U.S. patent application number 10/533398 was filed with the patent office on 2006-05-11 for surgical staple-clip and applier.
Invention is credited to Charles C. Hart.
Application Number | 20060100649 10/533398 |
Document ID | / |
Family ID | 32682030 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060100649 |
Kind Code |
A1 |
Hart; Charles C. |
May 11, 2006 |
Surgical staple-clip and applier
Abstract
A surgical staple-clip including a clip component and a securing
member is used in a wide range of surgical procedures. The
staple-clip may be introduced to a surgical site in an un-assembled
condition through a small port or trocar. An applier for the
staple-clip comprising a pair of opposed jaw-like channels is
provided to position and apply the clip component and the securing
member. The clip component is positioned around a target tissue and
is compressed or clamped upon the tissue using only the force
required for a specific surgical procedure such as occlusion,
ligation or fixation. When the clip component is properly applied,
the securing member is urged forward and over the clip component to
secure the staple-clip. The clip component may include traction
enhancement features such as surface interruptions, bumps, valleys
and ridges. With the staple-clip of the invention, the force
required to constrict or occlude the tissue is separate from the
force required to secure and maintain the staple-clip in position
and, as a result, the body tissue is not over-compressed and
nourishment to the body tissue is maintained. Other aspects of the
invention include thumb actuated clip appliers for use in hand
assisted laparoscopy (HAL). In one embodiment, a clip applier
includes a handle and a thumb actuated mechanism that is used to
slidably release clips onto a body tissue or vessel by sliding the
thumb actuated mechanism forward and backward using only one hand.
In another aspect of the invention, a two-stage clip is disclosed
having a clip component and a staple component for securing the
clip after it has been properly positioned.
Inventors: |
Hart; Charles C.;
(Summerville, SC) |
Correspondence
Address: |
APPLIED MEDICAL RESOUCES CORPORATION
22872 Avenida Empresa
Rancho Santa Margarita
CA
92688
US
|
Family ID: |
32682030 |
Appl. No.: |
10/533398 |
Filed: |
December 16, 2003 |
PCT Filed: |
December 16, 2003 |
PCT NO: |
PCT/US03/40318 |
371 Date: |
April 30, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60434344 |
Dec 17, 2002 |
|
|
|
Current U.S.
Class: |
606/157 |
Current CPC
Class: |
A61B 17/08 20130101;
A61B 2017/00858 20130101; A61B 2017/0641 20130101; A61B 17/0682
20130101; A61B 2017/0649 20130101; A61B 2017/1225 20130101; A61B
17/0643 20130101; A61B 17/0644 20130101; A61B 17/122 20130101; A61B
17/105 20130101; A61B 17/068 20130101; A61B 17/1285 20130101 |
Class at
Publication: |
606/157 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A medical device to constrict or occlude a body tissue or
vessel, comprising: a first tissue-engaging member 205 having
opposed walls 230, 232 and a first connecting wall 234 defining a
first elongate channel 236; a second tissue-engaging member 210
opposed to the first tissue-engaging member 205 having opposed
walls 240, 242 and a second connecting wall 244 defining a second
elongate channel 246; and a securing member 220 for securing the
first and the second tissue-engaging members 205, 210 such that
front faces of the first and the second connecting walls 234, 244
are opposed to each other.
2. The medical device of claim 1, wherein each of the front faces
of the first and the second connecting walls 234, 244 includes a
plurality of tissue-penetrating elements 238, 248.
3. The medical device of claim 1, wherein the securing member 220
is sized and configured to slide into the first and the second
elongate channels 236, 246 to securely clamp the first and the
second tissue-engaging members 205, 210 around the body tissue or
vessel with minimal compressive force.
4. The medical device of claim 3, wherein the force required to
secure and maintain adequate traction is independent from the force
required to constrict or occlude the body tissue or vessel.
5. The medical device of claim 4, wherein only a compressive force
needed to perform a specific surgical procedure such as occlusion,
ligation or fixation is applied to the body tissue.
6. The medical device of claim 5, wherein tissue necrosis due to
over-compression is eliminated.
7. The medical device of claim 1, wherein at least one of the first
and the second tissue engaging-members 205, 210 includes a
plurality of bumps, ridges, slots, and holes.
8. The medical device of claim 1, wherein the securing member 220
is a spring clip or a deformable clip acting as a retention member
and providing uniform pressure across the occluded tissue or
vessel.
9. The medical device of claim 2, wherein the first and the second
connecting walls 234, 244 and the tissue-penetrating elements 238,
248 are formed as an integral, one-piece construction.
10. The medical device of claim 2, wherein the tissue-penetrating
elements 238, 248 are formed in a plurality of rows.
11. The medical device of claim 10, wherein the number of
tissue-penetrating elements 238, 248 per row and the number of rows
vary according to each application.
12. The medical device of claim 10, wherein the tissue-penetrating
elements 238, 248 are aligned or staggered.
13. The medical device of claim 2, wherein the tissue-penetrating
elements 238, 248 and the securing member 220 have cross-sections
of any configuration including polygonal, circular and elliptical
configurations.
14. A medical device 500 to constrict or occlude a body tissue or
vessel, comprising: a first tissue-engaging portion 505 having a
first face including a plurality of tissue penetrating elements or
protrusions 525; a second tissue-engaging portion 510 opposing the
first tissue-engaging portion 505 having a second face including a
plurality of tissue penetrating elements or protrusions 530; and a
deformable portion 520 connecting the first and the second
tissue-engaging portions 505, 510.
15. The medical device of claim 14, wherein only a force required
to perform a specific surgical procedure such as occlusion,
ligation or fixation is applied to the body tissue or vessel.
16. The medical device of claim 15, wherein tissue necrosis due to
over-compression is eliminated.
17. The medical device of claim 14, wherein the medical device is
formed from a flat metal sheet that is die-cut, stamped or etched
forming a first notched or tooted portion of the first
tissue-engaging portion 505, a smooth connecting portion of the
deformable portion 520 and a second notched or toothed portion of
the second tissue-engaging portion 510.
18. The medical device of claim 17, wherein a plurality of notches
or teeth of the first and the second portions are bent so as to
extend in the same direction or plane and to form channels within
the notches or teeth.
19. The medical device of claim 17, wherein the device is formed in
a U-shape by bending the deformable portion 520 so that the notches
or teeth of the first and the second tissue-engaging portions 505,
510 are opposed.
20. The medical device of claim 14, wherein the device is formed
from any medically acceptable metal or plastic material that is
ductile, malleable or deformable.
21. The medical device of claim 20, wherein the metal includes
titanium and stainless steel.
22. An applier 600 for applying a medical device to constrict or
occlude a body tissue or vessel, the device having a first
tissue-engaging member 205 having opposed walls 230, 232 and a
first connecting wall 234 defining a first elongate channel 236, a
second tissue-engaging member 210 opposed to the first
tissue-engaging member having opposed walls 240, 242 and a second
connecting wall 244 defining a second elongate channel 246, and a
securing member 220 for securing the first and the second
tissue-engaging members 205, 210 such that front faces of the first
and the second connecting walls 234, 244 are opposed to each other,
the applier comprising: an elongate shaft 605 having a proximal end
and a distal end 610; a pair of opposed jaws 615, 620 connected at
the distal end of the elongate shaft 605; a handle operably
connected at the proximal end of the elongate shaft 605 to open and
close the opposed jaws 615, 620; and a sliding member 625 operably
connected within the elongate shaft 605 to advance the securing
member 220 over the first and the second tissue-engaging members
205, 210 after closure of the jaws 615, 620.
23. The applier of claim 22, wherein the jaws 615, 620 operate to
apply the first and the second tissue-engaging members 205, 210
around a target body tissue or vessel.
24. The applier of claim 23, wherein the first and the second
tissue-engaging members 205, 210 are applied to the jaws 615, 620
either manually or automatically.
25. The applier of claim 23, wherein the jaws 615, 620 are
compressed using only a force required for a specific surgical
procedure such as occlusion, ligation or fixation.
26. The applier of claim 25, wherein the first and the second
tissue-engaging members 205, 210 and the securing member 220 are
introduced to a surgical site in an un-assembled condition through
a small port or trocar.
27. The applier of claim 26, wherein the sliding member 625
operates to urge the securing member 220 forward and over the first
and second tissue-engaging members 205, 210 to secure the medical
device.
28. The applier of claim 27, wherein the applier and the medical
device are sized and configured for use in a minimally invasive or
laparoscopic surgical procedure.
29. The applier of claim 22, further comprising a plurality of
slots in each of the opposed jaws 615, 620 to receive a plurality
of the medical devices or multiple staple-clips to simultaneously
apply the medical devices or staple-clips.
30. The applier of claim 29, further comprising a cutting member to
be advanced between the medical devices or staple-clips after they
have been applied to transect the body tissue or vessel between the
medical devices or staple-clips.
31. A clip applier 850 for applying a clip to constrict or occlude
a body tissue or vessel, the clip having a first arm 880 including
a latch mechanism 890 at a distal end and a second arm 885 folded
over the firm arm 880 at a distal end and configured to interlock
or mate with the latch mechanism 890 of the first arm 880, the
applier comprising: a handle 885 for storing the clip; and a thumb
actuated mechanism 860 operably slidable along the handle 885 by
sliding the thumb actuated mechanism 860 forward 870a and backward
870b to release the clip.
32. The clip applier of claim 31, wherein the handle 855 further
comprises a reservoir for storing a plurality of clips 865.
33. The clip applier of claim 32, wherein the plurality of clips
865 are strung end-to-end in a clip sleeve 892 suspended through an
end port.
34. The clip applier of claim 33, wherein the plurality of clips
865 are formed from a single piece of material.
35. A clip 875 to constrict or occlude a body tissue or vessel,
comprising: a first arm 880 including a latch mechanism 890 at a
distal end; and a second arm 885 folded over the firm arm 880 at a
distal end and configured to interlock or mate with the latch
mechanism 890 of the first arm 880.
36. The clip of claim 35, wherein the latch mechanism 890 is a
hook.
37. The clip of claim 36, wherein at least one of the first and the
second arms 880, 885 includes tissue-penetrating elements 898 or
securing elements 1023,1024 on an inner face.
38. The clip of claim 35, further comprising a third arm 899
connecting the first arm 880 and the second arm 885.
39. A clamp 950 to constrict or occlude a body tissue or vessel,
comprising: a tubular section 955 having an opening 960 extending
from a proximal end 965 to a distal end 970; and a lead-in wire 975
operably attached to the proximal end 965 and is movable between an
open position and a closed position, wherein in the closed
position, the lead-in wire 975 is slidably received and secured in
the opening 960 of the tubular section 955.
40. The clip of claim 39, wherein the lead-in wire 975 is bent
against a wall of the tubular section 955 to further secure the
body tissue or vessel.
41. The clip of claim 39, wherein the clamp is used in donor
nephrectomy.
42. A medical device 1010 to constrict or occlude a body tissue or
vessel, comprising: a clip 1011 formed from a first wire including
opposed arms 1013, 1014 and openings 1015,1916; and a staple 1012
for securing the clip 1011, the staple 1012 formed from a second
wire having legs 1017, 1018 to puncture the body tissue or vessel
and to interlock the clip 1011 through the openings 1015, 1016.
43. The medical device of claim 42, wherein the arms 1013, 1014
further comprise a latch mechanism at their distal ends to mate
with each other when the arms 1013, 1014 are closed or clamped
together.
Description
[0001] This is a non-provisional application claiming the priority
of provisional application Ser. No. 60/434,344, filed on Dec. 17,
2002, entitled "Surgical Staple-Clip and Applier," which is fully
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention generally-relates to medical devices and,
more specifically, to a staple-clip and applier adapted for use in
surgical procedures.
[0004] 2. Discussion of the Prior Art
[0005] Clips and staples are widely used in many surgical
procedures such as occlusion, ligation and fixation of various body
tissues and vessels. Clips are generally U-shaped, open-ended wires
that are positioned around a target tissue and clamped together to
constrict or occlude the tissue. A clip applier is typically used
for applying the clips. Clip appliers can be configured for
applying a single clip or multiple clips in both open and minimally
invasive or laparoscopic surgeries. The individual clips are
provided in a loading cartridge or rack of a clip applier. With
minimally invasive surgery, a clip applier must be able to deliver
clips through a small access port or trocar having a diameter of
about 10 mm to 12 mm. Accordingly, the size of a deliverable
laparoscopic clip must be smaller than the inside diameter of the
trocar through which it is introduced. Typically, a 12 mm clip
applier is capable of delivering a clip that is no longer than 7-8
mm. It is not uncommon for laparoscopic surgeons to discover that
even the largest clip available is undersized for a particular
surgical procedure. Moreover, clips will occasionally move about or
slip off the tissue to which they have been applied. In some cases,
a surgeon may apply an excessive compressive force to the clip and
tissue to minimize movement or slippage of the clip. This excessive
compression may cause necrosis of tissue since nutrition to the
tissue is interrupted or eliminated.
[0006] Staples are also widely used in many surgical procedures to
constrict or occlude,a body tissue or vessel. A surgical staple
typically includes a pair of penetrating legs connected by a base
portion. Surgical staples are applied using a stapler, which
compresses the penetrating legs as the legs advance through the
body tissue and are bent against an opposing jaw of the stapler to
secure the staple to the body tissue. A feature of the staple is it
defines open portions that provide nourishment to the tissue even
when the staple is bent. Surgical staples have proved to be
effective, however, the staplers used for applying the staples are
often bulky and require a very strong closing or compressing force,
which is not ideal for minimally invasive or laparoscopic
surgeries. As such, it is desirable to find a staple/clip providing
good traction to prevent movement and slippage while requiring only
a force to close or compress the staple/clip. Specifically, it is
desirable to have a staple/clip where the force required to
constrict or occlude a body tissue is separate from the force
required to secure and maintain the device in position. The
staple-clip would provide good traction while maintain proper
nourishment to the body tissue. It is advantageous to use the
staple/clip, for example, to secure the renal vessel in donor
nephrectomy.
SUMMARY OF THE INVENTION
[0007] The present invention is directed to a surgical staple-clip
for use in a wide range of surgical procedures. The staple-clip
comprises a plurality of individual elements including a clip
component and a securing or fixation member connected with the clip
component to form a Composite staple-clip. The composite
staple-clip may be configured for use in both open and minimally
invasive or laparoscopic surgeries. The staple-clip may be
introduced to a surgical site in an un-assembled condition through
a small port or trocar. An applier for the staple-clip comprising a
pair of opposed jaw-like channels is provided to position and apply
the clip component and the securing member. The clip component is
positioned around a target tissue and is compressed or clamped upon
the tissue using only the force required for a specific surgical
procedure such as occlusion, ligation or fixation. When the clip
component is properly applied and the desired effects are observed,
the securing member is urged forward and over the clip component to
secure the staple-clip.
[0008] In one aspect of the invention, the clip component includes
traction enhancement features including surface interruptions,
bumps, valleys, ridges and the like. In another aspect of the
invention, the clip component includes tissue-penetrating features
similar to those of a staple. It is appreciated that with the
staple-clip of the invention, the force required to constrict or
occlude the tissue is separate from the force required to secure
and maintain the staple-clip in position. That is, only the
compressive force needed to perform a specific surgical procedure
such as occlusion, ligation or fixation is applied to the body
tissue, and the force normally required to secure and maintain a
clip of the prior art is not applied since traction and security
are supplied by the clip component and securing member of the
staple-clip. As a result, the body tissue is not over-compressed
and nourishment to the body tissue is maintained.
[0009] Other aspects of the invention include thumb actuated Clip
appliers for use in hand assisted laparoscopy (HAL). In one
embodiment, a clip applier includes a handle and a thumb actuated
mechanism that is used to slidably release clips onto a body tissue
or vessel by sliding the thumb actuated mechanism forward and
backward using only one hand. This design closes the jaws around
the body tissue or vessel and allows a closed clip to slide into
position. In another embodiment, a clip is provided having a first
arm and a second arm folded over the first arm. The first arm
includes a latch mechanism such as an inwardly turned portion or
hook at its distal end that is configured to interlock or mate with
a distal end of the second arm when the arms are clamped together.
The latch mechanism operates in a similar way to a hair clip and
responds to thumb pressure. An operator may single-handedly access
the clip and slide it onto a body tissue or vessel as needed. The
arms of the clip may include tissue-penetrating elements on the
inner, opposed faces of the arms.
[0010] In another aspect of the invention, a two-stage clip is
disclosed having a clip component and a staple component for
securing the clip after it has been properly positioned. The clip
component is formed from a first piece of material and includes
opposed arms, each of which includes openings allowing penetration
of legs of the staple component. The staple component is formed
from a second piece of material and is used to puncture a body
tissue or vessel and to interlock the clip component. The arms of
the clip component may include a latch mechanism at the distal ends
to mate with each other when the arms are closed or clamped
together. During use, the first stage closes the arms of the clip.
After the first stage, the clip can still be safely removed. The
second stage secures the clip permanently onto the body tissue or
vessel by applying the staple component to the clip component. In
another embodiment, a two-stage clip is formed entirely from a
single piece of material and includes a first arm and an opposed
second arm. The second arm further includes securing elements, all
of which are formed as an integral, one-piece construction. With
this construction, the securing elements may still remain open
after the first stage when the arms are clamped upon a body tissue
or vessel. A second action then presses the securing elements into
the body tissue or vessel.
[0011] These and other features and advantages of the invention
will become more apparent with a discussion of preferred
embodiments in reference to the associated drawings.
DESCRIPTION OF THE DRAWINGS
[0012] FIGS. 1(a) and 1(b) illustrate a typical surgical clip in an
open condition and a closed condition, respectively;
[0013] FIG. 2 illustrates the movement and slippage of a typical
surgical clip;
[0014] FIGS. 3(a) and 3(b) illustrate a typical surgical staple in
an open condition and a closed condition, respectively;
[0015] FIGS. 4(a) and 4(b) illustrate a typical arrangement of open
and closed surgical staples, respectively;
[0016] FIGS. 5(a) and 5(b) illustrate a typical surgical clip
applier and staple applier, respectively;
[0017] FIG. 6(a) is a perspective view of the clip components and
securing member of the staple-clip in accordance with an embodiment
of the invention;
[0018] FIG. 6(b) is a perspective view of the assembled staple-clip
of FIG. 6(a);
[0019] FIG. 7 is a perspective view of the assembled staple-clip of
FIG. 6(b) placed upon a body conduit or passage;
[0020] FIG. 8 is a perspective view of the staple-clip and applier
configured for use in a minimally invasive surgical procedure;
[0021] FIGS. 9(a), 9(c), 9(e) and 9(g) are side views of the
staple-clip of the invention in an open, closing, closed and locked
condition, respectively;
[0022] FIGS. 9(b), 9(d), 9(f) and 9(h) are end views of the
staple-clip of FIGS. 9(a), 9(c), 9(e) and 9(g), respectively;
[0023] FIGS. 10(a) and 10(b) are perspective views of a clip in an
open and closed condition, respectively, having a monolithic
construction in accordance with another embodiment of the
invention;
[0024] FIGS. 10(c) and 10(d) are side views of the clip of FIGS.
10(a) and 10(b), respectively, having pointed tissue-penetrating
elements;
[0025] FIGS. 10(e) and 10(f) are end views of the clip of FIGS.
10(c) and 10(d), respectively;
[0026] FIGS. 11(a) and 11(b) are side views of the staple-clip
before and after placement upon a body conduit or passage,
respectively;
[0027] FIGS. 11(c) and 11(d) are end views of the staple-clip of
FIGS. 11(a) and 11(b), respectively;
[0028] FIGS. 12(a) and 12(b) are schematic side views of a
staple-clip applier in a closed and open condition,
respectively;
[0029] FIGS. 12(c) and 12(d) are front, end views of the
staple-clip applier of FIGS. 12(a) and 12(b), respectively;
[0030] FIGS. 13(a) and 13(b) are perspective views of the tissue
contacting face portions of a staple-clip in another aspect of the
invention;
[0031] FIG. 14 illustrates the sequence of placing the securing
member upon the tissue-engaging members of the staple-clip of the
invention;
[0032] FIGS. 15(a), 15(b) and 15(c) illustrate the invention sized
and configured to pass through a small trocar port in a first
condition, second condition and final condition, respectively;
[0033] FIG. 16 illustrates placement of a single staple-clip of the
invention;
[0034] FIG. 17 illustrates parallel placement of the staple-clips
of the invention;
[0035] FIG. 18 illustrates parallel placement of the staple-clips
of the invention with a cutting element placed between the
staple-clips;
[0036] FIG. 19 illustrates a laparoscopic stapler configured for
use in donor nephrectomy in accordance with another aspect of the
invention;
[0037] FIGS. 20(a)-20(e) illustrate various thumb actuated clip
appliers for use in hand assisted laparoscopy (HAL) in accordance
with additional aspects of the invention;
[0038] FIG. 21 illustrates a spring like coil for suturing a body
tissue or vessel in accordance with another aspect of the
invention;
[0039] FIG. 22 illustrates a plurality of staples formed from a
single piece of material in accordance with another aspect of the
invention;
[0040] FIG. 23 illustrates a temporary HAL clamp for use in donor
nephrectomy in accordance with another aspect of the invention;
[0041] FIGS. 24-26 illustrate various two-stage staple-clips in
accordance with additional aspects of the invention; and
[0042] FIG. 27 illustrates a holder to press a body tissue flat and
to provide clearance during placement of a staple-clip having sharp
features.
DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE
INVENTION
[0043] FIGS. 1 and 2 illustrate a surgical clip 10 of the prior art
having a generally open shape including a first leg 15, a second
leg 20 and a base 30 connecting the first leg 15 and the second leg
20. The clip 10 can be positioned around a body conduit or passage,
e.g., a blood vessel, and compressed using a clip applier 150 as
illustrated in FIG. 5(a). The clip applier 150 generally comprises
an elongate shaft 155, sized and configured to fit through a
surgical trocar port, a distal end 160 having a pair of opposed
jaws 165, 167 and a proximal end 170 having a handle 180 to open
and close the jaws 165, 167. The clip 10, held in an open
condition, is supplied to the jaws 165, 167 either automatically or
manually. The clip 10 is advanced to a desired site and
subsequently closed or compressed. With the first and second legs
15 and 20 properly formed, the jaws 165, 167 can be opened and
moved away from the tissue leaving the clip 10 clamped around the
tissue. The clip 10 derives its strength from the material from
which it is made. The material chosen must be sufficiently
malleable to allow the clip to be compressed as illustrated in FIG.
1(b) while preventing spring-back of the material after application
of a compressive force.
[0044] There are many factors that must be considered in applying a
surgical clip to a body tissue or vessel. First, the clip must be
sufficiently wide to completely encompass the tissue. As
illustrated in FIG. 1(a), the clip 10 must have an open area 50
that is wide enough to encompass the target tissue. Second, the
clip must be compressible with a reasonable application force,
i.e., a force that an operator feels comfortable applying to the
body tissue. Third, the clip, once applied, must not move from the
location where it was applied. As illustrated in FIG. 2, the clip
10 must not slip along axes 80(a) or 80(b) or slip off of body
vessel 60. A fourth factor is that the clip 10 should not compress
the body tissue so much that it constricts, interrupts or destroys
the nourishment of the tissue. As can be seen, the above factors of
clip-based ligation or fixation are difficult to achieve using a
single wire-formed clip. Moreover, the issues of compression and
traction must be separated if proper nourishment of the tissue is
to be preserved while maintaining a secure placement of the
clip.
[0045] Surgical staples are another device that is commonly used
for occlusion, ligation and fixation of body tissues and vessels.
Referring to FIG. 3(a), a typical surgical staple 100 comprises
generally straight, penetrating leg portions 110 and 120 connected
together by a base portion 130. As the penetrating leg portions
110, 120 are applied to a body tissue or vessel, the leg portions
advance through the tissue and are bent against the opposing jaw of
the stapler and toward each other as illustrated in FIG. 3(b). The
bending of the staple 100 forms a confinement of the body tissue
that is, for the most part, independent of the compression of the
tissue itself. FIG. 5(b) illustrates a laparoscopic stapler 190
that operates in much the same way as a clip applier. During use,
the stapler 190 is advanced over a portion of body tissue and is
compressed to deliver at least one, and more often several,
penetrating surgical staples. See, for example, FIGS. 4(a) and
4(b). The compressed surgical staple 100 has a general shape of the
capital letter "B" where fluid nourishment of the tissue is
provided through open portions 140 of the folded staple 100.
Surgical staples have proved to be effective and are a standard in
surgery. However, the staplers used for applying the staples are
often bulky and require a very strong closing or compressing force,
which is not ideal for minimally invasive or laparoscopic
surgeries. Accordingly, there is a need in the art for a device
having features and advantages of both the staple and clip. The
staple/clip would provide good traction to prevent the device from
moving or dislodging from the body tissue while maintaining proper
nourishment to the tissue. In addition, the force required to
constrict or occlude the body tissue would be separated from the
force required to secure and maintain the device in position.
Specifically, the portion of tissue to be treated would not be
compressed more than is necessary to achieve the desired
result.
[0046] FIG. 6(a) illustrates a surgical staple-clip 200 in
accordance with a first embodiment of the invention. The
staple-clip 200 comprises a first tissue-engaging member 205, a
second tissue-engaging member 210 opposed to the first
tissue-engaging member 205, and a securing or fixation member 220
for securing the first and second tissue-engaging members 205, 210.
The first tissue-engaging member 205 comprises generally opposed
walls 230, 232 and a connecting wall 234 that together define an
elongate channel 236. The second tissue-engaging member 210 is
similar to the first tissue-engaging member 205 and comprises
generally opposed walls 240, 242 and a connecting wall 244 that
together define an elongate channel 246. The tissue-engaging
members 205, 210 are normally held such that the front faces of the
connecting walls 234, 244, respectively, are opposed to each other.
The opposing front faces of the connecting walls 234, 244 may
include a plurality of tissue-penetrating elements 238, 248,
respectively.
[0047] An advantage of the staple-clip of the invention is it
provides good traction without requiring an excessive compressive
force to be applied to the staple-clip. In particular, the securing
member 220 is sized and configured to slide into the elongate
channels 236, 246 to securely clamp the tissue-engaging members
205, 210 around a body tissue or vessel with minimal compressive
force. More specifically, the force required to secure and maintain
the staple-clip (to provide adequate traction) is independent from
the force required to constrict or occlude a body tissue or vessel.
With the staple-clip of the invention, only the compressive force
needed to perform a specific surgical procedure such as occlusion,
ligation or fixation is applied to the body tissue, and the force
normally required to secure and maintain a clip of the prior art is
not applied since traction and security are supplied by the
tissue-engaging members 205, 210. In other words, the staple-clip
of the present invention provides the necessary traction without
requiring an excessive compressive force to keep the staple-clip
from moving or becoming loose. As a result, nourishment of the
lightly compressed tissue is maintained and tissue necrosis due to
over-compression is eliminated.
[0048] In another aspect of the invention, the tissue-engaging
members include traction enhancing features including bumps,
ridges, slots, holes, etc. as generally illustrated in FIGS. 13(a)
and 13(b). The traction enhancing features are sized and configured
to grip tissue and provide traction and security beyond that which
might be achieved by over-compressing a typical clip. The securing
member 220 may be a spring-clip or a deformable clip acting as a
retention member and providing a uniform pressure across the
occluded tissue or vessel to prevent loosening of the staple-clip
200 over time as illustrated in FIGS. 7, 9(a)-9(h) and 14. The
tissue-penetrating elements 238, 248 are configured to penetrate
the tissue and to prevent the tissue from moving or sliding when
clamped as illustrated in FIGS. 11(a)-11(d), 16 and 17.
[0049] It is appreciated that the connecting walls 234, 244 and the
respective tissue-penetrating elements 238, 248 may be formed as an
integral, one-piece construction. It is further appreciated that
the number of rows of tissue-penetrating elements and the number of
tissue-penetrating elements per row may vary according to each
application and the shape and size of the clip and body tissue. It
is further noted that the tissue-penetrating elements in each row
may be aligned or staggered as desired. The tissue-engaging members
205,210 and the securing member 220 may have cross-sections of any
configuration including polygonal, circular and elliptical
configurations.
[0050] Referring to FIG. 10, there is shown a monolithic
staple-clip 500 in accordance with another aspect of the invention.
The monolithic staple-clip 500 has a general shape of the capital
letter "U". The staple-clip 500 comprises a first tissue-engaging
portion or leg 505, an opposed second tissue-engaging portion or
leg 510 and a deformable connecting portion 520 connecting the
first and second tissue-engaging portions 505 and 510. Each of the
opposing faces of the tissue-engaging portions 505, 510 comprises a
plurality of tissue penetrating elements or protrusions 525, 530,
respectively. The protrusions are sized and configured to penetrate
tissue that is captured between the tissue-engaging portions and
provide traction and security beyond that which might be achieved
by over-compressing a typical clip. Similar to other aspects of the
invention, only the force required to perform a specific surgical
procedure such as occlusion, ligation or fixation is applied to a
body tissue and the force previously needed to secure and maintain
the clip is no longer applied. Nourishment of the lightly
compressed tissue is thus maintained and tissue necrosis due to
over-compression is eliminated.
[0051] The monolithic staple-clip 500 may be formed from a flat
metal sheet that is die-cut, stamped or etched forming a first
notched or toothed portion, a smooth connecting portion and a
second notched or toothed portion. The notches or teeth of the
first and second portions are then bent so as to extend in the same
direction or plane and to form channels within the notches or
teeth. The staple-clip is then formed in a U-shape by bending the
connecting portion so that the notches or teeth of the two
tissue-engaging portions are opposed. A preferred embodiment of the
monolithic staple-clip comprises a malleable material such as
Titanium or stainless steel. Other materials include any medically
acceptable metal or plastic material that is ductile, malleable or
deformable.
[0052] It is appreciated that the staple-clips of the invention can
be applied to a body tissue or vessel using an applier 600 as
illustrated in FIGS. 12(a)-12(d). The staple-clip applier 600
generally comprises an elongate shaft 605, sized and configured to
fit through a surgical trocar port, a distal end 610 having a pair
of opposed jaws 615, 620, and a proximal end (not shown) having a
handle to open and close the jaws 615, 620. The staple-clip applier
600 further comprises a sliding member 625 to advance the securing
member 220 over the tissue-engaging members 205, 210 after closure
of the jaws 615, 620 as further described below. The jaws 615, 620
operate to apply the tissue-engaging members 205, 210,
respectively, around a target body tissue or vessel. The
tissue-engaging members are supplied to the jaws either manually or
automatically. With the tissue-engaging members 205, 210 properly
placed, the jaws 615, 620 can be compressed using only the force
required for a specific surgical procedure such as occlusion,
ligation or fixation. When the tissue-engaging members 205, 210 are
properly applied, the sliding member 625 can then urge the securing
member 220 forward and over the tissue-engaging members 205, 210 to
secure the staple-clip 200 as illustrated in FIGS. 9(a)-9(h),
11(a)-11(d) and 14. The tissue-engaging members 205, 210 and
securing member 220 may be introduced to a surgical site in an
un-assembled condition through a small port or trocar. FIGS. 8 and
15(a)-15(c) further illustrate the staple-clip and applier sized
and configured for use in a minimally invasive or laparoscopic
surgical procedure.
[0053] Multiple staple-clips may also be loaded in a staple-clip
applier and advanced individually or simultaneously between the
jaws. In the case of simultaneously applying the staple-clips, the
applier must include a plurality of slots in the opposed jaws to
receive the multiple staple-clips. A cutting member such as a blade
may be included in the applier to be advanced between the
staple-clips after they have been applied to transect the body
tissue between the staple-clips as illustrated in FIGS. 17 and
18.
[0054] In another aspect of the invention, FIG. 19 depicts a
traditional laparoscopic stapler 800 that is configured
specifically for donor nephrectomy. The stapler 800 includes a
plurality of rows of staples on the patient side 805 and a
temporary clip 810 that substitutes for a typical set of staples on
the kidney side 815. The stapler 800 operates like existing place
and cut staplers with the exception that a temporary clip or clips
810 replace the set of staples on the kidney side 815. The
temporary clip 810 may be a staple cartridge configured for use in
donor nephrectomy. An advantage of this configuration is it
salvages a greater portion of the vessel for the transplant
procedure.
[0055] Another aspect of the invention is directed to hand assisted
laparoscopy (HAL), the widespread acceptance of which has created
many opportunities for surgical advancement utilizing single hand
procedures. FIGS. 20(a)-20(e) illustrate thumb actuated clip
appliers 850, 875 and 895 in accordance with the teachings of the
invention. The clip applier 850 includes a handle 855 and a thumb
actuated mechanism 860. An operator can slidably release clips 865
onto a vessel by sliding the thumb actuated mechanism 860 forward
870a and backward 870b using only one hand as illustrated in FIGS.
20(a)-20(b). This design closes the jaws around the vessel and
allows a closed clip to slide into position. The handle 855 also
serves as a reservoir for additional clips 865. The clip 875 is
also designed for HAL applications and includes a first arm 880 and
a second arm 885 folded over the first arm 880. The first arm 880
includes a latch mechanism 890 such as an inwardly turned portion
or hook at its distal end that is configured to interlock or mate
with a distal end of the second arm 885 when the arms are clamped
together. The latch mechanism 890 operates in a similar way to a
hair clip and responds to thumb pressure. An operator may
single-handedly access the clip 875 and slide it onto a body tissue
or vessel as needed.
[0056] A plurality of clips 875 may be strung end-to-end in a clip
sleeve 892 suspended through an open port. An advantage of the clip
875 is there is no instrument to misplace. The clip sleeve 892
holding the clips 875 can also be withdrawn or fed through any open
port or trocar. The clip sleeve 892 can also be designed to keep
the clips 875 partially closed, enabling the use of smaller ports
or trocars. The clip 895 as illustrated in FIG. 20(e) is similar to
the clip 875 but further includes tissue-penetrating elements 898
on the inner faces of arms 896, 897. The clip 895 may also include
a third arm 899 connecting the arms 896, 897.
[0057] In another aspect of the invention as illustrated in FIG.
21, a spring like coil 900 is used for suturing a body tissue or
vessel in place of clips and staples. The spring like coil 900 is
applied onto a body tissue or vessel 905 by using a stapler 910
having grooved jaws 910, 915. The spring like coil 900 is
preferably loaded or twisted into one of the grooved jaws 910, 915,
which is then compressed or clamped against the other grooved jaw
to constrict or occlude the vessel 905. An advantage of this design
is closure of the coil 900 provides a stitch like nature that
replicates a uniformly applied suture. In one configuration, a
single coil is inserted in place of each suture. It is appreciated
that a single coil or multiple coils may be loaded into the grooved
jaws of a stapler for each specific surgical procedure or
closure.
[0058] In yet another aspect of the invention, FIG. 22 illustrates
multiple staples 925 formed from a single piece of material 930 to
reduce the high manufacturing costs associated with current stapler
cartridges. These costs savings translate to increased margins or
reduced product cost. Each of the staples 925 has an angled leg 935
and an inclined rail 940 for easy push up and closure by a stapler.
The staples 925 all share a common portion 945, which allows the
row of staples to be formed as an integral, one-piece construction.
The staples 925 can also be formed to offset each other and to
emulate multiple rows. An advantage of this aspect of the invention
is it provides a compact cartridge that is suitable for donor
nephrectomy.
[0059] FIG. 23 illustrates a temporary HAL clamp 950 for use in
donor nephrectomy in accordance with another aspect of the
invention. The clamp 950 includes a tubular section 955 defining an
opening 960 extending from a proximal end 965 to a distal end 970,
and a lead-in wire 975 operably attached to the proximal end 965.
The lead-in wire 975 is movable between an open position and a
closed position. When closed, the lead-in wire 975 is slidably
received and secured in the opening 960 of the tubular section 955.
During use, an operator may manually wrap a vessel or vessels
(e.g., the renal artery and vein can be cinched together into the
clamp) around the lead-in wire 975 and secure the wire 975 in the
opening 960 of the tubular section 955. The lead-in wire 975 may be
bent against the wall of the tubular section 955 to further secure
the vessel(s) for kidney removal and transport.
[0060] FIGS. 24, 25 and 26 illustrate two-stage clips 1010, 1020
and 1030, respectively, in accordance with additional embodiments
of the invention. The clips 1010, 1020 and 1030 require an applier
(not shown) for placement onto a body tissue or vessel. The clip
1010 includes a clip component 1011 and a staple 1012 for securing
the clip after it has been properly positioned. The clip component
1011 is formed from a single wire and includes opposed arms 1013,
1014. Each of the arms 1013, 1014 includes openings 1015, 1016,
respectively, allowing penetration of legs 1017,1018 of the staple
1012. The staple 1012 is formed from a second wire and is used to
puncture the body tissue or vessel and interlock the clip component
1011. The arms 1013,1014 may include a latch mechanism at the
distal ends to mate with each other when the arms are closed or
clamped together. During use, the first stage closes the arms 1013,
1014 of the clip. After the first stage, the clip can still be
safely removed. The second stage secures the clip permanently onto
the body tissue or vessel by applying the staple 1012 to the clip
component 1011.
[0061] The two-stage clip 1020 as shown in FIG., 25 is formed
entirely from a single piece of material and includes a first arm
1021 and an opposed second arm 1022. The second arm 1022 further
includes securing elements 1023, 1024, all of which are formed as
an integral, one-piece construction. With this construction, the
securing elements 1023, 1024 may still remain at an angle after the
first stage (when the arms 1021 and 1022 are clamped upon a body
tissue or vessel). A second action then presses the securing
elements 1023, 1024 into the body tissue or vessel. The clip 1030
as shown in FIG. 26 is similar to the clip 1010 and includes a clip
component 1031 and a staple component 1032 for securing the clip
after it has been properly positioned. The clip component 1031
includes opposed arms 1013, 1014 defining openings 1035, 1036,
respectively. The staple component 1032 includes opposed arms 1037,
1038 having tissue-securing elements 1039, 1040, respectively,
which operate to secure the clip onto a body tissue or vessel
through the openings 1035, 1036. The clip 1030 may be formed in
sheet stock.
[0062] FIG. 27 illustrates a tissue holder 1100 for use with
staple-clips that may include sharp features, e.g.,
tissue-penetrating elements, that can potentially injure tissue
during a surgical procedure. In particular, the tissue holder 1100
is used to press a body tissue flat and to provide clearance during
placement of a staple-clip.
[0063] Although exemplary embodiments of the invention have been
shown and described, many alterations and modifications may be made
by those having ordinary skill in the art without departing from
the spirit and scope of the invention. Therefore, it must be
understood that the illustrated embodiments have been set forth
only for the purposes of examples and that they should not be taken
as limiting the invention. In addition, the words used in this
specification to describe the invention and its various embodiments
are to be understood not only in the sense of their commonly
defined meanings, but to include any special definition given in
this specification.
* * * * *