Claims for Patent: 8,147,561

Summary for Patent: 8,147,561

Title:	Methods and devices to curb appetite and/or reduce food intake
Abstract:	The present invention relates to methods and devices that help to curb appetite and/or reduce food intake. In one embodiment, the methods and devices of the present invention include a small intestinal/duodenal insert comprising an elongated member with at least one flow reduction element that can cause the stimulation of one or more biological signals of satiety.
Inventor(s):	Binmoeller; Kenneth F. (Rancho Sante Fe, CA)
Assignee:	Endosphere, Inc. (Columbus, OH)
Application Number:	11/300,283
Patent Claims:	1. A duodenal/small intestinal insert comprising: an elongated solid central shaft member, the elongated solid central shaft member having a proximal end and a distal end and a curved longitudinal axis extending from the proximal end to the distal end, wherein the elongated solid central shaft member has a pre-set shape prior to insertion in the gastrointestinal tract such that a portion of the curved longitudinal axis mimics an angulation of the duodenum of a human being and returns to the pre-set shape after insertion into the gastrointestinal tract; an anchoring member engaged with the proximal end of the elongated solid central shaft member; at least one flow reduction element coupled to the elongated solid central shaft member at a distance from the anchoring member such that when the anchoring member is in an antrum of the stomach, the at least one flow reduction element is within a small intestine; and a bioactive material on or within the solid shaft member or the at least one flow reduction element. 2. The duodenal/small intestinal insert of claim 1, wherein the bioactive material is a by-product of digestion selected from the group consisting of sugars, fatty acids, amino acids and peptides. 3. The duodenal/small intestinal insert of claim 1, wherein the bioactive material is a drug. 4. The duodenal/small intestinal insert of claim 3 wherein the drug is selected from one or more of the group consisting of altretamin, fluorouracil, amsacrin, hydroxycarbamide, asparaginase, ifosfamid, bleomycin, lomustin, busulfan, melphalan, chlorambucil, mercaptopurin, chlormethin, methotrexate, cisplatin, mitomycin, cyclophosphamide, procarbazin, cytarabin, teniposid, dacarbazin, thiotepa, dactinomycin, tioguanin, daunorubicin, treosulphan, doxorubicin, tiophosphamide, estramucin, vinblastine, etoglucide, vincristine, etoposid, vindesin, penicillin, ampicillin, nafcillin, amoxicillin, oxacillin, azlocillin, penicillin G, carbenicillin, penicillin V, dicloxacillin, phenethicillin, floxacillin, piperacillin, mecillinam, sulbenicillin, methicillin, ticarcillin, mezlocillin, cefaclor, cephalothin, cefadroxil, cephapirin, cefamandole, cephradine, cefatrizine, cefsulodine, cefazolin, ceftazidim, ceforanide, ceftriaxon, cefoxitin, cefuroxime, cephacetrile, latamoxef, cephalexin, amikacin, neomycin, dibekacyn, kanamycin, gentamycin, netilmycin, kanamycin, tobramycin, amphotericin B, novobiocin, bacitracin, nystatin, clindamycin, polymyxins, colistin, rovamycin, erythromycin, spectinomycin, lincomycin, vancomycin, chlortetracycline, oxytetracycline, demeclocycline, rolitetracycline, doxycycline, tetracycline, minocycline, chloramphenicol, rifamycin, rifampicin, thiamphenicol, sulfadiazine, sulfamethizol, sulfadimethoxin, sulfamethoxazole, sulfadimidin, sulfamethoxypyridazine, sulfafurazole, sulfaphenazol, sulfalene, sulfisomidin, sulfamerazine, sulfisoxazole, trimethoprim with sulfamethoxazole, sulfametrole, methanamine, norfloxacin, cinoxacin, nalidixic acid, nitrofurantoine, nifurtoinol, oxolinic acid; metronidazole; aminosalicyclic acid, isoniazide, cycloserine, rifampicine, ethambutol, tiocarlide, ethionamide, viomycin; amithiozone, rifampicine, clofazimine, sodium sulfoxone, diaminodiphenylsulfone, amphotericin B, ketoconazole, clotrimazole, miconazole, econazole, natamycin, flucytosine, nystatine, griseofulvin, aciclovir, idoxuridine, amantidine, methisazone, cytarabine, vidarabine, ganciclovir, chloroquine, iodoquinol, clioquinol, metronidazole, dehydroemetine, paromomycin, diloxanide, furoatetinidazole, emetine, chloroquine, pyrimethamine, hydroxychloroquine, quinine, mefloquine, sulfadoxine/pyrimethamine, pentamidine, sodium suramin, primaquine, trimethoprim, proguanil, antimony potassium tartrate, niridazole, antimony sodium dimercaptosuccinate, oxamniquine, bephenium, piperazine, dichlorophen, praziquantel, diethylcarbamazine, pyrantel parmoate, hycanthone, pyrivium pamoate, levamisole, stibophen, mebendazole, tetramisole, metrifonate, thiobendazole, niclosamide, acetylsalicyclic acid, mefenamic acid, aclofenac, naproxen, azopropanone, niflumic acid, benzydamine, oxyphenbutazone, diclofenac, piroxicam, fenoprofen, pirprofen, flurbiprofen, sodium salicyclate, ibuprofensulindac, indomethacin, tiaprofenic acid, ketoprofen, tolmetin, colchicine, allopurinol, alfentanil, methadone, bezitramide, morphine, buprenorfine, nicomorphine, butorfanol, pentazocine, codeine, pethidine, dextromoramide, piritranide, dextropropoxyphene, sufentanil, fentanyl, articaine, mepivacaine, bupivacaine, prilocaine, etidocaine, procaine, lidocaine, tetracaine, amantidine, diphenhydramine, apomorphine, ethopropazine, benztropine mesylate, lergotril, biperiden, levodopa, bromocriptine, lisuride, carbidopa, metixen, chlorphenoxamine, orphenadrine, cycrimine, procyclidine, dexetimide, trihexyphenidyl, baclofen, carisoprodol, chlormezanone, chlorzoxazone, cyclobenzaprine, dantrolene, diazepam, febarbamate, mefenoxalone, mephenesin, metoxalone, methocarbamol, tolperisone, levothyronine, liothyronine, carbimazole, methimazole, methylthiouracil and propylthiouracil. 5. The duodenal/small intestinal insert of claim 1, wherein the bioactive material is a hormone. 6. The duodenal/small intestinal insert of claim 5 wherein the hormone is a natural or synthetic hormone selected from one or more of the group consisting of cortisol, deoxycorticosterone, fluorohydrocortisone, beclomethasone, betamethasone, cortisone, dexamethasone, fluocinolone, fluocinonide, fluocortolone, fluorometholone, fluprednisolone, flurandrenolide, halcinonide, hydrocortisone, medrysone, methylprednisolone, paramethasone, prednisolone, prednisone, triamcinolone (acetonide), danazole, fluoxymesterone, mesterolone, dihydrotestosterone methyltestosterone, testosterone, dehydroepiandrosetone, dehydroepiandrostendione, calusterone, nandrolone, dromostanolone, oxandrolone, ethylestrenol, oxymetholone, methandriol, stanozolol methandrostenolone, testolactone, cyproterone acetate, diethylstilbestrol, estradiol, estriol, ethinylestradiol, mestranol, quinestrol chlorotrianisene, clomiphene, ethamoxytriphetol, nafoxidine, tamoxifen, allylestrenol, desogestrel, dimethisterone, dydrogesterone, ethinylestrenol, ethisterone, ethynadiol diacetate, etynodiol, hydroxyprogesterone, levonorgestrel, lynestrenol, medroxyprogesterone, megestrol acetate, norethindrone, norethisterone, norethynodrel, norgestrel, progesterone, inhibin, antidiuretic hormone, proopiomelanocortin, follicle stimulating hormone, prolactin, angiogenin, epidermal growth factor, calcitonin, erythropoietin, thyrotropic releasing hormone, insulin, growth hormones, human chorionic gonadotropin, luteinizing hormone, adrenocorticotropic hormone (ACTH), lutenizing hormone releasing hormone (LHRH), parathyroid hormone (PTH), thyrotropin releasing hormone (TRH), vasopressin and corticotropin releasing hormone. 7. The duodenal/small intestinal insert of claim 1 wherein the pre-set shape comprises an angle selected from the group consisting of about 70.degree., about 71.degree., about 72.degree., about 73.degree., about 74.degree., about 75.degree., about 76.degree., about 77.degree., about 78.degree., about 79.degree., about 80.degree., about 81.degree., about 82.degree., about 83.degree., about 84.degree., about 85.degree., about 86.degree., about 87.degree., about 88.degree., about 89.degree., and about 90.degree.. 8. The duodenal/small intestinal insert of claim 1, wherein the pre-set shape comprises two angles, each matching an angle of the small intestine. 9. The duodenal/small intestinal insert of claim 1 wherein an expanded diameter of the at least one flow reduction element is about 1 cm to about 3 cm. 10. The duodenal/small intestinal insert of claim 1, wherein the bioactive material is a dip-coating, a spray-coating, or a sputter-coating adhered to the surface of the solid shaft member or the at least one flow reduction element. 11. The duodenal/small intestinal insert of claim 1, wherein the bioactive material is adhered to the surface of the elongated solid central shaft member or the at least one flow reduction element, and the insert further comprising a barrier layer over the bioactive material, the barrier layer configured to reduce the rate of release of the bioactive material from the elongated solid central shaft member or the at least one flow reduction element. 12. The duodenal/small intestinal insert of claim 11, wherein the barrier layer is about 50 to about 20,000 angstroms thick. 13. The duodenal/small intestinal insert of claim 11, wherein the barrier layer comprises a biocompatible inorganic material. 14. The duodenal/small intestinal insert of claim 13, wherein the biocompatible inorganic material is a silicide, an oxide, a nitride, or a carbide. 15. The duodenal/small intestinal insert of claim 11, wherein the barrier layer comprises a biocompatible organic material. 16. The duodenal/small intestinal insert of claim 15, wherein the biocompatible organic material is polyacrylonitrile, polyvinylidene chloride, nylon 6-6, a perfluoropolymer, polyethylene terephalate, polyethylene 2,6-napthalene dicarboxylate, or polycarbone. 17. The duodenal/small intestinal insert of claim 11, wherein the barrier layer comprises a biocompatible biodegradable material. 18. The duodenal/small intestinal insert of claim 17, wherein the biocompatible biodegradable material comprises hydroxyapatite, carbonated hydroxyapatite, tricalcium phosphate, beta-tricalcium phosphate, octacalcium phosphate, amorphous calcium phosphate, calcium orthophosphate, or calcium phosphate. 19. The duodenal/small intestinal insert of claim 1, wherein the bioactive material is a drug or a hormone, and wherein the amount of the drug or hormone on or within the elongated solid central shaft member is high enough to treat a diseased area outside of the gastrointestinal tract. 20. The duodenal/small intestinal insert of claim 1, further comprising a polymer sleeve positioned around the elongated solid central shaft member, the sleeve moveable along the longitudinal axis of the elongated solid central shaft member to cause at least one portion of the sleeve to expand at a predetermined location to form the flow reduction element. 21. The duodenal/small intestinal insert of claim 20, wherein the polymer sleeve is movable along the longitudinal axis of the elongated solid central shaft member to cause a plurality of portions of the sleeve to expand at predetermined locations to form a plurality of flow reduction elements. 22. The duodenal/small intestinal insert of claim 1, wherein the elongated solid central shaft member is formed from a shape memory material. 23. The duodenal/small intestinal insert of claim 1, wherein the flow reduction element is concentric with the elongated solid central shaft member. 24. The duodenal/small intestinal insert of claim 1, wherein the flow reduction element is eccentric to the elongated solid central shaft member. 25. The duodenal/small intestinal insert of claim 1, wherein the flow reduction element occupies about 30-80% of a diameter of a small intestine diameter. 26. The duodenal/small intestinal insert of claim 25, wherein the flow reduction element occupies about 40%-60% of the small intestine diameter. 27. The duodenal/small intestinal insert of claim 1, wherein the flow reduction element is configured to self expand from a first volume to a second volume when unrestrained. 28. The duodenal/small intestinal insert of claim 1, wherein the flow reduction element is formed from open or closed cell foam. 29. The duodenal/small intestinal insert of claim 1, wherein the anchoring member is a toroid shaped anchoring member configured to reside in the antrum and, when fully deployed, restricts distal migration of the elongated solid central shaft member. 30. The duodenal/small intestinal insert of claim 1, wherein the anchoring member comprises two or more balloons eccentrically arranged on the proximal end of the elongated solid central shaft member. 31. The duodenal/small intestinal insert of claim 30, wherein the balloons are inflatable and their combined diameter is larger than an opening of a pylorus. 32. The duodenal/small intestinal insert of claim 1, wherein the anchoring member comprises two or more volume occupying members that are configured to self expand from a first volume to a second volume when unrestrained and their combined diameter is larger than an opening into a pylorus. 33. The duodenal/small intestinal insert of claim 1, wherein the anchoring member comprises a collapsible, umbrella cage with a closed end and an open end, the closed end connected to the proximal end of the elongated solid central shaft member. 34. A method of using a duodenal insert to deliver a bioactive material, the duodenal insert including an elongated solid central shaft member having a proximal end and a distal end and a curved longitudinal axis extending from the proximal end to the distal end, the duodenal insert further including an anchoring member engaged with the proximal end of the elongated solid central shaft member, at least one flow reduction element coupled to the elongated solid central shaft member, and a bioactive material on or within the solid shaft member or the at least one flow reduction element, wherein the elongated solid central shaft member has a pre-set shape such that a portion of the curved longitudinal axis mimics an angulation of a duodenum, the method comprising: straightening the elongated solid central shaft member from the pre-set shape; after straightening, advancing the duodenal insert along an alimentary canal of a human being until the distal end of the elongated solid central shaft member is in the duodenum of the human being; returning the elongated solid central shaft member to the pre-set shape after the advancing; and expanding the flow reduction element when the flow reduction element is distal to a pylorus of the human being; wherein the returning step or the expanding step places the bioactive material in the duodenum. 35. The method of claim 34 wherein the bioactive material is a drug. 36. The duodenal/small intestinal insert of claim 35 wherein the drug is selected from one or more of the group consisting of altretamin, fluorouracil, amsacrin, hydroxycarbamide, asparaginase, ifosfamid, bleomycin, lomustin, busulfan, melphalan, chlorambucil, mercaptopurin, chlormethin, methotrexate, cisplatin, mitomycin, cyclophosphamide, procarbazin, cytarabin, teniposid, dacarbazin, thiotepa, dactinomycin, tioguanin, daunorubicin, treosulphan, doxorubicin, tiophosphamide, estramucin, vinblastine, etoglucide, vincristine, etoposid, vindesin, penicillin, ampicillin, nafcillin, amoxicillin, oxacillin, aziocillin, penicillin G, carbenicillin, penicillin V, dicloxacillin, phenethicillin, floxacillin, piperacillin, mecillinam, sulbenicillin, methicillin, ticarcillin, mezlocillin, cefaclor, cephalothin, cefadroxil, cephapirin, cefamandole, cephradine, cefatrizine, cefsulodine, cefazolin, ceftazidim, ceforanide, ceftriaxon, cefoxitin, cefuroxime, cephacetrile, latamoxef, cephalexin, amikacin, neomycin, dibekacyn, kanamycin, gentamycin, netilmycin, kanamycin, tobramycin, amphotericin B, novobiocin, bacitracin, nystatin, clindamycin, polymyxins, colistin, rovamycin, erythromycin, spectinomycin, lincomycin, vancomycin, chlortetracycline, oxytetracycline, demeclocycline, rolitetracycline, doxycycline, tetracycline, minocycline, chloramphenicol, rifamycin, rifampicin, thiamphenicol, sulfadiazine, sulfamethizol, sulfadimethoxin, sulfamethoxazole, sulfadimidin, sulfamethoxypyridazine, sulfafurazole, sulfaphenazol, sulfalene, sulfisomidin, sulfamerazine, sulfisoxazole, trimethoprim with sulfamethoxazole, sulfametrole, methanamine, norfloxacin, cinoxacin, nalidixic acid, nitrofurantoin, nifurtoinol, oxolinic acid; metronidazole; aminosalicyclic acid, isoniazide, cycloserine, rifampicine, ethambutol, tiocarlide, ethionamide, viomycin; amithiozone, rifampicine, clofazimine, sodium sulfoxone, diaminodiphenylsulfone, amphotericin B, ketoconazole, clotrimazole, miconazole, econazole, natamycin, flucytosine, nystatine, griseofulvin, aciclovir, idoxuridine, amantidine, methisazone, cytarabine, vidarabine, ganciclovir, chloroquine, iodoquinol, clioquinol, metronidazole, dehydroemetine, paromomycin, diloxanide, furoatetinidazole, emetine, chloroquine, pyrimethamine, hydroxychloroquine, quinine, mefloquine, sulfadoxine/pyrimethamine, pentamidine, sodium suramin, primaquine, trimethoprim, proguanil, antimony potassium tartrate, niridazole, antimony sodium dimercaptosuccinate, oxamniquine, bephenium, piperazine, dichlorophen, praziquantel, diethylcarbamazine, pyrantel parmoate, hycanthone, pyrivium pamoate, levamisole, stibophen, mebendazole, tetramisole, metrifonate, thiobendazole, niclosamide, acetylsalicyclic acid, mefenamic acid, aclofenac, naproxen, azopropanone, niflumic acid, benzydamine, oxyphenbutazone, diclofenac, piroxicam, fenoprofen, pirprofen, flurbiprofen, sodium salicyclate, ibuprofensulindac, indomethacin, tiaprofenic acid, ketoprofen, tolmetin, colchicine, allopurinol, alfentanil, methadone, bezitramide, morphine, buprenorfine, nicomorphine, butorfanol, pentazocine, codeine, pethidine, dextromoramide, piritranide, dextropropoxyphene, sufentanil, fentanyl, articaine, mepivacaine, bupivacaine, prilocaine, etidocaine, procaine, lidocaine, tetracaine, amantidine, diphenhydramine, apomorphine, ethopropazine, benztropine mesylate, lergotril, biperiden, levodopa, bromocriptine, lisuride, carbidopa, metixen, chlorphenoxamine, orphenadrine, cycrimine, procyclidine, dexetimide, trihexyphenidyl, baclofen, carisoprodol, chlormezanone, chlorzoxazone, cyclobenzaprine, dantrolene, diazepam, febarbamate, mefenoxalone, mephenesin, metoxalone, methocarbamol, tolperisone, levothyronine, liothyronine, carbimazole, methimazole, methylthiouracil and propylthiouracil. 37. The method of claim 34 wherein the bioactive material is a hormone. 38. The method of claim 37 wherein the hormone is a natural or synthetic hormone selected from one or more of the group consisting of cortisol, deoxycorticosterone, fluorohydrocortisone, beclomethasone, betamethasone, cortisone, dexamethasone, fluocinolone, fluocinonide, fluocortolone, fluorometholone, fluprednisolone, flurandrenolide, halcinonide, hydrocortisone, medrysone, methylprednisolone, paramethasone, prednisolone, prednisone, triamcinolone (acetonide), danazole, fluoxymesterone, mesterolone, dihydrotestosterone methyltestosterone, testosterone, dehydroepiandrosetone, dehydroepiandrostendione, calusterone, nandrolone, dromostanolone, oxandrolone, ethylestrenol, oxymetholone, methandriol, stanozolol methandrostenolone, testolactone, cyproterone acetate, diethylstilbestrol, estradiol, estriol, ethinylestradiol, mestranol, quinestrol chlorotrianisene, clomiphene, ethamoxytriphetol, nafoxidine, tamoxifen, allylestrenol, desogestrel, dimethisterone, dydrogesterone, ethinylestrenol, ethisterone, ethynadiol diacetate, etynodiol, hydroxyprogesterone, levonorgestrel, lynestrenol, medroxyprogesterone, megestrol acetate, norethindrone, norethisterone, norethynodrel, norgestrel, progesterone, inhibin, antidiuretic hormone, proopiomelanocortin, follicle stimulating hormone, prolactin, angiogenin, epidermal growth factor, calcitonin, erythropoietin, thyrotropic releasing hormone, insulin, growth hormones, human chorionic gonadotropin, luteinizing hormone, adrenocorticotropic hormone (ACTH), lutenizing hormone releasing hormone (LHRH), parathyroid hormone (PTH), thyrotropin releasing hormone (TRH), vasopressin and corticotropin releasing hormone. 39. The method of claim 34 wherein the pre-set shape comprises an angle selected from the group consisting of about 70.degree., about 71.degree., about 72.degree., about 73.degree., about 74.degree., about 75.degree., about 76.degree., about 77.degree., about 78.degree., about 79.degree., about 80.degree., about 81.degree., about 82.degree., about 83.degree., about 84.degree., about 85.degree., about 86.degree., about 87.degree., about 88.degree., about 89.degree., and about 90.degree.. 40. The method of claim 34, wherein the pre-set shape comprises two angles, each matching an angle of the duodenum. 41. The method of claim 34, wherein the advancing step is performed using a working channel of an endoscope. 42. The method of claim 34, wherein the expanding step is performed when the flow reduction element is advanced out of a working channel of an endoscope. 43. The method of claim 34, further comprising deploying the anchoring member into a portion of a stomach proximal to a pylorus of the human being. 44. The method of claim 43, wherein the deploying the anchoring member step positions the anchoring member within an antrum of a stomach of the human being. 45. The method of claim 43, wherein when the anchoring member is in the stomach, the elongated solid central shaft member passes through a pyloric valve while allowing the pyloric valve to function. 46. The method of claim 34, wherein the advancing step places the distal end of the elongated solid central shaft member into a horizontal duodenum of the human being. 47. The method of claim 34, wherein after the expanding step, the flow reduction element has a diameter sized to partially block a flow of food through the duodenum of the patient. 48. The method of claim 34, wherein the straightening is performed such that the duodenal insert can be inserted with an endoscope. 49. The method of claim 34, further comprising identifying a diseased area of the human being, and wherein after the returning step or the expanding step, the duodenal insert is configured to release the bioactive material to treat the diseased area. 50. The method of claim 49, wherein the diseased area is outside of a gastrointestinal tract of the human being.

Details for Patent 8,147,561

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	01/15/1974		2024-02-26
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	12/27/1984		2024-02-26
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/15/1985		2024-02-26