WO2022240431A1 - Champ opératoire pour l'utilisation sur une peau fragile et son procédé d'utilisation - Google Patents

Champ opératoire pour l'utilisation sur une peau fragile et son procédé d'utilisation Download PDF

Info

Publication number
WO2022240431A1
WO2022240431A1 PCT/US2021/046940 US2021046940W WO2022240431A1 WO 2022240431 A1 WO2022240431 A1 WO 2022240431A1 US 2021046940 W US2021046940 W US 2021046940W WO 2022240431 A1 WO2022240431 A1 WO 2022240431A1
Authority
WO
WIPO (PCT)
Prior art keywords
drape
grams
skin
lipoglycopeptides
itraconazole
Prior art date
Application number
PCT/US2021/046940
Other languages
English (en)
Inventor
Alyce FLUDER
Gregory ROBB
Adam LEVY
Stephen BANCO
Original Assignee
Nexgel, Inc.
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 Nexgel, Inc. filed Critical Nexgel, Inc.
Priority to AU2021445517A priority Critical patent/AU2021445517A1/en
Priority to KR1020237042225A priority patent/KR20240017821A/ko
Priority to EP21942116.1A priority patent/EP4333913A1/fr
Publication of WO2022240431A1 publication Critical patent/WO2022240431A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M35/00Devices for applying media, e.g. remedies, on the human body
    • 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
    • A61F13/00051Accessories for dressings
    • A61F13/00063Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • 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
    • A61F13/02Adhesive bandages or dressings
    • A61F13/023Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • A61F13/0233Adhesive bandages or dressings wound covering film layers without a fluid retention layer characterised by the oclusive layer skin contacting layer
    • 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
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0246Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/0253Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
    • 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
    • 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145Hydrogels or hydrocolloids
    • 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically 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)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un champ opératoire d'incision composé d'un film souple ayant disposé sur une surface un adhésif d'hydrogel formulé et traité pour fournir une bonne adhérence à la peau, associé à une très faible force de décollement requise pour le retrait du champ. Éventuellement, l'hydrogel peut contenir un ou plusieurs agents dopants fournissant des propriétés antibiotiques, antivirales et/ou antifongiques à l'hydrogel. Lors de l'utilisation, le champ est retiré de la peau par décollement sous un angle élevé, préférablement supérieur à 160 ° pour réduire la force transmise à la peau sous-jacente.
PCT/US2021/046940 2021-05-08 2021-08-20 Champ opératoire pour l'utilisation sur une peau fragile et son procédé d'utilisation WO2022240431A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2021445517A AU2021445517A1 (en) 2021-05-08 2021-08-20 Surgical drape for use on fragile skin and method of use thereof
KR1020237042225A KR20240017821A (ko) 2021-05-08 2021-08-20 연약한 피부에 사용하기 위한 수술용 드레이프 및 그 사용 방법
EP21942116.1A EP4333913A1 (fr) 2021-05-08 2021-08-20 Champ opératoire pour l'utilisation sur une peau fragile et son procédé d'utilisation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163186079P 2021-05-08 2021-05-08
US63/186,079 2021-05-08

Publications (1)

Publication Number Publication Date
WO2022240431A1 true WO2022240431A1 (fr) 2022-11-17

Family

ID=84027772

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2021/046940 WO2022240431A1 (fr) 2021-05-08 2021-08-20 Champ opératoire pour l'utilisation sur une peau fragile et son procédé d'utilisation

Country Status (4)

Country Link
EP (1) EP4333913A1 (fr)
KR (1) KR20240017821A (fr)
AU (1) AU2021445517A1 (fr)
WO (1) WO2022240431A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4750482A (en) * 1982-02-25 1988-06-14 Pfizer Inc. Hydrophilic, elastomeric, pressure-sensitive adhesive
US5306504A (en) * 1992-12-09 1994-04-26 Paper Manufactures Company Skin adhesive hydrogel, its preparation and uses
US5419913A (en) * 1992-03-05 1995-05-30 Podell; Howard I. Adhesive bandages, wound dressings, sutures, drapes, orthodontic rubber bands, toothbrushes, and the like
US5645855A (en) * 1996-03-13 1997-07-08 Ridge Scientific Enterprises, Inc. Adhesive compositions including polyvinylpyrrolidone acrylic acid polymers, and polyamines
US20080193706A1 (en) * 2004-05-12 2008-08-14 Shunsuke Takaki Iodine-Containing Hot Melt Pressure Sensitive Adhesive Capable Of Being Melted And Coated At A Temperature Not Higher Than 100c, And A Medical Adhesive Sheet Product With Such A Pressure Sensitive Adhesive

Patent Citations (5)

* Cited by examiner, † Cited by third party
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
US20080193706A1 (en) * 2004-05-12 2008-08-14 Shunsuke Takaki Iodine-Containing Hot Melt Pressure Sensitive Adhesive Capable Of Being Melted And Coated At A Temperature Not Higher Than 100c, And A Medical Adhesive Sheet Product With Such A Pressure Sensitive Adhesive

Also Published As

Publication number Publication date
EP4333913A1 (fr) 2024-03-13
KR20240017821A (ko) 2024-02-08
AU2021445517A1 (en) 2023-12-21

Similar Documents

Publication Publication Date Title
Narkhede et al. Postoperative mesh infection—still a concern in laparoscopic era
US20190000436A1 (en) Methods and products for reducing tissue trauma using water-absorbing stress-distributing materials
JP5393030B2 (ja) 医療機器及び医療機器を製造する方法
US10485892B2 (en) Method for local reduction of microbial skin flora
ES2815660T3 (es) Procedimiento de reducción local de la flora microbiana cutánea
Ahmed et al. Calcium alginate-based antimicrobial film dressings for potential healing of infected foot ulcers
US8609128B2 (en) Cyanoacrylate-based liquid microbial sealant drape
US20070009580A1 (en) Non-adhesive hydrogels
KR20060018878A (ko) 접착제 조성물, 이를 포함하는 물품 및 제조 방법
JP6803382B2 (ja) 外科的用途のための抗菌性組成物
US8951552B2 (en) In situ film-forming bioactive solutions of absorbable multiblock copolymers
WO2014130567A1 (fr) Polymères d'hydrogel antimicrobiens
Shiels et al. Chlorhexidine-releasing implant coating on intramedullary nail reduces infection in a rat model
CN107921283A (zh) 包括阿来西定的伤口护理产品
US20070036846A1 (en) Wound dressing and method of manufacture thereof
WO2022240431A1 (fr) Champ opératoire pour l'utilisation sur une peau fragile et son procédé d'utilisation
KR102096257B1 (ko) 폴리비닐피롤리돈 및 유니티올을 포함하는 방부제 조성물 및 조성물의 용도
EP2381974B1 (fr) Procédé de formation et composition membranaire résultante pour préservation de site chirurgical
US8828425B2 (en) In situ-formed bioactive tissue adherent films of absorbable crystallizable polymers
Shi et al. The value of continuous closed negative pressure drainage combined with antibacterial biofilm dressing in postoperative wound healing for severe pancreatitis
Cases A comparative study of chlorhexidine-alcohol versus povidone-iodine for surgical site antisepsis in clean & clean contaminated cases
Thomas et al. Improvements in medicated tulle dressings
Singh et al. AURAL HAEMATOMA IN BEETAL BUCK (MALE GOAT): A CASE REPORT.
RU2790779C1 (ru) Способ лечения остаточных длительно существующих ожоговых ран
Babina et al. Effectiveness of Perioperative Local Use of Anesthetics and Antiseptics in Patients with Purulent-necrotic Lesions of Lower Extremities in Diabetes Mellitus

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21942116

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2021445517

Country of ref document: AU

Ref document number: AU2021445517

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2021942116

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2021445517

Country of ref document: AU

Date of ref document: 20210820

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2021942116

Country of ref document: EP

Effective date: 20231208