U.S. patent application number 11/982174 was filed with the patent office on 2008-10-16 for apparatus and method for minimally invasive suturing.
Invention is credited to Francis J. DiFrancesco, Jerry R. Griffiths, John C. Meade.
Application Number | 20080255590 11/982174 |
Document ID | / |
Family ID | 36090581 |
Filed Date | 2008-10-16 |
United States Patent
Application |
20080255590 |
Kind Code |
A1 |
Meade; John C. ; et
al. |
October 16, 2008 |
Apparatus and method for minimally invasive suturing
Abstract
An apparatus and method for minimally invasive suturing is
disclosed. A suturing device for minimally invasive suturing
includes an elongated barrel having a proximal end, a distal end,
and a longitudinal axis therebetween; a suture head assembly
extending from the distal end of the elongated barrel; a suturing
needle having a pointed end and a blunt end, the suturing needle
capable of rotating about an axis approximately perpendicular to a
longitudinal axis of the elongated barrel, wherein the pointed end
of the suturing needle is positioned within the suture head
assembly prior to and after rotation of the suturing needle; and an
actuator extending from the proximal end of the elongated barrel to
actuate a drive mechanism having a needle driver for engaging and
rotating the suturing needle.
Inventors: |
Meade; John C.; (Mendon,
MA) ; Griffiths; Jerry R.; (Pembroke, MA) ;
DiFrancesco; Francis J.; (Foxboro, MA) |
Correspondence
Address: |
EDWARDS ANGELL PALMER & DODGE LLP
P.O. BOX 55874
BOSTON
MA
02205
US
|
Family ID: |
36090581 |
Appl. No.: |
11/982174 |
Filed: |
November 1, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11231135 |
Sep 20, 2005 |
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11982174 |
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11387127 |
Mar 22, 2006 |
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11231135 |
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10127254 |
Apr 22, 2002 |
6923819 |
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11387127 |
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60611362 |
Sep 20, 2004 |
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Current U.S.
Class: |
606/144 |
Current CPC
Class: |
A61B 17/0625 20130101;
A61B 2017/2923 20130101; A61B 2017/2943 20130101; A61B 17/06066
20130101; A61B 2017/06028 20130101; A61B 17/0482 20130101; A61B
2017/2927 20130101; A61B 17/0469 20130101 |
Class at
Publication: |
606/144 |
International
Class: |
A61B 17/062 20060101
A61B017/062 |
Claims
1. A surgical suturing apparatus, comprising: a) a suture housing;
b) a needle mounted within the suture housing for movement about an
arcuate path; c) a drive assembly operably associated with the
needle for controlling movement of the needle with a suture secured
thereto about the arcuate path in a manner facilitating application
of the suture to tissue; and d) wherein the suture housing has an
open position and a closed position, and the needle can be removed
from the suture housing when in the open position.
2. The suturing apparatus according to claim 1, wherein the drive
assembly moves the needle about a continuous circular path.
3. The suturing apparatus according to claim 1, wherein the suture
housing is shaped and dimensioned for insertion through a natural
orifice of a patient.
4. The suturing apparatus according to claim 1, wherein the suture
housing is shaped and dimensioned for laparoscopic insertion
through a trocar.
5. The suturing apparatus according to claim 1, wherein the suture
housing includes a first housing member and a second housing
member, and a hinge connects the first housing member and the
second housing member.
6. The suturing apparatus according to claim 1, wherein a needle
may be reloaded within the suture housing when in its open
position.
7. A surgical suturing apparatus shaped and dimensioned for
insertion through a natural orifice of a patient, comprising: a) a
suture housing; b) a needle mounted within the suture housing for
movement about an arcuate path; c) a drive assembly operably
associated with the needle for controlling movement of the needle
with a suture secured thereto about the arcuate path in a manner
facilitating application of the suture to tissue; and d) wherein
the suture housing has an open position and a closed position,
wherein the needle can be removed from the suture housing when in
the open position.
8. A surgical suturing apparatus shaped and dimensioned for
laparoscopic insertion through a trocar, comprising: a) a suture
housing; b) a needle mounted within the suture housing for movement
about an arcuate path; c) a drive assembly operably associated with
the needle for controlling movement of the needle with a suture
secured thereto about the arcuate path in a manner facilitating
application of the suture to tissue; and d) wherein the suture
housing has an open position and a closed position, wherein the
needle can be removed from the suture housing when in the open
position.
9. A surgical suturing apparatus, comprising: a) a suture housing;
b) a needle having a proximal end and a distal end, the needle
being mounted within the suture housing for movement about an
arcuate path; c) a drive assembly operably associated with the
needle for controlling movement of the needle with a suture secured
thereto about the arcuate path in a manner facilitating application
of the suture to tissue; and d) means for determining the position
of a predetermined point on the needle relative to the needle's
path of travel when the predetermined point not visually
detectable.
10. A surgical suturing apparatus, comprising: a) a suture housing;
b) a needle mounted within the suture housing for movement about an
arcuate path; c) a drive assembly operably associated with the
needle for controlling movement of the needle with a suture secured
thereto about an arcuate path in a first direction in a manner
facilitating application of the suture to tissue; and d) an
anti-backup mechanism associated with the needle for preventing
movement of the needle in a second direction opposite to the first
direction.
11. The suturing apparatus according to claim 10, wherein the drive
assembly moves the needle about a continuous circular path.
12. The suturing apparatus according to claim 10, wherein the
suture housing is shaped and dimensioned for insertion through a
natural orifice of a patient.
13. The suturing apparatus according to claim 10, wherein the
suture housing is shaped and dimensioned for laparoscopic insertion
through a trocar.
14. The suturing apparatus according to claim 10, wherein the
anti-backup mechanism includes a lever arm secured to the suture
housing for selectively engaging the needle.
15. The suturing apparatus according to claim 14, wherein the lever
arm is pivotally secured to the suture housing.
16. The suturing apparatus according to claim 10, wherein the
anti-backup mechanism includes a biased latch mounted within the
suture housing for selectively engaging the needle.
17. The suturing apparatus according to claim 10, wherein the
anti-backup mechanism further prevents the needle from moving
between actuations of the drive assembly.
18. A surgical suturing apparatus shaped and dimensioned for
insertion through a natural orifice of a patient, comprising: a) a
suture housing; b) a needle mounted within the suture housing for
movement about an arcuate path; c) a drive assembly operably
associated with the needle for controlling movement of the needle
with a suture secured thereto about an arcuate path in a first
direction in a manner facilitating application of the suture to
tissue; and d) an anti-backup mechanism associated with the needle
for preventing movement of the needle in a second direction
opposite to the first direction.
19. The suturing apparatus according to claim 18, wherein the drive
assembly moves the needle about a continuous circular path.
20. The suturing apparatus according to claim 18, wherein the
anti-backup mechanism includes a lever arm secured to the suture
housing for selectively engaging the needle.
21. The suturing apparatus according to claim 18, wherein the
anti-backup mechanism includes a biased latch mounted within the
suture housing for selectively engaging the needle.
22. A surgical suturing apparatus shaped and dimensioned for
laparoscopic insertion through a trocar, comprising: a) a suture
housing; b) a needle mounted within the suture housing for movement
about an arcuate path; c) a drive assembly operably associated with
the needle for controlling movement of the needle with a suture
secured thereto about an arcuate path in a first direction in a
manner facilitating application of the suture to tissue; and d) an
anti-backup mechanism associated with the needle for preventing
movement of the needle in a second direction opposite to the first
direction.
23. The suturing apparatus according to claim 22, wherein the drive
assembly moves the needle about a continuous circular path.
24. The suturing apparatus according to claim 22, wherein the
anti-backup mechanism includes a lever arm secured to the suture
housing for selectively engaging the needle.
25. The suturing apparatus according to claim 22, wherein the
anti-backup mechanism includes a biased latch mounted within the
suture housing for selectively engaging the needle.
26. A surgical suturing apparatus, comprising: a) a flexible member
having a proximal end and a distal end, the proximal end having a
handle attached thereto, the distal end having a suturing body
attached thereto, wherein the handle is operatively connected to
the suturing body; b) the suturing body comprising a suture housing
in which a needle and drive assembly are housed for movement of the
needle with a suture secured thereto about an arcuate path
facilitating application of a suture to tissue; and c) means for
accommodating and operating different sized needles and different
sized sutures while maintaining the operative connection between
the handle and the suturing body.
27. The suturing apparatus according to claim 26, wherein the means
for accommodating includes a cartridge housing the needle.
28. The suturing apparatus according to claim 26, wherein the drive
assembly moves the needle about a continuous circular path.
29. The suturing apparatus according to claim 26, wherein the
suture housing is shaped and dimensioned for insertion through a
natural orifice of a patient.
30. The suturing apparatus according to claim 26, wherein the
suture housing is shaped and dimensioned for laparoscopic insertion
through a trocar.
31. A surgical suturing apparatus shaped and dimensioned for
insertion through a natural orifice of a patient, comprising: a) a
flexible member having a proximal end and a distal end, the
proximal end having a handle attached thereto, the distal end
having a suturing body attached thereto, wherein the handle is
operatively connected to the suturing body; b) the suturing body
comprising a suture housing in which a needle and drive assembly
are housed for movement of the needle with a suture secured thereto
about an arcuate path facilitating application of a suture to
tissue; and c) means for accommodating and operating different
sized needles and different sized sutures while maintaining the
operative connection between the handle and the suturing body.
32. The suturing apparatus according to claim 31, wherein the means
for accommodating includes a cartridge housing the needle.
33. A surgical suturing apparatus shaped and dimensioned for
laparoscopic insertion through a trocar, comprising: a) a flexible
member having a proximal end and a distal end, the proximal end
having a handle attached thereto, the distal end having a suturing
body attached thereto, wherein the handle is operatively connected
to the suturing body; b) the suturing body comprising a suture
housing in which a needle and drive assembly are housed for
movement of the needle with a suture secured thereto about an
arcuate path facilitating application of a suture to tissue; and c)
means for accommodating and operating different sized needles and
different sized sutures while maintaining the operative connection
between the handle and the suturing body.
34. The suturing apparatus according to claim 33, wherein the means
for accommodating includes a cartridge housing the needle.
35. A method for suture lacing, comprising: a) providing a suture
with a needle attached thereto; b) inserting the needle and suture
into an organ through a passageway; c) throwing a single stitch
through a first tissue member, throwing a single stitch through an
opposed and spaced apart second tissue member; d) repeating step
(c) at least once; e) bringing the first and second tissue members
in contact by tensioning the suture, whereby suture drag is
minimized during the tensioning and even tissue compression
substantially achieved; and f) securing the suture.
36. The method according to claim 35, wherein the suture includes
first and second leads, and the step of securing includes knotting
the first and second leads of the suture.
37. The method according to claim 35, wherein the suture includes
first and second leads and the step of securing includes anchoring
at least one of the first and second leads of the suture to
tissue.
38. The method according to claim 37, wherein the step of securing
includes anchoring both the first and second leads of the suture to
tissue.
39. The method according to claim 35, wherein the step of inserting
includes insertion through a natural orifice of a patient.
40. The method according to claim 35, wherein the step of inserting
includes insertion through a trocar.
41. A method for suture lacing, comprising: a) inserting a needle
with a suture secured thereto through a passageway, wherein the
suture includes a first lead and a second lead; b) anchoring the
first lead of the suture to a first tissue member; c) alternately
throwing the suture through a first tissue member and an opposed
second tissue member; and d) securing the suture.
42. The method according to claim 41, further including the step of
anchoring the second lead to either the first tissue member or the
second tissue member.
43. The method according to claim 41, wherein the step of inserting
includes insertion through a natural orifice of a patient.
44. The method according to claim 41, wherein the step of inserting
includes insertion through a trocar.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. patent application
Ser. No. 11/231,135, filed Sep. 20, 2005, U.S. Provisional
Application Ser. No. 60/611,362, filed Sep. 20, 2004, U.S. patent
application Ser. No. 11/387,127, filed Mar. 22, 2006, U.S. patent
application Ser. No. 10/127,254, filed Apr. 22, 2002, now U.S. Pat.
No. 6,923,819, U.S. Provisional Application Ser. No. 60/298,281,
filed on Jun. 14, 2001 and U.S. Provisional Application Ser. No.
60/939,887, filed May 24, 2007. Each of these applications is
incorporated by reference herein in its entirety.
FIELD
[0002] The embodiments disclosed herein relate to a medical device
for suturing tissue, and more particularly to a device for the
manipulation and control of a suturing needle during minimally
invasive suturing, and methods for using such a device for suturing
tissue.
BACKGROUND
[0003] Minimally invasive surgery (MIS) has allowed physicians to
carry out many surgical procedures with less pain and disability
than conventional, open surgery. Unlike conventional open surgery,
where the surgical site is readily accessible through a large
incision, enabling the surgeon to easily visualize and manipulate
both tissue and instruments, MIS requires the surgeon to operate
remotely by inserting and manipulating instruments through small
punctures ("keyhole surgery") or through natural orifices,
including the vagina, the esophagus, or the anus.
[0004] In MIS, a small puncture is typically made in the body.
Medical instruments are then inserted through a cannula. A cannula
has a small inside diameter, typically 5-10 millimeters (mm), and
sometimes up to 20 millimeters (mm) or more. A number of such
cannulas are inserted into the body for any given operation.
Minimally invasive surgical instruments are necessarily smaller,
and are also generally longer and therefore are more difficult to
manipulate with precision.
[0005] Perhaps the most problematic surgical task in MIS is
suturing. Suturing requires coordinated manipulation with both
hands of small needles and sutures that are difficult to visualize
(particularly when only indirect, two-dimensional video imaging is
available) as well as the several instruments (including
needle-drivers and pick-up forceps) ordinarily used to suture by
hand. In an environment characterized by limited space, limited
visualization, and limited mobility, many surgeons find minimally
invasive suturing by hand an extremely difficult, often virtually
impossible, surgical task.
[0006] In the preferred method of suturing by hand, a grasping
forceps ("needle driver") is held by the surgeon and is used to
grip a curved needle near the needle's tail. Pronation of the
surgeon's wrist drives the needle into the tissue. When the point
of the curved needle emerges from the tissue, the surgeon releases
the needle from the grip of the needle driver and grasps the point
with another forceps ("pick-ups"). The surgeon then pulls the
curved needle by the needle point, preferably in a circular path
following the arc of the needle's curvature to follow the most
atraumatic path through the tissue, until the entire length of the
needle has exited the tissue. Each time a stitch is placed, the
curved needle is thus driven around in a complete circular arc.
Individual (interrupted) stitches are placed by tying off the
suture following the placement of each stitch. Running (continuous)
stitches are placed by repeatedly driving the curved needle in a
complete circular arc repeatedly until the desired length of suture
and number of stitches has been placed. In order to place
additional interrupted or continuous stitches, the surgeon must let
go of the point of the needle and re-grasp the needle near the
needle's tail.
[0007] In the manual suturing technique described above, the direct
handling of the needle can result in accidental needle pricks
through a surgeon or nurse's gloves, posing a potential risk of
infection for the surgeon, nurse, staff, and patient, or 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 internal organs or vessels and
causing a serious, and often fatal infection.
[0008] Various devices for suturing for MIS are described in U.S.
Pat. No. 5,643,295 entitled "Methods and Apparatus for Suturing
Tissue"; U.S. Pat. No. 5,665,096 entitled "Needle Driving Apparatus
and Methods of Suturing Tissue"; U.S. Pat. No. 5,665,109 entitled
"Methods and Apparatus for Suturing Tissue"; U.S. Pat. No.
5,759,188 entitled "Suturing Instrument with Rotatably Mounted
Needle Driver and Catcher"; U.S. Pat. No. 5,860,992 entitled
"Endoscopic Suturing Devices and Methods"; U.S. Pat. No. 5,954,733
entitled "Suturing Instrument with Rotatably Mounted Needle Driver
and Catcher"; U.S. Pat. No. 6,719,763 entitled "Endoscopic Suturing
Device"; and U.S. Pat. No. 6,755,843 entitled "Endoscopic Suturing
Device", all of which are incorporated by reference in their
entireties for the teachings therein.
[0009] Assignees' U.S. Pat. No. 5,437,681, U.S. Pat. No. 5,540,705
and U.S. Pat. No. 6,923,819 disclose a suturing device with thread
management comprising a protective cartridge, suturing needle and
needle rotation drive, the disclosures of which are hereby
incorporated by reference. The devices described in the
above-mentioned patents and patent application comprise a mechanism
for driving a protected needle however, the needle is rotated about
an axis that is parallel to the axis of the device. In addition,
the orientation and size of the suturing device makes it difficult
to visualize and cumbersome to use for MIS.
[0010] Therefore, there remains a need in the art for a minimally
invasive suturing device that is easily manipulated within the
small diameter of the cannula; functions in an environment
characterized by limited space, limited visualization, and limited
mobility; mimics the preferred method of suturing used by surgeons;
permits the surgeon to secure and tie knots quickly and with
controlled tension; places continuous stitches; and protects user's
from accidental needle sticks during needle handling, as well as
internal organs and vessels, from inadvertent needle-pricks.
SUMMARY
[0011] Devices and methods for minimally invasive suturing of
tissue internal to a body are disclosed herein.
[0012] According to aspects illustrated herein, there is provided a
medical device for closing openings internal to a patient's body,
which closely emulates or replicates the manual suturing actions
carried out by a surgeon. The device offers several advantages over
conventional methods used by surgeons for suturing tissue during
minimally invasive surgery in that the device provides a hand-held
suturing instrument of relatively simple mechanical construction
that requires no external motive source. The presently disclosed
embodiments provide relative ease of operation for the surgeon with
only one hand.
[0013] According to aspects illustrated herein, there a suture head
assembly may be removably attached to an actuator mechanism of the
suturing device. The diameter of the device is small enough to fit
into a typical cannula, thus making the device extremely easy to
maneuver, as well as suture, during endoscopic or other MIS
procedures. Also, the suture head assembly of the device can be
laterally articulated to the left of center, to the right of
center, up, and down, once inside the cannula, which is ideal for
use in the course of endoscopic surgery, including laparoscopy,
thoracoscopy and arthroscopy, as well as other less-invasive
surgical procedures.
[0014] The device of the present disclosed embodiments closely
emulates or replicates the manual suturing actions carried out by a
surgeon. For example, during manual suturing by hand, the needle is
held in forceps and travels in a circular arc with no obstructions
anywhere in the interior of the arc. The design of the suturing
device of the present disclosed embodiments allows for a lack of
obstruction in the center of the arc of the needle during suturing.
In other words, there is no hub at the center of the circular arc
of the suturing needle. The entire area within the circular arc of
the needle is unobstructed. This allows for the user to have better
visualization during operation, unlike the present mechanical
suturing methods, while maintaining control over needle
movement.
[0015] The "locomotive-type" drive mechanism of the device of the
presently disclosed embodiments enables the small diameter of the
device and affords better visualization during operation because of
the lack of a hub. There are many benefits afforded by the design
of the suturing device of the presently disclosed embodiments,
including, but not limited to, more tissue can fit into the device,
thus enabling a bigger bite of tissue and a more secure suture; the
device can be used to ligate, that is, place a loop of suture
around a blood vessel, duct, or other tubular structure; and the
device can be inserted further into smaller incisions/openings (one
side of the aperture can be inserted deeply, for example).
[0016] A benefit provided by the suturing device of the presently
disclosed embodiments is that the device 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 that
passed 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
the needle's own curve, which is the preferred method of suturing,
in the most atraumatic way of passing a needle through tissue. A
benefit provided by the suturing device of the presently disclosed
embodiments is the ability of the suturing needle to pull the
suturing thread entirely through the tissue segments being closed,
following each stitch. When using the suturing device of the
presently disclosed embodiments, no ancillary instruments or tools
such as needle holders, pick-up forceps or the like are needed to
complete the stitch. A forceps can be used to tighten the
knots.
[0017] According to aspects illustrated herein, there is provided a
suturing device that includes a suturing needle that is protected
by a housing, the suturing needle is not exposed to or handled
directly by the user, thereby preventing inadvertent needle sticks.
The configuration of the suturing device of the presently disclosed
embodiments also protects against inadvertent penetration of
internal organs or vessels by the needle, since the housing acts as
a shield between the organs and the needle.
[0018] The suturing device of the presently disclosed embodiments
is useful for suturing tissue internal to a body. The device
includes an elongated barrel having a proximal end, a distal end,
and a longitudinal axis therebetween; a suture head assembly
extending from the distal end of the elongated barrel; a suturing
needle having a pointed end and a blunt end, the suturing needle
capable of rotating about an axis approximately perpendicular to a
longitudinal axis of the elongated barrel, wherein the pointed end
of the suturing needle is positioned within the suture head
assembly prior to and after rotation of the suturing needle; and an
actuator extending from the proximal end of the elongated barrel to
actuate a drive mechanism having a needle driver for engaging and
rotating the suturing needle.
[0019] According to aspects illustrated herein, there is provided a
method for suturing tissue during minimally invasive surgery that
includes (a) engaging a cartridge to a suture head assembly at a
distal end of a suturing device, the cartridge having a protective
housing and a suturing needle with a pointed end and a blunt end;
(b) introducing the distal end of the suturing device into a body
cavity; (c) positioning an opening in the cartridge to span a
plurality of separated tissue segments or a single tissue segment;
(d) activating an actuator coupled to a drive mechanism that
engages the suturing needle to cause rotational movement of the
suturing needle about an axis approximately perpendicular to a
longitudinal axis of the suturing device and advance the suturing
needle through the plurality of separated tissue segments or the
single tissue segment; (e) pulling a suturing material attached to
the suturing needle through the plurality of separated tissue
segments or the single tissue segment forming a stitch; and
repeating steps (c) through (e) to cause a plurality of stitches to
be placed through the separated tissue segments or the single
tissue segment.
[0020] According to aspects illustrated herein, there is provided a
method for suturing tissue during minimally invasive surgery that
includes (a) engaging a suturing needle with a pointed end and a
blunt end to a suture head assembly at a distal end of a suturing
device, the suture head assembly includes a curved track, whereby
the suturing needle follows a curved path along the track during
rotation of the suturing needle, and a latch that provides a
protective housing for the suturing needle; (b) introducing the
distal end of the suturing device into a body cavity; (c)
positioning an opening in the needle holder assembly to span a
plurality of separated tissue segments or a single tissue segment;
(d) activating an actuator coupled to a drive mechanism that
engages the suturing needle to cause rotational movement of the
suturing needle about an axis approximately perpendicular to a
longitudinal axis of the suturing device and advance the suturing
needle through the plurality of separated tissue segments or the
single tissue segment; (e) pulling a suturing material attached to
the suturing needle through the plurality of separated tissue
segments or a single tissue segment forming a stitch; and repeating
steps (c) through (e) to cause a plurality of stitches to be placed
through the separated tissue segments or a single tissue
segment.
[0021] According to aspects illustrated herein, there is provided a
method for suturing tissue during minimally invasive surgery that
includes inserting a distal end of a suturing device having a
suturing needle with a pointed end into a body; positioning the
suturing needle to span a plurality of separated tissue segments;
activating an actuator a first time causing the pointed end of the
suturing needle to extend beyond a protective housing of a
cartridge to engage the plurality of separated tissue segments; and
activating the actuator a second time to cause the suturing needle
to complete a revolution and pull a suture extending from the
suturing needle through the plurality of separated tissue segments
to form a stitch.
[0022] In addition to the advantages discussed above, the suturing
device of the presently disclosed embodiments is relatively simple
and cost efficient to manufacture. Therefore, the suturing device
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.
[0023] These and other advantages of the presently disclosed
embodiments will be obvious through the embodiments described
hereinafter. The presently disclosed embodiments accordingly
comprise the features of construction, combination of elements and
arrangement of parts that will be exemplified in the following
detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The presently disclosed embodiments 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 presently disclosed embodiments.
[0025] FIG. 1 is a perspective view of a suturing device of the
presently disclosed embodiments.
[0026] FIGS. 2A and 2B are views of the suture head assembly of the
suturing device of FIG. 1. FIG. 2A is an exploded perspective view
of the suture head. FIG. 2B is a perspective assembly view of the
suture head.
[0027] FIGS. 3A and 3B are segmented assembly views of the suture
head assembly of FIG. 2.
[0028] FIGS. 4A and 4B are cutaway segmental views of the suture
head assembly showing interaction points of a suturing needle with
a portion of the drive mechanism. FIG. 4A shows the position of the
suturing needle and drive mechanism in a "home" position prior to
use or after a complete full cycle. FIG. 4B shows the position of
the suturing needle and drive mechanism after one full actuation of
the handle, where the suturing needle is in a "rotation"
position.
[0029] FIGS. 5A and 5B are expanded views of the working end of the
suture head assembly with a suturing needle in the home position.
FIG. 5A shows the relationship between the pawl and anti-rotate
spring when the suturing needle is in the home position. FIG. 5B
shows a close-up view of the anti-rotate spring.
[0030] FIGS. 6A and 6B are expanded views of the working end of the
suture head assembly during use of the device. FIG. 6A shows the
position of the suturing needle and the pawl immediately after the
user squeezes the handle. The user then releases the handle and the
pawl returns to the start position (FIG. 6B) while the suturing
needle remains in the rotation position.
[0031] FIGS. 7A and 7B are expanded views of the pawl in contact
with the C-brace while driving the suturing needle. FIG. 7A shows a
close-up view of the pawl spring loaded with a spring. FIG. 7B
shows a close-up view of the pawl, showing the heel and tip.
[0032] FIGS. 8 and 9 are side elevational views of a much larger
scale of the internal portions of the drive mechanism located
within the handle and elongated barrel. FIG. 8 shows the drive
mechanism when the handle is in an open position and FIG. 9 shows
the drive mechanism when the handle is in a closed position.
[0033] FIGS. 10-13 are top and bottom views of the cables that
provide the connection between the drive mechanism located in the
suture head assembly and the elongated barrel when the handle is in
the open and closed positions. FIG. 10 shows a top view when the
handle is in the open position. FIG. 11 shows a bottom view when
the handle is in the open position. FIG. 12 shows a top view when
the handle is in the closed position. FIG. 13 shows a bottom view
when the handle is in the closed position.
[0034] FIG. 14 is a close-up view of the cartridge holder with a
tab that locks into a mating groove on the cartridge holder
assembly.
[0035] FIG. 15 is a suturing needle positioned in the track of the
cartridge.
[0036] FIG. 16 shows the relation between the cartridge holder
assembly, cartridge, latch and C-brace.
[0037] FIGS. 17A, 17B and 17C show the suture head assembly. FIG.
17A shows a side view of the suture head assembly. FIG. 17B is a
close-up side view showing the relationship between the lever and
latch during attachment and ejection of the needle and cartridge
from the cartridge holder assembly. FIG. 17C shows a top view of
the suture head assembly.
[0038] FIG. 18 is an expanded view of a curved suturing needle with
notches on the surface of the needle.
[0039] FIGS. 19A and 19B are two embodiments of the curved suturing
needle.
[0040] FIGS. 20-23 show different views of the suture head assembly
attached to the elongated barrel via a rotation rod. The primary
fixation point of the suture head assembly to the elongated barrel
is at the axis of lateral rotation. FIG. 20 shows a side view of
the suture head assembly. FIG. 21 shows a bottom view of the suture
head assembly. FIG. 22 shows a bottom view of the suture head
assembly articulated to the left. FIG. 23 shows a bottom view of
the suture head assembly articulated to the right.
[0041] FIGS. 24 and 25 are perspective views of a suturing device.
FIG. 24 shows a perspective view of the suturing device with the
handles in the open position. FIG. 25 shows a perspective view of
the suturing device with the handles in the closed position.
[0042] FIG. 26 is a segmented assembly view of the suture head
assembly of FIGS. 24 and 25.
[0043] FIGS. 27A and 27B are cutaway segmental views of the suture
head assembly of FIGS. 24 and 25 showing interaction points of a
suturing needle with a portion of the drive mechanism. FIG. 27A
shows the position of the suturing needle and drive mechanism in a
"home" position prior to use or after a complete full cycle. FIG.
27B shows another view of the suturing needle and drive
mechanism.
[0044] FIG. 28 is a close-up view of the needle holder assembly for
the suture head assembly of FIGS. 24 and 25.
[0045] FIG. 29 is a close-up view of the distal end of the suture
head assembly of FIGS. 24 and 25.
[0046] FIGS. 30 and 31 show the suture head assembly of FIGS. 24
and 25. FIG. 30 shows the suture head assembly with the latch in
the open position. FIG. 31 shows the suture head assembly with the
latch in the closed or locked position.
[0047] FIG. 32 is a view of a curved suturing needle with notches
on the face of the suturing needle to be used with the suturing
device of FIGS. 24 and 25.
[0048] FIG. 33 shows a view of the pawl in contact with the
suturing needle for the suturing device of FIGS. 24 and 25.
[0049] FIGS. 34 and 35 show a close-up view of the suture head
assembly of FIGS. 24 and 25 and the associated pulleys that move
the drive mechanism. FIG. 34 shows a top view of the suture head
assembly. FIG. 35 shows a side view of the suture head
assembly.
[0050] FIGS. 36 and 37 are top views of the suture head assembly
and cables that connect the drive mechanism located in the suture
head assembly and the elongated barrel when the handle is in the
open position for the suture device of FIGS. 24 and 25. FIG. 36
shows a top view of the front pulley and cable when the handle is
in the open position. FIG. 37 shows a top view of the return pulley
and cable when the handle is in the open position.
[0051] FIG. 38 shows a side elevational view of the suturing device
of FIGS. 24 and 25 showing parts of the drive mechanism.
[0052] While the above-identified drawings set forth presently
disclosed embodiments, other embodiments are also contemplated, as
noted in the discussion. This disclosure presents illustrative
embodiments 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 spirit of the principles
of the presently disclosed embodiments.
DETAILED DESCRIPTION
[0053] The suturing device of the presently disclosed embodiments
is shown generally at 50 in FIG. 1. Referring to FIG. 1, the
suturing device 50 can be used to produce a continuous or
interrupted stitch or suture so as to enable closure of openings
internal to a patient's body. The suturing device 50 can be
utilized to suture any type of anatomical tissue in any type of
anatomical cavity; and, accordingly, while the device 50 is
described hereinafter for use with a cannula in endoscopic
procedures, such as laparoscopy, the device 50 can be used in open
surgery and with catheters and other small and large diameter
tubular or hollow, cylindrical members providing access to small
cavities, such as veins and arteries, as well as large cavities,
such as the abdomen.
[0054] In an embodiment suturing device 50 includes an actuator
mechanism shown generally at 52 which comprises an elongated barrel
54 and a handle 60 that extends from the undersides at a proximal
end of the elongated barrel 54. A suture head assembly 56 is
attached to the distal end of the elongated barrel 54. In an
embodiment, the suture head assembly 56 is removably attached to
the distal end of the elongated barrel 54. The length of the suture
head assembly 56 can range from about 20 mm to about 100 mm. In an
embodiment, the length of the suture head assembly 56 is about 50
mm. The length of the elongated barrel 54 can range from about 50
mm to about 400 mm. Those skilled in the art will recognize that
the elongated barrel 54 can be made shorter or longer depending on
the intended use of the device 50. In an embodiment, the elongated
barrel 54 is about 300 mm. In an embodiment, the elongated barrel
54 is about 350 mm. An articulation lever 66, just distal to the
top of the handle 60 is pushed or pulled to cause the suture head
assembly 56 to rotate. Moving the articulation lever 66 clockwise,
moves the suture head assembly 56 to the right and moving the
articulation lever 66 counterclockwise, moves the suture head
assembly 56 to the left. The articulation lever 66 can also be
moved to articulate the suture head assembly 56 up and down. The
suture head assembly 56 is locked in place with a locking lever 64
located on an underside of the device 50, below the articulation
lever 66. The suture head assembly 56 may be articulated, and the
elongated barrel 54 may be any length appropriate for the intended
clinical application of the device 50. The diameter of the device
50 can range from about 3 mm to about 20 mm. In an embodiment, the
diameter of the device 50 is about 12 mm. In an embodiment, the
diameter of the device 50 is about 3 mm. A flush port 62 is located
on the side of the elongated barrel 54 in order to provide a port
of entry for cleaning fluids or suction such that the device 50 can
be cleaned prior to or after use.
[0055] The handle 60 is a grip that is squeezed in order to actuate
the suturing device 50. The suturing device 50 is actuated by the
actuator mechanism 52 coupled to a drive mechanism 70. The actuator
mechanism 52 of the suturing device 50 may comprise 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 actuator mechanism 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. Those skilled in the art
will recognize that any actuator mechanism of any type known in the
art can be within the spirit and scope of the presently disclosed
embodiments.
[0056] FIG. 2A is an exploded perspective view of the suture head
assembly 56 with a cartridge holder assembly 90 located at the
distal end to which a cartridge 88 can be attached. In an
embodiment, the suture head assembly 56 is fabricated as a single
piece FIG. 2B is a perspective assembly view of the suture head
assembly of the presently disclosed embodiments showing part of the
drive mechanism 70, shown as a gear train/pulley system including
pulleys 72, 74, 76 and 78. Located within the elongated barrel 54
are mechanical parts including drive shafts, belts, rods, cables,
or hydraulic tubes which run from the elongated barrel 54 through
the spherical portion 58 and then engages with the drive mechanism
70 in the suture head assembly 56. Connected at the proximal end of
the suture head assembly 56 there is a spherical portion 58 that
contains part of the drive mechanism 70 including two idler pulleys
80 and cables 84 and 86. The spherical portion 58 resides within
the distal portion of the elongated barrel 54 and rotates in a
frictionless fashion. In an embodiment, the drive mechanism 70
includes a gear train/pulley system ("locomotive-type" drive
mechanism) and cables and rods that extend from the distal end of
the suture head assembly 56 to the proximal end of the elongated
barrel 54.
[0057] The suture head assembly 56 is that portion of the device 50
within which the mechanism for driving the curved needle 120 in a
complete 360.degree. circular arc, as well as the cartridge holder
assembly 90 for attaching and releasing the cartridge 88 are
situated. The suturing device 50 is unique in the fact that the
orientation of the suture head assembly 56 is such that the when
the cartridge 88 is attached to the suture head assembly 56 the
needle 120 is driven in a curved path about an axis approximately
perpendicular to the longitudinal axis of the device 50. In this
way, the needle 120 may be optimally visualized as the needle 120
is driven in a circular arc. Also, as shown in FIG. 2B, the needle
120 and cartridge 88 are in a plane parallel to the drive mechanism
70 and fit into the same space in the suture head assembly 56.
[0058] The improved visibility offered by the shape and
configuration of the suture head assembly 56 enables precise device
placement over the incision, and uniform advancement of the
suturing device 50 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. In an embodiment, the entire device 50 or parts
of the device 50, such as the suture head assembly 56, the
elongated barrel 54, the handle 60, and the needle 120 and
cartridge 88, are composed of a sterilizable medical grade plastic
material, in which case, the entire device 50 or parts of the
device 50 may discarded and disposed after a single use. In an
embodiment, the device 50 is composed of a sterilizable medical
grade metallic material such as stainless steel to enable reuse
subsequent to sterilization following a prior use. In an
embodiment, the device 50 is composed of a sterilizable medical
grade metallic material such as titanium to enable reuse subsequent
to sterilization following a prior use. The use of titanium is
ideal for certain procedures including Magnetic Resonance Imaging
(MRI) and Computed Tomography (CT) because they are X-Ray
radiolucent and do not interfere with MRI and CT scans.
[0059] FIGS. 3A and 3B provide detailed segmental views of the
suture head assembly 56 showing the cartridge holder assembly 90,
the disposable needle cartridge 88, a curved suturing needle 120,
and parts of the drive mechanism 70 including a plurality of
pulleys, 72, 74, 76, 78 and 80 involved in driving the needle
driver 98 through a semicircular path. In an embodiment, the needle
driver is a pawl 98. A shoulder screw 108 is used to keep a latch
110 locked in place over the disposable cartridge 88 and the
suturing needle 120. Pulleys 72, 74, 76 and 78 are engaged with an
actuator arm 102, which is attached to the pawl 98. The pawl 98
interfits with two notches 132 located on the needle 120 at
180.degree. apart which drives the curved needle 120 in a
completely circular arc. The suture head assembly 56 is configured
so that the pawl 98 or other needle driver known in the art, does
not intrude into or obstruct the area within the curve of the
needle 120. The entire area within the circular arc of the needle
120 is unobstructed; there is no hub at the center of the circular
arc so that the device 50 can encompass the maximum volume of
tissue within the circular arc of the curved needle 120. In this
way, the needle 120 may be rotated through a relatively large arc,
allowing the needle 120 to obtain a sufficient "bite" into the
tissue. Preferably, the needle 120 will have a radius of curvature
of about 3 mm to about 40 mm. In an embodiment, the device 50
sutures within the limit of the diameter of the suture head
assembly 56, which is advantageous to suturing through small
cannulas during minimally invasive surgery. In an embodiment, the
diameter of the curved needle 120 does not exceed the diameter of
the suture head assembly 56.
[0060] FIGS. 4A and 4B show detailed views of the drive mechanism
70 located in the suture head assembly 56 with respect to driving
the needle 120 during use of the device 50 (the cartridge housing
88 has been removed to show the drive mechanism 70 in detail). The
drive mechanism 70 includes a plurality of pulleys, 72, 74, 76 and
78, and the associated axel pins 82, involved in driving the pawl
98 through a semicircular path. The actuator arm 102 engages
pulleys 72 and 76 and are pinned 75 to pulleys 72 and 76. As
pulleys 76 and 78 rotate with the motion of the cables 86 and 84,
respectively, that reside in the elongated barrel 54 (not shown),
pulley 74 acts as an idler pulley, transferring the motion to the
most distal pulley 72. Pulley 72 and pulley 76 rotate through
identical arcs. The actuator arm 102 provides a connection to the
pawl 98. The pawl 98 is located in the distal end of the actuator
arm 102. The pawl 98 is attached to the actuator arm 102 by an
integral shaft and collar 100 that fits loosely into the actuator
arm 102 allowing smooth movement. As the handle 60 is closed and
opened, the pawl 98 moves through the same arc as pulleys 72 and
76. The pawl 98 at the distal end of the actuator arm 102 is
capable of engaging the notches 132 located along the radially
inner edge of the needle 120. The actuator arm 102 is activated by
the user upon squeezing of the handle 60, and is capable of
sweeping back and forth in an arc spanning about 190.degree. or
more. FIG. 4A shows a detailed view of the drive mechanism 70 and
the suturing needle 120 either prior to using the device 50 or
after one complete full cycle of the device 50. FIG. 4B shows a
detailed view of the drive mechanism 70 and the suturing needle 120
after one squeeze of the handle 60. As shown, the drive mechanism
70 has moved in a circular arc greater than about 180.degree., and
about 190.degree., while the suturing needle 120 has moved in a
circular arc of about 190.degree. to drive through the tissue or
vessel to be sutured.
[0061] The outer surface of the actuator arm 102 is shaped to
accommodate a C-brace (not shown) that causes the pawl 98 to engage
the needle 120 and thereby remain in contact. The advancing
movement of the needle 120 during operation causes the notches 132
along the radially inner edge of the needle 120 to align with the
pawl 98 in the actuator arm 102, thereby causing the pawl 98 to
engage the notches 132 due to a positive pressure exerted by the
C-brace (not shown), and to "lock" into the notches 132. The rotary
advancing movement of the needle 120 is therefore controlled to
occur sequentially through about 190.degree. each time the needle
is actuated.
[0062] FIG. 5A shows a close-up view of the distal end of the
suture head assembly 56 with the cartridge 88 and the needle 120 in
view as well as the relationship between the pawl 98 and the
actuator arm 102 with respect to the needle 120. The needle 120 is
enclosed within the cartridge 88, so the sharp pointed end 124 is
not exposed. This needle position, as loaded, is referred to as the
"home" position (FIG. 5A). In the home position, the needle 120 is
fully contained within the cartridge housing 88 to eliminate
needle-pricks during handling of the cartridge 88 or the loaded
device. Squeezing the device handle 60 fully, two times, operates
the device 50 through one full cycle. As shown in FIG. 6A, the
first full actuation of the handle 60 drives the needle 120 through
an about 190.degree. arc. The pointed end of the needle 124 exits
the protective enclosure of the cartridge 88, drives through the
tissue to be sutured, and re-enters the protection of the cartridge
88 of the device 50. This position, after the first squeeze of the
handle 60, is referred to as the "rotation" position. As shown in
FIG. 6B, the handle 60 is then released, and the needle 120 remains
in the rotation position while the pawl 98 and the actuator arm 120
return to their start position. The handle 60 is then squeezed
again driving the needle 120 through an about 190.degree. arc and
returning the needle 120 to the home position.
[0063] FIG. 5A shows the needle 120 in the home position, the pawl
98 is engaged in the notch 132 near the suture end of needle 126.
An anti-rotate spring 136 is engaged in the notch 134 on the outer
surface of the needle 120, not allowing the needle 120 to move
backwards in the cartridge 88 of the device 50. A close-up view of
the anti-rotate spring 136 is shown in FIG. 5B. In an embodiment,
the needle 120 comprises at least one anti-rotate notch 134 and is
engaged with at least one anti-rotate spring 136. As the pawl 98
drives the needle 120 through a first semi circular arc, the
anti-rotate spring 136 slips out of the notch 134 and slides over
the outer surface of the needle 120. As the pawl 98 reaches the end
of a first drive stroke, the anti-rotate spring 136 snaps in behind
the rear corner of the needle 120, near the suturing material or
thread 146 (see FIG. 6A). As the pawl 98 returns to the start
position, the anti-rotate spring 136 holds the needle 120 in place,
preventing the needle 120 from moving with the pawl 98 back toward
the start position. The pawl 98 returns to the start position and
engages the notch 132 in the needle 120 near the pointed end 124
(see FIG. 6B). When the handle 60 is squeezed a second time, the
needle 120 is driven back to the home position.
[0064] The width of the aperture 118 in the cartridge 88 is
comparable to and corresponds with the width of the gap in the
needle 120 so that when the needle 120 is in the home position (as
shown in FIG. 5A) the needle 120 does not project materially into
the aperture 118. Such an alignment causes the needle 120 to reside
entirely within the cartridge 88, thereby preventing inadvertent
contact of the sharp pointed end 124 with the user's fingers during
handling of the disposable needle cartridge 88 for placement on the
cartridge holder assembly 90 or disposal after use, and while
operating the suturing device 50. Such protection of the needle 120
in the suturing device 50 prevents accidental "needle-pricks" from
occurring, thereby substantially reducing the risk of infection
caused by pathogenic bacteria or viruses that may contaminate the
needle 120 during or after use prior to disposal. The needle 120
may be rotated in a curved track 92 of the cartridge 88 about the
longitudinal axis of the suturing device 50 to advance the pointed
needle end 124 so that the needle 120 first spans the aperture 118
and then returns to the home position. The suturing material or
thread 146 is attached to the needle 120, and therefore follows the
path of the needle 120. The suturing material or thread 146 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 50, 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. The terminal
end of the suturing material or thread 146 may contain a knot or
button to prevent the suturing material or thread 146 from pulling
through the sutured tissue during placement of the first stitch. In
an embodiment, the cartridge 88 comprises the suturing needle 120
attached to the terminal end suturing material or thread 146, and
an appropriate length of suturing material or thread 146 are all
packaged in a sterilizable medical packaging material.
[0065] FIG. 7A shows a close-up view of the pawl 98 which rides in
a track formed by the C-brace 106 and the suture head assembly 56.
The pawl 98 is spring loaded with a spring 104. The spring 104 is
engaged to the tip of the pawl 98b as shown in FIG. 7A. The spring
104 engages the pawl tip 98b into the notch 132 in the needle 120
during the driving stroke of the device 50 when the handle 60 is
closed. The spring 104 also allows the tip of the pawl 98b to
rotate out of notch 132 of the needle 120 during the return of the
pawl 98 to the start position when the handle 60 is opened. The
heel of the pawl 98a stays in contact with the C-brace 106 during
the driving stroke of the device 50, preventing the pawl 98 from
over-rotating and locking the needle 120. FIG. 7B shows a close-up
view of the pawl 98 showing the pawl heel 98a and the pawl tip 98b.
Referring now to FIGS. 8 and 9 in conjunction with FIG. 1, the user
introduces the distal end portion of suturing device 50 into a body
cavity, via a cannula assembly (not shown), and then laterally
articulates the suture head assembly 56 using the articulation
lever 66 located just distal to the top of the handle 60. The
suture head assembly 56 is then positioned relative to the
tissue/vessel to be sutured, and the user locks the suture head
assembly 56 in place using the locking lever 64. The user then,
through manipulation of suturing device 50, positions a plurality
of separated tissue segments into the opening defined at the distal
end portion of the suture head assembly 56 and within the aperture
of the cartridge 118. The user, using only one hand, may manipulate
the device 50 while actuating the handle 60 to close an incision
with a continuous suture whose stitches may be individually
tensioned precisely and uniformly along the length of the suture
similar to suturing done by hand in the conventional way. The user
may employ a single suture which would extend the entire length of
the incision or multiple sutures.
[0066] The device 50 starts with the needle 120 in the home
position and the handle 60 fully open (see FIG. 8). In an
embodiment, the handle 60 is made up of a grip which rests in the
user's palm and is squeezed in order to actuate the device 50. To
drive the needle 120 through the tissue to be sutured, the user
squeezes the handle 60 moving the needle 120 from the home position
to the rotation position. The handle 60 contains linkages 144 to
both the upper drive rod 142 and the lower drive rod 140. Squeezing
the handle 60 (see FIG. 9) causes the two drive rods 140 and 142 to
move in opposite directions. The upper drive rod 142, moves forward
while the lower drive rod 140 moves backward. The drive rods are
connected to the suture head assembly 56 with cables 84 and 86 and
idler pulleys 80. The upper rod 142 is connected to pulley 78 with
cable 84. The lower rod 140 is connected to pulley 76 with cable
86.
[0067] FIGS. 10 and 11 in conjunction with FIG. 8, show the
connections and positions of cables 84 and 86 and the drive pulleys
72, 74, 76 and 78 when the handle 60 is in the open position. FIGS.
12 and 13 in conjunction with FIG. 9, show the connections and
positions of cables 84 and 86 and the drive pulleys 72, 74, 76 and
78 when the handle 60 is in the closed position. The force to move
needle 120 from the home position to the rotation position comes
from the lower rod 140 pulling backward on the drive cable 86. The
lower rod 140 extends nearly the full length of the elongated
barrel 54, connecting to drive cable 86, at the proximal end of the
elongated barrel 54. As shown in FIG. 11, cable 86 exits the
elongated barrel 54 and enters the suture head assembly 56, passing
over an idler pulley 80 located in the spherical portion 58, then
wrapping clockwise (as viewed from the bottom) around pulley 76 and
is secured to pulley 76 located in the suture head assembly 56. The
pulling action of cable 86 causes pulley 76 to rotate through an
arc of approximately 190.degree.. As lower rod 140 pulls backward,
the upper rod 142 moves forward. The upper rod 142 also extends
nearly the full length of the elongated barrel 54, connecting to
drive cable 84, at the proximal end of the elongated barrel 54. As
shown in FIG. 10, cable 84 also exits the elongated barrel 54 and
enters suture head assembly 56, passing over a second idler pulley
80 located in the spherical portion 58, then wrapping (clockwise as
viewed from the top) around pulley 78 and is secured to pulley 78
located in the suture head assembly 56. Pulley 78 is directly
linked to pulley 76 through the actuator arm 102, and cables 84 and
86 are wrapped in opposing directions, so that as cable 86 unwinds
from pulley 76, cable 84 winds onto pulley 78.
[0068] The needle 120 is held in a path of rotation by a
combination of three components. The cartridge 88, the C-brace 106
and the cartridge holder assembly 90 interact to constrain the
needle 120 to the path of rotation (see FIG. 5). The cartridge 88
is a semicircular shaped component that is held into the device 50
by a plurality of extensions 94 located on each end of the
cartridge 88 (see FIGS. 14 and 15). In an embodiment, the plurality
of extensions 94 takes the form of tabs. In an embodiment, the
cartridge 88 is made from a sterilizable medical grade metallic
material such as stainless steel. The cartridge 88 provides some of
the support structure for keeping the needle 120 in a rotational
path and therefore should be constructed from a material with
structural integrity. Those skilled in the art will recognize that
any high-strength medical grade material may be used to fabricate
the cartridge 88, such as a high-strength plastic. In an
embodiment, the plurality of extensions are tabs extending from the
cartridge housing 88. The plurality of extensions 94 lock into
mating grooves 96 located along on the distal edge of the cartridge
holder assembly 90 that are located diametrically opposite to one
another, and are capable of engaging the plurality of extensions 94
correspondingly located in the needle cartridge housing 88 as shown
in FIG. 16.
[0069] The proximal end of cartridge 88 is held in place by a
cartridge holder assembly 90, as shown in FIG. 17A. The cartridge
holder assembly 90 also includes a latch 110, a lever 112,
associated pins 114 and 116, a shoulder screw 108, an anti-rotate
spring 136 and at least one groove 96 that can engage with the
plurality of extensions 94 located on the cartridge 88. It is the
interaction of all of the elements of the cartridge holder assembly
90 that hold and lock the cartridge 88 in place. The latch 110
slides back to release the cartridge 88 and forward to lock the
cartridge 88 in place. The latch 110 also has a built into ejector
feature, as shown in FIG. 17B. A lever 112 is located distal and
below the needle 120 and the cartridge 88. The lever 112 pivots on
a pin 114. A second pin 116 located above the pivot pin 114,
engages with a slot in the latch 110. To release the needle 120 and
the cartridge 88, the latch 110 is pulled back and the lever 112 is
rotated up and back, causing pin 116 to move back with the latch
110 and to rotate about pin 114 thus pushing the needle 120 and the
cartridge 88 from the cartridge holder assembly 90. The needle 120
and the cartridge 88 are then removed from the device 50 by a
slight proximal motion to disengage the plurality of extensions 94
from their mating grooves 96 in the cartridge holder assembly 90.
FIG. 17C shows the needle 120 as it is driven through a first semi
circular arc (the handle 60 has partially completed a first full
squeeze). As the pawl 98 drives the needle 120 through a first semi
circular arc, the anti-rotate spring 136 slips out of the notch 134
and slides over the outer surface of the needle 120.
[0070] Loading of the needle 120 and the cartridge 88 is
accomplished by engaging the plurality of extensions 94 into both
grooves 96 on the cartridge holder assembly 90 and then pressing
the proximal ends down against the sloped distal surface of the
latch 110. The latch 110 is spring loaded at the proximal end, thus
can slide back as the needle 120 and the cartridge 88 are pressed
into place and then snap closed to the locked position, retaining
the needle 120 and the cartridge 88. The lever 112 is down and out
of the way of the operation of the needle 120 and the cartridge
88.
[0071] FIG. 18 shows a close-up view of the needle 120. The two
notches 132 are located about 180.degree. apart on the inner
surface and assist in driving the needle 120. The pawl 98 engages
the notches 132 when driving the needle 120 through the circular
motion. A third notch 134 is located on the outer surface of the
needle 120. The notch 134 assists in preventing rotation of the
needle 120 and provides an anti-rotation feature. In an embodiment
(see FIGS. 19A and 19B), the needle 120 is formed as a circular
split ring with a gap 122, a sharp, pointed end 124, and a blunt
end 126. The needle 120 further comprises an opening 130 to
accommodate the leading end of the suturing material or thread 146.
In an embodiment, the opening 130 is the form of an eye though
which the leading end of the suturing material or thread 146 may be
passed through for attachment to the needle 120. In the illustrated
needle 120 (FIG. 19A), the opening 130 is located adjacent to the
blunt end 126. The opening 130 however, can be positioned anywhere
along the arc or the needle 120 between the apex 128 and the blunt
end 126. In an embodiment (FIG. 19B), the needle 120 comprises an
opening 130 in the form of a cylindrical bore aligned axially with
respect to the needle 120, located at the blunt end 126 (FIG. 19B).
The leading end of the suturing material or thread 146 is inserted
into the opening 130 and restrained by mechanically crimping. To
enable the needle 120 to penetrate tissue to a required depth, the
arc length of the needle 120 is preferably about 240.degree. to
about 300.degree.. The needle 120 comprises two symmetric notches
132 along the radially inner edge ("inner notches") that are
positioned proximally to the sharp, pointed end 124 and the blunt
end 126 of the needle 120. The notches 132 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
132 are engaged by the needle driver 98 of the drive mechanism 70
and enable the needle 120 to undergo a rotary movement upon
actuation of the drive mechanism 70, thereby causing the needle 120
to penetrate into and advance through tissue. A similar triangular
notch 134 is located on the radially outer edge ("outer notch") of
the needle 120 proximally to the inner notch 132 closer to the
sharp, pointed end 124. The outer notch 134 engages with the
anti-rotate spring 136 located on the cartridge holder assembly 90,
whereby rotation of the needle 120 in a direction opposite to the
advancing direction or "needle backing-up" is prevented. The
positive engagement of the needle outer notch 134 during operation
of the suturing device precludes needle 120 from straying out of
sequence during the suturing process.
[0072] The suture head assembly 56 of the device 50 can be
laterally articulated to the left of center and also to the right
of center. In an embodiment, the suture head assembly 56 can be
laterally articulated through an arc of about 22.5.degree. to the
left of center and also to the right of center, for a total of
about 45.degree. or more. In addition, the suture head assembly can
be articulated up and down. In an embodiment, the suture head
assembly 56 can be articulated up and down. The ability of the
suture head assembly 56 to be articulated to the left and right of
center, as well as up and down, permits the user to position the
suture head assembly 56 for many different types of suturing
applications. The articulation lever 66, just distal of the top of
the handle 60 is pushed or pulled to cause the suture head assembly
56 to rotate. Viewed from above, moving the articulation lever 66
clockwise, moves suture head assembly 56 to the right and moving
the articulation lever 66 counterclockwise, moves suture head
assembly 56 to the left. The suture head assembly 56 is locked in
place with the locking lever 64 located on the bottom of the device
50, below the articulation lever 66. Movement is accomplished using
the solid articulation rod 68 to link the articulation lever 66 to
the suture head assembly 56. The articulation rod 68 is pinned to
the articulation lever 66 and to one side of the most proximal
section of the suture head assembly 56 so that the articulation rod
68 pushes or pulls the suture head assembly 56 through a full range
of motion (see FIGS. 20-23).
[0073] FIGS. 20-23 show the articulation rod 68 in the elongated
barrel 54 and the connection to the suture head assembly 56. The
suture head assembly 56 is shown moving from left articulation, to
straight to right articulation (some components are not shown to
allow clear viewing of the linkage). FIG. 20 shows a side view of
the suture head assembly 56. FIG. 21 shows a bottom view of the
suture head assembly 56 with no articulation. FIG. 22 shows a
bottom view of the suture head assembly 56 articulated to the left.
FIG. 23 shows a bottom view of the suture head assembly 56
articulated to the right. FIGS. 20-23 show a number of items. The
articulation rod 68 runs down the center of the elongated barrel 54
and is attached to one side of the spherical portion 58. The
function of the articulation rod 68 is to push and pull the suture
head assembly 56 through an articulation. The two idler pulleys 80,
which drive cables 84 and 86 are located in the spherical portion
58. Looking at FIG. 20, the two idler pulleys 80 seem to be one on
top of the other, instead however, they are located in plane with
either pulley 76 and lower rod 140 or pulley 78 and upper rod
142.
[0074] In an embodiment, the entire suturing device 50 can be
designed as a single unit which may be either reusable or disposed
after a single use. In an embodiment, the entire suturing device 50
can be designed from a number of units which, each unit may be
either reusable or disposed after a single use.
[0075] The suturing device 50 is configured to provide a "pistol
like" grip for the user that includes an elongated barrel 54 and a
handle 60 that extends from the proximal end of the elongated
barrel 54. The elongated barrel 54 has either a linear or
non-linear configuration, including but not limited to, straight,
curved and angled configurations. A suture head assembly 56 is
removably attached to the distal end of the elongated barrel 54.
The suture head assembly 56 contains a portion of the drive
mechanism 70 of the device 50. The working end of the suture head
assembly 56 has a cartridge holder assembly 90 to which a
disposable cartridge 88 that is capable of accommodating a suturing
needle 120 may reside.
[0076] The disposable cartridge 88 has a generally cylindrical
housing with an opening or aperture 118 in the sidewall of the
housing at the distal or working end thereof. An arcuate suturing
needle 120 having a sharp, pointed end 124 is slidably mounted in a
circular track 92 of the cartridge 88. A blunt end of the needle
126 is connected to a suturing material or thread 146. The radius
of the arc defining the arcuate suturing needle 120 is
approximately equal to the circumference to the cartridge housing
88 at the aperture 118 therein. The needle 120 normally resides in
a "home" position in the track 92 such that the gap in the arcuate
suturing needle 122 is in alignment with the aperture 118 in the
cartridge 88. The sharp, pointed end of the needle 124 is situated
on one side and entirely within the confines of the housing
aperture 118; the pointed end of the needle 124 is, therefore,
shielded by the cartridge housing 88. The blunt end of the suturing
needle 126 that is attached to the suturing material or thread 146
is located at the opposite side of the aperture 118. The sharp,
pointed end of the needle 124 is, therefore, wholly contained
within the cartridge 88 and does not protrude beyond the housing of
the cartridge 88. Thus, the sharp pointed end of the needle 124 is
not exposed to the user.
[0077] In accordance with the presently disclosed embodiments, the
needle 120 may be releasably engaged by a needle driver 98 that is
rotatably mounted within the suture head assembly 56 so that the
needle 120 can be rotated from the home position by about
360.degree. about the central vertical axis of the cartridge 88.
Such a rotary action of the needle 120 causes the sharp point 124
to advance across the cartridge housing 88 so as to span the
aperture 118. Thus, when the device 50 is positioned such that the
incised tissue segments to be sutured are situated at the housing
aperture 118, the needle 120 penetrates the tissue segments and
spans the incision between them. A continued rotary movement of the
needle 120 causes the needle 120 to return to the home position,
and thereby causes the suturing material or thread 146 attached to
the needle 120 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 material or thread 146 follows the curved path of
the needle 120 to bind the tissues together with a stitch of
material or thread 146 across the incision in a manner similar to
manual suturing, wherein the needle 120 is "pushed" from the blunt
end 126 and then "pulled" from the pointed end 124 by the pawl 98.
Preferably, an anchoring mechanism is provided at the trailing
terminal end of the suturing material or thread 146 to prevent the
material 146 from being pulled completely through and out of the
tissue segments. For example, the anchoring mechanism can be a
pre-tied or a welded loop, a knot wherein the suture material or
thread 146 is simply tied, or a double-stranded, looped suture is
that attached to the suturing needle 120. The rotary movement of
the needle 120 within the needle cartridge 88 is accomplished by a
pawl 98 that may be operated by the user by holding the suturing
device 50 with one hand in a pistol-like grip around the handle 60,
and using at least one finger of that hand to activate.
[0078] The suturing device 50 of the presently disclosed
embodiments can be used for a laparoscopic procedure, including but
not limited to laparoscopic colostomy, colectomy, adrenalectomy,
splenectomy, repair of paraesophageal hernia, inguinal hernia
repair, ventral hernia repair, Nissen fundoplication, liver
lobectomy, gastrectomy, small bowel resection, treatment of small
bowel obstruction, distal pancreatectomy, nephrectomy and gastric
bypass. Those skilled in the art will recognize that the presently
disclosed embodiments can be used in other laparoscopic
procedures.
[0079] In using the device 50 of the presently disclosed
embodiments, the abdomen is insufflated with gas to create a
working space for the user. Any gas known to those skilled in the
art including, but not limited to, nitrogen or carbon dioxide, can
be used. Access portals are established using trocars in locations
to suit the particular surgical procedure. A variety of surgical
instruments may then be inserted into the body through these access
ports/cannulas. The user then introduces the distal end portion of
suturing device 50 into a cannula, and then laterally articulates
the suture head assembly 56 using the articulation lever 66 located
just distal to the top of the handle 60. The suture head assembly
56 is then positioned relative to the tissue/vessel to be sutured
together, and the user locks the suture head assembly 56 in place
using the locking lever 64. The user then, through manipulation of
suturing device 50, positions a plurality of separated tissue
segments into the opening defined at the distal end portion of the
suture head assembly 56 and within the aperture 118 of the
cartridge 88. The user, using only one hand, may manipulate the
device 50 while actuating the handle 60 to close an incision with a
continuous suture whose stitches may be individually tensioned
precisely and uniformly along the length of the suture similar to
suturing done by hand in the conventional way. The user may employ
a single suture which would extend the entire length of the
incision or multiple sutures. Thus, by placement of the device 50
with the needle cartridge aperture 118 spanning the incised tissue
segments and actuating the handle 60, the suturing device 50
enables the user to lay down a running stitch or interrupted stitch
to close the tissue incision in a time efficient manner. Those
skilled in the art will recognize that any conventional procedure
for conducting laparoscopic surgery can be used with the device
50.
[0080] The needle cartridge 88 is disposably mounted on a cartridge
holder assembly 90 at the distal end of the suture head assembly
56. The minimalized structural design of the suture head assembly
56 enables the user to have a clear, unobstructed view of the
suturing needle 120 during advancement through the tissue segments
during the course of a suturing operation, thereby enabling precise
placement of the suturing device 50 to provide uniform sutures and
precluding the risk of tearing tissue by placement too close to the
edge of the incision. The suturing device 50 is then advanced a
short distance along the incision and the aforementioned operation
is repeated to produce another stitch comprising the suturing
material or thread 146.
[0081] The user may continue to manipulate the suturing device 50,
alternately advancing and actuating rotation of the needle 120
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, the stitch is
tightened by exerting a pull on the suturing material or thread 146
so that the resultant suture is 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. Once the appropriate amount of suture material or
thread 146 has been placed, the user can use a needle grasper to
tighten and knot the formed stitches.
[0082] The presently disclosed embodiments provide a method for
suturing tissue during minimally invasive surgery including
engaging a cartridge 88 to a suture head assembly 56 at a distal
end of a suturing device 50, the cartridge 88 having a protective
housing and a suturing needle 120 with a pointed end 124 and a
blunt end 126; introducing the distal end of the suturing device 50
into a body cavity; positioning an opening 118 in the cartridge 88
to span a plurality of separated tissue segments; activating an
actuator 52 coupled to a drive mechanism 70 that engages the
suturing needle 120 to cause rotational movement of the suturing
needle 120 about an axis approximately perpendicular to a
longitudinal axis of the suturing device 50 and advance the
suturing needle 120 through the plurality of separated tissue
segments; and pulling a suturing material 146 attached to the
suturing needle 120 through the plurality of separated tissue
segments forming a stitch.
[0083] The presently disclosed embodiments provide a method for
suturing tissue during minimally invasive surgery including (a)
engaging a cartridge 88 to a suture head assembly 56 at a distal
end of a suturing device 50, the cartridge 88 having a protective
housing and a suturing needle 120 with a pointed end 124 and a
blunt end 126; (b) introducing the distal end of the suturing
device 50 into a body cavity; (c) positioning an opening 118 in the
cartridge 88 to span a plurality of separated tissue segments; (d)
activating an actuator 52 coupled to a drive mechanism 70 that
engages the suturing needle 120 to cause rotational movement of the
suturing needle 120 about an axis approximately perpendicular to a
longitudinal axis of the suturing device 50 and advance the
suturing needle 120 through the plurality of separated tissue
segments; (e) pulling a suturing material 146 attached to the
suturing needle 120 through the plurality of separated tissue
segments forming a stitch and repeating steps (c) through (e) to
cause a plurality of stitches to be placed through the separated
tissue segments.
[0084] The presently disclosed embodiments provide a method for
suturing tissue during minimally invasive surgery including
inserting a distal end of a suturing device 50 having a suturing
needle 120 with a pointed end 124 into a body; positioning the
suturing needle 120 to span a plurality of separated tissue
segments; activating an actuator 52 a first time causing the
pointed end 124 of the suturing needle 120 to extend beyond a
protective housing of a cartridge 88 to engage the plurality of
separated tissue segments; activating the actuator 52 a second time
to cause the suturing needle 120 to complete a revolution and pull
a suture 146 extending from the suturing needle 120 through the
plurality of separated tissue segments to form a stitch.
[0085] The suturing device 50 may be configured in different ways
with respect to length and angle of the suture head assembly 56.
The size of the needle 120, the needle cartridge 88, the cartridge
aperture 118 and the 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.
[0086] FIGS. 24 and 25 show an alternative embodiment of a suturing
device shown generally at 150. Referring to FIGS. 24 and 25, the
suturing device 150 can be used to produce a continuous or
interrupted stitch or suture so as to enable closure of openings
internal to a patient's body. The suturing device 150 can be
utilized to suture any type of anatomical tissue in any type of
anatomical cavity; and, accordingly, while the device 150 is
described hereinafter for use with a cannula in endoscopic
procedures, such as laparoscopy, the device 150 can be used in open
surgery and with catheters and other small and large diameter
tubular or hollow, cylindrical members providing access to small
cavities, such as veins and arteries, as well as large cavities,
such as the abdomen.
[0087] In an embodiment, the suturing device 150 includes an
actuator mechanism shown generally at 152 which comprises an
elongated barrel 154 and a handle 160 that extends from the
undersides at a proximal end of the elongated barrel 154. Located
within the elongated barrel 154 are mechanical parts including
cables which run from the elongated barrel 154 through a spherical
portion 158 and then engages with the drive mechanism in a suture
head assembly 156. The spherical portion 158 resides within the
distal portion of the elongated barrel 154 and rotates with low
friction. In an embodiment, a drive mechanism 170 includes a pulley
system and cables that extend from the distal end of the suture
head assembly 156 to the proximal end of the elongated barrel
154.
[0088] The suture head assembly 156 houses the mechanism for
driving a curved needle 220 in a complete 360.degree. circular arc.
The orientation of the suture head assembly 156 is such that when
the needle 220 is attached to the suture head assembly 156 the
needle 220 is driven in a curved path about an axis approximately
perpendicular to the longitudinal axis of the device 150. In this
way, the needle 220 may be optimally visualized as the needle 220
is driven in a circular arc. Also, as shown in FIGS. 24 and 25, the
needle 220 is in a plane parallel to the drive mechanism and fits
into the same space in the suture head assembly 156.
[0089] The improved visibility offered by the shape and
configuration of the suture head assembly 156 enables precise
device placement over the incision, and uniform advancement of the
suturing device 150 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. In an embodiment, the entire device 150 or
parts of the device 150, such as the suture head assembly 156, the
elongated barrel 154, the handle 160, and the needle 220, are
composed of a sterilizable medical grade plastic material, in which
case, the entire device 150 or parts of the device 150 may
discarded and disposed after a single use. In an embodiment, the
device 150 is composed of a sterilizable medical grade metallic
material such as stainless steel to enable reuse subsequent to
sterilization following a prior use. In an embodiment, the device
150 is composed of a sterilizable medical grade metallic material
such as titanium to enable reuse subsequent to sterilization
following a prior use. The use of titanium is beneficial for
certain procedures including Magnetic Resonance Imaging (MRI) and
Computed Tomography (CT) because they are X-Ray radiolucent and do
not interfere with MRI and CT scans.
[0090] FIG. 24 shows the handle 160 in an open position. FIG. 25
shows the handle 160 in the closed position. The suture head
assembly 156 is attached to the distal end of the elongated barrel
154. In an embodiment, the suture head assembly 156 is removably
attached to the distal end of the elongated barrel 154. The length
of the suture head assembly 156 can range from about 10 mm to about
100 mm. In an embodiment, the length of the suture head assembly
156 is about 40 mm. The length of the elongated barrel 154 can
range from about 50 mm to about 400 mm. Those skilled in the art
will recognize that the elongated barrel 154 can be made shorter or
longer depending on the intended use of the device 150. In an
embodiment, the elongated barrel 154 is about 300 mm. In an
embodiment, the elongated barrel 154 is about 350 mm. An
articulation lever 166, just distal to the top of the handle 160 is
pushed or pulled to cause the suture head assembly 156 to rotate.
Moving the articulation lever 166 clockwise, moves the suture head
assembly 156 to the right and moving the articulation lever 166
counterclockwise, moves the suture head assembly 156 to the left.
The articulation lever 166 can also be moved to articulate the
suture head assembly 156 up and down. The suture head assembly 156
is locked in place with a locking lever 164 located on an underside
of the device 150, below the articulation lever 166. The suture
head assembly 156 may be articulated, and the elongated barrel 154
may be any length appropriate for the intended clinical application
of the device 150. The diameter of the device 150 can range from
about 3 mm to about 20 mm. In an embodiment, the diameter of the
device 150 is about 12 mm. In an embodiment, the diameter of the
device 150 is about 3 mm.
[0091] The handle 160 may be a grip that is squeezed in order to
actuate the suturing device 150. The suturing device 150 is
actuated by the actuator mechanism 152 coupled to a drive mechanism
170. The actuator mechanism 152 of the suturing device 150 may
comprise a triggering mechanism that is known in the art, such as
for example, the triggering mechanisms disclosed in U.S. Pat. No.
6,053,908 and U.S. Pat. No. 5,344,061, both of which are hereby
incorporated by reference. Alternatively, the actuator mechanism
152 can be either a manually operable button or switch, or
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. Those
skilled in the art will recognize that any actuator mechanism of
any type known in the art can be within the spirit and scope of the
presently disclosed embodiments.
[0092] FIG. 26 provides an assembly view of the suture head
assembly 156. The suture head assembly 156 is fabricated from
multiple pieces including a holder assembly 190, a needle holder
assembly 188, a latch 210, and parts of the drive mechanism 170
including a plurality of pulleys, 172, 174 and 176 and two idler
pulleys 180 involved in driving a needle driver 198 through a
semicircular path. Pulleys 172 and 174 consist of a set of four
pulleys, or two sets of pulleys, labeled 178. In an embodiment, the
needle driver is a pawl 198. A shoulder screw 208 and a plurality
of needle assembly extensions 194 are used to keep the latch 210
locked in place over the needle holder assembly 188 and the
suturing needle 220. The needle holder assembly 188 includes a
curved track 192 where the needle 220 rides. Pulleys 172, 174 and
176 are engaged with an actuator arm 202, which is attached to the
pawl 198. The pawl 198 interfits with two notches 232 located on
the face of the needle 220 at about 180.degree. apart which drives
the curved needle 220 in a circular arc. The suture head assembly
156 is configured so that the pawl 198 or other needle driver known
in the art, does not intrude into or obstruct the area within the
curve of the needle 220. The area within the circular arc of the
needle 220 is unobstructed; there is not a hub at the center of the
circular arc so that the device 150 can encompass the maximum
volume of tissue within the circular arc of the curved needle 220.
In this way, the needle 220 may be rotated through a relatively
large arc, allowing the needle 220 to obtain a sufficient "bite"
into the tissue. Preferably, the needle 220 will have a radius of
curvature of about 3 mm to about 40 mm. In an embodiment, the
device 150 sutures within the limit of the diameter of the suture
head assembly 156, which is advantageous to suturing through small
cannulas during minimally invasive surgery. In an embodiment, the
diameter of the curved needle 220 does not exceed the diameter of
the suture head assembly 156.
[0093] FIGS. 27A and 27B show detailed views of the drive mechanism
170 located in the suture head assembly 156 with respect to driving
the needle 220 during use of the device 150 (the needle holder
assembly 188 and the holder assembly 190 have been removed to show
the drive mechanism 170 in detail). The drive mechanism 170
includes the actuator arm 202 that engages pulleys 172, 174, and
176 and the pawl 198 that drives the needle 220 through a curved
path. The pawl 198 is located in the distal end of the actuator arm
202 and is capable of engaging the notches 232 located along the
face of the needle 220. A flat spring 200 keeps the pawl 198
engaged into the notches 232 of the needle 220. When the needle 220
is pushed around, the pawl 198 will be pushed back up against the
flat spring 200 and allow the needle 220 to cycle. As the handle
160 is closed and opened, the pawl 198 moves through the same arc
as the pulleys. The actuator arm 202 is activated by the user upon
squeezing of the handle 160, and is capable of sweeping back and
forth in an arc spanning about 190.degree. or more.
[0094] FIG. 28 shows a close-up view of the needle holder assembly
188 showing the curved track 192 where the needle 220 resides as
well as the needle holder assembly extensions 194 that help keep
the latch 210 in place. The suturing needle 220 follows a curved
path along the track 192 during rotation of the suturing needle
220. The curved track 192 for the needle 220 may be machined into
the needle assembly 188 and provides a captive curved track 192 so
that the needle 220 can be driven around with precision. The curved
track 192 includes an inside slot and a larger slot surrounding the
inside slot. The larger outside slot provides clearance for the
pawl 198, so that the pawl 198 can maneuver around without hitting
anything, and the smaller inside slot provides clearance for a pawl
tip 199, which goes through the smaller inside slot and then into
the needle 220 so that the pawl tip 199 can drive the needle
220.
[0095] FIG. 29 shows a close-up view of the suture head assembly
156 with the needle holder assembly 188, the holder assembly 190,
the latch 210 and the needle 220 in view as well as the
relationship between the pawl 198 and the actuator arm 202 with
respect to the needle 220. The needle 220 is enclosed within the
needle holder assembly 188, so the sharp pointed end 224 of the
needle 220 is not exposed. This needle 220 position, as loaded, is
referred to as the "home" position. In the home position, the
needle 220 is fully contained within the needle holder assembly 188
to eliminate needle-pricks during handling of the suture head
assembly 156. The needle assembly extensions 194 form a
"tongue-in-groove" connection with the latch 210, which keeps the
forces from the needle 220 from opening the thin members of the
latch 210. The needle assembly extensions 194 cause an entrapment
at a distal end of the suturing device, thus locking the latch 210
in place. Squeezing the device handle 160 fully operates the device
150 through one full cycle. The first full actuation of the handle
160 drives the needle 220 through an about 190.degree. arc. The
pointed end 224 of the needle 220 exits the protective enclosure of
the needle holder assembly 188, drives through the tissue to be
sutured, and re-enters the protection of the needle holder assembly
188 of the device 150. This position, after the first squeeze of
the handle 160, is referred to as the "rotation" position. The
handle 160 is then released, and the needle 220 remains in the
rotation position while the pawl 198 and the actuator arm 220
return to their start position. The handle 160 is then squeezed
again driving the needle 220 through an about 190.degree. arc and
returning the needle 220 to the home position. A flat pawl spring
200 keeps the pawl 198 engaged into the pawl notches 232 on the
needle 220. When the needle 220 is pushed around the pawl 198 will
be pushed back up against the flat pawl spring 200 and allow the
needle 220 to cycle.
[0096] FIGS. 30 and 31 show top views of the suture head assembly
156. Needle holder assembly 188 forms a connection with the latch
210. The latch 210 forms a top cover over the suturing needle 220
which is in the curved track 192 of the needle holder assembly 188.
FIG. 30 shows the latch 210 in the open position, which is for
needle 220 removal and insertion into the needle holder assembly
188. To insert and/or remove the needle 220 a user may turn the
needle 220 180.degree. in its curved track 192 from the as-drawn
position. A user may grab the needle 220 by hand or with a surgical
tool to either install the needle 220 or remove the needle 220. By
grabbing the needle 220, lifting the needle 220 out, the needle 220
is removed. By grabbing the needle 220 the needle can be inserted
when the latch 210 in the open position. FIG. 31 shows the latch
210 in the locked position, also known as the forward position.
[0097] FIG. 32 shows the suturing needle 220. The two notches 232
are located about 180.degree. apart on the face of the needle 220
and assist in driving the needle 220. The pawl 198 engages the
notches 232 when driving the needle 220 through the circular
motion. A third notch 234 is located on the outer surface of the
needle 220. The notch 234 provides an anti-rotation feature by
preventing rotation of the needle 220. The needle 220 is formed as
a circular split ring with a gap 222, a sharp, pointed end 224, and
a blunt end 226. The needle 220 further comprises an opening 230 to
accommodate the leading end of the suturing material or thread 246.
In an embodiment, the opening 230 is the form of an eye though
which the leading end of the suturing material or thread 246 may be
passed through for attachment to the needle 220. In the illustrated
needle 220, the needle 220 comprises an opening 230 in the form of
a cylindrical bore aligned axially with respect to the needle 220,
located at the blunt end 226. The opening 230, can be positioned
anywhere along the arc or the needle 220 between the apex 228 and
the blunt end 226. The leading end of the suturing material or
thread 246 is inserted into the opening 230 and restrained by
mechanically crimping or other connection methods known in the art.
To enable the needle 220 to penetrate tissue to a required depth,
the arc length of the needle 220 is preferably about 240.degree. to
about 300.degree.. The needle 220 comprises two symmetric notches
232 along the face ("drive notches"). The notches 232 are located
directly opposite to each other. A similar notch 234 is located on
the radially outer edge ("outer notch") of the needle 220
proximally to the inner notch 232 closer to the sharp, pointed end
224. The outer notch 234 engages with an anti-rotate spring,
whereby rotation of the needle 220 in a direction opposite to the
advancing direction or "needle backing-up" is prevented. The
positive engagement of the needle outer notch 234 during operation
of the suturing device precludes the needle 220 from straying out
of sequence during the suturing process.
[0098] FIG. 33 shows a close-up view of the pawl tip 199 engaging
the drive notches 232 of the needle 220. The drive notches 232 are
engaged by the pawl tip 199 of the drive mechanism 170 and enable
the needle 220 to undergo a rotary movement upon actuation of the
drive mechanism 170, thereby causing the needle 220 to penetrate
into and advance through tissue.
[0099] FIGS. 34 and 35 show parts of the drive mechanism 170
including return pulleys 172 and 174. Pulleys 172 and 174 are
connected to each other using wires 175. As can be seen in FIG. 27A
and FIG. 27B; pulleys 172 and 174 are made up of four pulleys 178
that are connected together by laser welding or other methods known
in the art. The four pulleys 178 produce an over-rotation, about a
190'-rotation. The over-rotation leads to the wire 175 design where
there is a wire 175 on each set of pulleys 178. As shown in FIG. 34
and FIG. 35, there are two wires 175 with four pulleys 178,
resulting in the four pulleys 178 being in synch with one another,
even under load. The four pulleys 178 are rotationally in sync,
i.e., one pulley 178 will follow the other pulley 178, because the
wires 175 are configured to be pulling against one another. The
wire 175 may be attached to the pulleys 178 via a hole that the
wires 175 are soldered into. FIG. 35 shows a side view of the
suture head assembly 156 which shows the two wires 175 connecting
the four pulleys 178 together for synchronized rotation.
[0100] FIGS. 36 and 37 in conjunction with FIG. 38, show the
connections and positions of cables 184 and 186 to the drive pulley
176 and to the return pulleys 172 and 174, respectively, and to the
when the handle 160 is in the open position. The cables 184 and 186
may be made from stainless steel. Connected at the proximal end of
the suture head assembly 156 there is the spherical portion 158
that contains part of the drive mechanism 170 including two idler
pulleys 180 and cables 184 and 186. FIG. 36 shows a top view of the
suture head assembly 156 with the cable 184 running through two
idler pulleys 180 and wrapped around drive pulley 176. FIG. 37
shows a top view of the suture head assembly 156 with the cable 186
running through two idler pulleys 180 and wrapped around return
pulley 174. The cable 186 runs from return pulley 174 through the
elongated barrel 154 and to the very proximal end of the handle
160. The force to move the needle 220 from the home position (shown
in FIGS. 36 and 37) to a rotation position comes from a return
spring 240 that is connected to the cable 184, resulting in a
pre-load (shown in FIG. 38). When the trigger of the handle 160 is
squeezed closed, the handle 160 moves to the closed position and
the drive pulley 176 turns counterclockwise, driving the needle
220. At the same time, the cable 186 drives the return pulley 174
counterclockwise and cycles the actuator arm 202 to drive the
needle 220 forward through the tissue. The needle 220 is driven
through a circular motion, through a cycle, and the cable 184 is
compressing the return spring 240 on the other end. When the handle
160 closes more, the actuator arm 202 drives the needle. When the
trigger of the handle 160 is released, the front pulley 178, which
is now fully charged with the return spring 240, will return the
needle 220 to the home position. Relaxing the trigger of handle 160
takes no power.
[0101] FIG. 38 shows a side elevational view of the suturing device
150. The handle 160 includes a number of internal parts. A cable
connector 182 has a hole and a shoulder. The shoulder rides against
the end of the return spring 240, and the hole provides an opening
for the cable 184. The return spring 240 is compressed and the
cable 184 is soldered or locked to the connector 182, so that the
cable 184 provides a preload onto the return spring 240. The cable
184 runs from the connector 182 through the return spring 240 over
pulley 244, through the elongated barrel 154, through the spherical
portion 158, between the idler pulleys 180 and fixed to the drive
pulley 176. The cable 186 is connected at the very proximal end of
the handle 160 and lies under pulley 245, over pulley 242, through
the elongated barrel 154, through the spherical portion 158,
between the idler pulleys 180 and fixed to the return pulley
174.
[0102] When the handle 160 is translated from the open position to
the closed position the needle 220 is driven through the tissue. A
user has a tactile feel as the needle 220 moves. If the needle 220
runs across something that is impenetrable, the handle 160 will
stop moving and the user could feel this in their hand holding the
handle. When the handle 160 is in a closed position, the return
spring 240 takes on a charge, the return spring 240 has shortened
in length. When the handle 160 is released, the return spring 240
pulls the cable 184 and brings the needle 220 back to the home
position and also brings the handle 160 back to the open position.
The return spring 240 provides a load on the cable 184. A loop is
formed throughout the suturing device 150 that includes the cables
184 and 186 and the pulleys 172, 174 and 176 such that cable 184 is
attached at one end to the return spring 240, at the other end to
the drive pulley 176. The cable 186 is attached to the return
pulley 174 and then cable 186 attaches to the very proximal end of
the handle 160, thus forming a loop. The return spring 240 can be
set to a desired spring-rate so that the return spring 240 performs
as desired by the user. The return spring 240 should have a small
amount of preload to make sure that the handle 160 opens all the
way, which provides that the driving mechanism 170 would return the
needle 220 to the home position.
[0103] The cables 184 and 186 extend through the elongated barrel
154 and connect to the drive mechanism 170 in the suture head
assembly 156. The long length of the cables 184 and 186 provides a
small amount of a spring buffer. If the suturing device 150 were to
become bound or something locked up at the suture head assembly 156
this would not translate. If the user continued to pull on the
handle 160 to close the handle 160, the cables 184 and 186 would
stretch and should not break. The two idler pulleys 180, which
drive the cables 184 and 186 are located in the spherical portion
158. As shown in FIG. 39, the two idler pulleys 180 appear to be
one on top of the other, but they are located in a plane with
either pulleys 174 and 176 or pulley 178.
[0104] In an embodiment, the entire suturing device 150 can be
designed as a single unit which may be either reusable or disposed
after a single use. In an embodiment, the entire suturing device
150 can be designed from a number of separable parts where each
unit may be either reusable or disposed after a single use.
[0105] The suturing device 150 is configured to provide a "pistol
like" grip for the user that includes an elongated barrel 154 and a
handle 160 that extends from the proximal end of the elongated
barrel 154. The elongated barrel 154 has either a linear or
non-linear configuration, including but not limited to, straight,
curved and angled configurations. A suture head assembly 156 is
removably attached to the distal end of the elongated barrel 154.
The suture head assembly 156 contains a portion of the drive
mechanism 170 of the device 150. The working end of the suture head
assembly 156 has a needle holder assembly 188 to which a suturing
needle 220 may reside. A latch 210 forms a cover over the needle
220.
[0106] An arcuate suturing needle 220 having a sharp, pointed end
224 is slidably mounted in a circular track 192 of the needle
holder assembly 188. The blunt end of the needle 226 is connected
to the suturing material or thread 246. The needle 220 normally
resides in a "home" position in the track 192 such that the gap in
the arcuate suturing needle 222 is in alignment with an aperture
218 in the needle holder assembly 188. The sharp, pointed end of
the needle 224 is situated on one side and entirely within the
confines of the needle holder aperture 218; the pointed end of the
needle 224 is, therefore, shielded by the needle holder assembly
188. The blunt end of the suturing needle 226 that is attached to
the suturing material or thread 246 is located at the opposite side
of the aperture 218. The sharp, pointed end of the needle 224 is,
therefore, wholly contained within the needle holder assembly 188
and does not protrude beyond the housing of the needle holder
assembly 188. Thus, the sharp pointed end of the needle 224 is not
exposed to the user.
[0107] In accordance with the presently disclosed embodiments, the
needle 220 may be releasably engaged by the needle driver 198 that
is rotatably mounted within the suture head assembly 156 so that
the needle 220 can be rotated from the home position by about
360.degree. about the central vertical axis of the needle holder
assembly 188. Such a rotary action of the needle 220 causes the
sharp point 224 to advance across the needle holder assembly 188 so
as to span the aperture 218. Thus, when the device 150 is
positioned such that the incised tissue segments to be sutured are
situated at the needle holder assembly aperture 218, the needle 220
penetrates the tissue segments and spans the incision between them.
A continued rotary movement of the needle 220 causes the needle 220
to return to the home position, and thereby causes the suturing
material or thread 246 attached to the needle 220 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 material or thread
246 follows the curved path of the needle 220 to bind the tissues
together with a stitch of material or thread 246 across the
incision in a manner similar to manual suturing, wherein the needle
220 is "pushed" from the blunt end 226 and then "pulled" from the
pointed end 224 by the pawl 198. Preferably, an anchoring mechanism
is provided at the trailing terminal end of the suturing material
or thread 246 to prevent the material 246 from being pulled
completely through and out of the tissue segments. For example, the
anchoring mechanism can be a pre-tied or a welded loop, a knot
wherein the suture material or thread 246 is simply tied, or a
double-stranded, looped suture is that attached to the suturing
needle 220. The rotary movement of the needle 220 within the needle
holder assembly 188 is accomplished by a pawl 198 that may be
operated by the user by holding the suturing device 150 with one
hand in a pistol-like grip around the handle 160, and using at
least one finger of that hand to activate.
[0108] The suturing device 150 of the presently disclosed
embodiments can be used for a laparoscopic procedure, including but
not limited to laparoscopic colostomy, colectomy, adrenalectomy,
splenectomy, repair of paraesophageal hernia, inguinal hernia
repair, ventral hernia repair, Nissen fundoplication, liver
lobectomy, gastrectomy, small bowel resection, treatment of small
bowel obstruction, distal pancreatectomy, nephrectomy and gastric
bypass. Those skilled in the art will recognize that the presently
disclosed embodiments can be used in other laparoscopic
procedures.
[0109] In using the device 150 of the presently disclosed
embodiments, the abdomen is insufflated with gas to create a
working space for the user. Any gas known to those skilled in the
art including, but not limited to, nitrogen or carbon dioxide, can
be used. Access portals are established using trocars in locations
to suit the particular surgical procedure. A variety of surgical
instruments may then be inserted into the body through these access
ports/cannulas. The user then introduces the distal end portion of
suturing device 150 into a cannula, and then laterally articulates
the suture head assembly 156 using the articulation lever 166
located just distal to the top of the handle 160. The suture head
assembly 156 is then positioned relative to the tissue/vessel to be
sutured together, and the user locks the suture head assembly 156
in place using the locking lever 164. The user then, through
manipulation of the suturing device 150, positions a plurality of
separated tissue segments into the opening defined at the distal
end portion of the suture head assembly 156 and within the aperture
218 of the needle holder assembly 188. The user, using only one
hand, may manipulate the device 150 while actuating the handle 160
to close an incision with a continuous suture whose stitches may be
individually tensioned precisely and uniformly along the length of
the suture similar to suturing done by hand in the conventional
way. The user may employ a single suture which would extend the
entire length of the incision or multiple sutures. Thus, by
placement of the device 150 with the needle holder assembly
aperture 218 spanning the incised tissue segments and actuating the
handle 160, the suturing device 150 enables the user to lay down a
running stitch or interrupted stitch to close the tissue incision
in a time efficient manner. Those skilled in the art will recognize
that any conventional procedure for conducting laparoscopic surgery
can be used with the device 150.
[0110] The minimalized structural design of the suture head
assembly 156 enables the user to have a clear, unobstructed view of
the suturing needle 220 during advancement through the tissue
segments during the course of a suturing operation, thereby
enabling precise placement of the suturing device 150 to provide
uniform sutures and precluding the risk of tearing tissue by
placement too close to the edge of the incision. The suturing
device 150 is then advanced a short distance along the incision and
the aforementioned operation is repeated to produce another stitch
comprising the suturing material or thread 246.
[0111] The user may continue to manipulate the suturing device 150,
alternately advancing and actuating rotation of the needle 220
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, the stitch is
tightened by exerting a pull on the suturing material or thread 246
so that the resultant suture is 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. Once the appropriate amount of suture material or
thread 246 has been placed, the user can use a needle grasper to
tighten and knot the formed stitches.
[0112] The suturing device 150 may be configured in different ways
with respect to length and angle of the suture head assembly 156.
The size of the needle 220, the needle holder assembly 188, the
needle holder aperture 218 and the 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.
[0113] In accordance with another aspect of the invention, a
suturing device is provided in accordance with the teachings of
issued U.S. Pat. No. 6,923,819, which is incorporated by reference
herein in its entirety. In accordance with a preferred embodiment,
a suturing device is provided accordingly that may have 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.
[0114] All patents, patent applications, and published references
cited herein are hereby incorporated by reference in their
entirety. It will be appreciated that various of the
above-disclosed and other features and functions, or alternatives
thereof, may be desirably combined into many other different
systems or applications. Various presently unforeseen or
unanticipated alternatives, modifications, variations, or
improvements therein may be subsequently made by those skilled in
the art which are also intended to be encompassed by the following
claims.
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