrates an exploded view of the invention that
shows how adjuster cylinder 90 inserts into hollow chamber 100.
Viewing FIG. 15, adjuster cylinder 90 is a hollow tube having an
inner and outer diameters sized so that the adjuster cylinder 90
may slide over shaft 120 but slide inside of hollow chamber 100,
thereby disengaging the interleaving members 303, 304 or ratcheting
devices 140, 150. Adjuster cylinder 90 has a lower end 90a, and may
have a cutting edge 90b.
[0115] Alternatively, the tissue-retaining device may be as shown
in FIGS. 18a-18d. Viewing FIG. 18a, pelvis 600 is shown from a
retropubic view. Cooper's ligament 602 is located on pelvis 600.
Sutured to Cooper's ligament 602 is anchor 20, which has a hollow
portion 66 extending therethrough. Shaft 120 inserts through anchor
20 and is shown exiting skin surface 601. Anchor 20 may be
configured with one or more suture holes 67 that allow anchor 20 to
be attached to Cooper's ligament 602. In this embodiment, anchor 20
lacks a barb 102. Shaft 120 inserts through hollow portion 66.
Shaft 120 is adjusted using a shaft 120 having threads 68 (see FIG.
18c) corresponding to threads position in the hollow portion 66, or
by placing corresponding interleaving members or ratcheting devices
140 within hollow portion 66 and corresponding interleaving members
or ratcheting devices 150 on shaft 120. Shaft tip 120b may be sharp
so that it can penetrate a tissue and skin surface 601.
[0116] Shown in FIG. 18b is an enlarged view of FIG. 18a, to more
clearly show ratcheting devices 150 (interleaving members) on shaft
120. Ratcheting devices 150 (interleaving members) shown in FIG.
18b are annular projections similar to those shown in FIGS. 5c and
8a. Shown in FIG. 18c is the same device as shown in FIG. 18b, but
shaft 120 has threads 68 positioned thereon allowing shaft 120 to
rotatably engage corresponding threads on the interior walls of
hollow portion 66. Attachment member 23 rotatably attaches to shaft
120 and is shown as a ball and socket 15. FIG. 18d illustrates an
embodiment wherein anchor 20 has multiple hollow portions 66 so
that two shafts 120 can engage anchor 20.
Examples of Use of Adjustable Tissue Anchor
[0117] Referring to FIGS. 16a-16g, one of the procedures where the
adjustable anchor is advantageous is the retropubic bladder neck
suspension or retropubic Goebell-Stoeckel sling procedure. In this
procedure, it is necessary to support the neck of the bladder
through the use of a sling. The following application will
demonstrate the use of the adjustable tissue anchor in this
procedure, using two anchors: one non-adjustable anchor and one
adjustable anchor. If the sling is to be tacked to the bladder
neck, it is desirable to use two adjustable anchors. The procedure
could be performed transvaginally or by laparotomy.
[0118] The surgeon first sets a non-adjustable anchor into a
suitable connective tissue on one side of the bladder neck,
Cooper's Ligament 602 or rectus fascia using the procedure(s)
previously described. Anchor 20 may have a sling attached thereto
by sutures. The sling is suspended under the urethra and fixed with
sutures. The surgeon attaches a second adjustable anchor to the
other end of the sling (by use of sutures or by use of a tissue
clamp 52 as attachment member 23 on shaft 120) and loads the
adjustable anchor 20 onto delivery device 1. Alternatively, the
adjustable tissue anchor 20 shown in FIGS. 18a-18c could be sutured
to Cooper's Ligament 602, rectus fascia 603, or tendon bilaterally
and subsequently adjusted postoperatively. This is accomplished
using ratcheting devices 140, 150 ratcheted or thread and screw
adjustment mechanism (i.e., interleaving members). The surgeon
proceeds to set adjustable anchor 20 into a suitable location on
the other side of the bladder neck using a delivery device 1 as
shown in FIG. 12 or in FIGS. 5a-5c.
[0119] Viewing FIGS. 16a-16g, delivery device 1, with the tissue
anchor 20 located therewithin or thereupon, is positioned next to
the area where attachment is desired. Delivery device 1 is then
advanced forcing shaft tip 130, and the sharp end 125 of body 99 to
penetrate into tissue. The barb 102 is retracted or collapsed by
barb retainer 94. Retainer 94 remains stationary as the surgeon
pushes body 99 into the tissue, and barb 102 moves into or through
the tissue via the opening created by body 99. Body 99 and shaft
120 then penetrate and insert through the rectus fascia 603 (tendon
or other desired tissue), until barbs 102 are located in the soft
subcutaneous tissue between the rectus fascias and the skin surface
601 and deploys. Shaft 120 trails from the tissue into which anchor
20 is embedded. At this point, delivery device 1 may be removed (if
desired), and anchor 20 may be anchored at the inferior border of
the rectus fascia 603 or underneath the rectus fascia 603 in a
sandwich-like fashion by applying a tissue-retaining device 27,
such as button 62.
[0120] Next, shaft 120 is advanced by hand or with a hemostat, or
using adjuster cylinder 90 until shaft 120 contacts the underside
of skin surface 601. Adjuster cylinder 90 may comprise a cutting
edge 90b for tissue penetration as shown in FIGS. 16a-16c. For
instance, the adjuster cylinder 90 could be advanced over shaft 120
from below and completely through delivery device 1 until adjuster
cylinder 90 advances into and punctures skin 601.
[0121] Alternatively, if shaft 120 is adapted to penetrate a
tissue, shaft 120 may be advanced through skin surface 601 by
moving shaft 120 upward or moving the abdominal wall downward,
forcing shaft 120 through skin surface 601.
[0122] In another method, the surgeon locates the exit point of
shaft 120 by pressing the abdominal wall until it contacts shaft
120 and makes a small incision with a scalpel at the exit point. By
further depression of the abdominal wall, the surgeon causes shaft
120 to exit through the abdominal wall incision. The surgeon grasps
and holds the protruding shaft 120 and removes pressure on the
tissue and abdominal wall, thus fully deploying adjustable anchor
20. If this particular procedure is followed, shaft tip 130 need
not be adapted to penetrate skin surface 601. Delivery device 1 and
anchor 20 shown in FIG. 12 or 15 may deploy in this fashion.
[0123] Yet another method would be applicable with delivery device
1 having a plunger 5 adapted to activate shaft 120. In such an
embodiment, shaft 120 is advanced by operation of plunger 5.
[0124] After shaft 120 passes through skin surface 601, it is held
above skin surface 601, and the tension on the sutures or sling is
adjusted by pulling or pushing shaft 120, using adjuster cylinder
90 to disengage the interleaving members, if needed. Once proper
tension is achieved, the adjuster cylinder 90 is removed, and the
interleaving members/ratcheting devices 140, 150 engage, fixing
shaft 120 in place. Shaft 120 is left trailing above skin surface
601 for further postoperative adjustment.
[0125] Viewing FIG. 16a, to ease movement of shaft 120 through
hollow chamber 100, ratcheting devices 140, 150 (interleaving
member 303, 304) are disengaged using adjuster cylinder 90 inserted
into hollow chamber 100 between shaft 120 and interior walls 121
(see FIG. 5a) of body 99. Alternatively, when shaft 120 first
protrudes from the incision, adjuster cylinder 90 may be positioned
through the abdominal wall (see FIG. 16g). When anchor 20 fully
deploys, adjuster cylinder 90 is removed, and shaft 120 is left
trailing through skin surface 601 as previously described.
[0126] An alternative procedure using a plunger-adapted delivery
device 1 follows, using a two-plunger delivery device 1 shown in
FIG. 13. Initially, delivery device 1 is positioned adjacent to the
area to be anchored and housing 2 and hollow body portion 7 pushed
upward penetrating the tissue (note the sharp end 125a of hollow
body portion 7 may be adapted to penetrate a tissue). Once sharp
end 125a is properly positioned for deployment of anchor 20,
(generally above the surface of the penetrated tissue), the surgeon
will deploy at least first plunger 301 to activate body 99,
although it may be desirable to operate both plungers 301, 302.
This deploys barb 102 in the soft subcutaneous tissue, superior or
exterior to the rectus fascia 603 or other tissue involved. Shaft
120 is advanced by plunger 302, until shaft 120 penetrates skin
surface 601. The surgeon may assist by pressing downward on the
abdominal wall, thus reducing the distance that second plunger 302
must be depressed. Sharp end 125 and/or tip 130 should be adapted
for tissue penetration as described.
[0127] Once shaft 120 advances through the abdominal wall, the
surgeon grasps it with a hemostat. Pressure is removed from the
abdominal wall, delivery device 1 is removed, and anchor 20 is
fully deployed. Shaft 120 is exposed above skin surface 601 and
barb 102 is set within or on the rectus fascia 603 or other
appropriate tissue for later adjustment.
[0128] The surgeon may now pull (or push) on shaft 120 to raise (or
lower) the attached sling until the sling is properly positioned
under the bladder neck with suitable tension. Upward movement of
shaft 120 may be difficult due to resistance caused by the
interleaved first and second ratcheting devices, 140 and 150
(interleaving members 303, 304). When resistance is a problem, the
surgeon may position adjuster cylinder 90 around shaft 120, push
adjuster cylinder 90 down over shaft 120 through skin surface 601
until adjuster cylinder 90 contacts and disengages first and second
ratcheting devices 140, 150 (interleaving members 303, 304) located
within body 99. Adjuster cylinder 90 eases resistance. When the
sling is properly tensioned, adjuster cylinder 90 is removed,
allowing the first and second ratcheting devices 140, 150
(interleaving members 303, 304) to interleave, resisting movement
of shaft 120 with respect to body 99 and setting the sling tension
at this point. Note that it is desirable for several inches of tip
130 to protrude from the abdominal wall to assist in later
adjustments. Tension adjustments may be gauged by having indicia
markings 80 placed on shaft 120 (see FIGS. 16a-16h and FIG.
18b).
[0129] The exposed end of shaft 120 is taped against the abdominal
wall. Postoperatively, the tension on the sling could be adjusted
through the operation of the interleaved ratcheting devices 140,
150 (or interleaving members 303, 304) by adjusting the shaft 120
of the tissue anchor protruding through the abdominal skin
incrementally, as described above. The patient could be brought
back one to several weeks later, and the sling could be adjusted at
that time in order to achieve appropriate tension minimizing
urethral obstruction postoperatively. The tension is adjusted by
axially pulling up or pushing down on shaft 120. Again, if too much
resistance is encountered because of the interleaved ratcheting
devices 140, 150 (or interleaving members 303, 304), the resistance
can be eased by using adjuster cylinder 90 as described above. The
tension is adjusted to the desired level, and adjuster cylinder 90
is removed, allowing ratcheting devices 140, 150 (or interleaving
members 303,304) to again interleave, resisting movement of shaft
120 relative to body 99. Anchor 20 is now once again substantially
fixed in position.
[0130] The patient's progress is followed, and when a surgeon
believes that appropriate tension has been placed, shaft 120 is cut
below skin surface 601. This is done with a hollow needle (e.g. 21
gauge beveled) which slides down shaft 120 and cuts shaft 120 in
the subcutaneous tissue at the junction with body 99, leaving
anchor 20 behind with the sling at the appropriate tension.
Alternatively, the exposed portion of the shaft 120 may be cut
below skin surface 601 by depressing the skin around shaft 120 and
cutting shaft 120. The skin is then released and recoils leaving
the cut tip remote from skin surface 601.
[0131] The ability to adjust the tension postoperatively obviates
the need for postoperative long-term catheterization. It also
obviates the need for re-operation for obstructive uropathy by
adjusting the sling postoperatively when the patient is awake and
experiences normal daily activities without tissue inflammation.
This gives the surgeon a realistic appraisal of the true tension
that is needed for optimum correction of incontinence.
[0132] Referring to FIGS. 17 and 18c-d, adjustment of tissue or
sling tension is accomplished by rotation of anchor shaft 120
clockwise or counterclockwise (for increasing or decreasing tissue
tension respectively) along the 120 axial shaft. This moves shaft
120 up or down, through body 99 secured to or within tissue by the
action of corresponding threads 801 on shaft 120 and threads 802 on
the interior walls of body 99. After appropriate tensioning
adjustments were made to shaft 120 trailing through the skin or
tissue could be trimmed as previously described with the ratcheted
anchor 20. FIG. 17 illustrates a similar anchor 20 to the one used
in FIGS. 16a-16g, except the interleaving members on this
embodiment include interleaving threads 801, 802. When using
interleaving threads 801, 802, however, it is desirable that shaft
120 freely rotate while attachment member 23 does not. For this
reason, attachment member 23 connects to shaft 120 using a ball and
socket joint 15.
[0133] FIGS. 16a-16g illustrate a series of drawings depicting one
particular embodiment of an adjustable tissue anchor 20 being
positioned within a tissue. FIG. 16a illustrates anchor 20 placed
against the underside of the rectus fascia 603. Delivery device 1
includes shaft 120 having first interleaving members 303 (or
ratcheting devices 150) on its exterior and an attachment member
23. Shaft 120 is positioned within adjuster cylinder 90. Adjuster
cylinder 90 and shaft 120 are positioned within hollow chamber 100.
Hollow chamber 100 has second interleaving members 304 (or
ratcheting devices 140) positioned on its interior walls 121 for
interleaving with first interleaving members 303 on shaft 120.
Adjuster cylinder 90 keeps first and second interleaving members
303, 304 from engaging. Barb 102 is shown as a set of deployable
wings. Surrounding barbs 102 is a sleeve 96, which is slidably
positioned over barbs 102 to keep barbs 102 from deploying before
they insert into a tissue.
[0134] Viewing FIG. 16b, anchor 20 begins to penetrate the rectus
fascia 603. The first penetration may occur by cutting edge 90b of
adjuster cylinder 90, by sharp end 125 of anchor 20, or by both as
shown. Viewing FIG. 16c, barb 102 penetrates the rectus fascia 603,
slides through sleeve 96, which remains below the rectus fascia
603. Barb 102 advances into the subcutaneous tissue and
deploys.
[0135] Viewing FIG. 16d, the surgeon pushes adjuster cylinder 90 or
anchor shaft 120 to advance cylinder 90 against and through skin
surface 601. Alternatively, cylinder 90 may be pressed against the
underside of skin surface 601, and the surgeon then accesses
cylinder 90 using an exterior incision on skin surface 601.
Alternatively, tip 130 may penetrate skin surface 601. Viewing FIG.
16e, shaft 120 extends through skin surface 601 where shaft 120 has
been pushed through the protruding adjuster cylinder 90 while in
the position shown in FIG. 16d.
[0136] Viewing FIG. 16f, the adjuster cylinder 90 has been removed
by a surgeon by withdrawing it away from skin surface 601. A button
62 has been positioned relative to shaft 120 and interleaving
members 401 on shaft 120 engage interleaving members 402 in center
hole 404 of button 62. The interleaving members 401, 402 affix
button 62 to shaft 120. As now depicted, anchor 20 is fully set,
and barbs 102 resist downward displacement. Upward displacement is
resisted by button 62. Shaft 120, however, protrudes through skin
surface 601 and may be pulled to increase tension, or pushed to
release tension on any device attached to attachment member 23.
[0137] FIG. 16g illustrates an adjuster cylinder 90 having a
funneled upper end 403. Cylinder 90 is reinserted through skin
surface 601 to allow shaft 120 to be easily moved without
resistance from interleaving members 303, 304. The use of the
adjuster cylinder 90 in positioning of shaft 120 is optional.
[0138] Finally, shown in FIG. 20 is a long anchor shaft 120
deployed within a flexible delivery system, such as an endoscope.
Generally, anchor 20 will be placed against the desired placement
location, and advanced through the scope, using a rigid or flexible
plunger 5 (not shown). Also shown are the video camera 65 and a
screen for remote viewing of the procedure.
[0139] The terms ratcheting devices and interleaving members are
used coextensively throughout. It should be noted that interleaving
members may be substituted for ratcheting devices and vice versa,
depending on a surgeon's desires. As used in the claims,
interleaving members is intended to include ratcheting devices. In
either case, ratcheting devices or interleaving members include
elements that will substantially fix the position of anchor 20 or
of shaft 120 positioned within anchor 20. The ratcheting devices
and/or interleaving members also allow movement of anchor 20 or
shaft 120 so that tension on the sling can be increased by moving
shaft 120 or anchor 20 upward or decreased by moving shaft 120 or
anchor 20 downward. Ratcheting devices do not exclude elements or
configurations that allow shaft 120 or anchor 20 to move in
multiple directions.
[0140] Although the preferred embodiment has been described, it
will be appreciated by those skilled in the art to which the
present invention pertains that modifications, changes, and
improvements may be made without departing from the spirit of the
invention defined by the claims.
* * * * *