Resorbable nonwoven pouches for medical device implants

Patent metadata

Field	Value
Publication number	US-11612754-B2
Application number	US-201916553651-A
Country	US
Kind code	B2
Filing date	Aug 28, 2019
Priority date	Dec 21, 2018
Publication date	Mar 28, 2023
Grant date	Mar 28, 2023

Abstract

Nonwoven resorbable pouches that at least partially enclose implantable medical devices and improved methods for producing the implantable medical device pouches are described. The nonwoven pouches may comprise one or more drugs. Implantable medical devices that are placed in the pouches prior to implantation are prevented from migrating from the site of implantation by tissue ingrowth into the pouch. Antibiotics may be incorporated into the pouches to prevent post-operative infections. The pouches may be formed in fewer steps than conventional pouches, and without polymer coatings. Nonwoven pouches can be formed in one step by dry spinning instead of using multiple processing steps. In embodiments, the nonwoven pouches are smoother on the inside than the outside to tightly fit the implantable medical devices internally while encouraging external tissue ingrowth. In embodiments, the nonwoven pouches eliminate the use of knitted or woven multifilament fibers that can trap bacteria and result in post-operative infection.

First claim

The invention claimed is:

1. A porous resorbable implantable pouch formed of nonwoven polymeric fibers, the pouch adapted to at least partially enclose an implantable medical device, comprising an inside surface and an outside surface, wherein the inside surface of the pouch is smooth having an average roughness from 1 to 15 microns measured by stylus profilometry, the outside surface of the pouch is rougher than the smooth inside surface, and wherein a ratio of outside surface roughness to inside surface roughness is from 3/2 to 3/1.

2. The pouch of claim 1 , wherein the implantable medical device is selected from the group consisting of: breast implant, cardiac rhythm management device, pacemaker, defibrillator, pulse generator, implantable access system, muscle and nerve stimulators, ventricular assist device, gastric stimulators, infusion pump, drug pump, neurostimulator, vagal nerve stimulator, spinal cord neuromodulator, deep brain stimulator, and sacral nerve stimulator.

3. The pouch of claim 1 , wherein the pouch has at least one of the following properties: (i) a plurality of pores with average diameters between 10 μm and 100 μm, (ii) an average thickness of 0.4 to 0.8 mm, (iii) a tensile strength in any direction of 0.1 N to 100 N, and (iv) an elongation to break of 5% to 250%.

4. The pouch of claim 1 , wherein the pouch further comprises resorbable polymeric oriented fiber rebar to reinforce the pouch.

5. The pouch of claim 1 , wherein the pouch further comprises at least one bioactive agent.

6. The pouch of claim 5 , wherein greater than 5% by weight of the at least one bioactive agent is released one day after the pouch is implanted in a patient.

7. The pouch of claim 5 , wherein the at least one bioactive agent is selected from the group consisting of: antimicrobial agent, anesthetic, anti-inflammatory agent, anti-fibrotic agent, anti-scarring agent, leukotriene, silver, chlorhexidine, vancomycin, cephalosporin, gentamicin, triclosan, rifampin, tetracycline, minocycline or salt thereof, minocycline hydrochloride, COX-1 inhibitor, COX-2 inhibitor, and derivatives thereof.

8. The pouch of claim 5 , wherein the at least one bioactive agent is present inside the fibers of the pouch.

9. The pouch of claim 1 , wherein the fibers of the polymeric pouch comprise one or more of the following polymers: polylactic acid; polyglycolic acid; copolymers of glycolic and lactic acids; polycaprolactone; poly(orthoester); polyanhydride; poly(phosphazene); polyhydroxyalkanoate; poly-3-hydroxybutyrate; poly-3-hydroxybutyrate -co-3-hydroxyvalerate; poly-4-hydroxybutyrate; poly-3-hydroxybutyrate-co-4-hydroxybutyrate; poly-3-hydroxybutyrate-co-3-hydroxyhexanoate; polycarbonate; tyrosine polycarbonate; polyester, polyimide, polyesteramide; poly(dioxanone); poly(alkylene alkylate); poly(butylene succinate) or copolymer thereof, succinic acid-1,4-butanediol-malic acid copolyester, polyether; polyethylene oxide, polypropylene oxide; polyvinyl pyrrolidone; polyurethane; polyetherester; polyacetal; polycyanoacrylate; polyketal; polyphosphate; polyphosphoester; polyalkylene oxalate; polyalkylene succinate; poly(maleic acid); and collagen.

10. The pouch of claim 1 , wherein the fibers of the polymeric pouch comprise a polymer with at least one of the following monomers: glycolic acid; lactic acid; trimethylene carbonate; c-caprolactone; p-dioxanone; 3-hydroxybutyrate; 4-hydroxybutyrate; succinic acid; adipic acid; and 1,4-butanediol.

11. The pouch of claim 1 , wherein the pouch is produced by a method comprising the steps of: (i) covering a three-dimensional collector with polymeric spun fibers, (ii) cutting an opening in the pouch, and (iii) removing the pouch from the collector.

12. The pouch of claim 11 , wherein the method further comprises at least one of the following steps: (a) the collector is rotated about an axis, and moved back and forth along an axis to cover the collector with polymeric fibers, (b) the polymeric spun fibers are dry spun, electrospun, or melt spun, and (c) the polymeric spun fibers comprise at least one bioactive agent.

13. The pouch of claim 1 , wherein the pouch is formed by one of the following steps: (i) spinning a solution of poly-4-hydroxybutyrate containing rifampin and minocycline or salt thereof, (ii) co-spinning separate solutions of poly-4-hydroxybutyrate, rifampin and minocycline or a salt thereof, (iii) co-spinning a solution of poly-4-hydroxybutyrate and a solution of rifampin and minocycline or salt thereof, and (iv) co-spinning a solution of poly-4-hydroxybutyrate and rifampin and a solution of minocycline or salt thereof, or spinning the solutions of (i)-(iv) wherein poly-4-hydroxybutyrate is replaced by poly(butylene succinate) or copolymer thereof.

14. An implantable medical pouch for at least partially enclosing an implantable medical device, the pouch comprising a drug-eluting, nonwoven, resorbable porous material, the pouch further comprising an inside surface and an outside surface, and wherein the inside surface of the pouch is smooth having an average roughness from 1 to 15 microns measured by stylus profilometry, the outside surface of the pouch is rougher than the smooth inside surface, and wherein a ratio of outside surface roughness to inside surface roughness is from 3/2 to 3/1, and wherein the drug is incorporated into the material such that the drug elutes from the bulk of the pouch.

Assignees

• Tepha Inc

Inventors

• Limem Skander
• Martin David
• Rizk Said
• Williams Simon F

Classifications

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61B2050/314

  Flexible bags or pouches · CPC title

• A61B2017/00004

  (bio)absorbable, (bio)resorbable or resorptive · CPC title

• A61N1/372 Primary

  Arrangements in connection with the implantation of stimulators · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title