Implants and constructs including hollow fibers

Abstract

Hollow fiber drug delivery devices are described. Device can contain structural or solid fibers. Fabric can be formed by fibers being interwoven or joined to each other. All or some of the fibers can be resorbable. Fibers can be subdivided, by deformations or closure points, into numerous compartments that separately deliver drug. Deformations can be located at points of fiber intersection or joining. Different drug or drug formulation can be provided in different places. Fibers can be given appropriate surface treatments or coatings to achieve desired properties such as wetting of pores and surfaces. Different release characteristics in different directions can be achieved. The hollow fibers can contain solid particles of drug, and can contain gel. Possible applications include hernia meshes, pouches, sutures, catheters, wound dressings, stents, nerve regrowth guides, refillable/drainable devices, and devices that deliver drug to lymphatic flow.

1 . A medical device configured for implantation within a subject's body, comprising:
 one or more hollow, non-metallic fibers having native-permeable walls that define interior lumens, wherein a drug is located in at least some of said lumen, wherein the walls comprise pores, wherein said walls provide a drug release rate that after implantation provides a pharmaceutically effective amount of drug, and wherein:   (a) the hollow, non-metallic fibers are comprised in a fiber-complex, which is a fabric construct or a yarn construct, or (b) at least some of said lumens further contains a polymeric substance, said polymeric substance having a molecular weight such that said polymeric substance is resistant to passing through said wall, said polymeric substance comprising (i) a polymeric substance that absorbs water when in the presence of aqueous bodily fluids, (ii) a viscosity-enhancing or gel-forming substance that produces a high viscosity liquid or a gel when in aqueous solution, or (iii) a swellable material that increases its volume upon absorption of bodily fluids, or   (c) the permeable wall comprises a base material that is treated to render it more hydrophilic than in its untreated condition, or   (d) different parts of said lumen(s) contain a distinct second drug or a formulation of the first drug that is different from a formulation of the drug compared to fibers in another part of said device, or   (e) the hollow, non-metallic fiber or fibers are comprised in a suture and are attached to suture lead end that has a sharpness and stiffness selected for use as a suture lead, or   (f) the medical device further comprises a reservoir of drug, the reservoir in fluid communication with the hollow, non-metallic fibers, or   (g) one or more of the hollow, non-metallic fibers terminates in (i) a port configured to provide a fluid connection to a conduit for filing or draining that hollow fiber from outside the subject's body or (ii) a fluid connection to such a conduit, or   (h) one or more of the hollow, non-metallic fibers is arrayed along a catheter, or   (i) one or more of the hollow, non-metallic fibers having end(s) fixed in a potting material configured to provide a connector to a supply or drain line, or   (j) a said hollow, non-metallic fiber has one or more deformations at selected place(s) along its length that obstruct fluid communication in the fiber interior, said the walls of hollow fiber exhibiting a molecular weight cutoff of about 500 Daltons or higher (e.g., about 1,000 Daltons or higher, or about 2,000 Daltons or higher); or   (k) a device according to one of (a) through (j), wherein the device is resorbable; or   (l) any combination of the foregoing.   
     
     
         2 . The medical device of  claim 1 , wherein the medical device is a fiber-complex pursuant to (a), wherein a plurality of the hollow, non-metallic fibers are present and are joined to form the fiber-complex. 
     
     
         3 . The medical device of  claim 1 , wherein the medical device comprises a first fabric construct pursuant to (a) and, laminated against the first fabric construct, (1) a barrier layer resistant to permeation of the drug through the barrier or (2) second fabric construct comprising second fibers. 
     
     
         4 . The medical device of  claim 3 , wherein the medical device is pursuant to (1). 
     
     
         5 . The medical device of  claim 4  that is a tissue guide, wherein the fabric construct is configured to substantially surround an area of tissue, and wherein the barrier layer is exterior to the fabric construct. 
     
     
         6 . The medical device of  claim 1 , wherein the medical device is pursuant to (d). 
     
     
         7 . The medical device of  claim 1 , wherein the medical device is pursuant to (b). 
     
     
         8 . The medical device of  claim 7 , wherein the medical device is pursuant to (b)(ii), and wherein at least in portions of the device the drug is in a reservoir-providing amount comprising particles comprising drug, wherein the drug particles are suspended in a viscous fluid comprising the viscosity-enhancing or gel-forming substance. 
     
     
         9 . The medical device of  claim 1 , wherein the medical device is pursuant to (c). 
     
     
         10 . The medical device of  claim 1  that is a suture, wherein the medical device is pursuant to (e). 
     
     
         11 . The medical device of  claim 1 , wherein the medical device is pursuant to (f). 
     
     
         12 . The medical device of  claim 11 , wherein the reservoir is a manifold in fluid communication with multiple said hollow, non-metallic fibers. 
     
     
         13 . The medical device of  claim 1 , wherein the medical device is pursuant to (g). 
     
     
         14 . A method for treating a subject, comprising:
 implanting into a tissue location of the subject a medical device, wherein the tissue location has an initial interstitial flow, a real-time interstitial flow and has a hydrodynamic permeability, the device comprising a permeable wall and a chamber comprising drug, wherein the hydrodynamic permeability of the wall is approximately equal to or greater than a hydrodynamic permeability of the tissue,   having the real-time interstitial flow penetrate the wall into the chamber with a penetrating velocity, wherein the penetrating velocity is greater than the initial interstitial velocity, and   providing hydrodynamic driven release of the drug into the local interstitial flow.   
     
     
         15 . A method of implanting within the body of a subject a medical device comprising one or more hollow, non-metallic fibers having a native-permeable wall that defines an interior lumen, wherein a drug selected for effectiveness against a medical indication is located in at least some of said interior lumen, wherein said wall provides for release of the drug, the medical device placed so as to deliver an effective amount of the drug at a disease affected tissue while delivering less than such an amount at a tissue different from the affected tissue. 
     
     
         16 . The method of  claim 15 , wherein the hollow, non-metallic fiber(s) are linearly cohesive with two ends, and wherein one or more resorbable second fibers or linking structures structurally restrain the linearly cohesive fibers to form a fabric construct, and wherein the method further comprises leaving the medical device in the subject for a period of time for the resorbable fibers or linking structures to be sufficiently degraded so that the linearly cohesive fibers are no longer structurally restrained, and pulling a portion of the linearly cohesive fibers to pull the linearly cohesive fibers from the body of the subject. 
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 14 , wherein the drug is effective to limit the formation of a biofilm on the medical device. 
     
     
         19 . The method of  claim 14 , wherein the device comprises a second drug, and wherein the first drug is an antibiotic that is effective against a first class of pathogens and the second drug is an antibiotic that is effective against a second class of pathogens different from said first class. 
     
     
         20 . The method of  claim 14 , wherein the device is a fiber-complex pursuant to (a), wherein a said hollow, non-metallic fiber has deformations at selected place(s) along its length that obstruct fluid communication in the fiber lumen such that the device uniformly releases drug. 
     
     
         21 . The method of  claim 14 , wherein the device is resorbable.