U.S. patent application number 10/296161 was filed with the patent office on 2003-11-06 for finger-guided suture device.
Invention is credited to Levy, Gil.
Application Number | 20030208100 10/296161 |
Document ID | / |
Family ID | 24310926 |
Filed Date | 2003-11-06 |
United States Patent
Application |
20030208100 |
Kind Code |
A1 |
Levy, Gil |
November 6, 2003 |
Finger-guided suture device
Abstract
A finger-guided suture device is disclosed. The device includes
a thimble-like element to surround a portion of a finger and an
ejectable substantially semi-circular surgical needle for
collecting retaining and guiding a surgical suture via a distal
portion of the needle upon contact. Also included is a mechanism
for ejecting the needle from, and withdrawing the needle into, the
thimble-like element, so as to place a suture. Also disclosed are
surgical methods employing the device.
Inventors: |
Levy, Gil; (Tel Aviv,
IL) |
Correspondence
Address: |
Anthony Castorina
G E Ehrlich
Suite 207
2001 Jefferson Davis Highway
Arlington
VA
22202
US
|
Family ID: |
24310926 |
Appl. No.: |
10/296161 |
Filed: |
November 22, 2002 |
PCT Filed: |
May 24, 2001 |
PCT NO: |
PCT/IL01/00485 |
Current U.S.
Class: |
600/30 ;
606/139 |
Current CPC
Class: |
A61B 2017/00805
20130101; A61B 17/062 20130101; A61B 17/0491 20130101; A61B
2017/00438 20130101; A61B 2017/00265 20130101; A61B 17/0482
20130101; A61B 17/0469 20130101; A61B 17/0485 20130101 |
Class at
Publication: |
600/30 ;
606/139 |
International
Class: |
A61F 002/02 |
Claims
What is claimed is:
1. A finger-guided suture device, comprising: (a) a thimble-like
element being adapted to surround a portion of a surgeon's finger;
(b) an ejectable, substantially semi-circular surgical needle being
engaged within a housing being formed within, or connected to, a
wall of said thimble-like element, said surgical needle being
designed for collecting said surgical suture via a distal portion
of said surgical needle upon contact therewith and for retaining
and guiding said surgical suture while suturing; and (c) a
mechanism for ejecting said surgical needle from said thimble-like
element and thereafter withdrawing said surgical needle into said
thimble-like element, so as to place a suture.
2. The finger-guided suture device of claim 1, wherein said thimble
like element is constructed and constructed to expose the ventral
tactile portions of the distal phalanx of said surgeon's finger, so
as to enable said surgeon to tactile sense a body location to be
sutured.
3. The finger-guided suture device of claim 1, further comprising:
(d) a cartridge for holding said surgical suture and presenting it
for collection by said distal portion of said surgical needle.
4. The finger-guided suture device of claim 3, wherein said
cartridge includes at least one mechanism designed and constructed,
so as to maintain a predetermined tension of said surgical
suture.
5. The finger-guided suture device of claim 4, wherein said at
least one mechanism designed and constructed, so as to maintain a
predetermined tension of said surgical suture comprises at least
one piece of flexible material containing at least one hole through
which said surgical suture passes.
6. The finger-guided suture device of claim 5, wherein said at
least one piece of flexible material containing at least one hole
is selected from the group consisting of a single piece of flexible
material containing two holes and a pair of pieces of flexible
material each containing one hole.
7. The finger-guided suture device of claim 5, wherein said
flexible material is selected from the group consisting of silicon,
latex, rubber, fabric, and fabric with an eyelet.
8. The finger-guided suture device of claim 7, wherein said eyelet
is constructed of material selected from the group consisting of
silicon, latex, rubber and fabric.
9. The finger-guided suture device of claim 1, wherein said
mechanism for ejecting said surgical needle from, and withdrawing
said surgical needle into, said thimble-like element, is selected
from the group consisting of a belt actuated mechanism, a gear
actuated mechanism and a combined gear and belt actuated
mechanism.
10. The finger-guided suture device of claim 1, wherein said
surgical needle is formed with a feature selected from the group
consisting of a notch, a hook, at least one arm, and an openable
loop at said distal end thereof.
11. The finger-guided suture device of claim 1, further comprising
an adapter insertable between said thimble-like element and the
surgeon's finger, so as to adapt the suture device to fingers of
different size.
12. The finger-guided suture device of claim 1, wherein said
mechanism includes a first portion engaged within said housing and
which is in contact with said ejectable surgical needle and a
second, remote, portion extending out of the patient's body and
which is operable by a free hand of the surgeon so as to eject said
surgical needle from said thimble-like element.
13. The finger-guided suture device of claim 12, wherein said first
portion of said mechanism comprises a rotatable wheel having an
axle, said axle serves for engaging said surgical needle and
imparting a rotational motion in at least one direction thereto,
said surgical needle includes a mechanism for engaging said
rotatable wheel and a locking piece for insuring that said surgical
needle and said rotatable wheel remain engaged.
14. The finger-guided suture device of claim 12, wherein said first
portion of said mechanism comprises a rotatable wheel having a
mechanism for engaging a drive arm and imparting a rotational
motion in at least one direction thereto, said drive arm is
designed and constructed engageable by said rotatable wheel and by
said surgical needle and to impart a rotational motion of said
rotatable wheel in at least one direction to said surgical needle,
wherein said surgical needle further includes a mechanism for
engaging said drive arm and a disk for ensuring that said surgical
needle, said drive arm and said rotatable wheel remain engaged.
15. The finger-guided suture device of claim 12, wherein said
remote portion extending out of the patient's body and which is
operable by a free hand of the surgeon so as to eject said surgical
needle from said thimble-like element comprises: (i) a hand
operable actuator designed and constructed to operate a drive
mechanism; (ii) a drive housing for containing at least a portion
of said drive mechanism; and (iii) at least a portion of said drive
mechanism, said drive mechanism being for imparting a rotational
motion in at least one direction to said surgical needle.
16. The finger-guided suture device of claim 15, wherein said hand
operable actuator of said remote portion comprises: (1) a handle
for engaging at least one finger of said free hand of said surgeon;
(2) an extending piece containing a plurality of arcuate teeth and
being movable through said drive housing; (3) a pressure sensitive
spring; and (4) a brake handle, said brake handle operable in a
first direction by said pressure sensitive spring and in a second
direction by said at least one finger of said free hand of said
surgeon.
17. The finger-guided suture device of claim 15, wherein said drive
mechanism comprises: (1) a plurality of arcuate teeth deployed in a
linear arrangement along an extending piece of a handle; (2) a
first gear with a first circular arrangement of arcuate teeth, said
first circular arrangement of arcuate teeth being for engaging with
said plurality of arcuate teeth deployed in said linear arrangement
along said extending piece, such that linear displacement of said
extending piece is translated into rotational motion of said first
gear; (3) a second gear including a second circular arrangement of
arcuate teeth, said arcuate teeth of said second gear being for
engaging said first circular arrangement of arcuate teeth of said
first gear, such that rotational motion of said first gear causes
rotational motion of said second gear; and (4) a cable in contact
with at least one point on said second gear, such that rotational
motion of said second gear is translated to linear motion of at
least a portion of said cable.
18. The finger-guided suture device of claim 17, wherein said drive
mechanism further comprises: (5) a ratchet for alternately engaging
and releasing at least one arcuate tooth of said first gear; (6) a
ratchet control arm for alternately engaging and releasing said
ratchet; (7) a brake handle for alternately operating said ratchet
control arm; wherein, when said brake handle operates said ratchet
control arm, said ratchet control arm releases said ratchet, said
ratchet engages said at least one arcuate tooth of said first gear
and said first gear is prevented from rotating; and whereas, when
said brake handle does not operate said ratchet control arm, said
ratchet control arm engages said ratchet, said ratchet releases
said at least one arcuate tooth of said first gear and said first
gear is free to rotate.
19. The finger-guided suture device of claim 1, wherein said
thimble-like element is constructed so as to be mounted over a
dorsal side of the distal phalanx of said surgeon's finger, thereby
exposing the entire ventral tactile portions of the distal
phalanx.
20. The finger-guided suture device of claim 1, wherein said
thimble-like element is constructed so as to fully surround the
distal phalanx and expose the tip of the ventral tactile portion of
the distal phalanx.
21. The finger-guided suture device of claim 1, wherein said
thimble-like element is constructed so as to be mounted over a
ventral side of the distal phalanx of the surgeon's finger and
expose the tip of the ventral tactile portion of the distal
phalanx.
22. The finger-guided suture device of claim 1, wherein said
surgical needle is ejectable in a direction generally perpendicular
to a longitudinal axis of said thimble like element.
23. The finger-guided suture device of claim 1, wherein said
surgical needle travels along at least a portion of a circular
path, said path being on a plane which substantially parallels a
plane traversing the surgeon's finger from top to bottom.
24. The finger-guided suture device of claim 1, wherein said
surgical needle travels along at least a portion of a circular
path, said path being on a plane which substantially parallels a
plane traversing the surgeon's finger from side to side.
25. The finger-guided suture device of claim 1, wherein said
surgical needle travels along at least a portion of a circular
path, said path being on a plane which is substantially
perpendicular to the longitudinal axis of the surgeon's finger.
26. The finger-guided suture device of claim 1, further comprising
an optical head engaged by said thimble like element.
27. The finger-guided suture device of claim 1, further comprising
said surgical suture formed with a loop for collection by said
surgical needle.
28. The finger-guided suture device of claim 1, wherein said wall
is a side wall of said thimble-like element.
29. The finger-guided suture device of claim 1, wherein said wall
is a front wall of said thimble-like element.
30. The finger-guided suture device of claim 1, further comprising
a reporting mechanism for reporting at least one situation selected
from the group consisting of a full ejection of said substantially
semi-circular surgical needle, a full withdrawal of said
substantially semi-circular surgical needle, a degree of ejection
of said substantially semi-circular surgical needle and a degree of
withdrawal of said substantially semi-circular surgical needle.
31. A surgical procedure for bladder-neck suspension for treatment
of urinary incontinence, the procedure comprising the step of
suspending a pelvic fascia and a vaginal wall lateral to a urethra
of a patient to Cooper's ligament by sutures being placed using a
finger-guided suture device having an ejectable substantially
semi-circular surgical needle being designed for collecting said
surgical suture via a distal portion of said surgical needle upon
contact therewith and for retaining and guiding said surgical
suture while suturing
32. A surgical procedure for treatment of rectal prolapse, the
procedure comprising the step of constricting an anal opening by
sutures being applied by using a finger-guided suture device having
an ejectable, substantially semi-circular surgical needle being
designed for collecting said surgical suture via a distal portion
of said surgical needle upon contact therewith and for retaining
and guiding said surgical suture while suturing.
33. A surgical procedure for treatment of esophageal reflux, the
procedure comprising the step of positioning a vessel loop around a
esophagus of a patient using a finger-guided suture device having
an ejectable, substantially semi-circular surgical needle being
designed for collecting said surgical suture via a distal portion
of said surgical needle upon contact therewith and for retaining
and guiding said surgical suture while suturing.
34. A surgical procedure for treatment of vaginal prolapse, the
procedure comprising the step of tying an upper part of a vagina of
a patient to a sacrospinous ligament of the patient by sutures
being placed using a finger-guided suture device having an
ejectable, substantially semi-circular surgical needle being
designed for collecting said surgical suture via a distal portion
of said surgical needle upon contact therewith and for retaining
and guiding said surgical suture while suturing
35. A surgical procedure for treatment of rupture of a rectum in
large animals, the procedure comprising the step of suturing the
rupture using a finger-guided suture device having an ejectable,
substantially semi-circular surgical needle being designed for
collecting said surgical suture via a distal portion of said
surgical needle upon contact therewith and for retaining and
guiding said surgical suture while suturing.
36. A surgical procedure for treatment of rupture of a cervix in
large animals, the procedure comprising the step of suturing the
rupture using a finger-guided suture device having an ejectable,
substantially semi-circular surgical needle being designed for
collecting said surgical suture via a distal portion of said
surgical needle upon contact therewith and for retaining and
guiding said surgical suture while suturing.
37. A surgical procedure for treatment of rupture of a uterus in
large animals, the procedure comprising the step of suturing the
rupture using a finger-guided suture device having an ejectable,
substantially semi-circular surgical needle being designed for
collecting said surgical suture via a distal portion of said
surgical needle upon contact therewith and for retaining and
guiding said surgical suture while suturing.
Description
FIELD AND BACKGROUND OF THE INVENTION
[0001] The present invention relates to suture devices, and more
particularly, to a finger-guided suture device for placing sutures
especially in body locations of limited minimal-invasive
accessibility. The present invention further relates to surgical
procedures in which one or more finger-guided suture devices of the
present invention are used to place one or more sutures, especially
in body locations of limited minimal-invasive accessibility.
[0002] For years, there has been a discernible, clear tendency in
surgery and invasive diagnosis, especially, but not exclusively, in
abdominal, joint, vaginal, in-utero and brain, surgeries or
diagnoses, to develop procedures that would reduce the need for
major access-providing incisions with their concomitant
requirements of general anesthesia, extended hospitalization and
increased infection hazard. One step in this direction was the
introduction of endoscopy and laparoscopy, which, through provision
of minimal incision in, e.g., the abdominal wall of joint covering
skin, permits the introduction into the abdominal cavity or joint
of a miniature television camera including a light source, as well
as of various surgical instruments, including suture devices.
[0003] PCT/US97/11494 teaches a number of surgical instruments
which can be mounted directly on a surgeon's fingertip in a way
that the surgeon can insert his or her hand into a natural cavity
of the patient or through a minimal incision to perform surgical
procedures, and also to use his or her fingers to manipulate
tissues, thus enabling the surgeon to perform the procedures with
the benefits of minimally invasive surgery, but with much greater
tactile sense, control, and ease of manipulation. However, these
surgical instruments (i) are carried by a finger and operated by
the thumb, thereby are not applicable for procedures in which a
single finger is employed for tactile sensing an operated intrabody
location; (ii) include an operating head which permanently extends
far beyond the fingertip on which the surgical instrument is
mounted, which limits the tactile sensing of the surgeon; and/or
(iii) prevent tactile sensing by the instrument carrying fingertip
altogether.
[0004] According to the teachings of PCT/US97/11494 suturing can be
performed while the surgeon uses tactile information collected by a
single fingertip for tactile sensing the intrabody site to be
stitched prior to the actual suturing. Several non-limiting
examples of such suturing procedures are described in detail in the
sections that follow. However, once the surgeon has collected the
tactile information, surgery is conducted blindly within the body
of the patient. According to the teachings of PCT/US97/11494, both
the hands of the surgeon are engaged. Evidently, blindly operating
surgical instruments intrabodily based on finger tip tactile
information collected earlier may prove inconvenient, inaccurate
and may increase the chance of inadvertently harming the
patient.
[0005] PCT/IL99/00084 teaches design of finger-guided suture
devices which can be used to perform extra- as well as intrabody
suturing of tissue. This application does not teach construction
and use of a device which causes a needle to penetrate a bodily
tissue, engage a piece of suture material and pull the suture
material through the bodily tissue as the needle is retracted there
through. In addition, this application fails to teach a
construction which allows safe withdrawal of the needle in case of
early detected misplacement other than pulling it via the hand or
suture.
[0006] There is thus a widely recognized need for, and it would be
highly advantageous to have, finger-guided suture devices devoid of
the limitations associated with the prior art instruments and which
enable a surgeon using a finger-guided surgical device to penetrate
a bodily tissue with a suture needle, engage a piece of suture
material with the needle and pull the suture material through the
bodily tissue as the needle is retracted there through.
SUMMARY OF THE INVENTION
[0007] According to one aspect of the present invention there is
provided a finger-guided suture device. The device comprises (a) a
thimble-like element being adapted to surround a portion of a
surgeon's finger; (b) an ejectable substantially semi-circular
surgical needle being engaged within a housing being formed within,
or connected to, a wall of the thimble-like element, the surgical
needle being designed for collecting the surgical suture via a
distal portion of the surgical needle upon contact therewith and
for retaining and guiding the surgical suture while suturing; and
(c) a mechanism for ejecting the surgical needle from the
thimble-like element and thereafter withdrawing the surgical needle
into the thimble-like element, so as to place a suture.
[0008] According to another aspect of the present invention there
is provided a surgical procedure for bladder-neck suspension for
treatment of urinary incontinence, the procedure comprising the
step of suspending a pelvic fascia and a vaginal wall lateral to a
urethra of a patient to Cooper's ligament by sutures being placed
using a finger-guided suture device having an ejectable
substantially semi-circular surgical needle being designed for
collecting the surgical suture via a distal portion of the surgical
needle upon contact therewith and for retaining and guiding the
surgical suture while suturing
[0009] According to yet another aspect of the present invention
there is provided a surgical procedure for treatment of rectal
prolapse, the procedure comprising the step of constricting an anal
opening by sutures being applied by using a finger-guided suture
device having an ejectable substantially semi-circular surgical
needle being designed for collecting the surgical suture via a
distal portion of the surgical needle upon contact therewith and
for retaining and guiding the surgical suture while suturing.
[0010] According to still another aspect of the present invention
there is provided a surgical procedure for treatment of esophageal
reflux, the procedure comprising the step of positioning a vessel
loop around a esophagus of a patient using a finger-guided suture
device having an ejectable, substantially semi-circular surgical
needle being designed for collecting the surgical suture via a
distal portion of the surgical needle upon contact therewith and
for retaining and guiding the surgical suture while suturing.
[0011] According to an additional aspect of the present invention
there is provided a surgical procedure for treatment of vaginal
prolapse, the procedure comprising the step of tying an upper part
of a vagina of a patient to a sacrospinous ligament of the patient
by sutures being placed using a finger-guided suture device having
an ejectable, substantially semi-circular surgical needle being
designed for collecting the surgical suture via a distal portion of
the surgical needle upon contact therewith and for retaining and
guiding the surgical suture while suturing.
[0012] According to yet additional aspect of the present invention
there is provided a surgical procedure for treatment of rupture of
a rectum in large animals, the procedure comprising the step of
suturing the rupture using a finger-guided suture device having an
ejectable, substantially semi-circular surgical needle being
designed for collecting the surgical suture via a distal portion of
the surgical needle upon contact therewith and for retaining and
guiding the surgical suture while suturing.
[0013] According to still additional aspect of the present
invention there is provided a surgical procedure for treatment of
rupture of a cervix in large animals, the procedure comprising the
step of suturing the rupture using a finger-guided suture device
having an ejectable, substantially semi-circular surgical needle
being designed for collecting the surgical suture via a distal
portion of the surgical needle upon contact therewith and for
retaining and guiding the surgical suture while suturing.
[0014] According to still additional aspect of the present
invention there is provided a surgical procedure for treatment of
rupture of a uterus in large animals, the procedure comprising the
step of suturing the rupture using a finger-guided suture device
having an ejectable, substantially semi-circular surgical needle
being designed for collecting the surgical suture via a distal
portion of the surgical needle upon contact therewith and for
retaining and guiding the surgical suture while suturing.
[0015] According to further features in preferred embodiments of
the invention described below, the thimble like element is
constructed and constructed to expose the ventral tactile portions
of the distal phalanx of the surgeon's finger, so as to enable the
surgeon to tactile sense a body location to be sutured.
[0016] According to still further features in the described
preferred embodiments, the finger-guided suture device further
comprises a cartridge for holding the surgical suture and
presenting it for collection by the distal portion of the surgical
needle.
[0017] According to still further features in the described
preferred embodiments the cartridge includes at least one mechanism
designed and constructed, so as to maintain a predetermined tension
of the surgical suture.
[0018] According to still further features in the described
preferred embodiments the at least one mechanism designed and
constructed, so as to maintain a predetermined tension of the
surgical suture comprises at least one piece of flexible material
containing at least one hole through which the surgical suture
passes.
[0019] According to still further features in the described
preferred embodiments the at least one piece of flexible material
containing at least one hole is selected from the group consisting
of a single piece of flexible material containing two holes and a
pair of pieces of flexible material each containing one hole.
[0020] According to still further features in the described
preferred embodiments the flexible material is selected from the
group consisting of silicon, latex, rubber, fabric, and fabric with
an eyelet.
[0021] According to still further features in the described
preferred embodiments the eyelet is constructed of material
selected from the group consisting of silicon, latex, rubber and
fabric.
[0022] According to still further features in the described
preferred embodiments the mechanism for ejecting the surgical
needle from, and withdrawing the surgical needle into, the
thimble-like element, is selected from the group consisting of a
belt actuated mechanism, a gear actuated mechanism and a combined
gear and belt actuated mechanism.
[0023] According to still further features in the described
preferred embodiments the surgical needle is formed with a feature
selected from the group consisting of a notch, a hook, at least one
arm, and an openable loop at the distal end thereof.
[0024] According to still further features in the described
preferred embodiments the finger-guided suture device further
comprises an adapter insertable between the thimble-like element
and the surgeon's finger, so as to adapt the suture device to
fingers of different size.
[0025] According to still further features in the described
preferred embodiments the mechanism includes a first portion
engaged within the housing and which is in contact with the
ejectable surgical needle and a second, remote, portion extending
out of the patient's body and which is operable by a free hand of
the surgeon so as to eject the surgical needle from the
thimble-like element.
[0026] According to still further features in the described
preferred embodiments the first portion of the mechanism comprises
a rotatable wheel having an axle, the axle serves for engaging the
surgical needle and imparting a rotational motion in at least one
direction thereto, the surgical needle includes a mechanism for
engaging the rotatable wheel and a locking piece for insuring that
the surgical needle and the rotatable wheel remain engaged.
[0027] According to still further features in the described
preferred embodiments the first portion of the mechanism comprises
a rotatable wheel having a mechanism for engaging a drive arm and
imparting a rotational motion in at least one direction thereto,
the drive arm is designed and constructed engageable by the
rotatable wheel and by the surgical needle and to impart a
rotational motion of the rotatable wheel in at least one direction
to the surgical needle, wherein the surgical needle further
includes a mechanism for engaging the drive arm and a disk for
ensuring that the surgical needle, the drive arm and the rotatable
wheel remain engaged.
[0028] According to still further features in the described
preferred embodiments the remote portion extending out of the
patient's body and which is operable by a free hand of the surgeon
so as to eject the surgical needle from the thimble-like element
comprises: (i) a hand operable actuator designed and constructed to
operate a drive mechanism; (ii) a drive housing for containing at
least a portion of the drive mechanism; and (iii) at least a
portion of the drive mechanism, the drive mechanism being for
imparting a rotational motion in at least one direction to the
surgical needle.
[0029] According to still further features in the described
preferred embodiments the hand operable actuator of the remote
portion comprises (1) a handle for engaging at least one finger of
the free hand of the surgeon; (2) an extending piece containing a
plurality of arcurate teeth and being movable through the drive
housing; (3) a pressure sensitive spring; and (4) a brake handle,
the brake handle operable in a first direction by the pressure
sensitive spring and in a second direction by the at least one
finger of the free hand of the surgeon.
[0030] According to still further features in the described
preferred embodiments the drive mechanism comprises (1) a plurality
of arcuate teeth deployed in a linear arrangement along an
extending piece of a handle; (2) a first gear with a first circular
arrangement of arcuate teeth, the first circular arrangement of
arcuate teeth being for engaging with the plurality of arcuate
teeth deployed in the linear arrangement along the extending piece,
such that linear displacement of the extending piece is translated
into rotational motion of the first gear; (3) a second gear
including a second circular arrangement of arcuate teeth, the
arcuate teeth of the second gear being for engaging the first
circular arrangement of arcuate teeth of the first gear, such that
rotational motion of the first gear causes rotational motion of the
second gear; and (4) a cable in contact with at least one point on
the second gear, such that rotational motion of the second gear is
translated to linear motion of at least a portion of the cable.
[0031] According to still further features in the described
preferred embodiments the drive mechanism further comprises (5) a
ratchet for alternately engaging and releasing at least one arcuate
tooth of the first gear; (6) a ratchet control arm for alternately
engaging and releasing the ratchet; (7) a brake handle for
alternately operating the ratchet control arm. These components are
arranged so that when the brake handle operates the ratchet control
arm, the ratchet control arm releases the ratchet, the ratchet
engages the at least one arcuate tooth of the first gear and the
first gear is prevented from rotating. This means that when the
brake handle does not operate the ratchet control arm, the ratchet
control arm engages the ratchet, the ratchet releases the at least
one arcuate tooth of the first gear and the first gear is free to
rotate.
[0032] According to still further features in the described
preferred embodiments the thimble-like element is constructed so as
to be mounted over a dorsal side of the distal phalanx of the
surgeon's finger, thereby exposing the entire ventral tactile
portions of the distal phalanx.
[0033] According to still further features in the described
preferred embodiments the thimble-like element is constructed so as
to fully surround the distal phalanx and expose the tip of the
ventral tactile portion of the distal phalanx.
[0034] According to still further features in the described
preferred embodiments the thimble-like element is constructed so as
to be mounted over a ventral side of the distal phalanx of the
surgeon's finger and expose the tip of the ventral tactile portion
of the distal phalanx.
[0035] According to still further features in the described
preferred embodiments the surgical needle is ejectable in a
direction generally perpendicular to a longitudinal axis of the
thimble like element.
[0036] According to still further features in the described
preferred embodiments the surgical needle travels along at least a
portion of a circular path, the path being on a plane which
substantially parallels a plane traversing the surgeon's finger
from top to bottom.
[0037] According to still further features in the described
preferred embodiments the surgical needle travels along at least a
portion of a circular path, the path being on a plane which
substantially parallels a plane traversing the surgeon's finger
from side to side.
[0038] According to still further features in the described
preferred embodiments the surgical needle travels along at least a
portion of a circular path, the path being on a plane which is
substantially perpendicular to the longitudinal axis of the
surgeon's finger.
[0039] According to still further features in the described
preferred embodiments the finger-guided suture device further
comprises an optical head engaged by the thimble like element.
[0040] According to still further features in the described
preferred embodiments the finger-guided suture device further
comprises the surgical suture formed with a loop for collection by
the surgical needle.
[0041] According to still further features in the described
preferred embodiments the wall is a side wall of the thimble-like
element.
[0042] According to still further features in the described
preferred embodiments the wall is a front wall of the thimble-like
element.
[0043] According to still further features in the described
preferred embodiments the finger-guided suture device further
comprises a reporting mechanism for reporting at least one
situation selected from the group consisting of a full ejection of
the substantially semi-circular surgical needle, a full withdrawal
of the substantially semi-circular surgical needle, a degree of
ejection of the substantially semi-circular surgical needle and a
degree of withdrawal of the substantially semi-circular surgical
needle.
[0044] The present invention successfully addresses the
shortcomings of the presently known configurations by providing a
finger guided suture including a needle which is capable of
collecting the surgical suture via a distal portion of the surgical
needle upon contact therewith and retaining and guiding the
surgical suture while suturing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] The invention is herein described, by way of example only,
with reference to the accompanying drawings. With specific
reference now to the drawings in detail, it is stressed that the
particulars shown are by way of example and for purposes of
illustrative discussion of the preferred embodiments of the present
invention only, and are presented in the cause of providing what is
believed to be the most useful and readily understood description
of the principles and conceptual aspects of the invention. In this
regard, no attempt is made to show structural details of the
invention in more detail than is necessary for a fundamental
understanding of the invention, the description taken with the
drawings making apparent to those skilled in the art how the
several forms of the invention may be embodied in practice.
[0046] In the drawings:
[0047] FIG. 1 is a perspective view of one embodiment of a
finger-guided suture device according to the present invention
including an external actuation device;
[0048] FIG. 2 is a perspective view of a second embodiment of a
finger-guided suture device according to the present invention
including an external actuation device;
[0049] FIG. 3 depicts the assembly of a surgical needle and a drive
wheel according to the embodiment of the finger-guided suture
device depicted in FIG. 1;
[0050] FIG. 4 is an exploded view of the finger-guided suture
device according to the embodiment depicted in FIG. 1;
[0051] FIG. 5 depicts a cartridge, with cover removed, of the
finger-guided suture device according to the embodiment depicted in
FIG. 1;
[0052] FIG. 6 shows the assembly of the cartridge to a thimble like
element according to the embodiment of the finger-guided suture
device depicted in FIG. 1;
[0053] FIG. 7 shows how a surgical suture may be engaged by a
surgical needle according to the embodiment of the finger-guided
suture device depicted in FIG. 1;
[0054] FIG. 8 is a perspective view of the finger-guided suture
device according to the embodiment depicted in FIG. 1 in which
engagement of a suture by the needle is depicted;
[0055] FIG. 9 is an underside perspective view of the finger-guided
suture device according to the embodiment depicted in FIG. 1;
[0056] FIG. 10 is a top view of a finger-guided suture device
according to the embodiment depicted in FIG. 1;
[0057] FIG. 11 is perspective view of the finger-guided suture
device according to the embodiment depicted in FIG. 2 in which the
assembly of the surgical needle is shown;
[0058] FIG. 12 is a an exploded view of a drive arm of the
finger-guided suture device according to the embodiment depicted in
FIG. 2;
[0059] FIG. 13 is an exploded view detailing assembly of pulleys of
a finger-guided suture device according to the embodiment depicted
in FIG. 2;
[0060] FIG. 14 is an exploded view of a finger-guided suture device
according to the embodiment depicted in FIG. 2 showing assembly of
the drive arm and drive wheel;
[0061] FIG. 15 depicts the assembly of the upper and lower portions
of the finger-guided suture device according to the embodiment
depicted in FIG. 2;
[0062] FIG. 16 is an exploded view of a cartridge of the
finger-guided suture device according to the embodiment depicted in
FIG. 2;
[0063] FIG. 17 depicts the assembly of the cartridge of the type
depicted in FIG. 16 into the finger-guided suture device according
to the embodiment depicted in FIG. 2;
[0064] FIG. 18 is a perspective view of the finger-guided suture
device according to the embodiment depicted in FIG. 2 in which
engagement of the suture by the needle is depicted;
[0065] FIG. 19 is a cutaway view of the finger-guided suture device
according to the embodiment depicted in FIG. 2 in which engagement
of the suture by the needle is depicted;
[0066] FIG. 20 is an exploded view of a portion of the
finger-guided suture device according to the embodiment depicted in
FIG. 2 in which the relative placements of the drive arm, needle
and drive wheel are illustrated;
[0067] FIG. 21 is a perspective view of a handle of one embodiment
of an external actuation device according to the present invention
as pictured in FIGS. 1 and 2;
[0068] FIG. 22 is an exploded view of a portion of the drive
mechanism of one embodiment of an external actuation device
according to the present invention as pictured in FIGS. 1 and
2;
[0069] FIG. 23 is an exploded view of the drive housing of the
drive mechanism of one embodiment of an external actuation device
according to the present invention as pictured in FIGS. 1 and 2,
showing the assembly of a handle and a first drive wheel
therein;
[0070] FIG. 24 is an exploded view of the drive housing of the
drive mechanism of one embodiment of an external actuation device
according to the present invention as pictured in FIGS. 1 and 2,
showing the assembly of a lockable ratchet and a ratchet locking
arm therein;
[0071] FIG. 25 depicts the assembly of the portion of the drive
mechanism shown in FIG. 22 into the drive housing of FIGS. 23 and
24;
[0072] FIG. 26 depicts positioning of a cover on the drive housing
of FIGS. 23 and 24 and 25;
[0073] FIG. 27 shows the covered drive housing of FIG. 26 with the
handle of FIG. 21 protruding;
[0074] FIG. 28 is a cutaway top view of the assembled drive housing
of FIGS. 25, 26 and 27 showing engagement of the ratchet locking
arm with the locking ratchet;
[0075] FIG. 29 is a cutaway top view of the assembled drive housing
of FIGS. 25, 26 and 27 and 28 showing disengagement of the ratchet
locking arm from the locking ratchet.
[0076] FIG. 30 is a cutaway top view of the assembled drive housing
of FIGS. 25, 26 and 27 and 28 and 29 showing partial disengagement
of the ratchet locking arm from the locking ratchet.
[0077] FIGS. 31a-c show a hook, at least one arm, and an openable
loop at a distal end of the surgical needle.
[0078] FIGS. 32a-b are of adapters for use with a thimble like
element according to the present invention.
[0079] FIG. 33 is a schematic representation of the vagina and the
urethra after a surgical procedure is completed using a device
according to the present invention. (v is vagina, s is suture, U is
Urethra and CL is Cooper's Ligament);
[0080] FIGS. 34a-b show a finger guided suture device according to
the present invention equipped with an optical head.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0081] The present invention is of a finger-guided suture device
which can be used to place sutures, especially in body locations of
limited minimal-invasive accessibility and further to surgical
procedures employing the device. Specifically, the present
invention can be used to allow a surgeon while tactilely sensing an
intrabodily location to collect surgical suture via a distal
portion of a surgical needle upon contact therewith and retain and
guide the surgical suture while suturing.
[0082] The principles and operation of a finger guided suture
device according to the present invention may be better understood
with reference to the drawings and accompanying descriptions.
[0083] Before explaining at least one embodiment of the invention
in detail, it is to be understood that the invention is not limited
in its application to the details of construction and the
arrangement of the components set forth in the following
description or illustrated in the drawings. The invention is
capable of other embodiments or of being practiced or carried out
in various ways. Also, it is to be understood that the phraseology
and terminology employed herein is for the purpose of description
and should not be regarded as limiting.
[0084] In the drawings two embodiments of a finger-guided suture
device, which is referred to herein below as device 20, are
pictured (FIGS. 1 and 2). The preferred embodiments of the device
depicted in FIG. 1 are further detailed in FIGS. 3-10, while the
preferred embodiments of the device depicted in FIG. 2 are further
detailed in FIGS. 11-20.
[0085] Device 20 includes a thimble like element 22, a surgical
needle 24, and a mechanism 30 for driving needle 24 in order to
form a suture. Mechanism 30 is divided into a first portion 54
(FIGS. 3 and 12) and a second remote portion 56 in the two pictured
embodiments of device 20. Remote portion 56 of drive mechanism 30
is detailed in FIGS. 21-30. The two portions 54 and 56 of mechanism
30 are connected by a pipe or tube 53 containing a cable 100 (FIGS.
4 and 15) which serves to drive needle 24.
[0086] Thimble-like element 22 (FIGS. 8, 9, 10, 17, 18, and 19) is
adapted to surround a portion of a surgeon's finger. Thimble-like
element 22 is constructed to expose the ventral tactile portions of
the distal phalanx of the surgeon's finger, so as to enable the
surgeon to tactile sense a body location to be sutured (FIGS. 4, 6,
8, 9, 15, 17 and 18). In the preferred embodiments of FIGS. 11, 15,
17, 18 and 19 thimble-like element 22 is constructed so as to be
mounted over a dorsal side of the distal phalanx of the surgeon's
finger, thereby exposing the entire ventral tactile portions of the
distal phalanx. In the preferred embodiment pictured in FIGS. 4, 8,
and 9, thimble-like element 22 is constructed so as to fully
surround the distal phalanx and expose the tip of the ventral
tactile portion of the distal phalanx such that it can be mounted
over a ventral side of the distal phalanx of the surgeon's finger
and expose the tip of the ventral tactile portion of the distal
phalanx. Device 20 may further include an adapter 600 insertable
between the thimble-like element 22 and the surgeon's finger, so as
to adapt the suture device to fingers of different size (FIGS.
32a-b).
[0087] Surgical needle 24 is an ejectable substantially
semi-circular needle engaged within a housing 25 being formed
within, or connected to, a wall 112 of thimble-like element 22.
Wall 112 may be, for example a sidewall (FIG. 1) or a front wall
(FIG. 2) of thimble like element 22. Needle 24 is designed for
collecting a surgical suture 26 via a distal portion 28 of needle
24 upon contact with suture 26 and for retaining and guiding suture
26 while suturing. Suture 26 is collected retained and guided by,
for example, notch 44 of needle 24. The function of notch 44 may be
performed equally well by, for example, a hook 46, at least one arm
48, or an openable loop 50 at distal end 28 of needle 24 (FIGS.
31a, b and c).
[0088] According to a preferred embodiment of the present invention
surgical needle 24 is ejectable in a direction generally
perpendicular to a longitudinal axis of thimble like element 22
(FIGS. 11-20).
[0089] According to another preferred embodiment of the present
invention surgical needle 24 travels along at least a portion of a
circular path, the path being on a plane which substantially
parallels a plane traversing the surgeon's finger from top to
bottom (FIGS. 11-20).
[0090] According to yet another preferred embodiment of the present
invention surgical needle 24 travels along at least a portion of a
circular path, the path being on a plane which substantially
parallels a plane traversing the surgeon's finger from side-to side
(FIGS. 3-10).
[0091] According to still another preferred embodiment of the
present invention surgical needle 24 travels along at least a
portion of a circular path, the path being on a plane which is
substantially perpendicular to the longitudinal axis of the
surgeon's finger (FIGS. 3-10).
[0092] Mechanism 30 serves for ejecting surgical needle 24 from
housing 25 formed in thimble-like element 22 via an exit point 21
and thereafter withdrawing surgical needle 24 into housing 25 of
thimble-like element 22 via an entry point 23, so as to place a
suture. Distal portion 28 of needle 24 collects suture 26 after
passing through entry point 23 by engaging a loop 110 of suture 26
in a notch 44 formed at a distal end of needle 24. In the pictured
embodiments of device 20, needle 24 is then withdrawn back through
entry point 23 and into exit point 21 placing a suture. Mechanism
30 may be, for example, a belt actuated mechanism, a gear actuated
mechanism or a combined gear and belt actuated mechanism (as
depicted in the drawings). More details of the alternative
preferred embodiments of mechanism 30 are further described
hereinbelow.
[0093] Thus, in the pictured preferred embodiments finger-guided
suture device further include surgical suture 26 formed with loop
110 (FIGS. 5 and 16) for collection by surgical needle 24. Loop 110
is contained within a cartridge 32 which serves for holding
surgical suture 26 and for presenting it for collection via notch
44 formed at distal portion 28 of surgical needle 24. Cartridge 32
(FIGS. 5 and 16) includes at least one mechanism designed and
constructed, so as to maintain a predetermined tension of surgical
suture 26. A mechanism which is suitable for maintaining such a
predetermined tension may be, for example, at least one piece of
flexible material 36 containing at least one hole 38 through which
surgical suture 26 passes. A single piece of flexible material 36
containing two holes 38 (FIG. 5) or a pair of pieces of flexible
material 36 each containing one hole 38 (FIG. 16) can, for example,
be employed. Flexible material 36 may be, for example, silicon,
latex, rubber, fabric, or fabric with an eyelet. An eyelet may be
constructed of material including, but not limited to, silicon,
latex, rubber or fabric. Friction on suture 26 as it passes through
cartridge 32 is reduced by rounding of corners 35 within cartridge
32. Cartridge 32 is covered with a cover 29 and affixed to housing
25 of device 20 by bolts 114 which pass through bolt holes 113
(FIGS. 6 and 17). Although bolts are pictured in all figures, other
connecting means, including but not limited to, screws, rivets,
nails, pins, glue, soldering, heat pressing and/or welding might be
employed to assemble components of device 20 without substantially
affecting its functions.
[0094] Drive mechanism 30 which serves for driving needle 24
includes a first portion 54 (FIGS. 3, 7, 12 and 14) engaged within
housing 25. First portion 54 is in contact with needle 24. Drive
mechanism 30 also includes a second, remote, portion 56 (FIGS. 1
and 2) extending out of the patient's body and which is operable by
a free hand of the surgeon so as to eject needle 24 from
thimble-like element 22. Pipe or tube 53 containing cable 100
operatively connects first portion 54 to second portion 56.
[0095] According to one pictured preferred embodiment (FIGS. 3 and
7) first portion 54 of mechanism 30 includes a rotatable wheel 53
having an axle 60. Axle 60 serves for engaging surgical needle 24
and imparting thereto a rotational motion 62 in at least one
direction. Axle 60 fits into axle seats 59 (FIG. 4). Cable 100 is
contained in pipe 53 which is seated in pipe seat 55. Pulley 27
serves to reduce friction on cable 100. According to this preferred
embodiment, needle 24 includes a mechanism 64 for engaging
rotatable wheel 58. Further according to this preferred embodiment,
first portion 54 of mechanism 30 also includes a locking piece 66
for insuring that surgical needle 24 and rotatable wheel 58 remain
engaged.
[0096] According to an alternative pictured preferred embodiment
(FIGS. 12 and 14) first portion 54 of mechanism 30 includes
rotatable wheel 58 which has mechanism 64 which serves for engaging
an axle 71 of a drive arm 68 and imparting a rotational motion, as
indicated by 62, in at least one direction thereto. Drive arm 68 is
designed and constructed to be engageable by both rotatable wheel
58 and needle 24. A needle engaging piece 69 fits into a mechanism
65 which serves for engaging drive arm 68 of needle 24 and imparts
a rotational motion, as indicated at 62, of rotatable wheel 58 in
at least one direction to surgical needle 24. A disk 70 ensures
that needle 24, drive arm 68 and rotatable wheel 58 remain engaged.
In this preferred embodiment cable 100 passes over a pair of
pulleys 27 mounted on a pair of axles 31 in housing 25 (FIG. 13).
Needle 24 rotates about axle 60 (FIG. 11) and has a range of motion
which is restricted by a stopping piece 67 (FIG. 12). Again, pipe
53 serves to contain cable 100.
[0097] Remote portion 56 (FIGS. 21-30) of drive mechanism 30
includes a hand operable actuator 72 (FIG. 21) for operating drive
mechanism 30. Remote portion 56 also includes a drive housing 76
for containing at least a portion 74 of drive mechanism 30, and at
least a portion 74 (FIG. 22) of drive mechanism 30. Drive mechanism
30 functions to impart a rotational motion in at least one
direction to needle 24.
[0098] Hand operable actuator 72 of remote portion 56 of drive
mechanism 30 includes a handle 78 for engaging at least one finger
of the free hand of the surgeon. Actuator 72 of remote portion 56
also includes an extending piece 80 containing a plurality of
arcuate teeth 82. Extending piece 80 is movable through drive
housing 76 by means of pressure applied to handle 78 by at least
one finger of the free hand of the surgeon. Actuator 72 of remote
portion 56 also includes a pressure sensitive spring 84 and a brake
handle 86. Brake handle 86 is operable in a first direction by
pressure sensitive spring 84 and in a second direction by the at
least one finger of the free hand of the surgeon.
[0099] Remote portion 56 of drive mechanism 30 includes plurality
of arcuate teeth 82 deployed in a linear arrangement along an
extending piece 80 of handle 78. Drive mechanism 30 further
includes a first gear 92 with a first circular arrangement of
arcuate teeth 94. First circular arrangement of arcuate teeth 94
serves for engaging plurality of arcuate teeth 82 along extending
piece 80. Linear displacement of extending piece 80 is therefore
translated into rotational motion of first gear 92. Remote portion
56 of drive mechanism 30 further includes a second gear 96. Second
gear 96 includes a second circular arrangement of arcuate teeth 98
for engaging first circular arrangement of arcuate teeth 94 of
first gear 92. In the pictured embodiment, second circular
arrangement of arcuate teeth 98 is actually two concentric circular
arrangements of arcuate teeth, although a single circular
arrangement of arcuate teeth might be employed without
significantly affecting the performance of device 20. A cover 95
covers second gear 96. Cable 100 is fitted around at least a
portion of second gear 96 and is fixed to gear 96 in at least one
point by a cable holding piece 97, placed in a holding piece well
99 and secured via bolts 114 which fit into bolt holes 113.
Therefore, rotational motion of first gear 92 causes rotational
motion of second gear 96. Remote portion 56 of drive mechanism 30
further includes at least a portion of cable 100 in contact with at
least one point on second gear 96, such that rotational motion of
second gear 96 is translated to linear motion of cable 100. First
gear 92 and second gear 96 are fitted on, and rotate about, axles
91 and 101, respectively (FIG. 23).
[0100] In the pictured preferred embodiments of device 20, remote
portion 56 of drive mechanism 30 further includes a ratchet 102 for
alternately engaging and releasing at least one arcuate tooth 94 of
the first gear 92. Remote portion 56 of drive mechanism 30 further
includes a ratchet control arm 104 for alternately engaging and
releasing ratchet 102. Remote portion 56 of drive mechanism 30
further includes a brake handle 86 for alternately operating the
ratchet control arm. These components are operatively arranged so
that when brake handle 86 operates ratchet control arm 104, ratchet
control arm 104 releases ratchet 102, ratchet 102 engages at least
one arcuate tooth 94 of first gear 92 and preventing it from
rotating. This means that when brake handle 86 does not operate
ratchet control arm 104, ratchet control 104 arm engages ratchet
102, ratchet 102 releases at least one arcuate tooth 94 of first
gear 92 which is then free to rotate.
[0101] A typical sequence of events during use of device 20
includes placement of thimble like element 22 onto a finger of a
first hand of a surgeon and insertion of the finger bearing device
20 into an intrabody location. After tactile sensing, the surgeon
aligns device 20 with a location for suture placement. At this time
the surgeon places at least one finger of a second hand into handle
78 of actuator 72 while stabilizing actuator 72 with one or more
additional fingers placed in additional loops 83. Referring now to
FIG. 28, the surgeon then begins to move handle 78 towards housing
73 so that arcuate teeth 82 of extending piece 80 engage arcuate
teeth 94 of first gear 92. First gear rotates in a clockwise
direction, thereby rotating second gear 96 (covered by cover 95).
This causes a linear displacement of cable 100 which is translated
to rotational motion 62 of rotatable wheel 58 (FIGS. 3 and 12).
This rotational motion causes semi circular needle 24 to be ejected
from housing 25 of thimble like element 22 via exit point 21. As
handle 78 continues to move towards drive housing 73, needle 24
enters housing 25 via entry point 23. At this point distal portion
28 of needle 24 passes through loop 110 of suture 26 so that notch
44 is in proximity to suture 26. During this process, first
engagement point 77 of ratchet control arm 104 engages second
engagement point 79 of ratchet 102 so that third engagement point
81 of ratchet 102 does not engage arcuate teeth 94 of first gear
92. When brake 85 of brake handle 86 reaches activator 103 of
ratchet control arm 104 and presses upon it, ratchet control arm
104 overcomes the tension of control arm spring 107 so that first
engagement point 77 releases second engagement point 79 (FIG. 29).
At this point ratchet spring 109 moves ratchet 102 so that third
engagement point 81 engages at least one tooth 94 of first gear 92
thereby arresting it. This prevents further motion of second gear
96, cable 100, rotatable wheel 58 and needle 24. At this point,
further progress of needle 24 is also blocked by stopping piece 67
of disc 70 According to a preferred embodiment of the present
invention of device 20, the surgeon now releases finger pressure on
brake handle 86 allowing spring 84 to move brake 85 away from
activator 103 of ratchet control arm 104 and continues to move
handle 78 away from housing 73. At this point (FIG. 30), first and
second engagement points (77 and 79) are disengaged but third
engagement point 81 is still holding at least one arcuate tooth of
first gear 92. As handle 78 moves away from housing 73, arcuate
teeth 82 impart a counterclockwise rotational motion to first gear
92. Ratchet spring 109 is now free to release third engagement
point 81 of ratchet 102 from first gear 92. Counterclockwise
rotational motion of first gear 92 imparts a clockwise rotational
motion to second gear 96 which, as is mentioned above, is covered
by cover 95. The clockwise rotational motion of second gear 96 is
translated to linear displacement of cable 100 in a second
direction. This reverses the direction of rotational motion 62 of
rotatable wheel 58 causing withdrawal of needle 24. At this point
notch 44 collects suture 26 as needle 24 is withdrawn through entry
point 23 and into exit point 21, thereby placing a suture.
[0102] As shown, for example, in FIGS. 34a-b, according to a
preferred embodiment of the present invention finger-guided suture
device 20 further includes at least one optical head 700 engaged by
thimble-like element 22 thereof. Optical head 700 communicates with
a monitor or any other display for presenting the surgeon with
details of the path to the body location to be treated or the
treated body location itself prior, during or after treatment.
Optical head 700 can include a miniaturized camera and/or
preferably a bundle of optic-fibers to generate an image which is
representable on a monitor or any other display. In addition,
optical head 700 can include one or more optical elements such as,
but not limited to, lenses, prisms, reflectors and the like. Of
particular interest is a fish-eye lens which can be used to provide
a larger field of view for optical head 700.
[0103] According to a preferred embodiment of the present
invention, optical head 700 includes a lens for focusing imagery
data onto a bundle of fiber optics which transmit the imagery data
to a sensor, such as, but not limited to, a camera which is remote
and connectable to the device or instrument. This feature is of
importance in cases where the device is of a disposal type.
[0104] Finger-guided suture device 20 may further include a
reporting mechanism for reporting a situation such as a full
ejection of the substantially semi-circular surgical needle 24, a
full withdrawal of the substantially semi-circular surgical needle
24, a degree of ejection of the substantially semi-circular
surgical needle 24 or a degree of withdrawal of the substantially
semi-circular surgical needle 24. The reporting mechanism may be,
for example, optical head 700.
[0105] The suture device described hereinabove enjoy several
important advantages over the designs described in the background
section since it provides: (i) complete control of the needle
motion at any time, i.e., the surgeon can retrieve the needle back
to its housing at any time of the procedure without loosing the
needle in the tissue; (ii) the possibility to use different types
of suture material with the same needle which is realized in this
case since the suture is not attached to the needle, thus allowing
to load different types of suture into the cartridge and use the
same needle; (iii) optimal security to the surgeon during the
needle motion; (iv) optimal security to the patient since the depth
of the needle bite is fixed in advanced and can not be change
during the needle motion; and (v) optimal suture placement since
the size of the surgical bite is fixed and known in advanced, thus
the suture material can be placed in an accurate way.
[0106] The following sections relate to the use of the
finger-guided suture devices herein described in various surgical
procedures. It is understood that these procedures are provided as
examples and are not to be taken as limiting. It will be
appreciated by one ordinarily skilled in the art of surgery that
many other procedures can be performed using the devices of the
present invention. More particularly, the following exemplary
surgical procedures describe surgical protocols in which a single
finger of a surgeon is inserted intrabodily and is employed to
tactile sense a body location to be treated. However, it will be
appreciated that the devices of the present invention may find uses
in other extra or intrabody surgical procedures.
[0107] While the suturing devices according to the invention will
be described and explained herein as being applied in a novel
procedure for bladder-neck suspension used for treatment of urinary
incontinence (genuine stress urinary incontinence--GSUI) in
females, it is also suitable for application in, e.g.,
sacro-spinous ligament fixation, and for anchoring suture material,
even in conventional transabdominal pelvic surgery, where in obese
patients exposure is limited and the surgeon has to rely on
palpation of pelvic structures.
[0108] The procedure is a surgical treatment of genuine stress
urinary incontinence (GSUI) in females, and aims at the correction
of the suspension of the anatomical area defined as the "bladder
neck", i.e., returning the bladder neck to its former, normal
position. Such procedures are known, the one having the highest
success rate being the Burch Colposuspension, in which the pelvic
fascia and vaginal wall lateral to the urethra is suspended to
Cooper's ligament. While this procedure indeed appears to be the
most promising, it still is a transabdominal method, requiring
general anesthesia, an extensive abdominal incision and
hospitalization.
[0109] While the procedure facilitated by the present invention
follows the same anatomical principles as the above-mentioned Burch
method, it is, in contradistinction thereto, a transvaginal, rather
than a transabdominal, bilateral suspension of the bladder neck to
Cooper's ligament. It is this distinction which turns the
treatment, as a matter of fact, into an office, outpatient
procedure.
[0110] In cases of Rectal Prolapse, which is a known complication
of Cystic Fibrosis, the surgical correction can be performed by
constriction of the anal opening which might cause chronic
defecation dysfunction or through an abdominal approach. In the
transabdominal procedure the upper part of the rectum is anchored
to the Sacral bone. Using any of the suturing devices of the
present invention can render the anchoring procedure in the small
and deep pelvic area an easier and shorter process, avoiding the
need of extensive dissection to expose the correct anatomical
target.
[0111] Another procedure that will benefit from the use of the
suturing devices of the present invention is in the case of
treating Esophageal reflux in children. The surgical correction is
based on reconstruction of a one way valve mechanism around the
Esophagus. Passing a "Vessel loop", i.e., a thin rubber band,
around the Esophagus prevents the reflux. Any of the suturing
devices of the present invention can replace the need for
dissection of the Esophagus and makes it easy to pass the Vessel
loop behind the esophagus in a short and safe fashion.
[0112] Normal vaginal delivery exposes the female pelvic floor to
muscle and connective tissue trauma which in some cases results in
pelvic floor relaxation and pelvic organ prolapse. Vaginal prolapse
is a result of weakening of connective tissue support to the
vaginal vault apex. One of the most common surgical techniques used
to correct vaginal prolapse includes tying the upper part of the
vagina to a connective tissue condensation stretched from both
sides of the sacrum. This anatomical structure is called The
Sacrospinous Ligament, and the procedure is called Sacrospinous
Ligament Fixation. In order to perform the procedure, the surgeon
needs to open the posterior wall of the vagina and enter to a space
beside the rectum to reach the ligament. A surgical thread is
anchored to the ligament and is thereafter tied to the vagina, thus
fixing the upper part of the vagina to the ligament. Since the
location of the ligament is deep in the pelvic hole, the surgeon
needs to perform extensive dissection to expose the ligament and
place the suture material under direct visualization using long
instruments. However, palpation of the ligament is easy and within
reach of the surgeon's finger. Mounting any of the suturing devices
according to the present invention over the surgeon's finger thus
enables the surgeon to place the suture in the correct location,
avoiding the need for extensive dissection, reducing blood lose and
shortening operation time. Palpation of the correct location makes
the procedure even safer by reducing the risk of injury to pelvic
blood vessels behind certain areas of the ligament.
[0113] Rupture of the rectum in large animals, especially horses
and cows, oftentimes happens during rectal examination when a
peristaltic wave passes over the wrist of the examiner, or
following insertion of a stallion's penis into the rectum. Usually
a colostomy is done to bypass the rectum and then an attempt is
made to suture the tear in the rectum at a distance of 30 to 40 cm
from the anus. The suture is placed blindly by palpation of the
tear and an attempt is made to place a suture using a needle held
by the finger of the operator. Any of the suturing devices
according the present invention can be employed to assist suturing
the tear.
[0114] Injury to the cervix after foaling is a known complication.
This leads to infertility because of loss of the fetus through the
cervix 1 to 3 months after conception. The present treatment
involves placement of sutures into the cervix after conception, so
as to reduce the size of the opening. These sutures are inserted
blindly by a needle held by the fingers. Any of the suturing
devices according to the present invention can be used instead.
[0115] In cases of rupture of the uterus at parturition, often the
tear is large and repair must be done by means of a laparotomy.
However, a small tear can be caused by a foot of the foal. Present
treatment is effected by placing sutures in the uterus after
parturition. These sutures close the small openings and prevent
rupture of the uterus in the next pregnancy. Presently, these
sutures are placed blindly by a needle held by the fingers. Any of
the suturing devices according to the present invention can be used
instead.
[0116] Although the invention has been described in conjunction
with specific embodiments thereof, it is evident that many
alternatives, modifications and variations will be apparent to
those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall
within the spirit and broad scope of the appended claims. All
publications, patents and patent applications mentioned in this
specification are herein incorporated in their entirety by
reference into the specification, to the same extent as if each
individual publication, patent or patent application was
specifically and individually indicated to be incorporated herein
by reference. In addition, citation or identification of any
reference in this application shall not be construed as an
admission that such reference is available as prior art to the
present invention.
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