US20120115384A1 - Resorbable Laparoscopically Deployable Hemostat - Google Patents

Resorbable Laparoscopically Deployable Hemostat Download PDF

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Publication number
US20120115384A1
US20120115384A1 US13/197,972 US201113197972A US2012115384A1 US 20120115384 A1 US20120115384 A1 US 20120115384A1 US 201113197972 A US201113197972 A US 201113197972A US 2012115384 A1 US2012115384 A1 US 2012115384A1
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United States
Prior art keywords
felt
fabric
resorbable
dressing
resorbable hemostatic
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Abandoned
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US13/197,972
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English (en)
Inventor
Benjamin D. Fitz
Dwayne Looney
Thomas Lee Craven
Clifford Dey
Atul Garg
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Cilag GmbH International
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Ethicon Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46020044&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20120115384(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ethicon Inc filed Critical Ethicon Inc
Priority to US13/197,972 priority Critical patent/US20120115384A1/en
Priority to BR112013011754-0A priority patent/BR112013011754B1/pt
Priority to CN201611213898.6A priority patent/CN107029276B/zh
Priority to AU2011326102A priority patent/AU2011326102B2/en
Priority to CA2817533A priority patent/CA2817533C/en
Priority to EP11839057.4A priority patent/EP2638194B1/en
Priority to CN201180064693.5A priority patent/CN103298436B/zh
Priority to ES11839057.4T priority patent/ES2643662T3/es
Priority to MX2013005254A priority patent/MX356346B/es
Priority to JP2013538817A priority patent/JP5968897B2/ja
Priority to PCT/US2011/059696 priority patent/WO2012064687A2/en
Priority to RU2013126439/12A priority patent/RU2581356C2/ru
Priority to KR1020137014481A priority patent/KR101896230B1/ko
Assigned to ETHICON, INC. reassignment ETHICON, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CRAVEN, THOMAS LEE, DEY, CLIFFORD, FITZ, BENJAMIN D., GARG, ATUL, LOONEY, DWAYNE
Publication of US20120115384A1 publication Critical patent/US20120115384A1/en
Assigned to ETHICON, LLC reassignment ETHICON, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ETHICON, INC.
Priority to US15/450,706 priority patent/US10111782B2/en
Assigned to CILAG GMBH INTERNATIONAL reassignment CILAG GMBH INTERNATIONAL ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ETHICON LLC
Abandoned legal-status Critical Current

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    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B1/00—Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B1/14—Other fabrics or articles characterised primarily by the use of particular thread materials
    • 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
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01008—Non-adhesive bandages or dressings characterised by the material
    • A61F13/01012—Non-adhesive bandages or dressings characterised by the material being made of natural material, e.g. cellulose-, protein-, collagen-based
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/64—Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the 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
    • A61F13/00987—Apparatus or processes for manufacturing non-adhesive dressings or bandages
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28—Polysaccharides or their derivatives
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/44—Medicaments
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/42—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
    • D04H1/425—Cellulose series
    • D04H1/4258—Regenerated cellulose series
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/44—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling
    • D04H1/46—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/50—FELT FABRIC
    • Y10T442/51—From natural organic fiber [e.g., wool, etc.]

Definitions

  • hemostatic wound dressings include knitted or non-woven fabrics comprising oxidized regenerated cellulose (ORC), which is oxidized cellulose with increased homogeneity of the cellulose fiber.
  • ORC oxidized regenerated cellulose
  • examples of such hemostatic wound dressings commercially available include Surgicel® resorbable hemostat; Surgicel Nu-Knit® resorbable hemostat; and Surgicel® Fibrillar resorbable hemostat; all available from Johnson & Johnson Wound Management Worldwide, a division of Ethicon, Inc., Somerville, N.J., a Johnson & Johnson Company.
  • Other examples of commercial resorbable hemostats containing oxidized cellulose include Oxycel® resorbable cellulose surgical dressing from Becton Dickinson and Company, Morris Plains, N.J.
  • the commercially available oxidized cellulose hemostats noted above are knitted or non-woven fabrics having a porous structure for providing hemostasis.
  • U.S. Pat. No. 3,364,200 to Ashton and Moser describes a resorbable, surgical hemostat in the form of pledgets of integrated oxidized cellulose staple fibers.
  • pledgets could be used to introduce hemostatic material through a trocar during laparoscopic surgical procedures.
  • the need for very specific properties allowing for hemostatic materials based on cellulose fibers to be introduced into operational space through a trocar or similar device become apparent with the advent and broad spread of the use of the laparoscopic techniques several years after the issuance of the U.S. Pat. No. 3,364,200 in 1968.
  • U.S. Pat. No. 7,229,689 to Qin et al. discloses a nonwoven, felt wound dressing formed by carding polysaccharide fibers to produce a web, cross lapping said web to form a thick layer of felt, needle punching the felt to form a needled non-woven structure, and slitting said needled non-woven structure to form individual wound dressings.
  • This invention relates to polysaccharide fibers having water absorption properties characterized by the incorporation within the fibers of at least one substance having anti-microbial properties, and to wound dressings formed from said fibers.
  • the polysaccharide fibers are preferably formed from alginate or alginate containing additional polysaccharide materials to give additional absorbency.
  • the fibers preferably contain a silver compound as an antimicrobial agent.
  • U.S. Pat. No. 6,735,835 to Wong discloses a method of making a non-woven fabric that includes carding and needle punching.
  • a method of manufacturing a non-woven fabric comprising opening and mixing different input fibers to form a uniform fiber mixture having predetermined proportions of the different input fibers; carding the fiber mixture to form a uniform web of predetermined thickness travelling in a first direction; laying onto the web high tenacity yarns which extend in the first direction and are spaced apart transversely of the first direction; depositing fixed lengths of the web in alternating fashion on a conveyor travelling in a second direction transverse to the first direction to form on the conveyor a mat consisting of overlapping lengths of the web; and needle-punching the mat to form the non-woven fabric.
  • U.S. Pat. No. 5,824,335 to Dorigatti et al. teaches bioresorbable non-woven fabric materials for use in surgery, said materials constituting threads embedded in a matrix, wherein both the matrix and the threads constitute auto-crosslinked hyaluronic acid, with the production of the non-woven surgical fabric that includes carding and needle punching.
  • U.S. Pat. No. 3,837,338 to Chesky et al. teaches a conformable non-woven bandage comprising a felted cellulosic nonwoven fabric, in which the fibers have substantial freedom of movement relative to each other, is mechanically compacted into a series of undulations, to yield a bandage material that does not decrease in width when elongated by 10% or more.
  • U.S. Pat. No. 5,503,623 to Tilton teaches instrumentation and method for laparoscopic insertion and application of sheet like surgical material, such as an adhesion barrier, and undertakes to enable the laparoscopic surgeon to utilize large and full size sheets of InterceedTM in abdominal (including pelvic) surgery.
  • sheet like surgical material such as an adhesion barrier
  • Tilton provides a method and apparatus of grasping and furling the sheet and then unfurling, releasing and applying it after passage into the patient's abdominal cavity.
  • the instrument consists of an operational grasping and furling portion which is rotated to furl the sheet like material. It is then “backloaded” or drawn into a tubular portion of the instrument, an inserter sheath for passage through the valved “port”. Once the sheet like material is in the abdominal cavity it is unfurled.
  • the grasping portion of the instrument provides for proper and easier alignment and then application of the unfurled sheet. Additional flexibility is achieved by an articulation mechanism which allows horizontal movement of the grasping/furling element to produce an angle in the instrument body.
  • U.S. Pat. No. 5,957,939 to Heaven discloses a medical device for deploying surgical fabrics at an operative site within a body cavity of a patient.
  • the device includes a deploying member in the form of an elongated inserter shaft with a supporting member in the form of a sheet of plastic attached to a distal end of the shaft.
  • a sheet of surgical fabric is placed on the supporting member and rolled around the inserter shaft.
  • An introducer tube surrounds the rolled-up fabric and supporting member to prevent them from unrolling. The introducer tube may then be inserted into the body cavity and retracted to allow the supporting member to self-unwind the fabric sheet within the body cavity.
  • the present invention is directed to a resorbable hemostatic dressing comprising a single layer of three-dimensionally entangled nonwoven felt that is not separable into distinct layers by hand consisting essentially of oxidized cellulose fibers, wherein the felt has sufficient mechanical strength and flexibility to retain its structural integrity when deployed laparoscopically.
  • the felt can, independently of one another, have a basis weight of from 70 to 200 grams per square meter, a tensile strength of more than 0.89 newtons, a Z-direction tensile strength of more than 0.22 newtons, a tear strength of greater than 0.22 newtons, and water absorption up to about 1000% of its weight.
  • the oxidized regenerated cellulose fibers can have, on average, a diameter from about 5 microns to about 25 microns.
  • the inventive dressing having rectangular dimensions of 1 inch ⁇ 2 inches can have an insertion force for deployment through a laparoscopic trocar that, for a felt having the basis weight of from about 150 to about 200 grams per meter squared, is less than 89 newtons; that, for a felt having the basis weight of from about 100 to about 125 grams per meter squared, is less than 35.6 newtons; or that, for a felt having the basis weight of from about 70 to about 80 grams per meter squared, is less than 13.3 newtons.
  • the inventive dressing contains a three-dimensionally entangled felt that consists essentially of strands having a crimp of from about 5 crimps/inch to about 12 crimps/inch and a staple length from about 11 ⁇ 2 to about 41 ⁇ 4 inches.
  • the present invention is also directed to methods for manufacturing the resorbable hemostatic nonwoven dressings described above comprising the steps of providing cellulose yarn having filaments of minimal twist; forming a multi-yarn, single feed circular knitted cellulose fabric having minimal twist; scouring the cellulose fabric; oxidizing the scoured fabric; pliabilizing the oxidized fabric; de-knitting the pliabilized fabric to form a continuous strand having a crimp from about 5 crimps/inch to about 12 crimps/inch; cutting the continuous strand to form staples, said staples having length from about 11 ⁇ 2 to about 41 ⁇ 4 inches; carding the staples into a carded batt; and needle-punching and three-dimensionally entangling the carded batt to form a single layer non-woven felt.
  • the steps of de-knitting and cutting are preferably performed at low tension or minimal time at high tension.
  • the step of de-knitting is preferably performed without subsequent spooling and followed immediately by cutting.
  • the carded batt can comprise approximately 10 to 17 layers of carded web, more preferably about 12 layers of carded web.
  • a method of manufacturing of resorbable hemostatic nonwoven felt comprises the steps described below.
  • Knitting step A knitted cellulose structure was made using a circular knitting machine. Multiple fiber bundles were brought together into a single tow untwisted. This tow was fed into the knitting machine and a circular knit structure was created.
  • a circular knit is a type of weft knit, in which the material can be continuously unraveled.
  • a 6 inch circular textile thus was generated utilizing a knitting machine set up with a single row of needles in a circular pattern that yielded a de-knittable single jersey knit. Inventors have discovered that avoiding twisting of fibers during knitting further facilitated the later opening and carding step.
  • a multi-yarn, single feed circular knit was made, representing a continuous “sock” or tube of knit.
  • the multi-yarn single feed was made having none or minimal twist, preferably less than 5/inch of the yarns.
  • the inventors have discovered that presence of substantial twist prior to oxidation resulted in the opening or de-knitting step being substantially more complicated. Oxidation would only increase this level of difficulty based on what we had seen with the non-twisted yarn.
  • the inventors have discovered that the decrease of the tensile properties of the material after oxidation required minimal or no twist in order to successfully perform the further downstream processing including the steps of de-knitting and cutting.
  • the twisted fibers resulted in more complicated de-knitting and higher fiber breakage and increased scrap.
  • Scouring step including steam stretch.
  • the purposes of the scouring with steam stretch are to remove any residual knitting oils and other contaminants on the knit structures.
  • After the scouring step which is water-based, it is necessary to remove water. In the removal of the water (drying) the knit structure shrinks, which is known for Rayon structures.
  • the steam stretch step is then performed to return the knit structure to near its pre-scouring dimensions.
  • the scouring is performed with hot water with added detergents and subsequent water rinses, as known in the art, followed by the drying step and by the steam stretch consisting of treating the fabric with the steam and simultaneously applying tension, as known in the art.
  • Oxidation step The fabric was then oxidized as it is known in the art. Methods of producing highly oxidized tri-carboxylic acid derivatives of cellulose as hemostatic materials, involving two-stage oxidation by successive processing with an iodine-containing compound and nitrogen oxides. A reference is made to the U.S. Pat. No. 7,279,177 and references cited therein, describing hemostatic wound dressings and methods of making same, which is hereby incorporated by reference in its entirety. Oxidized cellulosic materials are typically prepared by preliminary oxidation with metaperiodate or periodic acid to yield periodate-oxidized, dialdehyde cellulose to form the intermediate for forming carboxylic-oxidized cellulose.
  • the dialdehyde cellulose intermediate then is further oxidized by NO 2 to yield the carboxylic-oxidized cellulose, which then is used as a hemostatic, anti-microbial and wound-healing agent.
  • Regenerated cellulose and a detailed description of how to make regenerated oxidized cellulose is set forth in U.S. Pat. No. 3,364,200 and U.S. Pat. No. 5,180,398, the contents each of which is hereby incorporated by reference as if set forth in its entirety.
  • teachings concerning regenerated oxidized cellulose and methods of making same are well within the knowledge of one skilled in the art of hemostatic wound dressings.
  • U.S. Pat. No. 5,180,398 discloses the preparation of carboxylic-oxidized cellulose with an oxidizing agent such as nitrogen dioxide in a per-fluorocarbon solvent. After oxidation by either method, the fabric is thoroughly washed with a solvent such as carbon tetrachloride, followed by aqueous solution of 50 percent isopropyl alcohol (IPA), and finally with 99% IPA.
  • IPA isopropyl alcohol
  • Pliabilization step According to an embodiment of the present invention, pliabilizing or stretching a knitted material that has undergone a chemical process of oxidation that has rendered the material stiff was performed.
  • the fabric was pliabilized by techniques known to these skilled in the art.
  • One known method is the method of using rings inside the fabric tube that are held in place by cone shaped pins that are located outside of the tube but interfering with the inner diameter of the rings. The thickness and diameter of the rings vary with the size of the tube.
  • Other methods of pliabilization can be applied, mechanized or manual.
  • De-Knitting and Cutting steps The fabric was then de-knitted into a continuous strand and cut to form fiber staple. De-knitting and cutting was used at low tension or minimal time at high tension, to preserve the crimp for better entanglement and to keep it from breaking in later processes. The tension used was always lower than the strength of the strand, to avoid or minimize the yarn breaks. The tensile strength of ORC yarn was measured using an Instron. In a preferred embodiment the de-knitting tension should be lower than 60 grams-force, as measured by a force gauge. De-knitting was performed without subsequent spooling but with immediately following cutting resulting in preserving crimp. The length of staples was from about 11 ⁇ 2 to about 41 ⁇ 4 inches or up to 6 inch. The inventors have tried to use staples which are approximately 1 inch long but the final needlepunched product lacked the structural integrity.
  • Carding step the staple yarn was then carded into a carded batt for subsequent needlepunching.
  • staple fibers were input into a machine with rotating cylinders having fine metallic teeth.
  • the staple fiber is “brushed” via the cylinder teeth which act to separate the staple yarn-bundle into individual filaments.
  • the “brushed” filaments (web) were layered on a take-up roller into a batt. Batt was approximately 10 to 17 layers of carded web, typically about 12-layers web forming the carded batt, which was then needlepunched to make a single layer ‘felt’.
  • Needle-punching for 3D entanglement and forming a single layer felt the fibers formed at the previous step were then needle punched to form the felt of the present invention as follows: The carded batt was fed into the needlepunching process in which a bed of barbed needles penetrated the batt as the batt passes through the machine. The barbed needles pull the batt fibers through each other three-dimensionally entangling the filaments and increasing the structure density. The output of the needlepunch process was the non-woven felt of the present invention.
  • nonwoven fabric includes, but is not limited to, bonded fabrics, formed fabrics, or engineered fabrics, that are manufactured by processes other than, weaving or knitting. More specifically, the term “nonwoven fabric” refers to a porous, textile-like material, usually in flat sheet form, composed primarily or entirely of staple fibers assembled in a web, sheet or batt. The structure of the nonwoven fabric is based on the arrangement of, for example, staple fibers that are typically arranged more or less randomly.
  • the tensile, stress-strain and tactile properties of the nonwoven fabric ordinarily stem from fiber to fiber friction created by entanglement and reinforcement of, for example, staple fibers, and/or from adhesive, chemical or physical bonding.
  • the raw materials used to manufacture the nonwoven fabric may be yarns, scrims, netting, or filaments made by processes that include, weaving or knitting.
  • the resorbable hemostatic nonwoven felt comprises a single layer of three-dimensionally entangled oxidized regenerated cellulose fibers, wherein the felt has mechanical strength characterized by retention of structural integrity when deployed laparoscopically.
  • the resorbable hemostatic nonwoven felt is further characterized by retention of structural integrity when a rectangular sample having dimensions of 1 inch ⁇ 2 inches is deployed through a laparoscopic trocar having 5 mm diameter.
  • the inventors have discovered that the resorbable hemostatic nonwoven felt was resiliently compressible, having sufficient mechanical flexibility, strength, and basis weight for effective use as a hemostat for effective laparoscopic deployment.
  • the resorbable hemostatic nonwoven felt is further characterized by fast hemostatic activity, with time to hemostasis of approximately 4 to 6 minutes in the porcine linear incision spleen model.
  • the resorbable hemostatic nonwoven felt has a basis weight of from 70 to 200 grams per square meter.
  • the resorbable hemostatic nonwoven felt is further characterized by a tensile strength of more than 0.89 newtons [0.2 LBF] at the same basis weight for the rectangular sample having dimensions of 1 inch ⁇ 2 inches.
  • the resorbable hemostatic nonwoven felt is further characterized by a Z-direction tensile strength of more than 0.22 newtons [0.05 LBF].
  • Z-direction tensile strength of more than 0.22 newtons [0.05 LBF].
  • known marketed non-woven fibrillated non-entangled ORC material was attempted to be evaluated for Z-direction tensile strength, and the inventors have found that Z-direction tensile strength was so low that material could not be mounted in tensile testing jig without delaminating.
  • the resorbable hemostatic nonwoven felt is made of oxidized regenerated cellulose fibers having diameter from about 5 microns to about 25 microns.
  • the resorbable hemostatic nonwoven felt was capable of absorbing about 1000% of its weight in water.
  • the felt tested in a water saturation test was able to absorb about 1000% of its weight in water.
  • the test includes weighing the sample, saturating the sample with water, letting the excess water to drain for a specified time, weighing the sample with water.
  • the felt tested in a water saturation test was able to absorb about 1000% of its weight in water 1000% by weight vs. 400% for knit structures.
  • non-woven fibrillated non-entangled ORC material with basis weight of from 200 to 400 grams/meter squared cannot be subjected to this test due to lack of integrity in this test.
  • trocar insertion force (dry) for a rectangular sample of the resorbable hemostatic nonwoven felt of the present invention having dimensions of 1 inch ⁇ 2 inches is shown as a function of the basis weight, as measured by an Instron machine for insertion into a 5 mm diameter trocar, for the felt of the present invention, indicating acceptable insertion forces. It was discovered that the felt retained structural integrity after the insertion, as indicated by absence of tear and approximately same geometric area after deployment.
  • the insertion force was measured by mounting a laparoscopic dissector in a jig to the top moving-head of an Instron material test machine 5544 with a 100 lb load cell. A 5 mm Ethicon Endosurgery Endopath Xcel trocar was then mounted in the non-moving base. The 1 in ⁇ 2 in rectangular test article was grasped at a corner in the dissector and inserted through the trocar at 0.5 inch/sec. by the Instron. The compression stress time-course was measured and recorded by the Instron software.
  • the resorbable hemostatic nonwoven felt was further characterized by the insertion force for deploying the rectangular sample having dimensions of 1 inch ⁇ 2 inches through the laparoscopic trocar:
  • the felt of this invention Upon exiting from trocar, the felt of this invention was observed to be easier to manipulate and position and the felt was less wrinkled when compared to known knitted hemostats.
  • the felt was exiting from trocar quickly and without additional unfurling effort reverted to the pre-insertion shape, exhibiting resilient compressibility and having sufficient mechanical flexibility, strength, and basis weight for effective use as a hemostat for effective laparoscopic deployment.
  • non-woven fibrillated non-entangled ORC material with basis weight of from 200 to 400 grams/meter squared was not possible to insert into trocar.
  • the resorbable hemostatic nonwoven felt is made of yarn which is 150 Denier 42-filament yarn, 100 Denier 90-filament yarn, 60 Denier 24-filament yarn, or combinations thereof.
  • the resorbable hemostatic nonwoven felt is made of yarns characterized by crimp from about 5/inch to about 12/inch and comprises staples having length from about 11 ⁇ 2 to about 41 ⁇ 4 inches.
  • the inventors have unexpectedly discovered a method of manufacturing and a resulting material which has desirable hemostatic and mechanical properties and is deployable laparoscopically. Specifically, the material has hemostatic properties similar to non-woven oxidized regenerated cellulose materials and mechanical properties enabling laparoscopic deployment similar to knit or woven oxidized regenerated cellulose materials
  • the resorbable hemostatic nonwoven felt is manufactured by a method comprising the steps of
  • the resorbable hemostatic nonwoven felt was further found to have improved properties of being less adherent to the surgical tools and other materials within the surgical operational space, especially when exposed to contact with wet materials and surfaces, and simultaneously provides hemostasis similar to or better than conventional and known cellulose-containing hemostatic wound dressings. Comparative evaluations of the degree to which ORC-based hemostatic agents adhered to surgical instruments and gloves were conducted on the present resorbable hemostatic nonwoven felt in comparison to known marketed non-woven fibrillated non-entangled ORC material.
  • the diameter of an individual fiber was approximately 18 to 25 microns as measured from SEM image, so the fibers and the yarns used had 150/42 denier per filament (dpf) ( ⁇ 3.6 dpf) down to 100/90 ( ⁇ 1.1 dpf) or approx 5 microns diameter to 25 microns diameter for the filaments.
  • the felt is formed of fibers having uniform staple length and or controlled staple length distribution, and lesser amount of fines which are defined as short easily shed fibers fragments.
  • Known ORC-based non-woven materials have higher amount of fines.
  • non-woven fibrillated non-entangled ORC material with basis weight of from 200 to 400 grams/meter squared had wider distribution and much shorter staples about 0.5-0.6 inch long.
  • the felt is a single layer felt and has no layers peelable from each other.
  • non-woven fibrillated non-entangled ORC material with basis weight of from 200 to 400 grams/meter squared has a plurality of layers that are separable in layers and has a much lower Z-strength. Material was delaminating when attempted to be mounted in the test jig for peeling test.
  • the felt has higher entanglement and interlocking of the fibers compared to the known non-woven oxidized regenerated cellulose based hemostatic materials.
  • Mechanical Z-direction entanglement process of needlepunching is utilized.
  • Other types of 3D entanglement can be utilized for instance hydro-entanglement.
  • non-woven fibrillated non-entangled ORC material with basis weight of from 200 to 400 grams/meter squared has manufacturing method lacking needlepunching process step providing for 3D entanglement.
  • the resorbable hemostatic nonwoven felt further has improved properties of being less adherent to the surgical tools and other materials within the surgical operational space, especially when exposed to contact with wet materials and surfaces, and simultaneously provides hemostasis similar to or better than conventional and known cellulose-containing hemostatic wound dressings.
  • the Hemostatic activity of the resorbable hemostatic nonwoven felt of the present invention was tested using The Acute Swine Splenic Incision Hemostasis Model.
  • the Linear Incision Spleen Model 15-mm long ⁇ 3-mm deep incisions were made on the spleen and the test or control article (A, B, C, or E) was applied to a freshly created wound site followed by an occlusive digital pressure (tamponade). Pressure was initially applied for one minute and was timed using an electronic timer. Following the one-minute initial tamponade, digital pressure was discontinued; the gauze pad on the article was immediately removed. A 30-second hemostasis evaluation period was performed.
  • Tables 1-3 The results of the testing of hemostatic activity are shown in Tables 1-3. Tables 1 and 2 represent two different sets of experiments. Table 3 represents a summary of the result of Table 2. Test articles for Tables 2 and 3:
  • Control used was gauze which represented negative control.
  • Tear strength in machine direction cut of the resorbable hemostatic nonwoven felt of the present invention was measured. The tear strength was tested using Instron material testing machine and demonstrated high strength for a non-woven ORC material.
  • Instron material testing machine was 5500R: TJ 8, having 10 lbs load cell and 90 PSI grips with 1 ⁇ 1.5 inch smooth steel faces.
  • the samples cut in machine direction were provided for tear strength test.
  • Sample preparation included cutting 1 inch in length tear using scissors. This was done to allow clamping of the samples into the Instron grips and to initiate a tear in a controlled direction.
  • the distance between the Instron grips was set at 1 inch.
  • the either side of the cut edge of the sample was loaded on the Instron grips such that 0.5 inch of sample length is inside the grips.
  • the Instron cross head moved at 12 inch/min to propagate the tear along the sample. The test was manually stopped when the tear propagated through the sample. The results of the measurements are presented in Table 4.

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  • Nonwoven Fabrics (AREA)
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US13/197,972 2010-11-10 2011-08-04 Resorbable Laparoscopically Deployable Hemostat Abandoned US20120115384A1 (en)

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Application Number Priority Date Filing Date Title
US13/197,972 US20120115384A1 (en) 2010-11-10 2011-08-04 Resorbable Laparoscopically Deployable Hemostat
KR1020137014481A KR101896230B1 (ko) 2010-11-10 2011-11-08 재흡수 가능한 복강경 전개식 지혈기
MX2013005254A MX356346B (es) 2010-11-10 2011-11-08 Un hemostato reabsorbible que puede desplegarse laparoscópicamente.
PCT/US2011/059696 WO2012064687A2 (en) 2010-11-10 2011-11-08 A resorbable laparoscopically deployable hemostat
AU2011326102A AU2011326102B2 (en) 2010-11-10 2011-11-08 A resorbable laparoscopically deployable hemostat
CA2817533A CA2817533C (en) 2010-11-10 2011-11-08 A resorbable laparoscopically deployable hemostat
EP11839057.4A EP2638194B1 (en) 2010-11-10 2011-11-08 A resorbable laparoscopically deployable hemostat
CN201180064693.5A CN103298436B (zh) 2010-11-10 2011-11-08 可通过腹腔镜部署的吸收性止血剂
ES11839057.4T ES2643662T3 (es) 2010-11-10 2011-11-08 Un hemóstato desplegable laparoscópicamente reabsorbible
BR112013011754-0A BR112013011754B1 (pt) 2010-11-10 2011-11-08 curativo hemostático reabsorvível flexível e seu método de produção
JP2013538817A JP5968897B2 (ja) 2010-11-10 2011-11-08 吸収性腹腔鏡展開式止血材
CN201611213898.6A CN107029276B (zh) 2010-11-10 2011-11-08 可通过腹腔镜部署的吸收性止血剂
RU2013126439/12A RU2581356C2 (ru) 2010-11-10 2011-11-08 Рассасывающееся лапароскопически развертываемое кровоостанавливающее средство
US15/450,706 US10111782B2 (en) 2010-11-10 2017-03-06 Resorbable laparoscopically deployable hemostat

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WO2018056584A1 (ko) 2016-09-21 2018-03-29 삼성전자 주식회사 피부 상태 측정 방법 및 이를 위한 전자 장치
WO2020009174A1 (ja) * 2018-07-05 2020-01-09 帝人ファーマ株式会社 内視鏡用止血材
KR20200135018A (ko) * 2019-05-24 2020-12-02 주식회사 삼양바이오팜 섬유 웹, 피브릴상 섬유 집합체 또는 부직포를 제조하기 위한 장치 및 방법, 및 그에 의하여 제조된 섬유 웹, 피브릴상 섬유 집합체 또는 부직포

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EP2638194A2 (en) 2013-09-18
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ES2643662T3 (es) 2017-11-23
CA2817533C (en) 2019-02-12
CN103298436A (zh) 2013-09-11
MX2013005254A (es) 2013-10-30
BR112013011754B1 (pt) 2020-12-01
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CN103298436B (zh) 2017-12-12
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US20170172805A1 (en) 2017-06-22
CA2817533A1 (en) 2012-05-18
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AU2011326102A1 (en) 2013-05-30
CN107029276B (zh) 2020-11-10
WO2012064687A2 (en) 2012-05-18
KR101896230B1 (ko) 2018-09-10
RU2013126439A (ru) 2014-12-20
MX356346B (es) 2018-05-23
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BR112013011754A2 (pt) 2019-11-05
WO2012064687A3 (en) 2012-07-26

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