EP4333913A1 - Chirurgisches abdecktuch zur verwendung auf zerbrechlicher haut und verfahren zur verwendung davon - Google Patents
Chirurgisches abdecktuch zur verwendung auf zerbrechlicher haut und verfahren zur verwendung davonInfo
- Publication number
- EP4333913A1 EP4333913A1 EP21942116.1A EP21942116A EP4333913A1 EP 4333913 A1 EP4333913 A1 EP 4333913A1 EP 21942116 A EP21942116 A EP 21942116A EP 4333913 A1 EP4333913 A1 EP 4333913A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- drape
- grams
- skin
- lipoglycopeptides
- itraconazole
- 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.)
- Pending
Links
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- HJLSLZFTEKNLFI-UHFFFAOYSA-N Tinidazole Chemical compound CCS(=O)(=O)CCN1C(C)=NC=C1[N+]([O-])=O HJLSLZFTEKNLFI-UHFFFAOYSA-N 0.000 claims description 4
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- APKFDSVGJQXUKY-INPOYWNPSA-N amphotericin B Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@H](C)[C@@H](O)[C@@H](C)[C@H](C)OC(=O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 APKFDSVGJQXUKY-INPOYWNPSA-N 0.000 claims description 4
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- JYIKNQVWKBUSNH-WVDDFWQHSA-N caspofungin Chemical compound C1([C@H](O)[C@@H](O)[C@H]2C(=O)N[C@H](C(=O)N3CC[C@H](O)[C@H]3C(=O)N[C@H](NCCN)[C@H](O)C[C@@H](C(N[C@H](C(=O)N3C[C@H](O)C[C@H]3C(=O)N2)[C@@H](C)O)=O)NC(=O)CCCCCCCC[C@@H](C)C[C@@H](C)CC)[C@H](O)CCN)=CC=C(O)C=C1 JYIKNQVWKBUSNH-WVDDFWQHSA-N 0.000 claims description 4
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- 229960004413 flucytosine Drugs 0.000 claims description 4
- XRECTZIEBJDKEO-UHFFFAOYSA-N flucytosine Chemical compound NC1=NC(=O)NC=C1F XRECTZIEBJDKEO-UHFFFAOYSA-N 0.000 claims description 4
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- 229910052740 iodine Inorganic materials 0.000 claims description 4
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- RSWOJTICKMKTER-QXLBVTBOSA-N isavuconazonium Chemical compound CNCC(=O)OCC1=CC=CN=C1N(C)C(=O)OC(C)[N+]1=CN(C[C@@](O)([C@@H](C)C=2SC=C(N=2)C=2C=CC(=CC=2)C#N)C=2C(=CC=C(F)C=2)F)N=C1 RSWOJTICKMKTER-QXLBVTBOSA-N 0.000 claims description 4
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- 229960000282 metronidazole Drugs 0.000 claims description 4
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 claims description 4
- 229960002159 micafungin Drugs 0.000 claims description 4
- PIEUQSKUWLMALL-YABMTYFHSA-N micafungin Chemical compound C1=CC(OCCCCC)=CC=C1C1=CC(C=2C=CC(=CC=2)C(=O)N[C@@H]2C(N[C@H](C(=O)N3C[C@H](O)C[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)N3C[C@H](C)[C@H](O)[C@H]3C(=O)N[C@H](O)[C@H](O)C2)[C@H](O)CC(N)=O)[C@H](O)[C@@H](O)C=2C=C(OS(O)(=O)=O)C(O)=CC=2)[C@@H](C)O)=O)=NO1 PIEUQSKUWLMALL-YABMTYFHSA-N 0.000 claims description 4
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/023—Adhesive bandages or dressings wound covering film layers without a fluid retention layer
- A61F13/0233—Adhesive bandages or dressings wound covering film layers without a fluid retention layer characterised by the oclusive layer skin contacting layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0253—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/145—Hydrogels or hydrocolloids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
Definitions
- the present invention relates to drapes for the protection of living tissues. More particularly, it relates to flexible incise surgical drapes which are useful in the protection of human and animal skin from attack by harmful agents such as microorganisms, and from damage due to physical stresses imposed by detachment of the drape from the skin.
- the drape is comprised of a structural layer and a specially adapted adhesive hydrogel layer, the hydrogel layer optionally containing dopants such as antibiotics, antivirals, antifungals, salts, colorants and medications.
- Surgical drapes are commonly used by medical personnel to create and maintain a sterile field through which the patient may be accessed for a surgical procedure.
- Surgical drapes can help reduce the risk of surgical site infections by immobilizing microorganisms on the skin and by providing continuous antimicrobial activity.
- Surgical drapes may also provide a fluid-resistant barrier. Many drapes feature an absorbent, protective barrier of material throughout the drape that inhibits strikethrough and provides resistance to microbial penetration.
- Surgical site infections are both damaging to patient recovery and expensive to treat. On average, a surgical site infection adds 9.7 more post operative hospital days and costs $20,842 in extra hospital charges (de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical Site Infection: Incidence and Impact on Hospital Utilization and Treatment Costs. Am J Infect Control 2009; 37:387-97.)
- hydrogels as wound dressings, specifically because these dressings exhibit no adhesion to the wound. That is the reason that they are used to cover bums, as the lack of adhesion allows the healing tissue to move freely and reduces scarring. When dressings are changed, the lack of adhesion prevents reinjury to the underlying tissue.
- Some patients needing surgery have skin that is more fragile than usual and is prone to damage from applied forces. Such patients may suffer from skin ailments ranging from autoimmune diseases of the skin to damage from infections by vims, bacteria, and fungus, to advanced age that results in frailty of the skin. In such patients, removal of a surgical drape that is affixed to the skin by an adhesive often results in erythema, skin stripping, and adhesive residue damage to the skin requiring follow-up intervention to prevent and treat infection and to promote healing.
- the hydrogel of the present invention has sufficient adhesion to retain the surgical drape in position during a surgical procedure, and yet exhibits little or no peel force at high peel angles so that removing the drape does not inflict injury on the skin to which it is adhered.
- FIG. l is a section view of a surgical drape according to the present invention.
- the present invention is a surgical drape comprised of a flexible film having disposed on one surface a hydrogel adhesive formulated and processed to provide good adhesion to skin, combined with very low peeling force required for removal of the drape.
- the hydrogel may contain one or more dopants providing antibiotic, antiviral and/or antifungal properties to the hydrogel.
- the drape is removed from the skin by peeling at a high angle, preferably greater than 160° to reduce the force transmitted to the underlying skin.
- an incise surgical drape comprising:
- a flexible film having a top surface and a bottom surface
- a hydrogel adhesive layer disposed on the bottom surface of the film; a.
- the hydrogel comprising a mixture of from 10% to 30% polyvinylpyrrolidone (PVP, e.g, K90) and from 5% to 40% Polyethylene glycol (e.g., PEG 300,
- the hydrogel may contain one or more dopants (additives) selected to provide desired properties such as antibacterial, antiviral, and antifungal, coloring, or other medication.
- dopants additives selected to provide desired properties such as antibacterial, antiviral, and antifungal, coloring, or other medication.
- Drape 10 comprises a flexible film 11 having a top surface 11a and a bottom surface 1 lb. Disposed on bottom surface 1 lb is a hydrogel layer 12.
- flexible film 11 is comprised of polyethylene, and may be any appropriate thickness as required for structural stability and flexibility, as well as suitability for incision during a surgical procedure.
- other polymeric films known in the art may be employed.
- other films or fabrics having sufficient dimensional strength may be employed, such as woven or non-woven fabrics comprising natural fibers, synthetic fibers, or a mixture thereof.
- a uniform degassed slurry comprising a mixture of from 10% to 30% polyvinylpyrrolidone (PVP, K90) and from 5% to 40% Polyethylene glycol (PEG 300), by weight, with the remainder being water, and small amounts of an organic acid (e.g., citric acid) to adjust pH to within a range of 4 to 9, and a medically acceptable preservative (e.g., 0.1% benzalkonium chloride solution or parabens) is prepared.
- the slurry is uniformly deposited or extruded onto film 11, and the slurry is then exposed to electron beam radiation to initiate crosslinking of the PVP and PEG, thereby forming hydrogel layer 12.
- Electron beam energy used may range from 1 megarad to 12 megarads. Varying the ratio of PVP to PEG, the concentration of the mixture in the slurry, and the amount of electron radiation exposure permits hydrogels having varying degrees of adhesion to skin to be produced.
- the peel force required to remove the surgical drape from clean stainless steel is at or near 0 grams using a 180° peel angle, and less than 65 grams using a 90° peel angle.
- Alternative embodiments may exhibit peel force up to 10 grams using a 180° peel angle. In practice, fragile skin is left undamaged by removal of the surgical drape of the present invention, even after an extended period of adhesion.
- An alternative embodiment may substitute PEG 400 for some or all of the PEG 300.
- Another embodiment may add a dopant to the slurry to provide antibacterial, antifungal, and/or antiviral activity, selected from the following:
- Lipopeptides Fluoroquinolone; Lipoglycopeptides; Cephalosporin; Macrocyclics; Beta- lactams; Penicillins; Cephalosporins; Oxacephems; Carbacephems; Monobactams; Carbapenems; Macrolides; Lincosamides; Streptogramins; Aminoglycosides; Quinolones; Sulfonamides; Tetracyclines; Chloramphenicol; Metronidazole; Tinidazole; Nitrofurantoin; Glycopeptides; Lipoglycopeptides; Oxazolidinones; Rifamycins; Polypeptides; Tuberactinomycins; Topical antibiotics (including silver compounds, chitosan, antimicrobial peptides); Betadyne; Chlorhexadine; Povidone-iodine; Iodine; Hydrogen Peroxide; Nystatin;
- Example 1 (Prior Art): 3MTM IobanTM 2 Antimicrobial Incise Drape:
- Example 3 20% PVP / 20% PEG approx. 6 mils thick
- Example 4 25% PVP / 15% PEG approx. 6 mils thick
- Example 5 20% PVP / 17.5% PEG approx. 6 mils thick
- Example 7 25% PVP / 25% PEG approx. 7 mils thick
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Dispersion Chemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Materials For Medical Uses (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163186079P | 2021-05-08 | 2021-05-08 | |
| PCT/US2021/046940 WO2022240431A1 (en) | 2021-05-08 | 2021-08-20 | Surgical drape for use on fragile skin and method of use thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4333913A1 true EP4333913A1 (de) | 2024-03-13 |
Family
ID=84027772
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP21942116.1A Pending EP4333913A1 (de) | 2021-05-08 | 2021-08-20 | Chirurgisches abdecktuch zur verwendung auf zerbrechlicher haut und verfahren zur verwendung davon |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP4333913A1 (de) |
| KR (1) | KR20240017821A (de) |
| AU (1) | AU2021445517A1 (de) |
| WO (1) | WO2022240431A1 (de) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4750482A (en) * | 1982-02-25 | 1988-06-14 | Pfizer Inc. | Hydrophilic, elastomeric, pressure-sensitive adhesive |
| US5419913A (en) * | 1992-03-05 | 1995-05-30 | Podell; Howard I. | Adhesive bandages, wound dressings, sutures, drapes, orthodontic rubber bands, toothbrushes, and the like |
| US5306504A (en) * | 1992-12-09 | 1994-04-26 | Paper Manufactures Company | Skin adhesive hydrogel, its preparation and uses |
| US5645855A (en) * | 1996-03-13 | 1997-07-08 | Ridge Scientific Enterprises, Inc. | Adhesive compositions including polyvinylpyrrolidone acrylic acid polymers, and polyamines |
| JP2005325165A (ja) * | 2004-05-12 | 2005-11-24 | Three M Innovative Properties Co | １００℃以下の温度で溶融塗布可能なヨウ素含有ホットメルト粘着剤および該粘着剤を用いた医療用粘着シート製品 |
-
2021
- 2021-08-20 EP EP21942116.1A patent/EP4333913A1/de active Pending
- 2021-08-20 KR KR1020237042225A patent/KR20240017821A/ko unknown
- 2021-08-20 AU AU2021445517A patent/AU2021445517A1/en active Pending
- 2021-08-20 WO PCT/US2021/046940 patent/WO2022240431A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| AU2021445517A1 (en) | 2023-12-21 |
| WO2022240431A1 (en) | 2022-11-17 |
| KR20240017821A (ko) | 2024-02-08 |
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