U.S. patent application number 14/103641 was filed with the patent office on 2014-10-16 for wound clamp.
This patent application is currently assigned to INNOVATIVE TRAUMA CARE INC.. The applicant listed for this patent is Innovative Trauma Care Inc.. Invention is credited to Ian Atkinson, Steve Dralle, Dennis Filips, Prasanna Lakshminarasimhan, Kelly Mottet.
Application Number | 20140309687 14/103641 |
Document ID | / |
Family ID | 51687307 |
Filed Date | 2014-10-16 |
United States Patent
Application |
20140309687 |
Kind Code |
A1 |
Atkinson; Ian ; et
al. |
October 16, 2014 |
WOUND CLAMP
Abstract
The present disclosure provides a wound closure device
including: (a) a first opposing member and a second opposing member
disposed on opposing sides of a central axis, each resiliently
moveable between a closed position and open position relative to
each other, each of the opposing members having a distal edge; (b)
skin penetrating means for anchoring the device; (c) a pressure bar
along each distal edge; (d) releasable locking means for biasing or
maintaining the device in the closed position; and optionally (e)
an accessory component.
Inventors: |
Atkinson; Ian; (Cochrane,
CA) ; Filips; Dennis; (Ottawa, CA) ;
Lakshminarasimhan; Prasanna; (Edmonton, CA) ; Dralle;
Steve; (San Antonio, TX) ; Mottet; Kelly;
(Edmonton, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Innovative Trauma Care Inc. |
Edmonton |
|
CA |
|
|
Assignee: |
INNOVATIVE TRAUMA CARE INC.
Edmonton
CA
|
Family ID: |
51687307 |
Appl. No.: |
14/103641 |
Filed: |
December 11, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13877897 |
Apr 24, 2013 |
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PCT/CA2011/001170 |
Oct 19, 2011 |
|
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14103641 |
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61735893 |
Dec 11, 2012 |
|
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61394566 |
Oct 19, 2010 |
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Current U.S.
Class: |
606/218 |
Current CPC
Class: |
A61M 25/02 20130101;
A61B 17/08 20130101; A61M 2025/028 20130101; A61M 2025/024
20130101; A61B 2217/005 20130101; A61M 2025/0286 20130101; A61B
2017/081 20130101; A61B 90/57 20160201; A61B 17/083 20130101 |
Class at
Publication: |
606/218 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A wound closure device comprising: (a) a first opposing member
and a second opposing member engaged about a longitudinal axis,
each pivotally moveable around the axis between a closed position
and an open position relative to each other, and moveable
longitudinally along the axis from a first position to a second
position, each of the opposing members having a proximal edge
adjacent the longitudinal axis and a distal edge, and an outer face
and an inner face; (b) a first ratchet on the first member, and a
second ratchet on the second member, which engage each other to
maintain the opposing members in the closed position, when the
first and second members are in the first position, and which
disengage when the first and second members are in the second
position; (c) a plurality of needles disposed on the distal edges
of the first and second members; and (d) an accessory
component.
2. The wound closure device of claim 1, further comprising a
pressure bar attached to the distal end of each of the opposing
members.
3. The wound closure device of claim 2, further comprising a
stabilizer bar attached to the outer face of each opposing
member.
4. The wound closure device of claim 1, further comprising a grip
attached to the outer face of each opposing member, wherein the
grip comprises a first gripping surface parallel to the
longitudinal axis, and a gripping surface substantially
perpendicular to the first gripping surface.
5. The wound closure device of claim 1, wherein each opposing
member is semi-cylindrical.
6. The wound closure device of claim 1, wherein the needles are
straight or are curved, with a radius of curvature substantially
similar to the radius of curvature of the opposing members.
7. The wound closure device of claim 1, further comprising a first
spring disposed between the first and second members to bias the
first and second members towards the first position, and a second
spring disposed between the first and second members to bias the
first and second members towards the open position.
8. The wound closure device of claim 1, further comprising a
medical instrument coupled to the accessory component.
9. The wound closure device of claim 1, further comprising an
integrated port.
10. The wound closure device of claim 1, wherein the accessory
component comprises means for securing a medical device to the
wound closure device.
11. The wound closure device of claim 10, wherein the accessory
component comprises an articulated arm.
12. The wound closure device of claim 8, wherein the medical
instrument is selected from a needle, tube, catheter, and
cannula.
13. A wound closure device comprising: (a) a first opposing member
and a second opposing member engaged about a longitudinal axis,
each pivotally moveable around the axis between a closed position
and an open position relative to each other, each of the opposing
members having a proximal edge adjacent the longitudinal axis and a
distal edge; (b) skin penetrating means for anchoring the device;
(c) a pressure bar along each distal edge; (d) releasable locking
means for biasing or maintaining the device in the closed position;
and (e) an accessory component.
14. The device of claim 13, wherein each opposing member comprises
an end closure member substantially perpendicular to the distal
edge and aligned with an opposing end closure member.
15. The device of claim 13, wherein the skin penetrating means
comprises a plurality of needles disposed along each pressure
bar.
16. The device of claim 15, wherein the needles are of sufficient
length to penetrate the skin and pierce underlying tissue.
17. The device of claim 15, wherein the needles are straight or are
curved, with a radius of curvature substantially similar to a
radius of curvature of the opposing members.
18. The device of claim 13, wherein the two opposing members
frictionally engage each other to remain in a closed position.
19. The device of claim 19, wherein the frictional engagement is
enhanced by a plurality of longitudinal ridges on one or both of
the opposing member bearing surfaces.
20. The device of claim 13, wherein the releasable locking means
comprising a one-way cylindrical bearing disposed between the two
opposing members, and a longitudinal pin disposed within the
bearing, wherein the one-way bearing rotates with one opposing
member, and the pin rotates with the other opposing member, and
wherein the pin comprises an engagement section which engages the
bearing to rotate freely in one direction but not the other
direction, and a reduced diameter section where the pin freely
rotates in either direction, and the pin is moveable longitudinally
to slide the reduced diameter section into and out of the
bearing.
21. The device of claim 20, wherein the device comprises two
releasable locking means, one at either end of the device.
22. The wound closure device of claim 13, further comprising a
medical instrument coupled to the accessory component.
23. The wound closure device of claim 13, further comprising an
integrated port.
24. The wound closure device of claim 13, wherein the accessory
component comprises means for securing a medical device to the
wound closure device.
25. The wound closure device of claim 24, wherein the accessory
component comprises an articulated arm.
26. The wound closure device of claim 22, wherein the medical
instrument is selected from a needle, tube, catheter, and
cannula.
27. A wound closure device comprising: (a) a first opposing member
and a second opposing member disposed on opposing sides of a
central axis, each resiliently moveable between a closed position
and open position relative to each other, each of the opposing
members having a distal edge; (b) skin penetrating means for
anchoring the device; (c) a pressure bar along each distal edge;
and (d) releasable locking means for biasing or maintaining the
device in the closed position.
28. The device of claim 27, wherein the skin penetrating means
comprises a plurality of needles disposed along each pressure
bar.
29. The device of claim 28, wherein the needles are of sufficient
length to penetrate the skin and pierce underlying tissue.
30. The device of claim 28, wherein the needles are straight or are
curved, with a radius of curvature substantially similar to a
radius of curvature of the opposing members.
31. The device of claim 27, wherein the releasable locking means
comprising ratchet teeth or a slide lock component.
32. The device of claim 27, wherein the device comprises two
releasable locking means, one at either end of the device.
33. The wound closure device of claim 27, further comprising an
accessory component.
34. The wound closure device of claim 33, further comprising a
medical instrument coupled to the accessory component.
35. The wound closure device of claim 27, further comprising an
integrated port.
36. The wound closure device of claim 33, wherein the accessory
component comprises means for securing a medical device to the
wound closure device.
37. The wound closure device of claim 36, wherein the accessory
component comprises an articulated arm.
38. The wound closure device of claim 34, wherein the medical
instrument is selected from a needle, tube, catheter, and
cannula.
39. A method for performing a medical procedure on a subject,
comprising: (a) deploying the wound closure device of any of claim
1, 13 or 27 to a wound of the subject; and (b) locking the wound
closure device in the closed position, thereby performing a medical
procedure on the subject.
40. The method of claim 39, further comprising coupling a medical
instrument to the wound closure device.
41. The wound closure device of claim 27, wherein in closing of a
wound skin is lifted and approximated between the pressure bars.
Description
CROSS REFERENCE TO RELATED APPLICATION(S)
[0001] This application claims the benefit under 35 USC
.sctn.119(e) to U.S. Application Ser. No. 61/735,893 filed Dec. 11,
2012; and is a continuation-in-part of U.S. application Ser. No.
13/877,897 filed Apr. 24, 2013, now pending; which is a 35 USC
.sctn.371 National Stage application of International Application
No. PCT/CA2011/001170 filed Oct. 19, 2011, now expired; which
claims the benefit under 35 USC .sctn.119(e) to U.S. Application
Ser. No. 61/394,566 filed Oct. 19, 2010, now expired. The
disclosure of each of the prior applications is considered part of
and is incorporated by reference in the disclosure of this
application.
FIELD OF THE INVENTION
[0002] The present invention relates to a clamp device for wound
closure. In particular, the invention relates to a haemorrhage
control device and accessories thereto for closing a wound,
particularly in emergency situations, such as during military
operations or civilian disaster situations.
BACKGROUND
[0003] In both military and non-military emergency medical
situations, it is often necessary to temporarily close a wound to
prevent bleeding and to avoid contaminating the wound. In many
situations, it is impractical to suture or staple a wound closed,
which will often take five to ten minutes.
[0004] While utilization of strap style tourniquets have been
widely accepted for field care, these devices present a number of
disadvantages. Tourniquets are slow and difficult to maneuver and
place around the extremity. They are limited by how high they can
be placed on a limb and do not address major bleeding in the groin
or axilla where larger blood vessels run or other areas of the
body, such as the trunk, neck, or scalp. They create a lot of pain
for the casualty and there is a risk of limb loss when left on too
long. Pneumatic tourniquets are less painful but share all of the
anatomical restrictions and are less sturdy for military field
use.
[0005] As an alternative to manual pressure and packing with gauze,
hemostatic agents and dressings have been developed to accelerate
the clotting process in wounds. One such product, referred to as
QuickClot.TM. (Z-Medica) comprises granular zeolites which are
applied to the injured vessel, causing water absorption from the
blood to the zeolite to concentrate clotting factors and speed up
clot formation. However, the granular form is awkward to apply in a
windy environment, and the powder or bandage device is still
subject to movement during extraction of the wounded patient, which
can loosen the clot and cause leakage through the puncture to
increase blood loss. Furthermore, the granular material is very
exothermic, to the extent it can cause burns, and is difficult to
combine with manual pressure because of the temperature generated.
QuickClot.TM. has since been replaced with Combat Gauze.TM.
(Z-Medica) which is a gauze impregnated with a kaolin substance
which is not exothermic and does not have the disadvantages of a
granular powder. It takes at least three to five minutes of manual
pressure over the hemostatic agent before it is effective.
[0006] Even in a field hospital, bleeding from wounds can be
problematic when faced with multiple penetration wounds.
Penetrating wounds may not appear to bleed because the patient is
in shock, but will often commence or resume bleeding upon
resuscitation and return of systolic blood pressure. The surgeon
often does not have enough time to close multiple wounds before
bringing the patient to an operating room for urgent surgery.
[0007] Additionally, pre-hospital drainage procedures are becoming
more common and varied. It is a well-known technique to apply and
fix a tube, such as a drainage tube, through the skin in order to
drain fluid or air from a cavity such as the chest. Chest tube
insertion (also known as a chest drain, tube thoracostomy or
intercostal drain) is the definitive procedure for treating tension
pneumothorax and hemothorax, and can be a life-saving
procedure.
[0008] A common problem is securing the tube to the patient. It is
very easy to remove these tubes when in place if not anchored
properly. In the pre-hospital setting, inexperienced doctors and
paramedics commonly perform insertion and fixation of the tube.
These individuals are trained in advanced life support, but rarely
have any surgical training to anchor a chest tube properly.
Moreover, since trauma mortality is time-sensitive, emergency
pre-hospital care requires rapid solutions that sometimes may lead
to ineffective fixations. Agitated, hypoxemic patients or those
experiencing brain trauma might try to pull the tube out with the
risk that poorly anchored tubes can fail.
[0009] Current fixation protocols require the tube to be secured to
the skin using sutures tied tightly around the tube. However,
sometimes these tubes slip through the knot and are pulled out,
inadvertently migrating away from the cavity especially during
loading and transport of the patient.
[0010] It is conventional to anchor tubing to the body of a patient
by taping the tubing to the skin or an adhesive based anchoring
devices. Tape can easily tear off the skin, thereby releasing the
tubing. When blood or fluids are present, many adhesives do not
effectively adhere to the skin and risk failure. Surgical incision
of the skin of the chest wall with a scalpel to insert the tube
likely makes the skin wet with blood, reducing adherence.
[0011] Surgical incision in the field by minimally trained
individuals reduces the tight fit of the tube to the incision, thus
reducing the stability of the tube and potentially allowing it to
move, change its angle of penetration, or become disengaged from
the chest wall. Reinsertion of an unsanitized tube back into the
incision after migration out of the wound may lead to increased
infection risk.
[0012] Many wound closure devices are known in the art, however,
may be improved upon in many different facets. There is a need in
the art for a wound closure device which may be convenient to use,
is relatively compact, and is effective in closing a wound under
difficult situations which may arise in emergency situations, such
as during warfare, terrorist attacks, accidents or during natural
disasters. A device is also required that can anchor a tube in
place at or near the site of a drain that is easy to perform and
makes it safer and more secure if the use of the tube is considered
in a pre-hospital setting which may be used with a wound closure
device.
SUMMARY OF THE INVENTION
[0013] The present invention relates to a wound closure device. The
device rapidly re-approximates the skin edges by engaging the skin
to seal the wound. The device is configured to open and close in a
clam-shell configuration, and may be configured to be operated
one-handed. In one embodiment, the device comprises needles which
puncture the skin edges when the device is closed, and a pressure
bar which applies pressure substantially perpendicular to the long
axis of the wound. In one embodiment, the pressure bar comprises
end closure members which are disposed substantially perpendicular
to the pressure bar. The pressure is initially exerted manually by
closing the device onto the skin surrounding the wound. The device
may be maintained in a closed position by a biasing means, by a
ratcheting mechanism, by friction or some other mechanical
configuration.
[0014] Without restriction to a theory, the applicants believe that
by closing the wound tightly between two opposing members, blood
loss from the wound can be minimized even if there are significant
wounds below the surface of the skin, if the wound is in a
compressible zone. The patient may then be transported to a
surgical facility with a minimized risk of bleeding out in the
meantime. In one embodiment, the end closure members hem in the
wound from the ends, further enhancing the closure of the
wound.
[0015] Control of bleeding is achieved when pressure in or on the
wound exceeds arterial or venous pressures. Packing of the wound
with gauze or hemostatic agents prior to skin closure may be
preferable for some wounds. Since the device seals off the skin
from the outside it can also be used to prevent bowel evisceration
out of a wound or to treat a sucking chest wound.
[0016] Therefore, in one aspect, the invention may comprise a wound
closure device comprising: (a) a first opposing member and a second
opposing member engaged about a longitudinal axis, each pivotally
moveable around the axis between a closed position and an open
position relative to each other, and moveable longitudinally along
the axis from a first position to a second position, each of the
opposing members having a proximal edge adjacent the longitudinal
axis and a distal edge, and an outer face and an inner face; (b) a
first ratchet on the first member, and a second ratchet on the
second member, which engage each other to maintain the opposing
members in the closed position, when the first and second members
are in the first position, and which disengage when the first and
second members are in the second position; and (c) a plurality of
needles disposed on the distal edges of the first and second
members. In one embodiment, each opposing member comprises an end
closure member at each end, which is substantially perpendicular to
the distal edge, and is aligned with an end closure member on the
other opposing member.
[0017] In another aspect, the invention comprises a wound closure
device comprising: (a) a first opposing member and a second
opposing member engaged about a longitudinal axis, each pivotally
moveable around the axis between a closed position and an open
position relative to each other, each of the opposing members
having a proximal edge adjacent the longitudinal axis and a distal
edge; (b) skin penetrating means for anchoring the device; (c) a
pressure bar along each distal edge; and (d) releasable means for
biasing or maintaining the device in the closed position.
[0018] In another aspect, the invention may comprise a wound
closure device comprising: (a) a first opposing member and a second
opposing member engaged about a longitudinal axis, each pivotally
moveable around the axis between a closed position and an open
position relative to each other, and moveable longitudinally along
the axis from a first position to a second position, each of the
opposing members having a proximal edge adjacent the longitudinal
axis and a distal edge, and an outer face and an inner face; (b) a
first ratchet on the first member, and a second ratchet on the
second member, which engage each other to maintain the opposing
members in the closed position, when the first and second members
are in the first position, and which disengage when the first and
second members are in the second position; (c) a plurality of
needles disposed on the distal edges of the first and second
members; and (d) an accessory component. In one embodiment, each
opposing member comprises an end closure member at each end, which
is substantially perpendicular to the distal edge, and is aligned
with an end closure member on the other opposing member.
[0019] In another aspect, the invention comprises a wound closure
device comprising: (a) a first opposing member and a second
opposing member engaged about a longitudinal axis, each pivotally
moveable around the axis between a closed position and an open
position relative to each other, each of the opposing members
having a proximal edge adjacent the longitudinal axis and a distal
edge; (b) skin penetrating means for anchoring the device; (c) a
pressure bar along each distal edge; (d) releasable means for
biasing or maintaining the device in the closed position; and (e)
an accessory component.
[0020] In another aspect, the invention comprises a wound closure
device comprising: (a) a first opposing member and a second
opposing member disposed on opposing sides of a central axis, each
resiliently moveable between a closed position and open position
relative to each other, each of the opposing members having a
distal edge; (b) skin penetrating means for anchoring the device;
(c) a pressure bar along each distal edge; (d) releasable locking
means for biasing or maintaining the device in the closed position;
and optionally (e) an accessory component.
[0021] In yet another aspect, the invention provides a method for
performing a medical procedure on a subject. The method includes:
(a) deploying a wound closure device of the invention to a wound of
the subject; and (b) locking the wound closure device in the closed
position, thereby performing a medical procedure on the subject.
The method may further include coupling a medical instrument to the
wound closure device.
BRIEF DESCRIPTION OF THE FIGURES
[0022] In the drawings, like elements are assigned like reference
numerals. The drawings are not necessarily to scale, with the
emphasis instead placed upon the principles of the present
invention. Additionally, each of the embodiments depicted are but
one of a number of possible arrangements utilizing the fundamental
concepts of the present invention. The drawings are briefly
described as follows:
[0023] FIG. 1 is a bottom view of one embodiment of a clamp in the
full open position.
[0024] FIG. 2 is a bottom view of a clamp in a partially closed
position.
[0025] FIG. 3 is a bottom view of a clamp in a fully closed
position.
[0026] FIGS. 4A, 4B, 4C, 4D are end views of a clamp in an open and
partially closed and closed position, respectively.
[0027] FIG. 5 is a top view of a clamp in a partially closed
position.
[0028] FIG. 6 is a side view of a clamp in a closed position.
[0029] FIG. 7A is a top view of the clamp in the closed position
with the ratchets engaged. FIG. 7B is a top view of the clamp in
the closed position but with the ratchets disengaged, allowing the
device to be opened.
[0030] FIG. 8 is an end view of a clamp closed on a wound.
[0031] FIG. 9 is a top view of an alternative embodiment of the
clamp.
[0032] FIG. 10 is a view of a further alternative embodiment of the
clamp.
[0033] FIG. 11 is a top view of the embodiment of FIG. 10.
[0034] FIG. 12 is an end view of the embodiment of FIG. 10.
[0035] FIG. 13 is a side view of the embodiment of FIG. 10.
[0036] FIG. 14 is a top view of the embodiment of FIG. 10 in an
open position.
[0037] FIG. 15 is a cross-sectional view along line 15-15 in FIG.
14.
[0038] FIG. 16 is an isometric view of one embodiment of a
clamp.
[0039] FIG. 17 is an isometric view of one embodiment of a
clamp.
[0040] FIG. 18 is an isometric view of one embodiment of a
clamp.
[0041] FIG. 19 is an isometric view of one embodiment of a
clamp.
[0042] FIG. 20 is a side view of one embodiment of a clamp.
[0043] FIG. 21 is a side view of one embodiment of a clamp.
[0044] FIG. 22 is a top view of one embodiment of multiple
clamps.
[0045] FIG. 23 is a perspective view of one embodiment of a clamp
and accessory component.
[0046] FIG. 24 is a perspective view of one embodiment of a clamp
and accessory component.
[0047] FIG. 25 is a perspective view of one embodiment of an
accessory component.
[0048] FIG. 26 is a perspective view of one embodiment of a clamp
and accessory component.
[0049] FIG. 27 is a perspective view of one embodiment of a clamp
and accessory component.
[0050] FIG. 28 is a perspective view of one embodiment of a clamp
and accessory component.
[0051] FIG. 29 is a perspective view of one embodiment of a clamp
and accessory component.
[0052] FIG. 30 is a perspective view of one embodiment of a clamp
and accessory component.
[0053] FIG. 31 is a series of illustrations of one embodiment of a
clamp and accessory component.
[0054] FIG. 32 is a side view of one embodiment of a clamp and
accessory component.
DETAILED DESCRIPTION
[0055] The invention relates to a wound closure device. When
describing the present invention, all terms not defined herein have
their common art-recognized meanings. To the extent that the
following description is of a specific embodiment or a particular
use of the invention, it is intended to be illustrative only, and
not limiting of the claimed invention. The following description is
intended to cover all alternatives, modifications and equivalents
that are included in the spirit and scope of the invention, as
defined in the appended claims.
[0056] In general terms, one embodiment of the wound closure device
is configured in a clamshell type configuration, with a first
opposing member (4) and a second opposing member (6) pivotally
attached to each other about a pin (2) which defines a longitudinal
axis of rotation. Each of the opposing members having an outer face
and inner face and two ends. In one embodiment, each opposing
member approximates a bisected cylinder which has a proximal edge
(5) and a distal edge (7). The longitudinal pivoting axis (2) is
adjacent the proximal edge. The two bisected cylinder halves
approximate a cylinder when in the closed position, where the two
distal edges are proximal to each other. When the first and second
members are pivoted to an open position, the two distal edges are
spread apart.
[0057] While the first and second opposing members (4, 6) are
illustrated herein to be half- cylinder sections in the embodiment
illustrated, they may be approximated by interconnected curved arms
or another equivalent configuration.
[0058] In one embodiment, each opposing member comprises an end
closure member (8) at each end. Each end closure member (8) is
substantially perpendicular to the distal edge, and is aligned with
an end closure member on the other opposing member. Preferably,
when the device is in a closed position, two opposing end closure
members (8) abut each other, or come towards each other, in order
to enclose or partially enclose the volume between the two opposing
members at each end. In an alternative embodiment, the distal edges
(7) may be curved so that the distance between the two distal edges
(7) is reduced towards the ends when the device is in a closed
position. Either configuration is intended to minimize leakage from
the wound from the ends of the wound.
[0059] Without restriction to a theory, the applicants believe that
by closing the wound tightly, between the two opposing members and
between the end closure members, blood loss from the wound can be
minimized even if there are significant wounds below the surface of
the skin, in a compressible zone of the body. The patient may then
be transported to a surgical facility with a minimized risk of
bleeding out in the meantime.
[0060] In one embodiment, the opposing members (4, 6) have needles
(12) for piercing the skin on opposite sides of the wound. The
needles have two primary functions. The first is to anchor the
device into place when it is closed in place to seal a wound. If
the device were to solely rely on frictional engagement with the
skin, it might easily be knocked off. The second is to cause the
skin and underlying tissue to bunch up between the opposing
members, as is illustrated in FIG. 8. In one embodiment, the
needles are long enough to penetrate the dermal layer (D) and
extend into the underlying tissue. This action enhances the sealing
action of the device.
[0061] In one embodiment, the needles (12) are alternately placed
along the length of the opposing members such that the needles are
interleaved. In one embodiment, the needles are curved such that
the piercing of skin and closing of the device brings opposing
edges of the wound up into the device, as is illustrated in FIG. 8.
As a result, dermis to dermis contact along the length of the wound
is promoted, which enhances the seal created by the device. As one
skilled in the art will appreciate, the needles may have a radius
of curvature similar to that of the first and second members.
[0062] In one embodiment, each of the opposing members (4, 6) has a
pressure bar (18, 20) along the distal edge (7) of the member. Once
the device is closed on a wound, the pressure bars (18, 20) exert
relatively even pressure along the length of the wound to close the
wound. The pressure bar may comprise frictional elements to help
grip the skin, such as ridges (21) which run parallel to the distal
edge.
[0063] In one embodiment, the pressure bar (18, 20) is configured
to interact with or hide the needles of the opposing member in
order to prevent exposing the needles when the device is being
handled in the closed position. In one embodiment, the pressure
bars may be lined with a resilient material (32) which envelops the
needle tips, such as neoprene or another rubbery material. The
resilient material may also aid in the application of pressure to
the wound.
[0064] In one embodiment, each of the opposing members (4, 6) has a
grip (10) on the outer face. In one embodiment, the grips are
raised concave surfaces placed near the pivot axis. The grips each
provide a first gripping surface (40) which is substantially
parallel to the longitudinal axis, which facilitates a one-handed
opening motion. In one embodiment, the grips provide a second
gripping surface (42) to push the first and second members apart
along the longitudinal axis. The second gripping surface (42) may
be substantially perpendicular to the longitudinal axis. Different
grip configurations may provide suitable first and second gripping
surfaces. In one embodiment, the grips may be optimized for such
use, as is shown in FIG. 9.
[0065] The device can be stored in a closed position, and is then
opened by a user for use. In preferred embodiments, various
mechanisms may be used to bias the device into an open position,
but allow for storage in a closed position, and also allow for
locking into a closed position when the device is in storage or in
use. The device may also be stored in an open position. In one
embodiments, various mechanisms allow for storage in an open
position.
[0066] In one embodiment, the device may be biased towards its open
position by a first spring (26) but is held in the closed position
by cooperating ratchets (14, 16) disposed on the inner face of the
first and second members. The ratchets (14, 16) are disengaged by
moving the first member longitudinally away from the second member,
as shown by the arrows in FIG. 7B, allowing the device to be
opened. A second spring (28) places longitudinal pressure on the
first and second members to keep the ratchets engaged.
[0067] A plurality of ratchet teeth on each opposing ratchet
permits the user to control the closed position. In the fully
closed position, the distal edges of the opposing members are
adjacent each other, the opposing needles overlap, and all the
ratchet teeth are engaged, as shown in FIG. 4D. The device may be
partially closed, such as when placed on a wound, by engaging only
the end teeth of the opposing ratchets. Once the device is opened,
it may be closed on the wound by forcing the two opposing members
closed, against the pressure of the first spring (26), until the
opposing ratchets engage each other.
[0068] In an alternative embodiment, the surfaces of the two
opposing members which rotationally engage each other, about the
longitudinal axis, may bear elements which frictionally engage each
other. For example, one opposing member may comprise an outer
cylindrical surface, while the other comprises an inner cylindrical
surface. The two cylindrical surfaces bear against each other, and
may provide sufficient friction to maintain the device in a closed
position. Frictional elements such as raised ridges on the
cylindrical bearing surfaces may provide additional friction.
[0069] In another embodiment, the device comprises a releasable
engagement mechanism comprising a one-way bearing. As shown in FIG.
10, the two opposing members (4, 6) rotationally engage each other
about an axial pin (2) with a cylindrical bearing. The pin (2) is
keyed at each end (3) so as to rotate with an outer cylinder (50)
while being moveable in the axial direction. An inner cylinder (52)
rotates within the outer cylinder (50). A one-way bearing (54) fits
within and is affixed to the inner cylinder and is frictionally
engages an engagement section of the pin (2) which passes through
the bearing (54). The pin (2) comprises two telescoping sections
which are biased outwards with an internal spring, and which can be
overcome by pressing the two ends (3) inwards. The pin (2) also
comprises a reduced diameter portion which is smaller than the
engagement section and the inner diameter of the bearing (54). When
the pin is in a relaxed state, the engagement section of the pin
engages the inner diameter of the one-way bearing, which permits
the device to rotate closed, but prevents rotation in the open
direction. When the pin is compressed by squeezing the two ends
(3), the pin slides laterally such that the reduced diameter
portion is disposed within the one-way bearing, permitting free
rotation in either direction.
[0070] In one embodiment, the cylinder and one-way bearing
assemblies are provided at both ends of the device, which permits
greater torque loads on the device in the closed position. It also
permits slightly asymmetric application of the device on a wound,
where the distal edges of the two opposing members are not exactly
parallel. The torsional force acting on the one-way bearing at each
end may be different.
[0071] Accordingly, a user can with one hand and one motion close
the device about a wound, and the device will remain locked in a
closed position. The device can be unlocked to release the device
to its open position by a simple movement, again permitting
one-handed use, if necessary or desired.
[0072] The scope of the invention includes alternative mechanical
configurations which permit rotation of the two opposing members
and a releasable locking or latching of the device into a closed
position.
[0073] In one embodiment, as shown in FIG. 8, each of the opposing
members (4, 6) may have an optional stabilizing pad (22, 24) for
balancing the device about a closed wound. Because of the mass of
the device, it may have a tendency to sway when in position, closed
on a wound. The stabilizing pads (22, 24) prevent or limit that
swaying motion. In one embodiment, the stabilizing pads are
extended along the length of the distal edge, approximately tangent
to the cylinder formed by the closed members and parallel to the
surface of the wound. In one embodiment, each of the opposing
members (4, 6) defines a number of openings (30), which allow the
user to visualize the wound. The openings (30) may also allow
access for medical or surgical instruments while the device is in
use.
[0074] In some embodiments, the wound closure device is adapted as
a low profile wound closure device which provides for additional
flexibility in application, as well as convenience and mobility of
the patient upon application. FIGS. 16-18 illustrate embodiments in
which the wound closure device is adapted as a clip type device. As
shown in FIGS. 16-19 two opposing members (4, 6) are disposed on
opposing sides of a central axis, each resiliently moveable between
a closed position and open position relative to each other, each of
the opposing members having a distal edge. The device further
includes skin penetrating means on the distal edge, such as
needles, for anchoring the device. A pressure bar (18, 20) is also
disposed along each distal edge. A releasable locking means for
maintaining the device in the closed position is also included.
[0075] In one embodiment, the wound closure device is a clip type
device having ratchets for maintaining the device in the closed
position. As shown in FIG. 16, ratchet teeth are disposed on
opposing members (4, 6). As shown in FIG. 20, in operation, a
pivotal force is applied to the central axis to rotate each
pressure bar (18, 20) downward approximately 90.degree. and insert
needles into a patient's skin on opposing sides of a wound. The
pressure bars are then rotated upward causing the ratchet teeth
(60, 62) disposed on each opposing member (4, 6) to engage teeth
(64, 66) disposed on connector members (70, 72). Engagement of the
teeth locks the pressure bars to the closed position thereby
approximating the skin and sealing the wound.
[0076] In another embodiment, the wound closure device is a clip
type device having closure straps for maintaining the device in the
closed position. As shown in FIGS. 17-19, strap members (80, 82)
are disposed on opposing sides of the device. As shown in FIG. 21,
in operation, a pivotal force is applied to the central axis to
rotate each pressure bar (18, 20) downward approximately 90.degree.
and insert needles into a patient's skin on opposing sides of a
wound. The pressure bars are then rotated upward by relaxing the
pivotal pressure. Strap members (80, 82) are then slid along
connecting members (70, 72) toward the center axis to lock the
pressure bars (18, 20) in the closed position thereby approximating
the skin and sealing the wound. The device may further include
teeth (90, 92) disposed on connecting members (70, 72) which engage
strap members (80, 82) to lock the device in the closed
configuration.
[0077] In embodiments, multiple would closure devices may be
applied to close a wound. For example, 2, 3, 4, 5, 6, 7 or greater
wound closure devices may be applied to a wound. In one embodiment,
the devices may be aligned side by side along the length of the
wound. Depending on the type of wound closure devices used in
combination, there may be gaps that are formed between the devices.
As shown in FIG. 22, where clip type devices having external
closure straps are aligned side by side, a gap exists between each
device. As shown in FIG. 22, where clip type devices having
internal closure straps are aligned side by side, there is no gap
between each device.
[0078] In embodiments, the wound closure device may be configured
with an accessory component adapted to directly or indirectly
secure or anchor the device to another medical instrument. The
wound closure device is anchored to the skin via pressure bars and
skin penetrating means. The accessory component allows for rapid
attachment of the accessory to the wound closure device, and takes
advantage of the anchorage of the wound closure device into the
skin to secure or anchor another medical instrument, such as a
tube.
[0079] Attachment of accessory instruments to the wound closure
device allows a variety of additional indications for use of the
device. For example, an accessory port may be used as a means of
inserting a device into a wound for delivery of therapeutics such
as hemostatic agents, infection control agents, agents to reduce
clot lysis and the like. Additionally, an accessory port may be
used as a means inserting a device into a wound to remove material,
such as a vacuum tube/dressing to create negative pressure through
a suction device, or a needle decompression device to remove air
from a chest wound.
[0080] As such, in one aspect, the present disclosure provides a
method for insertion and anchorage of a needle decompression needle
for use with a chest wound to perform needle decompression; e.g.,
to avoid conversion of an open pneumothorax into a tension
pneumothorax.
[0081] In one aspect, the present disclosure provides a method for
insertion and anchorage of a catheter or needle for insertion of
therapeutic agents into a hematoma; e.g., one created following use
of the wound closure device of the invention in the fluid-tight
sealing of an open wound. Such a technique could be necessary with
a vacuum drainage tube to remove fluid accumulation, or similarly
to remove air from a cavity by inserting a needle, just as an
example. This configuration of the device is well-suited to
immediate application at the point of injury. By using the wound
closure device to create a hematoma for open wound control, it
becomes possible to direct other materials and agents to the
hematoma, such as clotting agents to accelerate clotting,
antibiotics to reduce infection, and agents to reduce clot
lysis.
[0082] In one aspect, the present disclosure provides a method to
maintain vacuum pressure on a wound cavity by means of anchoring an
inserted suction tube and suction device to the wound closure
device.
[0083] In one aspect, the present disclosure provides a method for
anchoring the needle/tube for insertion or removal of material
to/from the wound cavity by attachment of the device to the dermis
surrounding the wound by operating the pressure bars of the wound
closure device to secure it to the dermis and keep the device from
slipping when the patient moves or is moved.
[0084] In one aspect, the present disclosure provides a method for
connecting an accessory component to the wound closure device by
means of threaded holes (such as but not limited to luer lock
threading), quick-connect ends, pressure fittings, adaptors, and
the like.
[0085] For example, FIG. 23 shows an accessory component attached
to a wound closure device and securing a tube which enters the
patient near placement of the closure device. The accessory
component (95) includes an articulating arm (100) secured along the
longitudinal axis of the closure device which can be pivoted to any
side of the closure device allowing the accessory component to
operate in multiple geometries. In a further example, FIG. 24 shows
an accessory component (95) securing a catheter to a wound closure
device.
[0086] In a further embodiment, the wound closure device includes
an accessory component as shown in FIG. 25. The accessory component
includes attachment surfaces (110, 112) that are mounted to a wound
closure device. A tube may be entered through grooves (120, 122)
disposed in plates (130, 132) which are pressed together via
springs (134), thereby holding the tube in place and anchoring the
wound closure device to the inserted tube.
[0087] In one embodiment, the wound closure device includes an
accessory component as shown in FIGS. 26 and 27. The accessory
component is shown mounted to a wound closure device. In this
configuration, a tube is secured to the wound closure device
adjacent the wound closure device.
[0088] In one embodiment, the wound closure device includes an
accessory component as shown in FIG. 28. The accessory component is
shown mounted to a wound closure device. In this configuration, a
tube is secured to the wound closure device such that the tube
traverses through a central region of the device, running through
opposing members (18, 20).
[0089] In one embodiment, the wound closure device includes an
accessory component as shown in FIG. 29. The accessory component is
shown mounted to a clip type wound closure device. In this
configuration, a tube is secured to the wound closure device
adjacent the wound closure device.
[0090] In one embodiment, the wound closure device includes an
accessory component as shown in FIG. 30. The accessory component is
shown mounted to a clip type wound closure device. In this
configuration, a medical instrument is secured to the wound closure
device such that the instrument traverses through a central region
of the device.
[0091] As discussed herein, allowing for attachment of accessories
to the wound closure device of the inventions makes the device
capable of use in contexts other than just wound closure. In one
embodiment, the wound closure device includes an accessory
component configured as a port directly disposed in the wound
closure device as shown in FIG. 31. The wound closure device of
FIG. 31, includes a threaded port (120) disposed in an opposing
member of the device, therefore allowing for use of the device to
provide a port system.
[0092] In various embodiments, the wound closure device includes an
accessory component configured as a port which can be used as an
injection port, thereby allowing for methods of wound access to
attach insertion devices to inject hemostatic agent into a wound
site while at the same time approximating wounded skin with
pressure to actively clot blood and staunch blood flow at active
bleeding wound sites to reduce the risk of exsanguination. Such a
device could also be used to insert other materials into the wound,
such as therapeutic agents, and the like.
[0093] In one embodiment, the port is used as an vacuum access
port, which allows for methods of wound access to provide
vacuum-assisted care to collapse an interior wound cavity with
light vacuum while at the same time approximating wounded skin with
pressure to actively reduce the size of the cavity and promote
healing. A vacuum access port created according to the invention
may also be used to remove chest fluid accumulation, or similarly
to remove air from the pleural cavity of the sealed chest by
inserting a vacuum tube and pump.
[0094] In various embodiments the port functions as a quick connect
adaptor, a luer lock, or other port, as a means to fix a wound
access device to the skin. Means for permitting the insertion of
solid valves, needles, trocars or other devices into a wound prior
to closure or after closure of the device is envisioned.
[0095] In more particular embodiments, the wound closure device
further includes one or more accessory components such as: one or
more ports having a threading with a known pitch; means for
attaching the one or more port to a needle or tube for use by an
accessory, an adapter, a thread on the needle, a pressure fitting,
or other attachment mechanism; means for permitting the needle or
tube to be fixed from migrating into or out of the wound by
attachment to the closure device; means for attaching one or more
ports to a syringe or pump for use by an adapter, a thread on the
syringe or pump, a pressure fitting, or other attachment mechanism;
means for permitting the syringe or pump to be fixed from migrating
by attachment to the gripping bar; means for viewing the accessory
placement for accurate placement by at least one visual port.
[0096] In various particular embodiments, the wound closure device
includes pressure bars having various geometries that increase
friction with skin. For example, a pressure bar may have a
non-uniform surface, such as serrations, protrusions or teeth to
improve the grasp on the skin for an air-tight seal which is
required for suction and vacuum applications.
[0097] In one embodiment, wound closure device is secured to and
anchors a drainage tube. As such, in certain aspects the closure
device is suitable for treating tension pneumothorax and for
treating hemothorax.
[0098] In one embodiment, the wound closure device includes a means
for securing a medical component to the closure device via straps
or cable ties. As shown in FIG. 32, the wound closure device may is
configured with slots (140, 142) in the pressure bar (18) allowing
a self-locking cable tie to attach to the closure device. In the
embodiment shown, the cable tie is looped and tightened around a
drainage tube, the cable tie fastens the drainage tube to the
clamp. Due to the self-locking mechanism of the tie, the drainage
tube cannot be pulled free from the clamp. Once the device is
attached to the skin, and the tube is attached to the device, the
tube is fixed to the body and cannot migrate. One skilled in the
art would understand that a variety of medical components may be
secured to the device in this manner in addition to drainage
tubes.
[0099] In one embodiment, the wound closure device is provided as a
kit comprising a wound closure device in a sterile package, which
may be opened with one hand. Therefore, it may be seen that a user
may take the sterile package, open it and remove the device which
is stored in its closed position, open it with one hand, place it
on a wound, and close it, all with one hand and in very little
time.
[0100] The following examples are provided to further illustrate
the advantages and features of the present invention, but are not
intended to limit the scope of the invention. While they are
typical of those that might be used, other procedures,
methodologies, or techniques known to those skilled in the art may
alternatively be used.
EXAMPLE 1
Wound Closure Device With Port
[0101] The wound closure device was constructed having a threaded
port integrated into an opposable member of the device. The
prototype device was used on a sucking chest wound. A catheter was
inserted into the port prior to wound closure by the device. The
catheter was inserted into the wound, followed by closing the skin
to create an air tight seal with the exception of the catheter
itself. With the wound closure device in the closed position, it
approximated a threaded port for needle decompression of a
potential pneumothorax. The catheter was determined to be secure
when subjected to pulling force. The device was determined to be
functional as the only air escaping from the closed sucking chest
wound (air tight seal) was through the catheter of the device. The
catheter remained where it was, did not go further in or further
out.
EXAMPLE 2
Wound Closure Device With Cable Ties
[0102] The wound closure device with cable ties embedded into the
pressure bars of the device was constructed as shown in FIG. 32.
Holes were disposed into the pressure bars through which cable ties
were threaded to attach the cable tie/chest tube to the skin of the
patient. A chest tube with a Heimlich valve was inserted into a
sucking chest wound that caused a pneumothorax. Embedding the wound
closure device into the skin, the cable tie was looped around the
chest tube and tightened. The chest tube was determined to be
anchored into the wound and could not be forced deeper into the
wound, nor pulled out.
[0103] Although the invention has been described with reference to
the above example, it will be understood that modifications and
variations are encompassed within the spirit and scope of the
invention. Accordingly, the invention is limited only by the
following claims.
* * * * *