U.S. patent application number 10/412044 was filed with the patent office on 2003-10-09 for surgical device with malleable shaft.
This patent application is currently assigned to Allegiance Healthcare Corporation. Invention is credited to Block, Thomas J., Cosgrove, Delos M. III, Gray, Joel Donald, Williams, Donald B..
Application Number | 20030191494 10/412044 |
Document ID | / |
Family ID | 25468567 |
Filed Date | 2003-10-09 |
United States Patent
Application |
20030191494 |
Kind Code |
A1 |
Gray, Joel Donald ; et
al. |
October 9, 2003 |
Surgical device with malleable shaft
Abstract
The present invention provides a surgical device having a tissue
engaging portion, a shaft member, and a handle assembly. The tissue
engaging portion includes first and second opposed jaws for
grasping, securing, and occluding body tissue and conduits. The
shaft member is operatively coupled to the tissue engaging portion
and is capable of being placed in different curvatures. The handle
assembly is operatively coupled to both the shaft member and to the
tissue engaging portion. The shaft member of the present invention
allows the surgeon to bend and adjust the shape of the surgical
device to minimize its intrusion and to allow for proper
positioning in predetermined body locations. In a preferred
embodiment, a portion of the device is disposable.
Inventors: |
Gray, Joel Donald;
(Barrington, IL) ; Williams, Donald B.; (Lake
Forest, IL) ; Block, Thomas J.; (Imperial, MO)
; Cosgrove, Delos M. III; (Hunting Valley, OH) |
Correspondence
Address: |
Attn: Kimberly Diliberti
Allegiance Healthcare Corporation
1430 Waukegan Road
McGaw Park
IL
60085-6787
US
|
Assignee: |
Allegiance Healthcare
Corporation
|
Family ID: |
25468567 |
Appl. No.: |
10/412044 |
Filed: |
April 11, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10412044 |
Apr 11, 2003 |
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09432523 |
Nov 3, 1999 |
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09432523 |
Nov 3, 1999 |
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08936394 |
Sep 25, 1997 |
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6139563 |
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Current U.S.
Class: |
606/205 ;
606/206; 606/207 |
Current CPC
Class: |
A61B 17/122 20130101;
A61B 2017/2905 20130101; A61B 2017/292 20130101; A61B 2017/2936
20130101; A61B 2017/0046 20130101; A61B 2090/508 20160201; A61B
2017/00314 20130101; A61B 2017/0023 20130101; A61B 2017/294
20130101; A61B 17/1285 20130101; A61B 17/29 20130101 |
Class at
Publication: |
606/205 ;
606/206; 606/207 |
International
Class: |
A61B 017/28 |
Claims
What is claimed is:
1. A surgical device having a longitudinal axis extending between a
proximal end and a distal end, comprising: tissue engaging means
including first and second opposed jaws for grasping, securing, and
occluding body tissue and conduits; a shaft member operatively
coupled to the tissue engaging means, the shaft member capable of
being placed in different curvatures; and a handle assembly
operatively coupled to the shaft member and to the tissue engaging
means.
2. The surgical device of claim 1 further comprising a jaw
actuating means for actuating the jaws of the tissue engaging means
between an open position and a closed position, the actuating means
being operatively connected to the tissue engaging means and to the
handle assembly.
3. The surgical device of claim 2 wherein the shaft member
comprises a malleable tube with the jaw actuating means extending
axially there through.
4. The surgical device of claim 2 wherein the shaft member
comprises a series of interconnected ball and socket segments with
the jaw actuating means extending axially there through.
5. The surgical device of claim 2 wherein the shaft member
comprises soft metal tubing with the jaw actuating means extending
axially there through.
6. The surgical device of claim 2 wherein the shaft member
comprises wound metal tubing with the jaw actuating means extending
axially there through.
7. The surgical device of claim 2 wherein the shaft member
comprises a dual-channeled plastic tube having a first and a second
channel, the jaw actuating means extending axially through the
first channel and a malleable rod extending axially through the
second channel.
8. The surgical device of claim 1 further comprising a compression
return spring for biasing the tissue engaging means to an open
position.
9. The surgical device of claim 1 wherein the tissue engaging means
further includes a hinged end at which the jaws are hinged
together.
10. The surgical device of claim 9 further comprising a jaw
actuating means for actuating the jaws of the tissue engaging means
between an open position and a closed position, the actuating means
operatively connected to the tissue engaging means and to the
handle assembly.
11. The surgical device of claim 10 wherein the jaw actuating means
comprises a drive rod.
12. The surgical device of claim 11 wherein a jaw actuating member
is provided at the hinged end of the tissue engaging means for
squeezing together the jaws of the tissue engaging means in
response to actuation of the drive rod by the handle assembly.
13. The surgical device of claim 10 wherein the jaw actuating means
comprises a cable.
14. The surgical device of claim 13 wherein the hinged end of the
tissue engaging means includes a hole there through, the hole
interacting with a hook provided at one end of the cable.
15. The surgical device of claim 14 wherein the shaft member is
provided with a end member which, upon actuation of the cable by
the handle assembly, interacts with the jaws of the tissue engaging
means to bring the jaws to the closed position.
16. The surgical device of claim 10 wherein the jaw actuating means
comprises a wire member having a hook at one end operatively
coupled to the jaws of the tissue engaging means.
17. The surgical device of claim 18 wherein each jaw is provided
with a diagonal slot at one end, the hook of the wire member
interacting with the diagonal slots of the jaws to move the jaws
between the open and closed positions.
18. The surgical device of claim 17 further provided with a clevis
which houses a portion of the wire member and the slotted ends of
the jaws.
19. The surgical device of claim 10 wherein one jaw of the tissue
engaging means is provided with a slot at one end, the jaw
actuating means being operatively coupled with the slot via a
pin.
20. The surgical device of claim 11 wherein the tissue engaging
means is further provided with a socket for coupling to the jaw
actuating means.
21. The surgical device of claim 20 wherein one end of the jaw
actuating means is provided with a ball for coupling to the socket
of the tissue engaging means.
22. The surgical device of claim 21 wherein another end of the jaw
actuating means is provided with a ball for coupling to the handle
assembly.
23. The surgical device of claim 1 wherein the tissue engaging
means and the shaft member are disposable.
24. The surgical device of claim 1 wherein the tissue engaging
means is disposable
25. The surgical device of claim 1 wherein the shaft member is
disposable.
26. A surgical device having a longitudinal axis extending between
a proximal end and a distal end, comprising: tissue engaging means
including first and second opposed jaws for grasping, securing, and
occluding body tissue and conduits; a shaft member operatively
coupled to the tissue engaging means, the shaft member capable of
being placed and locked in different curvatures; a handle assembly
operatively coupled to the shaft member and to the tissue engaging
means; and a jaw actuating means for actuating the jaws of the
tissue engaging means between an open and a closed position.
27. The surgical device of claim 26 wherein the jaw actuating means
comprises a cable operatively connected to the tissue engaging
means, extending through the shaft member, and operatively
connected to the handle assembly.
28. The surgical device of claim 27 wherein the shaft member
comprises a series of interconnected ball and socket segments with
the jaw actuating cable extending axially there through.
29. The surgical device of claim 28 further comprising a tightening
knob for exerting axial compression on the segments, thereby
allowing the shaft member to be locked in any shape.
30. The surgical device of claim 27 wherein the shaft member
comprises a flexible tube with the jaw actuating cable extending
axially there through.
31. The surgical device of claim 30 further comprising a malleable
applier instrument for grasping the jaws of the tissue engaging
means for insertion together into an incision.
32. The surgical device of claim 31 wherein the malleable applier
instrument is capable of being released and removed from the
incision once the jaws of the tissue engaging means have been
actuated to the closed position.
33. A surgical device having a longitudinal axis extending between
a proximal end and a distal end, comprising: tissue engaging means
including first and second opposed jaws for grasping, securing, and
occluding body tissue and conduits; a shaft member operatively
coupled to the tissue engaging means, the shaft member being
constructed of malleable material and thus capable of being placed
in different curvatures; a handle assembly operatively coupled to
the shaft member and to the tissue engaging means; and a jaw
actuating means for actuating the jaws of the tissue engaging means
between an open and a closed position, the jaw actuating means
extending axially through the shaft member and being provided with
coupling means at each end which enable the jaw actuating means and
the shaft member to be separated from the remainder of the device
to be disposed.
34. The surgical device of claim 33 wherein the tissue engaging
means is provided with a socket for coupling to the jaw actuating
means.
35. The surgical device of claim 34 wherein the coupling means of
the jaw actuating means comprises a first ball provided at one end
of the actuating means for coupling with the socket of the tissue
engaging means.
36. The surgical device of claim 35 wherein the coupling means of
the jaw actuating means further comprises a second ball provided at
another end of the jaw actuating means for coupling with the handle
assembly.
Description
FIELD OF THE INVENTION
[0001] This invention relates generally to surgical devices and
more specifically to a surgical device with a malleable shaft for
use in grasping, securing, and occluding body tissue and
conduits.
BACKGROUND OF THE INVENTION
[0002] Surgical devices generally include, but are not limited to,
clamps, scissors, forceps, dissectors, and retractors. Typically,
such surgical devices consist of three elements: a handle, tissue
engaging means, and a member extending between the handle and the
tissue engaging means. The handle opens and closes the jaws of the
tissue engaging means and often has a locking mechanism to hold the
jaws closed. The jaws of the tissue engaging means vary extensively
in configuration, length, angle, and delicacy depending upon the
function of the device and the tissue being engaged. There are many
variations of the member provided between the handle and the tissue
engaging means. Such members have been provided in a large number
of lengths, bends, and angles in order to allow the surgeon to
place the jaws in a large number of locations in a wide variety of
human body shapes and sizes.
[0003] Traditionally, surgeries have been quite invasive to the
patient's body, often involving large open incisions. Such
surgeries result in great trauma to the patients and require long
periods of recovery time. Because these surgeries often involve
large incisions, there has not been a strong need for providing
surgical devices of a size and detail appropriate for a limited
work area. In addition, in order to provide surgeons with a number
of choices, surgical devices of various shapes have been
provided.
[0004] In the recent past, minimally-invasive surgery (MIS) has
grown in popularity as an alternative to traditional, large
incision surgery. The term MIS refers to performing surgery in
smaller incisions in order to reduce the trauma experienced by the
patient, increase the speed of healing, and reduce the recovery
time. For the patient, this ultimately equates to less time in the
hospital which adds to the cost effectiveness of these
procedures.
[0005] Understandably, it is very challenging for surgeons to
perform surgical tasks in small, MIS incisions. The normal concerns
of surgery are compounded with the unique problems brought about by
MIS procedures. For example, since the objectives of open surgeries
and MIS surgeries are often the same, the occluding of body
conduits is still of concern. However, surgical devices of the past
were designed for occluding of body conduits during open surgery
wherein the size of the surgical device was not constrained by
narrow diameters of small, MIS incisions. Thus, such surgical
devices, which are necessary in most all procedures, protrude out
of the MIS incision and have the potential to interfere with the
surgeons' hands as they try to visualize, cut, dissect or suture
within the incision. Additionally, in the area of non-minimally
invasive surgery, the use of instruments has increased as the
surgery techniques have become more and more complex.
[0006] Thus, it would be advantageous to have a surgical device
which minimizes the degree to which it potentially interferes with
the surgeon during any surgery, thereby allowing the surgeon to
perform more efficient surgery. It would be further advantageous to
have a surgical device that allows proper positioning to
predetermined body locations within the small incisions.
BRIEF DESCRIPTIONS OF THE INVENTION
[0007] The present invention provides a surgical device which
minimizes the degree which it potentially interferes with the
surgeon during surgery, particularly but not limited to, MIS. The
present invention also provides a surgical device that allows
proper positioning to predetermined body locations. The present
invention achieves these objectives by utilizing a surgical device
with a malleable shaft which allows the surgeon to bend and adjust
the shape of the device to minimize its intrusion and to allow for
proper positioning in predetermined body locations. The surgical
device of the present invention is further provided with tissue
engaging means and a handle portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a side view of a preferred embodiment made in
accordance with the principles of the present invention.
[0009] FIG. 2 is a side view of an alternate embodiment of the
handle and ratchet assembly of the present invention.
[0010] FIG. 2a is a side view of the ratcheting means shown in the
assembly of FIG. 2.
[0011] FIG. 3 is a side view of an alternate embodiment made in
accordance with the principles of the present invention.
[0012] FIG. 3a is a side view of the tissue engaging means of the
embodiment of FIG. 3, the tissue engaging means being in the closed
position.
[0013] FIG. 3b is a side view of the tissue engaging means of the
embodiment of FIG. 3, the tissue engaging means being in the open
position.
[0014] FIG. 3c is a cross sectional view of the tissue engaging
means of the embodiment of FIG. 3.
[0015] FIG. 4 is a cross-sectional view of the mechanism which
enables handle to shaft rotation.
[0016] FIG. 5 is a cross-sectional view of a malleable embodiment
of the shaft member made in accordance with the principles of the
present invention.
[0017] FIGS. 6a-6c are side views of an alternate embodiment of the
jaw actuating mechanism made in accordance with the principles of
the present invention.
[0018] FIG. 7 is a side view of a wound tubing embodiment of the
shaft member made in accordance with the principles of the present
invention.
[0019] FIG. 7a is a cross-sectional view of the wound tubing
embodiment of the shaft member shown in FIG. 7.
[0020] FIG. 7b is a cross-sectional view of the wound tubing
embodiment of the shaft member shown in FIG. 7, placed in a bent
shape.
[0021] FIG. 7c is a side view of a ball and socket embodiment of
the shaft member made in accordance with the principles of the
present invention.
[0022] FIG. 7d is a cross-sectional view of the ball and socket
embodiment of the shaft member shown in FIG. 7c.
[0023] FIG. 7e is a cross-sectional view of the ball and socket
embodiment of the shaft member shown in FIG. 7c, placed in a bent
shape.
[0024] FIG. 8 is a top view of an alternate embodiment of the jaw
actuating mechanism made in accordance with the principles of the
present invention.
[0025] FIG. 8a is a cross-sectional view of the jaw actuating
mechanism shown in FIG. 8, taken along the plane of line 8a-8a.
[0026] FIG. 8b is a top view of the jaw actuating mechanism shown
in FIG. 8, in the closed position.
[0027] FIG. 8c is a top view of the jaw actuating mechanism shown
in FIG. 8, shown with alternate jaws.
[0028] FIG. 9 is a perspective view of an alternate preferred
embodiment made in accordance with the principles of the present
invention.
[0029] FIG. 9a is a detail view of the ball and socket arrangement
used in the embodiment of FIG. 9.
[0030] FIG. 10 is a perspective view of a disposable embodiment
made in accordance with the principles of the present
invention.
[0031] FIGS. 11 and 12 are cross-sectional views of the coupling
arrangement between the jaw actuating means and the tissue engaging
means of the embodiment of FIG. 10.
[0032] FIGS. 13 and 14 are cross-sectional views of the coupling
arrangement between the jaw actuating means and the handle assembly
of the embodiment of FIG. 10.
[0033] FIG. 15a is a cross-sectional view of the coupling
arrangement of FIGS. 11 and 12, in the locked position.
[0034] FIG. 15b is a cross-sectional view taken along the plane of
line 15a-15a of FIG. 15a.
[0035] FIG. 16a is a cross-sectional view of the coupling
arrangement of FIGS. 11 and 12, in the unlocked position.
[0036] FIG. 16b is a cross-sectional view taken along the plane of
line 16a-16a of FIG. 16a.
[0037] FIG. 17 is a cross-sectional view of an alternate embodiment
of the jaw actuating mechanism made in accordance with the
principles of the present invention.
[0038] FIG. 17a is a top view of the jaw actuating mechanism shown
in FIG. 17.
[0039] FIG. 17b is a cross-sectional view of the jaw actuating
mechanism shown in FIG. 17, in the closed position.
[0040] FIGS. 18 and 19 are cross-sectional views of an alternate
embodiment of the coupling arrangement between the jaw actuating
means and the handle assembly made in accordance with the
principles of the present invention.
[0041] FIG. 18a is an enlarged view of the coupling arrangement of
FIG. 18.
[0042] FIG. 19a is an enlarged view of the coupling arrangement of
FIG. 19.
DETAILED DESCRIPTION OF THE INVENTION
[0043] Referring first to FIG. 1, a surgical device 10 made in
accordance with the principles of the present invention is shown.
The surgical device 10 generally includes a handle portion 12, a
shaft member 14, and tissue engaging means 16. Although the figures
depict a clamping device, it should be understood that the
principles of the present invention are not limited to clamping
devices and can be applied to other surgical devices such as, for
example, scissors, forceps, dissectors, and retractors.
[0044] The handle portion 12 functions to move the tissue engaging
means 16 between open and closed positions. The handle portion 12
comprises a ratchet handle assembly 19 having an angled handle. It
should be understood that alternate handle assemblies having
different orientations or ratchet designs could also be employed.
The handle assembly 19 of the present invention includes a pair of
elongate legs 21, 23 which terminate at distal ends with finger
grips and which are pivotably connected together at an intermediate
location along the lengths thereof at a pivot element 26. A shaft
support element 28 for the shaft member 14 is mounted to the
proximal end of leg 21. While leg 21 remains stationary with
respect to the shaft support element 28, leg 23 moves with respect
to leg 21 about the pivot element 26. Additionally, the proximal
end of leg 23 is operatively connected to an actuating means 31
which extends axially through the shaft member 14 and is
operatively coupled to the tissue engaging means 16. In the
preferred embodiment, the actuating means 31 comprises a cable.
However, other alternate equivalent actuating means could also be
employed.
[0045] The handle assembly 19 is further provided with a ratcheting
mechanism 35 which is mounted on one of the legs and which
interacts with the other leg to hold the tissue engaging means in
the closed position. To move the tissue engaging means to the open
position, lever 36 is depressed to release leg 23 and the tissue
engaging means from the closed position. To move the tissue
engaging means from the open position to the closed position, leg
23 is pushed toward leg 21, the proximal end of leg 23 pulling back
on the actuating means 31 and thereby actuating the tissue engaging
means. Actuation of the tissue engaging means will be discussed in
more detail below.
[0046] An alternate handle assembly and ratcheting mechanism that
could be used with the present invention is shown in FIG. 2. The
handle assembly 19 includes two elongate legs 22, 24 operatively
coupled together at one end. The legs terminate at distal ends with
finger grips. Each of the legs is also provided with a lateral
extension 25, 27 carrying ratcheting means 29. The ratcheting means
29.cooperate in the manner shown in FIG. 2a. As the legs are moved
relative to one another, the ratcheting means cooperate to set the
tissue engaging means of the device in the desired position.
[0047] In an alternate embodiment of the handle assembly, shown in
FIG. 3, leg 123 can be mounted on a shaft support element 128 for
shaft member 114 while leg 121 moves about the pivot element 126.
The proximal end of leg 121 is operatively connected to piston 130
which reciprocates axially within shaft support element 128. When
leg 121 is moved toward leg 123, leg 121 acts upon piston 130 which
in turn pushes on the actuating means 131. The actuating means 131
in turn acts on the tissue engaging means 116.
[0048] The present invention can also be provided with a mechanism
that enables the handle assembly 19 to rotate freely relative to
the shaft member 14 to allow the handle to lie flat on the
operating table and out of the surgeon's way. FIG. 4 shows the
detailed view of this mechanism. As knob 39 is loosened from its
attachment with the support element 28 of the handle assembly, the
force applied by the knob 39 against bearing 40 and gasket 41 is
removed. Consequently, the shaft member 14 can then rotate freely
with respect to the support element 28. To set the handle assembly
in the desired position with respect to the shaft member, the knob
39 is tightened against the support element 28, thereby acting
against the gasket. The gasket 41 thereby functions as a brake,
preventing the shaft member to be rotated with respect to the
handle assembly after tightening.
[0049] The surgical device is further provided with a shaft member
14 which connects the handle assembly 12 to the tissue engaging
means 16. As seen in FIG. 1, one end of the shaft member 14 is
operatively coupled to the shaft support element 28 of the handle
assembly 19 while the opposite end of the shaft member 14 is
operatively coupled to the tissue engaging means 16. In the present
invention, the shape of the shaft member 14 can be reconfigured in
order to enable proper positioning of the tissue engaging means to
predetermined body locations. The shaft member 14 can be
manipulated to the desired shape to avoid obstructions in an area
of work or placed out of the way of the surgeon. It can take a
number of forms to accomplish its function.
[0050] The shaft member can take a malleable form. Due to its
malleable nature, the shaft can be placed in various arrangements
to reach desired body locations. In such an embodiment of the
present invention, the shaft member comprises a malleable tube with
the actuating means extending axially there through. One end of the
actuating means is operatively connected to the tissue engaging
means while the other end is operatively coupled to the handle
assembly. In one embodiment of the present invention, the ends of
the actuating means can be coupled to the tissue engaging means and
to the handle assembly via a ball and socket coupling. Each end of
the actuating means is provided with a member in the shape of a
ball which mates with a socket carried by the tissue engaging means
and the handle assembly. FIG. 9a is a detailed view of the ball and
socket coupling arrangement between the actuating means and the
tissue engaging means. However, alternate equivalent coupling means
could also be utilized.
[0051] The malleable tube of the shaft member could comprise tubing
made of soft metal such as, for example, annealed stainless steel,
brass, or aluminum, or wound tubing made of steel that is bendable
and that can be placed in different shapes. Such a wound tubing
embodiment of the shaft member 14 is depicted in FIGS. 7-7b. For a
soft metal tube, the bending moment required to create a permanent
set in the shaft in the range of approximately 0.5 in-lbs to 8
in-lbs, and preferably approximately 2 in-lbs. Alternately, the
shaft member 414 could comprise a dual-channeled tube 416 having
the actuating means extending through one channel 419 and a
malleable rod 422 extending through the other channel 425 along the
length of the tube. The channel 419 housing the jaw actuating means
(not shown) preferably extends through the center of the tube 416,
with the channel 425 housing the malleable rod 422 extending
off-center, as shown in FIG. 5. Alternately, the malleable rod 422
can be positioned in other locations in the tube 416 with respect
to its center. Due to the presence of the malleable rod 422, the
tube 416 can be placed in various shapes. In a further alternate
embodiment, a plurality of malleable rods, rather than a single
malleable rod, can be employed to keep the tube in the desired
shape.
[0052] The shaft member can also take a form that is both flexible
and rigid. This form has the ability to be flexible so that the
surgeon can form a predetermined shape to fit into a particular
body opening and pathway. The state of the shaft can be changed
from rigid to flexible and vice versa. Such an embodiment of the
present invention is shown in FIG. 1 and in detail in FIGS. 7c-7e.
The shaft member 14 comprises a series of interconnected ball and
socket segments 38 through which the actuating cable 31 passes.
FIGS. 7d-7e show the cross-section of a typical ball and socket
segment, while FIG. 7e shows the interaction between adjacent
segments when the shaft member is placed in a desired shape.
Referring back to FIG. 1, a tightening knob 42 is also provided
adjacent the shaft support element 28 which can be actuated in
order to exert axial compression on the segments 38. This
compression allows the ball and socket segments 38 of the shaft
member 14 to be locked in any shape selected by the surgeon or
other user of the surgical device.
[0053] Alternately, the shaft member comprises a flexible tube with
the actuating cable extending axially there through. A second
applier instrument that is malleable grasps the shaft member and
together the two are inserted into the incision. Once the tissue
engaging means are in the closed position, the applier instrument
is released and removed.
[0054] The surgical device is further provided with a tissue
engaging means 16 which functions to grasp, secure, and occlude
body tissue and conduits. The tissue engaging means 16 includes a
pair of jaws 46, 48, the jaws being connected at one end by a hinge
50. The jaws are moveable by various mechanisms between an open
position and a closed position. The tissue engaging means can also
be provided with a compression return spring 53 to assist the jaws
in returning to the open position.
[0055] Since it is important to surgeons to reduce the size and
bulk of the hinge of the jaws in order to increase visualization
and to minimize the space the tissue engaging means occupies, in
one embodiment of the present invention, the jaws are coaxial with
the longitudinal axis of the shaft member. This orientation, which
is shown in FIGS. 3, 6, 8 and 9, reduces the size and bulk of the
hinge while still maintaining the strength required by the jaws.
However, the tissue engaging means can be placed in alternate
arrangements with respect to the shaft member. For example, in FIG.
1, the tissue engaging means is arranged at approximately a
90.degree. angle with respect to the shaft member.
[0056] In one embodiment of the invention, the shaft member is
separable from the tissue engaging means. In use, the shaft member
is utilized to place the tissue engaging means in the location
desired. The shaft member is then released from the tissue engaging
means and removed from the patient's body, leaving the tissue
engaging means within the body. The tissue engaging means has a
suture or tether attached to it, which extends out of the incision.
When the tissue engaging means is to be removed, the shaft member
is inserted back into the incision and is guided to the tissue
engaging means by the suture or tether. The shaft member then is
coupled to the tissue engaging means and the entire device is
removed.
[0057] The jaws can be actuated by a number of different
mechanisms, as shown in FIGS. 3, 6, 8, 9, and 10. Despite the use
of a non-rigid shaft member, the present invention is capable of
exerting a force on the tissue engaging means in the range of
approximately 10-20 lbs. In the embodiment of FIG. 3, the hinged
end of each jaw is provided with a reduced thickness portion 154,
155. In the open position of the tissue engaging means, shown in
FIG. 3b, a jaw actuating member 156 mates with the reduced
thickness portions of the jaws. In use, the handle assembly 112 is
actuated, thereby pushing the actuating means 131 forward. The
actuating means 131 in turn pushes the actuating member 156,
thereby causing it to slide forward and out of the reduced
thickness portions, as shown in FIG. 3a. This motion squeezes the
jaws 146, 148 to the closed position while the reverse motion
separates the jaws 146, 148 to the open position.
[0058] In the alternate embodiment of FIGS. 6a to 6c, the hinged
end of each jaw is provided with a hole 259 which interacts with a
hook 261 provided at the end of the actuating cable 231. Spring 253
is provided to maintain the jaws 246, 248 in the open position, as
shown in FIG. 6a. To place the jaws 246, 248 in the closed
position, the handle assembly is actuated, thereby pulling the
cable 231 and hook 261 back through the shaft member 214. As the
cable 231 is pulled back, the jaws 246, 248 are actuated to the
closed position by their interaction with a conical end member 264
provided on the shaft member 214.
[0059] FIG. 8 depicts a further alternate embodiment of the jaw
actuating mechanism. The mechanism includes a cylindrical clevis
520 having two longitudinal slots 522, 524 along its length, the
slots located opposite of one another. The clevis 520 further
includes a longitudinal cut-out 527 along its length. The jaws 546,
548 are disposed at one end of the clevis 520. The opposite end of
the clevis 520 is provided with a cylindrical extension 529 through
which the jaw actuating mechanism extends. In this embodiment, the
jaw actuating mechanism comprises a wire driver 531 which extends
through the cylindrical extension 529 and is operatively connected
to one end of the jaws.
[0060] The jaws 546, 548 of this embodiment are provided with a
diagonal slot 567, 569 at one end. As shown in FIG. 8b, the slotted
ends of the jaws are disposed within the cut-out 527 of the clevis
when the jaws are in the closed position. The jaws are attached
along their median portion to the clevis by a screw 572 extending
transversely across the longitudinal cut-out 527. The remainder of
the jaws, the tissue engaging ends, extend from the clevis 520.
[0061] The end of the wire driver 531 which is coupled to the jaws
546, 548 is provided with a hook 561. As seen in FIG. 8a, a portion
of the hook 561 is accommodated within each of the longitudinal
slots. The remaining portion of the hook is coupled to the slots
567, 569 of the jaws. To actuate the jaws to an open position, the
driver 531 is pushed toward the jaws. This motion causes the hook
561 to travel to one end of each of the slots 567, 569, thereby
causing the jaws 546, 548 to pivot about the screw and move to the
open position. As shown in FIG. 8, the slotted ends of the jaws
extended outwardly from the longitudinal cut-out 527 when the jaws
are in the open position. To return the jaws back to the closed
position, the driver 531 is moved in the direction away from the
jaws, thereby causing the driver to move to the opposite end of the
slots 567, 569. The jaws again move about the screw to the closed
position. In the closed position, the slotted ends of the jaws are
within the cut-out 527. As can be seen by referring to FIGS. 8 and
8c, this type of actuating mechanism can be used with different
tissue engaging means.
[0062] A further preferred alternate embodiment of the present
invention is depicted in FIG. 9. The surgical device 510 generally
includes a handle assembly 512 comprising shaft support 528 and
legs 521, 523, a shaft member 514 with an actuating cable 531
extending therethrough, and tissue engaging means 516 including
jaws 646, 648. The actuating cable 531 is coupled to the leg 523
and to jaw 646 by a ball and socket arrangement, as mentioned above
and as shown in detail in FIG. 9a. When leg 523 of the handle
assembly is moved toward leg 521, this movement pulls on the
actuating cable 531. The actuating cable 531 in turn pulls jaw 646,
causing it to move toward jaw 648 and to the closed position. When
it is desired to return the jaws to the opened position, leg 523 is
released, thereby releasing the force on the cable and returning
the jaws to the open position.
[0063] In the embodiment of FIG. 9, the shaft member 514 can take
one of two forms. The shaft member 514 can comprise the
dual-channeled tube, as discussed above and shown in FIG. 5.
Alternately, the shaft member can be comprised of tubing made of
soft metal such as, for example, annealed stainless steel, brass or
aluminum that is bendable and that can be placed in different
shapes. In either instance, the shaft member is of a malleable type
so that it can be placed in various arrangements to reach desired
body locations.
[0064] In order to save the time and costs involved in sterilizing
the surgical device and to reduce the cost and waste involved with
fully disposable devices, the surgical device of the present
invention can be made in part of disposable material so that the
remainder of the surgical device is reusable. In one embodiment of
the present invention, the tissue engaging means and the shaft
member are made of disposable material, and a handle portion is
made of re-useable material such as stainless steel. Alternately,
only the tissue engaging means is made of disposable material, and
the shaft member and the handle portion of re-useable material.
[0065] One such disposable device is shown in FIG. 10. The device
710 includes a disposable shaft member 714 operatively coupled to
the tissue engaging means 716 and to the handle assembly 712, both
made of re-useable material. The shaft member 714 is comprised of a
malleable tube, preferably of a soft metal such as, for example,
annealed stainless steel, brass or aluminum, having a plastic
covering for cosmetic purposes. Alternately, the shaft member 714
is comprised of a malleable plastic tube, preferably of
polyethylene or some other suitable plastic extrusion.
[0066] A jaw actuating means 731, comprising either a flexible
cable or rod, extends through the tube 715, the actuating means 731
being capable of sliding freely within the tube. Each end of the
actuating means 731 extends from a respective end of the malleable
tube 715 and is provided with a spherical ball 720, 722 at its tip.
As shown in FIGS. 11-14, both the tissue engaging means 716 and the
handle assembly 712 are provided with a mating socket 724, 726 for
the spherical ball 720, 722. As discussed below, the malleable tube
715 is coupled to the tissue engaging means 716 and to the handle
assembly 712 by the mating of the spherical balls 720, 722 with the
sockets 724, 726.
[0067] Referring to FIGS. 11 and 12, one of the jaws 748 of the
tissue engaging means 716 is provided at one end with a cylinder
733. The other jaw 746 of the tissue engaging means 716 is provided
with a bolt 737. The bolt 737 includes a cut-out portion 739 in
which one end of jaw 746 pivots. The bolt 737 then extends away
from jaw 746 through the cylinder 733 to mate with the jaw
actuating means 731. As mentioned above, the bolt 737 is provided
with the socket 724 which mates with the spherical ball 720 of the
jaw actuating means 731. The cylinder 733 is also provided with a
spring 741 which biases the bolt 737 and in turn the jaw 746 to the
open position. To actuate the jaws of the tissue engaging means
from the open position shown in FIG. 11 to a closed position, the
handle assembly 712 is actuated to pull one end of the jaw
actuating means 731 in the direction away from the tissue engaging
means 716. Due to the ball and socket coupling, the bolt 737 is
also pulled away from the tissue engaging means 716. This action
causes the bolt 737 to act on jaw 746 via the cut-out portion 739,
the jaw 746 pivoting to the closed position shown in FIG. 12. Since
the jaws are spring biased to the open position, upon release of
the pressure on the legs of the handle assembly, the jaws are
returned to the open position.
[0068] As shown in FIGS. 13 and 14, a similar ball and socket
coupling is employed to couple the jaw actuating means 731 to the
handle assembly 712. One of the legs of the handle assembly 712 is
provided at one end with a cylinder 735 while the other leg 723 is
provided with a bolt 739. The bolt 739 includes a cut-out portion
743 in which the end of leg 723 pivots. The bolt 739 then extends
away from the leg 723 through the cylinder 735 to mate with the jaw
actuating means 731. To mate with the spherical ball 722 of the jaw
actuating means 731, the bolt 739 is provided with a socket 726. In
order to actuate the tissue engaging means 716 to the closed
position, the legs 721, 723 of the handle assembly 712 are moved
from the position shown in FIG. 13, in which the legs are apart
from one another, to the position shown in FIG. 14, in which the
legs are brought together. With this action, leg 723 acts on the
bolt 739 pulling it in a direction away from the tissue engaging
means 716. The bolt 739 in turn acts on the jaw actuating means
731, pulling it in a direction away from the tissue engaging means
716. As discussed above, this action causes the opposite end of the
jaw actuating means 731 to act on jaw 746 of the tissue engaging
means 716, thereby bringing the jaws together to the closed
position, as shown in FIG. 12.
[0069] To enable the shaft member 714 to be separated from the
handle assembly 712 and the tissue engaging means 716 and thus
disposable, locking clips 751, 753 are provided at each ball and
socket coupling. As seen from FIGS. 15b and 16b, each clip is
provided with an opening 755 generally in the shape of the numeral
"8." To lock the ball 720 of the jaw actuating means 731 to the
socket 724 of the bolt 737, the locking clip 751 is placed in the
position shown in FIG. 15b. To unlock the ball 720 of the jaw
actuating means 731 from the socket 724 of the bolt 737 and thus
allow the shaft member 714 to be separated and disposed, the
locking clip 751 is placed in the position shown in FIG. 16b.
[0070] Another preferred alternate embodiment of the present
invention is depicted in FIGS. 17-19. The device 810 includes a
tissue engaging means 816 with jaws 846, 848, a shaft member 814,
and a handle assembly 812 with handles 821, 823. The shaft member
814 is comprised of a malleable tube, preferably of a soft metal
such as, for example, annealed stainless steel, brass or aluminum.
Each end of the shaft member is provided with a terminal member
840, 841. As shown in the figures, a jaw actuating means 831
comprising a cable extends through the shaft member 814. The jaw
actuating means is provided at each end with a terminal member 818,
819, each terminal member having a spherical ball 820, 822
associated therewith.
[0071] Referring to FIGS. 17-17b, the tissue engaging means 816 is
carried by a housing 824. Within the housing 824, a bolt member 837
moves, the bolt member being provided with a pin 832 and a socket
838 which cooperates with the spherical ball 820 of the jaw
actuating means 831. Jaw 846 of the tissue engaging means is
provided with a slot 825 which is operatively coupled to a bolt
member 837 via pin 832. The shaft member 814 is coupled to the
housing 824 by the cooperation between terminal member 840 and cap
833. To couple the shaft member with the housing, terminal member
840 is abutted against the housing 840 and the cap 833 is then
attached to housing 824 via a suitable means such as screw
threads.
[0072] To actuate the tissue engaging means from its open position,
shown in FIG. 17, to its closed position, shown in FIG. 17b, the
jaw actuating means is pulled in a direction away from the tissue
engaging means. This movement in turn causes the bolt member 837 to
move away from the tissue engaging means. As the bolt member moves
away, the pin 832 travels from one end of the slot to the other,
thereby causing the jaw to pivot about the fulcrum 850 to its
closed position. The coupling arrangement between the jaw actuating
means and the tissue engaging means allows the force required to
remain relatively low, particularly when taking into consideration
the long, thin configuration of the shaft member. Once the jaw
actuating means is released, it moves back towards the jaw
actuating means and the jaw 846 returns to its open position.
[0073] Referring to FIGS. 18-19, handle 821 of the handle assembly
is provided at one end with a housing 852. Within the housing 852,
a bolt member 839 moves, the bolt member 839 being provided with a
socket 855 for coupling with the jaw actuating means and a cut-out
portion 843 in which the end of leg 823 pivots. The shaft member
814 is coupled to the housing 852 by the cooperation between
terminal member 841 and cap 834. To couple the shaft member 814
with the housing 852, terminal member 841 is abutted against the
housing 852 and the cap 834 is then attached to housing 852 via a
suitable means such as screw threads.
[0074] In order to actuate the tissue engaging means 816 to the
closed position, the legs 821, 823 of the handle assembly 812 are
moved from the position shown in FIG. 18, in which the legs are
apart from one another, to the position shown in FIG. 19, in which
the legs are brought together. With this action, leg 823 acts on
the bolt member 839 pulling it in a direction away from the tissue
engaging means 816. The bolt member 839 in turn acts on the jaw
actuating means 831, pulling it in a direction away from the tissue
engaging means 816. As discussed above, this action causes the
opposite end of the jaw actuating means 831 to act on jaw 846 of
the tissue engaging means 816, thereby bringing the jaws together
to the closed position, as shown in FIG. 17b.
[0075] It should be understood that various changes in
modifications to the preferred embodiment described herein will be
apparent to those skilled in the art. Such changes and
modifications can be made without departing from the spirit and
scope of the present invention and without diminishing its
attendant advantages. It is therefore intended that such changes
and modifications be within the scope of the claims.
* * * * *