The present invention is in the field of wound covering devices having particular physical surface layer features and which contain compositions designed to promote healing of the wound.
Wound covering devices are known in the art. However, there still exists the need for wound dressings that promote wound healing, allow fluid containment and absorption of wound secretions. The present invention meets this need.
The present invention relates to wound dressings having a wound contacting layer that contains a wound healing composition and which is adapted to maintain a temperature different from ambient, for example achieve and maintain a heat-absorbing effect on the underlying tissues. The specific physico-chemical structure of the devices of the invention allows fluid containment and absorption of wound secretions whilst avoiding skin macerations.
In one aspect, the present invention thus relates to a cold adapted wound dressing device designed to promote healing of a wound to which it is applied, the dressing device comprising:
wherein the heat absorbing layer is adaptable to remove heat from the wound contacting layer and to reduce a temperature of the wound contacting surface to below an ambient temperature.
In another aspect, the present invention is directed to a method for promoting healing of a wound comprising applying the wound dressing device of the invention to the wound.
The present invention is a cold adapted wound dressing device, which has cooling and liquid absorption capabilities, and is useful in sterile and non-sterile environments for dressing wounds and other injuries. The present invention is not a bandage in the broad usage, because it is adapted to be sterilizable and to be in direct contact with a dermal/transdermal wound or surgical incision on the body. The cooling ability of the device is intended to temporarily lower the temperature of the body at the site of application, and to provide the attendant benefits of such a local temperature reduction.
In a preferred embodiment, a heat-sink made of hydrated absorbent polymers is contained in a portion of the device. Preferably, the hydrated polymers are of a type known as: super-absorbent polymers (SAPs) in the form of a hydrogel. See for examples: U.S. Pat. No. 4,668,564 to Orchard, and U.S. Pat. No. 5,750,585 to Park et al. Super-Absorbent Polymers typically are cross-linked copolymers of acrylic acid and sodium acrylate (
For this material to obtain “super-absorbent” properties, requires cross-linking the copolymer chains with a cross-linking agent, such as a bifunctional molecule. The bifunctional molecule must be able to react with the free carboxylic groups. After cross-linking, the polymer chains are attached to one another (
Exemplary cross-linking agents comprise, but are not limited to polyhydroxy compounds, diepoxy compounds, isocyanates, ethyleneglycoldimethacrylate (EGDM), and N,N-methylenebisacrylamide (BIS).
In the dry state the matrix network of the super-absorbent material is folded/compressed on itself. The matrix is highly hydrophilic and expands upon hydration when it comes into contact with water (
The performance of SAPs is characterized by its physical parameters: cross-linking, particle size distribution, morphology, etc., and also by the fluid they are hydrated with and/or subsequently come into contact with. The influence of ions and the pH on the absorption properties is exemplarily shown in
Most SAPs are synthesized by a polymerization (gel) process, in which the monomers are polymerized in solution. This results in the formation of a polymer block, which is sieved to obtain the desired particle size. SAPs resulting from this process have an irregular (chip-like) morphology (
However, it is possible to obtain SAPs having a more uniform morphology. This is accomplished using an inverse suspension process, in which monomer droplets are suspended in a media stabilized by a surfactant. Polymerization takes place in each droplet, and can lead to two different morphologies, agglomerated beads (
Table I shows desirable characteristics of SAPs for practice in the present invention.
As further examples, the following SAPs are can be practiced in the present invention: Aquakeep® and Norsocryl® which are SAPs that are able to absorb more than several hundred times their weight of pure water in a few seconds. (Arkema, Colombes Cedex, France: www.arkema.com). After swelling, the SAP liquid becomes a gel. Generally, SAPS are practicable for the absorption and retention of non viscous fluids, and used in such disposable products such as baby diapers, training pants, adult incontinence products and sanitary napkins. These SAPs typically are cross-linked copolymers of acrylic acid and sodium acrylate.
When hydrated with NaCl 0.9% or demineralised/sterile water in a proportion not exceeding about 20% of the total absorption capacity of the above SAPs (free absorption g/g—Edana recommended test method), the heat sink can be appropriately cooled or frozen. Chilling of the hydrated super-absorbent hydrogel prior to application of the present dressing to a wound site provides the heat sink (heat absorbing) feature of the dressing.
Referring now to the drawings, the details of preferred embodiments of the present invention are graphically and schematically illustrated. Like elements in the drawings are represented by like numbers, and any similar elements are represented by like numbers with a different lower case letter suffix.
As illustrated in
The wound covering portion 12 of the present cold adapted wound dressing device 10 has a wound contacting layer 16 configured as a porous matrix 30 that allows aqueous fluids to freely diffuse into and through the matrix 30. The matrix 30 in this embodiment is comprised of a fibrous material 32. However, materials other than fibrous may be used if they are adapted to maintain the structural integrity appropriate for a wound dressing. The porous matrix 30 has fluid absorbing properties and can absorb body-fluids and/or wound exudate. Fibrous SAPs having appropriate fluid absorption properties are known in the art and are selectable by the ordinary skilled artisan for practice in the present invention. Examples of cross-linked SAP's supports practicable in the matrix are: cellulose, wood pulp, alginates, etc. The wound-contacting layer and the dressing cover top layer can comprise polypropylene, polyethylene, polyester or any other bio-compatible synthetic layer as are known in the art.
The wound contacting layer 16 of the wound covering 12 has a wound contacting surface 20, which is intended to contact the wound at the wound site. In the embodiment exemplified in
In another embodiment, the material of the wound contacting layer can be collagen, poly(L-lactide) (polylactic acid; PLLA), and/or poly(glycolic-co-lactic acid) (PGLA) which are impregnated with the above mentioned compositions.
As also illustrated in the figures, the present cold adapted wound dressing device 10 has a wound contacting layer 16 that is a porous matrix 30 comprised of a fibrous material 32, which fibrous material 32 is impregnated with a wound treatment material 40. The wound treatment material 40 is a bio-affecting composition having wound healing efficacy, and can be composed of one or more active constituents 46. In the embodiment illustrated, a natural Hyaluronic Acid composition 46a is an active constituent of the wound treatment material 40. The natural Hyaluronic Acid composition can be contained in the matrix material 30 in the form of a gel, a cream, natural Hyaluronic Acid fibers 46a or a combination of any of these. Other active constituents 46b can be contained in the matrix material 30 as well, such as those noted above.
As illustrated in
In the preferred embodiment illustrated, the heat absorbing layer 50 of the cold adapted wound dressing device 10 comprised a hydrated “super absorbent polymer” (SAP) 70. SAPs 70 are known in the field. Examples include those disclosed in U.S. Pat. No. 5,750,585 to Parl et al. and U.S. Pat. No. 6,800,278 to Perrault et al. Choice of the SAP 70 to be practiced and it relative bio-compatibility will influence whether an embodiment wherein the heat absorbing layer 50 is in flow communication with the wound contacting layer 16 can be practiced.
To make the present cold adapted wound dressing device 10 a self contained unit, a bandage covering 74 can be added to the top surface 72 of the heat sink layer 50. See
Also, as exemplified in
The inventive wound dressings can be used in methods for promoting the healing of a wound in a patient, for example a mammal, such as a human being, said methods comprising applying the wound dressings of the invention to said wound.
The invention is further illustrated by the following non limiting examples and the appended figures. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, other compositions of matter, means, uses, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding exemplary embodiments described herein may likewise be utilized according to the present invention.
Adequate amounts of matrix material, like cellulose fibers, thermoplastic fibers and SAP powder with a total weight of 50-500 g/m2 were given into a powder mixer along with a defined quantity of dry medical grade sodium hyaluronate granules (for example a quantity to obtain a HA concentration of 0.1% w/w) and mixed for one hour at 120 rpm. Thereafter the resulting mixture was compressed by a calendar press at 55° C. to a dry “cake” with a diameter of 2-4 mm. A matrix obtained by this process, when being eluted with water having a temperature of 36° C., will release 60-80% of the HA as determined by the carbazol method. This shows that a matrix loaded with HA can serve as a reservoir for the uptake and release of HA to wound surfaces.
The same process was used for loading the matrix with medical grade chitosan of animal or non-animal origin, which is characterized by a deacetylation ratio of 60-95%.
Webs of non-woven thermoplastic fibers of an adequate texture and strength were lead through an aerosol chamber first and, subsequently, through a drying chamber in order to achieve an impregnation of the encasing material with 0.1 to 0.5% of HA (w/w). Spraying and padding the nonwoven material with HA based aqueous solutions before drying are alternative methods of impregnation.
Mechanical stabilization of the matrix inside the encasing material is an important measure in order to avoid lumping/agglomeration leading to dislocation of the matrix material inside the pad once this is soaked with water and exposed to vertical forces. This was achieved, for example, by partial ultrasound bonding of the encasing material to the matrix, which—to this extent—contained an adequate amount of thermoplastic fibers or powder.
A sterilized prototype version of the cold-adapted wound dressing device was used in patients after arthroscopic meniscectomy in order to improve their postsurgical course. The pads were sterilised by ethyleneoxide and unpacked in the sterile op-environment.
Thirty patients were included in this pilot, comparative study and divided into 2 groups, a prototype wound pad treatment group (n=20 patients) and a control group (n=10 patients)
The prototype wound pad treatment group underwent the following procedures:
After completion of arthroscopic meniscectomy, steri-strips were used for skin closure in all the 20 patients. For each patient a prototype cold-adapted wound dressing device (size 12×22 cm) was removed from the sterile packaging and about 100 mL 0.9% NaCl (approx. 0.5-0.8 mL NaCl/cm2) cooled to 4° C. were poured into the upper part of the device. The prototype cold-adapted wound dressing device retained this cold water in the SAP part of the device. 10 ml of Viscoseal (TRB Chemedica), a sterile viscoelastic solution containing 0.5% fermentative hyaluronic acid in a buffer solution, was applied to the lower part of the prototype cold-adapted wound dressing device which would be placed in contact with the wound surface. The prototype cold-adapted wound dressing device was then applied onto the closed incisions wounds (3 per joint) and was covered with an occlusive dressing and an elastic bandage. Patients were prescribed analgesics or classical NSAIDs and the number taken by each patient was recorded.
The control group underwent the following procedures:
After completion of arthroscopic meniscectomy, Steri-strips were used for skin closure in the 10 patients in this group. Standard, commercially available wound dressings were placed on the wound. No cooling packs were used in this group of patients. Patients were prescribed classical NSAIDs and the number taken by each patient was recorded. Analgesics were prescribed in case patients still had pain despite the intake of NSAIDs and the type and amount of analgesics taken by each patient was recorded
Pain in the treated joint was assessed by the patient at about 1 hour post-surgery (by which time the anaesthetic had worn out), and then every 2 hours over a 24 hour post-operative period (when the patient was awake), using a 100 mm visual analogue scale (VAS). This scale has a zero (0) anchor point indicating “no pain” and one hundred anchor point (100) indicating “intense pain”.
Skin temperature was measured by a nurse every 10 minutes for the 1st hour after surgery using a standard thermometer, the tip of which was placed adjacent to the skin in the operated region).
Determined or monitored were:
While the above description contains many specifics, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of one or another preferred embodiment thereof. Many other variations are possible, which would be obvious to one skilled in the art. Accordingly, the scope of the invention should be determined by the scope of the appended claims and their equivalents, and not just by the embodiments.
All documents cited herein are incorporated by reference in their entirety.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/EP2009/058550 | 7/7/2009 | WO | 00 | 6/1/2011 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2010/003935 | 1/14/2010 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
4668564 | Orchard | May 1987 | A |
5658582 | Dorigatti et al. | Aug 1997 | A |
5750585 | Park et al. | May 1998 | A |
5759570 | Arnold | Jun 1998 | A |
6331298 | Ferguson et al. | Dec 2001 | B1 |
6566575 | Stickels et al. | May 2003 | B1 |
6800278 | Perrault et al. | Oct 2004 | B1 |
20040153040 | Martineau et al. | Aug 2004 | A1 |
20050080368 | Hurwitz | Apr 2005 | A1 |
20070066924 | Hopman et al. | Mar 2007 | A1 |
20070088104 | Hung et al. | Apr 2007 | A1 |
20080058747 | Singh Kainth et al. | Mar 2008 | A1 |
Number | Date | Country |
---|---|---|
101 35 676 | Feb 2003 | DE |
7-16256 | Jun 2013 | JP |
2001017531 | Sep 2013 | JP |
2249467 | May 2004 | RU |
2004101621 | Jul 2005 | RU |
70 792 | Feb 2008 | RU |
WO 2005067837 | Jul 2005 | WO |
Entry |
---|
Jones et al., Wound dressings; Apr. 1, 2006; British Medical Journal; 332(7544):777-780; “Wound dressings”, PubMed [online], [retrieved Mar. 24, 2014] Retrieved from the Internet:<URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420733/>. |
Magnani et al., “Biological performance of two materials based on sulfated hyaluronic acid and polyurethane,” J. Mater. Chem. 9:2393-2398, 1999. |
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20110311610 A1 | Dec 2011 | US |
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61078447 | Jul 2008 | US |