U.S. patent application number 12/204806 was filed with the patent office on 2009-08-27 for methods and apparatus for treating pelvic floor prolapse.
Invention is credited to Vaso Adzich, Stephen G. Bell, Alessandro D'Afiero.
Application Number | 20090216075 12/204806 |
Document ID | / |
Family ID | 40998984 |
Filed Date | 2009-08-27 |
United States Patent
Application |
20090216075 |
Kind Code |
A1 |
Bell; Stephen G. ; et
al. |
August 27, 2009 |
Methods and Apparatus for Treating Pelvic Floor Prolapse
Abstract
This invention relates to a surgical implant system for
repairing pelvic prolapse in a patient. In particular, the present
invention relates to an implant, a delivery device and a method for
implanting and securing the implant to tissue structures in the
pelvic region of the body.
Inventors: |
Bell; Stephen G.; (Rome,
IT) ; Adzich; Vaso; (Santa Ana, CA) ;
D'Afiero; Alessandro; (Prov. Di Napoli, IT) |
Correspondence
Address: |
SCOTT EVANS
1252 COUNTRY HILLS DR.
SANTA ANA
CA
92705
US
|
Family ID: |
40998984 |
Appl. No.: |
12/204806 |
Filed: |
September 5, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61030439 |
Feb 21, 2008 |
|
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|
Current U.S.
Class: |
600/37 ; 128/898;
606/151; 606/99 |
Current CPC
Class: |
A61B 2017/00477
20130101; A61B 2017/00805 20130101; A61B 2017/00438 20130101; A61B
17/3423 20130101; A61F 2/0045 20130101; A61B 17/0293 20130101; A61B
46/30 20160201; A61B 17/0625 20130101; A61B 2017/003 20130101; A61B
17/06066 20130101 |
Class at
Publication: |
600/37 ; 606/99;
606/151; 128/898 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61B 17/58 20060101 A61B017/58; A61B 17/08 20060101
A61B017/08; A61B 19/00 20060101 A61B019/00 |
Claims
1. An apparatus for treating pelvic floor disorders comprising: an
implant having at least one arm extending from the implant that is
adapted to secure the implant to a tissue structure, a delivery
device having a housing with a passer disposed inside, said passer
configured to penetrate said tissue structure to form a generally
circular path when advanced from the housing, said passer further
adapted to couple to the arm and pull the arm through said path
when retracted.
2. The delivery device of claim 1, wherein the arm is detachably
coupled to the housing and positioned to intersect the expected
path of the passer such that a distal end of the passer couples to
the arm before the passer is retracted.
3. The delivery device of claim 1, wherein the arm is preloaded to
the housing.
4. The implant of claim 1 further comprising a mesh that is made
from a synthetic material, a biological material or a combination
of materials.
5. The arm of claim 2, further comprising a strap, cord, suture or
mesh and having an inner and an outer end.
6. The arm of claim 5, wherein the inner end of the arm includes a
connector configured to detachably couple the arm to the implant
such that the arm may be first secured to the tissue structure then
coupled to the implant.
7. The arm of claim 6, further comprising differentiators that can
be used to differentiate one arm of the implant from another arm of
the implant.
8. The differentiators of claim 7, further comprising the arm
color, shape, radiopacity, materials of construction or physical
structure.
9. The connector of claim 6, comprising a mechanical fastener, hook
and loop type fastener, button, suture, magnetic fastener, adhesive
or clamp.
10. The arm of claim 5, wherein the arm is tapered between the ends
and further comprises a tapered sleeve, the sleeve adapted to
reduce frictional drag as the arm is secured to the tissue
structure.
11. The arm of claim 5, further comprising an inner portion and an
outer portion, the two portions detachably joined together end to
end with a removable cord such that when the cord is removed or cut
the distal portion separates from the proximal portion.
12. A delivery device for securing an arm extending from an implant
to a tissue structure comprising: a housing with a passer disposed
within, the passer configured to penetrate at least a portion of
the tissue to form a generally circular path when advanced from the
housing in a plane orthogonal to the longitudinal axis of the
housing, said passer having a connector adapted to couple to the
arm after penetrating the tissue structure, and said passer further
adapted to pull the arm back through the path when retracted.
13. The delivery device of claim 12, further comprising a pivot and
an actuator coupled to the passer, said passer having a circular
radius and configured such that as the actuator is advanced, the
passer rotates about the pivot in the generally circular path.
14. The delivery device of claim 13, wherein the arm is disposed
about the housing such that the generally circular path of the
passer intersects a portion of the arm.
15. The generally circular path of claim 12, wherein the path
encircles a sacrospinous ligament.
16. The generally circular path of claim 12, wherein the path
encircles the arcus tendineus.
17. The apparatus of claim 12, wherein the connector couples to the
arm using a magnetic coupler,
18. The apparatus of claim 12, wherein the connector couples to the
arm using a mechanical coupler.
19. The mechanical coupler of claim 18, further comprising a barb,
a spear, a threaded connector, a snap, a bayonet system, a latch, a
clamp or a jaw.
20. The delivery device of claim 12, wherein the housing is
flexible and may have a preset or flexible shape.
21. The passer of claim 12, wherein the passer is made from a super
elastic alloy having a pre-set radius, the passer being confined to
a straightened condition by an outer tube and configured such that
as the passer is advanced from the tube in a plane orthogonal to
the housing longitudinal axis, a sharpened distal end penetrates
tissue in the generally circular path.
22. The generally circular path of claim 2 1, wherein the path
encircles a sacrospinous ligament, an arcus tendineus, or other
tissue structure.
23. The delivery device of claim 12, further comprising a finger
holder configured to retain a finger of an operator such that
tactile feel of the operator can guide the delivery device to an
anatomical position.
24. An apparatus for securing an arm of a surgical implant to at
least a portion of a tissue structure comprising: a tubular housing
containing a guide, said guide adapted to penetrate the tissue
structure in a substantially circular path when advanced from the
open distal end of the housing, a strap tube connected to the arm
and disposed about the guide, a pusher disposed about the guide in
a proximal position to the strap tube, and said pusher adapted to
push the strap tube along the guide.
25. The guide of claim 24, wherein the substantially circular path
initially extends away from the housing and then returns to
intersect the housing.
26. The substantially circular path of claim 19, wherein the path
encircles sacrospinous ligament, arcus tendineus, or other tissue
structure.
27. The housing of claim 25, further comprising a catch to retain
the strap tube after the strap tube is moved along the guide by the
pusher.
28. The apparatus of claim 20, wherein the guide is a
guidewire.
29. A surgical kit for treating pelvic prolapse comprising: an
implant arm having at least one arm extending therefrom, a delivery
device for securing said arm to a portion of pelvic tissue
comprising a passer configured to penetrate at least a portion of
the pelvic tissue in a generally circular path when advanced, said
passer having a connector adapted to couple to the arm after
penetrating the pelvic tissue, and said passer adapted to pull the
arm through the path when retracted.
30. The delivery device of claim 29, further comprising a pivot and
an actuator coupled to the passer, said passer having a circular
radius and configured such that as the actuator is advanced, the
passer rotates about the pivot in a generally circular path.
31. The circular path of claim 29, wherein the path encircles a
sacrospinous ligament, arcus tendineus, or other pelvic tissue
structure.
32. The surgical kit of claim 29, further comprising a funnel
having a wide and a narrow opening and an attached drape, the wide
opening forming an opening in the drape and the narrow opening
sized for placement into a surgical incision, said funnel further
adapted to receive the implant.
33. The funnel of claim 32, further comprising a retention ring
formed at the narrow opening that is configured to retain the
funnel in the incision, said funnel configured to hold the incision
open and to allow the arm to pass through the narrow neck after
passing through the portion of the vaginal wall.
34. The funnel of claim 32, wherein said funnel is sized to permit
at least partial closure of the incision and is configured to allow
the arm to pass through the narrow neck so that the tension of the
implant may be adjusted by pulling on the arm against the narrow
neck.
35. A method of securing an implant having at least one arm to the
pelvic cavity of a patient comprising: making an incision in the
vaginal wall, positioning a delivery device having a housing into
the incision, the delivery device also having a passer, advancing
the passer from the housing and penetrating an adjacent tissue
structure in a generally circular path, coupling the passer to the
arm, retracting the passer and pulling the coupled arm back through
said path.
36. The method of claim 35, further comprising withdrawing the
delivery device and the arm from the incision.
37. The method of claim 36, wherein withdrawing the delivery device
and pulling the arm through or around said path secures the arm to
the tissue structure.
38. The method of claim 35, further comprising coupling the arm of
the implant to the housing prior to the positioning step.
39. The method of claim 35, further comprising adjusting the
tension of the arm to position the implant.
40 The method of claim 36, further comprising coupling the arm to
the implant and adjusting the tension of the arm to position and
secure the implant.
41. The method of claim 35, wherein the tissue structure includes a
sacrospinous ligament, arcus tendineus, bone or other pelvic
structure.
42. The method of claim 35, further comprising positioning the
delivery device using a finger coupled to a distal end of the
device such that an operator can position a distal end of the
delivery device using tactile feedback.
43 The method of claim 35, further comprising positioning the
delivery device using an endoscope coupled to a distal end of the
delivery device.
44. The method of claim 35, further comprising positioning a funnel
in the incision, said funnel having a wide and a narrow opening and
an attached drape, the wide opening forming an opening in the drape
and the narrow opening sized for placement into the incision,
introducing the implant through the funnel, pulling a free end of
the arm back through the funnel after securing the delivery device
to the incision.
45. The method of claim 44, further comprising temporarily securing
the funnel in the incision with a retention ring formed at the
narrow opening.
46. The method of claim 44, further comprising pulling the free end
of the arm against the narrow opening to tension the arm.
47. A method of securing an implant having at least one arm to the
pelvic floor of a patient comprising: making an incision in the
vaginal wall, positioning a delivery device having a housing and a
guide into the incision, advancing the guide through at least a
portion of a tissue structure, said guide having a proximal end
adapted to penetrate tissue structures in a generally circular
path, advancing a strap tube which is connected to the arm and
disposed about the guide, along the path of the guide by using a
pusher, said pusher being disposed about the guide.
48. The method of claim 47, further comprising extending the guide
along a generally circular path that initially extends away from
the housing and then returns to intersect the housing.
49. The method of claim 48, further comprising connecting the strap
tube to the housing, withdrawing the guide and pusher into the
housing and removing the delivery device.
50. The method of claim 49 further comprising adjusting the tension
of the arm to position the implant.
51. The method of claim 50, further comprising coupling the arm to
the implant and adjusting the tension of the arm to position and
secure the implant.
52. The method of claim 47, wherein the tissue structure includes a
sacrospinous ligament, arcus tendineus, bone or other pelvic
structure.
Description
CLAIM OF PRIORITY
[0001] This application claims priority under 35 U.S.C.
.sctn.119(e) to U.S. Provisional Application No. 60/013,619, filed
Dec. 13, 2007, and U.S. Provisional Application No. 61/030,439,
filed Feb. 21, 2008 the entire contents of which are hereby
expressly incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates to a surgical implant system for
repairing pelvic floor prolapse in a patient. In particular, the
present invention relates to an implant, a delivery device and a
method for implanting and securing the implant to tissue structures
in the pelvic region of the body.
BACKGROUND OF THE INVENTION
[0003] Pelvic floor disorders are a type of abnormality that
affects the pelvic region and is a painful and dangerous condition
whereby delicate anatomical structures can shift and even protrude
into other pelvic structures such as the bladder, rectum and
vagina. Typical pelvic floor disorders include vaginal vault;
whereby the vagina prolapses on itself usually following
hysterectomy, rectocele; a protrusion of the rectum into the
posterior vaginal wall, enterocele; a protrusion of the small bowel
into the posterior vaginal space, uterocele; a collapse of the
support for the uterus and subsequent falling into the vagina and
urethrocele; a collapse of the bladder and/or the urethra into the
anterior vaginal wall. This displacement from a normal position of
these organs is caused by damage or stretching of complex
supporting structures such as ligaments or muscles. Once these
supporting structures are compromised, artificial methods must be
utilized to restore these anatomical structures to their proper
position and provide long term securement in place. This condition
is often treated by systems that position a surgical implant, often
a mesh, into the pelvic cavity. This mesh requires some fixation
through deep structures such as ligaments or muscles or through the
skin.
[0004] The mesh implants often have straps that fix in anterior and
posterior structures. The straps are positioned using various
needle assemblies that create pathways in tissue that extend from
the pelvic cavity to the skin. These needle assemblies pass from
outside the body into the pelvic cavity to collect the straps
whereby they may be pulled outside the body and secured.
Alternatively these straps may be secured by needles that create
pathways in tissue which are passed from inside the pelvic cavity
and pass in the opposite direction to the skin outside the body.
The passage of these long needles requires considerable skill so
that the needles do not damage nerves or blood vessels present in
the needle pathways. The passage of these needles is performed
without direct visualization so considerable skill on the part of
the surgeon is required to avoid these critical structures and to
place the implant correctly. In some procedures these mesh implants
are secured directly to the pelvic region using staples or suture
and these can pull out over time and are often the cause of
considerable pain and discomfort for the patient. Thus there is a
need for an improved device and method for the treatment of pelvic
floor disorders that eliminates the passage of these needles
through delicate structures and avoids sutures or staples. A device
that can deliver and secure a strap to the pelvic region from
within the pelvic floor region without requiring long needle passes
through the skin is needed.
SUMMARY OF THE INVENTION
[0005] The present invention generally describes systems and
methods to treat pelvic floor disorders, particularly pelvic
prolapse conditions and /or urinary incontinence using single
incision techniques through the vaginal wall. In this type of
procedure, access to the pelvic floor cavity is made through the
anterior or posterior vaginal wall so that supporting structures
such as slings or mesh implants may be introduced and secured to
support the urethra, bladdemeck, vagina, bladder and pelvic floor.
Access through the vagina may be used to insert, position, tension
and fixate an implant to the pelvic floor without requiring
dangerous blind procedures described previously. Devices and
methods that utilize single incision surgery may be safer, quicker
and less traumatic for the patient.
[0006] One aspect of the invention is an apparatus for treating
pelvic floor disorders. The invention includes an implant that has
at least one arm extending from the implant. The implant arm is
adapted to secure the implant to a tissue structure by generally
passing through or around the tissue. The invention also includes a
delivery device to deliver the apparatus to the treatment area and
may have a housing with a passer disposed inside. The passer may be
configured to penetrate pelvic tissue structures in a generally
circular path when it is advanced from the housing. The passer may
be further adapted to couple to the implant arm and pull the arm
through the path when it is retracted.
[0007] In another embodiment of the invention, the delivery device
may have the arm detachably coupled to the housing and the arm may
be positioned to intersect the expected path of the passer such
that a distal end of the passer contacts and couples to the arm
before the passer is retracted. The arm may also be preloaded onto
the housing before insertion into the pelvic floor region of the
body.
[0008] In another embodiment, the arm may be positioned
independently from the implant A connector may be configured to
detachably couple the arm to the implant such that the arm may be
first secured to a tissue structure, then the implant is introduced
and the arm may be coupled to the implant. This may allow strap
placement before the implant is introduced and secured. In another
aspect the arm may have an inner portion and an outer portion with
the two portions detachably joined together end to end with a
removable cord. This cord may be removed or severed so that the
distal portion separates from the proximal portion.
[0009] Another aspect of the invention is a delivery device for
securing an arm extending from an implant to a tissue structure.
This delivery device may have a housing with a passer disposed
within. This passer may be configured to penetrate at least a
portion of the tissue structure to form a generally circular path
when it is advanced from the housing. This advancement may be in a
plane orthogonal to the housing's longitudinal axis and the passer
may have a connector adapted to couple to the arm after penetrating
the tissue structure. The passer may be used to pull the arm back
through the path when it is retracted. This delivery device may
also include a pivot and an actuator that is coupled to the passer
and this passer may have a circular radius and be configured such
that as the actuator is advanced, the passer rotates about the
pivot in the generally circular path. In general the circular path
may encircle various ligaments or pelvic tissues such as the
sacrospinous ligament or the arcus tendineus.
[0010] In one embodiment the connector described is a magnetic
coupler and in another the connector is mechanical coupler. The
delivery device may be rigid or it may be flexible and may have a
preset or flexible shape.
[0011] In another embodiment the passer may be made from a super
elastic alloy that has a pre-set radius and the passer may be
confined to a straightened condition by an outer tube and
configured such that as the passer is advanced from the tube it
penetrates tissue in a generally circular path.
[0012] Another aspect of the invention is an apparatus for securing
an arm of a surgical implant to a tissue structure. The apparatus
may have a tubular housing that contains a guide and the guide may
be adapted to penetrate the tissue in a substantially circular path
when advanced from the open distal end of the housing. The
apparatus may further include a strap tube that is connected to the
arm and disposed about the guide. Additionally a pusher may be
disposed about the guide in a proximal position to the strap tube
and the pusher may be adapted to push the strap tube along the
guide.
[0013] A further embodiment of the invention is a surgical kit for
treating pelvic prolapse including an implant arm with at least one
arm, a delivery device for securing the arm to the pelvic tissue
and a funnel. The funnel may have an attached drape and a retention
ring adapted to retain the funnel in an incision.
[0014] Another aspect of the invention is a method of securing an
implant having at least one arm to the pelvic cavity of a patient.
The steps may include making an incision in the vaginal wall,
positioning a delivery device into the incision, advancing a passer
and penetrating adjacent tissue, coupling the passer to the arm,
retracting the passer and pulling the coupled arm back through the
tissue and withdrawing the delivery device and the arm from the
incision.
[0015] The method may further include positioning the delivery
device using a finger or an endoscope coupled to a distal end of
the device. The method may further include positioning a funnel in
the incision, introducing the implant through the funnel and
pulling a free end of the arm back through the funnel.
[0016] Another embodiment of the invention is a method of securing
an implant having at least one arm to the pelvic floor of a patient
including the steps of making an incision in the vaginal wall,
positioning a delivery device into the incision, advancing a guide
through tissue, advancing a strap tube along the path of the guide
by using a pusher, withdrawing the guide and pusher into the
housing and removing the delivery device.
[0017] It is understood that both the foregoing general description
and the following detailed description are exemplary and
explanatory only and are not restrictive of the invention as
claimed. The accompanying drawings illustrating an embodiment of
the invention and together with the description serve to explain
the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1A is a cutaway view of a normal pelvic cavity;
[0019] FIG. 1B is a cutaway view of a pelvic cavity having
urethrocele;
[0020] FIG. 1C is a cutaway view of a pelvic cavity having
rectocele;
[0021] FIG. 1D is a cutaway view of a pelvic cavity having
enterocele;
[0022] FIG. 2 is a perspective view of an embodiment of a surgical
implant;
[0023] FIG. 3 is a cutaway view of a pelvic cavity with the device
supporting the bladder;
[0024] FIG. 4A is a perspective view drawing of an embodiment of
the present invention showing an apparatus for securing an arm to a
pelvic tissue structure;
[0025] FIG. 4B is a perspective view drawing of an embodiment of
the present invention showing an alternate apparatus for securing
an arm to a pelvic tissue structure;
[0026] FIG. 4C is a perspective view drawing of an embodiment of
the present invention showing an another alternate apparatus for
securing an arm to a pelvic tissue structure;
[0027] FIG. 5A is a perspective view of a delivery device for
securing an arm to a pelvic tissue structure;
[0028] FIG. 5B is a perspective view of the delivery device of FIG.
5A showing a passer having a generally circular path around a
tissue structure;
[0029] FIG. 5C is a perspective view of the delivery device of FIG.
5B showing the arm being pulled by the passer;
[0030] FIG. 6A is a perspective view of an embodiment of a delivery
device for securing an arm showing a passer with a connector and an
arm with a receiver;
[0031] FIG. 6B is a perspective view of a delivery device of FIG.
6A showing a passer and arm connected using the connector and
receiver;
[0032] FIG. 6C is a perspective view of a passer with a threaded
connector and an arm with a threaded tube;
[0033] FIG. 7A is a perspective view of an embodiment of a delivery
device for securing an arm to a tissue structure;
[0034] FIG. 7B is a perspective view of the device of FIG. 7A
showing a deployed passer;
[0035] FIG. 7C is perspective view of the device of FIG. 7B with a
pusher and strap tube deployed;
[0036] FIG. 7D is perspective view of the device of FIG. 7C with
the passer and pusher withdrawn;
[0037] FIG. 8A is a drawing of an alternative shape of a delivery
device for securing an arm showing a substantially straight
shape;
[0038] FIG. 8B is a drawing of an alternative delivery device for
securing an arm showing an offset straight shape;
[0039] FIG. 8C is a drawing of an alternative delivery device for
securing an arm showing a curved shape;
[0040] FIG. 8D is a drawing of a flexible delivery device for
securing an arm;
[0041] FIG. 9A is a perspective view of a delivery device for
securing an arm having a finger loop;
[0042] FIG. 9B is a perspective view of a delivery device for
securing an arm having an endoscope attached;
[0043] FIG. 10 is a perspective view of an embodiment of a surgical
implant showing a funnel and drape.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0044] Although many different devices and several different
methods of accessing and repairing pelvic floor disorders such as
fecal or urinary incontinence, vaginal vault prolapse, vaginal
hernia, rectocele, enterocele, uterocele, and urethocele or
combinations of these disorders have been tried, including surgical
and laparoscopic procedures, a better device and method are needed.
Particularly a device that can be easily implanted and secured to
pelvic floor structures without requiring dangerous and highly
skilled needle passes through the skin is necessary. An implant and
implantation method that permit introduction of a delivery device
to which is attached a surgical implant to the pelvic cavity using
a small incision, that can be implanted and secured without
exceptional skill by the surgeon or risk to the patient may lead to
better outcomes.
[0045] Although the repair of pelvic floor disorders is
particularly referenced, it is anticipated that the apparatus and
methods described herein may be used for other surgical or
laparoscopic procedures whereby a tissue structure of the human
body requires strengthening or supporting. The delivery devices
described are applicable to pelvic floor disorders but may be used
wherever a strap, cord, arm or suture needs to be passed through a
tissue of the body.
[0046] Referring to FIG. 1A, there is shown a cross-sectional view
of a normal, pelvic region of a female body. The pelvic region
includes the uterus 1, pubic bone 2, bladder 3, urethra 4, vagina
5, fallopian tube 6, ovary 7, small bowel 8 and the rectum 9. These
organs and structures are shown for a healthy female without any
pelvic floor disorders. The organs such as the bladder 3, vagina 5,
ovary 7 and fallopian tube 6 are shown properly supported by
ligaments and connective tissue such that these organs are in their
correct anatomical location. FIGS. 1B-1D illustrate various
conditions of pelvic floor prolapse where the present invention may
be useful for treatment. FIG. 1B shows a pelvic floor afflicted
with urethrocele, or a collapse of the bladder 3 and/or urethra 4
into the anterior vaginal wall 10. This protrusion of the urethra
and bladder in this figure illustrates how the vagina of the
patient may become compromised and cause pain and discomfort to the
patient. FIG. 1 C shows a pelvic floor afflicted with rectocele, or
a collapse of the rectum 9 into the posterior vaginal wall 12. FIG.
1D shows a pelvic floor afflicted with enterocele, or a collapse of
the small bowel 8 into the upper portion of the posterior vaginal
wall 14. The proper return of these organs to their proper
orientation and location in the pelvic cavity is one of the objects
of this invention.
[0047] Referring now to FIG. 2, there is shown a surgical implant
28 comprised of an implant 30 and having at least one flexible arm
32A-E extending from the side of the implant. The implant 30 may be
constructed of a solid or a permeable material. The implant 30 may
have various shapes. An example of a permeable material is a mesh
that may be receptive to tissue ingrowth. Suitable materials for
making the mesh may be: polypropylene mesh such as that distributed
by C.R. Bard, Inc. of Murray Hill, N.J. under the trade name
"Marlex"; a polyethylene mesh material of the type distributed by
E. I. Du Pont de Nemours and Company of Wilmington, Del. under the
trade name "Alathon"; and a Dacron mesh material or a Nylon mesh
material of the type distributed by E. I. Du Pont de Nemours and
Company of Wilmington, Del. Additionally the mesh may be
constructed from a metallic mesh or a polymer mesh having
interwoven metallic filaments. These filaments may provide
additional strength to the mesh or make the mesh radiopaque for
later visualization. The mesh may be a single layer or have a
multilayer construction. The mesh may have one or more layers
constructed from a bioabsorbable material such that the mesh may be
reabsorbed by the body over time. The mesh may have one or more
layers constructed from a layer having anti-adhesion properties
such that ingrowth or attachment of tissue to the mesh is
inhibited. One or more layers may also be coated with an
anti-adhesional coating that is applied to a surface to inhibit
tissue attachment. These anti adhesional characteristics may be
particularly useful for those implant surfaces that are exposed to
the internal viscera of the abdominal cavity. In this situation it
may be helpful to inhibit potential attachment of various organs to
the implant One example of an adhesion resistant material is, for
example, a thread of polytetrafluoroethylene polymer material of
the type sold under the trade name "Gore-Tex" by W. L. Gore &
Associates, Inc.
[0048] The implant 30 may be made initially oversized compared to
the size of the pelvic disorder. The implant may be sized
substantially larger than the area of the disorder and the implant
30 may be trimmable so that the implant may be trimmed in situ to
fit the size of the interventional need. In this way one implant
size may be provided to the user and then the implant custom
trimmed to fit the surgical conditions.
[0049] The arm 32A-E may be used to secure the implant 30 to the
pelvic cavity and if more than one arm 32 is used then they are
preferably symmetrically arranged around the perimeter of the
implant 30. Although five arms 32A, 32B, 32C, 32D, and 32E are
shown in FIG. 2, this is for descriptive purposes only. The
apparatus 28 may use one, two, four or more arms. The placement of
the arm may be at an apex of the implant 30 or evenly spaced around
the perimeter. The arm may be integrally formed as an extension of
the implant 30 or may be a separate piece that is formed from the
same material as the implant 30. The arm and the implant 30 may
also be constructed from different materials.
[0050] The arm may be identified with unique identifying
characteristics called differentiators so that one arm may be
discerned from another. In this way an arm corresponding to a
particular location on the implant may be identified and the
anatomical position of the arm can be discerned. By way of example
that is not meant to be limiting, each arm may have a different
color coding so that when the implant is inside the pelvic space,
the orientation of the implant may be discerned and correct
positioning of the arms to avoid entanglement can be realized. The
arm may be further differentiated from other arms by degrees of
radiopacity, by an identifying structure such as interwoven
threads, by a printed number on the arm itself, or by differences
in materials. Other means of differentiation are possible and these
examples are not intended to be limiting.
[0051] The arm may have different configurations and the device 28
may utilize one configuration only for a particular implant or
multiple configurations may be utilized on a single implant.
However the arm is generally flexible and not rigid. While other
prior art devices utilize stiff and rigid engagement type arms and
especially rigid placement needles or trocars, the present
invention is flexible. The arms are adapted to pass through or in
some case around pelvic tissue structures such as the sacrospinous
ligament or the arcus tendineus.
[0052] Arm 32A is shown as a woven mesh that is integrally formed
as an extension of the implant mesh 30. In this configuration the
arm 32A is a mesh strap that may extend 2-20 inches from the
perimeter of the implant 30. As can be shown the arm 32A has a
tapered end 33 that reduces the width of the strap. The end of the
arm may have a piercing element 34 attached at the end of the
arm.
[0053] Arm 32B, having an inner end 35 and an outer end 36, is
shown coupled to the implant 30 at inner end 35. Inner end 35 is
located interiorly from the perimeter of the implant 30. This
attachment location may facilitate trimming the implant area at the
interventional site because the attachment point is set apart from
the edge that might be trimmed. The attachment location could be
located anywhere on the implant and is not limited to a particular
location. Secondly, arm 32B is not integral to the implant 30 but
is a separate arm. Arm 32B is attached to the implant with a
connector 37 at the end 35 of the arm 32B. This arm may be deployed
as part of the implant or may be decoupled from the implant and
re-coupled later. This configuration of implant allows separate
placement of the arm and implant. In some situations it may be
preferable to position the arm 32B prior to insertion of the
implant. In other situations it may be preferable to position the
arm after the implant is positioned. The connector 37 may be any
type of mechanical connector, magnetic connector, adhesive or other
connector. Some examples of mechanical connectors are hooks, snaps,
threaded sections, bayonet fastener, hook and loop type fastener,
snares, buttons, suture, or clamps although any type of connector
may be suitable and this list is not meant to be limiting.
[0054] Arm 32B also has a detachment zone 38 that is the coupling
zone for the inner portion 32B and the outer portion 40. Outer
portion 40 has inner and an outer ends 41 and 42. The inner end 41
of the outer portion 40 is coupled to the outer end 36 with the use
of cord 44. The cord 44 may be a thread, suture or other similar
material configured so that the two described ends 36 and 41 can be
coupled by loosely tying them together. An end of the cord 46 may
extend outside the body. Together the arm 32B and the outer portion
40 provide a long enough length of strap so that the combination
can be used to tension the implant by pulling the outer portion 40
from outside the body. However, once the implant is tensioned
properly any excess arm is unnecessary and is often removed so that
the end of the arm can be positioned inside the incision. Therefore
the excess may be cut away but the optimal cutting point may be
deep inside the pelvic cavity and difficult to reach especially
with a small incision. Therefore the detachment zone 38 is intended
to provide a remote method of detaching unneeded length of the arm
that is inside the incision. The cord 44 may be severed at the
detachable zone 38 with a blade or may be released by pulling on
the cord end 46 from outside the body. In another embodiment of the
invention the arm 32B terminates at outer end 36 and outer portion
40 is not present. However cord 44 may still be threaded through
the outer end 36 only. Tension may be applied to the arm by pulling
on the cord 44. After proper positioning and tensioning of the
implant 30, the cord may be removed from the arm 32B by pulling on
the cord end 46 so that the outer end 36 remains inside the pelvic
cavity.
[0055] In another embodiment of the arm 32C, the width of the arm
is reduced to facilitate pulling the arm through various tissue
structures. The reduced lateral profile may reduce friction and the
resultant force required to pull or push the arm. The arm 32C
profile may be reduced by spinning, forming or winding the arm 32C
material into a smaller diameter and thereby forming a cord or
leader. The arm 32C profile may be reduced by the use of a sleeve
50 disposed around the arm. Such a sleeve 50 may be made of
polyethylene, polypropylene, nylon, silicone or other suitable
polymer that may be useful to reduce the friction as the arm passes
through tissue structures. The sleeve 50 may be made from a shrink
tubing. Arm 32C may have all or a part of its length comprised of a
leader 52. This leader may be made of suture, cord, string, wire or
other suitable flexible material. This leader 52 may be coupled
directly to the implant 30 or may comprise a portion of the arm 32C
and a piercing member may or may not be attached at the end. The
outer end of the arm may also terminate with an anchor 54 or 56
attached to arms 32D and 32E. Arms 32D and 32E may be positioned in
a tissue structure either by pushing or pulling the arms as will be
shown. These arms' outer ends enter tissue structures and then
anchor into the tissue to secure the arm to the tissue. Various
anchor designs are anticipated and the anchors 54 and 56 are not
meant to be limiting. Anchor 54 is shown having lateral barbs 55
that may have a fixed configuration or these barbs may be
deployable after positioning. The anchor 56 is a barbed hook which
may pass easily into tissue and then inhibit reverse movement to
prevent pullout of the anchor and arm.
[0056] Referring now to FIG. 3, shown is a cross-sectional view of
a pelvic floor with an example of an implant 72 positioned to
support the urethra and bladder for the treatment of urethrocele.
An incision 70 has been made along the anterior wall 10 of the
vagina 5 to provide access to the bladder 3 and the urethra 4. The
incision is positioned to maximize the exposure to the prolapsed
area. The implant has been positioned around the bladder and
urethra to maximize support of these two organs. As can be seen by
comparing FIG. 3 to FIG. 1B, the bladder and the urethra have been
moved to their proper positions as shown in FIG. 1A. The implant 72
is shown as a mesh having open cells and two arms at one end 74a-b
and two arms at the opposite end 75a-b. These arms are secured to
pelvic tissue (not shown) to secure the implant. This is shown as
an illustration only and many other implant sizes, materials and
securement methods may be used. The implant may be placed through
the incision in the anterior vaginal wall 70 as shown and then the
delivery devices removed, the mesh positioned where needed and then
the incision is closed to complete the procedure.
[0057] Referring to FIGS. 4A-C, three embodiments of a delivery
device to position an arm are illustrated. Such a delivery device
and method may be used to position an arm in a tissue structure
through a confined space with little visibility such as found in
the incision and small spaces of the pelvic cavity. An intended
benefit of the described delivery device and method is to position
an arm as previously described through a smaller incision as with
other devices. Another intended benefit is that the positioning,
securement and tensioning of the arm attached to an implant can be
performed from inside the cavity without the need to pass anchoring
straps outside the body and without having to insert large needles
or trocars into the pelvic region from outside the body.
[0058] The delivery device 100 includes a housing 102 having a
cavity 104 disposed at its distal end 106. A curvilinear passer 108
having an inner end 109 and an outer end 110 is disposed inside the
housing 102. The outer end 110 is sharpened to facilitate passage
through tissue structures. The inner end 109 is coupled to the
housing 102 at a rotating pivot 112 so that the passer can rotate
about this pivot in a generally circular pathway. The passer 108 is
rotatably linked to an actuator 114 at linkage 116 and the actuator
is slidably disposed inside the housing. The outer end 110 of the
passer may also have a connector 118 that is adapted to couple to
an arm. As shown in FIGS. 5A-C, the delivery device 100 of FIG. 4A
is positioned at the delivery site with the cavity facing the
direction of activation. As the actuator 114 is moved toward the
distal end 106, the passer 108 is driven through the linkage 116
and pivots around the pivot 112. The passer then moves in a
generally circular pathway that conforms to the shape of the passer
into or around tissue structures 117 located inside or adjacent the
cavity. The mechanism may be useful to drive the passer 108 around
tissue structures 117 such as tendons, bone, ligaments or other
pelvic structures. As the passer traverses in a generally circular
pathway, it couples with an end of an arm 119 that is positioned
along the generally circular path of the passer using the connector
118. The connector 118 shown is a barbed hook that penetrates the
mesh of the arm 119. The arm 119 may be loaded onto the housing
such that the generally circular travel of the passer intersects an
end portion of the arm 119. The arm may be preloaded onto the
housing prior to insertion of the delivery device into the pelvic
cavity. This arm may be captured and temporarily coupled to the
delivery device. In this method, the arm of an implant would first
be positioned onto a housing and then the arm and the housing could
be delivered together into the pelvic cavity.
[0059] Once the arm 119 is coupled to the connector 118, the
actuator may be retracted away from the distal end 106 which also
retracts the passer 108. This movement pulls the arm 119 along the
generally circular pathway of the passer, and back into the
housing. The delivery device 100 may be withdrawn in the direction
of the arrow, pulling the arm through or around the tissue
structures. In the case of pelvic prolapse repair, the delivery
device 100 maybe used to position the arms in or around various
tissue structures such as the sacrospinous ligament, arcus
tendineus, bone or other pelvic structures.
[0060] An alternate delivery device 130 is shown in FIG. 4B
including a housing 132 having a tapered end 133 with a passer 134
slidably disposed inside. The passer 134 may have a sharpened end
136 and a connector 138 to couple with an engagement device. The
passer is made from a curved superelastic alloy such as Nitinol The
passer 134 is restrained inside the housing and when advanced
outside the housing, the passer assumes a curved shape. The passer
is driven through tissue structures as it is further advanced from
the housing traversing a generally circular pathway. The connector
138 located at the sharpened end 136 is adapted to couple with an
arm such that as the passer is retracted inside the housing 132,
the arm (not shown) is pulled through the generally circular
pathway of the passer. The mechanism may be useful to drive the
passer around tissue structures such as tendons, bone, ligaments or
other pelvic structures. The delivery device 130 may be withdrawn
pulling the arm through the tissue structures. In the case of
pelvic prolapse repair, the delivery device 130 maybe used to
position the arms in various tissue structures such as the
sacrospinous ligament or the arcus tendineus.
[0061] An alternate delivery device 140 is shown in FIG. 4C having
a passer 142 comprising an elongate hollow housing 144 coupled with
a steerable end portion 146. Disposed inside the hollow housing are
at least two controlling wires 147a-b that extend to the proximal
end. These controlling wires are attached to the steerable end
portion 146 such that by relaxing one wire and pulling another the
steerable end portion may be actuated to steer the steerable end
portion 146 in a particular direction. As can be seen, if the wires
are positioned next to a tissue structure and actuated to form a
curved configuration, as the passer 142 is advanced the passer will
traverse through a generally circular pathway. The passer may have
a sharpened end 148 and a connector 149 located at the end. The
connector 149 is adapted to couple with an arm such that as the
passer 142 is retracted and the steerable end portion is
straightened, the arm (not shown) is pulled through the generally
circular pathway. The delivery device 140 may be withdrawn pulling
the arm through the tissue structures. In the case of pelvic
prolapse repair, the delivery device 140 maybe used to position the
arms in various tissue structures such as the sacrospinous ligament
or the arcus tendineus.
[0062] Alternate connectors are illustrated in FIGS. 6A-C that may
be useful to connect a previously described passer with an arm. A
connector 150 is shown attached to a passer 152 similar to those
discussed. The connector 150 may be a magnet tip that is configured
to mate with a magnetic receiver 154 attached to an arm 155. As the
magnetic tip passes through tissue structures and approaches the
magnetic receiver 154, a magnetic coupling occurs and the arm 155
is detachably joined to the connector and passer. The magnetic
coupling should be strong enough to maintain the coupling as the
passer is withdrawn pulling the arm 155 through tissue structures.
Rare earth magnets may be used in this example.
[0063] Also shown is connector 160 attached to a passer (not shown)
similar to those discussed. The connector 160 may be a threaded rod
162 that is configured to mate with a similarly threaded tube 164
attached to an arm 165. As the threaded rod 162 passes through
tissue structures and approaches the threaded tube 164, the two may
be coupled by screwing the two together and the arm 165 is
detachably joined to the connector 160. The threaded coupling
should be strong enough to maintain the coupling as the passer is
withdrawn pulling the arm 165 through tissue structures.
[0064] In addition to these connector examples shown, the passer
152 may utilize any number of mechanical connectors such a barb, a
spear, a threaded connector, a snap, a bayonet system, a latch, a
clamp, hook and loop type fasteners or a jaw. Any connector that
can couple an end portion of the arm with the passer tip may be
used. Likewise any number of magnetic couplers as well as adhesives
may be utilized. The list of potential couplers is large and any
number of suitable connectors known by those skilled in the art may
be successfully employed. An alternate embodiment of an arm
delivery device 200 is shown in FIGS. 7A-D having an elongate
hollow body 201 enclosing an elongate tubular housing 202 that may
freely slide along the transverse axis of the body 201. The housing
202 has a guide 204 comprising an elongate flexible curvilinear rod
disposed therein. The guide 204 is adapted to assume a generally
circular shape when not constrained inside the housing. The guide
204 has a tip 206 configured to penetrate tissue structures of the
body. The delivery device 200 further comprises a strap tube 208
and a tubular pusher 210 disposed coaxially about the outside of
the housing such that both may slide along the transverse axis of
the housing. The strap tube 208 has distal 210 and proximal 211 end
portions with the distal end portion configured to couple to a
catch 212 located at an opening 214 in the body. The catch is
adapted to secure the strap tube to the body 201 as will be shown.
The strap tube 208 has an arm 216 attached to the proximal end
211.
[0065] In use, the body 201 is introduced into the pelvic cavity
through an incision in the vaginal wall and the guide 204 is
extended from the housing 202 such that the guide makes a generally
circular pathway through and around tissue structures 218 and
enters the opening 214 in the body 201. Alternatively other sites
other than the vaginal example given may be used to insert the
delivery device into the pelvic cavity. If this is used outside the
pelvic region, then other suitable entry sites may be used.
[0066] The housing 202 is then extended from the body and the strap
tube 208 is pushed from the housing along the guide 204 by the
pusher 210. The strap tube 208 is pushed through tissue structures
218 while following the guide until it enters the opening 214 and
is captured by the catch 212. At this point the strap tube is
coupled to the body 201. The guide, pusher and housing are
retracted back into the body and the body removed from the pelvic
space. As can be seen, as the body is withdrawn, the arm 216 is
positioned through and around tissue structures 218. The device of
FIGS. 5, 6 and 7 may be positioned and used in such a way that the
arm 119, 155 or 216 respectively is secured to pelvic tissue
structures.
[0067] As shown in FIGS. 8A-D, the various delivery devices
previously described may be made with various shapes and rigidities
to facilitate placement of the delivery device in the pelvic space.
The delivery device 230 is a generally straight and rigid device
with a handle 231 connected at the proximal end. Delivery device
232 has an angular offset bend along its length that may be useful
in certain anatomical conditions and delivery device 234 has a
general curvilinear shape. Alternatively the delivery device 236
may be flexible and not rigid or may be steerable by the
operator.
[0068] All the delivery devices previously described may be placed
in the pelvic cavity using positioning aids to guide and direct the
placement of the arms. These aids may utilize tactile or visual
feedback to the operator so that tissue structures such as
arteries, veins, nerves, bone, ligaments or tendons in the body can
be identified and the placement of the arm may be properly directed
compared to a blind approach. Referring to FIGS. 9A-C, the delivery
device may have a finger loop 250 configured at the distal end such
that an operator may place a finger into the loop and utilize
tactile feeling in the finger to guide placement of the delivery
device end. The finger loop 250 may be attached to the delivery
device at point 251 using adhesive or mechanical attachments. The
finger loop 250 may also be integrally formed as part of the
delivery device. Similarly, the delivery device 252 may have a
light source 254 attached to the outer body of the delivery device
252. This light source may be an LED light source and be adapted to
radiate a generally confined narrow beam of light. This light may
be directed such that the light may be seen through the skin. In
this way the operator can utilize the light as a marker to guide
positioning as described. In another embodiment the delivery device
may be constructed with loops 260 to couple an endoscope 262 to the
delivery device. In this way the placement and delivery of arms
using the delivery device may be controlled through direct
visualization by the operator.
[0069] Multiple arms may be used to secure an implant in the pelvic
space. These arms may have cords or leaders that extend from the
distal ends of the arms that may be used to tension the implant.
Keeping these ends organized and identified may be challenging.
Additionally the sterility of all of these loose ends and the
implant must be maintained in a crowded surgical site. To organize
and identify the various cords coming from the arms, the leaders
themselves or the arms may be color coded, shape coated or in some
other way uniquely identified with differentiators so that an
individual arm and its location to the implant and the pelvic
cavity can be determined.
[0070] A device to organize the method of implanting the implant
and providing a large sterile barrier is illustrated in FIG. 10. A
funnel 300 is shown positioned in the incision of a posterior
vaginal wall. The hourglass shaped funnel 300 has a wide opening
302 and a narrow opening 304 positioned in the incision and a
narrowed neck in between. The funnel may have a straight taper
configuration or other configurations as well. The narrow opening
304 may have a retention ring 308 that has an outer diameter
greater than the narrow opening 304. The retention ring 308 outer
diameter is sized so that once placed into the incision, it retains
the funnel 300 in the incision and prevents inadvertent
dislodgement of the funnel from the incision. A drape 310 is
attached to the wide opening 302 and extends radially outward from
the opening. The drape and funnel may be packaged sterile and the
drape is sized to cover an extended surgical area. As can be
appreciated when the narrow opening 304 of a sterile funnel is
inserted into an incision and the drape extended, an effective
sterile barrier is created so that an implant having multiple arms
may be inserted through the funnel and into the pelvic space in a
sterile, organized manner. Furthermore the arms or leaders attached
to the ends of the arms may be threaded back through the funnel
after positioning into a tissue structure. When the end of an arm
is pulled to apply tension to the implant the inside of the
retention ring 304 may act as a fulcrum point and protect the
incision edge from abrasion from the arm. The excess length of the
arm may be removed, the funnel and drape removed and the incision
closed to complete the operation. The excess length may be
particularly removed by severing or removing the cord 44 located in
a detachment zone 38 as shown in FIG. 2.
[0071] This invention has been described and specific examples of
the invention have been portrayed.
[0072] The use of those specifics is not intended to limit the
invention in anyway. Additionally, to the extent that there are
variations of the invention, which are within the spirit of the
disclosure or equivalent to the inventions found in the claims, it
is our intent that this patent will cover those variations as
well.
* * * * *