Title:
USE OF A POLYANIONIC POLYSACCHARIDE SOLUTION FOR THE PREVENTION OF ABSCESS FORMATION
Document Type and Number:
WIPO Patent Application WO/2000/045804
Kind Code:
A2
Abstract:
A method for the prevention or reduction in the severity of abscess formation in a human subject involves the use of a dilute solution of a polyanionic polysaccharide, preferably a solution of hyaluronic acid or carboxymethyl cellulose, which is applied to tissue at the site of a surgical procedure.
Inventors:
BURNS JAMES W
SKRABUT EUGENE
VAN GOOR HARRY
REIJNEN MICHEL M P J
Application Number:
PCT/US2000/002988
Publication Date:
August 10, 2000
Filing Date:
February 04, 2000
Assignee:
GENZYME CORP (US)
UNIV HOSPITAL NIJMEGEN (NL)
International Classes:
A61L2/18; A61B17/00; A61B17/42; A61K31/715; A61K31/717; A61K31/728; A61M1/14; A61M27/00; A61M31/00; A61P17/02; A61P41/00; C08B11/12; C08B37/00; (IPC1-7): A61K31/00
Domestic Patent References:
Other References:
REIJNEN, M.M. ET AL: "Prevention of intraabdominal abscesses and adhesions using a hyaluronic acid solution in a rat peritonitis model" ARCHIVES OF SURGERY, vol. 134, no. 9, September 1999 (1999-09), pages 997-1001, XP000952881 cited in the application
ONDERDONK, A.B. ET AL: "Immunomodulatory effects of derivatized hyaluronic acid-carboxymethylcellulose gels (DHA) in an animal model for intraabdominal sepsis" ABSTRACTS OF THE 99TH GENERAL MEETING OF THE AMERICAN SOCIETY FOR MICROBIOLOGY, vol. 99, 1 June 1999 (1999-06-01), page 11 XP000953083
TZIANABOS, A.O. ET AL: "Structure and function of Bacteroides fragilis capsular polysaccharides: Relationship to induction and prevention of abscesses" CLINICL INFECTIOUS DISEASES, vol. 20, no. suppl. 2, 1995, pages S132-S140, XP000952888
PATENT ABSTRACTS OF JAPAN vol. 1997, no. 12 (C, 25 December 1997 (1997-12-25) & JP 09 208476 A (TAKADA SEIYAKU KK), 12 August 1997 (1997-08-12)
PECK, L.S. ET AL: "Evaluation of CMC and HA solutions for adhesiolysis" JOURNAL OF INVESTIGATIVE SURGERY, vol. 8, 1995, pages 337-348, XP000953093
MUELLER, P.O.E. ET AL: "Intraperitoneal use of sodium carboxymethylcellulose in horses undergoing exploratory celiotomy" VETERINARY SURGERY, vol. 24, no. 2, 1995, pages 112-117, XP000953146
DATABASE EMBASE [Online] ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM, NL; AN: 1994166185, XP002151239 & NARAMA, I. ET AL: "26-week chronic toxicity study and 5-week recovery test of high molecular weight sodium hyaluronate (NRD101) in rats by intraperitoneal administration" JAPANESE PHARMACOLOGY AND THERAPEUTICS, vol. 22, no. SUPPL. 3, 1994, pages 93-134,
YAACOBI, Y. ET AL: "Prevention of postoperative abdominal adhesions by tissue precoating with polymer solutions" JOURNAL OF SURGICAL RESEARCH, vol. 55, no. 4, October 1993 (1993-10), pages 422-426, XP000952885 cited in the application
FOSCHI, D. ET AL: "Hyaluronic acid prevents oxygen free-radical damage to granulation tissue: a study in rats" INTERNATIONAL JOURNAL OF TISSUE REACTIONS, vol. 12, no. 6, 1990, pages 333-339, XP000953074
BURNS, J.W. ET AL: "Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions" JOURNAL OF SURGICAL RESEARCH, vol. 59, no. 6, - 1995 pages 644-652, XP000952895 cited in the application
Attorney, Agent or Firm:
Gosz, William G. (Greenfield & Sacks P.C. 600 Atlantic
Avenue Boston, MA, US)
Claims:
CLAIMS What is claimed is:
| 1. |
A method for preventing or reducing the severity of abscess formation resulting from a surgical procedure performed on a subject comprising contacting tissue in proximity to the site of the surgical procedure with a dilute solution of a polyanionic polysaccharide. |
| 2. |
The method of claim 1 wherein the polyanionic polysaccharide is hyaluronic acid. |
| 3. |
The method of claim 2 wherein the hyaluronic acid is derivatized. |
| 4. |
The method of claim 2 wherein the hyaluronic acid is crosslinked. |
| 5. |
The method of claim 1 wherein the polyanionic polysaccharide is carboxymethyl cellulose. |
| 6. |
The method of claim 5 wherein the carboxymethyl cellulose is derivatized. |
| 7. |
The method of claim 5 wherein the carboxymethyl cellulose is crosslinked. |
| 8. |
The method of claim 1 wherein the subject is a human patient. |
| 9. |
The method of claim 1 wherein the treatment comprises contacting the tissue site with the solution prior to surgery. |
| 10. |
The method of claim 1 wherein the treatment comprises contacting the tissue with the solution during surgery. |
| 11. |
The method of claim 1 wherein the treatment comprises contacting the tissue with the solution following surgery. |
| 12. |
The method of claim 1 wherein the solution is a 0.2% to 2.0% by weight solution. |
| 13. |
The method of claim 1 wherein the surgery is abdominal surgery. |
| 14. |
The method of claim 1 wherein the surgery is gynecological surgery. |
| 15. |
The method of claim 1 wherein the site of the surgical procedure is contaminated with bacteria. |
| 16. |
The method of claim 15 wherein the bacteria are selected from the group consisting of <BR> <BR> <BR> <BR> Bacteroides fragilis, Proteus sp, Escherichia coli, Enterococci, Staphylococci, coliforme gram negative bacteria and anaerobe gram negative rod bacteria. |
| 17. |
The method of claim 1 wherein the dilute solution is used as a lavage on a human patient during or following the surgical procedure. |
| 18. |
The method of claim 17 wherein the surgical procedure results in a perforated bowel. |
| 19. |
The method of claim 17 wherein the surgical procedure is an appendectomy. |
| 20. |
The method of claim 17 wherein the solution is left in the abdominal cavity of the patient following closure of the surgical site. |
| 21. |
The method of claim 17 wherein the dilute solution is supplied to the patient using a surgical drain. |
| 22. |
The method of claim 17 wherein the dilute solution is supplied to the patient using an intraperitoneal injection. |
| 23. |
The method of claim 17 wherein the dilute soultion is supplied to the patient using a dialysis port. |
| 24. |
The method of claim 17 wherein the dilute solution is supplied to the patient using an indwelling catheter. |
Description:
INTERNATIONALSEARCHREPORT- Intern ial ApplicationNo PCT/US00/02988 C. (Continuation) DOCUMENRS CONSIDERED TO BE RELEVANT Category Citationofdocument,withindication,whereappropriate,oftherele
vantpassagesRelevanttoclaimNo. P,XONDERDONK,A.B.ETAL:"Immunomodulatory1-3,5,6, | effectsofderivatizedhyaluronic9-13,15, acid-carboxymethylcellulosegels(DHA)in16 ananimalmodelforintraabdominalsepsis" ABSTRACTSOFTHE99THGENERALMEETINGOF THEAMERICANSOCIETYFORMICROBIOLOGY, vol.99,1June1999(1999-06-01),page11 XP000953083 abstractnumberA-51 XWO9104058A(NORPHARMCOINC.)1-4,8, 4April1991(1991-04-04)10,11, 13-17, 20,22 page17,line14-page18,line29 page50,CaseXIII;page51CaseXV;page 62,CaseXXXIV;page64,CaseXXXVII;page 67,line16-28 XUS5700787A(TZIANABOSETAL)1,8-11, 23December1997(1997-12-23)13, citedintheapplication15-20,22 column3,line9-11 column4,line34-45 column18,line47-column19,line49 XTZIANABOS,A.O.ETAL:"Structureand1,9-11, functionofBacteroidesfragiliscapsular13,15,16 polysaccharides:Relationshiptoinduction andpreventionofabscesses" CLINICLINFECTIOUSDISEASES, vol.20,no.suppl.2,1995,pages S132-S140,XP000952888 thewholedocument XPATENTABSTRACTSOFJAPAN1-3,8, vol.1997,no.12(C,10,11, 25December1997(1997-12-25)13,15, &JP09208476A(TAKADASEIYAKUKK),17,20 12August1997(1997-08-12) abstract APECK,L.S.ETAL:"EvaluationofCMCand1-9 HAsolutionsforadhesiolysis" JOURNALOFINVESTIGATIVESURGERY, vol.8,1995,pages337-348,XP000953093 thewholedocument AMUELLER,P.O.E.ETAL:"Intraperitoneal 1,5, useofsodiumcarboxymethylcellulosein10-13, horsesundergoingexploratoryceliotomy"15-18, VETERINARYSURGERY,20,22,24 vol.24,no.2,1995,pages112-117, XP000953146 thewholedocument 1-/- INTERNATIONALSEARCH REPORT PCT/US00/02988 C.(Continuation)DOCUMENTSCONSIDEREDTOBERELEVANT CategoryCitation ofdocument,withindication.whereappropriate,oftherelevantpass
agesRelevanttoclaimNo. ADATABASEEMBASE'Online!1-24 ELSEVIERSCIENCEPUBLISHERS,AMSTERDAM, NL; AN:1994166185, XP002151239 abstract &NARAMA,I.ETAL:"26-weekchronic toxicitystudyand5-weekrecoverytestof highmolecularweightsodiumhyaluronate (NRD101)inratsbyintraperitoneal administration" JAPANESEPHARMACOLOGYANDTHERAPEUTICS, vol.22,no.SUPPL.3,1994,pages93-134, AYAACOBI,Y.ETAL:"Preventionof1,5, postoperativeabdominaladhesionsby9-13,15, tissueprecoatingwithpolymersolutions"16 JOURNALOFSURGICALRESEARCH, vol.55,no.4,October1993(1993-10), pages422-426,XP000952885 citedintheapplication thewholedocument AFOSCHI,D.ETAL:"Hyaluronic acid1-9 preventsoxygenfree-radicaldamageto granulationtissue:astudyinrats" INTERNATIONALJOURNALOFTISSUEREACTIONS, vol.12,no.6,1990,pages333-339, XP000953074 thewholedocument ABURNS,J.W.ETAL:"Preventionoftissue1,5,9, injuryandpostsurgicaladhesionsby11-13, precoatingtissueswithhyaluronicacid15,16 solutions" JOURNALOFSURGICALRESEARCH, vol.59,no.6,-1995pages644-652, XP000952895 citedintheapplication thewholedocument 1 mFURTHER INFORMATION CONTINUED FROM PCT/ISA/210 ContinuationofBox1.2 Presentclaims1and8-24relatetoacompounddefinedonlyasa "polyanionicpolysaccharide".Theuseofthisvagueparameterinthe presentcontextisconsideredtoleadtoalackofclaritywithinthe meaningofArticle6PCT.Itisimpossibletocomparetheparametersthe
applicanthaschosentoemploywithwhatissetoutinthepriorart.The lackofclarityissuchastorenderameaningfulcompletesearch impossible.Consequently,thesearchhasbeenrestrictedtothe polysaccharidesspecificallymentionedintheclaimswithdueregard
to thegeneralideaunderlyingtheapplication. Theapplicant'sattentionisdrawntothefactthatclaims,orpartsof claims,relatingtoinventionsinrespectofwhichnointernational searchreporthasbeenestablishedneednotbethesubjectofan internationalpreliminaryexamination(Rule66.1(e)PCT).Theappli
cant isadvisedthattheEPOpolicywhenactingasanInternational PreliminaryExaminingAuthorityisnormallynottocarryouta preliminaryexaminationonmatterwhichhasnotbeensearched.Thisis
thecaseirrespectiveofwhetherornottheclaimsareamendedfollowin
g receiptofthesearchreportorduringanyChapterIIprocedure. INTERNATIONALSEARCHREPORT Intern qalApplicationNo !ormatlon on patent family members PCT/US 00/02988 PCT/US00/02988 PatentdocumentPublication Patent family Publication citedinsearchreportdate member(s)date WO9104058A04-04-1991AP 175 A 03-04-1992 AT 131068 T 15-12-1995 AU 1485097 A 22-05-1997 AU 674894 B 16-01-1997 AU 5227493 A 03-03-1994 AU 6433090 A 18-04-1991 BR 9006924 A 10-12-1991 CA 2042034 A 22-03-1991 CN 1051503 A 22-05-1991 DE 69024039 D 18-01-1996 DE 69024039 T 13-06-1996 DK 445255 T 04-03-1996 EP 0445255 A 11-09-1991 EP 0656213 A 07-06-1995 ES 2080837 T 16-02-1996 HK 44797 A 18-04-1997 HU 64699 A 28-02-1994 HU 9500656 A 28-11-1995 IL 95745 A 22-09-1999 IN 171745 A 26-12-1992 JP 4504579 T 13-08-1992 LT 1582A,B26-06-1995 NO 911952 A 05-07-1991 RO 112812 A 30-01-1998 SG 49658 A 15-06-1998 US 5827834 A 27-10-1998 US 5932560 A 03-08-1999 US 6048844 A 11-04-2000 US 5852002 A 22-12-1998 US 5929048 A 27-07-1999 US 5985850 A 16-11-1999 US 5914314 A 22-06-1999 US 5830882 A 03-11-1998 US 5811410 A 22-09-1998 US 6069135 A 30-05-2000 US 5985851 A 16-11-1999 ZA 9007564 A 28-08-1991 US5700787A23-12-1997US 5679654 A 21-10-1997 AU 1321799 A 18-03-1999 AU 702325 B 18-02-1999 AU 3543995 A 27-03-1996 CA 2197563 A 14-03-1996 EP 0778780 A 18-06-1997 JP 10507746 T 28-07-1998 WO 9607427 A 14-03-1996 JP09208476A12-08-1997NONE
