Calendered surgical meshes comprising polyhydroxyalkanoates

Patent metadata

Field	Value
Publication number	US-10874498-B2
Application number	US-201816122305-A
Country	US
Kind code	B2
Filing date	Sep 5, 2018
Priority date	Sep 6, 2017
Publication date	Dec 29, 2020
Grant date	Dec 29, 2020

Abstract

Calendered surgical meshes comprising polyhydroxyalkanoate polymers have been developed. These meshes, preferably made from poly-4-hydroxybutyrate or copolymer thereof, have a thickness that is between 50 to 99% of the thickness of the mesh prior to calendering, and a burst strength that is not less than 20% of the burst strength of the mesh prior to calendering. The thinner calendered meshes are particularly suitable for surgical applications where a thinner profile mesh with high burst strength is required, and where it is advantageous to have a mesh with a smooth surface. The meshes may be partially or fully resorbable, and are particularly suitable for use in the treatment of pelvic organ prolapse.

First claim

We claim:

1. A calendered surgical mesh comprising monofilament fiber of a poly-4-hydroxybutyrate homopolymer or copolymer thereof, wherein the calendered mesh has a pore size not less than 40% of the pore size of the mesh prior to calendering.

2. The calendered surgical mesh of claim 1 , wherein the mesh is knit or woven.

3. The calendered surgical mesh of claim 1 , wherein the fiber is oriented.

4. The calendered surgical mesh of claim 1 , wherein the mesh is resorbable.

5. The calendered surgical mesh of claim 1 , wherein the mesh is: (i) three-dimensional and can be temporarily deformed for implantation, (ii) contoured to fit a patient's tissue, or (iii) shaped into a plug.

6. The calendered surgical mesh of claim 1 , wherein the mesh can be deformed for placement in a patient by a minimally invasive method.

7. The calendered surgical mesh of claim 1 , further comprising a bioactive agent or additive.

8. The calendered surgical mesh of claim 7 , wherein the bioactive agent is an antimicrobial agent selected from the following group: rifampin; minocycline and its hydrochloride, sulfate, or phosphate salt; triclosan; chlorhexidine; vancomycin and its hydrochloride, sulfate, or phosphate salt; tetracycline and its hydrochloride, sulfate, or phosphate salt, and derivatives; gentamycin; cephalosporin antimicrobials; aztreonam; cefotetan and its disodium salt; loracarbef; cefoxitin and its sodium salt; cefazolin and its sodium salt; cefaclor; ceftibuten and its sodium salt; ceftizoxime; ceftizoxime sodium salt; cefoperazone and its sodium salt; cefuroxime and its sodium salt; cefuroxime axetil; cefprozil; ceftazidime; cefotaxime and its sodium salt; cefadroxil; ceftazidime and its sodium salt; cephalexin; cefamandole nafate; cefepime and its hydrochloride, sulfate, and phosphate salt; cefdinir and its sodium salt; ceftriaxone and its sodium salt; cefixime and its sodium salt; cefpodoxime proxetil; meropenem and its sodium salt; imipenem and its sodium salt; cilastatin and its sodium salt; azithromycin; clarithromycin; dirithromycin; erythromycin and hydrochloride, sulfate, or phosphate salts, ethylsuccinate, and stearate forms thereof, clindamycin; clindamycin hydrochloride, sulfate, or phosphate salt; lincomycin and hydrochloride, sulfate, or phosphate salt thereof, tobramycin and its hydrochloride, sulfate, or phosphate salt; streptomycin and its hydrochloride, sulfate, or phosphate salt; neomycin and its hydrochloride, sulfate, or phosphate salt; acetyl sulfisoxazole; colistimethate and its sodium salt; quinupristin; dalfopristin; amoxicillin; ampicillin and its sodium salt; clavulanic acid and its sodium or potassium salt; penicillin G; penicillin G benzathine, or procaine salt; penicillin G sodium or potassium salt; carbenicillin and its disodium or indanyl disodium salt; piperacillin and its sodium salt; ticarcillin and its disodium salt; sulbactam and its sodium salt; moxifloxacin; ciprofloxacin; ofloxacin; levofloxacins; norfloxacin; gatifloxacin; trovafloxacin mesylate; alatrofloxacin mesylate; trimethoprim; sulfamethoxazole; demeclocycline and its hydrochloride, sulfate, or phosphate salt; doxycycline and its hydrochloride, sulfate, or phosphate salt; oxytetracycline and its hydrochloride, sulfate, or phosphate salt; chlortetracycline and its hydrochloride, sulfate, or phosphate salt; metronidazole; dapsone; atovaquone; rifabutin; linezolide; polymyxin B and its hydrochloride, sulfate, or phosphate salt; sulfacetamide and its sodium salt; clarithromycin; and silver ions, salts, and complexes.

9. The calendered surgical mesh of claim 1 , wherein the monofilament fiber comprises poly-4-hydroxybutyrate homopolymer.

10. The calendered surgical mesh of claim 9 , wherein the calendered mesh has one or more of the following properties: (i) a burst strength not less than 80% of the burst strength of the surgical mesh prior to calendering; (ii) a burst strength between 30 N and 300 N measured by test method ASTM D6797-02 “Standard test method for bursting strength of fabrics constant rate of extension (CRE) ball burst test,” using a MTS Q-Test Elite universal testing machine or similar device and a testing fixture with a ⅜-inch diameter ball, (iii) a thickness between 50 to 99% of the mesh prior to calendering (iv) a thickness between 0.05 mm and 5 mm, (v) a pore size not less than 30% of the pore size of the mesh prior to calendering, (vi) a pore size between 0.05 mm 2 and 10 mm 2 , (vii) a suture pullout strength between 1 N and 100 N, (viii) a stiffness between 0.01 N and 5 N, (ix) an areal density between 5 gm/m 2 and 250 g/m 2 , (x) a surface area ratio between 0.5 cm 2 /cm 2 and 5 cm 2 /cm 2 , and (xi) oriented fibers, wherein the fibers have been stretched 6-11X their unoriented length.

11. The calendered surgical mesh of claim 10 , wherein the mesh has a thickness between 0.1 mm and 1 mm.

12. The calendered surgical mesh of claim 10 , wherein the mesh has a pore size not less than 20% of the pore size of the mesh prior to calendering.

13. A method of forming the calendered surgical mesh of claim 1 , the method comprising the steps of: knitting or weaving a mesh, and calendering the mesh in order to reduce the thickness of the mesh.

14. The method of claim 13 , wherein the mesh is calendered by heating the mesh under pressure.

15. The method of claim 14 , wherein the mesh is heated to a temperature between 25° C. and 50° C. under a pressure of 1-100 pounds per linear inch of the mesh width.

16. The method of claim 13 , further comprising one or more of the following steps: (i) heat setting the mesh, (ii) washing the mesh with an alcoholic solution, or (iii) sterilizing the mesh with ethylene oxide, electron beam irradiation or gamma-irradiation.

17. The method of claim 13 , wherein the mesh is formed from monofilament fiber with one or more of the following properties: (i) diameter between 20 μm and 900 μm, (ii) tensile strength between 100 MPa and 1,500 MPa, (iii) tensile modulus between 70 MPa and 2 GPa, (iv) elongation to break between 10% and 1100%, and (v) polymer or copolymer weight average molecular weight between 50 kDa and 1,200 kDa.

18. A method of using the calendered surgical mesh of claim 1 , wherein the calendered surgical mesh is implanted in a patient' body.

19. The method of claim 18 , wherein the calendered surgical mesh is implanted by a minimally invasive method.

20. The method of claim 19 , where the calendered surgical mesh is implanted laparoscopically for repair of a hernia, a breast lift, or pelvic organ prolapse.

Assignees

• Tepha Inc

Inventors

• Rizk Said
• Shah Bhavin
• Martin David P
• Williams Simon F

Classifications

• A61L27/18 Primary

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• D10B2509/08

  Hernia repair mesh · CPC title

• D04B21/12

  characterised by thread material · CPC title

• D01F6/625

  derived from hydroxy-carboxylic acids, e.g. lactones · CPC title

• D01D10/00

  Physical treatment of artificial filaments or the like during manufacture, i.e. during a continuous production process before the filaments have been collected (finishing D02J) · CPC title