CA1059853A - Flexible flocked dressing - Google Patents

Flexible flocked dressing

Info

Publication number
CA1059853A
CA1059853A CA224,975A CA224975A CA1059853A CA 1059853 A CA1059853 A CA 1059853A CA 224975 A CA224975 A CA 224975A CA 1059853 A CA1059853 A CA 1059853A
Authority
CA
Canada
Prior art keywords
tissue
dressing
wound
fibers
wound dressing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA224,975A
Other languages
French (fr)
Inventor
Bernard L. Williams
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth Holdings LLC
Original Assignee
American Cyanamid Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by American Cyanamid Co filed Critical American Cyanamid Co
Application granted granted Critical
Publication of CA1059853A publication Critical patent/CA1059853A/en
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/64Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
    • A61F13/01038
    • A61F13/01046
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00157Wound bandages for burns or skin transplants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00246Wound bandages in a special way pervious to air or vapours
    • A61F2013/00263Wound bandages in a special way pervious to air or vapours vapour permeability >500 g/m2/24h
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00519Plasters use for treating burn
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00544Plasters form or structure
    • A61F2013/00553Plasters form or structure with detachable parts
    • A61F2013/00561Plasters form or structure with detachable parts with adhesive connecting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00727Plasters means for wound humidity control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00855Plasters pervious to air or vapours
    • A61F2013/00876Plasters pervious to air or vapours vapour permeability >500 g/mg/24h
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00902Plasters containing means
    • A61F2013/0091Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/51Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the outer layers
    • A61F13/511Topsheet, i.e. the permeable cover or layer facing the skin
    • A61F2013/51186Topsheet, i.e. the permeable cover or layer facing the skin specially shaped topsheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/51Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the outer layers
    • A61F13/511Topsheet, i.e. the permeable cover or layer facing the skin
    • A61F13/513Topsheet, i.e. the permeable cover or layer facing the skin characterised by its function or properties, e.g. stretchability, breathability, rewet, visual effect; having areas of different permeability
    • A61F2013/51355Topsheet, i.e. the permeable cover or layer facing the skin characterised by its function or properties, e.g. stretchability, breathability, rewet, visual effect; having areas of different permeability for improving fluid flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/51Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the outer layers
    • A61F13/514Backsheet, i.e. the impermeable cover or layer furthest from the skin
    • A61F13/51401Backsheet, i.e. the impermeable cover or layer furthest from the skin characterised by the material
    • A61F2013/51409Backsheet, i.e. the impermeable cover or layer furthest from the skin characterised by the material being a film
    • A61F2013/51411Backsheet, i.e. the impermeable cover or layer furthest from the skin characterised by the material being a film being impervious to fluids but not for air or vapours
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/53Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium
    • A61F2013/530992Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium in the form of string or ball instead of sheets

Abstract

ABSTRACT OF THE INVENTION
A wound surface is protected by a wound dressing consisting of a moisture permeable elastomeric film whose moisture permeability is in the order of that of the intact human skin to which is adhesively flocked a layer of tissue compatible and tissue absorbable; fibers, such as polyglycolic acid. All tissue contacting material is absorbable by living tissue so that any material which is trapped within the wound is absorbable.

Description

lc~5g~53 BACKGROUND OF THE INVENTION
_ The primary concern is with the treatment of human patients and, to some extent, animals, which have incurred se-vere burns or tissue damage which leaves a substantially expo-;5 sed wound. One purpose is to convert the contaminated and open wound to a clean and closed wound in the shortest time possible.
It has been customary to use cadaver skin or porcineskin among other to protect wounds and to aid in the develop-ment oE granulation tissue prior to autografting.
- The wound dressing should decrease pain, reduce pro-tein loss, reduce evaporative heat and water losses from the wound surface and prevent further contamination. It is desir- ~ -able that the use of the dressing results in decreasing exist `,15 ing bacterial growth in the wound. At times a bleeding wound or wound losing plasma rapidly is present as a part of a larger wound and the dressing should aid in minimizing blood or plasma loss. It is desirable that the dressing remain flexible and adherent to the wound at all times and be sufficiently flex- ;
~$
ible to permit at least some flexing of the wound surface.
'`1 The desired degree of flexing to some extent varies with the location of the wound. For example, a wound surface adjacent ~
.,j : '.
a joint should preferably have greater flexibility than a wound adjacent a less flexed area such as a chest or back.
r~ 25 In general, the requirements for a wound dressing, particularly a burn dressing, are known and recognized.
DESCRIPTION OF THE PRIOR ART
The use of polyglycolic acid is disclosed in a series of patents and applicatio~ to Schmitt, et al:
U.S. Patent 3,297,033, Schmitt and Polistina, January 10, 1967, SVRGICAL SUTURES, discloses polyhydroxy-, , .

... . . . .

~9~53 :;
acetic ester absorbable sutures. The material is also called polyglycolic acid, and is disclosed as permitting small quanti-ties of comonomers to be present, such as dl-lactic acid, its optically active forms, homologs and analogs. A small quantity is recognized by the art as up to 15%, as shown by United States Patent 2,668,162, Lowe, February 2, 1954, PREPARATION OF HIGH
MOLECULAR WEIGHT POLY~NDROXY-ACETIC ESTER.
United States Patent 3,463,158, Schmitt and Polistina, August 26, 1969, POLYGLYCOLIC ACID PROSTHETIC DEVICES, dis-closes surgical uses of polyglycolic acid, and incorporates definitions of some terms.
United States Patent 3,620,218, Schmitt and Polistina, ~-November 16, 1971, CYLINDRICAL PROSTHETIC DEVICES OP POLY
- GLYCOLIC ACID, lists many uses of polyglycolic acid.
United States Patent 3,736,646, Schmitt and Epstein, June 5, 1973, METHOD OF ATTACHING SURGICAL NEEDLES TO MULTIFILA-MENT POLYGLYCOLIC ACID ABSORBABLE SUTURES, discloses surgical elements of a copolymer containing from 15 to 85 mol percent - glycolic acid and 85 to 15 mol percent lactic acid.
United States Patent 3,739,773, Schmitt and Polistina, June 19, 1973, POI.YGLYCOLIC PROSTHETIC DEVICES, claims parti-~, cularly bone pins, plates, nails and screws of polyg~l~ycolic acid. --United States Patent 3,875,937, Schmitt and Polistina, SURGICAL DRESSINGS OF ABSORBABLE POLYMERS, discloses additional ~ "
subject matter on surgical dressings of polyglycolic acid. ;
United States Patent 3,739,773, supra, lists a number of United States Patents on methods for preparing polyglycolic acid and starting materials therefor.
In United States Patent 3,620,218, supra, in Column 2 ~ -are listed a number of medical uses of polyglycolic acids, in-. , .
- 2 -~S~ 3 cluding in Column 2; line 52, knit-ted or woven ~ibrillar products, including ve].ours, and mentioning specifically in line 53, burn dressings, line 57, felt or sponge for liver hemostasis; line 63, foam as absorbable prosthesis;
and in lines 74 and 75, burn dressings (in combination with other polymeric films).
~Zhe use of gauzes, felts, and knitted fabrics as a wound dressing is quite conventional. The use of collagenous products as a sponge or pad has been disclosed. The requirements for surgical dressings are varied and more satisfactory dressings than presently available are constaNtly in demand.
U.S. Patent 3,526,224, R. M. Potts, September 1, 1970, DRESSI~G, discloses an occlusive dressing designed to act as a synthetic skin which has an elastomeric polyurethane film having a water vapor transmission rate of 150 to 500 g/m /2~ hrs. laminated to a knitted velour fabric. A tricot fabric of 30 denier textured 6.6 nylon yarn is suggested. The pile or nap side of the knitted velour forms the wound-contacting side of the dressing.
Studies are being made by and for governmental agencies on burn ;~
protection. One such "Development of a Synthetie Polymer Burn Covering"
Z prepared by Dynateck R/D Company, ~or the Office of ~aval Research, June 1973, ~ational Technical Information Service AD-76L,631 discloses the use o~ poly-meric films, including lactic acid polymers, and 75/25 lacticlglycolic co-polymers, and the disadvantages of flat, solvent cast films. A normal ~-insensible water loss from the human body is given as 2.2 mg/hr c~ , ~uoting Treger, " hysical Y~nctions of the Skin", Acsdemic Press, ke~ ~ork.

;', .. .. . .
,' ' , . ' . .: .: , SU~R~ OF T~IE INVENTION
This invention relates to a wound dressing, particularly adapted for major burns in humans in which at least a part of the skin has been destroyed or removed and which underlying tissue is ~ subject to moisture and liquid loss and bacterial contamination which ; dressing comprises an exterior surface of an elastomeric material such as polyurethane which has a moisture permeability of the order of that of the intact human skin and to which is adhesively flocked a layer ` of fibers of a tissue compatible and absorbable material which fibers are preferably predominantly at about right angles to the elastomeric layer and which are so spaced as to permit the invasion of granulation ;; tissue and which can be removed from the granulation tissue without .
pulling off such granulation tissue and with minimum damages to the developing granulation tissue to leave a bed for autografting or other .
', subsequent treatment.
Thus, according to the present invention, there is provided a wound dressing for the surface of living tissue from which at least part of the skin has been removed and which tissue is subject to moisture, loss, and bacterial contamination, which dressing is sufficiently flexible that it will conform and adapt to the surface of the tissue to minimize pools of fluid or air between the dressing and the tissue surface, which pools generate problems of infection, and which has a permeability to mois-ture of the order of that of the intact human skin ~approximately 2.2 mg/sq./cm./hr,) which comprises an eiastomeric layer which elastomeric layer has adhesively flocked to its surface a layer of fibers and which ;
fibers are of a tissue compatible material which is substantially absorbed by living tissue within about 90 days, and which fibers maintain their integrity for at least about 3 days.
The fibers themselves are absorbable by living tissue so that any of the fibers which are trapped within the wound are absorbed by the ~.~
.

1~59~3~;i3 living tissue without deletcrious effects.
The present wound dressing may be used on almost any ~ype of wound in which the skin is broken and body fluids, particularly blood and serum, are released by the wound. It is primarily designed for major burns in which a substantial area of the skin of a human is destroy-ed, a third degree burn, leaving underlying tissues which are either contam-inated, or subject to contamination by bacteria, or other contaminants, and which wound is of such a size that immediate protection of the tissue surface is required. It is desirable to change the wound from a contam-inated and open wound to a clean and closed wound in the shortest time possible, to de- -'~

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crease pain, and to minimi?.e protein loss, reduce ev~poratlve heat and water losses, and prevent furt~er contamination during the time required for the underlying tissues to build up a granu- ~-lating surface which will accept a skin autograft.
y skin autograft is meant skin taken from another area of the sub~ect, and which is living so that when placed on the granulating tissueJ the skin will graft to the granu-lating tissue and grow providing a skin surface at the wound area. With rare exceptions, the s~in of any other subject will be rejected and not graft to thewo~ed subject. The ; subject's own skin grafts to properl~ prepared granulatlng tissue and will grow so as to enlarge the skin covered area.
Wi~h major burns, a sufficientl~ large portion of the subject may be burned so that sites for donor skin are limited and it is necessar~ to protect burned areas for a prolonged period until graft donor sites can regenerate and be used for a sub- ~ ;
sequent graft.
The generalized subject of burn treatement of this type is fairly well recogni~ed as are mcm~ of the requirements for such a wound dressing. T~e medical profession recognizes the need for improvements in burn site protection during burn treatment, Survivabilit~ after major burns has been lmprovlng -- the present invention contributes towards suc~ improvement.
The use of a synthetic tissue absorbable dressing eliminates man~ disadvantages of prior art dressings, partic-ularl~ as to availabilit~, and represents a substantial step - forward in burn treatment.
The dressing should conform to the surface of the ` tissue. Conformation comprises an assessment of the supple-ness, ~esilienc~, and dressing~s ability to mimic the topo-graph~ of the wound in such a fashion that there is a minimum ., .
', ' ~

gap between the -tissue and the clressing which minimizes air gaps and pools of li~uid. If pools of liquid build up, whether of serum or blood, such pools become sites for the growth of undesirable microorganisms. If the dressing conforms aaequat-ely to the surface of the wound, the body's own defense mech-anisms are effective up to the zone of contact with the dress-ing, and bacterial contamination is minimized. In many in-stances, the body's defense mechanisms can clean a protected contaminated wound and permit the growth of granulation tissue even though the wound was initially contaminated.
In modern hospital technology, any area not known to be surgically clean must be regarded as contaminated or at least suspect, and treated as if contaminated.
For proper protection of the tissue surface, the gross escape of liquids such as serum or blood needs to be prevented by the dressing and the tissue needs to be protected from the atmosphere, but at the same time just as natural skin permits the escape of a certain amount of moisture, a wound dressing must permit the escape of at least some moisture to prevent the dressing from being lifted by the underlying flow '!
of fluids. If the rate of moisture loss is too high, there is a cooling effect from the heat required to convert the liquid to vapor; and electrolytes, proteins, and other mater-- ials in the underlying fluid concentrate and crust on the surface, or under the dressing, which leads to complications.
It is desirable that the permeability be of at least approx-~' imately that of the intact human skin (which is found to be about 2.2 mg./sq. cm./hr.) and may be several times this value.
A permeability of 4.7 mg./sq. cm./hr. has been found effec-tive under many conditions. The values are approximate as different skin areas lose moisture at a different rate and, ' ~5~S3 depending upon the temperature of the subject, the tempera-ture o~ the atmosphere, the movement of ambient air and under other variables, the natural skin has a considerable range of skin moisture loss. ~he natural skin is adaptable to a wide range of environmental conditions so that if the wound dressing has a moisture loss which is approximately that of the intact human skin and remains within this range of ac-ceptable conditions, the underlying tissues are protected ; and regenerate. There is a fine and, perhaps, unascertain-able line between the regenerative processes of the tissue when protected from ad~erse effects and the increase that might be caused by dressing characteristics and environ-mental factors. It is not necessary to ascribe the rate of ; healing to any special set of factors~ It is merely found that by using the present wound dressing, rapid healing is encouraged.
For adequate conformation, the wound dressing must be flexible so that it can conform to the topography of the wound and at the same time it must be sufficiently flexible that as the tissues move, the wound dressing can move with them. For instance, if the skin adjacent to a joint is in-jured, flexing of the joint and movement of the underlying tissues requires that the wound dressing have some flexibil-ity. The minimum required flexibility is exceeded by the present dressing and the dressing is sufficiently flexible for tissue movement over joints and other areas.
Basically, the tissue-contacting portion of the dressing is a flock of tissue compa-tible material which is substantially absorbed by living tissue within a period of about 90 days and which fibers maintain their intPgrity for at least about three days.

~L~59~3~ii3 A flock of fibers of` the order o~ 0.5 to 12 denier and from 10 to 30 mils long which are flocked onto an elastomeric layer gives protection to the wound surface.
It is desirable that the fibers be absorbable by living tissue as characteristics of a flocked surface are such -that some fibers are not tightly held, and some Or the fibers may remain in the wound, and non-absorbable materials can be the source of un-desirable side effects.
A preferred tissue absorbable polymer is polyglycolic acid, such as described in the Schmitt patents above and which is meeting with commerical success as a suture. Polymers in which tissue absorption results from the hydrolytic degradation of glycolic acid `, ester linkages give good results. Because strength of the fibers is not a maJor requirement, a copolymer containing considerable lactic acid makes a good dressing. Such polymers are disclosed in U.S.
Patent 3,736,646, supra.
A polymer having an ordered configuration Or glycolic acid ~-~
units and lactic acid units which is tissue absorbable is described .
: ~ :
at length in Canadian Serial No. 216,765, December 24, 1974, Augurt, Rosensa~t, and Perciaccante, UNSYMMETRICALLY SUBST~TUTED 1,4-DIOXANE-2, 5-DIONES.
Another absorbable polymer ~hich may be used for the graft is poly(N-acetyl-D-glucosamine) such as described in U.S. Patent
3~988,411, Richard Carl Capozza~ POLY(N-ACETYL-D-GLUCOSA~INL) PRODUCTS. '~
The i~portant thing about the tissue absorbable polymer is that it be of a material which is not deleterious to living human tissue and that it be spinnable as a fiber which forms a ~ine structure such that blood and other fluids do not flow rapidly there-through and it has su~ficient -~

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strength to malntain its integrity during the manufacture of a flock and that it maintains its integrity in contact ~ith the tissue long enough for granulation tissue to form ancl yet is absorbable within a reasonable length of time, for instance, about 90 days, so that it does not remain as a foreign body after the wound has healed.
Canadian Serial No. 216,765 and United States Patent 3,988,411 give examples of such materials.
Inasmuch as the use~ul characteristics of such ma-terials are largely as a function of size, shape and structure, these materials may be substituted for the polyglycolic acid fibers described in more detail in the following examples. ~ `
The fibers which conveniently are spun in abou-t 1 to about 12 denier are adhesively flocked to the elastomeric backing layer. By using an electro-static charge, as is conventional in flocking systems, the fibers are caused to stand on end and are predominantly at right angles to the elastomeric layer. The fibers may be adhesively united to the elastomeric layer by using the adhesive characteristics Or the elastomeric layer as it is ~ormed. ~ore conveniently, when the elastomeric layer is formed, a separate adhesive layer is placed thereon and the flocked fibers are placed on such adhesive layer and caused to stand on end electrostatically.
The elastomeric layer may be any material which is permeable to ; moisture, has a low Young's modulus and is thus readily conformable to the wound surface. A particularly useful material is polyurethane. A soft, ~lexible elastomeric layer of polyurethane o~ the order o~ 2 mils thick provides a barrier to excessive water loss, is permeable to .
, '.

:~ ' ._ g _ ,~ t,~

~ 59y35i3 moisture within the range o tha-t of the intact human skin, which is approximately 2.2 mg./sq. cm./hr., to two to four times this value, which permits moisture to pass through the backing la~er at such a rate that formation of liquid pools under the dressing is minimized, and yet the water loss is within a de-sirable range as regards heat loss and concentration oE dis-solved components in the body fluids which are underneath the dressing.
At the time of use, the wound shculd be debrided in accordance with usual techniques and substantially dried so that there is no standing liquid on the surface of the `l wound. Then, the soft flocked surface of the wound dressing is placed in contact with the wound, ~eing sure that it con-forms to the topography of the wound surface so that there are no gaps or spaces between the tissue and the dressing;
with the dressing being held in place by adhesive tape, add-tional bandages, or suturing. A low pressure bandage may be used to hold the dressing in place, depending upon the loca~
- tion of the dressing and the condition of the patient. The dressing is permitted to remain in place for approximately seven da~s. If less than four days in most subjects, there is not suff~cient time for adequate granulation tissue to grow under a dressing and if more than fourteen days,.;
much granulation tissue may grow and result in scar tissue.
At times a wound must have a first dressing applied and be :: .
permitted to heal so that granulation tissue is formed in part on the wound and then additional debridement or other treatment is undertaken in other areas, requiring a second wound dressing application to encourage the growth of addi-tional granulation tissue. There are times when many treat-ments are required hefore the wound is in condition for autografting or before skin for autografting becomes avail~

,, ~ , . - . ................. .

9~i3 able. For ma~or burlls or traumatic tissue damage, prolonged treatment ; may be required before the wound is ready for final grafting.
In other instancesJ a wound may be fairly minimal and the present ~OUIId dressing ma~ be applied even though a less adequate wound dressing could have been used and a single applicatiorl permits substantial healing Different areas of the same wound ma~ require different treatment.
The present wound dressing in particular functions as a temporary synthetic skin, giving a protective covering to any area of a body from which the skin is removed and the underlying tissues are exposed with the covering not interfering with normal physiological processes conducive to wound healing and autograft conditioning.
; The composite structure provides both a good moisture barrier and bacteria barrier. The conformability resulting from the elastomeric backing permits conformation to nearly any wound topography while the short fibers protruding from the flocked surface insure intimate contact and wetting at the wound surface which provides an intimate contact with the tissue absorbable fiber during the healing process~ Because the flocked surface is absorbable, there is no -/ 20 problem resulting from biological rejection of the flocked material and there can be no deleterious entrapment in regenerating tissue ` in tangled fibers, as can be the case of a sponge or woven web.
As shown in the attached drawing, a polyurethane ~: : ., such as described in U,S. Patent 3,582,423, Wang, June 1, 1971, - PROCESS FOR COATING POROUS SUBSTRATES, and sold as Helastic ` 13141 polyurethane, iâ cast on release coated paper to form a film with a thickness of 2 nils. The material is a reaction product of a hydrox~ terminated polyester such as diethylene - glycol adipate and p,p'-methylene dianilane and a mixture of -' 11 -.

2,4- and 2,6-toluene diisocyanates~ at about 25% solids. The polyester type segmented polyurethane is per~itted to harden to form a water vapor permeable elastomer layer, and then coated with an additional half a ~il thickness of the same polyurethane.
The polyurethane structure may be graphically de-scribed as:

NH2-Rl--ENH-CO-NH~ -NE~-CO-O-R3-Q-CO-NH-R2-NH--CO-NH-Rl ~NH2 where, Rl= ~ 2 CH

lS or ~ 2 ~
;, o o .~ " , 3 2 2~ CH2 CH2-CH2- CH2-C--CH -CH
or O O
:~ -CH-CH2~ 0-$-CH2-CH2-cH2-cH2-c-o CH-CH2 ~ ~
CH CH

or -CEI2-CH2-cH2 CH2~ O C 2 2 2 2 m The polyurethane film is cast by pouring the resin ~J dissolved in solvent on a release paper such as ~ silicone ~ ~ -'I i .
coated release paper, which is pulled through rollers set to leave about 4 mils of 25% solids solution on the release pap-er, so that when dry a 2 mil layer remains. After a second pass to leave an additional adhesive coat which dries to about 0.5 mils thickness, there are flocked 2 denier poly-glycolic acid fibers approximately 25 mils long with the fib-ers being subjected to a strong electrostatic field, in accord--. .
..

~q~5~ 3 ance with conventional procedures, to cause the fibers to stand at approximately right angles to the field and, hence, at right angles to the backing, while the polyurethane ad-hesi~e layer cures. The thus formed flock is shaken and then blown with air to remove any loose fibers, after which the flocked sheet is cut into 2" X 3" rectangles for indi~idual dressings.
As a surgical device, it is obviously desirable, almost mandatory, that the wound dressing be sterile at the ~ime of use. The wound dressing may be sterilized by an ap-propriate sterilizing cycle using ethylene oxide as a steril-izing agent. Radiation sterilization may be used, as may heat sterilization.
If ethylene oxide is used to sterilize, it is con-venient that the ethylene oxide be diluted with carbon dioxideor a chlorofluoroalkane to such an extent that the steriliz-ing gas is non-explosive. For st:orage stability, it is des-irable that the wound dressing be protected from atmospheric influences. Because the wound dressing contains hydrolyzable ;20 polyglycolic acid ester linkages, the lin~ages can be hydro-lyzed by ambient moisture under room storage. The wound dressing requires that the flocked fiber retain sufficient strength to be separated from the wound when the dressing is changed. Preferably, it should retain strength at least 10 25 days to two weeks. It is desirable that such storage condi- ~ -tions be used as to maintain the wound dressing in a dry en- -vironment so that whether used immediately after packaging or after a storage period of several years, the wound dress-ing has the same characteristics and, hence, has known pre-dictable attributes as far as the using surgeon is concerned.

A good method of sterilizing and storage is the same as is used for polyglycolic acid sutures on a commercial scale and as disclosed in U.S. Patent 3,723,839, Arthur Glick, April 24, 1973, STORAGE STABLE SURGICALLY ABSORBABLE POLYGLY-COLIC ACID PRODUCTS. As there described, the polyglycolicacid product is stored in a moisture proof envelope in which conveniently the product is packayed except for one open side and sterilized using ethylene oxide diluted so as to be non-j-explosive, and then while protecting sterility, the product ~- ~
10 is vacuum dried and the envelope sealed. By having the ~oil ~ -envelope hermetically sealed, as there taught, the wound ~ ;
dressing may be maintained in a usable form with consistent characteristics for a period of at least several years. Con-veniently, but not necessarily, the wound dressing may be~ ~
15 placed between two sheets of paper, or a single sheet of paper ;
with a fold, so that the wound dressing is held in flat con-`~dition between the sheets during storage and service to the using surgeon.

IA single envelope can be used, which, on stripping, '20 releases the wound dressing folded in a sheet of paper.
Such a single envelope package is shown in U.S. Patent 3,017, 990, Singerman, January 23, 1962, STERILE PACKAGE FOR SURGICAL
FABRIC.
:
For large sheets, the wound dressing may be fold-ed~ but for sheets up to 3" X 5" it is conveniently placed in an envelope large enough to hold the sheet flat. ~ plur-ality o~ sheets may be packaged in a single envelope if de-sired. Single sheets of about 3" X 5" are a surgically acceptable size, with the wound dressing being cut to size - -if necessary by the surgeon, or an assistant, at the time of ' :

.. . . .
.. : ,. - . ~ .
' : , , ~ .

i91~i3 use. For many surgical pxocedures, a single sheet is all that is required. For major burned areas, either a number of smaller sheets or a single layer sheet of the wound dressing gives good results. A series of smaller dressings gives more conformity on irregular areas. A single large sheet reduces the number of seam lines. Convenientlyl the wound dressing is made available in sterile form in sheets 3" X 5", 3" X
12", 3" X 18", 3" X 24" and continuous rolls, about 12" wide.
Other sizes and shapes can be provided to supply the using surgeon with a choice of sizes, consistent with reasonable inventory demands.
At the time of use, the enclosure is stripped open, the individual dressing removed and placed in contact with the wound surface. For burn areas with adjacent whole skin, the wound dressing may be held in place by adhesive strips.
On burn test subjects, the wound is cleaned from - burned tissue and other contaminants, in accordance with con-~` ventional debriding proceedings, and the wound covered by the wound dressing. After approxlmately seven days, the wound dressing is removed from the wound gently to avoid stripping granulation tissue, and the wound is ready for grafting, or additional treatment.
The treatment of the wound before applying the wound dressing may include antibacterial agents, anesthetics, etc.
The time before dressing change varies with the location o~ the wound, and the general condition of the pa-, 1 . .
tient. Some heal more rapidly than others. The surgeon incharge must adapt the treatment to the speciflc patient.

:, ,

Claims (6)

1. A wound dressing for the surface of living tissue from which at least part of the skin has been removed and which tissue is subject to moisture loss, and bacterial contamination, which dressing is sufficiently flexible that it will conform and adapt to the surface of the tissue to minimize pools of fluid or air between the dressing and the tissue surface, which pools generate problems of infection, and which has a permeability to moisture of the order of that of the intact human skin (approximately 2.2 mg/sq. cm./hr.) which comprises: an elastomeric layer which elastomeric lay-er has adhesively flocked to its surface a layer of fibers and which fibers are of a tissue compatible material which is substantially absorbed by living tissue within about 90 days, and which fibers maintain their integrity for at least about 3 days.
2. A wound dressing for the surface of living tissue from which at least part of the skin has been removed and which tissue is subject to moisture loss, and bacterial contamination, which dressing is sufficiently flexible that it will conform and adapt to the surface of the tissue to mini-mize pools of fluid or air between the dressing and the tissue surface, which pools generate problems of infection, and which has a permeability to moisture of the order of that of the intact human skin (approximately 2.2 mg/sq. cm./hr.), which comprises: an elastomeric layer of the order of 2 mils thick, and which elastomeric layer has adhesively flocked to its surface a layer of fibers of the order of 1 to 12 denier, and about 10 to 30 mils long, and which are predominantly at about right angles to the elastomeric layer, and which fibers are of a tissue compatible material which is substantially absorbed by living tissue within about 90 days, and which fibers maintain their integrity for at least about 3 days.
3. The wound dressing of Claim 2 in which the tissue compatible material is a polymer subject to hydro-lytic degradation to non-toxic, tissue compatible absorbable components, said polymer having glycolic acid ester linkages.
4. The wound dressing of Claim 3 in which the tis-sue compatible material is homopolymeric polyglycolic acid.
5. The wound dressing of Claim 3 in which the tis-sue compatible material is a polymer of 3-methyl-1,4 dioxane-2,5-dione.
6. The wound dressing of Claim 2 in which the tis-sue compatible material is a polymer of N-acetyl-D-glucosa-mine.
CA224,975A 1974-04-19 1975-04-18 Flexible flocked dressing Expired CA1059853A (en)

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SU598546A3 (en) 1978-03-15
PH11608A (en) 1978-04-12
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