US2018036451A1PendingUtilityA1

Hemostatic device

68
Assignee: ACELL INCPriority: Dec 9, 2011Filed: Aug 28, 2017Published: Feb 8, 2018
Est. expiryDec 9, 2031(~5.4 yrs left)· nominal 20-yr term from priority
C12N 5/00A61L 2300/236A61L 2400/04A61L 27/54A61F 2/00A61L 27/3666A61L 24/0005A61B 17/0057A61L 2300/418A61L 27/58A61L 2430/22A61L 2300/252A61L 15/40A61L 31/005A61K 9/14A61B 17/08A01N 65/00A61L 27/3633
68
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Claims

Abstract

A hemostatic device, method of making, and method of using for internal and external applications to wounds in the body of a patient to induce hemostasis at an anatomical site.

Claims

exact text as granted — not AI-modified
1 - 27 . (canceled) 
     
     
         28 . A bioresorbable composition, comprising:
 (i) a devitalized extracellular matrix material (ECM) derived from one or more layers of epithelial tissue, said ECM compressed, dehydrated, and particularized;   (ii) one or more non-cross-linked ECM components; and,   (iii) a sheet like backing comprising an ECM, same or different from the ECM in (i).   
     
     
         29 . The composition of  claim 28 , wherein said one or more layers of epithelial tissue is a native epithelial tissue. 
     
     
         30 . The composition of  claim 29  wherein said native epithelial tissue comprises a plurality of collagen types native to the epithelial tissue. 
     
     
         31 . The composition of  claim 30  wherein said plurality of collagen types is selected form the group consisting of type I collagen, type II collagen, type III collagen, type IV collagen type VII collagen and a combination thereof. 
     
     
         32 . The composition of  claim 28  wherein said ECM of (i) comprises a gel. 
     
     
         33 . The composition of  claim 32  wherein said sheet like backing is applied to said gel. 
     
     
         34 . The composition of  claim 28  wherein said sheet-like backing is selected from the group consisting of urinary bladder submucosa (UBS), liver-derived biomatrix (LBM), and small-intestine submucosa (SIS), urinary bladder matrix (UBM) and small intestinal matrix (SIM), and a combination thereof. 
     
     
         35 . The composition of  claim 28  wherein said sheet-like backing comprises compressed particulate ECM wherein one portion of said backing comprises a first density and another portion of said backing comprises a second density. 
     
     
         36 . The composition of  claim 35  wherein one side of said sheet-like backing is more porous than another side of said sheet like backing. 
     
     
         37 . The composition of  claim 28  wherein said ECM further comprises one or more of an epithelial basement membrane selected from the group consisting of, tunica muscularis mucosa, tunica propria, tunica submucosa, and tunica muscularis, and a combination thereof. 
     
     
         38 . The composition of  claim 28  further comprises a bioresorbable polymer lattice wherein said lattice further comprises said ECM of (ii) selected from the group consisting of a gel, a foam, or a powder, and a combination thereof. 
     
     
         39 . The composition of  claim 28  wherein said non-cross-linked ECM component is selected from the group consisting of collagen type IV, collagen type VII, glycosaminoglycans, fibronectin, laminin, and a combination thereof. 
     
     
         40 . A method for accelerating hemostasis comprising: applying to a site of injury in the body of a patient in need thereof, a bioresorbable hemostatic device comprising a compressed, particularized, dehydrated extracellular matrix material (ECM) wafer derived from an epithelial tissue, one or more ECM components in their native configuration, and a backing sheet comprising an ECM, said backing sheet joined to said wafer. 
     
     
         41 . The method of  claim 40  wherein the site of injury is selected from the group consisting of lung, heart, muscle, liver, kidney, spleen, intestine, nasal passage, nasal sinus, auditory canal, cervix, tooth socket, uterus, abdomen, thorax, cranium, urethra, vagina, vessel, intramedullary cavity, uterus, head structures, eye, dental alveolus, pelvic cavity, urinary bladder, subcutaneous tissue, muscle, organ resection sites, tissue resection sites, auditory canal, puncture wounds, hepatic lobectomy site, a partial nephrectomy site, a lumpectomy site, tissue voids, tissue or organ resection sites, open wounds, anastomosis site skin puncture wounds, lacerations, incisions, abdominal wounds, thoracic wounds, head wounds, brain wounds, skull wounds, skeletal fractures, extremity wounds, amputation sites, organ hemorrhage sites, tumor removal sites, diseased tissue removal/excision sites, intracranial, intrathoracic, intra-abdominal, intramedullary, intramuscular, and intrathecal. 
     
     
         42 . The method of  claim 40  wherein the applied bioresorbable hemostatic device is not removed from the injury site until hemostasis is achieved. 
     
     
         43 . The method of  claim 40  wherein the hemostatic device comprises a gel wherein said hemostatic device is introduced into a site, wound or body orifice where said injury site is located. 
     
     
         44 . The method of  claim 40  wherein the hemostatic device comprises a tampon. 
     
     
         45 . The method of  claim 40  wherein said native configuration of said ECM comprises a devitalized extracellular matrix material derived from a native epithelial tissue. 
     
     
         46 . The method of  claim 40  wherein said native configuration of said ECM comprises a plurality of collagen types native to the epithelial tissue. 
     
     
         47 . The method of  claim 40  wherein said ECM is selected from the group consisting of urinary bladder submucosa (UBS), liver-derived biomatrix (LBM), and small-intestine submucosa (SIS), urinary bladder matrix (UBM) and small intestinal matrix (SIM).

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