U.S. patent application number 15/377425 was filed with the patent office on 2017-03-30 for devices and methods for surgical suturing.
The applicant listed for this patent is EndoEvolution, LLC. Invention is credited to James H. Bleck, Gerald I. Brecher, Niall G. Deloughery, John C. Meade.
Application Number | 20170086821 15/377425 |
Document ID | / |
Family ID | 23149835 |
Filed Date | 2017-03-30 |
United States Patent
Application |
20170086821 |
Kind Code |
A1 |
Meade; John C. ; et
al. |
March 30, 2017 |
DEVICES AND METHODS FOR SURGICAL SUTURING
Abstract
An apparatus and a method for surgical suturing with thread
management. An apparatus for tissue suturing comprising a cartridge
having a suturing needle having a pointed end and a blunt end, the
suturing needle capable of rotating about an axis; a pusher
assembly comprising a cartridge holder having a needle rotation
drive capable of releasably engaging the cartridge and rotating the
suturing needle about the axis; and an actuator capable of
releasably engaging the needle rotation drive to rotate the needle
rotation drive. A method for suturing tissue comprising placing a
suturing device having a cartridge containing a suturing needle to
span separated tissue segments; activating an actuator to cause
rotational movement of the suturing needle through the separated
tissue segments; and deactivating the actuator to stop an advancing
movement of the suturing needle to cause a suturing material to be
pulled through the separated tissue segments forming a stitch.
Inventors: |
Meade; John C.; (Mendon,
MA) ; Deloughery; Niall G.; (Lemerick, IE) ;
Brecher; Gerald I.; (North Andover, MA) ; Bleck;
James H.; (Chelmsford, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EndoEvolution, LLC |
Raynham |
MA |
US |
|
|
Family ID: |
23149835 |
Appl. No.: |
15/377425 |
Filed: |
December 13, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15260094 |
Sep 8, 2016 |
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15377425 |
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13197870 |
Aug 4, 2011 |
9445807 |
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15260094 |
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11387127 |
Mar 22, 2006 |
8066737 |
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13197870 |
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11121810 |
May 4, 2005 |
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11387127 |
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10127254 |
Apr 22, 2002 |
6923819 |
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11121810 |
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60298281 |
Jun 14, 2001 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00473
20130101; A61B 17/0483 20130101; A61B 17/06004 20130101; A61B
17/0469 20130101; A61B 2017/00398 20130101; A61B 17/06166 20130101;
A61B 2017/00367 20130101; A61B 2017/0046 20130101; A61B 17/0482
20130101; A61B 2090/035 20160201; A61B 2017/06019 20130101; A61B
2017/06042 20130101; A61B 2017/0498 20130101; A61B 2017/06171
20130101; A61B 17/0625 20130101; A61B 2017/00544 20130101; A61B
17/1114 20130101; A61B 2017/00407 20130101; A61B 17/06114 20130101;
A61B 2017/06071 20130101; A61B 17/06 20130101; A61B 2017/06085
20130101; A61B 2017/00818 20130101; A61B 2017/06014 20130101; A61B
17/06066 20130101; A61B 2017/06028 20130101; A61B 2017/2927
20130101; A61B 17/0491 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 17/11 20060101 A61B017/11; A61B 17/06 20060101
A61B017/06 |
Claims
1. A surgical suturing device, comprising: a needle defined at
least in part by a leading end, a trailing end, an arced body
between the leading and trailing ends, and at least one engagement
surface formed into the needle; a length of suturing material
connected to the needle; a needle rotation drive including a needle
driver that reciprocates at least 180 degrees between a driven
position and a returned position, the needle driver adapted to
engage the engagement surfaces of the needle to rotate the needle
in a circular path in first rotational direction along a circular
needle track defined by a portion of the suturing device; and an
anti-rotate pawl that remains stationary with respect to the needle
along the needle track as the needle is advanced in the first
rotational direction by the needle driver, the anti-rotate pawl
being configured to engage the at least one engagement surface of
the needle to prevent the needle from rotating in a second
rotational direction opposite to the first rotational direction to
facilitate advancement of the needle along the needle track along
the first direction in a plurality of drive strokes of the needle
driver.
2. The surgical suturing device of claim 1, wherein the anti-rotate
pawl is positioned adjacent the driven position of the needle
driver.
3. The surgical suturing device of claim 1, wherein the anti-rotate
pawl extends into the needle's path of travel along the needle
track.
4. The surgical suturing device of claim 3, wherein the anti-rotate
pawl deflects at least partially in a plane that is defined by the
circular needle path.
5. The surgical suturing device of claim 1, wherein the anti-rotate
pawl includes a body configured to pivot about a pin and an edge
that is configured to move about the pivot between a first radially
inward position where the edge engages the at least one engagement
surface of the needle, to a second, radially outward position.
6. The surgical suturing device of claim 1, wherein the needle is
disposed in a removable cartridge that is removably attached to a
cartridge holder assembly of the surgical suturing device.
7. The surgical suturing device of claim 6, wherein the cartridge
holder assembly is configured to releasably engage the cartridge
and to bring the needle rotation drive into operational contact
with the suturing needle.
8. The surgical suturing device of claim 1, further comprising an
actuator configured to engage the needle rotation drive to drive
the suturing needle along the needle track.
9. The surgical suturing device of claim 6, wherein the suturing
material is also disposed within the cartridge.
10. The surgical suturing device of claim 9, wherein the cartridge
further includes a suturing material dispenser containing the
suturing material.
11. The suturing device of claim 10 wherein the cartridge further
includes a thread management system for managing the dispensation
of suturing material.
12. The surgical suturing device of claim 6, wherein the cartridge
further includes at least one mounting clip wherein the cartridge
is releasably engaged with the cartridge holder assembly having the
needle rotation drive.
13. The suturing device of claim 1 wherein the needle covers an arc
greater than about 180.degree. and less than about 330.degree., and
further wherein the needle further defines an aperture adjacent to
a blunt end of the needle for engaging the suturing material.
14. The suturing device of claim 1, wherein the needle is disposed
within a disposable portion of the suturing device.
15. The suturing device of claim 14, wherein the disposable portion
of the suturing device includes a removable cartridge.
16. A suturing device comprising: a cartridge having a protective
housing and a suturing needle having a pointed end and a second
end, the suturing needle being configured to rotate about an axis,
wherein the pointed end of the suturing needle is positioned within
the protective housing after a complete rotation of the suturing
needle about the axis; and an actuator including a cartridge holder
configured to releasably attach the cartridge, the actuator
including at least a portion of a needle rotation drive for driving
the needle about the axis, wherein engagement of the cartridge with
the cartridge holder operably couples the needle rotation drive of
the actuator to the suturing needle.
17. The suturing device of claim 16, wherein the actuator is
reusable and the cartridge is disposable.
18. The suturing device of claim 17, wherein the suturing needle
defines an opening in the second end thereof in the form of a
cylindrical bore aligned axially with respect to the needle.
19. The suturing device of claim 18, wherein a leading end of a
suturing material is inserted into the bore and restrained by
mechanically crimping material of the needle onto the suturing
material.
20. The suturing device of claim 19, wherein the needle is
configured to be advanced along a circular needle track defined by
the cartridge, across a gap in the needle track, and back into the
needle track.
21. The suturing device of claim 20, wherein a center of rotation
of the needle track that passes through the axis is unobstructed by
the needle rotation drive.
22. The suturing device of claim 21, wherein the needle path
defines a circular plane, and wherein a majority of the circular
plane is unobstructed by the needle rotation drive.
23. The suturing device of claim 22, wherein the device is
configured to push suture away from the circular needle track so
the suture does not get pinched by the needle as the needle
re-enters the circular needle track after passing across the
gap.
24. The suturing device of claim 16, further comprising a
deflectable anti-rotate lever that is configured to engage a
surface of the needle to prevent the needle from backing up in the
needle track.
25. The suturing device of claim 24, wherein the anti-rotate lever
is configured to be engaged by the needle while the needle drive
reciprocates from a driven position to a home position.
26. The suturing device of claim 16, wherein the device defines a
window near a distal end of the device that facilitates viewing of
the suturing needle as it is advanced along the needle track.
27. The suturing device of claim 16, wherein the actuator is
electrically automated.
28. The suturing device of claim 16, wherein the actuator includes
an electric motor.
29. The suturing device of claim 16, wherein the actuator includes
an electromagnetic motor.
30. The suturing device of claim 16, wherein the needle drive
includes a drive shaft.
31. The suturing device of claim 30, wherein the needle drive
further includes a flexible joint coupled to the drive shaft
configured to transmit torque.
32. The suturing device of claim 16, further comprising a drive
shaft configured to transmit torque through a flexible joint.
33. A suturing device comprising a needle rotation drive configured
to drive an arcuate suturing needle having a first pointed end and
a second end in a forward direction led by the first pointed end
about a circular orbit, the needle rotation drive being configured
to prevent the needle from moving in a backward direction opposite
to the forward direction to maintain positional registration of the
needle with respect to the needle rotation drive while the needle
rotation drive is operating.
34. The suturing device of claim 33, wherein the circular orbit
lays in a plane that is generally perpendicular to a longitudinal
axis of the suturing device
35. The suturing device of claim 33, further comprising an
actuatable control assembly disposed within a housing of the
suturing device, the actuatable control assembly including an
actuatable rack configured to linearly actuate along a linear
path.
36. The suturing device of claim 35, wherein the actuatable rack
includes at least one rack gear fixed to the actuatable rack,
wherein the control assembly is operable to control the needle
rotation drive in response to actuation of the control
assembly.
37. The suturing device of claim 36, wherein the actuable control
assembly is coupled to a motor, wherein the motor is operable to
actuate the rack.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims the benefit
of priority to U.S. patent application Ser. No. 15/260,094, filed
Sep. 8, 2016, which is a continuation of and claims the benefit of
priority to U.S. patent application Ser. No. 13/197,870, filed Aug.
4, 2011, which issued as U.S. Pat. No. 9,445,807, which in turn is
a continuation of and claims the benefit of priority to U.S. patent
application Ser. No. 11/387,127, filed Mar. 22, 2006, which is
issued as U.S. Pat. No. 8,066,737, which is in turn a divisional of
and claims the benefit of priority of application Ser. No.
11/121,810, filed on May 4, 2005, which is abandoned, and which is
in turn a divisional of and claims the benefit of priority of
application Ser. No. 10/127,254, filed on Apr. 22, 2002, now U.S.
Pat. No. 6,923,819, which in turn claims the benefit of priority to
U.S. Provisional Application Ser. No. 60/298,281, filed on Jun. 14,
2001. Each of the aforementioned patent applications is
incorporated by reference herein in its entirety for any purpose
whatsoever.
FIELD OF THE DISCLOSURE
[0002] The present disclosure relates to a surgical device for
suturing tissue. More particularly, the present disclosure relates
to a suturing device that enables the manipulation and control of
the suturing needle and suturing material during operation, and
methods for using such a device for suturing tissue.
BACKGROUND OF THE DISCLOSURE
[0003] Sutures are used in a variety of surgical applications
including closing ruptured or incised tissue, soft tissue
attachment, anastomosis, attachment of grafts, etc. Conventionally,
suturing of ruptured or incised tissues, for example, is
accomplished by the surgeon passing the sharpened tip of a curved
suturing needle with a suture attached to the opposite blunt end of
the needle through the incised tissue segments to be sutured such
that the needle tip penetrates the tissue segments causing the
needle to span the incision. The needle is then pulled through the
tissue segments manually causing the attached suture to follow the
curved path of the needle. Usually a knot is tied at the trailing
end of the suture to anchor the first stitch. This action is
performed repetitively with application of tension to the needle to
pull the entire suture through the tissue segments through
subsequent stitches until the entire incised segments are sutured
together with a plurality of stitches.
[0004] For example, conventional, open abdominal surgery, including
OB-Gyn procedures such as Cesarean delivery, creates a substantial
incision (typically eight or more inches in length) in the fascia.
In major orthopedic surgery, such as total hip replacement, even
longer incisions in two layers of fascia must be closed. The
closure of fascia must be done carefully at the conclusion of the
surgical procedure, prior to skin closure. Closing fascia by hand
suturing is a routine, repetitive, and time-consuming procedure.
Typical abdominal incisions may take as long as twenty minutes,
while in the case of hip replacement surgery, fascia closure can
take even longer. Alternative mechanical suturing devices, as well
as staplers, bone anchors, and suture-based arterial closure
devices have been used as alternatives to hand suturing in other
applications, since manual suturing is a tedious and the speed of
the procedure is mostly dependent on skill of the surgeon.
Moreover, manual suturing involves the handling and manipulation of
a sharp suturing needle with an instrument such as a needle
forceps, which can result in slipping and inadvertent, accidental
needle pricks through a surgeon's or nurse's gloves, posing a
potential risk of infection for the surgeon, nurse, staff, and
patient. Furthermore, the direct handling of the needle can cause
the needle to become contaminated with pathogenic bacteria that can
cause onset of infection at the site of the sutures. There is also
a risk of the needle penetrating the bowel and causing a serious,
and often fatal infection.
[0005] Suturing devices described in the art designed to overcome
these limitations are, however, either unduly complex design and
economically non-viable or relatively difficult to use and unsuited
for precise manipulation for suturing areas that are not easily
accessible. For example, the device disclosed in U.S. Pat. No.
4,557,265 has to be held sideways in relation to the direction of
the incision being closed. Another limitation of prior art suturing
devices is their inability to provide positive control over the
needle and suture during the suturing process. This can result in
non-uniform sutures with either overly loose or overly tight
stitches, which can cause excessive bleeding and risk tearing the
repaired tissue in the patient.
[0006] A suturing device that maintains a positive control over the
suturing needle and is capable of providing uniform stitches is
disclosed in U.S. Pat. Nos. 5,437,681 and 5,540,705. The disclosed
device requires a "scissors-like" grip and is operated by the
surgeon's thumb that provides articulation of the drive mechanism
that causes rotation of a linear drive shaft encased in a barrel,
which in turn causes a suturing needle encased in a disposable
cartridge mounted at the distal end of the barrel to rotate in an
advancing motion through the tissue. The device is, however,
limited in its efficient operability in the following ways: (1) the
rotational direction of the needle and the drive shaft is in a
direction that is perpendicular to the device actuating handles,
thereby rendering the device relatively difficult to manipulate and
control, (2) does not allow the user to view the needle and its
progress through the tissue during the suturing operation, since
the barrel containing the drive shaft leading to the needle
cartridge does not have an open construction to permit such
observation, because the action of the needle is blocked from
user's view by the nature of the instrument design, thereby making
it difficult for the user to position the advancing needle with
high accuracy along the junction of the incised tissue segments and
(3) the rate of needle advancement and, therefore, the size and
uniformity of the stitches is essentially controlled by the user by
the extent to which the articulation mechanism is depressed,
thereby rendering the process of obtaining uniform needle rotation,
tissue penetration and suture advancement difficult and entirely
dependent on the skill of the user.
SUMMARY OF THE DISCLOSURE
[0007] The present disclosure provides a suturing device that
closely emulates or replicates the manual suturing actions carried
out by a surgeon. The suturing device of the present disclosure
provides greater ease of use and allows better visualization for
the user during its operation than present mechanical suturing
methods, while maintaining control over needle movement,
advancement and suturing thread management during all phases of the
suturing process, thereby preventing entanglement of the suturing
thread material during needle movement.
[0008] A benefit provided the suturing device of the present
disclosure is that it enables maneuvering a suturing material
through a tissue incision in a manner substantially similar to the
way a surgeon would do so by hand. In particular, the suturing
device first pushes a suturing needle from the tail of the needle
and drives the point of the needle through the tissue. The device
then picks up the point of the needle after it has been driven
through the tissue, and pulls the remainder of the suturing needle
and the suture attached to the suturing needle through the tissue.
The suturing needle thus consistently follows the arc of its own
curve, which is the preferred method of suturing, in the most
non-traumatic way of passing a needle through tissue. A benefit
provided by the suturing device of the present disclosure is the
ability of the suturing needle to pull the suturing thread entirely
through the tissue segments being closed, following each stitch.
The present disclosure also relates to a suturing device comprising
a suturing needle that is protected by a housing cartridge, whereby
the suturing needle is not exposed to or handled directly by the
user, thereby precluding inadvertent needle sticks. The
configuration of the suturing device of the present disclosure also
protects against inadvertent penetration of a bowel by the needle,
since the cartridge acts as a shield between the bowel and the
needle.
[0009] The suturing needle of the present disclosure is configured
to fit into a cartridge, which in turn, is removably attached to
the distal end of the suturing device. The present disclosure
further provides an actuating means and a shaft and drive assembly
that provides a torquing force to the suturing needle to cause the
needle to advance through tissue during a suturing process without
inadvertent retraction.
[0010] The suturing device of the present disclosure offers several
advantages over conventional methods used by surgeons for suturing
tissue in that it provides a hand-held suturing instrument of
relatively simple mechanical construction and which requires no
external motive source. Embodiments of the present disclosure
provides relative ease of operation for the surgeon with only one
hand, thereby enabling the surgeon to move obstructing tissue,
debris and biological fluids from the suturing site with a free
hand, while eliminating the need for needle holders, pick-up
forceps, and other tools normally required for suturing by hand.
Furthermore, the suturing devices of the present disclosure can be
configured as to length, tip, needle, suture, and needle cartridge
size for use in conventional open surgery as well as in minimally
invasive surgery (MIS) and in "less-invasive" surgery, such as
through natural orifices or through small incisions. Additionally,
the suturing head can be oriented in any preferred direction and
either fixed in a particular orientation, or rendered movable in a
variety of orientations by an articulation means.
[0011] These and other advantages of the present disclosure will be
apparent through the embodiments described hereinafter. Embodiments
of the present disclosure accordingly include the features of
construction, combination of elements and arrangement of parts that
will be exemplified in the following detailed description.
[0012] The surgical suturing devices of the present disclosure is
configured to provide a "pistol like" grip for the user that
includes a barrel assembly and a handgrip that extends from the
proximal end of the barrel. The barrel assembly has either a linear
or non-linear configuration, including but not limited to,
straight, curved and angled configurations. The barrel assembly
comprises a plurality of hollow segments capable of being coupled
together by one or more universal joints that do not require a
permanent connection between the segments, enabling segments to be
pulled apart individually and separated. A cartridge holder is
removably attached to the distal end of the barrel assembly by a
plurality of support arms to which is releasably mounted a
disposable cartridge that is capable of accommodating a suturing
needle and a suturing thread material.
[0013] The disposable cartridge has a generally cylindrical housing
with an aperture in the sidewall of the housing at the distal or
working end thereof. An arcuate suturing needle having a sharp,
pointed tip at one end of the needle is slidably mounted in a
circular track at the distal end of the housing and opposite to the
location of the aperture. The needle is connected to a terminal end
of a suturing material or thread with a suturing thread source,
such as for example, a spool assembly that is contained either
entirely within, or remains external the cartridge. The radius of
the arc defining the arcuate suturing needle is approximately equal
to the circumference to the cartridge housing at the aperture
therein. The needle normally resides in a "home" position in its
track such that the gap in the arcuate suturing needle is in
alignment with the aperture in the cartridge housing. The sharp,
pointed end of the needle is situated on one side and entirely
within the confines of the housing aperture; the pointed end is,
therefore, always shielded by the cartridge housing. The blunt end
of the suturing needle that is attached to the suturing thread is
located at the opposite side of the aperture. The sharp, pointed
end of the needle is, therefore, wholly contained within the
cartridge and does not protrude and be exposed to the user.
[0014] In accordance with the present disclosure, the needle may be
releasably engaged by a driving means that is rotatably mounted
within the barrel assembly so that the needle can be rotated from
its home position by about 360.degree. about the central vertical
axis of the cartridge. Such a rotatory action of the needle causes
its sharp tip to advance across the cartridge housing so as to span
the aperture. Thus, when the device is positioned such that the
incised tissue segments to be sutured are situated at the housing
aperture, the needle penetrates the tissue segments and spans the
incision between them. A continued rotatory movement of the needle
causes it to return it to its original "home" position, and thereby
causes the suturing thread attached to the needle to be pulled into
and through the tissue in an inward direction on one side of the
tissue incision, and upwards and out through the tissue on the
opposite side of the incision. Thus, the suture follows the curved
path of the needle to bind the tissues together with a stitch of
thread across the incision in a manner identical to that of a
surgeon suturing manually, wherein the needle is "pushed" from the
tail and then "pulled" from the point by the drive mechanism.
Preferably, an anchoring means is provided at the trailing terminal
end of the suturing material to prevent the material from being
pulled completely through and out of the tissue segments. For
example, the anchoring means can be a pre-tied or a welded loop, a
knot wherein the suture is simply tied, or a double-stranded,
looped suture is that attached to the suturing needle.
[0015] The rotatory movement of the needle within the needle
cartridge is accomplished by a needle driver that may be operated
by the user by holding the suturing device with one hand in a
pistol-like grip around the handle, and using at least one finger
of that hand to activate a triggering lever. The suturing device
includes a finger operated trigger lever located proximally to the
handle, which when actuated, operates a drive shaft encased within
the universal joint barrel assembly through a drive mechanism so as
to cause the drive shaft to undergo a rotatory motion, thereby
causing the suturing needle to advance in a circular motion. Thus,
by placement of the device with the needle cartridge aperture
spanning the incised tissue segments and actuating the trigger
lever, the suturing device enables the user to lay down a running
stitch or interrupted stitch to close the tissue incision in a time
efficient manner.
[0016] The needle cartridge of the present disclosure is disposably
mounted on a cartridge holder assembly that is removably attached
to the distal end of the universal joint barrel assembly. The
cartridge holder assembly is supported by a plurality of support
arms that extend from the distal end of the universal joint barrel
assembly. The minimalized structural design of the support arms
enables the user to have a clear, unobstructed view of the suturing
needle as it advances through the tissue segments during the course
of a suturing operation, thereby enabling precise placement of the
suturing device to provide uniform sutures and precluding the risk
of tearing tissue by its placement too close to the edge of the
incision. The suturing devices of the disclosure is then advanced a
short distance along the incision and the aforementioned operation
is repeated to produce another stitch comprising the suturing
material. The suturing devices of the disclosure can either pull
the entire suture material through the tissues automatically under
controlled tension thereby replicating the actions of a surgeon
suturing manually so as to tighten the formed stitches without
tearing tissue. Alternatively, the surgeon simply pulls the thread
by hand to tighten the stitch placed over the incised tissue
segments by passage of the suturing needle of the suturing devices
of the disclosure.
[0017] The user may continue to manipulate the suturing device,
alternately advancing and actuating rotation of the needle about an
axis that is generally parallel to the direction of advancement to
create a continuous suture which may extend through the entire
length of the incision or a series of interrupted stitches. After
each individual stitch is laid down, it is tightened by exerting a
pull on the suturing material so that the resultant suture is neat
and tensioned uniformly along the length of the incised tissue
segments. Therefore, a tight closure of the segments is
accomplished and bleeding and tearing of tissue are minimized.
[0018] As will be described in greater detail below, the needle
driver may be operated by the surgeon holding the instrument with
one hand, and using at least one finger of that hand. The suturing
device includes a finger-operated lever that is functionally
coupled with internal gearing and forms part of a handgrip that is
located at one terminal end of the device, that enables the surgeon
to efficiently and effectively lay down a running stitch, or a
series of interrupted or uninterrupted stitches, to close a tissue
incision in a minimum amount of time.
[0019] The suturing devices of the present disclosure can
additionally include an associated thread management system, which
operates in conjunction with the needle driver to control or handle
the suturing material or thread during rotation of the suturing
needle. For example, the thread management roller pushes the thread
away from the track so the suture does not get pinched by the
needle as the needle re-enters the track. Thus, there is minimal
probability of the thread becoming tangled or hung up during the
suturing operation. The thread management system can also include a
mechanism whereby the suturing material or thread is controllably
"paid out" during the suturing process.
[0020] When using the suturing devices of the present disclosure,
no ancillary instruments or tools such as needle holders, pick-up
forceps or the like are needed to complete the suture. Also, the
suturing device may be configured in different ways with respect to
length and angle of the universal joint barrels, the angle between
barrel segments and the number and shape of the support arms. The
size of the needle, needle cartridge, cartridge aperture and
aperture position may also be varied for use in open surgery to
perform procedures such as closing of the fascia, skin closure,
soft tissue attachment, anastomosis, fixation of mesh, grafts and
other artificial materials. The suturing devices of the present
disclosure may also be designed with a very small working end or
tip at the end of a long rigid shaft or a flexible shaft that can
be oriented in any preferred direction so that the instrument may
be used for MIS, such as suturing in the course of endoscopic
surgery, including laparoscopy, thoracoscopy and arthroscopy, as
well as less-invasive surgical procedures.
[0021] In addition to offering all of the advantages discussed
above, the suturing devices of the present disclosure are
relatively simple and cost efficient to manufacture. Therefore, the
suturing devices should find widespread suturing applications that
include single stitches or continuous stitches, e.g. spiral,
mattress, purse string, etc., that are required to close tissue
incisions, attach grafts, or the like.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Embodiments of the present disclosure will be further
explained with reference to the attached drawings, wherein like
structures are referred to by like numerals throughout the several
views. The drawings shown are not necessarily to scale, with
emphasis instead generally being placed upon illustrating the
principles of the present disclosure.
[0023] FIG. 1 shows a pictorial view of the suturing device of the
present disclosure including the main components of a cartridge, a
cartridge holder assembly, drive shaft segments, a universal
coupling joint assembly and a sleeve, an actuator handle with an
actuating trigger.
[0024] FIG. 2 shows a sectional view of the shaft-universal joint
assembly attached to one embodiment of the suturing device
functional end comprising the pusher, cartridge assembly and
cartridge operable by a side drive mechanism.
[0025] FIG. 3A shows a segmented sectional view of suturing device
functional end comprising a universal joint assembly without and
with the universal joint sleeve. FIG. 3B shows an identical view
with the universal joint sleeve.
[0026] FIGS. 4A, 4B and 4C show enlarged views of a single
universal joint, joint coupler and a pair of coupled universal
joints respectively.
[0027] FIG. 5 shows an expanded view of the universal joint sleeve
configured at a 30.degree. angle.
[0028] FIG. 6 shows a detailed view of one embodiment of a
cartridge mount assembly comprising pair of supporting arms and a
shaft segment.
[0029] FIGS. 7A and 7B show two different views of one embodiment
of the needle cartridge.
[0030] FIGS. 8A and 8B show two embodiments of the curved suturing
needle with suture material ports that are operable by a side drive
mechanism.
[0031] FIG. 9 shows an expanded view of the thread management
roller housed in the cartridge.
[0032] FIG. 10 shows an expanded view of the "anti-rotate" pin
housed in the cartridge assembly.
[0033] FIG. 11A shows an expanded view of the pawl. FIG. 11B shows
an expanded view of the pusher comprising a cartridge holder
support arm with the pawl in place.
[0034] FIG. 12 shows a cut-away segment view showing interaction
points of a suturing needle with a cartridge holder and support arm
components.
[0035] FIG. 13 shows a segmented view of the relative configuration
of a suturing needle with respect to the cartridge holder.
[0036] FIG. 14 shows a segmented sectional view of the functional
end of a second embodiment of the suturing device operable by a
rear drive mechanism comprising a shaft segment, the pusher,
cartridge holder and cartridge (shown sectionally in FIGS.
15-19).
[0037] FIG. 15A shows a perspective view of a pusher with a
cartridge holder assembly comprising an attached cartridge with a
suture threading mechanism for restraining a suture material.
[0038] FIG. 15B shows a pusher comprising the cartridge holder
assembly and a cut-away section of a cartridge comprising the
curved suture needle that is operable by a rear drive
mechanism.
[0039] FIG. 16 shows an expanded view of a curved suturing needle
with suture material port that is operable by a rear drive
mechanism.
[0040] FIGS. 17A and 17B show front and rear views of the
cartridge.
[0041] FIG. 18 shows a cut-away sectional top view of a pusher
comprising a cartridge holder assembly with a locking gate.
[0042] FIGS. 19A, 19B and 19C shows the operation of the pusher arm
in a cartridge assembly operating in a rear drive mode. The pusher
arm traverses radially by opening the gate (FIG. 19A), which
springs to the closed position (FIGS. 19B and 19C) after its
passage.
[0043] FIGS. 20A, 20B and 20C show a three-dimensional, a sectional
and a cross-sectional view, respectively, of a ratchet assembly of
the present disclosure that is driven by a drive shaft and
activates a pusher arm upon device actuation.
[0044] While the above-identified drawings set forth preferred
embodiments of the present disclosure, other embodiments of the
present disclosure are also contemplated, as noted in the
discussion. This disclosure presents illustrative embodiments of
the present disclosure by way of representation and not limitation.
Numerous other modifications and embodiments can be devised by
those skilled in the art which fall within the scope and sprit of
the principles of the present disclosure.
DETAILED DESCRIPTION
[0045] The suturing device of the present disclosure is shown
generally at 1 in FIG. 1. Referring to FIG. 1, the illustrated
suturing device 1 of the present disclosure can be used to produce
a continuous or interrupted stitch or suture so as to enable
closure of the segments of an incised tissue. The suturing device 1
includes an actuator handle 12 comprising a proximal end 6 and a
distal end 8 that allows the device 1 to be held in a pistol grip
by the user, and a trigger lever 16. The actuator handle 12 is
attached to a pusher 9 at the distal end of handle 12. The pusher 9
comprises a of shaft barrel assembly to comprising a plurality of
shaft segments capable of housing a drive shaft (not shown) that
extend outwardly from a housing 14 at the distal end 8 of the
actuator handle 12. The shaft barrel assembly to is comprised of at
least two segments with symmetric coupling assemblies that are
coupled to one another with a universal joint coupler (not shown).
The coupled assembly is enclosed within a universal joint sleeve 18
such that the universal joint barrel is configured at an angle of
about 30.degree. from horizontal. The shaft segment to distal from
the actuator handle 12 is attached removably to a support arm
assembly 22 that is comprised of a pair of "skeletalized" arms
extending along mutually divergent axes so as to provide an opening
23 to view the device working end 19 during its operation. The
working end 19 of the suturing device 1 comprises a cartridge
holder assembly 20 that is removably attached to the support arm
assembly 22, to which the needle cartridge 24 is disposably
attached.
[0046] FIGS. 2-13 provide detailed views of the various components
of one embodiment of the suturing device 1 and the manner in which
the components are configured in the final assembled device to
enable its operation via a "side-drive" mechanism in the manner
described.
[0047] FIG. 2 shows the working end 19 of the suturing device 1
including the universal joint coupling sleeve 18, the universal
joint segment distal to the actuator handle (not shown) a "pusher"
9 comprising a support arm assembly 22 and a cartridge holder
assembly 20 with an attached disposable needle cartridge 24, and a
universal joint assembly (hidden) encased in a joint sleeve 18.
[0048] FIGS. 3A and 3B provide detailed segmental views of the
suturing device working-end 19 showing the disposable needle
cartridge 24 in a disengaged mode and a curved suturing needle 26
separated from the needle cartridge 24 to illustrate the relative
configuration of these segments with respect to the cartridge
holder assembly 20, the pusher 9 comprising the support arm
assembly 22 and the universal joint segments. FIG. 3A shows the
coupled junction mode involving coupling of the shaft segments 10
comprising a universal joint coupler (hidden), while FIG. 3B shows
the coupled shaft segments 10 encased in a coupling joint sleeve or
"sweep" 18 that aligns the cartridge mount 20 from the stem to the
actuator handle at about 30.degree.. The sweep 18 can be either
pre-configured to provide a pre-determined fixed angle for the
cartridge mount (relative to actuator handle), or can be configured
to be adjustable to provide the user with the ability to vary the
cartridge mount angle to a setting optimal for a particular
procedure.
[0049] FIGS. 4A-C show expanded views of the hollow universal joint
segment and the manner in which two identical segments are coupled.
As shown in FIG. 4A, the shaft segment to comprises a hollow
cylindrical barrel 28 with two open ends, and two pairs of arcuate
slots 32 and 34 at one end, wherein one pair of arcuate slots is
narrower than the other. Additionally, the joint segment contains a
plurality of circular openings 36 located on the cylinder surface
to accommodate a corresponding number of restraining pins in the
universal joint sleeve ("sweep") 18 that are identical in diameter.
Two shaft segments 10 having identical arcuate slot configurations
32 and 34 may be coupled together using a universal joint coupler
38 (FIG. 4B) comprising a plurality of pins 40 such that the
coupler engages the pair of narrow slots 32 of the conjoining joint
segments 32, thereby providing a junction connecting the two shaft
segments 10 that is non-rigid (FIG. 4C). The angle between coupled
segments 10 can, therefore, be varied. The coupled segments 10
provide a conduit for passage of a drive shaft (not shown) for
activating needle movement.
[0050] FIG. 5 shows a "transparent" view of the universal joint
sleeve or "sweep" 18, which comprises of a hollow tubular segment
with two open ends 28 whose tubular axis bends over a predetermined
angle. The sleeve 18 additionally comprises a plurality of slots 30
positioned along its side wall that are capable of engaging the
corresponding slots 36 on the shaft segments 10 that are positioned
appropriately by means of restraining bolts on pins 38. The sweep
18 therefore, enables the angle of the coupled shaft segments 10 to
be "locked" in a preferred angle. The sleeve 18 can be configured
to have either a fixed angle, or to have the capability to provide
the user the ability to adjust the angle to a preferred setting. In
one embodiment, the sweep 18 provides an angle of about 30.degree.
from horizontal. The angle for the coupled universal joint segments
10 determined by the sweep in turn, determines the angle of the
cartridge holder assembly 20 which is attached to the shaft segment
to at the distal end 8 of the actuator handle 12 (via the support
arm assembly 22). The cartridge holder angle relative to actuator
handle 12, in turn, determines the accessibility of the suturing
device 1 at the site of the suturing procedure which is critical,
depending on whether it is open and planar, or non-planar and
narrow.
[0051] FIG. 6 shows a detailed view of the pusher 9 that includes a
cartridge holder assembly 20 that is attached to a support arm
assembly comprising a pair of "skeletalized" support arms 22 which
in turn, is attached to the terminal end of shaft segment 10. The
open configuration of the "skeletalized" support arms 22 that are
minimal in bulk is an essential feature of suturing device 1 that
provides a relatively wide opening 23 that allows the user to
directly view the aperture in the needle cartridge and cartridge
(not shown) holder assembly 20, the incision in the tissue and
needle advancement through the incised tissue segments during
operation of suturing device 1. Although the embodiment shown in
FIG. 6 has a plurality of support arms 22, other variants include a
support arm assembly comprising a single support arm as illustrated
in FIG. 11B. The improved viewing ability offered by the shape and
configuration of the support arm assembly 22 enables precise device
placement over the incision, and uniform advancement of the
suturing device after every stitch to provide a uniform and
symmetric suture, thereby minimizing the risk of tearing tissue and
bleeding due to a stitch being positioned too close to the edge of
the incised tissue. The cartridge holder assembly 20 is composed of
a sterilizable medical grade material which can either be a
metallic material such as stainless steel to enable its reuse
subsequent to sterilization following a prior use, or a
sterilizable medical grade plastic material, in which case, it may
discarded and disposed after a single use. The cartridge holder
assembly 20 has a cylindrical configuration with a distal edge 40
and a proximal edge 42 with respect to the device actuator handle
(not shown), with an aperture 45 that corresponds in dimension and
location to coincide with a substantially similar aperture located
in the disposable needle cartridge. The cartridge holder assembly
20 additionally comprises a plurality of slots 44 located along on
the distal edge 40 in that are located diametrically opposite to
one another, and are capable of engaging the same plurality of
retaining clips correspondingly located in the needle cartridge
housing (not shown). The cartridge holder assembly 20 further
comprises a cylindrical slot 46 located on the distal edge 40 that
is capable of engaging a positioning pin of identical diameter
correspondingly located on the needle cartridge housing (not
shown). The proximal edge 42 of the cartridge holder assembly is
attached to the shaft segment to distal to the actuator handle 12
via a support assembly comprising at least one "skeletalized"
support arm 22.
[0052] FIGS. 7A and 7B show two different views of an embodiment of
a disposable suturing needle cartridge 24 in accordance with the
present disclosure, which is preferably offered in a sterilized
sealed package. The cartridge 24 comprises a circular housing 48
that may be formed of a suitable rigid medical grade sterilizable
metal or plastic material. The housing may be releasably retained
by the cartridge holder assembly 20 at the distal end 19 of
suturing device 1 (working end) by known means, such as a plurality
of clips 50 (shown in FIG. 7A) located along on the edge of an
inner lip 52 in diametrically opposite positions that are capable
of engaging the same plurality of slots correspondingly located in
the cartridge holder assembly 20. The cartridge 24 further
comprises a cylindrical positioning pin 54 located on the edge of
the inner lip 52 that is capable of engaging a cylindrical slot of
identical diameter correspondingly located on the cartridge holder
assembly 20. While the retaining clips 50 when engaged enable the
cartridge to be retained by the cartridge holder assembly 20, the
positioning pin 54 when engaged in the slot causes the aperture in
the cartridge 24 to be aligned with the corresponding aperture in
the cartridge holder assembly 20. The needle cartridge 24 further
comprises an aperture 56 and a circular groove or "track" 58 that
is inscribed in the inside surface of the housing 48, which lies in
a plane that is perpendicular to the longitudinal axis of both the
housing 48 and that of the suturing device 1. As shown in FIG. 7A,
the cartridge-housing aperture 56 interrupts the track 58. An
arcuate surgical suturing needle 26 composed of medical grade
stainless steel or similar material is slidably positioned in the
track 58.
[0053] FIGS. 8A and 8B show embodiments of the arcuate suturing
needle 26 of the present disclosure. In one embodiment (FIG. 8A),
the needle 26 is formed as a circular split ring with a gap 59, a
sharp, pointed end 60, and a blunt end 62. The needle 26 further
comprises an opening to accommodate the leading end of the suturing
material. In one embodiment, the opening is the form of an eye 64
through which the leading end of the suturing material may be
passed through for attaching it to the needle 26. In the
illustrated needle (FIG. 8A), the eye 64 is located adjacent to the
blunt end 62. The eye 64 however, can be positioned anywhere along
the arc or the needle 26 between its apex 61 and the blunt end 62.
In a preferred embodiment (FIG. 8B), the needle 26 comprises an
opening in the form of a cylindrical bore 66 aligned axially with
respect to the needle 26, located at the blunt end 62 (FIG. 8B).
The leading end of the suturing material is inserted into the bore
and restrained by mechanically crimping. To enable the needle 26 to
penetrate tissue to the required depth, the needle preferably has
an arcuate extent between about 280.degree. and about 330.degree.,
and more preferably, greater than about 270.degree.. The needle 26
comprises two symmetric notches 68 along the radially inner edge
("inner notches") that are positioned proximally to the sharp,
pointed end 60 and the blunt end 62 of the needle 26. The notches
68 are located directly opposite to each other, each having a
perpendicular (about 90.degree.) segment and an angular segment
that makes an angle of about 60.degree. with the perpendicular
segment. The inner notches 68 are engaged by the drive mechanism in
the cartridge holder assembly 20 and enable the needle 26 to
undergo a rotatory movement upon actuation of the drive mechanism,
thereby causing it to penetrate into and advance through tissue. A
similar triangular notch 70 is located on the radially outer edge
("outer notch") of the needle proximally to the inner notch 68
closer to the sharp, pointed end 60. The outer notch 70 engages
with an "anti-rotate" pin located in the cartridge holder assembly
20, whereby rotation of the needle 26 in a direction opposite to
the advancing direction or "needle backing-up" is prevented. The
positive engagement of the needle outer notch 70 during operation
of the suturing device 1, and thereby precludes needle 26 from
straying out of sequence during the suturing process.
[0054] The width of the aperture 56 in the cartridge housing 48 is
comparable to and corresponds with the width of the gap in the
needle 26 so that when the needle 26 is in the "home" position (as
shown in FIG. 7A) it does not project materially into the aperture
56. Such an alignment causes the needle to reside entirely within
the cartridge holder 20, thereby preventing inadvertent contact of
the sharp pointed end 60 with the user's fingers during handling of
the disposable needle cartridge 24 for its placement on the
cartridge holder 20 or its disposal after use, and while operating
the suturing device 1. Such protection of the needle 26 in the
suturing device of the present disclosure prevents accidental
"needle-pricks" from occurring, thereby substantially reducing the
risk of infection caused by pathogenic bacteria or viruses that may
contaminate the needle during or after its use prior to its
disposal. The needle 26 may be rotated in its curved track 58 about
the longitudinal axis of the suturing device 1 to advance the
pointed needle tip 60 so that the needle first spans the aperture
and then return to its original or home position. Since the
suturing material is attached to the needle 26, it follows the path
of the needle 26. The terminal end of the suturing material may
contain a knot or button to prevent it from pulling through the
sutured tissue during placement of the first stitch. The suturing
material or thread may be stored in an enclosed packaging either
externally or internally with respect to the needle cartridge
housing 48, and be pulled out of that packaging prior to placement
of the first stitch in the suturing process. In a preferred
embodiment, the cartridge housing 48 comprise the suturing needle
26 attached to the terminal end suturing material or thread, and an
appropriate length of suturing material are all packaged in a
terminally sterilizable medical packaging material.
[0055] FIG. 9 shows a thread management roller 72 of the present
disclosure which acts to push the thread away from the track so the
suture does not get pinched by the needle as the needle re-enters
the track. The thread management roller 72 comprises a spring
operated stop pin 74 that maintains a positive pressure against the
suturing material or thread, thereby preventively retaining the
suturing material in the thread retaining slot of the suturing
needle, while keeping the thread out of the needle track to
preclude the thread from jamming needle movement. The stop pin 74,
therefore, prevents jamming of needle movement by an inadvertent
entry of the suturing material into the needle slot within the
needle cartridge 24 when the material is pulled forward by the
advancing movement of the needle 26.
[0056] FIG. 10 shows an expanded view of the anti-rotate pin 75
that is capable of engaging the outer notch of the needle 26 to
prevent rotation of the needle 26 and prevent "needle backing-up"
and thereby precluding the needle 26 from straying out of
sequence.
[0057] FIG. 11B shows an expanded view of a pusher assembly
comprising pusher 76 and a pawl 78 (FIG. 11A) located at its tip,
which resides in a corresponding slot in the support arm 22 of the
pusher assembly, and is connected the support arm 22 by a pivot pin
80. The needle 26 is driven in a circular path by a rigid arm
("pusher") that extends from a hub located in the center of the
suturing device 1. The pawl 78 at the tip of the pusher 76 is
capable of interfitting with the wedge shaped notches located along
the radially inner edge of the needle. The pusher 76 is activated
by the user upon operation of the actuator trigger in the actuator
handle 12, and is capable of sweeping back and forth in an arc
spanning about 280.degree.. The outer surface of the pusher 76 is
shaped to accommodate a C-shaped spring (not shown) that causes the
wedge-shaped pawl 78 to push up against the needle 26 and thereby
remain in intimate contact. The advancing movement of needle 26
during its operation causes the triangular slots 68 along the
radially inner edge of needle 26 align with the wedge-shaped pawl
78 in the pusher 76, thereby causing the pawl 78 to engage the
slots 68 due to a positive pressure exerted on the pin by the
C-shaped spring, and to "lock" into the slots 68. The rotatory
advancing movement of the needle 26 is therefore controlled to
occur sequentially through about 280.degree. each time it is
actuated.
[0058] FIG. 12 shows a cut-away segmental view of the needle 26 in
the home position inside the cartridge (not shown) with respect to
the stem cartridge holder assembly (not shown). The relative
locations of the pawl 78 that engages the notches 68 in the
radially inner edge of the needle 26, the thread management roller
72 and the anti-rotate pin 75 that engages the notch 70 in the
radially outer edge of the needle 26 are shown in FIG. 12.
[0059] FIG. 13 shows a cut-away view of the needle 26 within the
cartridge (not shown) in the "home" position, the alignment of the
needle aperture with the corresponding aperture in the needle
cartridge holder 20, the relative position of the needle 26 and
cartridge holder 20 and aperture location with respect to the
coupled shaft segments 10 that are coupled by universal joint
coupler 38 and maintained at a fixed angle by the restraining
coupling sleeve or "sweep" (not shown).
[0060] FIGS. 14-20 show detailed component views of a preferred
embodiment of the suturing device of the present disclosure and the
manner in which the components are configured to enable its
operation as described herein.
[0061] FIG. 14 shows the working end of a preferred embodiment of
the suturing device of the present disclosure, comprising a
"pusher" 9 having a support arm assembly 80 and a cartridge holder
assembly 82 with the attached disposable needle cartridge 84. The
"pusher" 9 is connected to the drive mechanism via shaft segment 86
that is coupled via a universal joint coupling comprising a
universal joint assembly encased in a sleeve (not shown) to a
second shaft segment distal to the actuator handle 12. The shaft
segment 86 is attached to the universal joint assembly by pins that
engage slots 88 with corresponding slots in the coupling
assembly.
[0062] FIG. 15A shows segmental views of the pusher assembly
comprising a needle cartridge 84 engaged with cartridge holder
assembly 82. The cartridge 84 attaches to cartridge holder assembly
82 via a mounting clip 90 located at the apex of the arc of the
cartridge holder assembly 82 that slidably "locks" into position
with a complementary slot 92 located correspondingly on the apex of
cartridge 84. Both cartridge holder assembly 82 and cartridge 84
comprise an aperture 94 that are of similar dimension, and aligned
with one another in the "locked" position. The cartridge 84 further
comprises a suturing material management cleat 98 which is capable
of restrictibly maintaining suturing material 100 in a manner so as
to preclude its entanglement as it travels into cartridge 84 during
operation of the suturing device.
[0063] FIG. 15B shows a cut-away view of the pusher assembly
exposing a suturing needle 102 residing within cartridge 84 (not
shown) in the "home" position, wherein the alignment of the needle
aperture corresponds with apertures of both needle cartridge holder
assembly 82, and the cartridge 84. The needle 102 is placed in the
"home" position by engaging cartridge 84 with cartridge holder
assembly 82 in a locked position, whereupon it is restrained by
clip 104 in a manner causing it to be engaged with notches located
along the radially rear edge of the needle (not shown) that is
proximal to cartridge holder assembly 82 by correspondingly located
pins in a drive arm located in the cartridge holder assembly 82
that is part of a "rear-drive" needle rotation drive operating
mechanism.
[0064] FIG. 16 shows a preferred embodiment of the curved suturing
needle 102 of the disclosure. The needle 102 is formed as a
circular split ring with an aperture (or gap) 106, as sharp,
pointed end 108 and the opposite end 110. A cylindrical bore 112
aligned axially with respect to the needle, located at the blunted
110. The leading end of the suturing material is inserted into the
bore and restrained by mechanically crimping. Alternatively, the
opening for accommodating the suture material can be in the form of
an "eye" wherein the leading end of the suturing material may be
passed through for attaching it to the needle 102. To enable the
needle 102 to penetrate tissue to the required depth, the needle
102 preferably has an arcuate extent between about 280.degree. and
about 330.degree., and more preferably, greater than about
270.degree.. Needle 26 comprises two symmetric notches ("rear
notches") 114 along the radially rear edge, i.e. the edge proximal
to the cartridge holder 82, that are positioned proximally to the
sharp pointed end 108 and the opposite blunt end 110 of the needle
102, respectively. The rear notches 114 are located directly
opposite to one another, each having a perpendicular (about
90.degree.) segment and an angular segment that makes an angle of
about 60.degree. with the perpendicular segment. The rear notches
114 are engaged by the drive mechanism in the cartridge holder
assembly and enable the needle to undergo a rotational movement
upon actuation of the drive mechanism, thereby causing it to
penetrate and advance through tissue. A similar triangular notch
116 is located on the radially outer edge ("outer notch") of the
needle proximally to the rear notch 114 that is closer to the
sharp, pointed end 108. The outer notch 116 engages with an
"anti-rotate" pin located in the cartridge holder assembly, whereby
rotation of the needle in a direction opposite to the advancing
direction or "needle backing-up" is prevented. The positive
engagement of the needle outer notch 116 during operation,
therefore, precludes the needle from straying out of sequence
during the suturing process.
[0065] FIGS. 17A and 17B show the outer and inner views,
respectively, of the cartridge 84. The outer surface of the
cartridge 84 (FIG. 17A) comprises a suturing material management
cleat 98 which is capable of restrictibly maintaining the suturing
material in a manner to preclude its entanglement. The cartridge 84
further comprises a slot 92 located at the apex of an actuate edge
that slidably engages a complementarily located pin on the
cartridge holder assembly to "lock" it in position. The inner
surface of the cartridge 84 comprises a track 118 that permits the
suturing needle (not shown) housed within to travel in a rotational
motion from its "home position" so as to span aperture 106 during
operation. A slot 120 located radially on the inner surface of
cartridge 84 engages with a complementarily located pin on the
cartridge holder assembly such that when the pin is engaged
slidably in slot 120, the needle is constrained to remain in and
move along track 118.
[0066] FIG. 18 shows a top sectional view of a preferred embodiment
of a "pusher" 9 comprising a cartridge holder assembly 82 and
support arms 22. The cartridge holder assembly 82 comprises a
plurality of mounting clips 122 that are capable of receiving the
cartridge 84, and a mounting clip 90 at the apex of the radial edge
and slidably engaging a complementarily located slot in the
cartridge that engages cartridge holder assembly 82, thereby
causing the drive mechanism in the assembly 82 to engage the
suturing needle housed within the cartridge. The cartridge holder
assembly 82 further comprises a gate assembly 124 that prevents
needle 102 from leaving its track and falling out into the back of
the cartridge holder assembly 82. The gate assembly 124 is
maintained in a closed "home" position by a torque force exerted by
a spring 126 to which it is coupled via a pin 128, thereby
restricts lateral movement of needle 102. The gate assembly 124
opens during each actuation of the suturing device to permit a
circular movement of the drive mechanism that engages needle 102,
and closes to the home position immediately after passage of the
drive mechanism to preclude lateral movement and dislocation of
needle 102 within cartridge holder assembly 82.
[0067] FIGS. 19A, 19B and 19C show serial views of the "rear-drive"
needle operating drive mechanism operating within the cartridge
holder 82 of the pusher assembly (not shown). The "rear-drive"
mechanism comprises a driver arm 130 connected to a drive shaft 132
that is capable of circular motion so as to "sweep" along the
circular inner edge of the cartridge holder 82 comprising the gate
assembly 124. Actuation of the device causes the drive shaft 132 to
rotate in a clockwise direction, thereby causing driver arm 130 to
move circularly from its "home" rest position and move up to and
the past gate assembly 124, causing it to open in the process
(FIGS. 19A and 19B). The driver arm 130 continues to move
circularly until it comes to rest once again in the "home" position
(FIG. 19C). The gate assembly 124 returns to its closed home
position after passage of the driver arm 130, thereby allowing
driver arm 130 to "drive" needle 102 in a circular motion, while
preventing the needle 102 from becoming dislocated from track 118.
Thus, each time suturing device 1 is actuated, driver arm 130 moves
past the gate assembly 124, opening the gate assembly 124 in the
process. Since the gate assembly 124 moves back into its closed
"home" position after passage of the driver arm 130, it precludes
lateral movement of the needle 102, thereby preventing needle 102
from jamming due to misalignment during operation.
[0068] FIGS. 20A, 20B and 20C show the dimensional, sectional and
transparent sectional views, respectively, of a ratchet assembly
134 of the present disclosure that is part of the drive mechanism
for the suturing device 1. FIG. 20A shows the ratchet assembly 134
comprises a ratchet ring 136 with a predominantly arcuate outer
surface segment 138 having a plurality of teeth 138, and an arcuate
flat segment 140 that having a planar surface. The ratchet ring 136
includes a central circular bore (not shown) that fits slidably
over and attaches immovably to a pinion gear 142 comprising a shaft
144. The ratchet ring 136 further comprises a plurality of wedged
surfaces 139a and 139b that are proximal to the flat segment 140.
The ratchet assembly 134 is mounted on a base 146 comprising a
housing 148 that accommodates a pawl (hidden) that is activated by
a coil spring (not shown) and a shuttle 150, that is attached to a
support bracket 152 by a plurality of screws 153. FIG. 20B shows a
detailed sectional view of the ratchet ring 136 comprising a
circular bore 154 that is capable of slidably receiving and
attaching to the shaft 144 of the pinion gear 142 (not shown). The
ratchet ring 136 is mounted on the base 146 so that the teeth 138
of the ratchet ring 136 are interactively meshed with the pawl 156.
The pawl 156 is activated by a coil spring (not shown) that exerts
a positive pressure on the pawl 156 causing it to remain in
intimate contact with the teeth 138 of the ratchet ring 136. The
shuttle 150 is attached to the base so that it allows the ratchet
ring 136 to rotate in a unidirectional (such as, for example,
clockwise) until the circular movement is arrested by contact
between the shuttle 150 and a first wedge 139a in the ratchet ring
136. Movement of the shuttle 150 after contacting the first wedge
139a permits the ratchet ring 136 to rotate in a direction opposite
to the initial direction of rotation (such as, for example,
counter-clockwise) until the movement is stopped by contact of
shuttle 150 with the second wedge 139b. FIG. 20C shows a
transparent sectional view of the ratchet ring 136 where the teeth
138 of the ratchet ring 136 are enmeshed with the pawl 156, which
is maintained in intimate contact with the teeth 138 by a positive
pressure exerted by the action of a coil spring 158.
[0069] The ratchet assembly 134 of the present disclosure may be
suitably located within the handle 12 of the suturing device 1. In
a preferred embodiment, the ratchet assembly 134 is located at the
distal end 8 of the actuator handle 12, whereby the shaft 144 of
the ratchet assembly 134 is a part of a shaft segment to that is
terminally attached to a triggering mechanism of the suturing
device 1. Activation of the suturing device 1 by actuating the
triggering mechanism (not shown) via the trigger 16 in the actuator
handle 12 causes the shaft 144 and the attached ratchet ring 136
and the pinion gear 142 in the ratchet mechanism 134 to rotate
unidirectionally, the pinion gear 142 to drive the shaft segment to
coupled to the driver arm 130 of the rear-drive mechanism in the
pusher 9, which in turn, causes the engaged needle 102 to rotate in
the same direction to effectuate penetration of incised tissue by
the needle 102 pulling the suturing thread material with it. The
rotation of the shaft 144 is arrested after travelling about
280.degree. upon contact by a first wedge 139a with the shuttle
150, which in turn, terminates the first actuation step. The
shuttle 150 then permits the shaft 144 with the attached ratchet
ring 136 and the pinion gear 142 to rotate through an equal
distance in the opposite direction until the movement is stopped
once again by the contact by the shuttle 150 with the second wedge
139b. An advantage offered by the ratchet mechanism 134 of the
present disclosure is that the actuation step of the suturing
device 1 is pre-determined, that is, the ratchet assembly 134
prevents the user from performing an incomplete actuating event
that could result in an improper or incomplete suture by causing
the needle 102 to snag in the tissue. Furthermore, the ratchet
assembly 134 is capable of operation by the trigger 16 in a manner
independent of its orientation with respect to the trigger 16 and
actuator handle 12, such as for example, when it is oriented in an
upside down or sideways configuration.
[0070] The actuating means of the suturing device 1 of the present
disclosure may comprise of a triggering mechanism that is known in
the art, such as for example, the triggering mechanisms disclosed
in U.S. Pat. Nos. 6,053,908 and 5,344,061, both of which are hereby
incorporated by reference. Alternatively, the actuating means can
be either a manually operable button or switch, or a mechanically
operable by an automated electrical or a fuel driven device, such
as for example, an electrical, electromagnetic or pneumatic motor
powered by electrical, electromagnetic, compressed air, compressed
gas, hydraulic, vacuum or hydrocarbon fuels.
[0071] To commence suturing, any embodiment of the suturing device
1 of the present disclosure is placed at the site of the wound or
tissue incision such that it spans the wound or the two tissue
segments created by the incision, following which it is actuated by
operation of the actuator trigger 16 on the actuator handle 12. The
detailed operation of the suturing device 1 of the present
disclosure is described with reference to the preferred embodiment,
and is equally applicable to all other embodiments of the
disclosure described and contemplated herein. The pawl 156 in the
pusher mechanism of the suturing device 1 engages the notch 114
located radially rear edge proximal to the blunt end or "tail" of
the suturing needle 102 and pushes the needle in a circular path in
an arc spanning about 280.degree.. The sharp, pointed end 108 of
the needle 102 crosses the aperture 96 defined by the cartridge 84
and the cartridge holder 82, and penetrates the first tissue
segment located within the aperture 96, traverses the tissue
segment to penetrate the second tissue segment, and re-enters the
device on the opposite side of the aperture 96. The pusher 9 then
returns to its original location, whereupon the pawl 156 engages
the notch located radially rear edge 114 proximal to the sharp,
pointed end of the needle 102. The needle 102 with the attached
suturing material or thread is consequently pulled in a circular
path through an arc of about 280.degree.. The blunt end 110 of the
needle 102 and the suturing material therefore, pass through the
tissue segments and across the wound or incision so as to span the
wound or incision. The needle 102 comes to rest at its original
"home" position within the track in cartridge holder 82, having
advanced through a complete circular arc of about 360.degree.. The
needle 102 including the sharp, pointed end 102 remains entirely
contained within the cartridge 84. The suturing material or thread
may then be cut and secured by an appropriate method, such as for
example, by tying, or additional stitches may be placed along the
entire wound or incision by repeating the aforementioned process.
Every stitch, whether a single, interrupted stitch, or one of a
series of continuous, running stitches may be placed in like
manner. The suturing device 1 of the present disclosure, therefore,
may be used to insert either a single stitch, or to insert a suture
comprising a plurality of continuous stitches as a replacement
method for a more tedious and time-consuming manual suturing
process.
[0072] While a suturing device 1 having the separable suture
cartridge 84 containing the suturing needle 102, a pusher 9
comprising a cartridge holder 82 with the support arms 80, a drive
shaft assembly comprising the driver arm 130, and an actuator
handle 12 comprising the actuating trigger 16 and drive mechanism
has been described, the entire suturing device 1 can be designed as
a single unit which may be either reusable or disposed in its
entirety after a single use.
[0073] It will thus be seen that the examples set forth above among
those made apparent from the preceding description are efficiently
attained in the suturing device of the present disclosure. Also,
since certain changes may be made in the above description without
departing from the scope of the disclosure, it is intended that all
matter contained in the above description or shown in the
accompanying drawings shall be interpreted as illustrative, and not
in a limiting sense.
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