Auto-replenishing, wound-dressing apparatus and method

Abstract

Apparatus and methods to treat skin defects include a pump with reservoirs for a pressurization gas and a fluid, the fluid loaded at a factory and sealed or filled at point of use through a valve, septum, or the like. Upon activation, the pump generates a gas introduced into the gas reservoir, a movable wall of which displaces a movable wall of a fluid source, thus dispensing the fluid into the dressing to spread throughout irrespective of orientation of the dressing, maintaining a transport fluid (e.g. carrier) in the dressing and in contact with a skin defect being treated. Delivery may be periodic, constant, programmatically controlled, or manual. A dressing may maintain intimate contact, a transport fluid, and a controllable concentration of active ingredient against a skin defect. Apparatus and methods to replenish a dressing with a therapeutically effective concentration of a fluid deliver a fluid carrier containing an active ingredient. The fluid may be stored in and delivered from a pump mechanism including reservoirs for a pressurization gas and the fluid, which may be loaded at a factory and sealed or filled at point of use through a valve, septum, or the like. The dressing may have a distribution network, and multiple members, dispensing the fluid into a wick maintaining a transport fluid (e.g. carrier) distributed in the dressing and in contact with a skin defect being treated. Delivery may be periodic, constant, programmatically controlled, or manual to maintain intimate contact, a transport fluid, and a controllable concentration of active ingredient against wounded tissue.

1 . A dressing comprising:
 a feed conduit for delivering a fluid to a distribution member, the distribution member receiving and distributing the fluid substantially uniformly across the distribution member, irrespective of the orientation of the distribution member.   
     
     
         2 . The dressing of  claim 1 , wherein the fluid comprises an active ingredient. 
     
     
         3 . The dressing of  claim 1 , wherein an interface member is positioned between the distribution member and a skin defect being treated by the dressing, the interface member transporting the fluid from the distribution member into contact with a skin defect. 
     
     
         4 . The dressing of  claim 3 , wherein the interface member comprises at least one material chosen from a non-adhering polymer and a bioabsorbable polymer. 
     
     
         5 . The dressing of  claim 3 , wherein the interface member comprises at least one structure chosen from a sheet, a foam, a gel, gauze, a porous matrix, a honeycomb, a mop of fibrous material, a comminuted fibrous material, and a tubular structure. 
     
     
         6 . The dressing of  claim 1 , wherein the distribution member maintains a predetermined amount of fluid substantially uniformly across the distribution member and allows said distribution of fluid to communicate with a skin defect. 
     
     
         7 . The dressing of  claim 1 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly across the distribution member and allows said concentration of active ingredient in the fluid to communicate with a skin defect. 
     
     
         8 . The dressing of  claim 1 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly within a predetermined range of concentration across the distribution member and allows said concentration in said range to communicate with a skin defect. 
     
     
         9 . The dressing of  claim 1 , wherein the distribution member comprises material that allows the spread of fluid substantially uniformly across the distribution member by wicking action. 
     
     
         10 . The dressing of  claim 9 , wherein the force exerted on the fluid by the wicking action is greater than or equal to the force exerted on the fluid by gravity. 
     
     
         11 . The dressing of  claim 9 , wherein the distribution member comprises at least one material chosen from a polymer, a woven fabric, a non-woven fabric, a naturally occurring fiber, a sponge, a fiber matrix, a gauze, absorbent material, adsorbent material, a gel, and a foam. 
     
     
         12 . The dressing of  claim 1 , further comprising a protective member positioned adjacent the distribution member. 
     
     
         13 . The dressing of  claim 12 , wherein the protective member is semi-occlusive. 
     
     
         14 . The dressing of  claim 1 , wherein the feed conduit is connected to a fluid source for replenishing the fluid in the distribution member with or without additional human intervention. 
     
     
         15 . The dressing of  claim 14 , wherein the fluid source controls a fluid flow to the distribution member. 
     
     
         16 . The dressing of  claim 1 , comprising one or more members structured to operate as at least one of an interface member, a distribution member, a fluid transport member, a protective member, a tenting member, a fluid absorber, and a combination thereof. 
     
     
         17 . The dressing of  claim 1 , wherein the distribution member or dressing is configured to be cut to a desired size and still maintain a substantially uniform volume of fluid across the distribution member. 
     
     
         18 . The dressing of  claim 1 , wherein the distribution member comprises distribution tubes for distributing a volume of fluid substantially uniformly across the distribution member. 
     
     
         19 . The dressing of  claim 1 , wherein the distribution member comprises a porous pouch. 
     
     
         20 . A dressing comprising:
 a feed conduit for delivering a fluid to a distribution member, the distribution member receiving and distributing the fluid substantially uniformly across the distribution member, irrespective of the orientation of the distribution member;   wherein the distribution member comprises material that allows the spread of fluid substantially uniformly across the distribution member by wicking action; and   wherein the distribution member is configured to be cut to a desired size and still maintain a substantially uniform volume of fluid across the distribution member.   
     
     
         21 . A dressing comprising:
 a distribution member;   a feed conduit for delivering a fluid to the distribution member, the distribution member configured to receive and distribute the fluid substantially uniformly across the distribution member by wicking action, irrespective of the orientation of the distribution member; and   an interface member is positioned between the distribution member and a skin defect being treated by the dressing, the interface member transporting the fluid into contact with the skin defect.   
     
     
         22 . The dressing of  claim 21 , wherein the distribution member maintains a predetermined amount of fluid substantially uniformly across the distribution member. 
     
     
         23 . The dressing of  claim 22 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly across the distribution member and allows said concentration of active ingredient in the fluid to communicate with the skin defect. 
     
     
         24 . The dressing of  claim 23 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly within a predetermined range of concentration across the distribution member and allows said concentration in said range to communicate with the skin defect. 
     
     
         25 . The dressing of  claim 21 , further comprising a protective member positioned adjacent the distribution member. 
     
     
         26 . The dressing of  claim 25 , wherein the protective member is semi-occlusive. 
     
     
         27 . The dressing of  claim 25 , comprising one or more members structured to operate as at least one of the interface member, the distribution member, and the protective member, a fluid transport member, a tenting member, a fluid absorber, and a combination thereof. 
     
     
         28 . The dressing of  claim 21 , wherein the distribution member is configured to be cut to a desired size and still maintain a substantially uniform volume of fluid across the distribution member. 
     
     
         29 . A dressing comprising:
 a distribution member comprising at least one material chosen from a polymer, a woven fabric, a non-woven fabric, a naturally occurring fiber, a sponge, a fiber matrix, a gauze, absorbent material, adsorbent material, a gel, and a foam;   a feed conduit for delivering a fluid to the distribution member, the distribution member configured to receive and distribute the fluid substantially uniformly across the distribution member by wicking action, wherein the force exerted on the fluid by the wicking action is greater than the force exerted on the fluid by gravity, and wherein the distribution member is configured to maintain a predetermined amount of fluid substantially uniformly across the distribution member, wherein the fluid is received, distributed, and maintained irrespective of the orientation of the distribution member;   an interface member is positioned between the distribution member and a skin defect being treated by the dressing, the interface member transporting the fluid into contact with the skin defect, wherein the interface member comprises at least one material chosen from a non-adhering polymer and a bioabsorbable polymer; and   a semi-occlusive protective member positioned adjacent the distribution member.   
     
     
         30 . The dressing of  claim 29 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly across the distribution member and allows said concentration of active ingredient in the fluid to communicate with the skin defect. 
     
     
         31 . The dressing of  claim 30 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly within a predetermined range of concentration across the distribution member and allows said concentration in said range to communicate with the skin defect. 
     
     
         32 . The dressing of  claim 31 , wherein the distribution member is configured to be cut to a desired size and still maintain a substantially uniform volume of fluid across the distribution member 
     
     
         33 . The dressing of  claim 32 , comprising one or more members structured to operate as at least one of the interface member, the distribution member, the protective member, a fluid transport member, a tenting member, a fluid absorber, and a combination thereof. 
     
     
         34 . A method for treating a skin defect, the method comprising:
 providing a dressing comprising:
 a feed conduit; and 
 a distribution member in fluid communication with the feed conduit, the distribution member configured to receive a fluid and comprising a material to substantially uniformly distribute the fluid across the distribution member irrespective of the orientation of the distribution member; 
   applying the dressing to a skin defect;   supplying a fluid to the distribution member through the feed conduit; and   distributing the fluid substantially uniformly across the distribution member.   
     
     
         35 . The method of  claim 34 , wherein the fluid comprises an active ingredient. 
     
     
         36 . The method of  claim 34 , wherein an interface member is positioned between the distribution member and the skin defect being treated by the dressing, the interface member transporting the fluid into contact with the skin defect. 
     
     
         37 . The method of  claim 34 , wherein the distribution member maintains a predetermined amount of fluid substantially uniformly across the distribution member. 
     
     
         38 . The method of  claim 35 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly across the distribution member and allows said concentration of active ingredient in the fluid to communicate with the skin defect. 
     
     
         39 . The method of  claim 35 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly within a predetermined range of concentration across the distribution member and allows said concentration in said range to communicate with the skin defect. 
     
     
         40 . The method of  claim 34 , wherein the distribution member comprises material that allows the spread of fluid substantially uniformly across the distribution member by wicking action. 
     
     
         41 . The method of  claim 40 , where the force exerted on the fluid by the wicking action is greater than or equal to the force exerted on the fluid by gravity. 
     
     
         42 . The method of  claim 34 , further comprising a protective member positioned adjacent the distribution member. 
     
     
         43 . The method of  claim 34 , wherein the distribution member comprises distribution tubes for distributing a volume of fluid substantially uniformly across the distribution member. 
     
     
         44 . The method of  claim 34 , wherein the distribution member comprises a porous pouch. 
     
     
         45 . The method of  claim 34 , wherein supplying a fluid comprises supplying a pre-determined quantity of fluid containing an active ingredient. 
     
     
         46 . The method of  claim 34 , further comprising priming the dressing with a quantity of fluid. 
     
     
         47 . The method of  claim 34 , further comprising providing a bolus of fluid to the dressing. 
     
     
         48 . The method of  claim 34 , further comprising manually providing fluid from a fluid source to the dressing. 
     
     
         49 . The method of  claim 34 , further comprising automatically providing fluid from a fluid source to the dressing. 
     
     
         50 . The method of  claim 34 , wherein the dressing further comprises a controller, and wherein supplying the fluid to the distribution member comprises programming the controller to supply the fluid at a predetermined flow rate or time interval. 
     
     
         51 . The method of  claim 34 , further comprises substantially uniformly distributing the fluid to the skin defect from the distribution member. 
     
     
         52 . The method of  claim 35 , wherein supplying fluid to the distribution member comprises maintaining a fluid with a concentration of active ingredient greater than a predetermined threshold over a predetermined period of time. 
     
     
         53 . The method of  claim 35 , wherein supplying fluid to the distribution member comprises maintaining a fluid with a concentration of active ingredient lesser than a predetermined threshold over a predetermined period of time. 
     
     
         54 . The method of  claim 35 , wherein the active ingredient comprises at least one composition chosen from an antimicrobial, an antibiotic, an antifungal, an antiviral, an antiseptic, and an antibacterial agent. 
     
     
         55 . The method of  claim 35 , wherein the active ingredient comprises at least one composition chosen from an analgesic, a palliative, and an anti-inflammatory agent. 
     
     
         56 . The method of  claim 35 , wherein the active ingredient comprises at least one composition chosen from de-ionized water, a polymeric gel, a saline composition, and a hydrocolloid. 
     
     
         57 . The method of  claim 35 , wherein the active ingredient comprises at least one beneficial agent chosen from an enzymatic debrider, a tissue growth factor, a scar-reducing agent, tissue cells, topical nutrients, a coagulant, nitric oxide, oxygen gas, ozone, and a gene therapy agent. 
     
     
         58 . The method of  claim 35 , wherein the active ingredient is selected to be therapeutically effective in treating a dermatological disorder chosen from a skin defect, an allergy eruption, a skin cancer, a rash, a burn, a growth, a cyst, a wart, a tumor, an ulcer, a boil, an incision, a graft, oiliness, dryness, wrinkles, blemishes, discolorations, and trauma. 
     
     
         59 . The method of  claim 34 , further comprising trimming the dressing to a desired shape corresponding to a treatment area. 
     
     
         60 . A method for treating a skin defect, the method comprising:
 providing a dressing comprising:
 a feed conduit; and 
 a distribution member in fluid communication with the feed conduit, the distribution member configured to receive a fluid and comprising a material to substantially uniformly distribute the fluid across the distribution member irrespective of the orientation of the distribution member; 
   cutting the dressing to a desired shape;   applying the dressing to a skin defect;   supplying a fluid having an active ingredient to the distribution member through the feed conduit;   distributing the fluid substantially uniformly across the distribution member; and   distributing the fluid substantially uniformly to a skin defect irrespective of the orientation the distribution member.   
     
     
         61 . The method of  claim 60 , further comprising priming the dressing with a quantity of fluid. 
     
     
         62 . The method of  claim 60 , further comprising providing a bolus of fluid to the dressing. 
     
     
         63 . The method of  claim 60 , further comprising automatically controlling the supply of fluid to the distribution member. 
     
     
         64 . The method of  claim 63 , wherein controlling the supply of fluid comprises programming a controller to supply the fluid at a predetermined flow rate or time interval. 
     
     
         65 . The method of  claim 64 , wherein supplying fluid to the distribution member comprises maintaining a fluid with a concentration of active ingredient greater than a predetermined threshold over a predetermined period of time. 
     
     
         66 . The method of  claim 65 , wherein supplying fluid to the distribution member comprises maintaining a fluid with a concentration of active ingredient lesser than a predetermined threshold over a predetermined period of time. 
     
     
         67 . The method of  claim 60 , comprising one or more members structured to operate as at least one of an interface member, a distribution member, and a protective member. 
     
     
         68 . A fluid delivery system comprising:
 a housing having, an interior volume, inextensible and vented to discharge gas therefrom, and containing reservoir and a fluid source in contact with one another;   a fluid source containing a fluid having a first wall flexible to move in response to substantially any pressure and substantially impervious to the fluid, and an outlet to dispense the fluid;   a reservoir comprising a second wall, in contact with the first wall to move therewith, substantially impervious to a gas;   a galvanic cell in communication with the reservoir and comprising chemicals selected to produce a gas within the reservoir;   a dressing to expose the fluid to a skin defect of a subject, said dressing comprising a distribution member configured to receive the fluid and comprising a material to substantially uniformly distribute the fluid across the distribution member by wicking action irrespective of the orientation of the distribution member; and   a conduit connectable to the outlet and in fluid communication with the distribution member to replenish the fluid in the distribution member.   
     
     
         69 . The fluid delivery system of  claim 68 , wherein the fluid comprises an active ingredient. 
     
     
         70 . The fluid delivery system of  claim 68 , wherein the dressing further comprises a protective member positioned adjacent the distribution member. 
     
     
         71 . The fluid delivery system of  claim 70 , wherein the protective member is semi-occlusive. 
     
     
         72 . The fluid delivery system of  claim 68 , wherein an interface member is positioned between the distribution member and a skin defect being treated by the dressing, the interface member transporting the fluid into contact with the skin defect. 
     
     
         73 . The fluid delivery system of  claim 68 , wherein the distribution member comprises material that allows the spread of fluid substantially uniformly across the distribution member by wicking action. 
     
     
         74 . The fluid delivery system of  claim 73 , wherein the force exerted on the fluid by the wicking action is greater than or equal to the force exerted on the fluid by gravity. 
     
     
         75 . The fluid delivery system of  claim 68 , wherein the distribution member comprises distribution tubes for distributing a volume of fluid substantially uniformly across the distribution member. 
     
     
         76 . The fluid delivery system of  claim 68 , wherein the distribution member comprises a porous pouch. 
     
     
         77 . The fluid delivery system of  claim 68 , wherein the distribution member maintains a substantially uniform fluid volume across the distribution member and allows the fluid to communicate with the skin defect upon reaching or exceeding a predetermined saturation level. 
     
     
         78 . The dressing of  claim 68 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly across the distribution member and allows said concentration of active ingredient in the fluid to communicate with the skin defect. 
     
     
         79 . The dressing of  claim 68 , wherein the distribution member maintains a concentration of active ingredient in the fluid substantially uniformly within a predetermined range of concentration across the distribution member and allows said concentration in said range to communicate with the skin defect. 
     
     
         80 . The fluid delivery system of  claim 68 , wherein the fluid source outlet comprises a regulator to maintain pressure in the fluid source greater than the ambient pressure to minimize operational variations due to variations in at least one of the ambient temperature, the barometric pressure, or the orientation of the device. 
     
     
         81 . The fluid delivery system of  claim 68 , further comprising a controller connected to the galvanic cell in a circuit to control the generation of the gas in the reservoir, thereby controlling a delivery rate of the fluid from the fluid source. 
     
     
         82 . The fluid delivery system of  claim 81 , wherein the controller comprises a fixed or variable resistor and a switch. 
     
     
         83 . The fluid delivery system of  claim 81 , wherein at least a portion of the controller is located separately from the galvanic cell and is in communication with the cell by at least one of mechanical hardware, electromagnetic, radio frequency, magnetic, or optical feedback or circuit. 
     
     
         84 . The fluid delivery system of  claim 81 , wherein the controller is located inside the reservoir. 
     
     
         85 . The fluid delivery system of  claim 81 , wherein the controller further comprises a processor programmatically controlling the value of resistance in the circuit. 
     
     
         86 . The fluid delivery system of  claim 85 , further comprising a fill port in fluid communication with the fluid source. 
     
     
         87 . The fluid delivery system of  claim 86 , wherein the fill port comprises a septum through which a syringe may penetrate to access the fluid source. 
     
     
         88 . The fluid delivery system of  claim 68 , further comprising a sensor operably connected to provide inputs to the processor to control the value of resistance in accordance with an algorithm therewith.