A medical device for delivery of a therapeutic agent to a physiological target site includes a flexible receptacle containing said therapeutic agent, wherein at least a part of the receptacle is formed of a water-soluble or water-dispersible material. The therapeutic agent may include a haemostatic
A medical device for delivery of a therapeutic agent to a physiological target site includes a flexible receptacle containing said therapeutic agent, wherein at least a part of the receptacle is formed of a water-soluble or water-dispersible material. The therapeutic agent may include a haemostatic agent and the physiological target site may be a wound.
대표청구항▼
1. A haemostatic medical device for topical delivery of a haemostatic agent to a physiological wound site, said device comprising: a flowable haemostatic agent; anda flexible receptacle, the flexible receptacle having a configuration selected from the group consisting of a bag, a pouch, and a sachet
1. A haemostatic medical device for topical delivery of a haemostatic agent to a physiological wound site, said device comprising: a flowable haemostatic agent; anda flexible receptacle, the flexible receptacle having a configuration selected from the group consisting of a bag, a pouch, and a sachet, the flexible receptacle having an outer wall which is configured and arranged to overlie the physiological wound site, conform to a contour of the physiological wound site and make contact with bodily fluids, water or aqueous fluids present at the physiological wound site,wherein at least a portion of the outer wall of the flexible receptacle is formed of a water-soluble or water-dispersible material, andwherein the flowable haemostatic agent is contained within an interior of the flexible receptacle, andwherein said flowable haemostatic agent is capable of being delivered to the physiological wound site upon the dissolution or dispersion of the outer wall as a result of contact with the bodily fluids, water or aqueous fluids. 2. A haemostatic medical device according to claim 1, wherein the receptacle is completely water-soluble or water-dispersible. 3. A haemostatic medical device according to claim 1, wherein the water-soluble or water-dispersible material is susceptible to dissolution or dispersal at temperatures of around 45° C. or below. 4. A haemostatic medical device according to claim 3, wherein the water-soluble or water-dispersible material is susceptible to dissolution or dispersal at temperatures of around 41° C. or below. 5. A haemostatic medical device according to claim 4, wherein the water-soluble or water-dispersible material is susceptible to dissolution or dispersal at temperatures of around 37° C. or below. 6. A haemostatic medical device according to claim 1, wherein at body temperature the water-soluble or water-dispersible material begins to dissolve or disperse within around 1 second to around 120 seconds of exposure to bodily fluids, water or aqueous fluid(s). 7. A haemostatic medical device according to claim 6, wherein at body temperature the water-soluble or water-dispersible material begins to dissolve or disperse within around 5 seconds to around 120 seconds of exposure to bodily fluids, water or aqueous fluid(s). 8. A haemostatic medical device according to claim 7, wherein at body temperature the water-soluble or water-dispersible material begins to dissolve or disperse within around 60 seconds of exposure to bodily fluids, water or aqueous fluid(s). 9. A haemostatic medical device according to claim 8, wherein at body temperature the water-soluble or water-dispersible material begins to dissolve or disperse within around 30 seconds of exposure to bodily fluids, water or aqueous fluid(s). 10. A haemostatic medical device according to claim 1, wherein at body temperature substantially complete dissolution or dispersal of the water-soluble or water dispersible material occurs within around 1 second to around 30 minutes of exposure to bodily fluids, water or aqueous fluid(s). 11. A haemostatic medical device according to claim 10, wherein at body temperature substantially complete dissolution or dispersal of the water-soluble or water-dispersible material occurs within around 5 minutes of exposure to bodily fluids, water or aqueous fluid(s). 12. A haemostatic medical device according to claim 11, wherein at body temperature substantially complete dissolution or dispersal of the water-soluble or water-dispersible material occurs within around 2 minutes of exposure to bodily fluids, water or aqueous fluid(s). 13. A haemostatic medical device according to claim 1, wherein the receptacle is formed from a combination of at least one water-soluble or water-dispersible material with at least one further material which is neither water-soluble nor water-dispersible. 14. A haemostatic medical device according to claim 13, wherein the receptacle is formed from a fabric comprising a combination of at least one water-soluble or water-dispersible material with at least one further material which is neither water-soluble nor water-dispersible. 15. A haemostatic medical device according to claim 13, wherein the receptacle has at least one soluble region formed of the at least one water-soluble or water-dispersible material, and at least one insoluble region formed of the at least one material which is neither water-soluble nor water-dispersible. 16. A haemostatic medical device according to claim 13, wherein the receptacle is formed from a material comprising a sheet of a water-soluble or water-dispersible material together with a sheet of a material which is neither water-soluble nor water-dispersible. 17. A haemostatic medical device according to claim 1, wherein the receptacle is formed from a sheet material folded and sealed to provide for containment of the haemostatic agent. 18. A haemostatic medical device according to claim 1, wherein the receptacle is formed from a material selected from a film, foam, fabric or net material. 19. A haemostatic medical device according to claim 1, wherein the water-soluble or water-dispersible material comprises a polymeric material. 20. A haemostatic medical device according to claim 19, wherein the polymeric material comprises any of the following, either alone or combination: cellulose; cellulose derivatives; polyvinyl alcohol; polyvinyl pyrrolidone; pectins; chitosans; alginates; polysaccharides; gelatins; carrageenans; polyethylene glycol; natural gums; water-dispersible polyacrylates, including polyacrylic acid; methylmethacrylate copolymer; carboxyvinyl copolymers; superabsorbents; polylactic acid; polyurethane; poly glycolic acid; and hyaluronic acid. 21. A haemostatic medical device according to claim 13, wherein the receptacle is formed from a material comprising one or more of the following in any combination: plasticising agents; insolublising agents; solublising agents; surfactants; dispersed insoluble materials; dispersion adding materials; casting aids; bonding aids; adhesives; materials which render the receptacle susceptible to dispersion upon exposure to photochemical, ultraviolet, biological, or chemical sources. 22. A haemostatic medical device according to claim 21, wherein the insoluble materials comprise one or more of the following in any combination: cellulose, chitin, silica, water insoluble cellulose derivatives, calcium alginate, zeolite, sand, chalk, water-swellable compounds, polymeric materials. 23. A haemostatic medical device according to claim 1, wherein the receptacle is formed from a material susceptible to metabolisation within the body. 24. A haemostatic medical device according to claim 23, wherein the material susceptible to metabolisation within the body comprises any of the following, alone or in any combination: collagen, oxidised regenerated cellusose, poly lactic acid, poly glycolic acid, chitin, chitosan, gelatine and hyaluronic acid. 25. A haemostatic medical device according to claim 1, wherein the receptacle is generally square, rectangular, circular or elliptical. 26. A haemostatic medical device according to claim 1, wherein the receptacle comprises a tube, sphere, cone, cube, pyramid, horse shoe, or torus. 27. A haemostatic medical device according to claim 1, wherein the receptacle has a projection or protrusion for placement within a hole, cavity or orifice. 28. A haemostatic medical device according to claim 1, wherein the receptacle is formed from a material having a thickness of between around 10 μm and around 100 μm. 29. A haemostatic medical device according to claim 1, wherein the receptacle is apertured. 30. A haemostatic medical device according to claim 1, wherein the receptacle itself comprises a therapeutically active component. 31. A haemostatic medical device according to claim 1, wherein the haemostatic agent is a particulate material. 32. A haemostatic medical device according to claim 1, wherein the haemostatic agent is selected from a liquid, solution, gel, emulsion, foam or fibrous material. 33. A haemostatic medical device according to claim 1, wherein the haemostatic agent comprises a chitosan salt. 34. A haemostatic medical device according to claim 33, wherein the chitosan salt is selected from any of the following either alone or in combination: acetate, lactate, succinnate, malate, sulphate and acrylate. 35. A haemostatic medical device according to claim 33, wherein the chitosan salt constitutes at least around 5% by weight of the haemostatic agent. 36. A haemostatic medical device according to claim 35, wherein the chitosan salt constitutes at least around 20% by weight of the haemostatic agent. 37. A haemostatic medical device according to claim 33, wherein the chitosan salt is a particulate material. 38. A haemostatic medical device according to claim 37, wherein the chitosan salt has a particle size such that it will pass through a 5 mesh screen but be retained by a 80 mesh screen. 39. A haemostatic medical device according to claim 38, wherein the chitosan salt has a particle size such that it will pass through a 20 mesh screen but be retained by a 50 mesh screen. 40. A haemostatic medical device according to claim 1, wherein the haemostatic agent further comprises an inert material. 41. A haemostatic medical device according to claim 40, wherein the inert material is selected from any of the following either alone or in combination: cellulose, fumed silica, sand, clay, alginate, micro crystalline cellulose, oxidized regenerated cellulose, polyethylglycol, guar gum, xanthan gum, chitosan, chitosan derivatives, chitin, sucrose, lactose, pectin, carboxy methyl cellulose, ground corn meal, collagen, gelatine, poly vinyl alcohol, acrylic acid, poly acrylic acid polymers, barium sulphate, clay, lactose, sucrose and starch. 42. A haemostatic medical device according to claim 40, wherein the inert material constitutes at least around 30% by weight of the haemostatic agent. 43. A haemostatic medical device according to claim 40, wherein the inert material is a particulate material having a particle size approximating to the size of particles of the chitosan salt. 44. A haemostatic medical device according to claim 1, wherein the haemostatic agent comprises at least one medical surfactant. 45. A haemostatic medical device according to claim 44, wherein the medical surfactant is selected from any of the following either alone or in combination: block copolymers based on ethylene oxide and propylene oxide; fatty acids; fatty acid salts; silicone based surfactants; and emulsifiers. 46. A haemostatic medical device according to claim 44, wherein the medical surfactant constitutes from around 0.001% to around 10% by weight of the haemostatic agent. 47. A haemostatic medical device according to claim 46, wherein the medical surfactant constitutes from around 0.5% to around 1% by weight of the haemostatic agent. 48. A haemostatic medical device according to claim 33, wherein the haemostatic agent has a pH of from around 3.5 to around 6. 49. A haemostatic medical device according to claim 1, wherein the haemostatic agent is selected from any of the following either alone or in any combination: chitosan salts, starch-based haemostats, collagen powders, gelatin powders, superabsorbents, acrylic-based polymers, cationic materials, oxidised regenerated cellulose, alginate, Factor VIII, thrombin, fibrinogen, calcium, and vitamin K. 50. A method of manufacturing a medical or haemostatic device comprising the steps of: introducing a flowable therapeutic agent into a flexible receptacle, the flexible receptacle having a configuration selected from the group consisting of a bag, a pouch, and a sachet, at least a part of said receptacle being formed of a water-soluble or water-dispersible material, the flexible receptacle having an outer wall which is configured and arranged to overlie the physiological wound site, conform to a contour of the physiological wound site and make contact with bodily fluids, water or aqueous fluids present at the physiological target wound site; andcontaining the therapeutic agent within the flexible receptacle;wherein said flowable haemostatic agent is capable of being delivered to the physiological wound site upon the dissolution or dispersion of the outer wall as a result of contact with the bodily fluids, water or aqueous fluids. 51. A method according to claim 50, wherein a sheet of flexible material is longitudinally sealed to form a tube which is then filled with the therapeutic agent and transversely sealed at both ends to contain said therapeutic agent. 52. A method according to claim 50, wherein a sheet of flexible material is longitudinally sealed to form a tube which is then is sealed at a first end before introduction of the therapeutic agent and subsequent sealing at a second end to contain the therapeutic agent. 53. A method according to claim 51, wherein sealing is effected by any of the following either alone or in combination: heat, pressure, ultrasonics, moisture, and adhesive. 54. A method according to claim 50, wherein the method includes a sterilisation step. 55. A method according to claim 50, wherein the method is carried out in an environment of controlled moisture and/or temperature. 56. A method of delivering a flowable therapeutic agent to a physiological target site, comprising the steps of: providing a medical device comprising a flexible receptacle containing said flowable therapeutic agent, the flexible receptacle having a configuration selected from the group consisting of a bag, a pouch, and a sachet, wherein at least a part of the receptacle is formed of a water-soluble or water-dispersible material, the flexible receptacle having an outer wall which is configured and arranged to overlie the physiological wound site, conform to a contour of the physiological wound site and make contact with bodily fluids, water or aqueous fluids present at the physiological target wound site; andplacing the medical device at the physiological target site for a sufficient time to effect treatment;wherein said flowable haemostatic agent is capable of being delivered to the physiological wound site upon the dissolution or dispersion of the outer wall as a result of contact with the bodily fluids, water or aqueous fluids.
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이 특허에 인용된 특허 (5)
Brueggemann Helmut,DEX ; Dahmen Kurt,DEX ; Lehwald Dieter,DEX ; Theilmann Roland,DEX, Body of layered structure for absorbing liquids, the production and use thereof.
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