WO1988008690A1 - Wound closure device - Google Patents

Wound closure device Download PDF

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Publication number
WO1988008690A1
WO1988008690A1 PCT/GB1988/000361 GB8800361W WO8808690A1 WO 1988008690 A1 WO1988008690 A1 WO 1988008690A1 GB 8800361 W GB8800361 W GB 8800361W WO 8808690 A1 WO8808690 A1 WO 8808690A1
Authority
WO
WIPO (PCT)
Prior art keywords
adhesive
strips
incision
layer
coated
Prior art date
Application number
PCT/GB1988/000361
Other languages
French (fr)
Inventor
Christopher Daniel
Original Assignee
Smith And Nephew Associated Companies Plc
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 Smith And Nephew Associated Companies Plc filed Critical Smith And Nephew Associated Companies Plc
Publication of WO1988008690A1 publication Critical patent/WO1988008690A1/en

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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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L27/00Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
    • C08L27/02Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L27/04Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing chlorine atoms
    • C08L27/06Homopolymers or copolymers of vinyl chloride
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L71/00Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers

Definitions

  • the present invention relates to a surgical drape and wound closure device.
  • Sutures, clips or staples have long been used in the art of post-surgical wound closure. It is recognised that the use of such wound closure means suffers from various disadvantages, for example all of these types of means penetrate the patient's tissue which may cause additional bleeding. These wound closures are time consuming to apply, are discomforting when in position, are often painful to remove and may leave a scar and may provide a pathway for bacteria to infect the healing wound.
  • An alternative means for closing wounds is to apply a series of separate narrow adhesive strips on opposing skin edges and across the line of the incision. However, such narrow strips have the disadvantage that they tended to loosen and come apart if the patient moves sharply and it is often difficult to match the skin on opposite sides of the wound.
  • closure devices were prepared which included several strips which were anchored on one side of the incision, placed over the incision, the wound edges brought together and then other side of the device was anchored on the other side of the incision.
  • This type of device holds the opposed edges of the wound together even during patient movement.
  • a closure means comprises the two halves of a zipper mechanism and which are adhered on either side of an incision or proposed incision so that after the incision has been made between the halves of the zipper and the operation completed the two halves of the zipper are brought together and the zipper closed thereby holding both edges of the incision in close proximity for healing.
  • the present invention provides a surgical drape and wound closure device consisting of a moisture vapour permeable sheet material comprising a backing layer coated on one surface with an adhesive layer and having attached to the non-adhesive surface of the backing layer two rows of folded adhesive-coated strips and each row covered by an adhesive coated cover layer whereby an incision may be made through the sheet material between the rows of adhesive coated strips and after the cover layer is removed, the adhesive strips may be unfolded and placed across the incision and anchored to the sheet material on the opposite side of the incision thereby facilitating holding the edges of the wound in close proximity for wound healing.
  • the surgical drape portion of the device comprises a backing layer and coated on one surface thereof an adhesive layer.
  • the backing layer is preferably a film. Suitable materials for forming the backing layer therefore include those materials usually used for . forming surgical drape films including those described in British Patent No. 1280631 and European Patents Nos. 51935 and 91800.
  • Preferred materials for forming the film backing layer therefore include polyurethanes, for example thermoplastic polyurethanes as described in British Patent No. 1280631 and which are commercially available as the Estanes (Trade Mark), elastomeric polyether polyesters, for example Hytrel 4056 (Trade Mark) and hydrophilic polymers especially the hydrophilic polyurethanes described in European Patent No. 91800.
  • the thickness of the film backing layer will be from 12.5 to 75 m, more suitably 20 to 50/m and preferably 25 to 40/m.
  • the adhesive which is used to coat one surface of the backing layer will include any adhesive which is suitable for application to the skin.
  • the adhesive will be a pressure sensitive adhesive which includes acrylate ester copolymer adhesives and polyvinyl alkyl ether adhesives.
  • the adhesive will be applied at a weight per unit area of from 20 to 75gsm, more suitably 25 to 50gsm and preferably 25 to 40gsm.
  • the adhesive may be applied to the .backing layer as a continuous or discontinuous layer. Discontinuous layers include both porous, microporous and patterns spread layers.
  • the adhesive layer is a continuous layer.
  • the surgical drape portion of the device is meant to remain in position, adhered to healthy skin
  • the surgical drape will suitably have a moisture vapour permeability of greater than 250gm ⁇ 2 4hr _1 at 37°C and 100% to 10% relative humidity difference, more suitably the moisture vapour permeability will be greater than 300gm ⁇ 2 25hr _1 and preferably will be greater than 500gm ⁇ 2 24hr _1 , for example 800g ⁇ f 2 24h " r -1 , lOOOgrn "1 24hr _1 or 1200gm ⁇ 2 24hr _1 .
  • the surgical drape will be impervious to liquid water and will be bacteria proof.
  • the moisture permeability of surgical drape can be measured by the Payne Cup method (in the upright position) described in European Patent No. 46071.
  • the adhesive layer present on the backing layer may contain a medicament and in particular may contain an antibacterial agent as described in British Patent No. 2048120.
  • Preferred antibacterial agents include silver salts such as silver sulphadiazine, iodophors such as polyvinyl pyrrolidone-iodine complexes and chlorhexidine salts such as chlorhexidine diacetate or chlorhexidine digluconate.
  • the adhesive layer of the surgical drape will be covered by a release coated protector sheet which is removed prior to use.
  • the protector sheet is as conventionally used in the art including silicone-coated paper, glassin and surface treated siliconised polyethylene.
  • the surgical drape may have non-adhesive handles at each of two opposed sides to aid application of the device.
  • the handles may be removable as described in European Patent Application No. 161865.
  • the surgical drape may be provided with other application aids such as a frame as described in European Patent Applications 51935 and 81989 or handles as described in United States Patent Nos. 4372303 or 4374520.
  • the non-adhesive coated surface of the surgical drape carries two rows of folded adhesive-coated strips. Preferably the rows are arranged on either side of the centre line of the surgical drape.
  • the adhesive coated strips may be formed from a backing layer and an adhesive layer.
  • the backing layer may include any material and in particular material with some elasticity, which has been used for making wound closure strips for example non-woven fabric or polymeric film. Suitable non-woven fabrics include those described in British Patent No. 987533.
  • Suitable polymeric films include those which are suitable for forming the surgical drape including polyurethane and polyether polyester and microporous films such as polyvinyl chloride available as Porvic (Trade Mark).
  • the adhesive may be any which will adhere the strip to the surgical drape and may be any conventional synthetic or rubber adhesive.
  • Each adhesive strip will adhere along part of its length to the drape the remaining adhesive layer or the strip will be covered by a release paper.
  • Each adhesive strip will be folded so as to leave an open area in the surgical drape between the rows of strips in which an incision may be made without also cutting the strips.
  • the strips may be folded in two but preferably the strips will be folded into an S or Z-shape so that a double sided release sheet will be required between the two unadhered adhesive coated arms of the folded strip.
  • the strips in the two rows may be arranged in staggered formation so that when they are unfolded and placed across the incision two adjacent strips will not overlap.
  • the cover layer will also comprise a backing layer and an adhesive layer.
  • the backing layer may be any suitable plastics material but will be water-proof, that is will not be affected by water.
  • a suitable cover layer is a plasticised polyvinyl chloride.
  • the adhesive layer can extend over the whole or a part of the backing layer. When the adhesive layer extends over the whole of the backing layer the adhesive layer will comprise and adhesive which only lightly adheres to the drape material and the strips so that it can be easily removed without disturbing the drape or the strips. A rubber based adhesive is apt. Adhesion to the strips can be avoided however by limiting the extent of the adhesive layer to the marginal edges of the backing layer.
  • the surgical drape and wound closure device will be sterile.
  • the device may be packaged in a bacteria-proof pack which after sealing may be sterilised by conventional means such as ethylene oxide or gamma irradiation.
  • the sterile surgical drape and wound closure device is removed from the bacteria-proof pack, the protector paper is removed from the adhesive layer on the surgical drape portion and the adhesive surface is adhered to the skin of the patient which has previously been cleaned and sterilised.
  • An incision may be made through the surgical drape between the two rows of strips.
  • the cover layers are removed from the adhesive strips.
  • the strips are unfolded and the release paper removed.
  • the edges of the wound are brought together and the adhesive strips placed over the line of the incision and adhered to the opposite portion of the drape. This is done for each strip in turn.
  • the device may be left in position for several days and be removed when the incision has healed.
  • the moisture vapour permeability feature of the surgical drape ensures that skin beneath the drape does not become macerated.
  • the devices may be made by for example casting a solution of the polymer which forms the backing layer of the moisture vapour permeable sheet onto a double sided release paper.
  • a solution of the adhesive may be cast onto the backing layer and the two layers transferred to the other side of the release paper so that the adhesive layer is now covered by the release paper.
  • a layer of polymer which is to form the backing layer of the adhesive strip may be. cast onto a release paper.
  • a layer of adhesive may be cast onto this backing layer and a strip of double sided release paper laid down a centre portion of the adhesive coated polymer layer. One edge of the adhesive coated layer is folded over onto the release paper.
  • the adhesive coated layer may be cut into strips of the appropriate width and the remaining adhesive coated surface adhered to the non-adhesive coated surface cf the moisture vapour permeable backing layer.
  • the strips are arranged in two rows staggered from each other. The final fold is placed in the strip and the rows of strips covered by an adhesive coated polymer film.
  • Figure 1 shows a cross-section through the surgical drape and wound closure device.
  • Figure 2 shows a view from above of the surgical drape and wound closure device.
  • the surgical drape and wound clcsure device (1) shown in Figure 1 comprises a surgical drape component consisting of a backing layer (2) in the form of a moisture vapour permeable, conformable film usually of polyurethane.
  • the backing layer (2) has on one 'surface an adhesive layer (3) of a skin compatible adhesive usually an acrylate ester copolymer adhesive or a polyvinyl ethyl ether adhesive.
  • the backing layer and adhesive layer may have a weight per unit area of approximately 30gsm and a thickness of 37.5 m.
  • the adhesive layer (3) is covered by a protector (4) in the form of a siliconised paper or glassine sheet which is removed before application of the device to the skin.
  • the backing layer (2) may have at either side handles
  • non-adhesive handles are illustrated.
  • the handles (5) may be removed after placement of the device on the skin if the handles are joined to the backing layer (2) by means of perforation or tearable tape or may be adhered to the skin if they carry an adhesive layer.
  • the drape component On its non-adhesive surface the drape component carries a wound closure component in the form of adhesive coated strips. The strips are shown folded in an S or Z configuration. The strips consist of a backing layer
  • the wound closure strips lie along either edge of the backing layer (3) in a staggered configuration.
  • Each row of strips is. covered by a cover layer consisting of a backing layer (9) and an adhesive layer (10).
  • the cover layer protects the strips during the placement and incision through the surgical drape.
  • the surgical drape and wound closure device is placed in a bacteria proof pouch which is sealed and sterilised by irradiation.
  • the sterile surgical drape and wound closure device is removed from its sealed pouch, the protector (4) is removed and the device adhered to the skin over the proposed operation site with the aid of the non-adherent handles.
  • an incision may be made through the surgicald drape component and the surgical operation carried out.
  • the two cover layers may be removed from the wound closure strips and the strips unfolded. This will result in exposure of the adhesive in the middle section of each strip the strip is placed across the line of the incision and the two edges of the wound pulled together and the strip adhered across the line of incision.
  • the double sided release paper is removed to expose the final adhesive surface of the strip which is used to anchor the tape so that the two edges of the wound are kept together and in alignment.
  • Figure 2 shows a view from above of the surgical drape and wound closure device showing the wound closure strips in staggered arrangement covered by the two cover layers. The incision may be made along the length of the device through the surgical drape component between the two cover layers.

Abstract

A surgical drape and wound closure device (1) comprises a moisture vapour permeable sheet material (2) coated on one surface with an adhesive (3) and carrying on the non-adhesive surface two rows of folded adhesive coated strips (6). An incision may be made through the sheet material (2) between the rows of adhesive coated strips (6). At the end of the operation the adhesive strips (6) may be unfolded and placed across the incision and anchored to the sheet material (2) on the opposite side of the incision thereby facilitating holding the edges of the wound in close proximity for wound healing.

Description

- I
WOUND CLOSURE DEVICE
The present invention relates to a surgical drape and wound closure device.
Sutures, clips or staples have long been used in the art of post-surgical wound closure. It is recognised that the use of such wound closure means suffers from various disadvantages, for example all of these types of means penetrate the patient's tissue which may cause additional bleeding. These wound closures are time consuming to apply, are discomforting when in position, are often painful to remove and may leave a scar and may provide a pathway for bacteria to infect the healing wound. An alternative means for closing wounds is to apply a series of separate narrow adhesive strips on opposing skin edges and across the line of the incision. However, such narrow strips have the disadvantage that they tended to loosen and come apart if the patient moves sharply and it is often difficult to match the skin on opposite sides of the wound. In order to mitigate the disadvantages found in applying several single narrow strips, closure devices were prepared which included several strips which were anchored on one side of the incision, placed over the incision, the wound edges brought together and then other side of the device was anchored on the other side of the incision. This type of device holds the opposed edges of the wound together even during patient movement. Such a device is described in United States Patent No. 4423731. Other devices which work on a similar principle are the zipper devices in which a closure means comprises the two halves of a zipper mechanism and which are adhered on either side of an incision or proposed incision so that after the incision has been made between the halves of the zipper and the operation completed the two halves of the zipper are brought together and the zipper closed thereby holding both edges of the incision in close proximity for healing. Such a device is described in United States' Patent No. 3516409. Both these types of sutureless wound closure devices may be difficult to manipulate particularly if they are applied after the incision has been made, when both the edges of the wound and the wound closure device must be manipulated together. There is a further alternative to the above form of wound closure which combines a surgical drape and a wound closure device. The rationale behind this idea is that the incision may be made through the drape and the wound closure means used to close the wound after the operation. The placing of the wound edges in opposition is easier in these devices. Such combined surgical drape and wound closure devices are described in for example United States Patents Nos. 3698395, 4222383 and 4531521. The devices described in Patent Nos. 3698395 and 4222383 require that a part of or all the surgical drape portion of the device must be removed before closing the wound which risks disturbing the remainder wound closure means. United States Patent No. 4531521 avoids this disadvantage, however it may suffer in fact that the wound closure device is held on one side portion only of the top surface of the drape and this may cause uneven tension to be applied to the wound closure across the incision in use.
We have found that by combining a surgical drape in the form of a moisture vapour permeable sheet material comprising a backing layer coated on one surface with a pressure sensitive adhesive layer with a wound closure means in the form of adhesive coated strips attached to the non-adhesive surface of the backing layer, a combined surgical drape and wound closure device has been achieved which mitigates the disadvantages hereinbefore described.
Accordingly the present invention provides a surgical drape and wound closure device consisting of a moisture vapour permeable sheet material comprising a backing layer coated on one surface with an adhesive layer and having attached to the non-adhesive surface of the backing layer two rows of folded adhesive-coated strips and each row covered by an adhesive coated cover layer whereby an incision may be made through the sheet material between the rows of adhesive coated strips and after the cover layer is removed, the adhesive strips may be unfolded and placed across the incision and anchored to the sheet material on the opposite side of the incision thereby facilitating holding the edges of the wound in close proximity for wound healing.
The surgical drape portion of the device comprises a backing layer and coated on one surface thereof an adhesive layer. The backing layer is preferably a film. Suitable materials for forming the backing layer therefore include those materials usually used for . forming surgical drape films including those described in British Patent No. 1280631 and European Patents Nos. 51935 and 91800. Preferred materials for forming the film backing layer therefore include polyurethanes, for example thermoplastic polyurethanes as described in British Patent No. 1280631 and which are commercially available as the Estanes (Trade Mark), elastomeric polyether polyesters, for example Hytrel 4056 (Trade Mark) and hydrophilic polymers especially the hydrophilic polyurethanes described in European Patent No. 91800. Suitably the thickness of the film backing layer will be from 12.5 to 75 m, more suitably 20 to 50/m and preferably 25 to 40/m.
The adhesive which is used to coat one surface of the backing layer will include any adhesive which is suitable for application to the skin. The adhesive will be a pressure sensitive adhesive which includes acrylate ester copolymer adhesives and polyvinyl alkyl ether adhesives. Suitably the adhesive will be applied at a weight per unit area of from 20 to 75gsm, more suitably 25 to 50gsm and preferably 25 to 40gsm. The adhesive may be applied to the .backing layer as a continuous or discontinuous layer. Discontinuous layers include both porous, microporous and patterns spread layers. Preferably the adhesive layer is a continuous layer.
Since the surgical drape portion of the device is meant to remain in position, adhered to healthy skin, the surgical drape will suitably have a moisture vapour permeability of greater than 250gm~24hr_1 at 37°C and 100% to 10% relative humidity difference, more suitably the moisture vapour permeability will be greater than 300gm~225hr_1 and preferably will be greater than 500gm~224hr_1 , for example 800gπf224h"r-1 , lOOOgrn"124hr_1 or 1200gm~224hr_1. The surgical drape will be impervious to liquid water and will be bacteria proof.
The moisture permeability of surgical drape can be measured by the Payne Cup method (in the upright position) described in European Patent No. 46071. The adhesive layer present on the backing layer may contain a medicament and in particular may contain an antibacterial agent as described in British Patent No. 2048120. Preferred antibacterial agents include silver salts such as silver sulphadiazine, iodophors such as polyvinyl pyrrolidone-iodine complexes and chlorhexidine salts such as chlorhexidine diacetate or chlorhexidine digluconate.
Usually the adhesive layer of the surgical drape will be covered by a release coated protector sheet which is removed prior to use. The protector sheet is as conventionally used in the art including silicone-coated paper, glassin and surface treated siliconised polyethylene.
Aptly the surgical drape may have non-adhesive handles at each of two opposed sides to aid application of the device. Suitably the handles may be removable as described in European Patent Application No. 161865.
Aptly the surgical drape may be provided with other application aids such as a frame as described in European Patent Applications 51935 and 81989 or handles as described in United States Patent Nos. 4372303 or 4374520. The non-adhesive coated surface of the surgical drape carries two rows of folded adhesive-coated strips. Preferably the rows are arranged on either side of the centre line of the surgical drape. The adhesive coated strips may be formed from a backing layer and an adhesive layer. The backing layer may include any material and in particular material with some elasticity, which has been used for making wound closure strips for example non-woven fabric or polymeric film. Suitable non-woven fabrics include those described in British Patent No. 987533. Suitable polymeric films include those which are suitable for forming the surgical drape including polyurethane and polyether polyester and microporous films such as polyvinyl chloride available as Porvic (Trade Mark).
The adhesive may be any which will adhere the strip to the surgical drape and may be any conventional synthetic or rubber adhesive.
Each adhesive strip will adhere along part of its length to the drape the remaining adhesive layer or the strip will be covered by a release paper. Each adhesive strip will be folded so as to leave an open area in the surgical drape between the rows of strips in which an incision may be made without also cutting the strips. The strips may be folded in two but preferably the strips will be folded into an S or Z-shape so that a double sided release sheet will be required between the two unadhered adhesive coated arms of the folded strip.
The strips in the two rows may be arranged in staggered formation so that when they are unfolded and placed across the incision two adjacent strips will not overlap.
In order to protect the strips during the operating they may be covered by a cover layer. The cover layer will also comprise a backing layer and an adhesive layer. The backing layer may be any suitable plastics material but will be water-proof, that is will not be affected by water. A suitable cover layer is a plasticised polyvinyl chloride. The adhesive layer can extend over the whole or a part of the backing layer. When the adhesive layer extends over the whole of the backing layer the adhesive layer will comprise and adhesive which only lightly adheres to the drape material and the strips so that it can be easily removed without disturbing the drape or the strips. A rubber based adhesive is apt. Adhesion to the strips can be avoided however by limiting the extent of the adhesive layer to the marginal edges of the backing layer.
Suitably the surgical drape and wound closure device will be sterile. The device may be packaged in a bacteria-proof pack which after sealing may be sterilised by conventional means such as ethylene oxide or gamma irradiation.
In use the sterile surgical drape and wound closure device is removed from the bacteria-proof pack, the protector paper is removed from the adhesive layer on the surgical drape portion and the adhesive surface is adhered to the skin of the patient which has previously been cleaned and sterilised. An incision may be made through the surgical drape between the two rows of strips. At the conclusion of the operation the cover layers are removed from the adhesive strips. The strips are unfolded and the release paper removed. The edges of the wound are brought together and the adhesive strips placed over the line of the incision and adhered to the opposite portion of the drape. This is done for each strip in turn. The device may be left in position for several days and be removed when the incision has healed. The moisture vapour permeability feature of the surgical drape ensures that skin beneath the drape does not become macerated.
The devices may be made by for example casting a solution of the polymer which forms the backing layer of the moisture vapour permeable sheet onto a double sided release paper. A solution of the adhesive may be cast onto the backing layer and the two layers transferred to the other side of the release paper so that the adhesive layer is now covered by the release paper. A layer of polymer which is to form the backing layer of the adhesive strip may be. cast onto a release paper. A layer of adhesive may be cast onto this backing layer and a strip of double sided release paper laid down a centre portion of the adhesive coated polymer layer. One edge of the adhesive coated layer is folded over onto the release paper. The adhesive coated layer may be cut into strips of the appropriate width and the remaining adhesive coated surface adhered to the non-adhesive coated surface cf the moisture vapour permeable backing layer. The strips are arranged in two rows staggered from each other. The final fold is placed in the strip and the rows of strips covered by an adhesive coated polymer film.
A surgical drape and wound closure device embodying the invention will now be described by way of example only, with reference to the accompanying drawings in which:
Figure 1 shows a cross-section through the surgical drape and wound closure device.
Figure 2 shows a view from above of the surgical drape and wound closure device.
The surgical drape and wound clcsure device (1) shown in Figure 1 comprises a surgical drape component consisting of a backing layer (2) in the form of a moisture vapour permeable, conformable film usually of polyurethane. The backing layer (2) has on one 'surface an adhesive layer (3) of a skin compatible adhesive usually an acrylate ester copolymer adhesive or a polyvinyl ethyl ether adhesive. The backing layer and adhesive layer may have a weight per unit area of approximately 30gsm and a thickness of 37.5 m. The adhesive layer (3) is covered by a protector (4) in the form of a siliconised paper or glassine sheet which is removed before application of the device to the skin. The backing layer (2) may have at either side handles
(5) which may or may not also carry an adhesive layer, non-adhesive handles are illustrated. The handles (5) may be removed after placement of the device on the skin if the handles are joined to the backing layer (2) by means of perforation or tearable tape or may be adhered to the skin if they carry an adhesive layer. On its non-adhesive surface the drape component carries a wound closure component in the form of adhesive coated strips. The strips are shown folded in an S or Z configuration. The strips consist of a backing layer
(6) formed from conventional sutureless wound closure material such as non-woven fabric, elastomeric polymers such as polyurethane, polyvinyl chloride. The strips are adhered to the backing layer (2) along one side of the S or Z. The inside of the other two folded sides of the S or Z tape is covered by a layer of adhesive
(7) which is in contact with a double sided release paper (8) to prevent the two sides sticking to each other. The wound closure strips lie along either edge of the backing layer (3) in a staggered configuration. Each row of strips is. covered by a cover layer consisting of a backing layer (9) and an adhesive layer (10). The cover layer protects the strips during the placement and incision through the surgical drape. The surgical drape and wound closure device is placed in a bacteria proof pouch which is sealed and sterilised by irradiation.
In use the sterile surgical drape and wound closure device is removed from its sealed pouch, the protector (4) is removed and the device adhered to the skin over the proposed operation site with the aid of the non-adherent handles. Once in place, an incision may be made through the surgicald drape component and the surgical operation carried out. At the end of the operating, the two cover layers may be removed from the wound closure strips and the strips unfolded. This will result in exposure of the adhesive in the middle section of each strip the strip is placed across the line of the incision and the two edges of the wound pulled together and the strip adhered across the line of incision. The double sided release paper is removed to expose the final adhesive surface of the strip which is used to anchor the tape so that the two edges of the wound are kept together and in alignment. This is done for all the strips on the surgical drape component. Figure 2 shows a view from above of the surgical drape and wound closure device showing the wound closure strips in staggered arrangement covered by the two cover layers. The incision may be made along the length of the device through the surgical drape component between the two cover layers.

Claims

- lb-CLAIMS
1. A surgical drape and wound closure device consisting of a moisture vapour permeable sheet material comprising a backing layer coated on one surface with an adhesive layer and having attached to the non-adhesive surface of the backing layer two rows of folded adhesive-coated strips and each row covered by an adhesive coated cover layer whereby an incision may be made through the sheet material between the rows of adhesive coated strips and after the cover layer is removed, the adhesive strips may be unfolded and placed across the incision and anchored to the sheet material on the opposite side of the incision thereby facilitating holding the edges of the wound in close proximity for wound healing.
2. A device as claimed in claim 1 in which the surgical drape portion has a moisture vapour permeability of greater than 500gm~224hr-1 at 37°C and 100% to 10% relative humidity difference.
3. A device as claimed either of claims 1 or 2 in which the backing layer has a thickness of 20 to 50/m.
4. A device as claimed in any of claims 1 to 3 in which the backing layer comprises a polyurethane.
5. A device as claimed in any of claims 1 to 4 in which the adhesive is a pressure sensitive adhesive which comprises polyvinyl alkyl ether or acrylate ester copolymer.
6. A device as claimed in any of claims 1 to 5 in which the adhesive layer is continuous and has a weight per unit area of 25 to 50gsm.
7. A device as claimed in any of claims 1 to 6 in which the adhesive layer contains medicament.
8. A device as claimed in any of claims 1 to 7 in which the surgical drape has non-adhesive handles at opposed sides thereof to aid application of the device.
9. A device as claimed in any of claims 1 to 8 in which the adhesive coated strips are folded into an S or Z shape and have a double sided release sheet between the two unadhered coated arms of the folded strips.
10. A device as claimed in any of claims 1 to 9 in which the folded adhesive coated strips of the two rows are arranged in staggered formation so that the unfolded strips do not overlap when placed across the incision.
11. A device as claimed in any of claims 1 to 10 in which the cover layer comprises an adhesive layer which is lightly adhered to the surgical drape and the strips so that it can easily be removed without disturbing the surgical> drape or the strips.
12. A device as claimed in any of claims 1 to 11 which is sterile within a bacteria-proof pack.
PCT/GB1988/000361 1987-05-07 1988-05-09 Wound closure device WO1988008690A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8710836 1987-05-07
GB878710836A GB8710836D0 (en) 1987-05-07 1987-05-07 Wound closure

Publications (1)

Publication Number Publication Date
WO1988008690A1 true WO1988008690A1 (en) 1988-11-17

Family

ID=10616978

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1988/000361 WO1988008690A1 (en) 1987-05-07 1988-05-09 Wound closure device

Country Status (3)

Country Link
AU (1) AU1706888A (en)
GB (1) GB8710836D0 (en)
WO (1) WO1988008690A1 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0319163A2 (en) * 1987-11-16 1989-06-07 Smith & Nephew P.L.C. Adhesive dressings
WO1999016361A1 (en) * 1997-09-30 1999-04-08 Technical Alternatives, Ltd. Wound closure strips and packages thereof
US5979450A (en) * 1997-05-16 1999-11-09 3M Innovative Properties Company Surgical incise drape
CN109069705A (en) * 2016-05-04 2018-12-21 蒂瑞克斯股份有限公司 Anchor and application method
US11471570B2 (en) 2016-05-03 2022-10-18 Medtronic, Inc. Hemostatic devices and methods of use
US11577010B2 (en) 2016-05-03 2023-02-14 Medtronic, Inc. Hemostatic devices and methods of use

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US3516409A (en) * 1968-02-28 1970-06-23 Robert B Howell Slide fastener employing skin closure appliances and techniques
US3698395A (en) * 1971-03-12 1972-10-17 Harrith M Hasson Surgical closure
FR2210107A5 (en) * 1972-12-07 1974-07-05 Torre Robert Self-adhesive means for closing wounds - contg. two elements fixed in movable manner on either side of wounds
US4033341A (en) * 1976-03-03 1977-07-05 Johnson & Johnson Surgical drape having improved retaining means
WO1980001041A1 (en) * 1978-11-17 1980-05-29 Smith & Nephew Res Adhesive-coated sheet material incorporating anti-bacterial substances
US4222383A (en) * 1978-08-07 1980-09-16 Schossow George W Surgical drape and suture
EP0051935A2 (en) * 1980-11-10 1982-05-19 Minnesota Mining And Manufacturing Company Medical device for covering a portion of the anatomical surfaces of a living being
EP0081989A1 (en) * 1981-12-11 1983-06-22 Johnson & Johnson Products Inc. Film window dressing
EP0081987A1 (en) * 1981-12-11 1983-06-22 Johnson & Johnson Products Inc. Film dressing
EP0091800A1 (en) * 1982-04-08 1983-10-19 SMITH & NEPHEW plc Surgical adhesive dressing
US4423731A (en) * 1980-09-09 1984-01-03 Roomi Reyadh K Surgical dressings
US4531521A (en) * 1983-03-03 1985-07-30 Haverstock Charles B Skin closure means
EP0161865A2 (en) * 1984-05-03 1985-11-21 Smith and Nephew Associated Companies p.l.c. Adhesive wound dressing
US4596244A (en) * 1984-02-17 1986-06-24 Kimberly-Clark Corporation Perineal drape

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE304989C (en) *
US2669747A (en) * 1951-10-09 1954-02-23 Angelo J Detaranto Device for closing incisions in fowls or the like
US3516409A (en) * 1968-02-28 1970-06-23 Robert B Howell Slide fastener employing skin closure appliances and techniques
US3698395A (en) * 1971-03-12 1972-10-17 Harrith M Hasson Surgical closure
FR2210107A5 (en) * 1972-12-07 1974-07-05 Torre Robert Self-adhesive means for closing wounds - contg. two elements fixed in movable manner on either side of wounds
US4033341A (en) * 1976-03-03 1977-07-05 Johnson & Johnson Surgical drape having improved retaining means
US4222383A (en) * 1978-08-07 1980-09-16 Schossow George W Surgical drape and suture
WO1980001041A1 (en) * 1978-11-17 1980-05-29 Smith & Nephew Res Adhesive-coated sheet material incorporating anti-bacterial substances
US4423731A (en) * 1980-09-09 1984-01-03 Roomi Reyadh K Surgical dressings
EP0051935A2 (en) * 1980-11-10 1982-05-19 Minnesota Mining And Manufacturing Company Medical device for covering a portion of the anatomical surfaces of a living being
EP0081989A1 (en) * 1981-12-11 1983-06-22 Johnson & Johnson Products Inc. Film window dressing
EP0081987A1 (en) * 1981-12-11 1983-06-22 Johnson & Johnson Products Inc. Film dressing
EP0091800A1 (en) * 1982-04-08 1983-10-19 SMITH & NEPHEW plc Surgical adhesive dressing
US4531521A (en) * 1983-03-03 1985-07-30 Haverstock Charles B Skin closure means
US4596244A (en) * 1984-02-17 1986-06-24 Kimberly-Clark Corporation Perineal drape
EP0161865A2 (en) * 1984-05-03 1985-11-21 Smith and Nephew Associated Companies p.l.c. Adhesive wound dressing

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0319163A2 (en) * 1987-11-16 1989-06-07 Smith & Nephew P.L.C. Adhesive dressings
EP0319163A3 (en) * 1987-11-16 1989-09-06 Smith & Nephew P.L.C. Adhesive dressings
US5979450A (en) * 1997-05-16 1999-11-09 3M Innovative Properties Company Surgical incise drape
US6742522B1 (en) 1997-05-16 2004-06-01 3M Innovative Properties Company Surgical incise drape
WO1999016361A1 (en) * 1997-09-30 1999-04-08 Technical Alternatives, Ltd. Wound closure strips and packages thereof
US5947998A (en) * 1997-09-30 1999-09-07 Technical Alternatives, Ltd. Wound closure strips and packages thereof
US11471570B2 (en) 2016-05-03 2022-10-18 Medtronic, Inc. Hemostatic devices and methods of use
US11577010B2 (en) 2016-05-03 2023-02-14 Medtronic, Inc. Hemostatic devices and methods of use
CN109069705A (en) * 2016-05-04 2018-12-21 蒂瑞克斯股份有限公司 Anchor and application method
CN109069705B (en) * 2016-05-04 2021-11-23 美敦力公司 Anchoring device and method of use

Also Published As

Publication number Publication date
GB8710836D0 (en) 1987-06-10
AU1706888A (en) 1988-12-06

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