U.S. patent application number 14/072624 was filed with the patent office on 2014-02-27 for wound shield.
This patent application is currently assigned to Aalnex, Inc.. The applicant listed for this patent is Aalnex, Inc.. Invention is credited to Adel Aali.
Application Number | 20140058308 14/072624 |
Document ID | / |
Family ID | 38174663 |
Filed Date | 2014-02-27 |
United States Patent
Application |
20140058308 |
Kind Code |
A1 |
Aali; Adel |
February 27, 2014 |
WOUND SHIELD
Abstract
A wound shield may include a conformable frame to circumscribe a
wound. Any suitable dressing may be secured over the conformable
frame providing separation between the wound and the dressing. The
wound frame may provide pressure relief around a wound or pressure
sore to permit healing, allow compression for venous ulcers, retain
moisture within the wound environment, absorb exudate, relieve pain
and trauma associated with dressing removal, allow debridement and
application of topical medications and or other compounds or
chemicals, accelerate healing and facilitate monitoring of wounds.
A conformable frame may be composed of one or more layers of any
suitable material and may include adhesive on one or more surfaces
to secure the frame to the wound site, to secure the frame to
itself and or any suitable closure element and or to secure the
dressing to the conformable frame. A wound shield may be used for
humans or any suitable animal.
Inventors: |
Aali; Adel; (Irvine,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aalnex, Inc. |
Irvine |
CA |
US |
|
|
Assignee: |
Aalnex, Inc.
Irvine
CA
|
Family ID: |
38174663 |
Appl. No.: |
14/072624 |
Filed: |
November 5, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11303463 |
Dec 15, 2005 |
8586818 |
|
|
14072624 |
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Current U.S.
Class: |
602/42 |
Current CPC
Class: |
A61F 2013/00536
20130101; A61F 2013/00936 20130101; A61F 13/0206 20130101; A61F
13/02 20130101; A61F 2013/0097 20130101; A61F 13/022 20130101; A61F
2013/0054 20130101; A61F 2013/00272 20130101; A61F 2013/00217
20130101; A61F 2013/00927 20130101; A61F 15/008 20130101; A61F
2013/00948 20130101; A61F 13/0203 20130101; A61F 13/0226 20130101;
A61F 2013/00944 20130101; A61F 2013/0094 20130101 |
Class at
Publication: |
602/42 |
International
Class: |
A61F 13/02 20060101
A61F013/02 |
Claims
1. A shield for protecting and healing a patient's wound
comprising: a conformable frame having a first end and a second end
and one or more internal layers, the first end engaging the second
end to circumscribe the wound; a generally planer dressing to cover
the wound, the dressing securing the conformable frame between the
dressing and the wound; and adhesive securing the dressing to the
patient.
2. A shield for protecting and healing a wound having a generally
planar surface comprising: a conformable frame having a first end
and a second end and one or more internal, layers, the conformable
frame superficially circumscribing the wound; a moisture retaining
lid engaging the conformable frame to enclose a space about the
wound; first adhesive layer securing the conformable frame around
the wound; second adhesive layer securing the lid to the
conformable frame; and one or more access ports through the
conformable frame for insertion and removal of material from the
enclosed space.
3. The shield of claim 2 wherein the conformable frame further
comprises: an absorbent layer for absorbing wound exudates.
4. The shield of claim 2 wherein the conformable frame further
comprises: one or more layers oriented perpendicular to the wound
surface.
5. The shield of claim 2 wherein the conformable frame further
comprises: one or more layers oriented parallel to the wound
surface.
6. The shield of claim 2 wherein the conformable frame further
comprises: one or more absorbent extremities extending into the
enclosed space.
7. The shield of claim 5 where the one of more absorbent
extremities are cotton.
8. The shield of claim 6 where the one or more absorbent
extremities are formed integral to the conformable frame.
9. A method of shielding a wound on a patient comprising the steps:
separating a portion of conformable frame to form a first end and a
second end, the conformable frame having a cutaneous side and a
superficial side; engaging the first end to the second end to
circumscribe the wound; adhesively engaging the cutaneous side of
the conformable frame to the patient to circumscribe the wound;
separating a dressing from a scored sheet of dressings; and
adhesively engaging the separated dressing to the superficial side
of the conformable frame.
10. The method of claim 9 wherein the separating step further
comprises: separating a portion of conformable frame to form a
first end and a second end, the conformable frame having a
cutaneous side opposite a Superficial side, and an interior side
opposite an exterior side, the first end forming an acute angle
with exterior side.
11. The method of claim 9 wherein the separating step further
comprises: separating a portion of conformable frame to form a
first end and a second end, the conformable frame having a
cutaneous side opposite a superficial side, and an interior side
opposite an exterior side, the first end and the second end forming
an complementary angles with respect to the exterior side.
Description
FIELD OF THE INVENTIONS
[0001] The inventions described below relate to the field of wound
care management.
BACKGROUND OF THE INVENTIONS
[0002] Wounds occur when the integrity of any tissue is
compromised, affecting one or more layers of skin or underlying
tissue. Wounds may be caused by an act, surgical procedure, an
infectious disease or an underlying condition. Examples of open
wounds include punctures, abrasions, cuts, lacerations and burns.
Chronic wounds are also common ailments and include pressure
ulcers, diabetic ulcers, arterial ulcers, venous ulcers or
combination of all the above. Despite much progress made in the
wound care industry, an efficient and effective method and
apparatus for protecting the wound from injurious contacts is not
readily available.
[0003] Injurious contacts with foreign objects may be caused from
various sources, ranging from brushing of clothing or bed sheets to
fresh, uncovered wounds to adherence of wound dressing to the
wound. The latter issue, referred to here as the sticking issue,
leads to deleterious consequences for the patient. This problem is
particularly exacerbated when wounds are left unattended for a
substantial period. It is reported that in certain circumstances
patients are administered morphine to withstand the pain caused
form dressing removal, especially with wounds having a large
surface area. Equally important, tearing of skin graft, newly
formed cells or scab adhered to dressing disrupts the healing
process.
[0004] Wounds are generally covered to prevent contamination and
resulting infection. Wounds may also be covered for other reasons,
including retaining moisture and absorption of exudate. Wound
covering has traditionally consisted of application of dressings
that are in direct contact with the wound. When directly applied on
the wound, dressings adhere and mechanically anchor to wound
surface, which may include diffused wound fluid, skin graft, new
epidermal cells forming over the wound or the scabby covering of
the wound.
[0005] The sticking issue has traditionally been addressed by
soaking the wound and the dressing adhering to it in water for some
time to soften the scab and make removal easier. Another method is
the application of antibiotic ointments, such as polymyxin B
sulfate or bacitracin, to keep the bandage from sticking to the
wound. These methods, however, have not sufficiently addressed the
sticking issue. As can be appreciated by health care professionals,
soaking in water or application of ointments are not always
practicable or recommended.
[0006] To better address the sticking issue the medical industry
has developed "non-stick" dressings such as Telfa.RTM. and
Xeroform.RTM. and other dressings such as hydrocolloids, alginates,
hydrofilms, etc. Non-stick, however, is a relative term. Non-stick
dressings merely stick less than their traditional counterparts,
e.g., cotton gauze. Another problem with these dressings is that
their cost is prohibitive for use on wounds requiring constant
change of dressing.
[0007] "Non-contact" dressings have also been invented to address
the sticking issue. These dressings are primarily designed in the
shape of an inverted cup or a raised bandage. The general idea is
that the space within the cup or raised bandage covers the wound,
but does not come in contact with it.
[0008] Similar to the traditional and "non-stick" dressings
described above, "non-contact" dressings also fail to efficiently
and effectively protect the wound from contact, including
addressing the sticking issue. First, they cannot be sufficiently
deformed for the specific contours of different wounds, such as a
narrow, long laceration. Second, they are designed in specific
sizes that are not necessarily the desirable size for the
wound.
[0009] Aside from their size limitation and lack of deformability,
the prior art "non-contact" dressings have other drawbacks. Their
complicated design makes their costs a prohibitive factor and
application difficult. Moreover, whether several dressing sizes
bundled together, or more than one dressing is in use, the prior
art non-contact dressings are unable to address wounds on body
segments with small surface areas. For example, using a large
square, oval or circular bandage to cover a large, narrow and oddly
shaped laceration on the forearm or shin is impractical. The same
is true for the face and neck regions. Similarly, due to their
specific shape and size, the non-contact dressings of prior art are
not able to address wounds located in joints, such as elbows or
knees.
[0010] What is needed is a method and apparatus for dressing wounds
or other suitable injuries that is conformable, adjustable and
flexible to prevent contact with the surface of the wound and
improve the environment immediately adjacent the wound.
SUMMARY
[0011] A wound shield may include a conformable frame to
circumscribe a wound. Any suitable dressing may be secured over the
conformable frame, the conformable frame providing separation
between the wound and the dressing. The wound frame may provide
pressure relief around a wound or pressure sore to permit healing,
allow compression for venous ulcers, retain moisture within the
wound environment, absorb exudate, relieve pain and trauma
associated with dressing removal, allow debridement and application
of topical medications and or other compounds or chemicals,
accelerate healing and facilitate monitoring of wounds. A
conformable frame may be composed of one or more layers of any
suitable material and may include adhesive on one or more surfaces
to secure the frame to the wound site, to secure the frame to
itself and or any suitable closure element and or to secure the
dressing to the conformable frame. A wound shield may be used for
humans or any suitable animal.
[0012] A wound shield according to the present disclosure may be a
simple, versatile, inexpensive and readily applicable apparatus and
method for wound protection. It may include a conformable
wound-protecting frame that may conform to the specific contour and
size of any wound and may be used with any suitable dressing. A
wound shield prevents foreign objects such as clothing, dressings
and other such items from contacting the wound. Cotton gauze or
other suitable dressing may be placed on or engage a wound
protecting frame to completely protect the wound from harmful
contact with any object. Alternatively, special covers, seals, and
or lids may be placed on the wound shield to control moisture,
simplify wound monitoring and debridement and application of
medications.
[0013] A wound shield according to the present disclosure may
adhere to skin surrounding a wound via adhesive applied to a
surface of the wound-protecting frame to engage the skin. Medical
grade, hypoallergenic adhesives are preferred, although any
suitable adhesive may be used such as rubber-based, acrylic, vinyl
ether and suitable pressure-sensitive adhesives. For their obvious
advantages, adhesives that adhere to body hair less than their
conventional counterparts are preferred. Adhesives may also be
added to one or more surfaces of a wound-protecting frame not in
contact with skin to engage any suitable dressing, cover, lid or
any other suitable closure. Alternatively, no adhesive is used with
the wound shield, and the wound shield is retained in place by the
pressure applied from the dressing wrapped around the wound.
[0014] A conformable wound shield frame may be provided in any
suitable dispenser configuration. For example, the conformable,
frame may be wound around a reel and placed in a dispenser that can
be efficiently stored. When needed, the conformable frame may be
fed out of the dispenser, and cut to desired lengths.
Alternatively, the wound-protecting frame may be supplied in a
sheet form and cut to the desired length and width. Moreover, the
conformable frame may be prepackaged in several long strips with
various or equal widths that may be cut to desirable lengths
[0015] In use, a conformable frame is placed around a wound,
creating a boundary and providing a plane separate from the plane
of the wound to support the dressing. The conformable frame may be
used with any suitable closure to engage the ends of the
conformable frame and encircle a wound.
[0016] A wound shield according to the present disclosure may be
fully deformable to conform to specific contours of any wound
located on any surface of a body. It may be cut to a desirable
length to enclose all or any portion of the perimeter of any wound,
regardless of shape and size. In addition, the conformable frame
may be made of inexpensive and yet effective material.
[0017] Any suitable dressing may be used in conjunction with the
conformable frame, and may range from inexpensive, commonly used
cotton gauze to more costly and sophisticated dressings, including
for example, those constructed from transparent and or
multi-layered material with qualities such as exudate absorption,
bacteria impermeability and controlled air and or moisture
permeability. Health care professionals may mix and match various
dressings without restriction to complex and/or costly non-contact
dressings.
[0018] A wound shield according to the present disclosure has
sufficient rigidity to prevent injurious contacts to the wound,
including those caused by dressing adhering to the wound surface.
The conformable frame prevents contact to wounds regardless of
their size or location with any suitable dressing.
[0019] A wound shield according to the present disclosure may be
used for swift and effective wound debridement using any suitable
technique. For example, a wound shield may be used to create a
controlled space adjacent a wound for biological debridement, use
of maggots or other suitable techniques. Alternatively, mechanical
and or chemical debridement may also be effected within the
controlled space. Surgical debridement may also be performed
without removing the conformable frame from around the wound. The
wound shield minimizes wound and peri-wound disturbance by avoiding
repetitive dressing removals with the associated wound surface
disturbance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is a perspective view of a conformable frame
according to the present disclosure.
[0021] FIG. 2 is a cross section of the conformable frame of FIG. 1
taken along AA.
[0022] FIG. 3 is an alternate cross section of the conformable
frame of FIG. 1.
[0023] FIG. 4 is another alternate cross section of the conformable
frame of FIG. 1.
[0024] FIG. 5 is a still alternate cross section of the conformable
frame of FIG. 1.
[0025] FIG. 6 is a perspective view of an alternate conformable
frame according to the present disclosure.
[0026] FIG. 7 is a top view of a conformable frame similar to FIG.
6 illustrating alternative configurations.
[0027] FIG. 8 is a perspective view of a conformable frame
surrounding a small wound on the forearm.
[0028] FIG. 9 is a cross section of the conformable frame and
dressing on the wound of FIG. 8.
[0029] FIG. 10 is a perspective view of a conformable frame
surrounding a long, oddly shaped laceration on the forearm.
[0030] FIG. 11 is a perspective view of a conformable wound frame
surrounding two proximately located wounds on the forearm.
[0031] FIG. 12 is a perspective view of an alternate configuration
of a conformable wound frame surrounding two proximately located
wounds on the forearm.
[0032] FIG. 13 is a perspective view of a support or bridge member
according to the present disclosure.
[0033] FIG. 14 is a side view of an alternate support or bridge
member according to the present disclosure.
[0034] FIG. 15 is a perspective view of a conformable wound frame
surrounding two proximately located wounds on the forearm.
[0035] FIG. 16 is a perspective view of a connector used in
conjunction with a conformable member.
[0036] FIG. 17 is a perspective view of a dispenser according to
the present disclosure.
[0037] FIGS. 17A and 17B are top views of conformable frame joints
formed using the dispenser of FIG. 17.
[0038] FIG. 18 s a perspective view of an alternate deformable
wound frame according to the present disclosure.
[0039] FIG. 19 is a cross section of the conformable frame of FIG.
18 taken along C-C.
[0040] FIG. 19A is a cross section of the conformable frame of FIG.
18 taken along C-C with an alternate scaffold.
[0041] FIG. 20 is an alternate cross section of the conformable
frame of FIG. 18.
[0042] FIG. 21 is another alternate cross section of the
conformable frame of FIG. 18.
[0043] FIG. 22 is yet another alternate cross-section of the
conformable frame of FIG. 18.
[0044] FIG. 23 is an alternate cross section of the conformable
frame of FIG. 18 with a wicking element.
[0045] FIG. 24 is another alternate cross section of the
conformable frame of FIG. 23.
[0046] FIG. 25 is a perspective view of an alternate conformable
frame according to the present disclosure.
[0047] FIG. 26 is a cross section of an alternate conformable frame
and lid configuration.
[0048] FIG. 27 is a cross section of another alternate conformable
frame and lid configuration.
[0049] FIG. 28 is a cross section of a conformable frame with a
vacuum lid configuration.
DETAILED DESCRIPTION OF THE INVENTIONS
[0050] Referring to FIG. 1 and FIG. 2, conformable frame 10
provides perimeter protection for a wound and may conform to
specific contours of the wound site. Conformable frame 10 includes
exterior side 14 facing away from the wound and interior side 16
facing the wound, superficial surface 12 for engaging dressings and
cutaneous surface 18 in contact with the patient's skin, or any
other dressing or apparatus in contact with the patient's skin. Any
suitable adhesive may be applied to cutaneous surface 18 and or
superficial surface 12 such as adhesive 28 and 22 respectively.
Adhesive layers 22 and 28 may also be covered by a strip or a film,
such as film 24 and 26 respectively, that can be peeled off at the
time of use. Adhesive 28 secures conformable frame 10 to skin
surrounding a wound, or in some applications, to a dressing or
apparatus that is in contact with the patient's skin. When applied
to superficial surface 12, adhesive layer 22 may engage a dressing
or other suitable cover, to conformable frame 10.
[0051] In use, conformable frame 10 includes a first end 13 and a
second end 15. When positioned around a wound, first end 13 and
second end 15 may be engaged to completely circumscribe the wound
as shown in FIG. 8. An adhesive or other suitable material may be
applied to first end 13 and or second end 15 to secure the
engagement of first end 13 and second end 15. Conformable frame 10
may have any suitable cross-section as shown in FIG. 2 including
height 30 and width 32. The size of a wound site to be
circumscribed may require height 30 and width 32 to be available in
different dimensions. Larger wounds may have a dressing sag and
inadvertently contact the wound. First end 13 and or second end 15
may be cut, preshaped or scored such that first end 13 and or
second end 15 are not perpendicular to the interior and exterior
surfaces, or the superficial and cutaneous surfaces. The angle
between the end surface and the side of the conformable frame may
be selected to optimize the curvature of the conformable frame, or
to increase the mating surface areas of the ends.
[0052] Conformable frame 10 may be constructed from any suitable
material capable of deformation in the X and or Y and or Z-axes.
Silicone is one example of such material, as it is both rigid and
deformable. Polymers such as polypropylene, polyethylene and
polyurethane may also be used to form a deformable, and yet rigid
wound protector. Depending on its specific use, additional features
of a wound shield may include impermeability or controlled
permeability to water, bacteria and air, and absorption of fluids
exuding from the wound bed. A wound shield according to the present
disclosure may also include a selectable moisture vapor
transmission rate (MVTR).
[0053] Polyurethane foam may be used to form a wound-protecting
frame for its ability to absorb exudates.
[0054] Referring now to FIGS. 3-5, alternative cross sections may
be used. Any suitable cross section may be used.
[0055] Referring now to FIG. 6, alternatively, a conformable frame
such as conformable frame 34 may also include a plurality of
grooves, cuts or slots such as grooves 36, positioned in either the
wound or exterior side such as exterior side 38. Grooves 36 may
increase flexibility of conformable frame 34 when constructed of
material that may not have sufficient inherent flexibility to allow
appropriate conformability. Grooves 36 may be cut or otherwise
formed in conformable frame 34 using any suitable technique.
[0056] Referring now to FIG. 7, alternate configurations of grooves
36 are illustrated for example. Any suitable geometry may be used
for grooves 36. Grooves or slots or cuts such as cuts 42 may also
be combined in exterior side 38 as well as wound side 40 for
increased flexibility.
[0057] Referring now to FIG. 8 and FIG. 9, conformable frame 46 may
be superficially applied to any injured surface of a patient such
as forearm 44 using adhesive 58. Conformable frame 46 circumscribes
wound 48. First end 13 and second end 15 engage at plane 50. When
dressing 52 is used to promote healing of wound 48, conformable
frame 46 prevents dressing 52 from contacting wound 48 by creating
a separation 56 between dressing 52 and wound plane or skin surface
54. Separation 56 is controlled by height 30 of the conformable
frame.
[0058] As briefly described above, dressing 52 may be any suitable
dressing. Dressing 52 may also include adhesive along its perimeter
or longitudinal and/or its transverse lengths, so to facilitate its
adherence to skin surrounding conformable frame 46. Alternatively,
dressing 52 may be wrapped around the arm or other body parts on
which wound 48 is situated, or dressing 52 may be sized or cut to
size to engage only conformable frame 46. Dressings such as
dressing 52 may have any suitable MVTR parameters.
[0059] Referring now to FIG. 10, dressing 60 may be used to secure
conformable frame 66 around wound 64, which is a long, narrow,
oddly shaped laceration. Adhesive may be included around perimeter
62 of dressing 60. One or more dressing such as dressing 60 may be
used. Dressing 60 may be applied along the length, width, or in
tandem with another dressing 60 or other dressings to protect wound
64.
[0060] Referring now to FIG. 11, conformable frame 70 may be used
to protect one or more proximately located wounds such as wounds 72
and 74 on forearm 76. Dressing 78 may be separated from scored
dressing sheet 75 which may have one or more dressings scored into
sheet 75. Dressings such as dressing 52 or dressing 78 may be
separated from sheet 75 along scoring 52A or 78A respectively. Any
size or number of dressings may be pre-scored into a dressing sheet
such as sheet 75.
[0061] In an alternate configuration shown in FIG. 12 the
connection of first end 13 and second end 15 is transected by
conformable frame 10. The use of a figure-8 shape provides dressing
and pressure support between wounds 72 and 74. To prevent exudate
from flowing away from wounds 72 and 74 first end 13 and second end
15 may contact or otherwise engage side 14 and side 16
respectively.
[0062] A conformable frame according to the present disclosure may
not always completely circumscribe a wound. For wounds positioned
in awkward body locations, such as the elbow and knee or for any
other reason, a conformable frame may be cut into two or more
suitable lengths or frame elements. The frame elements may be
positioned around the wound as discussed above. Such manipulation
may allow positioning of a dressing without contacting the
wound.
[0063] In certain circumstances health care professionals may
recommend the airing of the wound, i.e., not covering the wound
with any dressings. As such, a conformable frame according to the
present disclosure may be used to simply protect the wound from
physical contact with other foreign objects, such as clothing or
bed sheets. This configuration may also be suitable for treatment
of pressure or abrasion sores from long term immobility.
Conformable frame may be used to surround such sores and relieve
the local pressure and permit the sores to heal.
[0064] For patients allergic to medically approved adhesives, the
conformable frame may be provided without adhesive or,
alternatively, with adhesive only on surface 12. In such
circumstances, conformable frame 10 must be secured to the wound
site with sufficient and appropriate pressure to engage conformable
frame 10 with the wound site.
[0065] For wound configurations such as illustrated in FIG. 11,
particularly large wounds, structurally weak dressings or high
pressure wound or sore sites it may be necessary to provide
additional support within the perimeter of a conformable frame to
support the selected dressing or relieve external pressure.
[0066] Referring now to FIG. 13, one or more bridge members such as
bridge member 80 may be used with the conformable frame of the
present disclosure to provide additional wound protection. A bridge
member may be used with wounds having large surface area or with
dressings having little structural strength, or in situations where
pressure may be applied to the center of the wound area.
Positioning of one or more bridge members such as bridge 82 on
conformable frame 70, as depicted in FIG. 15, may prevent dressing
78 from sinking and touching wounds 72 or 74.
[0067] A bridge member can have any suitable shape including
straight or curved edges, ends or separations. A bridge may also be
constructed from inexpensive medical grade rigid plastic polymers,
metal or wood particularly conditioned for medical use. Such
material may be structurally adapted to allow breakage or
separation along segment lines such as lines 86 and 88.
[0068] Medical grade adhesive may also be applied to second surface
90 which will come in contact with the conformable frame. A thin
layer of film or strip removable at time of use may cover the
adhesive as discussed above with respect to the conformable frame.
Alternatively, bridge member 80 may have adhesive on both second
side 90 and first side 92 to adhere not only to the conformable
frame, but also to the dressing.
[0069] Referring now to FIG. 14, alternate bridge member 84
includes a plurality of slots 94. Each slot or opening such as slot
94 may have any suitable shape and dimension providing that width
96 is sized to permit engagement of a suitable conformable frame in
the slot.
[0070] Referring now to FIG. 16, a connector such as connector 102
may be used to join ends 104 and 106 of conformable frame 108 and
provide complete closure around a wound such as wound 100. Any
suitable connector such as connector 102 may be used in
circumstances where it is desirable not to apply any adhesive to
surfaces of conformable frame 108, or where repetitive engagement
and disengagement of first and second ends 104 and 106 make
adhesive impractical. Lack of adhesive provides the opportunity for
first end 104 and second end 106 to move away from one another and
create an opening 110. As can be appreciated, exudate from wound
100, if any, may diffuse away from wound 100 through opening 110
and onto other body surfaces.
[0071] Connector 102 may be used to close opening 110 by indirectly
connecting first end 104 and second end 106. Connector member 102
may be hollow, and may be constructed from any suitable material,
including those used for construction of conformable frames.
Engagement receptacles 104A and 106A may be slightly larger than
the dimensions of first end 104 and second end 106 respectively.
This permits conformable frame 108 to be inserted into connector
member 102. Receptacles 104A and 106A should provide secure
engagement to first end 104 and second end 106 respectively. Any
other suitable configuration may also be used. Connectors such as
connector 102 may also be used to connect two or more conformable
frames.
[0072] Referring now to FIG. 17, conformable frames such as
conformable frame 10, conformable frame 34 and others may be stored
and dispensed from any suitable dispenser. For example, dispenser
120 may contain one or more coils such as coil 122 wound around a
reel or hub 124. Segment 126 may be a portion of conformable frame
from coil 122 that is withdrawn through outlet 128. Segment 126 may
be pulled out from outlet 128 and cut to a desired length with
scissors, or via one or more blades 130 positioned adjacent outlet
128.
[0073] Alternatively, a dispenser may be sterilized, and or may
have several outlets allowing it to contain several coils
containing conformable frames having different dimensions and or
characteristics. The number of coils or outlets contained in a
dispenser are examples provided for discussion purposes only and
should not be viewed as a limitation.
[0074] Referring now to FIG. 17A, conformable frame segment 126 is
separated from dispenser 120 forming first end 112 and second end
114. During separation of segment 126 first end 112 and second end
114 were cut, scored or otherwise separated to form angle 116 with
exterior side 118. Decreasing angle 116 increases the surface of
the first and second end enabling greater engagement. A first end
and second end may be cut to similar angled, complementary angles
or different angles. Alternatively, first end 112 and second end
114 may be precut or otherwise prepared in standard lengths with
assorted end profiles.
[0075] Referring now to FIG. 17B, first end 132 and second end 134
may be cut at a different angles 136 to simplify joining the first
and second ends and form curves or shapes having small radii.
[0076] In use, a second conformable frame may be positioned on the
superficial surface of a first conformable frame. This
configuration may be used in situations where a greater protective
height around a wound is preferable. A stacked assembly may include
more than two conformable frames.
[0077] Referring now to FIG. 18, conformable frame 140 may have
many different cross sectional dimensions as well as constituent
configurations. Conformable frames as discussed above may adopt any
suitable geometry. For some applications it may be useful for a
conformable frame to be composed of two or more internal layers
such as layers 150 and 152 illustrated in FIG. 19. For example,
layer 150 may be absorbent, or may include any suitable antibiotic
such as for example silver metal and or its salts. Layer 152 may be
made from any suitable material.
[0078] In some situations it may be preferable to change one or
more layers closest to a wound when the layer or layers become
saturated or otherwise unsuitable to remain close to the wound.
Layer 150 may also be removable to permit changing one or more
layers. A scaffold or other suitable apparatus such as scaffold 138
may be secured to exterior layer 152. Internal layer 150 may be
secured or otherwise engaged to either or both layer 152 and
scaffold 138.
[0079] Alternatively, internal layer 150 may be positioned using
scaffold 138. Securing layer 150 to layer 152 and scaffold 138
using water soluble adhesive would simplify removal of layer 150
and may also serve to identify a saturated layer as it separates
from the structural layer and the scaffold. If layer 150 needed to
be changed, any dressing or lid applied over conformable frame 140
may be disengaged. Layer 150 may be removed and a replacement layer
may be inserted using scaffold 138 as a guide and engagement
mechanism.
[0080] Referring now to FIG. 19A, an alternate scaffold 139 may
include lip 141 to frictionally engage layer 150 without the use of
adhesive or other bonding agent. Scaffold 138 and or scaffold 139
may also include holes or other suitable openings such as holes 135
and 143 and openings 145 in shelf 133 and or lip 141 as illustrated
in the associated close-up bottom views. Lip 141 may also permit
usage and of any suitable absorbent material in a non-contact
position relative to the wound. The absorbent material may be
frictionally engaged by lip 141 and supported by scaffold 139.
[0081] Some materials may have directional characteristics, and
when combined in multiple layers may offer unique benefits. Many
additional characteristics may also be useful, for example, layer
156 of FIG. 20 may be absorbent to absorb and retain exudate from
the wound, and layer 154 may be formed of a material providing
dimensional stability or structural integrity.
[0082] Similarly, referring to FIG. 22, layer 164 may be absorbent
and layer 166 may provide structural integrity and layer 166 may
enclose layer 164 to prevent exudates from wound side 144
transiting conformable frame 140 and exiting through exterior side
146. Any suitable material may be selected for each layer. Layer
168 may be any suitable material.
[0083] Referring now to FIG. 21, layers 158, 160 and 162 may also
provide one or more diagnostic indicators such as for example, ph
level, temperature, moisture level, O.sup.2 levels or any other
suitable parameter. The state of the parameter may be indicated by
one or more color states of one or more layers.
[0084] Referring now to FIG. 23, conformable frame 170 may include
one or more internal layers such as layers 172, 174 and 176 and one
or more absorbent appendages such as arm 178. Arm 178 and layer 176
may be composed of any suitable material for absorbing exudates
from wound 180. The physical geometry of arm 178 may vary for
varying applications. For example, arm 184, shown in FIG. 24
provides vertical relief from wound 180.
[0085] Alternatively as illustrated in FIG. 25, flexible absorbent
appendages may also be secured to a conformable frame such as
conformable frame 192. Absorbent appendages 194 may be provided to
absorb exudate from wound 180. Any suitable material or combination
of materials may be used as appendages 194 such as for example
natural fibers such as cotton or any suitable man-made fiber. Any
other suitable configuration may also be employed such as enclosing
one or more cotton balls or gauze within the space enclosed by a
conformable frame and a covering dressing.
[0086] Referring now to FIG. 26, conformable frame 200 may also be
used with a cover or lid 202 to provide a controlled environment in
enclosed space 204 adjacent a wound site. Lid 202 may be removably
engaged to conformable frame 200 using any suitable technique. Such
as frictional or adhesive engagement. Lid 202 may be formed of any
suitable material or combination of materials such as a structural
grid layer with one or more laminate layers to obtain suitable
performance and moisture transmission/retention.
[0087] Alternatively, lid 202 may also include one or more
absorptive elements such as cone 206 for removing moisture or
exudate from wounds such as wound 210. Absorptive elements may have
any suitable shape or dimension and may be formed of any suitable
material. For example, cone 206 may be formed of material that is
selectively absorbent to remove exudate and unwanted fluids.
[0088] Enclosed space 204 may be further controlled as illustrated
in FIG. 27. Conformable frame 212 may include one or more access
ports such as inlet port 214 and outlet port 216. Use of access
ports permits irrigation, treatment, and or debridement of wound
210 without removing wound protection shield 218. Fluid or other
material may be introduced into enclosed space 204 through inlet
port 214. In the case of used fluid or exudate, removal may be
accomplished using outlet port 216. Access ports such as inlet port
214 and outlet port 216 may be reclosable to secure enclosed space
204. Alternatively, conformable frame 212 may be formed of material
that permits a Syringe to be inserted through the conformable frame
for insertion of material or to remove material. Access ports may
also be formed in the cover or lid 202.
[0089] Referring now to FIG. 28 enclosed vacuum space 211 may be
created and maintained by the use of a suitable cover or lid such
as vacuum lid 205. A partial or complete vacuum may be created in
space 211 by vacuum device 209 through adapter 207 or through a
conformable frame such as conformable frame 212 using inlet port
214 or outlet port 216. Using a conformable frame and specifically
adapted lid such as lid 205 may permit a vacuum device such as
vacuum device 209 to be located on lid 205 without creating
unsatisfactory pressure on or adjacent wound 210. Lid 205 may
require an adapter such as adapter 207 or lid 205 may be
specifically formed to adapt to a vacuum device or connector to a
vacuum device to create a full or partial vacuum within space
211.
[0090] Thus, while the preferred embodiments of the devices and
methods have been described in reference to the environment in
which they were developed, they are merely illustrative of the
principles of the inventions. Other embodiments and configurations
may be devised without departing from the spirit of the inventions
and the scope of the appended claims.
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