U.S. patent application number 11/094624 was filed with the patent office on 2005-11-10 for anchors for use in attachment of bladder tissues to pelvic floor tissues following a prostatectomy.
This patent application is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Gill, Robert P., Hess, Christopher J., Issa, Muta M., Voegele, James W., Weisenburgh, William B. II.
Application Number | 20050251175 11/094624 |
Document ID | / |
Family ID | 40396618 |
Filed Date | 2005-11-10 |
United States Patent
Application |
20050251175 |
Kind Code |
A1 |
Weisenburgh, William B. II ;
et al. |
November 10, 2005 |
Anchors for use in attachment of bladder tissues to pelvic floor
tissues following a prostatectomy
Abstract
Embodiments for an anchor for use in effecting the anastomosis
of a patient's bladder and urethra following a prostatectomy are
disclosed. The anchor may comprise a shaft with a lodging
structure. Alternative embodiments may include a penetration
limiting structure, a driver interface proximate to a rearward end,
a forward end with a penetration facilitating shape that may
comprise a point defined by three flat intersecting faces, a
bioabsorbable portion of one or more bioabsorbable materials, and a
metal portion of one alloy, or a plurality of alloys which may have
differing expansion properties.
Inventors: |
Weisenburgh, William B. II;
(Maineville, OH) ; Gill, Robert P.; (Mason,
OH) ; Hess, Christopher J.; (Cincinnati, OH) ;
Voegele, James W.; (Cincinnati, OH) ; Issa, Muta
M.; (Atlanta, GA) |
Correspondence
Address: |
U.S. Docket Clerk
P.O. Box 1222
Johnson & Johnson Law Department
New Brunswick
NJ
08903
US
|
Assignee: |
Ethicon Endo-Surgery, Inc.
|
Family ID: |
40396618 |
Appl. No.: |
11/094624 |
Filed: |
March 30, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60569195 |
May 7, 2004 |
|
|
|
60582302 |
Jun 23, 2004 |
|
|
|
60639836 |
Dec 28, 2004 |
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 2017/0647 20130101;
A61B 17/11 20130101; A61B 2017/1103 20130101; A61B 17/064 20130101;
A61B 17/0644 20130101; A61B 2017/0419 20130101; A61B 2017/06176
20130101; A61B 2017/1139 20130101; A61B 2017/1135 20130101; A61B
2017/2923 20130101; A61B 2017/2905 20130101; A61B 2017/00004
20130101; A61B 2017/0412 20130101; A61B 17/0482 20130101; A61B
17/115 20130101; A61B 2017/0427 20130101; A61B 17/1155 20130101;
A61B 17/0401 20130101; A61B 17/068 20130101; A61B 2017/0417
20130101; A61B 2017/22069 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 017/08 |
Claims
We claim:
1. An anchor for installation into tissues of the pelvic floor, and
for use in a procedure to effect anastomosis of a patient's bladder
and urethra following a prostatectomy, comprising: a shaft, having
a length of about 1/2 to about 21/2 inches, and forward and
rearward ends; a driver interface proximate to said rearward end; a
lodging structure on said shaft; a penetration facilitating shape
on said forward end; and a bioabsorbable portion.
2. The anchor of claim 1 wherein said bioabsorbable portion
comprises two joined bioabsorbable materials having differing
degradation profiles.
3. The anchor of claim 1 further comprising a surface on said
bioabsorbable portion having a groove therein.
4. The anchor of claim 2 further comprising a surface on said
bioabsorbable portion having a groove therein.
5. The anchor of claim 1 wherein said penetration facilitating
shape comprises a point defined by three flat intersecting
faces.
6. The anchor of claim 1 further comprising a penetration limiting
structure on said shaft.
7. The anchor of claim 1 wherein said driver interface comprises a
hollow section of said shaft along a portion of said length.
8. An anchor for installation into tissues of the pelvic floor, and
for use in a procedure to effect anastomosis of a patient's bladder
and urethra following a prostatectomy, comprising: a shaft, having
a length of about 1/2 to about 21/2 inches, and forward and
rearward ends; a driver interface proximate to said rearward end; a
lodging structure on said shaft; a penetration limiting structure
on said shaft; and a penetration facilitating shape on said forward
end.
9. The anchor of claim 8 further comprising a bioabsorbable
portion.
10. The anchor of claim 9 further comprising a surface on said
bioabsorbable portion having a groove therein.
11. The anchor of claim 8 wherein said penetration facilitating
shape comprises a point defined by three flat intersecting
faces.
12. The anchor of claim 8 wherein said driver interface comprises a
hollow section of said shaft along a portion of said length.
13. The anchor of claim 8 further comprising a portion consisting
essentially of nitinol.
14. An anchor for installation into tissues of the pelvic floor,
and for use in a procedure to effect anastomosis of a patient's
bladder and urethra following a prostatectomy, comprising: a shaft,
having a length of about 1/2 to about 21/2 inches, and forward and
rearward ends; a driver interface proximate to said rearward end; a
lodging structure on said shaft; a portion comprising a metal
alloy; a penetration facilitating shape on said forward end.
15. The anchor of claim 15 wherein said penetration facilitating
shape comprises a point formed by three flat intersecting
faces.
16. The anchor of claim 15 wherein said driver interface comprises
a hollow section of said shaft along a portion of said length.
17. The anchor of claim 15 wherein said metal alloy is nitinol.
18. The anchor of claim 15 wherein said metal alloy is stainless
steel.
19. The anchor of claim 15 further comprising a portion comprising
at least two different joined metal alloys having differing
expansion properties.
20. The anchor of claim 15 further comprising a penetration
limiting structure on said shaft.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of the filing date(s) of
one or more of U.S. provisional applications: METHODS AND DEVICE
FOR ANASTOMOSIS, Ser. No. 60/569,195, filed May 7, 2004; METHODS
AND DEVICE FOR ANASTOMOSIS, Ser. No. 60/582,302, filed Jun. 23,
2004, and METHOD AND INSTRUMENT FOR EFFECTING ANASTOMOSIS OF
RESPECTIVE TISSUES DEFINING TWO BODY LUMENS, Ser. No. 60/639,836,
filed Dec. 28, 2004.
[0002] This application relates to and incorporates by reference in
their entirety, for any and all purposes, the following
non-provisional applications, filed substantially contemporaneously
herewith and having one or more inventors in common with the
instant application:
[0003] INSTRUMENT FOR EFFECTING ANASTOMOSIS OF RESPECTIVE TISSUES
DEFINING TWO BODY LUMENS, Ser. No. (to be issued), filed Mar. 30,
2005;
[0004] METHOD AND INSTRUMENT FOR EFFECTING ANASTOMOSIS OF
RESPECTIVE TISSUES DEFINING TWO BODY LUMENS, Ser. No. (to be
issued), filed Mar. 30, 2005;
[0005] METHOD AND INSTRUMENT FOR EFFECTING ANASTOMOSIS OF
RESPECTIVE TISSUES DEFINING TWO BODY LUMENS, Ser. No. (to be
issued), filed Mar. 30, 2005;
[0006] INSTRUMENT FOR EFFECTING ANASTOMOSIS OF RESPECTIVE TISSUES
DEFINING TWO BODY LUMENS, Ser. No. (to be issued), filed Mar. 30,
2005;
[0007] INSTRUMENT FOR EFFECTING ANASTOMOSIS OF RESPECTIVE TISSUES
DEFINING TWO BODY LUMENS, Ser. No. (to be issued), filed Mar. 30,
2005;
[0008] INSTRUMENT FOR EFFECTING ANASTOMOSIS OF RESPECTIVE TISSUES
DEFINING TWO BODY LUMENS, Ser. No. (to be issued), filed Mar. 30,
2005;
[0009] DEVICE FOR ALTERNATELY HOLDING, OR EFFECTING RELATIVE
LONGITUDINAL MOVEMENT, OF MEMBERS OF A MEDICAL INSTRUMENT, Ser. No.
(to be issued), filed Mar. 30, 2005; and
[0010] METHOD AND INSTRUMENT FOR EFFECTING ANASTOMOSIS OF
RESPECTIVE TISSUES DEFINING TWO BODY LUMENS, Ser. No. (to be
issued), filed Mar. 30, 2005.
FIELD OF THE INVENTION
[0011] The present invention relates generally to the anastomosis
of two hollow organs, a hollow organ and a vessel or two vessels,
and is particularly directed to a method and embodiments of a
device that accomplish the same in a minimally invasive manner.
More particularly, the present invention also relates to an
anastomosis instrument and method that may be used for the
anastomosis of the bladder and urethra, especially after a
patient's prostate has been removed in a prostatectomy.
BACKGROUND OF THE INVENTION
[0012] Prostate cancer is the second most common malignancy in
males after cutaneous malignancies and is the second most common
cause of cancer death among men in the United States. Prostate
cancer is predominantly a disease of elderly men, and the absolute
number of cases is expected to increase as worldwide life
expectancy increases.
[0013] The retropubic approach to prostatectomy as a treatment for
prostate cancer was introduced by Millin in 1947. The operation had
distinct advantages over perineal prostatectomy in that urologists
were more familiar with retropubic anatomy. The retropubic approach
to radical prostatectomy also offers the advantage of the ability
to perform an extraperitoneal pelvic lymph node dissection for
staging purposes. During the past decade, modification in the
technique of radical retropubic prostatectomy and the introduction
of the anatomic nerve-sparing method resulted in a dramatic
decrease in the two morbidities associated with the operation that
cause the most concern--incontinence and impotence.
[0014] In a radical retropubic prostatectomy, the surgeon removes
all or most of the patient's prostate. Because the urethra travels
through the prostate, the upper part of the urethra is removed in
the surgery. In order to restore proper urinary functions, the
bladder and the urethra must be reconnected.
[0015] Providing this connection is particularly difficult due to
the limited working space and the small size of the urethra. The
size of the urethra makes it difficult to accurately place the
suture thread through the wall of the urethra. Heretofore, surgeons
would execute painstaking suturing operations with tiny, fine
needles to reconnect the bladder to the urethra. It has been found
that the use of sutures for this purpose has caused certain
problems in recovery. These problems include necrosis of the
sutured tissues, stricture of the urethra that impedes the flow of
fluid through it, and a urethra-bladder connection that is not
fluid-tight. In addition, when suturing the urethra to the bladder
the surgeon can possibly inadvertently pierce the nearby
neurovascular bundle, which can cause incontinence or impotence.
The suturing process itself has also been found to be cumbersome,
requiring the surgeon to grasp and stretch the bladder and urethra
together before making the fine sutures. Sutures may also tear the
urethra, resulting in further complications.
[0016] With radical retropubic prostatectomies becoming more
common, faster and simpler ways to reconnect the bladder and
urethra are in demand. It would be further advantageous to provide
a means for the anastomosis of the urethra and bladder that does
not require the use of potentially damaging sutures.
[0017] Additionally, there are other surgical procedures requiring
the connection of vessels, hollow organs and tissues defining other
body lumens. While some of these structures are large, and more
easily manipulated by the surgeon, tissue structures defining other
body lumens are smaller and more difficult to manipulate and hold
in position while joining ends thereof after, for example, a
transactional operation. Accordingly, a faster and simpler way to
connect vessels, hollow organs and other tissues defining body
lumens would be advantageous.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawings incorporated in and forming a part
of the specification illustrate several aspects of the present
invention, and together with the description serve to explain the
principles of the invention. In the drawings:
[0019] FIG. 1 is a partial, vertical sectional schematic depiction
of the positional relationships of the human male bladder, prostate
and urethra, and surrounding pelvic floor, prior to a
prostatectomy;
[0020] FIG. 2 is a partial, vertical sectional schematic depiction
of the positional relationships of the human male bladder and
urethra, and surrounding pelvic floor, following a
prostatectomy;
[0021] FIG. 3 is a perspective view of an anastomotic instrument
having an actuator handle, a driver assembly and a positioner
assembly in accordance with one embodiment of the present
invention;
[0022] FIG. 4 is a longitudinal cross-sectional view of the
actuator handle of the anastomotic instrument shown in FIG. 3;
[0023] FIG. 5 is an expanded longitudinal cross-sectional view of
the proximal end of the actuator handle of the anastomotic
instrument shown in FIG. 3;
[0024] FIG. 6 is an expanded longitudinal cross-sectional view of
the distal end of the actuator handle of the anastomotic instrument
shown in FIG. 3;
[0025] FIG. 7 is a longitudinal cross-sectional view of the tube
assembly, positioner assembly and driver assembly of the instrument
shown in FIG. 3;
[0026] FIG. 8 is an expanded longitudinal cross-sectional view of
the bridge assembly portion of the tube assembly shown in FIG.
7;
[0027] FIG. 9 is an expanded transverse cross-sectional view of the
bridge assembly shown in FIG. 8;
[0028] FIG. 10 is an expanded longitudinal cross-sectional view of
the bridge assembly shown in FIG. 8;
[0029] FIG. 11 is an expanded longitudinal cross-sectional view of
a positioner assembly part of the anastomotic instrument shown in
FIG. 3;
[0030] FIG. 12 is a longitudinal cross-sectional view of the driver
assembly part of the anastomotic instrument shown in FIG. 3;
[0031] FIG. 13 is a perspective illustration of embodiments of the
positioner and driver assemblies of the anastomotic instrument
shown in FIG. 3;
[0032] FIG. 14 is a perspective illustration of embodiments of the
positioner and driver assemblies of the anastomotic instrument
shown in FIG. 3 with the positioner and driver assemblies shown in
open positions;
[0033] FIG. 15 is a cross-sectional overhead view of the positioner
and driver assemblies of the anastomotic instrument shown in FIG.
14 showing the driver arms and positioner arms in open
positions;
[0034] FIG. 16 is an expanded perspective view of the driver
assembly of the anastomotic instrument shown in FIG. 14, showing
driver arms, driver pins and anchors;
[0035] FIG. 17 is a longitudinal cross-sectional view of another
embodiment of an anastomotic instrument in accordance with the
present invention;
[0036] FIG. 18 is a transverse cross-sectional view of a driver
assembly part of the anastomotic instrument shown in FIG. 17;
[0037] FIG. 19 is a longitudinal cross-sectional view of the
anastomotic instrument shown in FIG. 17, with driver and positioner
petal assemblies shown in opened positions;
[0038] FIG. 20 is a longitudinal cross-sectional view of the
anastomotic instrument shown in FIG. 17, showing positioner petals
in contact with tissue and anchor driver pins and anchors partially
deployed into tissues;
[0039] FIG. 21 is a longitudinal cross-sectional view of the
anastomotic instrument shown in FIG. 17, showing positioner petals
in contact with tissues and anchor driver pins and anchors driven
into tissues;
[0040] FIG. 22 is a longitudinal cross-sectional view of another
alternate embodiment of an anastomotic instrument of the present
invention;
[0041] FIG. 23 is a cross-sectional view of the driver assembly
part of the anastomotic instrument shown in FIG. 22;
[0042] FIG. 24 is a longitudinal cross-sectional view of the
anastomotic instrument shown in FIG. 22, with positioner petals
shown in opened positions;
[0043] FIG. 25 is a longitudinal cross-sectional view of the
anastomotic instrument shown in FIG. 22, with positioner petals and
a driver assembly shown in opened positions;
[0044] FIG. 26 is a longitudinal cross-sectional view of the
anastomotic instrument shown in FIG. 22, showing positioner petals
in contact with tissue and anchor driver pins and anchors driven
into tissues;
[0045] FIG. 27 is an overhead view of the positioner assembly of
the anastomotic instrument shown in FIG. 24 with the driver
assembly removed for purposes of illustration, showing the
positioner petals in opened positions;
[0046] FIG. 28 is a perspective illustration of the alternate
anastomotic instrument shown in FIG. 17, shown in a closed
position;
[0047] FIG. 29 is a perspective illustration of the alternate
anastomotic instrument shown in FIG. 17, shown in an opened
position;
[0048] FIG. 30 is a perspective illustration of the alternate
anastomotic instrument shown in FIG. 22, shown in an opened
position;
[0049] FIG. 31 is an illustration of an anastomotic instrument
fully inserted through a patient's urethra and into the bladder,
following a prostatectomy;
[0050] FIG. 32 is an illustration showing an anastomotic instrument
fully inserted through a patient's urethra and into the bladder
following a prostatectomy, with driver and positioner assemblies
opened;
[0051] FIG. 33 is an illustration showing an anastomotic instrument
fully inserted through a patient's urethra and into the bladder
following a prostatectomy, with a positioner assembly urging the
bladder wall into contact with the pelvic floor with the openings
in the bladder and urethra aligned;
[0052] FIG. 34 is an illustration showing an anastomotic instrument
fully inserted through a patient's urethra and into the bladder
following a prostatectomy, and with a driver assembly actuated and
anchors driven through the bladder wall and into the pelvic
floor;
[0053] FIG. 35 is an illustration showing an anastomotic instrument
inserted through the urethra and into the bladder, with a driver
assembly and driver pins retracted and withdrawn from anchors,
which are left installed through the bladder wall and into the
pelvic floor;
[0054] FIG. 36 is an illustration showing an anastomotic instrument
fully inserted through a patient's urethra and into the bladder
following a prostatectomy, with driver and positioner assemblies
returned to initial retracted positions following installation of
anchors;
[0055] FIG. 37 is an illustration showing the bladder and urethra
after installation of anchors and removal of an anastomotic
instrument used to effect such installation, and showing a guide
wire left in place for guiding a catheter into the bladder through
the urethra;
[0056] FIG. 38 is a schematic illustration showing the bladder and
urethra after installation of anchors and removal of an anastomotic
instrument used to effect such installation, and showing a balloon
catheter system inserted into the bladder through the urethra and
leading to a urine collection bag;
[0057] FIG. 39 is a perspective illustration of an embodiment of an
anchor;
[0058] FIG. 40 is a perspective illustration of an alternate
embodiment of an anchor;
[0059] FIG. 41 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0060] FIG. 42 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0061] FIG. 43 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0062] FIG. 44 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0063] FIG. 45 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0064] FIG. 46 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0065] FIG. 47 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0066] FIG. 48 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0067] FIG. 49 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0068] FIG. 50 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0069] FIG. 51 is a perspective illustration of an alternate
embodiment of an anchor shaft and tip;
[0070] FIG. 52 is a schematic illustration of a driving button
assembly shown in a cocked position;
[0071] FIG. 53 is a schematic illustration of a driving button
assembly shown in a released position;
[0072] FIG. 54 is a schematic illustration of a driving button
assembly shown in a forward seating position;
[0073] FIG. 55 is a perspective view of an embodiment of an
antegrade vesico urethral anastomosis instrument in accordance with
the present invention;
[0074] FIG. 56 is a partial view of the instrument shown in FIG.
55, including a curved tube assembly and anastomosis end effector,
inserted into the bladder of a patient as used in accordance with
the present invention;
[0075] FIG. 57 is a partial view of the instrument shown in FIG.
55, including an opened positioner assembly as used in accordance
with the present invention;
[0076] FIG. 58 is a partial view of the instrument shown in FIG.
55, including an opened anchor assembly as used in accordance with
the present invention;
[0077] FIG. 59 is a partial view of the instrument shown in FIG.
55, showing positioner arms urging the bladder wall into contact
with the pelvic floor in accordance with the present invention;
[0078] FIG. 60 is a partial view of the instrument shown in FIG.
55, after anchors have been driven through the bladder wall into
the pelvic floor in accordance with the present invention;
[0079] FIG. 61 is a partial view of the instrument shown in FIG.
55, following withdrawal of anchor driver pins from installed
anchors in accordance with the present invention;
[0080] FIG. 62 is a partial view of the instrument shown in FIG.
55, after partial retraction of the instrument to unfold a harness
in accordance with the present invention;
[0081] FIG. 63 is a partial view of the instrument shown in FIG.
55, following closing of an anchor assembly and positioner assembly
in preparation for their withdrawal, to leave a balloon assembly
and catheter behind in accordance with the present invention;
[0082] FIG. 64 is a partial view of the instrument shown in FIG.
55, after removal of a positioner assembly and anchor assembly,
used in accordance with the present invention, has commenced;
[0083] FIG. 65 is a partial view of the instrument shown in FIG.
55, after removal of a positioner assembly and anchor assembly, and
after inflation of a balloon secured with an anchored harness, used
in accordance with the present invention;
[0084] FIG. 66 is a perspective view of a harness portion of the
instrument shown in FIG. 55, as it may be secured to anchors via
harness anchoring loops;
[0085] FIG. 67 is a longitudinal cross-sectional view of an
embodiment of a balloon assembly that may be adapted for use in
accordance with the present invention;
[0086] FIG. 68 is a transverse cross-sectional view of a catheter
that may be used in accordance with the present invention;
[0087] FIG. 69 is a longitudinal cross-sectional view of one
embodiment of a catheter cap and a urine collection bag that may be
used in accordance with the present invention;
[0088] FIG. 70 is an exploded view of an embodiment of an end
effector assembly of the instrument shown in FIG. 55;
[0089] FIG. 71 is a longitudinal and perspective sectional, partial
view of an embodiment of an end effector assembly of the instrument
shown in FIG. 55, showing an open anchor assembly and partially
open positioner assembly;
[0090] FIG. 72 is a longitudinal and perspective sectional view of
a transitional tube portion of an anastomosis instrument such as
shown in FIG. 55, showing exemplary linkages for actuator
tubes;
[0091] FIG. 73 is a longitudinal cross-sectional view of a closing
tube latching collar portion of the instrument shown in FIG. 55, in
a closed position;
[0092] FIG. 74 is a longitudinal cross-sectional view of a closing
tube latching collar portion of the instrument shown in FIG. 55, in
an open position;
[0093] FIG. 75 is a side cross-sectional view of an embodiment of a
handle assembly of the instrument shown in FIG. 55;
[0094] FIG. 76 is an exploded perspective view of the handle
assembly shown in FIG. 75;
[0095] FIG. 77 is a sectional view of a positioner assembly and
connected portions of the handle assembly shown in FIG. 55, showing
the components involved in the operation of the positioner
assembly;
[0096] FIG. 78 is a perspective view of a positioner assembly of
the instrument shown in FIG. 55, shown partially open;
[0097] FIG. 79 is a sectional view of an anchor assembly and
connected portions of the handle assembly shown in FIG. 55, showing
the components involved in opening and closing the anchor
assembly;
[0098] FIG. 80 is an exploded perspective view of a closing tube
latching collar, and associated components, of the instrument shown
in FIG. 55;
[0099] FIG. 81 is a sectional view of an anchor assembly and
connected portions of the handle assembly shown in FIG. 55, showing
the components involved in driving anchors;
[0100] FIG. 82 is a sectional view of a curved spine tube and
connected portions of the handle assembly shown in FIG. 55, showing
a fixed, skeletal structure of the instrument;
[0101] FIG. 83 is a perspective view of the distal and proximal
ends of another embodiment of an anastomotic instrument of the
present invention, shown in a retracted, pre-deployment position,
with the intermediate section removed for ease of depiction in the
drawing;
[0102] FIG. 84 is a longitudinal cross section of the distal end of
the instrument shown in FIG. 83, shown in a retracted,
pre-deployment position;
[0103] FIG. 85 is a longitudinal cross section of an embodiment of
a handle assembly adapted for use at the proximal end of an
anastomotic instrument of the present invention;
[0104] FIG. 86 is a partial transverse cross section of the
instrument shown in FIG. 84, indicated at 86-86 of FIG. 84, showing
sectional views of an outer driver assembly tube, anchor driver
pin, inner driver assembly tube, positioner tube, and anchor,
loaded into the instrument in a pre-deployment position;
[0105] FIG. 87 is a side view of a forward member of an anchor that
may be used with the instrument shown in FIG. 83, shown in a
pre-deployment position as in contact with an anchor driver
pin;
[0106] FIG. 88 is a longitudinal cross section of the instrument
shown in FIG. 83, shown in a retracted, pre-deployment position
after insertion into and through a patient's urethra and into the
bladder, following a prostatectomy;
[0107] FIG. 89 is a longitudinal cross section of the instrument
shown in FIG. 83, shown after insertion into and through a
patient's urethra and into the bladder, and after a positioner has
been moved to a deployed position;
[0108] FIG. 90 is a longitudinal cross section of an embodiment of
the instrument shown in FIG. 83, shown after insertion into and
through a patient's urethra and into the bladder, after a
positioner has been moved to a deployed position, and after the
bladder wall has been urged into contact with the pelvic floor with
the openings in the bladder and urethra aligned;
[0109] FIG. 91 is a longitudinal cross section of the instrument
shown in FIG. 83, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, and after actuation of an anchor driver
assembly to drive anchors into the tissues of the pelvic floor and
bladder wall, surrounding the aligned urethra opening and bladder
opening;
[0110] FIG. 92 is a longitudinal cross section of the instrument
shown in FIG. 83, shown after insertion into and through the
urethra and into the bladder, after a positioner has been moved to
a deployed position, after the bladder wall has been urged into
contact with the pelvic floor with the openings in the bladder and
urethra aligned, after anchors have been installed, and after
retraction of an anchor driver assembly has commenced, to leave a
positioner and positioner tube behind to enable draining of urine
from the bladder during recovery and healing;
[0111] FIG. 93 is a longitudinal cross section of another
alternative embodiment of an anastomotic instrument of the present
invention, shown after a positioner has been moved to a deployed
position, comprising an alternative configuration of driver pins
and an outer driver assembly tube;
[0112] FIG. 94 is a longitudinal cross section of another
alternative embodiment of an anastomotic instrument of the present
invention, shown after a positioner has been moved to a deployed
position, comprising an alternative configuration of driver pins
and an outer driver assembly tube, and showing an alternative
pre-deployment orientation of rearward members and connecting
members of anchors;
[0113] FIG. 95 is a perspective view of the distal and proximal
ends of another embodiment of an anastomotic instrument in
accordance with the present invention, shown in a retracted,
pre-deployment position, with the intermediate section removed for
ease of depiction in the drawing;
[0114] FIG. 96 is a longitudinal cross section of the distal end of
the instrument shown in FIG. 95, shown in a retracted,
pre-deployment position;
[0115] FIG. 97 is a partial transverse cross section of the
instrument shown in FIG. 96, indicated at 97-97 of FIG. 96, showing
sectional views of a second anchor guide collar, first anchor guide
collar, positioner tube, and a first anchor and trailing suture,
loaded into the instrument in pre-deployment positions;
[0116] FIG. 98 is a partial transverse cross section of the
instrument shown in FIG. 96, indicated at 98-98 of FIG. 96, showing
sectional views of an outer driver assembly tube, anchor guide
collar, anchor driver pin, inner driver assembly tube, positioner
tube, and second anchor and an end of a trailing suture, loaded
into the instrument in pre-deployment positions;
[0117] FIG. 99 is an enlarged perspective view of an embodiment of
a first anchor that may be used in the instrument shown in FIG. 95,
shown in a deployed shape;
[0118] FIG. 100 is an enlarged frontal view of an embodiment of a
second anchor that may be used in the instrument shown in FIG. 95,
shown in a deployed shape;
[0119] FIG. 101 is an enlarged side view of the second anchor shown
in FIG. 100;
[0120] FIG. 102 is a longitudinal cross section of the instrument
shown in FIG. 95, shown in a retracted, pre-deployment position
after insertion into and through a patient's urethra and into the
bladder, following a prostatectomy;
[0121] FIG. 103 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after insertion into and through a
patient's urethra and into the bladder, and after a positioner has
been moved to a deployed position;
[0122] FIG. 104 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, and after the bladder wall has been
urged into contact with the pelvic floor with the openings in the
bladder and urethra aligned;
[0123] FIG. 105 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, and after a first actuation of an anchor
driver assembly to drive first anchors into the tissues of the
bladder wall surrounding the bladder opening;
[0124] FIG. 106 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, after a first actuation of an anchor driver
assembly to drive first anchors into the tissues of the bladder
wall surrounding the bladder opening, and after repositioning of
anchor driver pins in preparation to drive second anchors;
[0125] FIG. 107 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after insertion into and through a
patient's urethra and into the bladder, after the positioner has
been moved to a deployed position, after the bladder wall has been
urged into contact with the pelvic floor with the openings in the
bladder and urethra aligned, after a first actuation of an anchor
driver assembly to drive first anchors into the tissues of the
bladder wall surrounding the bladder opening, and after a second
actuation of an anchor assembly to drive second anchors into the
tissues surrounding the urethra opening;
[0126] FIG. 108 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, after anchor pairs and connecting sutures have
been installed, and after retraction of an anchor driver assembly
has commenced, to leave the positioner and a positioner tube behind
to enable draining of urine and other fluids from the bladder
during recovery and healing;
[0127] FIG. 109 is a longitudinal cross section of the instrument
shown in FIG. 95, shown after retraction of an anchor driver
assembly and after the anastomosis procedure has been completed,
with a positioner in a retracted position ready for withdrawal of
the remaining parts of the instrument from the bladder, down
through the urethra and out of the patient's body;
[0128] FIG. 110 is a perspective view of another embodiment of the
distal and proximal ends of an anastomotic instrument of the
present invention, with the intermediate section removed for ease
of depiction in the drawing;
[0129] FIG. 111 is a longitudinal cross section of the instrument
shown in FIG. 110, shown in a retracted and pre-deployment position
after insertion into and through a patient's urethra and into the
bladder, following a prostatectomy;
[0130] FIG. 112 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through a
patient's urethra and into the bladder, and after a positioner has
been moved to a deployed position;
[0131] FIG. 113 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through the
urethra and into the bladder, after a positioner has been moved to
a deployed position, and after an expander collar has been drawn
into a fastener driver assembly to expand a fastener set;
[0132] FIG. 114 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after an expander collar has been
drawn into a fastener driver assembly to expand a fastener set, and
after the bladder wall has been urged into contact with the pelvic
floor with the openings in the bladder and urethra aligned;
[0133] FIG. 115 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, and after actuation of a fastener driver
assembly has begun;
[0134] FIG. 116 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, and after a fastener driver assembly has been
fully actuated to install a fastener set;
[0135] FIG. 117 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, after a fastener driver assembly has been
fully actuated to install a fastener set, and after an expander
collar has been moved out of the fastener driver assembly to allow
the fastener driver assembly to assume a smaller diameter which
will allow it to be retracted through the installed fastener
set;
[0136] FIG. 118 is a longitudinal cross section of the instrument
shown in FIG. 110, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, after a fastener set has been installed, and
after a fastener driver assembly has been withdrawn from the
patient to leave the positioner and a positioner tube behind to
enable draining of urine and other fluids from the bladder during
recovery and healing;
[0137] FIG. 119 is an enlarged perspective view of a fastener set
that may be used with the instrument shown in FIG. 110, shown in
the shape it may have prior to expansion and installation;
[0138] FIG. 120 is an enlarged perspective view of a fastener set
that may be used with the instrument shown in FIG. 110, shown in
the shape may have after expansion and installation;
[0139] FIG. 121 is an enlarged perspective view of an end cap of an
actuator rod that may be used with the instrument shown in FIG.
110;
[0140] FIG. 122 is a longitudinal cross section of another
embodiment of an anastomotic instrument of the present invention,
in a pre-deployment, retracted position;
[0141] FIG. 123 is a longitudinal cross section of the instrument
shown in FIG. 122, shown after insertion into and through a
patient's urethra and into the bladder, following a
prostatectomy;
[0142] FIG. 124 is a longitudinal cross section of the instrument
shown in FIG. 122, shown after insertion into and through a
patient's urethra and into the bladder, and after a positioner has
been moved to a deployed position;
[0143] FIG. 125 is a longitudinal cross section of the instrument
shown in FIG. 122, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, and after the bladder wall has been
urged into contact with the pelvic floor with the openings in the
bladder and urethra aligned;
[0144] FIG. 126 is a longitudinal cross section of the instrument
shown in FIG. 122, shown after insertion into and through a
patient's urethra and into the bladder, after a positioner has been
moved to a deployed position, after the bladder wall has been urged
into contact with the pelvic floor with the openings in the bladder
and urethra aligned, and after a lodging member has been moved to a
deployed position;
[0145] FIG. 127 is an enlarged perspective view of an end cap of a
positioner actuating rod, that may be used with the instrument
shown in FIG. 122;
[0146] FIG. 128 is a schematic view of the instrument shown in FIG.
122, shown inserted into a patient with a positioner in a deployed
position, with the instrument connected at its proximal end to a
urine collection bag;
[0147] FIG. 129 is a longitudinal cross section of another
embodiment of the instrument of the present invention, configured
for an antegrade anastomosis procedure, shown in a deployed
position;
[0148] FIG. 130 is a longitudinal cross section of another
embodiment of the instrument of the present invention, configured
for an antegrade anastomosis procedure, shown in a deployed
position;
[0149] FIG. 131 is a perspective view of an embodiment of a lodging
member having perforations and projections;
[0150] FIG. 132 is a longitudinal cross section of the lodging
member shown in FIG. 131;
[0151] FIG. 133 is a longitudinal cross section of another
embodiment of a lodging member having perforations and
projections;
[0152] FIG. 134 is a perspective view of an anastomotic instrument
having an actuator handle, a tube assembly and an end effector
assembly in accordance with one embodiment of the present
invention;
[0153] FIG. 135 is a longitudinal cross-sectional view of an end
effector assembly of an anastomotic instrument in accordance with
one embodiment of the present invention, shown inserted into and
through a patient's urethra and into the bladder opening;
[0154] FIG. 136 is a longitudinal cross-sectional view of an end
effector assembly of an anastomotic instrument in accordance with
one embodiment of the present invention, shown inserted into and
through a patient's urethra and into the bladder lumen, with a
positioner assembly and an anchor driver assembly opened, and with
the positioner assembly urging the bladder wall into contact with
the pelvic floor;
[0155] FIG. 137 is a longitudinal cross-sectional view of an end
effector assembly of an anastomotic instrument in accordance with
one embodiment of the present invention, shown inserted into and
through a patient's urethra and into the bladder lumen, with a
positioner assembly opened, and after a driver assembly has driven
anchors through the bladder wall and into the pelvic floor;
[0156] FIG. 138 is a longitudinal cross-sectional view of an end
effector assembly of an anastomotic instrument in accordance with
one embodiment of the present invention, shown inserted into and
through a patient's urethra and into the bladder lumen, with a
positioner assembly opened, after a driver assembly has driven
anchors through the bladder wall and into the pelvic floor, and
after driver pins have been withdrawn from the anchors;
[0157] FIG. 139 is a longitudinal cross-sectional view of an end
effector assembly of an anastomotic instrument in accordance with
one embodiment of the present invention, shown inserted into and
through a patient's urethra and into the bladder lumen, with a
positioner assembly opened, after a driver assembly has driven
anchors through the bladder wall and into the pelvic floor, after
driver pins have been withdrawn from anchors driven into the pelvic
floor, and after the driver assembly has been closed;
[0158] FIG. 140 is a longitudinal cross-sectional view of an end
effector assembly of an anastomotic instrument in accordance with
one embodiment of the present invention, shown inserted into and
through a patient's urethra and into the bladder lumen, with a
positioner assembly opened, after a driver assembly has driven
anchors through the bladder wall and into the pelvic floor, after
driver pins have been withdrawn from anchors driven into the pelvic
floor, and after the driver assembly and positioner assembly have
been closed;
[0159] FIG. 141 is a longitudinal cross-sectional view of
components of an end effector assembly of an anastomotic instrument
in accordance with one embodiment of the present invention, shown
inserted into and through a patient's urethra and into the bladder
lumen, after installation of anchors, and after positioner and
anchor driver assemblies have been withdrawn to leave behind an end
cap assembly, anchors installed through the bladder wall and into
the pelvic floor, and a balloon harness attached therebetween;
[0160] FIG. 142 is a longitudinal cross-sectional view of
components of an end effector assembly of an anastomotic instrument
in accordance with one embodiment of the present invention, shown
inserted into and through a patient's urethra and into the bladder
lumen, after installation of anchors, after positioner and anchor
driver assemblies have been withdrawn to leave behind an end cap
assembly, anchors installed through the bladder wall and into the
pelvic floor, and a balloon harness attached therebetween, and
after insertion of a balloon catheter assembly;
[0161] FIG. 143 is a longitudinal cross-sectional view of
components of an end effector assembly of an anastomotic instrument
in accordance with one embodiment of the present invention, shown
inserted into and through a patient's urethra and into the bladder
lumen, after installation of anchors, after positioner and anchor
driver assemblies have been withdrawn to leave behind an end cap
assembly, anchors installed through the bladder wall and into the
pelvic floor, and a balloon harness attached therebetween, after
insertion of a balloon catheter assembly, and after inflation of a
balloon;
[0162] FIG. 144 is a longitudinal cross-sectional view of
components of an end effector assembly of an anastomotic instrument
in accordance with one embodiment of the present invention, shown
inserted into and through a patient's urethra and into the bladder
lumen, after installation of anchors, after positioner and anchor
driver assemblies have been withdrawn to leave behind an end cap
assembly, anchors installed through the bladder wall and into the
pelvic floor, and a balloon harness attached therebetween, after
insertion of a balloon catheter assembly, and after inflation of a
balloon, shown one possible alternative embodiment;
[0163] FIG. 145 is a longitudinal cross-sectional view of
components of an end effector assembly of an anastomotic instrument
in accordance with one embodiment of the present invention, shown
after the anastomosis procedure has been substantially completed,
after withdrawal of a balloon catheter assembly, and in successive
positions during withdrawal of an end cap assembly and balloon
harness;
[0164] FIG. 146 is a perspective, exploded view of exemplary
embodiments of an end cap assembly, balloon harness, and catheter
end plug portion of a balloon catheter assembly; and
[0165] FIG. 147 is a transverse (horizontal), superior (top)
partial planar view of the human male pelvis and pelvic floor
architecture, depicting preferred locations for installation of
anchors.
[0166] Reference will now be made in detail to various alternative
embodiments of the method and instrument of the invention, and
various alternative components thereof, illustrated in the
accompanying drawings.
DETAILED DESCRIPTION OF THE INVENTION
[0167] Before the present method and embodiments of an instrument
are disclosed and described, it is to be understood that this
invention is not limited to the particular process steps and
materials disclosed herein as such process steps and materials may
vary somewhat. It is also to be understood that the terminology
used herein is used for the purpose of describing particular
embodiments only and is not intended to be limiting since the scope
of the present invention will be limited only by the appended
claims.
[0168] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood to one of
ordinary skill in the art to which this invention belongs. Although
any method, instrument and materials similar or equivalent to those
described herein may be used in the practice or testing of the
invention, particular embodiments of a method, instrument and
materials are now described.
[0169] It must be noted that, as used in this specification and the
appended claims, the singular forms "a," "an," and "the" include
plural referents unless the content clearly dictates otherwise.
[0170] In describing and claiming the present invention, the
following terminology will be used in accordance with the
definitions set out below.
[0171] As used herein, the term "anastomosis" means the surgical
joining of respective tissues defining body lumens and other hollow
body structures, especially the joining of hollow vessels,
passageways or organs to create an intercommunication between
them.
[0172] The term "patient," used herein, refers to any human or
animal on which an anastomosis may be performed.
[0173] As used herein, the term "biocompatible" includes any
material that is compatible with the living tissues and system(s)
of a patient by not being substantially toxic or injurious and not
causing immunological rejection. "Biocompatibility" includes the
tendency of a material to be biocompatible.
[0174] As used herein, the term "bioabsorbable" includes the
ability of a material to be dissolved and/or degraded, and
absorbed, by the body.
[0175] As used herein, the term "shape memory" includes the
tendency of a material, such as but not limited to a suitably
prepared nickel-titanium alloy ("nitinol"), to return to a
preformed shape, following deformation from such shape.
[0176] As used herein, the term "integral" means that two or more
parts so described are affixed, fastened or joined together so as
to move or function together as a substantially unitary part.
"Integral" includes, but is not limited to, parts that are
continuous in the sense that they are formed from the same
continuous material, but also includes discontinuous parts that are
joined, fastened or affixed together by any means so as become
substantially immovably affixed to, and substantially unitary with,
each other.
[0177] As used herein, the term "proximal" (or any form thereof),
with respect to a component of an instrument, means that portion of
the component that is generally nearest the surgeon, or nearest to
the end of the instrument handled by the surgeon, when in use; and
with respect to a direction of travel of a component of an
instrument, means toward the end of the instrument generally
nearest the surgeon, or handled by the surgeon, when in use.
[0178] As used herein, the term "distal" (or any form thereof),
with respect to a component of an instrument, means that portion of
the component that is generally farthest from the surgeon, or
farthest from the end of the instrument handled by the surgeon,
when in use; and with respect to a direction of travel of a
component of an instrument, means away from the end of the
instrument generally nearest the surgeon, or handled by the
surgeon, when in use.
[0179] As used herein, the term "transverse" (or any form thereof),
with respect to an axis, means extending in a line, plane or
direction that is across such axis, i.e., not collinear or parallel
therewith. "Transverse" as used herein is not to be limited to
"perpendicular".
[0180] As used herein, the term "longitudinal axis", with respect
to an instrument, means the exact or approximate central axis
defined by said instrument along its greater dimension, i.e., along
its length, from its distal end to its proximal end, and vice
versa, and is not intended to be limited to imply a straight line,
wherein, for example, an instrument includes a bend angle as
described herein, it is intended that "longitudinal axis" as used
herein follows such bend angle. Where used in association with an
end effector, the term "longitudinal axis" means the exact or
approximate central axis defined by said end effector extending
along its greater dimension, i.e., along its length, from its
distal end to its proximal end, and vice versa.
[0181] The method and instrument of the present invention utilizes
a simple, effective mechanical arrangement for performing
anastomosis of respective tissues defining two body lumens, for
example, connecting the bladder to the urethra following a
prostatectomy. By eliminating more painstaking, cumbersome suturing
techniques, anastomosis techniques are improved. For use in the
disclosed procedure, there are provided various embodiments of an
improved instrument for bringing bladder wall tissues into contact
with the pelvic floor tissues, with the openings in the bladder and
urethra aligned, and for securing them in position so that they may
knit and heal together.
[0182] By utilizing the disclosed techniques and an instrument of
the present invention, the number of steps in the anastomosis
procedure may be decreased, decreasing cost and reducing the
required time for the procedure. The present invention may also
eliminate complications associated with other anastomosis
techniques that require hand suturing.
[0183] The present invention provides for a system that allows for,
for example, connecting the bladder to the urethra using an
instrument inserted through the urethra and into the bladder (in
retrograde direction) without the need for access inside the
bladder for manipulation and actuation of the instrument.
Alternatively, the system and instrument may be configured such
that it may be inserted into the bladder and then the urethra in an
antegrade direction, through small incisions in the patient's
abdomen and an upper surface of the bladder. Again, manipulation
and actuation of the instrument may be performed by the surgeon
from outside the patient's body.
[0184] Referring now to the drawings in detail, wherein like
numerals indicate the same elements throughout the views, FIG. 1
schematically illustrates in vertical cross section the positioning
of a human male bladder 1, bladder wall 2, prostate 3, pelvic floor
7 and urethra 5, prior to a prostatectomy. In a radical
prostatectomy, the prostate 3, a lower portion of the bladder wall
2, and an upper portion of the urethra 5 are excised, removing the
fluid connection between the bladder lumen 8 and the remaining
portion of the urethra. The substantially horizontal broken lines
in FIG. 1 schematically illustrate the lines along which the
prostate and adjacent bladder and urethra tissues are excised.
[0185] FIG. 2 depicts an anatomical cross-section of the abdominal
cavity following a radical prostatectomy wherein the excision of a
portion of the bladder wall 2 results in a bladder opening 4 and
the excision of the prostate results in a urethra opening 6 in
urethra 5. Following this surgery, bladder opening 4 is typically
reduced in size by means known in the art, such as a "tennis
racket" suture technique.
Rotationally-Opened Embodiment
[0186] FIGS. 3-16 show an embodiment of an instrument 10 which may
be used to perform an anastomosis procedure, for example, a
procedure to effect anastomosis of a patient's bladder and urethra
following a prostatectomy.
[0187] As shown configured for use in a retrograde manner in FIG.
3, one embodiment of the anastomotic applier instrument 10 in
accordance with the invention may comprise an elongated tube
assembly 500, a driver assembly 300 secured onto the distal end of
the tube assembly 500, an optional positioner assembly 400 which
may be used to bring the bladder wall and the pelvic floor tissues
into close proximity or contact, and an actuator handle 100 for
effecting opening of the positioner and driver assemblies and the
driving and seating of anchors. In general, the instrument may be
used for performing a vesico-urethral anastomosis after the
prostate has been removed in a radical retropubic prostatectomy
(see FIGS. 1 and 2). This connection is necessary to restore the
patient's urinary functions after the prostatectomy.
[0188] FIG. 4 shows an embodiment of an actuator handle 100 of the
anastomotic instrument shown in FIG. 3. Handle 100 is operatively
connected to the proximal end of the elongated tube assembly 500,
which transmits manipulating and actuating forces from the handle
100 to the positioner assembly 400 and driver assembly 300 at the
distal end of the tube assembly 500. Two tubes, outer tube 510 and
medial actuator tube 280, exit handle 100 at its distal end. Outer
tube 510 is affixed by any suitable means to and is substantially
integral with handle housing 112, and housing 112 and outer tube
510 are substantially stationary and skeletal with respect to the
other, moving, parts of the handle 100 and tube assembly 500.
Medial actuator tube 280 both rotates and moves longitudinally with
respect to outer tube 510, in response to input from the surgeon as
will be hereinafter described, and thereby transmits rotational and
longitudinal actuating forces and movement through tube assembly
500.
[0189] In the embodiment shown in FIGS. 4-6, the handle 100 may
comprise a housing 112 having actuating mechanisms disposed therein
as will be hereinafter described. The housing 112 may include two
or more parts, having alignment pins 105 and mating holes to
facilitate assembly and make the parts integral after assembly.
[0190] Housing 112 contains actuating mechanisms to effect
rotational and longitudinal actuating forces and movement in medial
actuator tube 280. Referring to FIG. 5, knob 110 may be an
actuating member for manipulation by a surgeon, and may be adapted
to be pushed distally by the surgeon, and urged back proximally by
knob return spring 150, with respect to housing 112. Knob 110 may
also be adapted to be rotated by the surgeon with respect to
housing 112 by the surgeon. Thus, knob 110 may be rotatable and
movable longitudinally within housing 112, within the limits of
longitudinal travel defined by knob track 116 in housing 112, as
the ends thereof stop longitudinal movement of knob 110 by contact
with knob rim 111. Knob 110 may also be hollow, having guidewire
passage 114 therethrough. Within guidewire passage 114 of knob 110
may be one or more longitudinal spline grooves 115. Spline grooves
115 can slidably mate with one or more splines 185 of proximal
rotation tube 180. Thus, it can be appreciated that knob 110 and
proximal rotation tube 180 may be coupled with respect to
rotational movement, but not coupled with respect to longitudinal
movement and therefore, be longitudinally slidable with respect to
one another. Thus configured, rotation of knob 110 can effect
corresponding rotation of proximal rotation tube 180. In turn,
proximal rotation tube 180 may be fixedly coupled to medial
actuator tube 280. Thus, rotation of knob 110 can effect
corresponding rotation of medial actuator tube 280, while
longitudinal movement of knob 110 will not effect longitudinal
movement of medial actuator tube 280.
[0191] Prior to the firing of the handle assembly as will be
described below, knob 110 may be turned to effect corresponding
rotational movement in medial actuator tube 280, so as to open
driver assembly 300 and positioner assembly 400 as will be
described below.
[0192] FIGS. 5 and 6, depict handle 100 in an uncocked,
pre-deployment position. As will be hereinafter described, one
embodiment of an anchor driver assembly of the present invention
(such as that shown in FIG. 3 at 300) requires longitudinal force
and movement of a member in a proximal direction in order to drive
anchors. This force and movement in a proximal direction may be
effected by handle 100 via medial actuator tube 280. Medial
actuator tube 280 may be drawn in a longitudinally proximal
direction, i.e., rearwardly, into handle 100, through a mechanism
that will now be described.
[0193] A driving spring 160 may be contained within housing 112, in
compression, as shown in FIGS. 5 and 6. The proximal end of driving
spring 160 contacts and acts against the distal end of a proximal
linking tube 140, urging linking tube 140 to move in a proximal
direction with respect to housing 112. The proximal end of linking
tube 140 rotatably and slidably fits around an interior spindle 117
of knob 110 and rests against spindle shoulder 118.
[0194] In the position shown in FIGS. 5 and 6, driving tube 120 is
in a forward, distal position inside housing 112. Driving tube 120
is connected at its distal end to proximal rotation tube 180 via
lip 123, such that proximal rotation tube 180 is free to rotate
within driving tube 120, but by the arrangement shown, driving tube
120 and proximal rotation tube 180 are configured to be linked and
move as a unit in a longitudinal direction. Driving tube 120 may be
prevented from rotating so as not to interfere with actuation of
driving button pawl 205, by one or more pins 128 affixed in housing
112, engaged in driving tube pin slot 129. At the top of FIG. 6, it
can be seen that driving button 202 may be integral with driving
button pawl 205, and driving button 202 and correspondingly driving
button pawl 205 are biased in a counterclockwise direction by
spring 235, such that pawl 205 is biased downward into driving tube
firing slot 210.
[0195] In order the ready the handle depicted in FIGS. 5 and 6 to
effect a longitudinal proximal movement of medial actuator tube 280
(which movement may be used to drive anchors as will be hereinafter
described), a surgeon may depress knob 110 in a longitudinal,
distal direction within housing 112 (to the right with respect to
FIG. 5). As a result of contact between shoulder 118 and the
proximal end of linking tube 140, this movement of knob 112 can
move linking tube 140 a corresponding direction and distance, and
also correspondingly, longitudinally compress and thereby charge
driving spring 160. Linking tube 140 has affixed at its proximal
end one or more driving tube engagers 170, which may be
spring-biased inwardly and have latching ends 171 that protrude
inwardly through slots in linking tube 140 as shown. Upon
longitudinal movement of linking tube 140 in a distal direction as
a result of depressing knob 110, latching ends 171 can moveably
engage and latch upon latching shoulder 126 of driving tube 120,
latching driving tube 120 to linking tube 140 such that the two
will move as a unit in a rearward, proximal longitudinal direction,
in response to force exerted on linking tube 140 by driving spring
160, once driving tube 120 is released as will be described below.
Thus, when a surgeon depresses knob 110 in a distal longitudinal
direction (to the right with respect to FIG. 5, driving spring 160
is charged and the handle is thereby cocked for driving anchors as
will be hereinafter described. After cocking, knob 110 is urged to
return to its proximal (rearward) position by knob return spring
150. Knob return spring 150 and driving spring 160 may be coaxially
aligned and separated by a spring divider 130.
[0196] Driving tube 120 is released and permitted to be driven in a
longitudinal proximal (rearward) direction with respect to housing
112 when the surgeon engages and urges driving button 202 forwardly
(with respect to FIG. 6). This rotates driving button 202 and
correspondingly, pawl 205 clockwise about pin 230, and lifts pawl
205 out of driving tube firing slot 210. Driving tube 120 is
thereby released to be driven rearwardly (to the left with respect
to FIGS. 5 and 6) under the force exerted by driving spring 160,
acting on linking tube 140, linked to driving tube 120 via driving
tube engagers 170. As driving tube 120 is driven rearwardly, it
correspondingly pulls medial actuator tube 280 rearwardly a
corresponding distance, via lip 123. This actuation constitutes
"firing" the handle 100 to pull medial actuator tube 280 in a
longitudinal proximal (rearward) direction into handle 100, which
may be used to drive anchors as will be described below.
[0197] After "firing" of handle 100, it may be desirable to effect
additional longitudinal movement of medial actuator tube 280 so as
to cause further seating of anchors, and afterward, to effect
withdrawal of anchor driver pins from anchors as will be described
below. Referring to FIG. 6, after firing, driving tube retraction
slot 225 in driving tube 120 is moved to a position beneath driving
button pawl 205, and pawl 205, at the urging of torsion spring 235
and/or pressure by the surgeon, moves into retraction slot 225. The
surgeon may then exert proximal and downward pressure (with respect
to FIG. 6) on driving button 202, which will both maintain pawl 205
in retraction slot 225, and also urge pin 230 down and out of
rocker detent 238 in driving button slot 240, enabling the surgeon
to urge driving tube 120 further proximally and thus further drive
anchors a distance allowed by seating extension 220 in driving
button slot 240, and/or further seat anchors into tissues, as will
be described below. This arrangement may also transfer to the
surgeon touch-perceptible feedback through driving button 202 as to
how much pressure is being exerted to drive and seat anchors.
[0198] After driving and seating of anchors, the surgeon may then
effect the withdrawal of anchor driver pins from anchors (as will
be described below) by effecting a return of medial actuator tube
to its original position as will now be described. The surgeon
exerts downward and distally-directed pressure on driving button
202. Such downward pressure maintains pawl 205 in retraction slot
225 and keeps pin 230 out of rocker detent 238, while urging
driving tube 120 distally (to the right with respect to FIG. 6). As
driving tube 120 is urged distally, medial actuator tube 280 is
urged distally a corresponding distance via driving tube lip 123
acting on proximal actuator tube 180, which is affixed to medial
actuator tube 280. This returning motion is limited by the distal
extent of driving button slot 240. When pin 230 reaches this
extent, the surgeon's release of pressure on driving button 202
will permit pin 230 to be urged upwardly (with respect to FIG. 6)
under the force exerted by torsion spring 235 into extension detent
245.
[0199] Following installation of anchors, knob 110 may be turned to
effect corresponding rotational movement in medial actuator tube
280 so as to retract or close driver assembly 300 and positioner
assembly 400 as will be described below.
[0200] It is contemplated that various pieces of the handle
assembly may be an integral structure formed from several
components, or these features may be an integrally molded from a
material such as plastic so as to form a single integral structure.
The handle assembly may be constructed from conventional materials
for surgical instruments, for example a metal such as stainless
steel or plastic. The instrument may be constructed primarily from
conventional metal or plastic materials so that it is inexpensive
to manufacture and can be disposable. The instrument may also be
sold in a package that is presterilized for surgical use.
[0201] Housing 112, driving button 202, spring divider 130 and knob
110 may be formed of plastic or any suitable material having
necessary properties of strength, stiffness and formability. It may
be desirable for spline grooves 115 to be a suitable metal for
improved hardness and wear resistance, such that spline grooves 115
would be part of a metal insert around which knob 110 is formed.
Proximal actuator tube 180, linking tube 140 and driving tube
engagers 170, driving tube 120, medial actuator tube 280 and outer
tube 510 may be formed of stainless steel, plastic or any other
suitable material having necessary properties of strength, hardness
and stiffness. Springs 150, 160 and 235 may be formed of spring
steel or any suitable material that would have suitable
formability, shape memory, stiffness (spring constant) and strength
properties. While proximal actuator tube 180, linking tube 140,
driving tube 120, medial actuator tube 280 and outer tube 510 are
depicted as having tube shapes, they may also have any shape
suitable for transmitting longitudinal and rotational forces and
movement to a distal end as required for an instrument of the
present invention.
[0202] It will be apparent to persons skilled in the art that a
variety of mechanisms might be configured and adapted to transmit
longitudinal (advancement and retraction) and rotational forces and
movement move from a proximal handle assembly to a distal end in
order to effect the forces and movement necessary to actuate an
instrument of the present invention. It will be apparent to persons
skilled in the art that the mechanism that supplies the driving
force supplied by driving spring 160 may also be other biasing or
driving devices including but not limited to levers, gears,
pressurized gases/fluids and any other mechanisms for selectively
deploying linear driving forces known in the art.
[0203] An alternative embodiment for the driving button assembly
shown in FIG. 6 will now be described. Referring to FIGS. 52-54,
driving button 202 is linked to the mechanism by driving button pin
230, captured by driving button pin boss 206. Driving button 202
includes driving button pawl 205, driving pin boss 206, driving
trigger 204 and retraction member 207. Driving button 202 is
angularly movable about driving button pin 230 which is captured by
driving pin boss 206, and driving button pin 230 may slidably ride
in a longitudinal direction with respect to the length of the
instrument, in driving button groove 240, which includes rocker
detent 238. One or more springs 235 are provided which act upon
driving button 202 in two ways: First, to urge driving button 202
upward such that driving button pin 230 is urged upward, in
orientation with respect to FIGS. 52-54, and such that driving pin
230 is urged into rocker detent 238, when driving trigger 204 is
not being depressed; second, to urge driving button 202 in a
counterclockwise direction, such that driving trigger 204 and
driving button pawl 205 are urged in a counterclockwise direction,
about driving button pin 230, with respect to FIGS. 52-54, thus
maintaining driving button pawl 205 engaged with driving tube
retention slot 210. It will be appreciated that a single torsion
spring configured and acting upon driving button 202 in a manner
such as shown in FIG. 6 (torsion spring 235) may be used to
accomplish the desired result, but also, that other suitable spring
or biasing mechanisms or configurations are possible. Driving
button pawl 205 is adapted to engage, alternatively, driving tube
retention slot 210, and driving tube retraction slot 225, of
driving tube 120, in a manner similar to that shown for the driving
button pawl 205 in FIG. 6.
[0204] Operation of the embodiment of driving button assembly shown
in FIGS. 52-54 will now be described. When an instrument such as
driver assembly 300 (FIG. 3) has been loaded with anchors and is in
the retracted position ready for insertion and subsequent use,
driving button assembly 200 will be in the position shown in FIG.
52. Driving button 202 is biased upwardly and in a counterclockwise
direction about driving button pin 230 by one or more springs 235
so that driving button pin 230 is maintained engaged in rocker
detent 238, and driving button pawl 205 is maintained engaged in
driving tube retention slot 210, restraining driving tube 120
against spring bias acting upon driving tube 120 as more fully
described above.
[0205] Once the applier has been inserted and opened to the
position shown in FIG. 14, the driving tube 120 is released and
driven by depressing driving trigger 204. FIG. 53 depicts a
"snapshot" of the positioning of driving button 202 relative to
driving tube 120, after driving trigger 204 is depressed to release
driving tube 120 by disengaging driving button pawl from driving
tube retention slot. With respect to FIG. 53, it can be seen that
downward pressure on driving trigger 204 causes clockwise rotation
of driving button 202 about driving button pin 230, causing driving
button pawl 205 to move upwardly and disengage from driving tube
retention slot 210. Disengagement of driving button pawl 205 from
driving tube retention slot 210 releases driving tube 120,
permitting it to move to the left (with respect to FIGS. 52-54)
under urging of a spring as more fully described above. This drives
driver pins and anchors as more fully described below.
[0206] FIG. 54 illustrates the positioning of driving button 202
relative to driving tube 120, when the mechanism is ready for
retraction of the driver pins from the installed anchors. It will
be appreciated from FIGS. 53 and 54 that continuing downward
pressure exerted by the surgeon on driving trigger 204 urges
driving button pawl 205 downward into driving tube retraction slot
225. At the same time, driving button pin boss 206 is urged
downward, and correspondingly, driving button pin 230 is urged
downward and out of rocker detent 238. When driving button 202 is
in this position, shown in FIG. 54, the surgeon may then engage
retraction member 207 to move driving button 202 to the right (with
respect to FIG. 54), which correspondingly pulls driving tube 120
to the right by engagement of driving button pawl 205 with driving
tube retraction slot 225. In this manner, the driver pins may be
withdrawn from the now-installed anchors as more fully described
below.
[0207] Referring back to FIGS. 3 and 7-9, it may be desirable that
tube assembly 500 be curved and flexible to facilitate insertion
into the patient. Accordingly, it may be desirable to manufacture
certain components of tube assembly 500, including outer tube 510,
medial actuator tube 280, distal rotation tube 580 and central tube
590, of materials that have suitable combined properties of
biocompatibility, strength, stiffness, flexibility, elasticity and
shape memory so as to provide a suitable balance of flexibility to
facilitate insertion, with strength, rigidity and shape memory to
facilitate manipulation to transfer longitudinal and rotational
forces from the handle assembly 100 to the positioner assembly 400
and driver assembly 300. The inventors have found that suitably
treated nitinol, known in the art for having such properties and
used for endoscopic surgical instruments with similar requirements,
is a suitable material. However, other materials such as styrene or
other polymers may be satisfactory for some components.
[0208] FIGS. 7-10 are views of the portion of tube assembly
including a bridge assembly 600. The tube assembly and bridge
assembly provide for isolation and transmission of rotational and
longitudinal advancement and retraction force and movement from
medial actuator tube 280 to a positioner assembly 400 and driver
assembly 300. In one embodiment, medial actuator tube 280 may
rotate, and longitudinally advance and retract within and with
respect to outer tube 510, and is operatively connected to a
positioner assembly 400 and a driver assembly 300, via a bridge
assembly 600. The bridge assembly 600 provides an operative
connection of the medial actuator tube 280 so as to limit
rotational movement, and transmit both limited rotational movement
and longitudinal movement to distal rotation tube 580, and is
adapted to allow an effective amount of rotational and longitudinal
travel. The bridge assembly 600 also provides an operative
connection of the medial actuator tube 280 to central tube 590 so
as to translate longitudinal movement to central tube 590.
[0209] Referring to FIGS. 9 and 10, medial actuator tube 280 has
therein one or more bridge slots 640, and terminates within bridge
assembly 600. Bridge 610 has a hub 650 located within medial
actuator tube 280, and one or more vanes 620, which protrude
through bridge slots 640 in medial actuator tube 280, and
longitudinally ride within one or more longitudinal bridge tracks
670 cut or formed within a bridge guide 660. Bridge guide 660 is
affixed within, and therefore integral with, outer tube 510. Thus,
vanes 620 and therefore bridge 610 may slide longitudinally within
bridge guide 660 and outer tube 510, but are prevented from
rotating.
[0210] It can be appreciated from FIGS. 9 and 10 that the range of
rotation of medial actuator tube 280 with respect to outer tube 510
is limited by the circumferential dimension of bridge slots 640 in
medial actuator tube 280, and contact between the edges of bridge
slots 640 and vanes 620. The circumferential dimension of bridge
slots 640 in actuator tube 280 may be varied according to the range
of rotation that may be required to actuate the instrument.
Longitudinal bridge tracks 670 may be long enough to allow vanes
620 to slide longitudinally to the full range of longitudinal
motion of medial rotation tube 280 that may be required to actuate
the instrument.
[0211] Central tube 590 is affixed within bridge hub 650 and is
integral therewith. Thus, longitudinal motion is translated from
medial actuator tube 280 to bridge vanes 620 and correspondingly
bridge hub 650 via interaction between bridge slots 640 and bridge
vanes 620. Correspondingly, longitudinal motion of bridge hub 650
is translated to central tube 590 because bridge hub 650 and
central tube 590 are integral. Thus, longitudinal motion of medial
actuator tube 280 is translated to corresponding longitudinal
motion of central tube 590.
[0212] At the same time, rotational motion of medial actuator tube
280 is not translated to central tube 590. As noted, central tube
590 is integral with bridge hub 650, and bridge hub 650 is
prevented from rotating by the situation of bridge vanes 620 in
bridge tracks 670, which are, in turn, integral with outer tube
510.
[0213] Referring to FIG. 10, distal rotation tube 580 is affixed
and integral with rotation spacer 288, which, in turn, is affixed
and integral with the distal end of medial actuator tube 280. Thus,
both longitudinal movement and rotation of medial actuator tube 280
are translated directly to corresponding longitudinal movement and
rotation of distal rotation tube 580. As previously noted, however,
the range of rotational movement of medial actuator tube 280 is
limited by the circumferential dimension of bridge slots 640, and
thus, the range of rotational movement of distal rotation tube 580
is correspondingly limited.
[0214] Central tube 590 and distal rotation tube 580 are not
affixed to one another and therefore distal rotation tube 580 may
rotate with respect to central tube 590.
[0215] A funnel guide 606 may be affixed to the proximal end 608 of
central tube 590, thereby providing for ease of feeding a guide
wire upward through medial actuator tube 280 and into central tube
590. Funnel guide 606 would not be affixed to medial actuator tube
280, and would be longitudinally and rotationally movable
therein.
[0216] Distal rotation tube 580 and central tube 590 may be located
within and supported through a bend in the tube assembly by
rotation tube stabilizer 530, a proximal end of which appears at
the right of FIGS. 8 and 10, and the entirety of which appears in
FIG. 7.
[0217] Referring now to FIG. 11-16, the tube assembly is operably
coupled with positioner assembly 400. A proximal positioner mount
410 is affixed and integral with outer tube 510. Distal positioner
mount 440 is affixed and made integral with proximal positioner
mount 410 by positioner mount connector members 412. Thus, proximal
positioner mount 410 and distal positioner mount 440, as made
integral with outer tube 510, provide a stationary reference and
mounting point for moving parts which will now be described.
[0218] Referring to FIGS. 11 and 12, as noted and described above,
central tube 590 may move longitudinally, but may not rotate, with
respect to outer tube 510, and thus, may move longitudinally, but
may not rotate, with respect to proximal positioner mount 410 and
distal positioner mount 440. Central tube 590 is affixed and
integral at its distal end with distal end cap 390. Distal driver
mount 340 is affixed and integral with tabs 392 of distal end cap
390. Proximal driver mount 310 is affixed and made integral with
distal driver mount 340 via driver mount connector members 314.
Thus, distal end cap 390, distal positioner mount 340, driver mount
connector members 314 and proximal driver mount 310 and central
tube 590 are integral and move longitudinally as a unit with
respect to outer tube 510, but may not rotate with respect to outer
tube 510.
[0219] It can be seen from FIGS. 3-14 that guidewire passage 114
leads through the center of handle assembly 100, through tube
assembly 500 (and within medial actuator tube 280), through central
tube 590, through positioner assembly 400 and driver assembly 300
and out distal end cap 390.
[0220] As noted and described above, distal rotation tube 580 may
rotate about central tube 590, in direct correspondence with
rotation of medial actuator tube 280, within a range limited by the
circumferential dimension of bridge slots 640 in medial actuator
tube 280 (see FIGS. 9 and 10). Within driver assembly 300, distal
rotation tube 580 terminates and is integrally affixed to distal
rotation tube collar 394 and gear tube 380. Thus, rotation of
distal rotation tube 580 causes directly corresponding rotation of
gear tube 380. In FIGS. 11 and 12, it can be seen that gear tube
380 resides directly outside distal rotation tube 580 and extends
proximally from distal driver mount 340 to proximal positioner
mount 410. In FIG. 11, it can be seen that clearance within
rotation tube stabilizer 530 is present to permit proximal
longitudinal movement of gear tube 380 thereinto.
[0221] Referring again to FIG. 12, and also FIG. 14, it can be seen
that distal driver gear 360 and proximal driver gear 320 reside
within driver assembly 300. Distal driver gear 360 and proximal
driver gear 320 are coaxial and integrally affixed to gear tube
380. Arcuate slots 361 in distal driver gear 360 and arcuate slots
321 in proximal driver gear 320 accommodate passage of driver mount
connector members 314 therethrough and also permit distal driver
gear 360 and proximal driver gear 320 to rotate within a limit
about the axis of gear tube 380 without interference from driver
mount connector members 314.
[0222] Referring to FIG. 11, distal positioner gear 460 and
proximal positioner gear 420 reside within positioner assembly 400.
Distal positioner gear 460 and proximal positioner gear 420 are
coaxial with, and longitudinally splined with, gear tube 380, such
that distal positioner gear 460 and proximal positioner gear 420
are coupled with gear tube 380 with respect to rotation, but
uncoupled with respect to relative longitudinal motion. Thus, gear
tube 380 may move longitudinally within positioner assembly 400,
without effecting corresponding longitudinal movement of positioner
assembly 400 or any parts thereof. Arcuate slots 461 in distal
driver gear 460 and arcuate slots 421 in proximal driver gear 420
accommodate passage of driver mount connector members 412
therethrough and also permit distal positioner gear 460 and
proximal positioner gear 420 to rotate within a limit about the
axis of gear tube 380 without interference from positioner mount
connector members 412.
[0223] Thus, it can be appreciated from the description above that
rotating medial actuator tube 280 correspondingly rotates distal
rotation tube 580 and gear tube 380, and finally, distal driver
gear 360, proximal driver gear 320, distal positioner gear 460 and
proximal positioner gear 420. It also may be seen that longitudinal
movement of central tube 590 with respect to outer tube 510 causes
corresponding longitudinal movement of driver assembly 300 with
respect to outer tube 510, but not longitudinal movement of
positioner assembly 400 with respect to outer tube 510.
[0224] Referring now to FIGS. 11, 13 and 14, distal positioner
pinions 462 are integral with and may rotate about pinion shafts
(not shown) which are rotatably supported in distal positioner
mount 440. Distal positioner pinions 462 mesh with distal
positioner gear 460, and may be driven thereby. Distal positioner
pinions 462 are also integral with distal positioner arms 470.
Similarly, proximal positioner pinions 422 are integral with and
may rotate about pinion shafts (not shown) which are rotatably
supported in proximal positioner mount 410. Proximal positioner
pinions 422 mesh with proximal positioner gear 420, and may be
driven thereby. Proximal positioner pinions 422 are also integral
with proximal positioner arms 430.
[0225] Thus, referring to FIGS. 11, 13 and 14, it can be seen that
rotation of distal rotation tube 580 correspondingly rotates gear
tube 380, and thus, distal and proximal positioner gears 460 and
420, which, in turn, drive distal and proximal positioner pinions
462 and 422, causing positioner arms 470 and 430 to either swing
outwardly (toward a position shown in FIG. 14) or inwardly (toward
a position shown in FIG. 13). It will be appreciated that the
position shown in FIG. 13 is the position in which positioner
assembly 400 would be placed during insertion into and retraction
from a patient. It will be further appreciated that the position
shown in FIG. 14 is the position in which positioner assembly 400
is ready for use for bringing the bladder wall surrounding the
bladder opening into contact with the pelvic floor, as will be
further described below. Finally, it will be appreciated from the
description set forth above (and referring also to FIGS. 8-10),
that the limits of the rotational motion of gear tube 380 required,
alternately, to extend or retract arms 470 and 430 of positioner
assembly 400, are defined by the circumferential dimension of
bridge slots 640 in medial rotation tube 280 and their interaction
with bridge vanes 620.
[0226] Referring now to FIGS. 12-16, distal driver pinions 362 are
integral with pinion shafts 316, which are rotatably supported in
distal driver mount 340. Distal driver pinions 362 mesh with distal
driver gear 360, and may be driven thereby. Distal driver pinions
362 are also integral with distal driver arms 370, which, in turn,
are integral with driver pins 376. Similarly, proximal driver
pinions 322 are integral with pinion shafts 316, which are
rotatably supported in proximal driver mount 310. Proximal driver
pinions 322 mesh with proximal driver gear 320, and may be driven
thereby. Proximal driver pinions 322 are also integral with
proximal driver arms 330, which, in turn, are integral with
additional driver pins 376.
[0227] Thus, referring to FIGS. 12-16, it can be seen that rotation
of distal rotation tube 580 correspondingly rotates gear tube 380,
and thus, distal and proximal driver gears 360 and 320, which, in
turn, drive distal and proximal driver pinions 362 and 322, causing
driver arms 370 and 330 to either swing outwardly (toward a
position shown in FIG. 14) or inwardly (toward a position shown in
FIG. 13). It will be appreciated that the position shown in FIG. 13
is the position in which driver assembly 300 would be placed during
insertion into and retraction from a patient. It will be further
appreciated that the position shown in FIG. 14 is the position in
which driver assembly 300 is ready for driving anchors, as will be
further described below. Finally, from the description set forth
above (and referring also to FIGS. 8-10), it will be appreciated
that the limits of the rotational motion of gear tube 380 required,
alternately, to extend or to retract arms 370 and 330 of driver
assembly 300, are defined by the circumferential dimension of
bridge slots 640 in medial rotation tube 280 and their interaction
with bridge vanes 620.
[0228] Referring to FIG. 14, one or more driver pins 376 are
affixed to driver arms 330 and 370. Each of the one or more driver
pins 376 are adapted to retain anchors 700 having anchor heads 710,
for example, by friction fit or other suitable means. Anchors 700
may have hollow bores within, opening at their heads 710, and
extending substantially within their lengths, and driver pins 376
may extend within such bores substantially the entire lengths
thereof, so that the distal ends of driver pins 376 drive anchors
700 at their forward ends, so as to prevent anchors 700 from
buckling or veering off-direction as they might otherwise do if
driven at their rearward ends proximate to heads 710.
[0229] Still referring to FIGS. 10-14, longitudinal force and
movement may be translated to the driver arms 370 to, alternately,
drive anchors 700 into tissues, and withdraw driver pins 376 from
anchors 700 after they are installed into tissues, as follows. As
previously noted and described, longitudinal force and movement is
translated directly from medial actuator tube 280 to central tube
590 via bridge assembly 600. As noted, central tube 590 is integral
with distal end cap 390, distal driver mount 340, driver mount
connector member 314 and proximal driver mount 310. Because driver
arms 330 and 370 are operably mounted within driver mounts 310 and
340, longitudinal force and movement exerted via medial actuator
tube 280, translated to central tube 590, is also translated
directly to longitudinal force and movement of driver arms 330 and
370 (and entire driver assembly 300), and thus to driver pins 376
and anchors 700. As can be appreciated from the description above,
gear tube 380 will be moved longitudinally in correspondence with
longitudinal movement of central tube 590 and driver assembly 300.
As noted, gear tube 380 is permitted to longitudinally move
relative to and through positioner assembly 400 by means of
longitudinal splines coupling gear tube 380 with proximal and
distal positioner gears 420 and 460, without effecting
corresponding longitudinal movement thereto.
[0230] It will be appreciated that sufficient proximal longitudinal
movement should be provided and translated to driver arms 330 and
370 and driver pins 376 by the mechanism described above so as to
carry and drive anchors 700 past positioner assembly 400 and into
the target tissues. The advancement/retraction longitudinal travel
distance of the driver assembly 300 can be generally greater than
the length of the anchors 700 in order to move the anchors past the
positioner and fully seat the anchors into the target tissues. In
the embodiment shown and described thus far, the position of the
anchors when installed in the tissues may be substantially parallel
with the longitudinal axis of the driver assembly 300, but the
position of the anchors may also be at an angle therewith.
Additionally, in the embodiment shown and described thus far, the
anchors may enter the target tissues substantially perpendicular
with them, as they are held by positioner assembly 400.
[0231] It is also contemplated that various integral components of
the positioner and driver assemblies described above may be formed,
molded or machined as a unitary, continuous structure. For example,
driver arms 330 and 370 may be unitary and continuous with driver
pins 376, rather than be assembled pieces.
[0232] Referring now to FIGS. 3 and 31-38, a surgeon may use the
embodiment just described in a retrograde direction in the
following manner. The driver assembly 300 may be loaded with one or
more anchors 700, as may be required, prior to use. The instrument
may then be inserted into the urethra and advanced in a retrograde
direction until the distal end of the instrument 10 is through the
urethra 5 (FIG. 31), through the bladder opening 4, and the driver
assembly 300 and positioner assembly 400 are inside the bladder
lumen 8.
[0233] After insertion into the bladder 1, instrument 10 may be
initially actuated by rotating knob 110 to open the positioner and
driver assemblies to the initial -deployment position as shown in
FIG. 32 (see also FIG. 14). The entire instrument may then be
retracted by pulling handle 100 in a proximal direction downwardly
through the urethra 5, bringing the opened positioner assembly into
contact with the bladder wall 2 surrounding the bladder opening 4,
and urging bladder wall 2 surrounding bladder opening 4 into
contact with pelvic floor 7 surrounding urethra opening 6, with the
respective openings 4 and 6 aligned, as shown in FIG. 33. Once in
position, the instrument may then be prepared for further actuation
by cocking the handle mechanism by depressing knob 110 as described
above. Next, it may be further actuated to drive anchors 700 by
depressing driving button 202, which will actuate the mechanism in
handle assembly 100 previously described so as to pull driver
assembly 300 in a proximal direction with respect to positioner
assembly 400, driving anchors 700 into and through the bladder wall
2 and into the underlying pelvic floor 7, in positions surrounding
the aligned openings 4 and 6, to positions shown in FIG. 34. As
noted above, using driving button 202, the surgeon may then desire
to further actuate the handle assembly 100 to further seat anchors
700 into the tissues. Next, still using driving button 202 as
described above, the surgeon may push driver assembly 300 in a
distal direction, withdrawing driver pins 376 from the installed
anchors 700, to the position shown in FIG. 35. Finally, knob 110
may be rotated again to re-close driver assembly 300 and positioner
assembly 400 to the position shown in FIG. 36. In the closed
position, the instrument 10 can then be withdrawn back out of the
urethra 5. Optionally, prior to withdrawal of the instrument from
the urethra, a guide wire 80 may be inserted through the instrument
(via a guide wire passage) and into the bladder lumen, and left
behind for use described below after withdrawal of the instrument,
see FIGS. 36 and 37.
[0234] Referring to FIG. 38, guide wire 80 may then be used to
guide a balloon catheter system 90 into the bladder lumen 8. As
shown in FIG. 38, one embodiment provides for a balloon catheter
system 90 wherein a balloon 94 is expanded to hold the catheter in
place. Drainage holes 92 allow urine to drain from the bladder 1
through a catheter tube 96 into a urine collection bag 98.
[0235] In another embodiment of the present invention, referring to
FIGS. 3 and 4, the actuator knob 110 is depressed first to cock the
actuator. Then the actuator knob is rotated causing a concurrent
rotation of the distal rotation tube, which thereby opens the
positioner and driver arms, and the anchors, to a distance of
approximately 2-8 mm out and parallel with the longitudinal axis of
the driver assembly.
[0236] It can be appreciated by one skilled in the art that the
positioner and driver assemblies may have alternate configurations
providing an instrument adapted to for use in a retrograde manner
as described above, or in an antegrade manner.
[0237] It can be appreciated by one skilled in the art that the
positioner assembly may have a variety of alternative
configurations including but not limited to embodiments described
herein (and thus including, without limitation, shuttlecock
assembly 800 with positioner petals 830 (FIGS. 17-21), umbrella
assembly 900 with reverse positioner petals 930 (FIGS. 22-27),
positioner assembly 1440 with positioner arms 1441 (FIGS. 56-64;
70, 71, 77, 78), or positioner 2017 (FIGS. 122-126), 2090 (FIGS.
110-118), 2122 (FIGS. 95, 96, 103-109) and 2168 (FIGS. 83, 84,
89-94) (all of which are described below)), providing an
alternately retractable and transversely extendible device useful
for, referring to FIG. 2, insertion in a retracted position in a
retrograde direction through the urethra 5 and into bladder opening
4, extending or expanding within bladder lumen 8, catching in
bladder opening 4 and manipulating to urge bladder wall 2
surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned;
or alternatively, insertion in a retracted position in an antegrade
direction through an incision in the abdomen and an upper surface
of the bladder 1, extending or expanding within bladder lumen 8,
catching in bladder opening 4 and manipulating to urge bladder wall
2 surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned.
Generally, the positioner assembly may comprise and make use of any
number of alternately extendable and retractable projections,
petals, arms, claws, or other grasping or catching members for
catching and gaining control of bladder wall 2 surrounding bladder
opening 4. The positioner assembly may have at least one member
operably connected to a longitudinal member of the instrument and
alternately transversely extendable from and retractable toward the
longitudinal axis thereof in response to input by a surgeon at a
proximal end of the instrument.
[0238] Alternatively, it can be appreciated by one skilled in the
art that when an anchor driver assembly is included with the
instrument that is functional to open and subsequently drive
anchors through the bladder wall and into the pelvic floor as
described herein, the positioner assembly or positioner as shown
may be dispensed with in some circumstances. For example, referring
to FIGS. 32 and 33, it can be appreciated that driver assembly 300,
when opened and drawn downwardly until the distal ends of anchors
700 contact and possibly puncture bladder wall 2 surrounding
bladder opening 4, can be sufficient for use in capturing bladder
wall 2 and drawing it downward into contact with, and securing it
to, pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, without the need for positioner assembly 400 as shown, in
some circumstances. Thus, driver assembly 300 with anchors 700 may
serve a dual function as a positioner and as an anchor driver
assembly.
"Shuttlecock" Embodiment
[0239] FIGS. 17-21 illustrate another embodiment of a method and
apparatus of the invention. As shown in FIGS. 17-19, a
"shuttlecock" assembly 800 is provided. (As used herein, the term
"shuttlecock" is only used for convenient reference to the present
embodiment described, because as depicted in the drawings it bears
some resemblances to a shuttlecock. The term is not, however,
intended to connote any limitations, concerning appearance or
otherwise. Those skilled in the art will appreciate that an
instrument incorporating the features and functions described may
or may not bear resemblances to a shuttlecock.) Affixed at the
distal end of central tube 590 is distal end cap 390. Central tube
590 may be located within positioner petal retainer actuator tube
810, and positioner petal retainer actuator tube 810 may be located
within driver pin actuator tube 820, and it can be appreciated from
FIGS. 17 and 18 that the three tubes 590, 810 and 820 may be
substantially coaxial. Tubes 590, 810 and 820 can also be
longitudinally movable with respect to each other.
[0240] Driver pins 376 may be affixed at one end to the distal end
of driver pin actuator tube 820. Driver pins 376 may be made of
spring wire or other suitable material having shape memory, and may
include shorter lengths affixed to the distal end of driver pin
actuator tube 820, bends 377, and greater lengths which receive
detachable hollow anchors 700. Prior to use of the instrument,
anchors 700 may be loaded onto driver pins 376, and may be
releasably held thereon by friction fit or any other suitable
means. When assembly 800 is in the retracted position shown in FIG.
17, the greater lengths of driver pins 376 may be held in a
retracted position lying substantially along tube 820 as shown.
When assembly 800 is in the opened position shown in FIG. 19, the
spring bias in bends 377 of driver pins 376 can cause the greater
lengths and free ends of driver pins 376, and correspondingly,
anchors 700 on driver pins 376, to move outwardly to the opened
position shown. Anchors 700 may have hollow bores within, opening
at their heads 710, and extending substantially within their
lengths, and driver pins 376 may extend within such bores
substantially the entire lengths thereof, so that the distal ends
of driver pins 376 may apply driving force proximate to the forward
ends of anchors 700, so as to prevent anchors 700 from buckling or
veering off-direction as they might otherwise do if driven at their
rearward ends proximate to heads 710.
[0241] Each of positioner petals 830 may be affixed at one end to
distal end cap 390. Positioner petals 830 may be made of a spring
metal or other suitable material having shape memory, biased so as
to spring outwardly to the opened position shown in FIG. 19 when
unrestrained, or may simply ride passively on top of driver pins
376 and anchors 700, being flexibly affixed or hinged to distal end
cap 390. When assembly 800 is in the retracted position shown in
FIG. 17, positioner petals 830 lie in a retracted position as
shown, to the outside of driver pins 376 and anchors 700. When
assembly 800 is in the opened position shown in FIG. 19, the tips
835 of positioner petals 830 have been moved outwardly to an opened
position shown, wherein the angle formed by the lengths of
positioner petals 830 and the axis of tubes 590, 810 and 820 may be
approximately 15 degrees.
[0242] When assembly 800 is in the retracted position shown in FIG.
17, positioner petals 830, and driver pins 376 and anchors 700, may
be retained against the urging of the spring bias in driver pins
376, by positioner petal retainer 860. As shown in FIG. 18,
positioner petal retainer 860 is connected to and made integral
with positioner petal retainer actuator tube 810 by positioner
petal retainer braces 862. As noted above, positioner petal
retainer actuator tube 810 is longitudinally movable with respect
to central tube 590 and driver pin actuator tube 820.
[0243] As shown in FIG. 19, driver pins 376 and positioner petals
830 are allowed to move to their opened positions when positioner
petal retainer 860 is moved upwardly toward distal end cap 390 (see
also FIG. 29). Because positioner petal retainer 860 is integral
with positioner petal retainer actuator tube 810 via positioner
petal retainer braces 862, pushing positioner petal retainer
actuator tube 810 toward distal end cap 390, while holding central
tube 590 and driver pin actuator tube 820 stationary, moves
positioner petal retainer 860 toward distal end cap 390, releasing
and allowing positioner petals 830 and driver pins 376 and anchors
700 to open to the position shown in FIG. 19 (see also FIGS. 28,
29). It can be understood from FIG. 18 that the positioning of
positioner petal retainer braces 862 between the separate
positioner petals 830 permits this relative motion.
[0244] As may be seen in FIG. 17, the entire shuttlecock assembly
800, including the central tube 590, positioner petal retainer
actuator tube 810 and driver pin actuator tube 820, are carried by
the outer tube 510 and centered therein by the outer tube end
collar 805. It will be understood by those skilled in the art that
tubes 590, 810, 820 and 510 may be held stationary and/or
selectively longitudinally moved with respect to each other by any
suitable proximal actuating mechanism.
[0245] Use and operation of this embodiment to perform anastomosis
in a retrograde manner to join a patient's bladder and urethra
following radical prostatectomy will now be described. Referring to
FIG. 2 for anatomical reference, shuttlecock assembly 800 (in a
retracted position such as shown in FIG. 17) is inserted into the
patient's urethra, and guided up through the urethra 5, through
bladder opening 4, and into the bladder lumen 8, to a fully
inserted position whereby shuttlecock assembly 800 may be opened
within the bladder as will be hereinafter described.
[0246] Once assembly 800 is in the fully inserted position,
referring back to FIGS. 17 and 19, positioner petals 830 and driver
pins 376 with anchors 700 are opened by pushing positioner petal
retainer actuator tube 810 toward distal end cap 390 while holding
central tube 590 and driver pin actuator tube 820 stationary.
Positioner petal retainer 860, being integral with positioner petal
retainer actuator tube 810 via positioner petal retainer braces
862, is thus moved toward distal end cap 390, which in turn allows
positioner petals 830 and driver pins 376 with anchors 700 to
spring outwardly into the opened position as shown in FIG. 19.
[0247] Again referring to FIG. 2 for anatomical reference, the
entire assembly 800, now in the opened position within the
patient's bladder, is then pulled toward the urethra opening 6 by
withdrawing tubes 590, 810, 820 and 510, together, back down
through the urethra. This brings positioner petal tips 835 into
contact with the inside of the bladder wall 2 at positions about
bladder opening 4, and urges bladder wall 2 surrounding bladder
opening 4 toward pelvic floor 7 surrounding urethra opening 6,
bringing these tissues into contact with openings 4 and 6
aligned.
[0248] Once the bladder wall 2 and pelvic floor 7 are brought into
contact, the next step is to drive anchors 700, by retracting
driver pin actuator tube 820 while holding the remaining tubes 590
and 810 stationary. Retracting driver pin actuator tube 820 causes
affixed driver pins 376 to drive anchors 700 into and through
bladder wall 2, as shown in FIG. 20, and then into pelvic floor 7,
as shown in FIG. 21. It will be appreciated that barbs 730 on
anchors 700 cause anchors 700 to lodge in pelvic floor 7, and that
heads 710 on anchors 700 act to retain bladder wall 2 in a position
in contact with pelvic floor 7, such that bladder opening 4 is held
in communication with urethra opening 6.
[0249] As with the first embodiment described herein, optionally,
prior to withdrawal of the instrument from the urethra, a guide
wire may be inserted through the instrument (via a guide wire
passage) and into the bladder lumen, and left behind for use
described above after withdrawal of the instrument, see FIGS. 37
and 38.
[0250] The sequence of steps described above is then reversed to
enable withdrawal of the shuttlecock instrument 800 from the
patient. Driver pin actuator tube 820 is pushed while holding
remaining tubes 590 and 810 stationary, causing driver pins 376 to
withdraw from anchors 700, which are now lodged in pelvic floor 7
through bladder wall 2. The entire assembly 800, still in the
opened position inside bladder lumen 8, is then pushed slightly
further into the bladder lumen and away from the urethra by pushing
tubes 590, 810, 820 and 510, together, back upwardly. The
instrument 800 is then brought into a closed position by retracting
positioner petal retainer actuator tube 810 while holding central
tube 590 and driver pin actuator tube 820 stationary. Positioner
petal retainer 860, being integral with positioner petal retainer
actuator tube 810 via positioner petal retainer braces 862, is thus
moved in a proximal direction to a position away from distal end
cap 390, which in turn urges positioner petals 830 and driver pins
376 inwardly into the retracted position (but now without anchors
700) as shown in FIG. 17. In a retracted position, the entire
assembly 800 may then be withdrawn downwardly through the urethra
and out of the patient.
[0251] It can be appreciated by one skilled in the art that the
shuttlecock assembly described above may be in alternate
configurations providing an instrument adapted for use in a
retrograde manner as described above, or an antegrade manner.
[0252] It can be appreciated by one skilled in the art that the
mechanism comprising the positioner petals and performing the
bladder positioning function thereof may have a variety of
alternative configurations including but not limited to embodiments
described herein (and thus including, without limitation, the
positioner assembly 400 described above (FIGS. 11, 13-14), umbrella
assembly 900 with reverse positioner petals 930 (FIGS. 22-27),
positioner assembly 1440 with positioner arms 1441 (FIGS. 56-64;
70, 71, 77, 78), or positioner 2017 (FIGS. 122-126), 2090 (FIGS.
110-118), 2122 (FIGS. 95, 96, 103-109) and 2168 (FIGS. 83, 84,
89-94) (all of which are described below), providing a transversely
retractable and extendible device useful for, referring to FIG. 2,
insertion in a retracted position in a retrograde direction through
the urethra 5 and into bladder opening 4, extending or expanding
within bladder lumen 8, catching in bladder opening 4 and
manipulating to urge bladder wall 2 surrounding bladder opening 4
into contact with pelvic floor 7 surrounding urethra opening 6 with
the respective openings aligned; or alternatively, insertion in a
retracted position in an antegrade direction through an incision in
the abdomen and an upper surface of the bladder 1, extending or
expanding within bladder lumen 8, catching in bladder opening 4 and
manipulating to urge bladder wall 2 surrounding bladder opening 4
into contact with pelvic floor 7 surrounding urethra opening 6 with
the respective openings aligned. Generally, the positioner assembly
may comprise and make use of any number of alternately extendable
and retractable projections, petals, arms, claws, or other grasping
or catching members for catching and gaining control of bladder
wall 2 surrounding bladder opening 4. The positioner assembly may
have at least one member operably connected to a longitudinal
member of the instrument and alternately transversely extendable
from and retractable toward the longitudinal axis thereof in
response to input by a surgeon at a proximal end of the
instrument.
[0253] Alternatively, it can be appreciated by one skilled in the
art that when an anchor driver assembly is included with the
instrument, that is functional to open and subsequently drive
anchors through the bladder wall and into the pelvic floor as
described herein, the positioner assembly or positioner petals as
shown may be dispensed with in some circumstances. For example,
referring to FIGS. 20 and 21, it can be appreciated that anchor
driver pins 376 and anchors 700, when opened within the bladder
lumen and drawn downwardly until the distal ends of anchors 700
contact and possibly puncture bladder wall 2 surrounding bladder
opening 4, can be sufficient for use in capturing bladder wall 2
and drawing it downward into contact with, and securing it to,
pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, without the need for positioner petals 830 as shown, in
some circumstances. Thus, driver pins 376 with anchors 700 may
serve a dual function as a positioner and as an anchor driver
assembly.
"Umbrella" Embodiment
[0254] FIGS. 22-27 illustrate another embodiment of the method and
apparatus of the invention. As shown in FIGS. 22-25, an "umbrella"
assembly 900 is provided. (As used herein, the term "umbrella" is
only used for convenient reference to the present embodiment
described, because as depicted in the drawings it bears some
resemblances to an umbrella. The term "umbrella" is not, however,
intended to connote any limitations, concerning appearance or
otherwise. Those skilled in the art will appreciate that an
instrument incorporating the features and functions described may
or may not bear resemblances to an umbrella.) Affixed at the distal
end of central tube 590 is distal end cap 390, and central tube 590
and distal end cap 390 are integral. Central tube 590 may be
located within driver pin spreader tube 893, and driver pin
spreader tube 893 is located within reverse positioner petal tube
935, and it can be appreciated from FIG. 22 that the three tubes
590, 893 and 935 may be substantially coaxial. Tubes 590, 893 and
935 can be also longitudinally movable with respect to each
other.
[0255] Driver pins 376 having bases 395 are affixed to end cap 390.
Driver pins 376 may be made of spring wire or other suitable
material having shape memory, and include lengths and free ends
that receive detachable hollow anchors 700. Prior to use of the
instrument, hollow anchors 700 may be loaded onto driver pins 376,
and releasably held thereon by friction fit or any other suitable
means. When assembly 900 is in the retracted position shown in FIG.
22, the greater lengths of driver pins 376 may be held in a
retracted position substantially parallel with the axis of tubes
590, 893 and 935, by spring bias or shape memory in driver pins
376. When assembly 900 is in the fully opened position shown in
FIG. 25, the lengths and free ends of driver pins 376 have been
urged outwardly to an opened position as shown. Anchors 700 may
have hollow bores within, opening at their heads 710, and extending
substantially within their lengths, and driver pins 376 may extend
within such bores substantially the entire lengths thereof, so that
the distal ends of driver pins 376 may apply driving force
proximate to the forward ends of anchors 700, so as to prevent
anchors 700 from buckling or veering off-direction as they might
otherwise do if driven at their rearward ends proximate to heads
710.
[0256] As may be appreciated by comparing FIGS. 24 and 25, driver
pins 376 with anchors 700 are moved from the retracted position to
the opened position by movement of driver pin spreader 890 toward
distal end cap 390. Driver pin spreader is hollow and integral with
driver pin spreader tube 893, and may move longitudinally with
respect to central tube 590 and reverse positioner petal tube 935.
Thus, as driver pin spreader tube 893 is moved toward distal end
cap 390, angled upper spreader face 891 of driver pin spreader 890
urges anchors 700 and correspondingly, driver pins 376, radially
outwardly to the opened position shown in FIG. 25.
[0257] As may be seen in FIGS. 23 and 24, reverse positioner petals
930 are integral with reverse positioner petal tube 935. Reverse
positioner petals 930 are made of spring metal or other suitable
material having shape memory, and are biased to assume the opened
position shown in FIG. 24. Thus, pushing reverse positioner petal
tube 935 toward distal end cap 390 while holding the other tubes
590, 893 and 510 stationary pushes positioner petals 930 out of
outer tube 510 through outer tube end collar 805 and allows them to
open to their biased positions shown in FIGS. 24 and 25.
[0258] As may be seen in FIG. 22, the entire umbrella assembly 900,
including the central tube 590, driver pin spreader tube 893 and
reverse positioner petal tube 935, are carried by the outer tube
510 and centered therein by the outer tube end collar 805. It will
be understood by those skilled in the mechanical design arts that
tubes 590, 893, 935 and 510 may be held stationary or selectively
longitudinally moved with respect to each other by any suitable
proximal actuating mechanism.
[0259] Use and operation of this embodiment to perform anastomosis
to join a patient's bladder and urethra following radical
retropubic prostatectomy will now be described. Referring to FIG. 2
for anatomical reference, umbrella assembly 900 (in retracted
position as shown in FIG. 22) is inserted into the patient's
urethra, and guided up through the urethra 5, and into bladder
lumen 8 through bladder opening 4, to a fully inserted position
whereby umbrella assembly 900 may be opened within the bladder
lumen as will be hereinafter described.
[0260] Once assembly 900 is in the fully inserted position,
referring back to FIGS. 22 and 24, reverse positioner petals 930
are extended and opened by pushing reverse positioner petal tube
935 toward distal end cap 390 while holding central tube 590 and
driver pin spreader tube 893 stationary. Next, referring to FIGS.
24 and 25, driver pins 376 with anchors 700 are opened by pushing
driver pin spreader tube 893 toward distal end cap 390 while
holding central tube 590 and reverse positioner petal tube 935
stationary. Thus assembly 900 is brought into the fully opened
position shown in FIG. 25.
[0261] Again referring to FIG. 2 for anatomical reference, the
entire assembly 900, now in the fully opened position within
bladder lumen 8, is then pulled toward urethra opening 6 by
withdrawing all tubes 590, 893, 935 and 510, together, back down
through the urethra. This brings reverse positioner petals 930 into
contact with bladder wall 2 at positions about bladder opening 4,
and urges bladder wall 2 toward and into contact with pelvic floor
7 about urethra opening 6, with the respective openings 4 and 6
aligned.
[0262] Once the bladder wall and pelvic floor are brought into
contact, the next step is to drive anchors 700, by pulling central
tube 590 while holding the remaining tubes 893 and 935 stationary.
Pulling central tube 590 causes driver pins 376 to drive anchors
700 into and through bladder wall 20, and then into pelvic floor 7,
as shown in FIG. 26. It will be appreciated that barbs 730 on
anchors 700 cause anchors 700 to lodge in pelvic floor 7, and that
heads 710 on anchors 700 act to retain bladder wall 20 in a
position in contact with pelvic floor 7, such that bladder opening
4 is held in communication with urethra opening 6.
[0263] As with the first embodiment described herein, optionally,
prior to withdrawal of the instrument from the urethra, a guide
wire may be inserted through the instrument (via a guide wire
passage) and into the bladder lumen, and left behind for use
described above after withdrawal of the instrument, see FIGS. 37
and 38.
[0264] The sequence of steps described above is then reversed to
enable withdrawal of the umbrella instrument 900 from the patient.
Central tube 590 is pushed while holding the remaining tubes 893
and 935 stationary, causing driver pins 376 to withdraw from
anchors 700, which are now lodged in pelvic floor 7 through bladder
wall 2. The entire assembly 900, still in the opened position
inside the patient's bladder, is then pushed slightly further into
the bladder and away from the urethra by pushing tubes 590, 893,
935 and 510, together, back into the urethra. The instrument 900 is
then brought into the retracted position as follows: Pulling driver
pin spreader tube 893 while holding central tube 590 and reverse
positioner petal tube 935 stationary moves driver pin spreader 890
from the position shown in FIG. 25 to the position shown in FIG.
24, allowing driver pins 376 to return to their normally biased,
retracted positions shown in FIG. 24 (but now without anchors 700).
Next, pulling reverse petal tube 935 while holding central tube 590
and driver pin spreader tube 893 stationary withdraws reverse
positioner petals 930 from their normally biased, opened positions
shown in FIG. 24, to their retracted positions inside outer tube
510, shown in FIG. 22. In the retracted position shown in FIG. 22,
the assembly 900 may then be withdrawn downwardly through the
urethra and out of the patient.
[0265] It can be appreciated by one skilled in the art that the
positioner assembly may be in alternate configurations providing an
applier adapted to for use in a retrograde manner as describe
above, or an antegrade manner.
[0266] It can be appreciated by one skilled in the art that the
mechanism comprising the positioner petals and performing the
bladder positioning function thereof may have a variety of
alternative configurations including but not limited to embodiments
described herein (and thus including, without limitation, the
positioner assembly 400 (FIGS. 11, 13, 14) or shuttlecock assembly
800 with positioner petals 830 (FIGS. 17-21) described above,
positioner assembly 1440 with positioner arms 1441 (FIGS. 56-64;
70, 71, 77, 78), or positioner 2017 (FIGS. 122-126), 2090 (FIGS.
110-118), 2122 (FIGS. 95, 96, 103-109) and 2168 (FIGS. 83, 84,
89-94) (all of which are described below)), providing a
transversely retractable and extendible device useful for,
referring to FIG. 2, insertion in a retracted position in a
retrograde direction through the urethra 5 and into bladder opening
4, extending or expanding within bladder lumen 8, catching in
bladder opening 4 and manipulating to urge bladder wall 2
surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned;
or alternatively, insertion in a retracted position in an antegrade
direction through an incision in the abdomen and an upper surface
of the bladder 1, extending or expanding within bladder lumen 8,
catching in bladder opening 4 and manipulating to urge bladder wall
2 surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned.
Generally, the positioner assembly may comprise and make use of any
number of alternately extendable and retractable projections,
petals, arms, claws, or other grasping or catching members for
catching and gaining control of bladder wall 2 surrounding bladder
opening 4. The positioner assembly may have at least one member
operably connected to a longitudinal member of the instrument and
alternately transversely extendable from and retractable toward the
longitudinal axis thereof in response to input by a surgeon at a
proximal end of the instrument.
[0267] Alternatively, it can be appreciated by one skilled in the
art that when an anchor driver assembly is included with the
instrument, that is functional to open and subsequently drive
anchors through the bladder wall and into the pelvic floor as
described herein, the positioner assembly or positioner petals as
shown may be dispensed with in some circumstances. For example,
referring to FIGS. 25 and 26, it can be appreciated that anchor
driver pins 376 and anchors 700, when opened within the bladder
lumen and drawn downwardly until the distal ends of anchors 700
contact and possibly puncture bladder wall 2 surrounding bladder
opening 4, can be sufficient for use in capturing bladder wall 2
and drawing it downward into contact with, and securing it to,
pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, without the need for reverse positioner petals 930 as
shown, in some circumstances. Thus, driver pins 376 with anchors
700 may serve a dual function as a positioner and as an anchor
driver assembly.
Balloon/Harness Embodiment
[0268] FIGS. 55-64 depict another embodiment of a method and
instrument in accordance with the present invention (shown in an
antegrade configuration), the instrument having a handle assembly
1100, a straight tube assembly 1200, a curved tube assembly 1300,
and an end effector assembly 1400. In one embodiment of the present
invention, instrument 1000 may be endo-scopically inserted into the
abdominal cavity of a patient to effect an anastomosis between the
urethra and bladder of a patient, thereby re-establishing the fluid
connection between bladder 1 and the urethra 5.
[0269] FIG. 56 depicts curved tube assembly 1300 and end effector
assembly 1400 after insertion into the bladder lumen 8 of a patient
through an opening in the abdomen and upper surface of the bladder
(not shown). The openings may be made, and abdominal insertion of
the instrument may be accomplished by, for example, inserting a
cannula with a trocar (not shown) into the abdomen and guiding it
to and through an upper surface of the bladder in a generally
antegrade direction, withdrawing the trocar, and inserting the
instrument through the cannula and into the bladder lumen. Curved
tube assembly 1300 may be flexible and may be provided with a bias
at a bend angle (from about approximately 55 degrees to about
approximately 90 degrees may be suitable) to provide curvature that
may be desirable for inserting end effector assembly 1400 into the
urethra 5 and actuating the instrument in an antegrade procedure.
The bend angle of curved tube assembly 1300 may vary depending upon
the particular needs of the procedure or surgeon utility.
[0270] FIG. 57 depicts end effector assembly 1400 with opened
positioner arms 1441 inside the bladder lumen 8. Following the
insertion of balloon assembly 1410 into bladder opening 4, distal
positioner tube 1445 has been moved downwardly and distally,
causing positioner arms 1441 to open to positions transverse to the
longitudinal axis of end effector assembly 1400. Positioner arms
1441 are adapted to be effective for use in catching and urging
bladder wall 2 surrounding bladder opening 4 toward pelvic floor 7
surrounding urethra opening 6.
[0271] FIG. 58 depicts the end effector assembly with anchor driver
assembly 1460 opened inside the bladder lumen. During the insertion
of end effector assembly 1400 into the bladder to the position
shown in FIG. 56, the anchor pivot arms 1461 of anchor driver
assembly 1460 are sheathed by anchor closing collar 1330 and are
restrained in a closed position lying along distal positioner tube
1445, as may be seen by comparing FIGS. 57 and 58. When anchor
closing collar 1330 is moved upwardly with respect to distal anchor
driver tube 1450, the anchor pivot arms 1461 are unsheathed,
allowing them to swing outwardly, under spring bias, to the
position shown in FIG. 58, bringing anchors 700 into a position
reading for driving.
[0272] FIG. 58 further illustrates positioning of the distal
balloon assembly 1410 in the urethra opening 6. Locating the
urethra opening 6 with end 1413 and inserting end 1413 into the
urethra opening 6 ensures that when the positioner arms 1441
contact and urge the bladder wall 2 toward the pelvic floor 7, the
urethra opening 6 and the bladder opening 4 will be substantially
aligned.
[0273] FIG. 59 illustrates the positioning of end effector assembly
1400, bladder wall 2, and pelvic floor 7 after instrument 1000 has
been urged downward, thus causing positioner arms 1441 to urge
bladder wall 2 downward into contact with pelvic floor 7, which may
be accomplished by pushing the entire instrument toward the pelvic
floor. As bladder wall 2 surrounding bladder opening 4 is urged
into contact with pelvic floor 7 surrounding urethra opening 6,
balloon assembly 1410 is urged into urethra opening 6
[0274] FIG. 60 illustrates the instrument after anchors 700 of
anchor driver assembly 1460 have been driven through the bladder
wall 2 into the pelvic floor 7 to secure bladder wall 2 surrounding
bladder opening 4 in contact with pelvic floor 7 surrounding
urethra opening 6, with bladder opening 4 and urethra opening 6
substantially aligned. Once in the opened and ready position, as
shown in FIG. 58, the anchors 700 may be driven through the bladder
wall into the pelvic floor by moving distal anchor driver tube 1450
in a distal direction (toward the distal end of the instrument),
which correspondingly moves the anchor pivot arms 1461, anchor
driver pin bases 1462, anchor driver pins (concealed within anchors
700 as shown), and thus anchors 700. Driving anchors 700 through
bladder wall 2 and into pelvic floor 7 positions the distal portion
of balloon assembly 1410 within the urethra 5 to insure that
anchors 700 are installed such that the bladder opening 4 and the
urethra opening 6 remain substantially aligned.
[0275] FIG. 61 illustrates the instrument after withdrawal of
anchor driver pins 1463 from the installed anchors 700 that are now
lodged in the pelvic floor 7 to secure the bladder wall 2 to the
pelvic floor 7. Anchors 700 may be provided with barbs or other
suitable structures adapted to lodge anchors 700 in tissues. As
such, when anchor driver assembly 1460 is withdrawn by remotely
pulling distal anchor driver tube 1450 while holding distal
positioner tube 1445 substantially stationary, anchors 700 remain
lodged in the tissue. Prior to use of the instrument, anchors 700
have been pre-loaded and may be releaseably held on the anchor
driver pins 1463 by a friction fit or any other suitable means
which will allow release when anchors 700 are lodged in tissues and
anchor driver pins 1463 are withdrawn therefrom.
[0276] FIG. 62 illustrates the end effector assembly 1400 after it
has been partially retracted so as to situate the proximal portion
of the balloon assembly 1410 within the bladder lumen 8. As the end
effector assembly 1400 is retracted, harness 1430 is unfolded and
exposed. Harness 1430 may be integral with harness collar 1433 and
may be affixed to anchors 700 at the anchor heads 710 with an
anchoring loop, that may consist of suture material, running
through both the anchor head 710 and the harness 1430. As the end
effector assembly 1400 is retracted, harness 1430 becomes unfolded
as the harness collar 1433 is moved upward. End effector assembly
1400 may be retracted until harness 1430 resists retraction as a
result of the attachment of harness 1430 to the anchor heads
710.
[0277] FIG. 63 illustrates the instrument after the positioner arms
1441 of the positioner assembly 1440 have been closed by retracting
the positioner tube 1445 away from the pelvic floor 7, and after
the anchor pivot arms 1461 have been closed by moving anchor
closing collar 1330 towards the pelvic floor while holding catheter
tube 1420 and distal anchor driver tube 1450 substantially
stationary. As will be apparent to a person of ordinary skill in
the art, the steps of closing the positioner arms 1441 and closing
the anchor pivot arms 1461 may be accomplished at any suitable time
or sequence during the procedure.
[0278] FIG. 64 illustrates the anchor driver assembly 1460 and the
positioner assembly 1440 after their withdrawal from the bladder I
has been commenced. Removing anchor driver assembly 1460 and
positioner assembly 1440 leaves behind catheter tube 1420, in
communication with balloon assembly 1410, also left behind.
Catheter tube 1420 may be a catheter that is left in place until
anastomosis is complete, to enable drainage of urine during
recovery and healing.
[0279] FIG. 65 illustrates balloon 1411 of balloon assembly 1410
after it has been inflated by pumping gas or fluid through an
inflation lumen 1423 in catheter tube 1420 (see FIGS. 67, 68).
Balloon 1411 may be inflated until it is restrained by harness
straps 1432, which then press balloon 1411 against the tissue
surrounding bladder opening 4 so as to apply sufficient pressure to
maintain contact between bladder wall 2 surrounding bladder opening
4 and pelvic floor 7 surrounding urethra opening 6, to effect
knitting of the respective tissues and thus effect anastomosis.
[0280] During recovery and healing, urine from the patient's
bladder may be drained through drainage holes 1421 that are in
communication with a urine drainage lumen 1422 in catheter tube
1420 (see FIGS. 67, 68). Drainage holes 1421 may be positioned, for
example, distally on the catheter tube 1420, or in any other
suitable location. Suitable gas or fluid pressure within balloon
1411 may be maintained until the anastomosis is complete, by
monitoring and adjusting the pressure within balloon 1411 through
inflation lumen 1423. The possibility of pressure necrosis in the
tissues beneath the balloon may be reduced by including, for
example, ribs 1415, or other bumps, nodules, projections, or other
features on the underside of balloon 1411, which may be effective
to reduce the loss of blood flow to tissue in contact with balloon
1411. These features may be solid or of uniform wall thickness.
[0281] Additionally, balloon 1411 may be designed with features
that effect the shape that it assumes upon inflation, and thus,
effect the shape and area of the lower surface of balloon 1411 that
contacts the bladder wall 2 upon inflation. For example, balloon
1411 may be designed and manufactured so as to have walls that are
thicker on an upper portion and thinner on a lower portion, so that
the lower portion of balloon 1411 is predisposed to expand
downwardly and outwardly between the harness straps, and thereby
present a larger surface area to contact the bladder wall 2.
Alternatively, balloon 1411 may be designed with features that
cause it to assume a specific advantageous shape upon
inflation.
[0282] Balloon assembly 1410, harness 1430, and catheter tube 1420
may removed from the patient by removing the harness anchoring loop
1435 attachment from the anchor heads 710 and harness straps 1432.
As shown in FIG. 66, harness straps 1432 may be affixed to the
anchor heads 710 by one or more harness anchoring loops 1435 that
pass through holes located in both the harness straps 1432 and the
anchor heads 710. As may be appreciated from FIGS. 66-69, free ends
of harness anchoring loops 1435 may extend through catheter tube
1420 to its proximal end. Thus, the balloon assembly 1410 may be
removed by pulling harness loop plug 1485 attached to one free end
of each of harness anchoring loops 1435 and pulling the harness
loop plug 1485 until the harness anchoring loops 1435 are
completely removed from the instrument. Removing the harness
anchoring loops 1435 from anchor heads 710 and harness straps 1432
disassociates the anchors 700 from the harness 1430 allowing the
balloon assembly 1410 to be retracted. FIG. 67 illustrates
anchoring loop passages 1436 where, in one embodiment of the
present invention, harness anchoring loops 1435 may pass through
the anchoring loop passage 1436 into the anchoring loop lumens 1424
of catheter tube 1420 (FIG. 68). Harness anchoring loops 1435 may
comprise suture material.
[0283] FIGS. 67 and 68 illustrate an embodiment of a method and
configuration of an instrument adapted to enable inflation of
balloon 1411 of balloon assembly 1410 in accordance with the
present invention. Catheter tube 1420 may include an inflation
lumen. 1423 that extends distally through the balloon assembly body
1412. An inflation port 1414 provides a passageway between
inflation lumen 1423 and the balloon cavity to enable inflation,
deflation and balloon pressure regulation. Gas or fluid pressure,
provided and regulated through inflation lumen 1423 may pass
through inflation port 1414 to adjust and regulate the pressure
within the balloon 1411 as may be desired to affect the pressure
the balloon exerts on the tissues. In one embodiment of the present
invention, balloon 1411 may be expanded until restricted by harness
straps 1432 of harness 1430. Balloon 1411 may be constructed from
an elastomeric material that fully encircles the balloon assembly
body 1412. The proximal and distal portions of balloon 1411 may be
glued or otherwise adhered to the balloon assembly body 1512 by any
suitable means.
[0284] FIG. 68 illustrates an embodiment of a catheter tube 1420 in
accordance with the present invention having a urine drainage lumen
1422, at least one anchoring loop lumen 1424, and an inflation
lumen 1423. It will be apparent to one of ordinary skill in the art
that various types of lumens are within the scope of the present
invention and that the lumens or catheter cross sections described
may be maintained within a single catheter or housed separately
depending on the needs of the user. Catheter tube 1420 may be any
suitable diameter.
[0285] FIG. 69 illustrates an embodiment of the proximal end of a
catheter tube 1420 as may be connected to a urine collection bag
1500. Gas or fluid may be delivered through backflow stop valve
1483 located in the collection bag (as shown) and/or in the
catheter. This may be accomplished by, for example, applying
sufficient positive pressure to open backflow stop valve 1490, or
by inserting a needle through the valve to apply pressure.
[0286] Still referring to FIGS. 68 and 69, a catheter cap 1480 is
provided, connected to urine collection bag 1500 via urine tube
1482. Urine tube 1482 may be provided with a urine backflow stop
valve 1483 to prevent urine backflow. Catheter cap 1480 may be
removably attached to catheter tube 1420 by, for example, threads
1481.
[0287] FIGS. 66-69 illustrate a way in which one or more harness
anchoring loops 1435 may be routed and contained within an
instrument, and within a tube such as, for example, catheter tube
1420. Those skilled in the art will appreciate that other
configurations are possible, as are other ways of attaching and
detaching anchor heads 710 with a harness strap 1432. Catheter tube
1420 may be constructed from any material that is substantially
biocompatible or suitable for use within the human body such as,
for example, latex, other suitable polymers, nitinol, or
combinations thereof.
[0288] Referring to FIGS. 58, 59, 64 and 70, catheter tube 1420 may
be located within distal positioner tube 1445 and positioner
assembly 1440. The distal end of positioner assembly 1440 may abut
harness collar 1433 of harness 1430. Positioner arms 1441 of the
positioner assembly 1440 are opened when the distal positioner tube
1445 is driven in a distal direction with respect to catheter tube
1420, compressing positioner assembly 1440 longitudinally against
harness collar 1433. Distal positioner tube 1445 may be coupled
with the positioner assembly 1440 by, for example, a pin or other
suitable attachment mechanism.
[0289] Referring to FIGS. 58, 59, 63, 64 and 70, distal positioner
tube 1445 may be located within distal anchor driver tube 1450.
When the anchor pivot arms 1461 are opened (as shown in FIGS. 58
and 59), the distal anchor driver tube 1450 may be moved to drive
the anchor driver assembly 1460 distally (and thus, in use,
downward towards the pelvic floor), so as to drive the anchors 700
through the bladder wall 2 and into the pelvic floor 7. Distal
anchor driver tube 1450 is coupled with anchor pivot arm yoke 1467
of anchor driver assembly 1460. Anchor pivot arm yoke 1467 may be
coupled with the anchor pivot arms 1461 by, for example, pins, or
any other suitable means, and biased to swing outwardly by anchor
pivot arm springs 1466 or other suitable biasing means. The anchor
pivot arms 1461 may be hingeably coupled with an anchor driver pin
base 1462 with an affixed anchor driver pin 1463. Pins, or any
other suitable attachment means permitting swinging movement, may
be used to couple the anchor driver pin base 1462 to the anchor
pivot arm 1461, and anchor pivot arm 1461 and driver pin base 1462
may have suitable cooperating shapes that limit the range of
relative swinging movement between them to a suitable angle as may
be appreciated from FIG. 59. Anchor pivot arm springs 1466 may be
included to bias anchor pivot arms 1461 toward an open position
shown in FIG. 59. Anchor driver assembly 1460 may be brought to a
closed position (shown in FIG. 63), with anchor pivot arms 1461
lying substantially alongside distal positioner tube 1445, by
moving anchor closing tube 1220 distally, which correspondingly
pushes ribbed flex tube 1325 and anchor closing collar 1330
distally, with respect to distal anchor driver tube 1450, causing
anchor closing collar 1330 to contact anchor pivot arms 1461, urge
them to a closed position, and then sheath and restrain them. This
motion is reversed in order to permit anchor pivot arms 1461 to
open.
[0290] Distal anchor driver tube 1450 may be substantially
coaxially located within curved spine tube 1305. Curved spine tube
1305 functions as a portion of a skeleton, on, in or about which
the other components reside and move. It may be desirable for
purposes of manipulability and use of the instrument that curved
spine tube 1305 be substantially rigid, or somewhat flexible, and
it may be formed of nitinol, or any other material having the
desired properties.
[0291] Still referring to FIGS. 59, 63, 64 and 70, curved spine
tube 1305 may be located within flex tube 1325. Flex tube 1325 may
be constructed from any suitable material such as, for example, a
substantially biocompatible polymer having sufficient flexibility
to permit the longitudinal movement of flex tube 1325 over and with
respect to curved spine tube 1305. Flex tube 1325 may be provided
with ribs, as shown, or other suitable features that impart or
increase flexibility. Flex tube 1325 may be affixed at its proximal
end to anchor closing tube 1220 via flex tube coupling 1225, and
affixed at its distal end to anchor closing collar 1330, by a pin
or other suitable attachment means. Anchor closing collar 1330 may
be adapted to contact, urge closing of, and sheath and restrain
anchor pivot arms 1461. Thus, anchor pivot arms 1461 and thus
anchor driver assembly 1460 may be placed in a closed position by
moving anchor closing tube 1220 distally, and placed in an open
position by moving anchor closing tube 1220 proximally, with
respect to distal anchor driver tube 1450.
[0292] FIG. 71 is a partial cross-sectional view, taken through the
central axis of the distal end of the instrument shown in FIG. 55,
illustrating particular exemplary components of the anchor and
positioner assemblies of the instrument and the manner in which
they may be connected to actuating tubes. Distal positioner tube
1445 is the innermost tube shown in FIG. 71, and terminates at
positioner proximal collar 1442, with which it may be made integral
by suitable means. Positioner arms 1441 are hingeably affixed to
positioner proximal collar 1442 at their proximal ends, and to
positioner distal collar 1443 at their distal ends. It will be
understood from examination of FIGS. 64 and 70 that catheter tube
1420, not shown in FIG. 71, may be located inside distal positioner
tube 1445, positioner distal collar 1442, and positioner proximal
collar 1443, when the instrument is completely assembled. It will
also be understood from FIGS. 64 and 70 that harness collar 1433 is
located on catheter tube 1420 adjacent to positioner distal collar
1443, when the instrument is completely assembled. Referring again
to FIG. 71, it can be understood that distal longitudinal movement
of distal positioner tube 1445, with respect to and toward harness
collar 1433, causes longitudinal compression of positioner assembly
1440 against harness collar 1433, which in turn causes positioner
arms 1441 to open outwardly from and transversely to the
longitudinal axis of the assembly as shown partially in FIG. 71,
toward fully opened positions that may be seen in FIGS. 58-62. The
construction of positioner assembly 1440 in this embodiment may be
seen in more detail in FIG. 78. It can be seen that longitudinal
compression of positioner assembly 1440 causes positioner arms 1441
to extend outwardly as enabled by their shapes and hinges 1444
between proximal and distal segments of positioner arms 1441. As
shown, positioner assembly 1440 may include positioner proximal
collar 1442, positioner arms 1441, and positioner distal collar
1443, may be a single unitary part formed of a substantially
biocompatible and flexible polymeric material suitable to allow
integral hinges 1444 to flex as shown when opening of bladder
assembly 1440 is required, and to return to an unflexed position
when closing of the positioner assembly 1440 is required.
[0293] Referring to FIGS. 58 and 59, in an open position,
positioner assembly 1440 is adapted to be useful for catching at
bladder opening 4 and urging bladder wall 2 thereabout downwardly
into contact with pelvic floor 7. Positioner assembly 1440 may
comprise the embodiment shown or any other suitable mechanism that
transversely extends one or more members that will catch in bladder
opening 4 and be useful for urging the bladder wall downwardly into
contact with the pelvic floor, in response to force and movement
translated from input from the surgeon at the proximal portion of
the instrument, and then retracts or closes such members in
response to force and movement translated from input from the
surgeon, when it is desired that the mechanism be withdrawn.
[0294] Referring again to FIG. 71, distal anchor driver tube 1450
may be affixed to, and integral with, anchor pivot arm yoke 1467.
Anchor pivot arms 1461 may be attached to pivot arm yoke 1467 by
pins as shown or other suitable means, and biased to swing
outwardly by springs 1466. The angle through which anchor pivot
arms 1461 may swing outwardly may be restricted by suitably
cooperating shapes of pivot arm yoke 1467 and anchor pivot arms
1461. Anchor driver pin bases 1462 may be pivotably attached to
anchor pivot arms 1461 by pins as shown or other suitable means.
The angle through which anchor driver pin bases 1462 may move with
respect to anchor pivot arms 1461 may be restricted by suitably
cooperating shapes of anchor pivot arms 1461 and pin bases 1462.
Anchor driver pins 1463 are affixed to pin bases 1462 and may be
integral therewith.
[0295] Anchors 700 may be hollow so as to fit onto anchor driver
pins 1463 and be releasably held thereon by friction fit or any
other suitable releasable means. Anchors 700 may have hollow bores
within, opening at their heads, and extending substantially within
their lengths, and driver pins 1463 may extend within such bores
substantially the entire lengths thereof, so that the distal ends
of driver pins 1463 may apply driving force proximate to the
forward ends of anchors 700, so as to prevent anchors 700 from
buckling or veering off-direction as they might otherwise do if
driven at their rearward ends. When anchors 700 are inserted into
tissues, barbs thereon, or any other suitable lodging structures,
cause anchors 700 to lodge in the tissues. Following insertion of
anchors 700 in tissues, anchor driver pins 1463 may then be
retracted from anchors 700 by retracting distal anchor driver tube
1450. It will be appreciated that it may be desirable that distal
anchor driver tube 1450 be flexible. Distal anchor driver tube 1450
may be formed from any suitable material such as, for example,
nitinol. The anchor pivot arm springs may be for example, leaf
springs, or any other suitable biasing device for biasing anchor
driver assembly 1460 in an open position when unsheathed by anchor
closing collar 1330.
[0296] Still referring to FIG. 71, anchor closing collar 1330 may
be integrally affixed to the distal end of flex tube 1325.
Referring to FIG. 70, the proximal end of flex tube 1325 may be
integrally affixed to anchor closing tube 1220 via flex tube
coupling 1225. Referring again to FIG. 71, flex tube 1325 and
integral anchor closing collar 1330 are not affixed to, and
longitudinally movable with respect to, anchor pivot arm yoke 1467
and curved spine tube 1305. Thus, it can be appreciated that distal
longitudinal movement of anchor closing tube 1220, with distal
anchor driver tube 1450 held stationary, can cause corresponding
distal longitudinal movement of anchor closing collar 1330, causing
it to contact anchor pivot arms 1461, urge them to a closed
position lying substantially alongside distal positioner tube 1445,
and sheath and restrain them, in positions that may be seen, for
example, in FIGS. 57 and 63. Conversely, moving anchor closing tube
1220 in a proximal direction, with distal anchor driver tube 1450
held stationary, pulls anchor closing collar 1330 up and off anchor
pivot arms 1461, allowing them to spring to an opened position
shown, for example, in FIGS. 58 and 71.
[0297] Distal positioner tube 1445 and distal anchor driver tube
1450 are not affixed to one another, and therefore, may be
longitudinally moved with respect to each other. This enables, for
example, distal anchor driver tube 1450 to be moved distally while
distal positioner tube is stationary, as would occur when anchors
700 are being driven through a bladder wall held stationary and in
contact with a pelvic floor, by positioner assembly 1440.
[0298] FIG. 72 illustrates an exemplary configuration of a
transition assembly that can be effective for translating relative
force and movement of/between actuating members of a handle
assembly 1100 to actuating members of an end effector assembly
1400, such as shown in FIG. 55. Distal positioner tube 1445 is
integral with positioner tube coupling 1206, which is in turn
integral with straight positioner tube 1209, which is operatively
connected with handle assembly 1100 as may be seen in FIGS. 55, 72
and 77. Thus, longitudinal force and movement in straight
positioner tube 1209 effected by the handle assembly is directly
translated to distal positioner tube 1445 via positioner tube
coupling 1206. Referring again to FIG. 72, distal anchor driver
tube 1450 is integral with anchor driver tube coupling 1207, which
is in turn integral with straight anchor driver tube 1208, which is
operatively connected to handle assembly 1100 as may be seen in
FIGS. 55, 72 and 81. Thus longitudinal force and movement in
straight anchor driver tube coupling 1207 effected by the handle
assembly is directly translated to distal anchor driver tube 1450
via anchor driver tube coupling 1207. Referring to FIGS. 72 and 82,
curved spine tube 1305 is integral with spine 1201, which is in
turn integral with handle housing 1101, and thus curved spine tube
1305, spine 1201 and handle housing 1101 form the instrument's
relative stationary skeleton about which the actuating components
move. As may be seen in FIGS. 73 and 74, spine tube 1201 may be
integrally fitted and affixed to the handle housing by a spine
retainer structure 1190 or other suitable structure integral with
the handle housing. Finally, still referring to FIG. 72, and also
FIGS. 55 and 79, flex tube 1325 is integral with flex tube coupling
1225 and anchor closing tube 1220, which is operatively connected
to handle assembly 1100. Thus, longitudinal force and movement in
anchor closing tube 1220 effected by the handle assembly is
directly translated to flex tube 1325 and thus anchor closing
collar 1330. It will be apparent to a person of ordinary skill in
the art that the configuration of components illustrated in FIG. 72
is only an example by which force and movement in components
effected by a handle assembly may be translated to components in an
end effector, and that this translation may be accomplished in a
variety of ways in accordance with the present invention.
[0299] FIG. 82 depicts an exemplary structure that may be
incorporated into the instrument to provide a skeletal ("ground")
structure about which other components move and are actuated, and
which can provide a structure to support manipulation of the entire
instrument as a unit. As previously noted, curved spine tube 1305
is integral with spine 1201. Spine 1201 is integral with handle
housing 1101. These three components are, thus, substantially
integral. Housing 1101 may be molded or formed of a suitable rigid
polymeric material. It may be desirable that spine 1201 and curved
spine tube 1305 be substantially rigid, and have suitable stiffness
and strength to support exertion of manipulative forces by the
surgeon upon the instrument necessary to insert the instrument into
a patient's abdomen, locate the bladder opening, urge the bladder
into contact with the pelvic floor, and hold the bladder in contact
with the pelvic floor during actuation of the instrument to drive
anchors. Spine 1201 and curved spine tube 1305 may be formed of
stainless steel, nitinol or any other suitable material. Curved
spine tube 1305 may be affixed or joined to spine 1201 by any
suitable means including but not limited to pins, welding, press
fitting, cooperating threads, adhesives, etc. Spine 1201 may be
affixed or joined to housing 1101 by any suitable means.
[0300] FIGS. 73, 74, 79 and 80 illustrate an exemplary mechanism
that may be incorporated into a handle assembly, by which an anchor
closing tube 1220 may be alternately, selectively, longitudinally
moved in proximal or distal directions and held so as to
alternatively, selectively, open or close an anchor assembly to
alternate positions shown, for example, in FIGS. 57 and 58. Anchor
closing tube 1220 may be coupled with closing tube latching collar
1180 by pins as shown in FIG. 80 or any other suitable means so
that the two components move together longitudinally as a unit.
Closing tube latch base 1179 may be integral with handle housing
1101, and thus may be part of the instrument's skeleton. Closing
tube latching collar 1180 freely rides upon closing tube spindle
1183, which assures suitable alignment of closing tube latching
collar with latch base 1179, and supports a proximal end of closing
tube spring 1181. Closing tube latching collar 1180 includes latch
members 1182 adapted to interact with cooperating features of
closing tube latch base 1179 so as to alternately, selectively, be
pushable proximally and rotatable to latch and be longitudinally
restrained within latch base 1179 in the position shown in FIG. 74,
or rotatable to unlatch and be released from latch base 1179 to
assume the position shown in FIG. 75. When in a position released
from latch base 1179, closing tube latching collar 1180 is biased
toward a distal position by closing tube spring 1181. Closing tube
latching collar 1180 may be restrained from disassociating distally
from closing tube spindle 1183 by cooperating rims or lips or any
other suitable means (not shown). Thus, it can be appreciated that
by the exemplary configuration of components shown, anchor closing
tube 1220 is biased in a distal position (thus, biasing anchor
closing collar 1330 in a distal position holding anchor driver
assembly 1460 in a closed position through exemplary mechanisms
described above) by closing tube spring 1181. When the surgeon
wishes to open the anchor assembly, he or she may push closing tube
latching collar 1180 proximally with respect to the handle housing
until closing tube latching members 1182 engage with cooperating
features of closing tube latch base 1179, and then turn closing
tube latching collar 1180 to latch into closing tube latch base
1179. This pulls anchor closing tube 1220 proximally, pulling
anchor closing collar 1330 proximally to release the anchor pivot
arms into an opened position.
[0301] FIGS. 75-77 illustrate an exemplary mechanism that may be
incorporated into the instrument to effect and translate force and
movement to open and hold open a positioner assembly in accordance
with the present invention. Positioner lever 1110 is pivotably
mounted on, and may pivot about, axle 1113 which is integral with
housing 1101. Positioner lever 1110 has a longer portion and a
shorter portion; the shorter portion has thereon positioner lever
teeth 1111. Positioner tube actuator rack 1160 rides longitudinally
between guides or a track integral with housing 1101, and is
longitudinally movable proximally and distally. Positioner tube
actuator rack 1160 has teeth 1159 thereon. Positioner lever 1110
and positioner tube actuator rack 1160 are situated such that
positioner tube actuator rack teeth 1159 and positioner lever teeth
1111 are enmeshed. Thus, with respect to FIGS. 75-77, it can be
appreciated that counterclockwise angular movement of positioner
lever 1110 about axle 1113 is translated to distal linear movement
of positioner tube actuator rack 1160, and vice versa. The distal
end of positioner tube actuator rack 1160 may be coupled with
straight positioner tube 1209 by cooperating rims or lips forming
an annular collar or other suitable means, such that the two parts
move longitudinally together as a unit, and straight positioner
tube 1209 may be made integral with distal positioner tube 1445 via
positioner tube coupling 1206 as previously described. Thus, it can
be appreciated that when a surgeon holding handle assembly 1100
pulls or squeezes positioner lever 1110, distal positioner tube
1445 is urged distally. Referring to FIG. 77, it can be appreciated
that when the entire instrument is assembled and positioner distal
collar 1443 is restrained distally by a balloon assembly (see,
e.g., FIGS. 56, 57), distal longitudinal movement of distal
positioner tube 1445 causes longitudinal compression of positioner
assembly 1440, which causes positioner arms 1441 to open outwardly
of the longitudinal axis, and vice versa. Positioner tube spring
1161, in compression, biases positioner tube actuator rack 1160
toward a proximal position. Thus, it can be appreciated from FIG.
77 that as a result, distal positioner tube 1445 is biased in a
proximal position, allowing positioner arms 1441 and positioner
assembly 1440 to assume a closed position. Driver/positioner
locking lever 1170 is pivotably mounted on and pivots about pin
1176, which may be integral with housing 1101, and is biased by
spring 1171, in compression, in a counterclockwise direction (with
respect to FIG. 75). Driver/positioner locking lever 1170 comprises
a driver/positioner locking latch 1178. When the handle assembly is
assembled and ready for use, a lower surface of driver/positioner
locking latch 1178 rests upon and is urged against an upper surface
of the proximal end 1177 of positioner tube actuator rack 1160. As
positioner lever 1110 is pulled or squeezed in counterclockwise
direction (with respect to FIG. 75), moving positioner tube
actuator rack 1160 distally as previously described, a notch 1174
at the proximal end 1177 of positioner tube actuator rack 1160
moves beneath locking latch 1178 of driver/positioner locking lever
1170, and locking latch 1178 moves into notch 1174 by urging of
spring 1171. This locks actuator rack 1160 into a distal position.
As a result, as may be appreciated from FIG. 77, positioner arms
1441 and positioner assembly 1440 may be locked into an opened
position. In order to then close positioner assembly 1440, the
surgeon may depress driver/positioner locking lever 1170, which
lifts locking latch 1178 out of notch 1174, permitting positioner
tube actuator rack 1160 to return to a proximal position under
urging of spring 1161.
[0302] FIGS. 75, 76 and 81 illustrate an exemplary mechanism that
may be incorporated into the instrument to effect and translate
force and movement to drive an anchor assembly in accordance with
the present invention. Anchor driver lever 1120 is pivotably
mounted on, and may pivot about, axle 1113 which is integral with
housing 1101. Anchor driver lever 1120 has a longer portion and a
shorter portion; the shorter portion has thereon anchor driver
lever teeth 1121. Anchor driver intermediate rack 1122 rides
longitudinally between guides or a track integral with housing
1101, and is longitudinally movable proximally and distally. Anchor
driver intermediate rack 1122 has proximal teeth 1127 and distal
teeth 1128 thereon. Anchor driver lever 1120 and anchor driver
intermediate rack 1122 are situated such that anchor driver
intermediate rack proximal teeth 1127 will engage anchor driver
lever teeth 1121 when anchor driver lever 1120 is moved
counterclockwise through a suitable angle (with respect to FIG.
75). Small anchor driver pinion 1123 and large anchor driver pinion
1124 are integral, and rotate about a pin supported by bosses in
housing 1101. Small anchor driver pinion 1123 and anchor driver
intermediate rack are situated such that small anchor driver pinion
1123 is enmeshed with anchor driver intermediate rack distal teeth
1128. Anchor driver rack 1125 rides longitudinally between guides
or a track integral with positioner tube actuator rack 1160, and a
length and a distal end of anchor driver rack 1125 may extend into
and be supported within spine 1201 as may be seen in FIG. 75.
Anchor driver rack 1125 has anchor driver teeth 1129 thereon.
Anchor driver rack 1125 and anchor driver lever 1120 are situated
such that anchor driver teeth 1129 are enmeshed with large anchor
driver pinion 1124. The distal end of anchor driver rack 1125 is
affixed by any suitable means to straight anchor driver tube 1208.
Thus, it may be appreciated from the foregoing, and examination of
FIGS. 75, 76 and 81, that moving anchor driver lever 1120 so as to
cause it to rotate counterclockwise (with respect to FIGS. 75 and
81) to the point where driver lever teeth 1121 mesh with proximal
teeth 1127 on intermediate driver rack 1122, will drive
intermediate driver rack 1122 distally, which in turn, will cause
small anchor driver pinion and large anchor driver pinion 1123 and
1124 to rotate counterclockwise, which, in turn, will drive anchor
driver rack 1125, straight anchor driver tube 1208, anchor driver
tube coupling 1207, distal anchor driver tube 1450, and thus,
anchor driver assembly 1460, distally. As may be appreciated from,
for example, FIGS. 59 and 60, when the instrument is fully
assembled and being used, this distal movement of anchor driver
assembly 1460 drives anchors 700 into the tissues.
[0303] Positioner lever 1110 and anchor driver lever 1120 abut one
another in side-by-side relationship, and both are mounted upon and
pivot about axle 1113. Positioner lever 1110 and anchor driver
lever 1120 are formed so as to have cooperating features where they
abut, such that counterclockwise movement of positioner lever 1110
effects corresponding counterclockwise movement of anchor driver
lever 1120 (with respect to FIG. 75). Driver lever spring 1126, in
tension, is connected between a hook or other suitable attachment
point in housing 1101 and an attachment point on the shorter
portion of anchor driver lever 1120 as shown. Thus, anchor driver
lever 1120 is biased in a clockwise direction (with respect to FIG.
75).
[0304] Additionally, anchor driver lever 1120 is prevented from
being depressed prior to activation of anchor positioner lever
1110. Driver lever locking hook 1172 is pivotably mounted on and
may rotate about a pin supported in housing 1101 as shown, and is
biased in a counterclockwise direction by spring 1171 in
compression, such that it hooks over a pin 1169 transversely
protruding from the shorter portion of anchor driver lever 1120 at
the position shown, preventing driver lever 1120 from moving
counterclockwise (the pin is not directly shown; it protrudes from
the back side of the component with respect to FIG. 75). However,
when positioner lever 1110 is depressed, locking hook release
member 1112 thereon engages locking hook 1172 and urges it in a
clockwise direction (with respect to FIG. 75), which causes it to
disengage from pin 1169, thereby releasing anchor driver lever 1120
so that it may move in a counterclockwise direction.
[0305] Additionally, when the instrument is ready for use, but
prior to deployment, anchor driver rack 1125 (and thus, anchor
driver assembly 1460) is locked in a proximal position, by
engagement of locking latch 1178 of driver/positioner locking lever
1170, with driver rack notch 1173. When actuation of the instrument
is begun by pulling and thereby rotating positioner lever 1110
counterclockwise, moving positioner tube actuator rack 1160
distally as previously described, a notch 1174 at the proximal end
1177 of positioner tube actuator rack 1160 moves beneath locking
latch 1178 of driver/positioner locking lever 1170, and locking
latch 1178 moves into notch 1174 by urging of spring 1171. As
locking latch 1178 moves into notch 1174, it moves out of driver
rack notch 1173, releasing driver rack 1125 so that it may be
driven by pulling anchor driver lever 1120 as previously
described.
[0306] Thus, it may be appreciated from the above description and
from FIGS. 73-82, that when the instrument is assembled and made
ready for use, positioner assembly 1440 is in a closed position,
and anchor driver assembly 1460 is held closed by anchor closing
collar 1330 and locked in a proximal position with respect to
positioner assembly 1440, placing the instrument in position to
facilitate insertion into the patient. After insertion of the
instrument into proper position within the patient with the end
effector assembly within a lumen, actuation may be commenced by
pulling positioner lever 1110 to the position in which it opens
positioner assembly 1440 and is locked in such position by
driver/positioner locking lever 1170 under urging of spring 1171.
When driver/positioner locking lever 1170 locks positioner lever
1110, it simultaneously unlocks anchor driver rack 1125 by
disengaging driver positioner locking latch 1178 from driver rack
notch 1173, freeing anchor driver rack 1125 to be driven in a
distal direction. Anchor driver assembly 1460 may then be opened by
pulling closing tube latching collar 1180 distally until it engages
latch base 1179, and rotating latching collar 1180 to latch into
latch base 1179. Anchor driver rack may then be driven in a distal
direction (to drive anchors) by pulling anchor driver lever 1120.
After anchors are driven, spring 1126 in tension urges anchor
driver lever 1120 to return, thus causing anchor driver rack 1125
and correspondingly anchor driver assembly 1460 to return to their
original proximal positions (and pulling anchor driver pins out of
anchors installed into tissues). Anchor driver assembly 1460 may
then be returned a closed position by rotating and disengaging
closing tube latching collar 1180 from latch base 1179, which
allows latching collar 1180 to return to its distal position urged
by spring 1181, moving closing collar 1330 distally and causing it
to close anchor driver assembly 1460. Finally, positioner assembly
1440 may be closed by depressing driver/positioner locking lever
1170, which lifts driver/positioner locking latch 1178 from notch
1174 in the proximal end 1177 of positioner tube actuator rack
1160, allowing positioner tube actuator rack 1160 to return to a
proximal position under urging of positioner tube spring 1161,
closing positioner assembly 1440. Thus, the instrument is returned
to a closed position ready for withdrawal from the patient.
[0307] Referring to FIGS. 55, 64, 65 and 75, it may be appreciated
that catheter tube 1420 may be routed through handle assembly 1100,
and through the entire instrument, to balloon assembly 1410, where
it may be affixed to harness collar 1433. In one embodiment the
catheter tube 1420 may extend proximally through the handle housing
1101 and out of the rear of the instrument 1000 as shown in FIG.
75. Anchor driver rack 1125 may be hollow, or may have a channel
and "U"-shaped cross-section, and driver/positioner locking lever
1170 and handle housing 1101 may have suitable holes or other
features, to accommodate passage of catheter tube 1420
therethrough. When the instrument is readied for use to install
anchors, catheter tube 1420 may be releasably gripped at or within
handle assembly 1110 by any suitable means so as to be held
stationary with respect to handle housing 1101, placing it in
tension with respect to positioner assembly 1440 when positioner
assembly 1440 is longitudinally compressed against harness collar
1433 to cause positioner assembly 1440 to open. After the
instrument has been actuated to drive anchors and returned a closed
position, catheter tube 1420 may then be released to permit
withdrawal of all components except for catheter tube 1420 and
balloon assembly 1410, for use in completing the anastomosis
procedure as described above.
[0308] Levers 1110, 1120 and 1170 and positioner tube actuator rack
1160 may be formed of any material having suitable properties of
strength, stiffness and formability or moldability, including
polymeric materials.
[0309] Small anchor driver pinion 1123, large anchor driver pinion
1124, anchor driver intermediate rack 1122, anchor driver rack
1125, positioner tube actuator rack 1160 and driver lever locking
hook 1172 may be made of any material having suitable strength for
small mechanical components, including steel or high-strength
polymers.
[0310] The above-described embodiment is only one example
describing portions of an instrument that may be used for one or
more of the bringing and holding of the bladder in contact with the
pelvic floor with the openings in the bladder and urethra aligned,
driving anchors through the bladder wall and into the pelvic floor
and securing a harness within the bladder lumen, inflating a
balloon within the harness and thereby applying pressure to the
bladder wall to effect knitting of the bladder wall with the pelvic
floor, and draining urine from the bladder during the time required
for recovery and healing, to effect an anastomosis between the
bladder and the urethra following a prostatectomy.
[0311] It will be appreciated by one skilled in the art that the
components described above may have alternative configurations and
embodiments useful for effecting the same steps. It will be
appreciated by one skilled in the art that the components described
above may, alternatively, be designed and configured so as to be
useful for effecting the above-described steps in a retrograde
direction rather than an antegrade direction as described
above.
[0312] It can be appreciated by one skilled in the art that the
mechanism comprising the positioner assembly 1440 and performing
the bladder positioning function thereof may have a variety of
alternative configurations including but not limited to embodiments
described herein (and thus including, without limitation, the
positioner assembly 400, shuttlecock assembly 800 with positioner
petals 830 (FIGS. 17-21), umbrella assembly 900 with reverse
positioner petals 930 (FIGS. 22-27), described above, or positioner
2017 (FIGS. 122-126), 2090 (FIGS. 110-118), 2122 (FIGS. 95, 96,
103-109) and 2168 (FIGS. 83, 84, 89-94) (all of which are described
below)), providing a transversely retractable and extendible device
useful for, referring to FIG. 2, insertion in a retracted position
in a retrograde direction through the urethra 5 and into bladder
opening 4, extending or expanding within bladder lumen 8, catching
in bladder opening 4 and manipulating to urge bladder wall 2
surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned;
or alternatively, insertion in a retracted position in an antegrade
direction through an incision in the abdomen and an upper surface
of the bladder 1, extending or expanding within bladder lumen 8,
catching in bladder opening 4 and manipulating to urge bladder wall
2 surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned.
Generally, the positioner assembly may comprise and make use of any
number of alternately extendable and retractable projections,
petals, arms, claws, or other grasping or catching members for
catching and gaining control of bladder wall 2 surrounding bladder
opening 4. The positioner assembly may have at least one member
operably connected to a longitudinal member of the instrument and
alternately extendable transversely from and retractable toward the
longitudinal axis thereof in response to input by a surgeon at a
proximal end of the instrument.
[0313] Alternatively, it can be appreciated by one skilled in the
art that when an anchor driver assembly is included with the
instrument, that is functional to open and subsequently drive
anchors through the bladder wall and into the pelvic floor as
described herein, the positioner assembly or positioner arms as
shown may be dispensed with in some circumstances. For example,
referring to FIGS. 58-61, it can be appreciated that anchor driver
pins 1463 and anchors 700, when opened within the bladder lumen and
pushed downwardly until the distal ends of anchors 700 contact and
possibly puncture bladder wall 2 surrounding bladder opening 4, can
be sufficient for use in capturing bladder wall 2 and pushing it
downward into contact with, and securing it to, pelvic floor 7,
with bladder opening 4 and urethra opening 6 aligned, without the
need for positioner assembly 1400 as shown, in some circumstances.
Thus, anchor driver assembly 1460 with anchors 700 may serve a dual
function as a positioner and as an anchor driver assembly.
Alternative Balloon/Harness Embodiment
[0314] FIG. 136 depicts another exemplary embodiment of an
instrument 3000 of the present invention, adapted for use in
effecting the anastomosis of the bladder and urethra tissues
following a radical prostatectomy in accordance with a method of
the present invention. The instrument may comprise a handle
assembly 3100, a tube assembly 3200 and an end effector assembly
3400. End effector assembly 3400 is adapted to facilitate
retrograde insertion into and through a patient's urethra 5 and
into the bladder lumen 8 through bladder opening 4. It will be
understood by those skilled in the art that instrument 3000 can,
alternatively, be designed and configured in an embodiment to be
effective to perform steps substantially similar to those herein
described via insertion from an antegrade direction, i.e., through
incisions through the abdomen and an upper surface of the bladder
(not shown), and downwardly through the bladder opening 4 and into
urethra opening 6. An example of such an embodiment is depicted and
described in co-pending U.S. applications Ser. Nos. 60/639,836 and
60/582,302.
[0315] FIG. 135 is a longitudinal cross-sectional view of end
effector assembly 3400 after insertion into and through the
patient's urethra 5 and into the bladder opening 4. It can be seen
that end effector assembly 3400 may comprise distal end cap
assembly 3410, balloon harness 3430, anchor driver assembly 3460,
and positioner assembly 3440. End effector assembly 3400 and the
assemblies it comprises, just identified, may be operably connected
to, and controlled by, handle assembly 3100 (shown in FIG. 136),
via tube assembly 3200, which may comprise spine tube 3210, central
rod or guide wire 3230, inner positioner tube 3240, outer
positioner tube 3241, anchor driver closing tube 3260 and anchor
driver tube 3261. These tubes and rod may be assembled so as to be
substantially coaxial. Central rod or guide wire 3230 may pass
through the length of the instrument within anchor driver closing
tube 3260, and may be affixed and made integral with end cap 3411
by any suitable means. Anchor driver closing tube 3260 may be
longitudinally movable with respect to central rod or guide wire
3230, and may be affixed and made integral with anchor closing
collar 3464 by any suitable means. Anchor driver closing tube 3260
may be located within anchor driver tube 3261, and may be
longitudinally movable with respect thereto. Anchor driver tube
3261 may be affixed and made integral with anchor pivot arm yoke
3467 by any suitable means. Anchor driver tube 3261 may be located
within inner positioner tube 3240, and may be longitudinally
movable with respect thereto. Inner positioner tube 3240 may be
affixed and made integral with positioner distal collar 3443 by any
suitable means. Inner positioner tube 3240 may be located within
outer positioner tube 3241, and may be longitudinally movable with
respect thereto. Outer positioner tube 3241 may be affixed and made
integral with positioner proximal collar 3442 and spine tube 3210
by any suitable means. Tubes 3210, 3241, 3240, 3261 and 3260, and
rod 3230, may be made of nitinol or any other material having
suitable combined properties of strength, stiffness and
biocompatibility as may be desirable for purposes of the present
embodiment. The instrument also includes balloon harness 3430,
which is attached at a distal end to end cap assembly 3410, and
releasably attached at proximal ends to anchors 700. Anchors 700
are releasably held by the instrument as will be described below.
Use of the present embodiment of an instrument and method, in
accordance with the present invention, and remaining components and
operation thereof, for effecting anastomosis of a patient's bladder
and urethra following a radical prostatectomy, will now be
described.
[0316] As previously noted, and as shown in FIG. 135, end effector
assembly 3400 may be inserted into and through the patient's
urethra in a retrograde direction and into the bladder opening 4,
and then into the bladder lumen as may be appreciated from FIG.
136. FIG. 136 depicts the end effector assembly after insertion
completely into the bladder lumen 8, after anchor driver assembly
3460 and positioner assembly 3440 have been opened for use, and
after positioner assembly 3440 has been brought into contact with
bladder wall 2 and used to urge the bladder wall 2 surrounding the
bladder opening into contact with the pelvic floor 7. To open the
positioner assembly 3440, the surgeon holds spine tube 3210 and
outer positioner tube 3241 stationary, and withdraws inner
positioner tube 3240 proximally, using handle assembly 3100 (shown
in FIG. 136). This draws positioner distal collar 3443 toward
positioner proximal collar 3442. Positioner arms 3441 have upper
segments hinged by any suitable means to positioner distal collar
3443 and lower segments hinged by any suitable means to positioner
proximal collar 3442, and also hinged together by any suitable
means. Thus, drawing positioner distal collar 3443 toward
positioner proximal collar 3442 in the manner described above
causes positioner arms 3441 to fold outwardly and transversely with
respect to the longitudinal axis of the instrument, as may be
appreciated from a comparison of FIGS. 135 and 136.
[0317] Once positioner arms 3441 of positioner assembly 3440 are
opened, the surgeon may manipulate the instrument to cause
positioner arms 3441 to urge bladder wall 2 downward into contact
with pelvic floor 7, as may be appreciated from FIG. 136. It will
also be appreciated from FIG. 136 that the respective openings in
the bladder and the urethra are aligned.
[0318] The surgeon may open the anchor driver assembly 3460 by
holding anchor driver closing tube 3260 stationary while
withdrawing anchor driver tube 3261 proximally, or, alternatively,
by holding anchor driver tube 3261 stationary while advancing
anchor driver closing tube 3260 distally, again, via use of handle
assembly 3100 (shown in FIG. 136). As noted above, anchor pivot arm
yoke 3467 is integral with anchor driver tube 3261, and anchor
closing collar 3464 is integral with anchor driver closing tube
3260. Anchor pivot arms 3461 are pivotably connected to anchor
pivot arm yoke 3467, and are biased to swing outwardly by anchor
pivot arm springs 3466. As shown in FIG. 135, when anchor driver
assembly 3460 is in a closed position, anchor closing collar 3464
sheaths and restrains anchor pivot arms 3461 in a retracted
position. When anchor pivot arm yoke 3467 is urged proximally down
and away from stationary anchor closing collar 3464, or
alternatively, when anchor closing collar 3464 is urged distally up
and away from stationary anchor pivot arm yoke 3467, anchor pivot
arms 3461 are released from anchor closing collar 3464 and allowed
to swing outwardly under urging of springs 3466, as may be
appreciated from a comparison of FIGS. 135 and 136. The angle at
which anchor pivot arms 3461 swing outwardly as described above may
be limited by, for example, suitable cooperating shapes of pivot
arms 3461 and anchor pivot arm yoke 3467, or, alternatively for
example, by cooperating shapes and limiting the relative
longitudinal travel between anchor closing collar 3464 and anchor
pivot arms 3461.
[0319] Referring to FIG. 136, it can be seen that anchor driver pin
bases 3462 are pivotably connected to anchor pivot arms 3461, and
may be biased to swing inwardly with respect thereto by any
suitable means, to assume a substantially downward orientation as
shown in FIG. 136. Anchor driver pins 3463 may be affixed and made
integral with anchor driver pin bases 3462. Anchors 700 may be
loaded onto anchor driver pins 3463 and held thereon by friction
fit or any other suitable releasable means. Anchors 700 may include
harness hooks 760 (as may be seen in greater detail in FIG. 141).
As may be appreciated from a comparison of FIGS. 135 and 136,
anchors 700 may be moved outwardly and into a position ready for
driving by opening anchor driver assembly 3460 as described
above.
[0320] Referring now to FIGS. 136 and 137, using handle assembly
3100 (see FIG. 136) the surgeon may drive anchors 700 downwardly
through the bladder wall 2 and into tissues of the pelvic floor 7
by withdrawing anchor driver tube 3261, which pulls anchor pivot
arm yoke 3467, and correspondingly, anchor pivot arms 3461, anchor
driver pin bases 3462, anchor driver pins 3463, and anchors 700,
downward. Anchor pivot arms 3461 and anchor driver pin bases 3462
may be situated on the instrument so that when driven downward,
anchors 700 do not interfere with, and are driven down between,
positioner arms 3441. Anchors 700 may comprise barbs or other
suitable lodging structures (not shown) on their shafts, so as to
cause them to be lodged in and resist withdrawal from the tissues
of the pelvic floor.
[0321] Referring now to FIGS. 137 and 138, the surgeon may retract
the driver pins 3463 from the now-installed anchors 700, by
advancing anchor driver tube 3261 distally, which will move anchor
pivot arm yoke 3467, and correspondingly, anchor pivot arms 3461,
anchor driver pin bases 3462, and anchor driver pins 3463, distally
upward. If anchors 700 are lodged or otherwise remain in the
tissues of the pelvic floor 7, anchor driver pins 3463 onto which
anchors 700 are held by releasable means, will release from anchors
700, leaving anchors 700 installed and lodged in the tissues as
shown in FIG. 138.
[0322] Referring to FIGS. 138 and 139, again, using handle assembly
3100 (shown in FIG. 136), the surgeon may close the anchor driver
assembly, and return it to its original position to facilitate
withdrawal from the patient, by distally advancing anchor driver
tube 3261 while holding anchor driver closing tube 3260 stationary.
Alternatively, the surgeon may proximally retract anchor driver
closing tube 3260 while holding anchor driver tube 3261 stationary.
Either sequence will bring anchor pivot arm yoke 3467, and
correspondingly, anchor pivot arms 3461, within anchor closing
collar 3464, causing anchor pivot arms 3461 to be moved upwardly
and inwardly relative to anchor closing collar 3464 and be sheathed
and restrained thereby, as depicted in FIG. 139.
[0323] In final preparation for withdrawal of anchor driver and
positioner assemblies, referring to FIGS. 139 and 140, the surgeon
may retract positioner arms 3441 by distally advancing inner
positioner tube 3240 while holding outer positioner tube 3241 and
spine tube 3210 stationary. This moves positioner distal collar
3443 distally and away from positioner proximal collar 3442,
drawing positioner arms 3441 inwardly to the position shown in FIG.
140.
[0324] With the anchor driver and positioner assemblies retracted
to the positions shown in FIG. 140, the surgeon may withdraw these
assemblies from the patient by withdrawing, together as a group,
spine tube 3210, outer positioner tube 3241, inner positioner tube
3240, anchor driver tube 3261 and anchor driver closing tube 3260,
leaving behind end cap assembly 3410, harness 3430 and anchors 700,
as may be seen by comparing FIGS. 140 and 141. Referring to FIG.
141, it can be seen that balloon harness 3430 has been attached to
bladder walls 2 surrounding bladder opening 4, which, in turn, may
be held in contact with the tissues of pelvic floor 7 surrounding
urethra opening 6, by installed anchors 700. Tails 3433 of harness
3430 may be held by anchors 700 by way of hooks 760 as shown or by
any other suitable means. Central rod 3230 can now serve as a guide
wire as will be described below, and may also be used to withdraw
the remaining portions of the instrument following completion of
the procedure.
[0325] It will be apparent to persons skilled in the art that a
variety of mechanisms might be comprised by handle assembly 3100
and configured and adapted to transmit longitudinal (advancement
and retraction) forces and movement to an end effector assembly
3400, in order to effect and translate the forces and movement
therein necessary to actuate the exemplary embodiments as described
above.
[0326] FIG. 146 shows end cap assembly 3410 and balloon harness
3430 in more detail. End cap assembly 3410 may comprise drainage
extension 3413 having thereon harness attachment neck 3415 and one
or more drainage holes 3414. End cap assembly 3410 may also include
snap-in collar 3412 and end cap 3411, which may be integrally
formed or assembled. End cap 3411 may be connected or affixed to
and made integral with central rod or guide wire 3230 by any
suitable means. Balloon harness 3430 may include attachment collar
3431, to fit around harness attachment neck 3415 and be held
thereon by their respective cooperating shapes and dimensions.
Balloon harness 3430 may also includes tails 3433 having therein
anchor hook holes 3432, through which anchor hooks 760 may pass,
thus attaching balloon harness 3430 to anchors 700 (see, again,
FIG. 141). Balloon harness 3430 may be made of any suitable
biocompatible polymer having properties of flexibility but
effectively limited elasticity so as to render it suitable for
remaining held in position and serving the balloon restraining
function that will be described below.
[0327] Returning to FIG. 141, and also referring to FIG. 142, the
next step in the exemplary method described herein is for the
surgeon to insert balloon catheter assembly 3500 into the patient
and into the balloon harness 3430 via central rod 3230, serving as
a guide wire.
[0328] Central rod 3230, serving as a guide wire, may be provided
with one or more markings along its length (not shown) that enable
the surgeon to determine the distance that a balloon catheter
assembly is inserted into the patient. By noting the length of the
balloon catheter assembly and its position with respect to the one
or more markings on central rod or guide wire 3230 after insertion,
the surgeon can determine whether the catheter assembly has been
inserted to the correct depth within the patient with respect to
the harness and distal end cap assembly.
[0329] Referring to FIGS. 142, 143 and 146, balloon catheter
assembly 3500 may comprise catheter tube 3510, balloon 3520
attached thereto, and catheter end plug 3530. Catheter tube 3510
may include inflation lumen 3511 and inflation port 3512. Balloon
3520 may have proximal and distal portions attached in any
substantially gas and/or fluid-tight manner at proximal and distal
points on catheter tube 3510, and may be ring-shaped upon inflation
or otherwise have a central passage through which catheter tube
3510 passes, as may be appreciated from FIG. 143. Catheter end plug
3530 may comprise snap-in button 3531, one or more drainage holes
3414, and catheter tube insert 3534, with stop collar 3535.
[0330] Referring again to FIG. 142, upon insertion of balloon
catheter assembly 3500, snap-in button 3531 of catheter end plug
3530 cooperates with and snaps into snap-in collar 3412 of distal
end cap assembly 3410, and is held thereby. Referring to FIGS. 142
and 143, balloon 3520 may then be inflated, and have its internal
pressure regulated, via inflation lumen 3511 and inflation port
3512 in catheter tube 3510. Referring to FIG. 143, it may be seen
that balloon 3520, upon inflation, may expand outwardly between the
straps of harness 3430, and be used to exert pressure on the
bladder walls 2 surrounding the bladder opening in order to, both,
press bladder walls 2 into contact with the tissues of pelvic floor
7, and seal off the bladder opening, pelvic floor and urethra from
urine and other materials collecting in the bladder during recovery
and healing. During recovery and healing, urine and other materials
collecting in the bladder may be drained into catheter tube 3510
via drainage holes 3414 and 3533, in distal end cap assembly 3410
and catheter end plug 3530, respectively. During recovery and
healing, catheter tube 3510 may be connected at a proximal end to a
urine collection bag (not shown).
[0331] It may be appreciated that the combination of a harness
structure anchored to the pelvic floor as depicted and described
herein, constraining and holding the inflated balloon of a balloon
catheter, has the desirable effect of constraining the catheter
from substantial axial or longitudinal movement within the urethra
during the period required for anastomosis.
[0332] Suitable gas or fluid pressure within balloon 3520 may be
maintained until anastomosis is complete, by monitoring and
adjusting the pressure within balloon 3520 through inflation lumen
3511. About 1 to 6 p.s.i. pressure within the balloon may be
suitable, and about 1.5 to 2.5 p.s.i. is preferred. The possibility
of pressure necrosis in the tissues beneath the balloon may be
reduced by including, for example, ribs or other bumps, nodules,
projections, or other features (not shown) on the underside of
balloon 3520, which may be effective to reduce the loss of blood
flow to tissue in contact with balloon 3520. These features may be
solid or of uniform wall thickness. Additionally, balloon 3520 may
be designed with features that effect the shape that it assumes
upon inflation, and thus, effect the shape and area of the lower
surface of balloon 3520 that contacts the bladder wall 2 upon
inflation. For example, balloon 3520 may be designed and
manufactured so as to have walls that are thicker on an upper
portion and thinner on a lower portion, so that the lower portion
of balloon 3520 is predisposed to expand downwardly and outwardly
between the harness straps, and thereby present a larger surface
area to contact the bladder wall 2. Alternatively, balloon 3520 may
be designed and manufactured so as to have walls that are thicker
on a lower portion and thinner on an upper portion, so that the
upper portion of balloon 3520 is predisposed to inflate first,
within the bladder lumen, and thereby draw the remaining portion of
the balloon up into the bladder lumen, and substantially out of the
pelvic floor region, before the lower portion fully inflates.
Alternatively, balloon 3520 may be designed with features that
cause it to assume other specific advantageous shapes upon
inflation to, for example, fill a large portion of the space
defined by the harness straps.
[0333] In order to facilitate inflation and assist in maintaining
suitable gas or fluid pressure within balloon 3520, a two-way check
valve may be installed along the inflation gas or fluid passage
including inflation lumen 3511. For example, a two-way check valve
may comprise a "duckbill" type valve or other valve that functions
to permit gas or fluid to pass into inflation lumen 3511 but
prevents gas or fluid from passing back out, in conjunction with a
pressure release valve that functions to permit gas or fluid to
pass out of the system if pressure within balloon 3520 and/or the
fluid passage exceeds a desired maximum amount.
[0334] FIG. 144 depicts an alternative manner of attachment of
balloon 3520 to the distal end of catheter tube 3510. In comparison
with balloon 3520 as depicted in FIG. 143, it can be seen in FIG.
144 that the sheet-like material forming the upper wall of balloon
3520 has been attached to the distal end of catheter tube 3510 in
inverted orientation, which may serve to enhance sealing at the
attachment point and improve the balloon's ability to sustain gas
or fluid pressure when inflated.
[0335] Following substantial completion of the anastomosis
procedure, i.e., following substantial knitting of the tissues of
the bladder walls and the pelvic floor surrounding the respective
openings of the bladder and the urethra, the balloon may be
deflated and the balloon catheter assembly 3500 withdrawn from the
patient. This leaves behind the end cap assembly 3410, harness 3430
and anchors 700, as may be seen by comparing FIGS. 144 and 145.
Following withdrawal of the balloon catheter assembly, end cap
assembly 3410 and harness 3430 may be withdrawn from the patient by
proximally withdrawing central rod or guide wire 3230 (shown in
progress in FIG. 145). It can be seen in FIG. 145 that the tails
3433 of harness 3430 may be removed from and released by harness
hooks 760 of anchors 700 by inversion of the position of harness
3430, and subsequent proximal tension exerted thereon, effected by
withdrawing distal end cap assembly 3230, causing harness tails
3433 to slide off attachment hooks 760. Anchors 700 may be left
behind in the patient.
[0336] As noted, central rod or guide wire 3230 may be attached to
and made integral with end cap 3411 by any suitable means. When
central rod or guide wire 3230 is made integral with end cap 3411,
it is substantially integral with the other components of end cap
assembly 3410 as described herein, and thus also with attachment
collar 3431 of balloon harness 3430. As such, central rod or guide
wire 3230 may be used for withdrawal of balloon harness 3430
following substantial completion of the anastomosis procedure.
[0337] The above-described embodiment is only one example
describing portions of an instrument that may be used for one or
more of the bringing and holding of the bladder in contact with the
pelvic floor with the openings in the bladder and urethra aligned,
driving anchors through the bladder wall and into the pelvic floor
and securing a harness within the bladder lumen, inflating a
balloon within the harness and thereby applying pressure to the
bladder wall to effect knitting of the bladder wall with the pelvic
floor, and draining urine from the bladder during the time required
for recovery and healing, to effect an anastomosis between the
bladder and the urethra following a prostatectomy.
[0338] It will be appreciated by one skilled in the art that the
components described above may have alternative configurations and
embodiments useful for effecting the same steps. It will be
appreciated by one skilled in the art that the components described
above may, alternatively, be designed and configured so as to be
useful for effecting the above-described steps in an antegrade
direction rather than a retrograde direction as described
above.
[0339] It can be appreciated by one skilled in the art that the
mechanism comprising the positioner assembly 3440 and performing
the bladder positioning function thereof may have a variety of
alternative configurations including but not limited to embodiments
described herein (and thus including, without limitation, the
positioner assembly 400, shuttlecock assembly 800 with positioner
petals 830 (FIGS. 17-21), umbrella assembly 900 with reverse
positioner petals 930 (FIGS. 22-27), described above, or positioner
2017 (FIGS. 122-126), 2090 (FIGS. 110-118), 2122 (FIGS. 95, 96,
103-109) and 2168 (FIGS. 83, 84, 89-94) (all of which are described
below)), providing a transversely retractable and extendible device
useful for, referring to FIG. 2, insertion in a retracted position
in a retrograde direction through the urethra 5 and into bladder
opening 4, extending or expanding within bladder lumen 8, catching
in bladder opening 4 and manipulating to urge bladder wall 2
surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned;
or alternatively, insertion in a retracted position in an antegrade
direction through an incision in the abdomen and an upper surface
of the bladder 1, extending or expanding within bladder lumen 8,
catching in bladder opening 4 and manipulating to urge bladder wall
2 surrounding bladder opening 4 into contact with pelvic floor 7
surrounding urethra opening 6 with the respective openings aligned.
Generally, the positioner assembly may comprise and make use of any
number of alternately extendable and retractable projections,
petals, arms, claws, or other grasping or catching members for
catching and gaining control of bladder wall 2 surrounding bladder
opening 4. The positioner assembly may have at least one member
operably connected to a longitudinal member of the instrument and
alternately extendable transversely from and retractable toward the
longitudinal axis thereof in response to input by a surgeon at a
proximal end of the instrument.
[0340] Alternatively, it can be appreciated by one skilled in the
art that when an anchor driver assembly is included with the
instrument, that is functional to open and subsequently drive
anchors through the bladder wall and into the pelvic floor as
described herein, the positioner assembly or positioner arms as
shown may be dispensed with in some circumstances. For example,
referring to FIGS. 135 and 136, it can be appreciated that anchor
driver pins 3463 and anchors 700, when opened within the bladder
lumen and pushed downwardly until the distal ends of anchors 700
contact and possibly puncture bladder wall 2 surrounding bladder
opening 4, can be sufficient for use in capturing bladder wall 2
and pushing it downward into contact with, and securing it to,
pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, without the need for positioner assembly 3440 as shown, in
some circumstances. Thus, anchor driver assembly 3460 with anchors
700 may serve a dual function as a positioner and as an anchor
driver assembly.
"H" Anchor Embodiment
[0341] FIG. 83 is a perspective view of another embodiment of an
anastomotic instrument 2150 of the present invention, in its
pre-deployment position, and FIG. 84 is a longitudinal
cross-sectional view of the distal end of the instrument, also
shown in its pre-deployment position. The instrument may comprise
anchor driver assembly 2151, which may include outer driver
assembly tube 2152, having distal end 2154, anchor driver tube 2155
which distally terminates with anchor driver pins 2156, and inner
driver assembly tube 2158 which distally terminates with anchor
track collar 2159. The described embodiment of the instrument may
further comprise positioner tube 2167, positioner 2168 affixed to
the distal end of positioner tube 2167, rod 2170 and rod cap 2171.
When the instrument is assembled and prepared for use, anchor
driver assembly 2151 may be loaded with one or more anchors 700,
each of which may comprise a forward member 750, shaft 720 and
rearward member 710.
[0342] Referring to FIG. 84 and as may be seen in more detail in
FIG. 86, positioner tube 2167, inner driver assembly tube 2158
distally terminating in anchor track collar 2159, and outer driver
assembly tube 2152, may be assembled such that they are
substantially coaxial. Anchor track collar 2159 and inner driver
assembly tube 2158 may have in their outer surfaces one or more
longitudinally-oriented anchor tracks 2160 which direct upwardly
and radially outwardly, moving longitudinally, proximally to
distally. Outer driver assembly tube 2152 may have one or more
anchor storage grooves 2153 on its inside surface, situated
opposite anchor tracks 2160. When the instrument is assembled and
ready for use, inner driver assembly tube 2158, with anchor track
collar 2159, and outer driver assembly tube 2152, are made integral
with respect to each other by any suitable means.
[0343] FIG. 87 is an enlarged view of the forward end of an anchor
that may be used in the present embodiment. Anchor 700 has forward
member 750 which may have a sharp forward end 751, and has shaft
720 which connects with a rearward member 710 (not shown in FIG.
87). Anchor 700 may be manufactured so as to be biased with shape
memory to assume an "H" shape, with the forward and rearward
members forming the vertical legs and the connecting member forming
the horizontal connection of the "H", and may be made of a material
having suitable properties of strength, flexibility, shape memory,
non-reactivity with body tissues and fluids, and biocompatibility.
Anchor 700 may also be made of one or more dissolving bioabsorbable
materials. Anchor 700 may, alternatively, be manufactured in a
variety of suitable shapes as depicted in FIGS. 40-51, and one of
the embodiments of the instrument described herein suitably adapted
for use with such anchors substantially as hereinafter
described.
[0344] FIGS. 84 and 86 depict anchors 700 loaded into the
instrument of the present embodiment, ready for deployment. As can
be seen from the drawings, as loaded, anchors 700 reside in the
spaces defined by anchor tracks 2160 and anchor storage grooves
2153. As can be appreciated from the drawings, the spaces defined
by the anchor tracks 2160 and anchor storage grooves 2153 restrain
the anchors 700 while the anchors are loaded in the instrument,
holding them such that forward lodging lodging members 750 and
penetration limiting members 710 are positioned lying
longitudinally alongside connecting members 720.
[0345] As can be seen in FIGS. 84 and 86, when the instrument is
ready for use, anchor driver pins 2156 also reside in anchor tracks
2160 with their distal ends behind the forward lodging lodging
members 750 in a position ready for driving anchors 700 as will be
hereinafter described. Anchor driver pins 2156 are integral with a
distal end of anchor driver tube 2155 (shown in FIG. 83). Anchor
driver tube 2155 is longitudinally movable with respect to outer
driver assembly tube 2152 and inner driver assembly tube 2158.
Anchor driver pins 2156 are formed from a suitable flexible, shape
memory material such as nitinol, and are biased so as to be
substantially straight in their natural positions.
[0346] As may be seen in FIG. 87, the end of anchor driver pin 2156
may have a recess 2157 or any other suitable feature for receiving
and holding forward member 750 during the anchor driving step as
will be hereinafter described.
[0347] The instrument may comprise one or more anchors, and the
associated tracks, grooves and anchor driver pins described above,
situated about the instrument in positions such that upon correct
rotational orientation of the instrument, the anchors may be driven
upwardly and radially outwardly into tissues in directions selected
to avoid nerve and/or circulatory system bundles or other sensitive
areas.
[0348] Referring again to FIG. 84, the instrument of the present
embodiment also includes positioner tube 2167. Affixed at the
distal end of positioner tube 2167 is positioner 2168, shown in its
pre-deployment shape in FIGS. 83 and 84. The pre-deployment shape
of positioner 2168, shown in FIGS. 83 and 84, facilitates insertion
of the instrument into the patient. Positioner 2168 may be made of
a suitable elastic and flexible polymeric material having shape
memory, manufactured so as to be biased to assume a normally
transversely-oriented shape such as, for example, that shown in
FIG. 89, upon retraction of rod 2170. As shown in FIG. 89,
positioner 2168 may have, about its perimeter, one or more drainage
holes 2169 which can permit urine, fluids or clotted material to
drain into positioner tube 2167 after the instrument has been
deployed. Positioner 2168 is alternately moved to its
pre-deployment position shown in FIGS. 83 and 84, or allowed to
return via shape memory to its normal (deployed) position shown in
FIG. 89, by longitudinal movement of rod 2170, and correspondingly,
end cap 2171, which is integrally affixed to rod 2170. Positioner
tube 2167 is longitudinally movable with respect to inner driver
assembly tube 2158, and vice versa.
[0349] Outer driver assembly tube 2152, anchor driver tube 2155,
inner driver assembly tube 2158, positioner tube 2167 and rod 2170
may be made of one or more materials having suitable combined
properties of shape memory, flexibility, strength and stiffness
that both enable the tubes and rod to flex during insertion into
the patient's body and through the urethra as will be hereinafter
described, but also will prevent them from collapsing, kinking,
binding, or breaking during use. The selected materials may also be
substantially non-reactive with body fluids and tissues, and be
substantially biocompatible. The inventors have determined that
nitinol, known in the art as suitable for a variety of surgical
devices and tubes, is one example of a suitable material.
[0350] It will be appreciated that a hollow tube may be used in the
instrument for positioner tube 2167 when a coaxial arrangement with
rod 2170 is desirable, or when positioner tube 2167 is to serve as
a catheter, such as will be further described below, but that a rod
may be substituted for positioner tube 2167 and be used to provide
substantially the same mechanical function, i.e., transmission of
forces to actuate the positioner, and thus may be used when a
catheter function, or a coaxial arrangement, and thus a tube, is
not required. Conversely, a tube can serve the purpose of rod 2170.
Thus, for purposes of claims set forth, unless otherwise specified
in a claim, the term "tube" where such element is operably affixed
or connected with, or contacts, the positioner, is intended to
include and cover a rod, and vice versa.
[0351] A method for performing anastomosis in a retrograde manner
using the above-described instrument, following a prostatectomy,
will now be described. Following a prostatectomy, the patient's
bladder 1 and urethra opening 6 are separated by a void formerly
occupied by the prostate, as shown in FIG. 2. It is necessary to
connect the bladder 1 with the urethra 5, with bladder opening 4
and urethra opening 6 aligned, to restore urinary functions after
recovery and healing.
[0352] As shown in FIG. 88, the anastomotic instrument is inserted
upwardly into and through the patient's urethra 5, through the
bladder opening 4, and into the bladder 1. The surgeon then
retracts rod 2170 and correspondingly, end cap 2171, which allows
positioner 2168 to assume its normal transversely-oriented shape
via shape memory, as shown in FIG. 89. The now-transverse
orientation of positioner 2168 prevents it from being retracted
without pulling bladder wall 2 surrounding bladder opening 4 with
it.
[0353] Next, the surgeon retracts the entire instrument downwardly
through the urethra, which causes positioner 2168 to pull bladder
walls 2 surrounding bladder opening 4 into contact with pelvic
floor 7, with bladder opening 4 and urethra opening 6 aligned, to
the position shown in FIG. 90.
[0354] Next referring to FIG. 91, anchor driver tube 2155 is moved
longitudinally upwardly and distally, which correspondingly causes
anchor driver pins 2156 to move upwardly and distally, inside
anchor tracks 2160, and then upwardly and radially outwardly,
driving forward lodging lodging members 750 of anchors 700 upwardly
and radially outwardly, first into and through the tissues of the
pelvic floor 7 surrounding the urethra opening 6, and then into and
through the tissues of the bladder wall 2 surrounding the bladder
opening 4, and into the bladder, as shown in FIG. 91. As may be
seen in FIG. 91, as forward lodging lodging members 750 are driven
into the tissues, connecting members 720 trail behind forward
lodging lodging members 750, into place in the tissues. Anchor
driver tube 2155 and correspondingly anchor driver pins 2156 are
then retracted back into the instrument, releasing lodging members
750 of anchors 700. When lodging members 750 of anchors 700 are
released by retraction of anchor driver pins 2156, they are no
longer restrained from their normal biased positions, and lodging
members 750 move under bias and contact with the bladder wall to a
position substantially transverse to the axes of connecting members
720 as may be seen in FIG. 92, such that lodging members 750
prevent anchors 700 from retracting back through the holes in the
tissues made by lodging members 750 during the driving step, and
thus, serve to lodge the anchors in the tissues. Similarly, when
penetration limiting members 710 are pulled out of the instrument,
they are no longer restrained from their normal biased positions,
and penetration limiting members 710 move under bias and contact
with the urethra wall to a position substantially transverse to the
axes of connecting members 720 as may be seen in FIG. 92, such that
penetration limiting members 710 may not be pulled through the
holes in the tissues made by lodging members 750 during the driving
step, and thus serve to limit further penetration of anchors 700
into the tissues. Upon completion of installation of anchors 700,
as can be seen in FIG. 92, anchors 700 hold the tissues of bladder
wall 2 surrounding bladder opening 4 in contact with the tissues of
pelvic floor 7 surrounding urethra opening 6, with the bladder
opening 4 and urethra opening 6 aligned. Thus held in contact, the
tissues of the bladder wall 2 and pelvic floor 7 may knit and heal
together with the bladder opening and urethra opening aligned.
[0355] Next, the entire anchor driver assembly, comprising inner
driver assembly tube 2158 and anchor track collar 2159, anchor
driver tube 2155, and outer driver assembly tube 2152, may be
retracted as a unit (as shown in progress in FIG. 92), down the
urethra and out of the patient's body, leaving behind positioner
tube 2167, positioner 2168 and rod 2170. Remaining positioner 2168
and positioner tube 2167 may now be used to exert supplemental
downward pressure on bladder walls 2 surrounding the bladder
opening 4 so as to enhance contact and knitting between the tissues
of bladder walls 2 surrounding the bladder opening 4, and the
tissues of pelvic floor 7 surrounding the urethra opening 6.
Additionally, or alternatively, positioner 2168, including drainage
holes 2169, and positioner tube 2167, may now be used to seal off
the junction between the bladder and urethra and drain urine and
other fluids from the bladder during recovery and healing. Used for
this purpose, positioner tube 2167 would be connected to a urine
collection bag (not shown) via intermediate tubing. Following
recovery and healing, rod 2170 and correspondingly end cap 2171 are
moved longitudinally upwardly and distally with respect to
positioner tube 2167, thus urging positioner 2168 into its
pre-deployment position as shown in FIGS. 83 and 84, and enabling
retraction of these remaining parts of the instrument out of the
bladder, down through the urethra, and out of the patient's
body.
[0356] FIGS. 93 and 94 depict an alternative embodiment and
alternative loaded anchor positions for the instrument of the
present invention. As can be seen, in this embodiment anchor driver
pins 2156 include rear driver steps 2172, which function to drive
penetration limiting members 710 of anchors 700 at the same time
the distal ends of anchor driver pins drive forward lodging lodging
members 750 of anchors 700. The geometry of outer driver assembly
tube 2152, anchor storage groove 2153 and/or anchor track 2160 are
suitably modified accordingly. With this alternative embodiment,
tension in shaft 720 during the driving step may be avoided and
driving and ejection of the anchor from the instrument may be
eased. Additionally, as depicted in FIG. 94, in this alternative
embodiment anchors 700 may be loaded with forward lodging lodging
members 750 and penetration limiting members 710 oriented in
opposite directions as shown, which may serve to improve the
positioning of rearward member 710 in the urethra after actuation
of the anchor driver assembly and driving of the anchors.
[0357] Those skilled in the art will appreciate that a variety of
simple mechanical devices may be configured or adapted to operate
and manipulate and outer driver assembly tube 2152 and inner driver
assembly tube 2158, anchor driver tube 2155, positioner tube 2167
and rod 2170, at the proximal end of the instrument as required by
the above steps, and so as to move and hold the instrument in
respective pre-deployment and/or retracted, and deployed and first
and second actuated, positions, including but not limited to the
handle assembly now to be described.
[0358] The right-hand side of FIG. 83, and FIG. 85, depict an
example of a simple proximal end handle assembly 2200 which may be
designed and configured to enable the surgeon to control and
manipulate various embodiments of the instrument. Handle assembly
2200 comprises rod 2201 having affixed knob 2202, fourth tube 2203,
third tube 2204 with integral stop collar 2205, second tube 2207
with integral actuation collar 2209, and first tube 2210. Tubes
2210, 2207, 2204 and 2203, and rod 2201, may be substantially
coaxial. Rod 2201 is longitudinally slidable with respect to fourth
tube 2203. Fourth tube 2203 is longitudinally slidable with respect
to third tube 2204 and stop collar 2205, and vice versa. First tube
2210 may be connected to third tube 2204 via connecting pins 2211,
thus making first tube 2210 and third tube 2204 integral. Second
tube 2207 is coaxially located between first tube 2210 and third
tube 2204, and is longitudinally slidable therewithin, to the
limits defined by longitudinal slots 2208 in second tube 2207 about
pins 2211.
[0359] Thus, it can be appreciated from FIGS. 84 and 85 that handle
assembly 2200 may be connected and made usable by the surgeon to
manipulate and operate anastomotic instrument 2150 by connecting,
or making integral, rod 2201 and rod 2170, fourth tube 2203 and
positioner tube 2167, third tube 2204 and inner driver assembly
tube 2158, second tube 2207 and anchor driver tube 2155, and first
tube 2210 and outer driver assembly tube 2152. As so configured,
second tube 2207 may be longitudinally slid with respect to the
remaining parts of the assembly by the surgeon gripping tube
actuation collar 2209, thus advancing or retracting anchor driver
tube 2155 and correspondingly anchor driver pins 2156, thereby
actuating anchor driver assembly 2151. Following installation of
the anchors, the entire anchor driver assembly 2151 may be
retracted from the patient's body by the surgeon gripping and
pulling first tube 2210, thus also retracting third tube 2204 via
connecting pins 2211 and second tube 2207, and correspondingly,
retracting outer anchor driver assembly tube 2152, inner driver
assembly tube 2158, and anchor driver tube 2155. This can be
accomplished while leaving behind fourth tube 2203 and rod 2201,
and thus positioner tube 2167 and rod 2170, as described above.
[0360] It will be appreciated by those skilled in the art of design
of mechanical surgical devices that the positioner need not be
limited to the exemplary embodiment made of flexible and elastic
polymeric shape memory material as described above, but that
alternative designs for such positioner are possible, which cause
the positioner to alternately assume a retracted position and a
deployed position, the deployed position suitable for catching in
the bladder opening and urging the bladder into contact with the
pelvic floor, in response to forces exerted or transmitted by tubes
or other members. The positioner may comprise, for example, any of
the positioner assemblies depicted in FIGS. 14, 19, 24 and 57, and
described hereinabove. Similarly, it will be appreciated by those
skilled in the art of design of mechanical surgical devices that
the anchor driver assembly need not be limited to the exemplary
three-tube assembly described herein, but that alternative designs
for such an assembly are possible, which are effective to install
one or more anchors into the tissues of the bladder and the urethra
about the respective openings when they are brought together, in
response to forces exerted or transmitted by tubes or other
members.
[0361] As previously noted, the combination of tubes, positioner
and driver assembly may be configured in an instrument adapted for
a retrograde anastomosis procedure, as described above, or
configured in an instrument adapted for an antegrade procedure. In
an antegrade procedure, instead of being inserted upwardly through
the urethra and into the bladder opening proximate the site of
excision of the prostate, the instrument is inserted downwardly
through a small incision in the patient's abdomen, through a small
incision on an upper surface of the patient's bladder, into the
bladder, through the bladder opening, and into the urethra opening.
The small incisions in the abdomen and upper surface of the bladder
may be made and held open for insertion of the instrument
therethrough with a cannula and trocar assembly.
Connecting Anchor Embodiment
[0362] FIG. 95 is a perspective view of another embodiment of an
anastomotic instrument 2100 of the present invention, in its
pre-deployment position, and FIG. 96 is a longitudinal
cross-sectional view of the distal end of the instrument, also
shown in its pre-deployment position. The instrument may comprise
anchor driver assembly 2101, which may include outer driver
assembly tube 2102, having distal end 2104, second anchor track
collar 2105, anchor driver tube 2109 which distally terminates with
anchor driver pins 2108, and inner driver assembly tube 2110 which
distally terminates with first anchor track collar 2112. The
present embodiment may further comprise positioner tube 2121,
positioner 2122 affixed to the distal end of positioner tube 2121,
rod 2124 and rod cap 2125. When the instrument is assembled and
prepared for use, anchor driver assembly 2101 may be loaded with
one or more anchor pairs, each pair comprising first anchor 700
with an attached length of suture 2117, and second anchor 701.
[0363] Referring to FIG. 96 and as may be seen in more detail in
FIGS. 97 and 98, positioner tube 2121, inner driver assembly tube
2110 distally terminating in first anchor track collar 2112, second
anchor track collar 2105, and outer driver assembly tube 2102, may
be assembled such that they are substantially coaxial, with first
anchor tracks 2111, second anchor tracks 2106 and anchor driver
pins 2108 longitudinally aligned. First anchor track collar 2112
may have in its outer surface one or more longitudinally-oriented
first anchor tracks 2111 including suture clearance tracks 2113,
which direct upwardly and radially outwardly, moving
longitudinally, proximally to distally. Second anchor track collar
2105 may have in its outer surface one or more
longitudinally-oriented second anchor tracks 2106, which also
direct upwardly and radially outwardly, moving longitudinally,
proximally to distally. Second anchor track collar 2105 also has
suture clearance tracks 2107 on its inside surface, situated
opposite suture clearance tracks 2113 in first anchor track collar
2112, and one or more longitudinally-oriented suture storage
grooves 2103 on its outer surface. Distal end 2104 of outer driver
assembly tube 2102 may have on its outer surface one or more
longitudinally-oriented suture storage grooves 2103, that align
with and thereby form extensions of suture storage grooves 2103 on
second anchor track collar 2105. When the instrument is assembled
and ready for use, inner driver assembly tube 2110, with first
anchor track collar 2112, second anchor track collar 2105, and
outer driver assembly tube 2102, may be made integral with respect
to each other by any suitable means.
[0364] FIGS. 99-101 are enlarged views of exemplary anchors that
may be used in the present embodiment. First anchor 700 may have
barb 730 and suture holes 735. Suture holes 735 may be used to
attach a length of trailing suture or other suitable connecting
member to first anchor 700 in preparation for use. Second anchor
701 may have barb 731 and suture notch 752. Suture notch 752 is
shaped and sized so as to be effective to capture and bindingly
hold a free end of suture or other suitable connecting member as
will be hereinafter described. Anchors 700 and 701 may be
manufactured so as to be biased to assume the shapes shown in FIGS.
99-101, and may be made of a material having suitable properties of
strength, flexibility, shape memory, non-reactivity with body
tissues and fluids, and biocompatibility. Anchors 700 and 701 may
also be made of dissolving bioabsorbable materials, or may be made
of suitably treated nitinol or surgical stainless steel.
[0365] FIGS. 96-98 depict first anchors 700 and second anchors 701
loaded into the present embodiment of an anastomotic instrument,
ready for deployment. As can be seen from the drawings, as loaded,
first anchors 700 may reside in the spaces defined by first anchor
tracks 2111 and the interior surface of second anchor track collar
2105. Similarly, second anchors 701 may reside in the spaces
defined by second anchor tracks 2106 and the interior surface of
outer driver assembly tube 2102. As can be appreciated from the
drawings, the spaces defined by the anchor tracks 2111 and 2106
restrain the barbs 730 and 731 of anchors 700 and 701 while the
anchors are loaded in the instrument. Sutures 2117 or other
suitable connecting members may be attached to the rear ends of
first anchors 700 via suture holes 735 (shown in FIG. 99) and trail
from the rear ends of first anchors 700, upwardly through suture
clearance tracks 2107, radially out and over second anchor track
collar 2105, and downwardly in suture storage grooves 2103,
terminating with free ends.
[0366] As can be seen in FIGS. 96-98, when the instrument is ready
for use anchor driver pins 2108 reside in first anchor tracks 2111
with their distal ends behind anchors 700 in preparation for
driving first anchors 700 as will be hereinafter described. Anchor
driver pins 2108 are integral with a distal end of anchor driver
tube 2109 (shown in FIG. 95). Anchor driver tube 2109 is
longitudinally movable with respect to outer driver assembly tube
2102 and inner driver assembly tube 2110. Anchor driver pins 2108
are made of a suitable flexible, shape memory material such as
nitinol, and are biased so as to have their distal ends spring
radially outwardly upon repositioning in preparation for driving
second anchors 701, as will be described below.
[0367] The instrument may comprise one or more pairs of anchors,
each pair comprising a first anchor and a second anchor, and the
associated tracks, grooves and anchor driver pins described above,
situated radially about the instrument in positions such upon
correct rotational orientation of the instrument, the anchors may
be driven into tissues in directions selected to avoid nerve and/or
circulatory system bundles or other sensitive areas.
[0368] Referring again to FIG. 96, the instrument of the present
embodiment also may include positioner tube 2121. Affixed at the
distal end of positioner tube 2121 is positioner 2122, shown in its
pre-deployment shape in FIGS. 95 and 96. The pre-deployment shape
of positioner 2122, shown in FIGS. 95 and 96, can facilitate
insertion of the instrument into the patient. Positioner 2122 may
be made of a suitable elastic and flexible polymeric material
having shape memory, manufactured so as to be biased to assume a
normally transversely-oriented shape as shown in FIG. 103, upon
retraction of rod 2124. As shown in FIG. 103, positioner 2122 may
have, about its perimeter, one or more drainage holes 2123 that can
permit urine, fluids or clotted material to drain into positioner
tube 2121 after the instrument has been deployed. Positioner 2122
may be, alternately, moved to a pre-deployment position shown in
FIGS. 95 and 96, or allowed to return via shape memory to a normal
(deployed) position shown in FIG. 103, by longitudinal movement of
rod 2124, and correspondingly, end cap 2125, which may be
integrally affixed to rod 2124. Positioner tube 2121 is
longitudinally movable with respect to inner driver assembly tube
2110, and vice versa.
[0369] Outer driver assembly tube 2102, anchor driver tube 2109,
inner driver assembly tube 2110, positioner tube 2121 and rod 2124
may be made of a material having suitable combined properties of
shape memory, flexibility, strength and stiffness that both enable
the tubes and rod to flex during insertion into the patient's body
and through the urethra as will be described below, but also will
prevent them from collapsing, kinking, binding, or breaking during
use. The selected material may also be substantially non-reactive
with body fluids and tissues, and be substantially biocompatible,
or be non-biocompatible with a biocompatible coating. The inventors
have determined that nitinol, known in the art as suitable for a
variety of surgical devices and tubes, is one example of a suitable
material.
[0370] It will be appreciated that hollow tubes may be used in the
instrument for positioner tube 2121 when a coaxial arrangement with
rod 2124 is desirable, or when positioner tube 2121 is to serve as
a catheter, such as will be further described below, but that a rod
may be substituted for positioner tube 2121 and be used to provide
substantially the same mechanical function, i.e., transmission of
forces to actuate the positioner, and thus may be used when a
catheter function, or a coaxial arrangement, and thus a tube, is
not required. Conversely, a tube can serve the purpose of rod 2124.
Thus, for purposes of the claims set forth herein, unless otherwise
specified in a claim, the term "tube" where such element is
operably affixed or connected with, or contacts, the positioner, is
intended to include and cover a rod, and vice versa.
[0371] A method for performing anastomosis of a patient's bladder
and urethra using the above-described anastomotic instrument,
following a prostatectomy, will now be described. Following a
prostatectomy, the patient's bladder 1 and urethra opening 6 are
separated by a void formerly occupied by the prostate, as shown in
FIG. 2. It is necessary to connect the bladder 1 with the urethra
5, with bladder opening 4 and urethra opening 6 aligned, to restore
urinary functions after recovery and healing.
[0372] As shown in FIG. 102, the anastomotic instrument may be
inserted upwardly into and through the patient's urethra 5, through
the bladder opening 4, and into the bladder 1. The surgeon then may
retract rod 2124 and correspondingly, end cap 2125, which will
permit positioner 2122 to assume its normal shape via shape memory,
as shown in FIG. 103. The now-transverse orientation of positioner
2122 will prevent it from being retracted without pulling bladder
wall 2 surrounding bladder opening 4 with it.
[0373] Next, the surgeon may retract the entire instrument
downwardly through the urethra, which will cause positioner 2122 to
pull bladder walls 2 surrounding bladder opening 4 into contact
with pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, to the position shown in FIG. 104.
[0374] Next referring to FIG. 105, anchor driver tube 2109 may be
moved longitudinally distally, which correspondingly will cause
anchor driver pins 2108 to move upwardly and distally inside first
anchor tracks 2111, driving first anchors 700 radially outwardly
into the surrounding tissues of bladder wall 2, as shown in FIG.
105. When anchors 700 are driven out of the instrument, they are no
longer restrained from their normal biased shapes, and thus barbs
730 can spring away from anchors 700 as shown, enabling anchors 700
to lodge in the tissues. After anchors 700 are driven into the
bladder wall tissues, the attached sutures 2117 will trail from the
rear ends of anchors 700, back out of the tissues, with their free
ends continuing to reside in suture storage grooves 2103, passing
over the exits of second anchor tracks 2106.
[0375] Next, referring to FIG. 106, anchor driver tube 2109 and
correspondingly, anchor driver pins 2108, may be longitudinally
retracted proximally. When the distal ends of anchor driver pins
2108 are retracted past the proximal end of second anchor track
collar 2105, the shape-memory bias of anchor driver pins 2108 will
cause their distal ends to move radially outwardly into position
behind second anchors 701, into the position shown in FIG. 106,
ready to drive second anchors 701 upwardly and outwardly through
second anchor tracks 2106.
[0376] Next, referring to FIG. 107, anchor driver tube 2109 and
correspondingly anchor driver pins 2108 may again be pushed
longitudinally distally, while will cause the distal ends of anchor
driver pins 2108 move distally into and through second anchor
tracks 2106, and drive second anchors 701 radially outwardly into
the surrounding tissues of pelvic floor 7, as shown in FIG. 107. As
the fore ends of second anchors 701 are driven out of the
instrument, suture notches 752 (see FIG. 100) will contact the
trailing lengths of sutures 2117 passing over the exits of second
anchor tracks 2106 (see FIG. 106), and capture and bindingly hold
these trailing lengths as second anchors 701 are driven into the
tissues, as shown in FIG. 107. Thus, for each installed pair of
anchors comprising first and second anchors 700 and 701, a suture
2117 (or other suitable connecting member) may be anchored into a
position holding the tissues of bladder wall 2 surrounding bladder
opening 4 in contact with the tissues of pelvic floor 7 surrounding
urethra opening 6, with the bladder opening 4 and urethra opening 6
aligned. Thus held in contact, the tissues of the bladder wall 2
and pelvic floor 7 may knit and heal together and the bladder
opening and urethra opening aligned.
[0377] Next, the entire anchor driver assembly, comprising inner
driver assembly tube 2110 and first anchor track collar 2112,
anchor driver tube 2109, second anchor track collar 2105, and outer
driver assembly tube 2102, may be retracted as a unit (as shown in
progress in FIG. 108), down the urethra and out of the patient's
body, leaving behind positioner tube 2121, positioner 2122 and rod
2124. Remaining positioner 2122 and positioner tube 2121 may now be
used to exert supplemental downward pressure on bladder walls 2
surrounding the bladder opening 4 so as to enhance contact and
knitting between the tissues of bladder walls 2 surrounding the
bladder opening 4, and the tissues of pelvic floor 7 surrounding
the urethra opening 6. Additionally, or alternatively, positioner
2122, including drainage holes 2123, and positioner tube 2121, may
now be used to seal off the junction between the bladder and
urethra and drain urine, fluids and/or clotted material from the
bladder during recovery and healing. Used for this purpose,
positioner tube 2121 would be connected to a urine collection bag
(not shown) via intermediate tubing. Following recovery and
healing, rod 2124 and correspondingly end cap 2125 may be moved
longitudinally upwardly or distally with respect to positioner tube
2121, thus urging positioner 2122 into its pre-deployment position
as shown in FIG. 109, and enabling retraction of these remaining
parts of the instrument out of the bladder, down through the
urethra, and out of the patient's body.
[0378] Those skilled in the art of the design of mechanical
surgical devices will appreciate that a variety of simple
mechanical devices may be configured or adapted to actuate and
manipulate outer driver assembly tube 2102 and inner driver
assembly tube 2110, anchor driver tube 2109, positioner tube 2121
and rod 2124, at the proximal end of the instrument as required by
the above steps, and so as to move and hold the instrument in
respective pre-deployment and/or retracted, and deployed and first
and second actuated, positions, including the handle assembly
depicted in FIGS. 83 and 85 and described above, or a variation
thereof.
[0379] It will be appreciated by those skilled in the art of design
of mechanical surgical devices that the positioner need not be
limited to the embodiment made of flexible and elastic polymeric
shape memory material as described herein, but that alternative
designs for such positioner are possible, which can cause the
positioner to alternately assume a retracted position and a
deployed position, the deployed position suitable for catching in
the bladder opening and urging the bladder into contact with the
pelvic floor, in response to forces exerted or transmitted by tubes
or other members. The positioner may comprise, for example, any of
the positioner assemblies depicted in FIGS. 14, 19, 24 and 57, and
described hereinabove. Similarly, it will be appreciated by those
skilled in the art of design of mechanical surgical devices that
the anchor driver assembly need not be limited to the three-tube
assembly described herein, but that alternative designs for such an
assembly are possible, which cause the anchor driver assembly to
install one or more connected pairs of anchors into the tissues of
the bladder and the urethra radially about the respective openings
of these lumens when they are brought together, in response to
forces exerted or transmitted by tubes or other members.
[0380] As previously noted, the combination of tubes, positioner
and driver assembly may be designed and configured in an instrument
adapted for a retrograde anastomosis procedure, as described above,
or configured in an instrument adapted for an antegrade procedure.
In an antegrade procedure, instead of being inserted upwardly
through the urethra and into the bladder opening proximate the site
of excision of the prostate, the instrument is inserted downwardly
through a small incision in the patient's abdomen, through a small
incision on an upper surface of the patient's bladder, into the
bladder, through the bladder opening, and into the urethra opening.
The small incisions in the abdomen and upper surface of the bladder
may be made with a cannula and trocar assembly and held open by the
cannula for insertion of the instrument therethrough.
Deformable Fastener Embodiment
[0381] FIG. 110 is a perspective view of another embodiment of an
anastomotic instrument 2050 of the present invention, in its
pre-deployment position, and FIG. 111 is a longitudinal
cross-sectional view of the instrument, also shown in its
pre-deployment position, after insertion into and through the
patient's urethra and into the bladder 1. The instrument may
comprise fastener driver assembly 2052 including outer tube 2051
and second tube 2060. Outer tube 2051 may terminate with flexible
fingers 2053, which in turn terminate with proximal fastener anvils
2054. Second tube 2060 may be immediately inside and substantially
coaxial with outer tube 2051. Second tube 2060 may terminate with
flexible fingers 2061, which in turn terminate with distal fastener
anvils 2062, which may be longitudinally aligned with and may
longitudinally oppose proximal fastener anvils 2054.
[0382] When the fastener driver assembly 2052 is being assembled in
preparation for its use, fastener set 2070 in its pre-deployment
shape (shown in enlarged perspective view in FIG. 119) is placed
onto second tube 2060 and moved over flexible fingers 2061 to a
position in which the upper prongs of fasteners 2072 of fastener
set 2070 are proximate to upper anvils 2062. Next, outer tube 2051
may be slid over and up second tube 2060, until lower anvils 2054
are in a position proximate to the lower prongs of fasteners 2072
of fastener set 2070, thus holding fastener set 2070 in a position
on the fastener driver assembly ready for deployment (as shown in
FIG. 10) via actuation of the fastener driver assembly as will be
described below.
[0383] Thus, it can be seen in FIGS. 110 and 111 that fastener
driver assembly 2052 may comprise outer tube 2051 with its flexible
fingers 2053 and lower anvils 2054, second tube 2060, with its
flexible fingers 2061 and upper anvils 2062. When fastener assembly
2052 is assembled and made ready for use, it may include fastener
set 2070 in a pre-deployment shape, placed as shown.
[0384] FIG. 119 shows an exemplary fastener set 2070 in a
pre-deployment shape. One or more individual fasteners 2072 may
have upper and lower prongs with ends turned slightly outwardly,
and may be linked together via serpentine links 2071. FIG. 120
shows fastener set 2070 as it would appear following installation.
In its installed shape, fastener set 2070 has been expanded in
circumference and diameter via deformation of serpentine links
2071, and fasteners 2072 have been pushed and deformed so as to
hook into tissues. Fastener set 2070 may be made of a suitable
substantially permanently deformable material that is non-reactive
with body fluids and tissues, and substantially biocompatible. The
inventors have determined that suitably treated surgical stainless
steel is one example of a suitable material. Alternatively, if it
is desired that the fastener set be bioabsorbable, a suitably
deformable substantially biocompatible and bioabsorbable material
may be selected. The inventors have determined that flexible
absorbable polymers (e.g., polydioxanone polymers, or polymers
containing lactides, glycolides, polyglactin, etc., such as the
polymers marketed by Johnson & Johnson and/or Ethicon, Inc.
under the trademarks "Vicryl" and "PDS II") such that the fastener
set can be absorbed (i.e., dissolved) in the patient's body after
anastomosis is complete. If the selected material is one that might
not sufficiently retain its position after deformation during
installation, the design of the fastener set may be modified so as
to include barbs on the prongs or other suitable lodging
structures, or include features that cause the prongs to meet and
interlock upon installation, to form substantially closed
rings.
[0385] Referring back to FIGS. 110 and 111, the instrument of the
present embodiment may also include third tube 2080, which may
terminate with expander collar 2081. Affixed at the distal end of
expander collar 2081 is positioner 2090, shown in a pre-deployment
shape in FIGS. 110 and 111.
[0386] The pre-deployment shape of positioner 2090, shown in FIGS.
110 and 111, can facilitate insertion of the instrument into the
patient. Positioner 2090 may be made of a suitable elastic and
flexible polymeric material having shape memory, manufactured so as
to be biased to assume a normally transversely oriented shape as
shown in FIG. 112, upon retraction of actuator rod 2092. As shown
in FIG. 112, positioner 2090 may have situated thereabout one or
more drainage holes 2091 which can permit urine, fluids or clotted
material to drain into third tube 2080 after the instrument has
been deployed. Positioner 2090 may be, alternately, moved to a
pre-deployment position shown in FIGS. 110 and 111, or allowed to
return via shape memory to a normal position shown in FIG. 112, by
longitudinal movement of rod 2092, and correspondingly, end cap
2093, which may be integrally affixed to rod 2092.
[0387] As shown in FIG. 121, end cap 2093 may have thereabout one
or more flutes 2094 which can serve to allow urine or other fluids
draining out of the bladder, through drainage holes 2091 in
positioner 2090, past end cap 2093 and down into third tube 2080,
by which they can be drained out of the patient.
[0388] Outer tube 2051, second tube 2060, third tube 2080 and rod
2092 may be made of a material having suitable combined properties
of shape memory, flexibility, strength and stiffness that both
enable the tubes and rod to flex during insertion into the
patient's body and through the urethra as will be hereinafter
described, but also will prevent them from collapsing, kinking,
binding, or breaking during use. The selected material may also be
substantially non-reactive with body fluids and tissues, and be
substantially biocompatible. The inventors have determined that
nitinol, known in the art as suitable for a variety of surgical
devices and tubes, is one example of a suitable material.
[0389] It will be appreciated that hollow tubes may be used in the
instrument for third tube 2080 when a coaxial arrangement with rod
2092 is desirable, or when third tube 2080 is to serve as a
catheter, such as will be further described below, but that a rod
may be substituted for third tube 2080 and be used to provide
substantially the same mechanical function, i.e., transmission of
forces to actuate the positioner, and thus may be used when a
catheter function, or a coaxial arrangement, and thus a tube, is
not required. Conversely, a tube can serve the purpose of rod 2092.
Thus, for purposes of the claims that may be set forth, unless
otherwise specified in a claim, the term "tube" where such element
is operably affixed or connected with, or contacts, the positioner,
is intended to include and cover a rod, and vice versa.
[0390] Referring to FIG. 110, the instrument 2050 may also comprise
a movable, removable, or releasable, collar or sleeve (not shown)
sheathing fastener driver assembly 2052 and/or the space between
expander collar 2081 and fastener driver assembly 2052, so as to
give the instrument a smoother longitudinal cross-sectional
profile, to ease insertion and/or retraction of the instrument from
a patient.
[0391] A method for performing anastomosis of a patient's bladder
and urethra using the above-described anastomotic instrument,
following a prostatectomy, will now be described. Following a
prostatectomy, the patient's bladder 1 and urethra opening 6 are
separated by a void formerly occupied by the prostate, as shown in
FIG. 2. It is necessary to connect the bladder 1 with the urethra
5, with bladder opening 4 and urethra opening 6 aligned, to restore
urinary functions after recovery and healing.
[0392] As shown in FIG. 111, the anastomotic instrument may be
inserted upwardly into and through the patient's urethra 5, through
the bladder opening 4, and into the bladder 1. The surgeon then may
proximally retract rod 2092 and correspondingly, end cap 2093,
which allows positioner 2090 to assume its normal shape via shape
memory, as shown in FIG. 112. The now-transverse orientation of
positioner 2090 will prevent it from being retracted without
pulling bladder wall 2 surrounding bladder opening 4 with it.
[0393] Next, the surgeon may proximally retract third tube 2080,
and correspondingly, expander collar 2081, drawing expander collar
2081 inside and between distal fastener anvils 2062, to the
position shown in FIG. 113. Drawing expander collar 2081 inside and
between distal fastener anvils 2062 will urge distal fastener
anvils 2062, and correspondingly, flexible fingers 2061 (shown in
FIG. 110) radially outwardly as indicated in FIG. 113. This
movement of flexible fingers 2061 radially outwardly forces
fastener set 2070, residing on and around flexible fingers 2061
below distal fastener anvils 2062, to expand in diameter and
circumference, via deformation of serpentine links 2071 (shown in
detail in FIG. 119).
[0394] Next, the surgeon may retract the entire instrument
downwardly through the urethra, which will cause positioner 2090 to
pull bladder walls 2 surrounding bladder opening 4 into contact
with pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, to the position shown in FIG. 114.
[0395] Next, outer tube 2051 may be moved distally, while second
tube 2060 and the remaining portions of the instrument are held
immobile. As can be appreciated from FIGS. 115 and 116, this
movement correspondingly moves proximal fastener anvils 2054 toward
distal fastener anvils 2062, such that they opposingly contact,
urge and deform upper and lower prongs of fasteners 2072 of
fastener set 2070 such that they are pushed into the surrounding
tissues of the bladder wall and pelvic floor, such that they form
substantially opposing, joined hooks in the respective tissues, or
even, possibly, ring shapes (see also FIG. 120). The fasteners,
thus installed, can serve to secure the tissues of the bladder wall
2 to the tissues of the pelvic floor 7, proximate the openings of
the bladder and urethra, with these openings aligned.
[0396] Next, the surgeon may move outer tube 2051 proximally while
holding second tube 2060 immobile, causing proximal fastener anvils
2054 and distal fastener anvils 2062 to release their grip on
fasteners 2072 and move apart, to the position shown in FIG. 117.
The surgeon then may move third tube 2080 and correspondingly,
expander collar 2081, distally while holding second tube 2060
immobile, pushing expander collar 2081 distally out from between
upper anvils 2062 and flexible fingers 2061, permitting flexible
fingers 2061 and upper anvils 2062 to return to their
pre-deployment positions, circumscribing a circle of a diameter
smaller than that of the now-enlarged, deployed fastener set, so as
to permit retraction of the fastener driver assembly
therethrough.
[0397] Next, entire fastener driver assembly 2052, comprising outer
tube 2051, flexible fingers 2053, proximal fastener anvils 2054,
second tube 2060, flexible fingers 2061 and distal fastener anvils
2062, may be retracted from the patient, leaving behind third tube
2080, expander collar 2081, positioner 2090, rod 2092 and end cap
2093 as shown in FIG. 118. Remaining positioner 2090 and third tube
2080 may now be used to exert supplemental downward pressure on
bladder walls 2 surrounding the bladder opening so as to enhance
contact and knitting between the tissues of bladder walls 2
surrounding the bladder opening, and the tissues of pelvic floor 7
surrounding the urethra opening. Additionally, or alternatively,
positioner 2090, including drainage holes 2091, and third tube 2080
may now be used to seal off the junction between the bladder and
urethra and drain urine, fluids and/or clotted material from the
bladder during recovery and healing. Fluids are permitted to flow
past end cap 2093 via flutes 2094 in end cap 2093, shown in FIG.
121. Used for this purpose, third tube 2080 would be connected to a
urine collection bag (not shown) via intermediate tubing. Following
recovery and healing, rod 2092 and correspondingly end cap 2093 are
moved distally with respect to third tube 2080, thus urging
positioner 2090 into its pre-deployment position shown in FIGS. 110
and 111, and enabling retraction of these remaining parts of the
instrument out of the bladder, down through the urethra, and out of
the patient's body.
[0398] Those skilled in the art of the design of mechanical
surgical devices will appreciate that a variety of simple
mechanical devices may be configured or adapted to operate and hold
outer tube 2051, second tube 2060, third tube 2080 and rod 2092, at
the proximal end of the instrument as required by the above steps,
and so as to move and hold the instrument in respective
pre-deployment and/or retracted, and deployed and actuated,
positions, including the handle assembly depicted in FIGS. 83 and
85 and described above, or a variation thereof.
[0399] It will be appreciated by those skilled in the art of design
of mechanical surgical devices that the positioner need not be
limited to the embodiment made of flexible and elastic polymeric
shape memory material as described immediately above, but that
alternative designs for such positioner are possible, which cause
the positioner to assume, alternately, a retracted position and a
deployed position, the deployed position suitable for catching in
the bladder opening and urging the bladder into contact with the
pelvic floor, in response to forces exerted or transmitted by tubes
or other members. The positioner may comprise, for example, any of
the positioner assemblies depicted in FIGS. 14, 19, 24 and 57, and
described above. Similarly, it will be appreciated by those skilled
in the art of design of mechanical surgical devices that the
fastener driver assembly need not be limited to the two-tube
assembly described herein, but that alternative designs for such an
assembly are possible, which can cause the fastener driver assembly
to install one or more fasteners in the tissues of the bladder and
the urethra about the respective openings of these lumens when they
are brought together, in response to forces exerted or transmitted
by tubes or other members.
[0400] As previously noted, the combination of tubes, positioner
and driver assembly may be configured in an instrument adapted for
a retrograde anastomosis procedure, as described above, or
configured in an instrument adapted for an antegrade procedure. In
an antegrade procedure, instead of being inserted upwardly through
the urethra, and into the bladder opening proximate the site of
excision of the prostate, the instrument is inserted downwardly
through a small incision in the patient's abdomen, through a small
incision on an upper surface of the patient's bladder, into the
bladder, through the bladder opening, and into the urethra opening.
The small incisions in the abdomen and upper surface of the bladder
may be made with a cannula and trocar assembly and held open by the
cannula for insertion of the instrument therethrough.
Lodging Member Embodiment
[0401] FIG. 122 illustrates in longitudinal cross-section another
embodiment of an anastomotic instrument 2010 of the present
invention, in its pre-deployment position. The instrument may
comprise inner tube 2011, outer tube 2012 and rod 2019, which may
be of sizes such that inner tube 2011 can be placed and be movable
within outer tube 2012, and rod 2019 can be placed and be movable
within inner tube 2011, in an approximately coaxial arrangement.
Inner tube 2011, outer tube 2012 and rod 2019 may be made of a
material having suitable combined properties of shape memory,
flexibility, strength and stiffness that both enable the tubes to
flex during insertion into the patient's body and through the
urethra as will be hereinafter described, but also will prevent
them from collapsing, kinking, binding, or breaking during use. The
selected material may also be substantially non-reactive with body
fluids and tissues, and be substantially biocompatible. The
inventors have determined that nitinol, known in the art as
suitable for a variety of surgical devices and tubes, is an example
of suitable material.
[0402] As shown in FIG. 122, instrument 2010 comprises positioner
2017. In its pre-deployment position positioner 2017 may be
substantially cylindrical, having a radius smaller or approximately
equal to the radius of first tube 2012, and may have a rounded
distal end. The pre-deployment shape of positioner 2017 will
facilitate insertion of the instrument into the patient. Positioner
2017 may be made of a suitable elastic and flexible polymeric
material having shape memory, manufactured so as to be biased to
assume a normally transversely-oriented shape as shown in FIG. 124,
upon retraction of rod 2019. As shown in FIG. 124, positioner 2017
may have, about its perimeter, one or more drainage holes 2018
which can permit urine, fluids or clotted material to drain into
inner tube 2011 when the instrument is deployed.
[0403] Instrument 2010 may also comprise lodging member 2013.
Lodging member 2013 also may be a tube-like member, with a proximal
end 2015 affixed to the distal end of outer tube 2012, and a distal
end 2014 affixed to the distal end of inner tube 2011. In the
present embodiment lodging member 2013 is operable upon deployment
to present transversely-extending ribs or other projections that
enable it, upon appropriate placement and longitudinal compression,
to lodge within the patient's urethra. As shown in FIG. 126,
lodging member 2013 may have a series of circumferential,
pre-formed folds 2016, which enable lodging member 2013 to
longitudinally compress when outer tube 2012 is pushed in a distal
direction while inner tube 2011 is held immobile. Thus, upon
longitudinal compression, lodging member 2013 can fold in
accordion-like fashion to present transversely-extending ribs or
other projections that when in position within the patient's
urethra, can serve to lodge the instrument in place. Lodging member
2013 may be formed of polyurethane but may also be formed of any
other suitable material.
[0404] Referring again to FIG. 122, rod 2019 is capped with end cap
2020, which may be rounded and adapted to spread the force exerted
by rod 2019 against the inside of positioner 2017 so as to prevent
rod 2019 from puncturing positioner 2017. Referring to FIG. 127,
end cap 2020 may have thereabout one or more flutes 2021 which can
allow urine, fluids or clotted material to flow past end cap 2020
when rod 2019 is retracted. As affixed to rod 2019, end cap 2020 is
substantially integral therewith.
[0405] It will be appreciated that hollow tubes may be used in the
instrument for inner tube 2011 and outer tube 2012 when a coaxial
arrangement is desirable, or when one or more of these members is
to serve as a catheter, such as will be further described below,
but that one or more rods may be substituted for tubes and be used
to provide substantially the same mechanical functions, i.e.,
transmission of forces to actuate the positioner and the lodging
member, and thus, may be used when a catheter function, or a
coaxial arrangement, and thus a tube, is not required. Thus, for
purposes of the claims that may be set forth, unless otherwise
specified in a claim, the term "tube" is intended to include and
cover a rod.
[0406] A method for performing anastomosis of a patient's bladder
and urethra, using the above-described retrograde anastomotic
instrument, following a prostatectomy, will now be described.
Following a prostatectomy, the patient's bladder 1 and urethra
opening 6 are separated by a void formerly occupied by the
prostate, as shown in FIG. 2. It is necessary to connect the
bladder 1 with the urethra 5, with bladder opening 4 and urethra
opening 6 aligned, to restore urinary functions after recovery and
healing.
[0407] As shown in FIG. 123, anastomotic instrument 2010 may be
inserted upwardly into and through the patient's urethra 5 (as can
be appreciated from FIG. 127), through the bladder opening 4, and
into the bladder 1. The surgeon may then proximally retract rod
2019 with attached end cap 2020, which will allow positioner 2017
to assume its normal shape, which extends transversely to the
longitudinal axis of the instrument within the bladder, beyond the
diameter of the bladder opening 4, as shown in FIG. 124. The
now-transverse orientation of positioner 2017 prevents it from
being retracted without pulling bladder wall 2 surrounding bladder
opening 4 with it.
[0408] Next, the surgeon may retract the entire instrument
downwardly through the urethra, which causes positioner 2017 to
pull bladder walls 2 surrounding bladder opening 4 into contact
with pelvic floor 7, with bladder opening 4 and urethra opening 6
aligned, in the position shown in FIG. 125.
[0409] Next, outer tube 2012 may be moved distally, while inner
tube 2011 is held immobile. As can be appreciated from FIG. 126,
because the proximal end of lodging member 2013 is affixed to the
distal end of outer tube 2012 at point A, and the distal end of
lodging member 2013 is affixed to the distal end of inner tube 2011
at point B as shown, this distal movement of outer tube 2012
relative to immobile inner tube 2011 will cause longitudinal
compression of lodging member 2013. Pre-formed circumferential
folds 2016 in lodging member 2013 cause lodging member 2013 to
compress in accordion-like fashion, resulting in the presentation
of transversely-extending ribs as shown, which enable the lodging
member 2013, and consequently, the entire instrument, to lodge in
the urethra in the position shown in FIG. 126.
[0410] As shown by way of example but not of limitation in FIGS.
131-133, lodging member 2013 may be configured in various
embodiments as shown, such as including perforations which can
serve to alleviate radial stresses in the material and thereby
facilitate deployment, and also cause lodging member 2013 to
present transversely-extending projections 2042, when
longitudinally compressed, enhancing its effectiveness in lodging
within the urethra. Lodging member 2013 may also be manufactured so
as to have a rough outer surface, which can also serve to enhance
its effectiveness in lodging within the urethra. It may be
desirable to design the lodging member so that any lodging
projections that enhance its effectiveness in lodging within the
urethra are limited in length so as not to substantially pierce or
penetrate surrounding tissues, so as to minimize the possibility of
causing permanent damage to sensitive areas in the tissues.
[0411] Those skilled in the art of the design of mechanical
surgical devices will appreciate that a variety of simple
mechanical devices may be configured or adapted to operate and hold
inner tube 2011, outer tube 2012 and rod 2019 at the proximal end
of the instrument as required by the above steps, and so as to move
and hold the instrument in respective retracted, and then deployed
and lodged, positions, including the handle assembly depicted in
FIGS. 83 and 85 and described above, or a variation thereof.
[0412] In the lodged position shown in FIG. 126, the instrument may
be used to hold the bladder wall 2 surrounding the bladder opening
4 in contact with the pelvic floor 7 surrounding the urethra
opening 6 with bladder opening 4 and urethra opening 6 aligned,
during the period of time necessary for these tissues to knit and
heal together naturally.
[0413] While the instrument is lodged in position shown in FIG. 126
during the time required for healing, urine, fluids and/or clotted
material may be drained out of bladder 1 via drainage holes 2018 in
positioner 2013, and flow past end cap 2020 of rod 2019 through
flutes 2021 in end cap 2020 (shown in enlarged perspective view in
FIG. 127), and generally out of the patient via inner tube 2011. As
shown in FIG. 128, the instrument may be connected via tubing to a
urine collection bag 2023.
[0414] It will be appreciated by those skilled in the art of design
of mechanical surgical devices that the positioner need not be
limited to the embodiment made of flexible and elastic polymeric
shape memory material as described herein, but that alternative
designs for such positioner are possible, which cause the
positioner to alternately assume a retracted position and a
deployed position, the deployed position suitable for catching in
the bladder opening and urging the bladder into contact with the
pelvic floor, in response to forces exerted or transmitted by tubes
or other members. The positioner may comprise, for example, any of
the positioner assemblies depicted in FIGS. 14, 19, 24 and 57, and
described hereinabove. Similarly, it will be appreciated by those
skilled in the art of design of mechanical surgical devices that
the lodging member need not be limited to the hollow pre-folded
polyurethane member described herein, but that alternative designs
for such lodging member are possible, which cause the lodging
member to alternately assume a retracted position and a deployed
position, the deployed position presenting one or more ribs or
projections that enable the lodging member to lodge within the
urethra, in response to forces exerted or transmitted by tubes or
other members.
[0415] As previously noted, the combination of tubes, positioner
and lodging member may be configured in an instrument adapted for a
retrograde anastomosis procedure, as described above, or configured
in an instrument adapted for an antegrade procedure, as will now be
described. In an antegrade procedure, instead of being inserted
upwardly through the urethra, and into the bladder opening
proximate the site of excision of the prostate, the instrument is
inserted downwardly through a small incision in the patient's
abdomen, through a small incision on an upper surface of the
patient's bladder, into the bladder, through the bladder opening,
and into the urethra opening. The small incisions in the abdomen
and upper surface of the bladder may be made with a trocar and
cannula assembly (not shown), and held open by the cannula for
insertion of the instrument therethrough.
[0416] As shown in FIG. 129, an antegrade anastomotic instrument
2030 may comprise outer tube 2031, first inner tube 2032 and second
inner tube 2034. Similar to the retrograde anastomotic instrument
described previously, these tubes may be sized such that first
inner tube 2032 can be placed and be longitudinally movable within
outer tube 2031, and second inner tube 2034 can be placed and be
longitudinally movable within first inner tube 2032. First inner
tube 2032 may have one or more drainage passages 2033 at its distal
end. Second inner tube 2034 may have one or more drainage passages
2035 at its distal end.
[0417] End cap 2036 may be affixed to the distal end of second
inner tube 2034. As shown, end cap 2036 may have a rounded distal
end that facilitates insertion of the instrument, and an extended
section 2037 that terminates at rim 2038.
[0418] As shown in FIG. 129, instrument 2030 may also comprise
lodging member 2013, which may be similar to the lodging member of
the retrograde anastomotic instrument previously described, and can
also be configured as shown by way of example in FIGS. 131-133.
Referring again to FIG. 129, lodging member 2013 may be affixed at
its proximal end to the distal end of first inner tube 2032 (at
point A as shown), and is affixed at its distal end to extended
section 2037 of end cap 2036 beneath rim 2038 (at point B as
shown). Thus, it can be appreciated that moving second inner tube
2034 longitudinally with respect to first inner tube 2032 will
cause either, alternately, longitudinal extension, or longitudinal
compression of lodging member 2013, and that extension of lodging
member 2013 will cause ribs or projections presented thereby to
retract into the pre-deployment position, and compression of
lodging member 2013 causes ribs or projections presented thereby to
extend to the deployed position (shown in FIG. 129), in a manner
substantially similar to that of the lodging member of the
retrograde anastomotic instrument previously described.
[0419] Antegrade anastomotic instrument 2030 also comprises
positioner 2017. Similar to the positioner of the retrograde
anastomotic instrument previously described, in its pre-deployment
position positioner 2017 may be substantially cylindrical.
[0420] The pre-deployment shape of positioner 2017 facilitates
insertion of the instrument. Positioner 2017 may be made of a
suitable elastic and flexible polymeric material having shape
memory, manufactured so as to be biased to normally assume a
transversely-oriented shape as shown in FIG. 129, upon retraction
of first inner tube 2032 relative to outer tube 2031. Positioner
2017 may be affixed at its proximal end to the distal end of outer
tube 2031 (at point C as shown in FIG. 129), and may be affixed at
its distal end to the distal end of first inner tube 2032 (at point
A as shown as FIG. 129).
[0421] Thus, it can be appreciated that longitudinal movement of
outer tube 2031 with respect to first inner tube 2032 will cause
positioner 2017 to assume its retracted, pre-deployment cylindrical
position (similar to that shown in FIG. 122), or its deployed
position as shown in FIG. 129.
[0422] As shown in FIG. 129, positioner 2017 may have, situated
thereabout, one or more drainage holes 2018 which can permit urine,
fluids or clotted material to drain, through drainage passages 2033
in first inner tube 2032, though drainage passages 2035 in second
inner tube 2034, and into second inner tube 2034.
[0423] A method for performing anastomosis of a patient's bladder
and urethra using the above-described antegrade anastomotic
instrument, following a prostatectomy, will now be described, with
reference to FIG. 2 for identification of parts of the patient's
anatomy and FIG. 129 for identification of parts of the instrument.
Following a prostatectomy, the patient's bladder 1 and urethra
opening 6 are separated by a void formerly occupied by the
prostate, as shown in FIG. 2. It is necessary to connect the
bladder 1 with the urethra 5 with bladder opening 4 and urethra
opening 6 aligned, to restore urinary functions after recovery and
healing.
[0424] A cannula with a trocar (not shown) is inserted into the
patient's abdomen, and through an upper surface of the patient's
bladder. The trocar is then removed and the cannula is left in
place. The antegrade anastomotic instrument in its pre-deployment
position is inserted into the cannula, until the entire positioner
2017 is within the bladder lumen. The surgeon then may move outer
tube 2031 in a distal direction with respect to first inner tube
2032, or alternatively or simultaneously, move first inner tube
2032 in a proximal longitudinal direction with respect to outer
tube 2031. This relative movement of the outer tube 2031 and first
inner tube 2032 will permit positioner 2017 to assume its
transversely-oriented position, shown in FIG. 129. The surgeon then
may manipulate the instrument to locate the bladder opening 4 with
end cap 2036, and insert end cap 2036 through bladder opening 4.
Positioner 2017 in its deployed position will contact bladder wall
2 and catch in bladder opening 4, and cannot pass therethrough. The
surgeon then may manipulate the instrument to urge bladder wall 2
surrounding bladder opening 4 downward toward pelvic floor 7, and
further manipulate the instrument to locate urethra opening 6, and
insert end cap 2036 into urethra opening 6. Thus, bladder wall 2
surrounding bladder opening 4 may be urged into contact with pelvic
floor 7 surrounding urethra opening 6, with bladder opening 4 and
urethra opening 6 aligned. Next, holding outer tube 2031 and first
inner tube 2032 immobile, the surgeon may retract second inner tube
2034 proximally. This will cause longitudinal compression of
lodging member 2013, so that it will assume the position shown in
FIG. 129, and lodge within the urethra.
[0425] Those skilled in the art of design of mechanical surgical
devices will appreciate that a variety of simple mechanical devices
may be configured to operate and hold outer tube 2031, first inner
tube 2032 and second inner tube 2034 by actuation and manipulation
at the proximal end of the instrument as required by the above
steps, and so as to operate the instrument and hold it in the
lodged position, including the handle assembly depicted in FIGS. 83
and 85 and described above, or a variation thereof.
[0426] In the lodged position, the instrument may be used to hold
the bladder wall 2 surrounding the bladder opening 4 in contact
with the pelvic floor 7 surrounding the urethra opening 6 with
bladder opening 4 and urethra opening 6 aligned, during the period
of time necessary for these tissues to knit and heal together
naturally.
[0427] While the instrument is lodged in position during the time
required for healing, urine and other fluids may be drained out of
bladder 1 via drainage holes 2018 in positioner 2017, through
drainage passages 2033 and 2035, and generally out of the patient
via second inner tube 2034. As shown in FIG. 129, the instrument
may be connected via tubing to a urine collection bag 2023.
[0428] FIG. 130 depicts an alternative embodiment of instrument
2030. As compared with the embodiment depicted in FIG. 129, first
inner tube 2032 may be reduced in radius and second inner tube 2039
may be a rod. Second inner tube 2039 may terminate at its distal
end with end cap 2036, having rim 2038 and extended section 2037.
Use and function of the instrument depicted in FIG. 130 may be
substantially similar to use and function of the instrument
depicted in FIG. 129, except that following deployment and lodging
of the instrument, urine and other fluids can be drained from the
bladder through drainage holes 2018 in positioner 2017, and
directly into outer tube 2031, which is connected to urine
collection bag 2023, eliminating the necessity for additional
drainage passages 2033, 2035 in internal tubes within the
instrument as shown in FIG. 129.
[0429] Other Refinements
[0430] The exemplary embodiments described herein for an instrument
in accordance with the present invention comprise one or more tubes
and/or rods, used for the translation of forces and movement from a
proximal handle assembly to an assembly or assemblies proximate to
a distal end of an instrument, and also, potentially, used as
catheters for, among other purposes, the transmission of gas or
fluid pressure, and the draining of urine or other fluids during
recovery and healing. The inventors have determined that nitinol,
which when suitably treated and formed, has combined properties of
strength, flexibility, elasticity, stiffness, hardness and
biocompatibility that make it suitable as a material for such
members, by way of example. Other materials may suffice,
particularly when one or more of the above-mentioned properties may
not be so stringently required. Thus, for example, a polymer such
as styrene might be used where it is not necessary, for example, to
translate force and movement (such as, for example, when the tube
functions only as a catheter). Of course, any other materials
having the necessary properties for the particular application may
be used.
[0431] With respect to instruments designed for a retrograde
post-prostatectomy bladder-urethra anastomosis procedure such as
described herein, it may be desirable to have a bend angle in the
tube assembly, such as in tube assembly 500 (FIG. 3), tube assembly
3200 (FIG. 134), or other tube assembly supporting an end effector.
A bend proximate to the end effector assembly, of about 80 to about
90 degrees (expressed as the angle at which a distal portion of the
tube assembly is bent away from a straight axis projected distally
from a proximal portion of the tube assembly), and preferably about
85 degrees (wherein the tube assembly defines an obtuse angle of
about 95 degrees), may be desirable. Such a bend angle may serve to
better facilitate manipulation of the instrument within the
anatomical architecture involved in the procedure, and facilitate
control of the positioning of the end effector assembly within the
bladder lumen to enable driving anchors at a desired or selected
angle with respect to the pelvic floor.
[0432] In order to be most effective at operating within the
limited space provided by the anatomical architecture involved in a
procedure to effect anastomosis of the bladder and urethra
following a prostatectomy, it is desirable that the end effector
assembly, including any positioner assembly, anchor driver assembly
and/or end cap or harness assembly, be limited in length.
Preferably, but not by way of limitation, the length of the end
effector assembly, following opening of the positioner, will be
less than about 2 inches, and more preferably, less than about 11/2
inches, from the proximal surfaces of the positioner when opened to
the distal end of the instrument. For similar reasons, for an
instrument of the present invention designed for use in a
retrograde procedure (involving insertion upwardly through the
urethra), the size of the urethra and other anatomical features
make it preferable that the end effector and the tube assembly be
limited to a diameter of about 28 french, or about 9.3
millimeters.
[0433] The inventors also have determined that it may be
advantageous for an instrument configured for retrograde insertion
(upwardly into and through the urethra) to have a detachable and
reattachable, or detached and attachable, end effector assembly.
For example, if the end effector assembly (comprising a positioner
assembly and an anchor driver assembly such as positioner 400 and
anchor driver 300 shown in FIG. 3, shuttlecock assembly 800 shown
in FIG. 17, umbrella assembly 900 shown in FIG. 22, or end effector
assembly 3400 shown in FIG. 134) is detached from and attachable to
the supporting tube assembly or other supporting longitudinal
member assembly, the end effector assembly may be separate or
detached from the supporting assembly prior to insertion. The
supporting assembly may then be inserted through the urethra
without the end effector assembly, which may ease insertion and
eliminate the possibility for components of the end effector
assembly, otherwise attached, to catch or cause tissue damage
within the urethra during insertion. Upon insertion, and after the
distal end of the supporting assembly is past the urethra and/or
above the pelvic floor, the end effector assembly may be introduced
into the patient's abdomen via a cannula through the abdominal
wall, and attached to the supporting assembly for use in the
anastomosis procedure, using any suitable means of guidance such as
an endoscope, external imaging techniques and/or tactile feel. It
can be appreciated that the supporting assembly and the end
effector assembly can have a variety of designs that enable
operable connection of their respective structural and operational
members to effect attachment and operability of the end effector
assembly.
[0434] Tubes, rods or other members that are to be inserted and/or
remain inside the patient for a substantial period of time during
the anastomosis procedure, such as but not limited to central rod
or guide wire 3230, catheter tube 3510 (FIGS. 141-144) and/or other
components may be provided with an antimicrobial coating, such as
that described in copending U.S. patent application Publication No.
2004/0220614. Additionally or alternatively, such components may be
provided with a hydrophilic or other friction-reducing coating.
[0435] Several embodiments of a method for effecting anastomosis of
the bladder and urethra following a prostatectomy, as depicted and
described herein, involve the driving of anchors into the pelvic
floor. In such a procedure it may be desirable for anchors to be
driven into the pelvic floor in locations that avoid sensitive
areas and thus reduce the potential for complications. For example,
referring to FIG. 147, it may be desirable to avoid driving anchors
into areas proximate to the dorsal veins D of the penis, other
neurovascular bundles N, the rectum R, or other sensitive
anatomical features. Accordingly, referring to FIG. 147, the
inventors have determined that anchors are preferably driven into
the pelvic floor at locations within the zones of about 8 to about
10 o'clock, and about 2 to about 4 o'clock, about the urethra U, as
shown at "A" and "B" respectively in FIG. 147. More preferably, as
may be the case, for example, with use of the balloon and harness
systems depicted and described herein, two anchors are driven into
the pelvic floor at locations at about 9 and about 3 o'clock about
the urethra.
[0436] It also is important, when using an instrument of the
present invention to install anchors, to avoid driving anchors
into, through or across the ureteric orifices of the bladder. The
various embodiments of an instrument described herein facilitate
avoidance of this event.
[0437] Anchors
[0438] As described herein, anchors 700 or other suitable fasteners
perform a holding function, holding the bladder wall to the pelvic
floor and/or holding a harness to the bladder wall and/or pelvic
floor. Each of the anchoring and/or fastening features discussed
herein is only exemplary of a large number of designs and
configurations possible within the scope of the invention.
[0439] An anchor 700 or other fastener may have one or more
suitable lodging structures that function to cause the anchor to
lodge in tissues after being driven thereinto, so as to resist
withdrawal from the tissues. Such lodging structures may comprise
barbs, circumferential ridges, projections or any other features
effective to cause the anchor to lodge in the tissues when driven
into them. The size, shape and number of suitable lodging
structures may vary. Additionally, the inventors have determined
that, whenever barbs are included on an anchor it may be desirable
when manufacturing such an anchor, to round off, or radius, the
protruding ends of the barbs (as viewed from the anchor forward
end), in order to reduce the possibility that the barbs will snag
on loose bladder wall tissue during insertion and opening of an
anchor driver assembly, on which the anchor is loaded, inside the
bladder.
[0440] An anchor or other fastener may also have a head or other
suitable penetration-limiting structure that may function to limit
the depth to which the anchor or other fastener may be driven and
may also function to assist in securing proximal tissues to
underlying, distal tissues. It will be appreciated that such a
penetration-limiting structure need not necessarily be located at
the rearward end of an anchor shaft to be effective.
[0441] It may be desirable that the forward end of an anchor be
pointed or have a chisel-like shape, to facilitate more effective
and/or less damaging penetration of tissues. Additionally, the
inventors have determined that a point formed on the forward end of
a cylindrical anchor shaft comprising three sloping flat faces in
planes intersecting each other at equal angles, facilitates
penetration of the anchor into tissues in a manner that minimizes
the potential for the anchor to veer off-target or off-direction
during driving.
[0442] When used to secure the walls of the bladder to the pelvic
floor, it may be desirable for anchors to be of a length sufficient
to penetrate through the bladder walls and the fascia layer of the
pelvic floor. For example but not by way of limitation, such
anchors are preferably about 1/2-inch to 21/2-inches in length. For
anchors that are to be installed near the rectum, it may be
desirable for them to be at the shorter end of the preferred range
of length.
[0443] Anchors 700 or other suitable fasteners may be formed from a
substantially biocompatible polymer or metal. Where shape memory
and elasticity may be desired, anchors may be manufactured using
elements made of an elastic material, such as an elastic metal
alloy or a thermally activated or activatable alloy, such as a
nickel-titanium alloy (for example nitinol) or stainless steel
alloy, so that the anchors or other fasteners may be preformed and
biased with shaped ends or barbs along the shaft, which can be
deployed by pushing them out of an instrument so that when they
pass into the target tissue, they resume their shape within the
target tissue.
[0444] If bioabsorbability is desired, anchors 700 or other
suitable fasteners may be formed of a suitably substantially
biocompatible and bioabsorbable material. The inventors have
determined that flexible absorbable polymers (e.g., polydioxanone
polymers, or polymers containing lactides, glycolides, polyglactin,
etc., such as the polymers marketed by Johnson & Johnson and/or
Ethicon, Inc. under the trademarks "Vicryl" and "PDS II") are
potentially suitable materials. Other bioabsorbable materials
having the necessary physical properties may be used.
[0445] When used to anchor harness straps for a balloon and harness
system such as depicted and described herein, bioabsorbable anchors
may be used to provide a bioabsorbable harness release mechanism
that avoids the necessity for, or reduces the importance of, a
structure or device capable of attaching a harness to, and then
releasing a harness from, an anchor by mechanical means. By way of
example but not of limitation, referring to FIG. 145, it can be
appreciated that if a structure such as harness hook 760 on anchor
700 is bioabsorbable, with a time degradation characteristic that
corresponds to the time required for the anastomosis procedure, the
degradation and dissolution of harness hook 760 through
bioabsorption will serve to release harness 3430, facilitating
removal from the patient.
[0446] Additionally, there may be situations when the control of
the degradation and absorption profile and/or particle breakup size
of a bioabsorbable anchor or other suitable fastener may be
desirable. For example, should one or more pieces of a
bioabsorbable anchor, such as, for example, the head of an anchor,
break away in a large piece as the anchor material is degrading
after deployment, it could cause a blockage. Accordingly,
bioabsorbable anchors or other suitable fasteners may be designed
and manufactured in a manner in which degradation rates and
particle breakup size may be controlled. For example, a
bioabsorbable anchor or other fastener may be formed with a cast,
molded, embossed or machined-in arrangement of scoring,
perforation, or grooving that creates areas of reduced thickness
and increased stress of the part in selected locations, encouraging
earlier fracture proximate to such areas for the purpose of
reducing the size of portions that may break away as the material
degrades. Alternatively, or additionally, a bioabsorbable anchor or
other fastener may be formed of joined materials, or comprise
joined components, having differing degradation/absorption profiles
such that zones of faster and slower degradation within the part
may be created, such that the possibility of breakaway and release
within a body lumen of pieces that are large enough to create a
possibility of blockage or other adverse effect is reduced.
[0447] An anchor shaft may be hollow so as to slidably fit over a
driver pin, and be substantially releasably held thereon by
friction fit or any other suitable means. Alternatively, an anchor
may have a solid shaft wherein a driver pin pushes against the
proximal end of the anchor or alternatively, fits over the proximal
end of the anchor and releasably grips it by friction fit or any
other suitable means.
[0448] It would be apparent to a person having skill in the art
field that there are various designs for anchors that would be
effective for anchoring the bladder to the pelvic floor over the
urethra opening. Anchors may be provided that have a plurality of
shafts, barbs and tips operatively linked to a driver assembly. It
is not necessary that the anchors are individual anchors, only that
each anchor's size and shape, alone or in combination, are
sufficient to effect and maintain contact between proximal and
underlying, distal target tissues for an appropriate period of
time.
[0449] In still a further embodiment, an anchor may be formed of a
bimetallic or other combination of at least two materials having
differing expansion properties, that will cause the part formed
therefrom to take a desired shape after heating, for example, by
the patient's body. In such a case, the anchor would be supplied in
a cold or room-temperature state and then allowed to attain the
final desired shape after installation, when heated by the
patient's body.
[0450] Although nitinol may be used in this service because of its
physical properties and its significant history in implantable
medical devices, it may also be suitable for use as an anchor
because of its overall suitability for use in conjunction with or
contemplation of use of magnetic resonance imaging (MRI)
technology.
[0451] In summary, numerous benefits are apparent which result from
employing the concepts of the invention. The foregoing description
of one or more embodiments of the invention has been presented for
purposes of illustration and description. It is not intended to be
exhaustive or to limit the invention to the precise form disclosed.
Obvious modifications or variations are possible in light of the
above teachings. The embodiments were chosen and described in order
to best illustrate the principles of the invention and its
practical application to thereby enable one of ordinary skill in
the art to best utilize the invention in various embodiments and
with various modifications as are suited to the particular use
contemplated. It is intended that the scope of the invention be
limited only by the claims appended hereto.
* * * * *