Pliable silk medical device

• US 10,648,109 B2
• Filed: 01/26/2017
• Issued: 05/12/2020
• Est. Priority Date: 01/26/2016
• Status: Expired due to Fees

• Current Assignee: Sofregen Medical Ireland Limited
• Original Assignee: Sofregen Medical Ireland Limited
• Inventors: Mortarino, Enrico, Akers, Jessica L., Patel, Kantilal N.
• Primary Examiner(s): Worrell, Danny
• Application Number:
  US16/069,635
• Publication Number:
  US 20190307917A1
• Time in Patent Office: 1,202 Days
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: D02G 3/02 Yarns or threads characterised by the material or by the materials from which they are made
• CPC Class Codes: D02G 3/28 Doubled, plied, or cabled threads D02G3/32, D02G3/36 take precedence; effect yarns D02G3/34; details of spindles, e.g. bearings D01H7/86
• CPC Class Codes: D04B 21/08 characterised by thread material
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2211/04 Silk
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

An implantable, pliable silk device (e.g., in a form of a knitted mesh) for use in human soft tissue support and/or repair that provides stretch or pliable properties, e.g., multi-directional elongation properties. Such a device permits physicians or users to alter or manipulate the device dimension and/or shape at the time of device implantation, thereby permitting the device to conform to the contour of a target area or tissue more easily and providing more precise positioning of the device over the target area or tissue. In some embodiments, the implantable pliable silk device comprises a knit pattern feature that substantially prevents unraveling and preserves the stability of the mesh when cut. For example, the pliable silk device is a knitted mesh comprising at least two yarns laid in a knit direction and engaging each other to define a plurality of nodes.

Claims

1. A process for forming a pliable silk fibroin mesh, the process comprising the steps of:

knitting a first silk fibroin yarn in a first wale direction using the knit pattern 1/1-1/3-3/3-3/1;

knitting a second silk fibroin yarn in a second wale direction using the knit pattern 3/1-1/1-1/3-3/3;

knitting a third silk fibroin yarn in a first course direction using the knit pattern 1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3; and

knitting a fourth silk fibroin yarn in a second course direction using the knit pattern 3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-1/1-1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5,

thereby forming the pliable silk fibroin mesh.

2. The process of claim 1, wherein the pliable silk fibroin mesh is characterized in that elongation at break along a direction of the pliable silk fibroin mesh formation is greater than 85% and elongation at break along a width of the pliable silk fibroin mesh is greater than 85%.

3. The process of claim 1, wherein the pliable silk fibroin mesh comprises pores having an average pore area of greater than 1 mm².

4. The process of claim 1, wherein the silk fibroin yarn comprises silk fibroin fibers.

5. The process of claim 1, wherein the silk fibroin yarn is sericin-depleted.

6. A pliable silk fibroin mesh formed by a process comprising:

knitting a first silk fibroin yarn in a first wale direction using the knit pattern 3/1-1/1-1/3-3/3;

knitting a second silk fibroin yarn in a second wale direction using the knit pattern 1/1-1/3-3/3-3/1;

knitting a third silk fibroin yarn in a first course direction using the knit pattern 3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-1/1-1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5; and

knitting a fourth silk fibroin yarn in a second course direction using the knit pattern 1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3.

7. The pliable silk fibroin mesh of claim 6, wherein the pliable silk fibroin mesh is characterized in that elongation at break along a direction of the pliable silk fibroin mesh formation is greater than 85% and elongation at break along a width of the pliable silk fibroin mesh is greater than 85%.

8. The pliable silk fibroin mesh of claim 6, wherein the pliable silk fibroin mesh comprises pores having an average pore area of greater than 1 mm².

9. The pliable silk fibroin mesh of claim 6, wherein the silk fibroin yarns are made of nine filament and twisted silk fibroin fibers.

10. The pliable silk fibroin mesh of claim 6, wherein the silk fibroin yarn is sericin-depleted.

11. An implantable device comprising a knitted network of silk fibroin yarns, wherein the knitted network is characterized in that average elongation at break along a direction of the knitted network formation is greater than 85% and average elongation at break along a width of the knitted network is greater than 85%, and wherein the average pore size of the knitted network is greater than 1 mm².

12. The implantable device of claim 11, wherein the knitted network exhibits one or more of the following characteristics:

(a) an average burst strength of about 0.3 MPa to about 1.5 MPa, or about 0.3 MPa to about 0.6 MPa;

(b) an average maximum tensile stress along the direction of the knitted network formation of about 0.2 MPa to about 0.4 MPa, or about 0.2 MPa to about 0.3 MPa;

(c) an average maximum tensile stress along the width of the knitted network of about 0.1 MPa to about 0.3 MPa, or about 0.15 MPa to about 0.2 MPa;

(d) an average tear strength along the direction of the knitted network formation of about 100 N to about 170 N or about 110 N to about 160 N;

(e) an average tear strength along the width of the knitted network of about 50 N to about 100 N or about 60 N to about 90 N;

(f) an average density of about 0.10 mg/mm³ to about 0.15 mg/mm³;

(g) an average elongation at a force of about 16 N along the direction of the knitted network formation of about 20% to about 50% or about 25% to about 40%; and

(h) an average elongation at a force of about 16 N along the width of the knitted network formation of about 20% to about 60% or about 30% to about 50%.

13. The implantable device of claim 11, wherein the silk fibroin yarn comprises silk fibroin fibers.

14. The implantable device of claim 11, wherein the silk fibroin yarn is sericin-depleted.

15. The implantable device of claim 11, wherein the silk fibroin yarn is made of 9 silk fibroin fibers.

16. The implantable device of claim 11, wherein the knitted network is formed by a process comprising at least one of the following steps:

(i) knitting a first silk fibroin yarn in a first wale direction using a knit pattern 1/1-1/3-3/3-3/1 or a portion thereof;

(ii) knitting a second silk fibroin yarn in a second wale direction using a knit pattern 3/1-1/1-1/3-3/3 or a portion thereof;

(iii) knitting a third silk fibroin yarn in a first course direction using a knit pattern 1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3 or a portion thereof; and

(iv) knitting a fourth silk fibroin yarn in a second course direction using a knit pattern 3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-1/1-1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5 or a portion thereof.

17. The implantable device of claim 11, wherein the knitted network is formed by a process comprising at least one of the following steps:

(i) knitting a first silk fibroin yarn in a first wale direction using a knit pattern 3/1-1/1-1/3-3/3 or a portion thereof;

(ii) knitting a second silk fibroin yarn in a second wale direction using a knit pattern 1/1-1/3-3/3-3/1 or a portion thereof;

(iii) knitting a third silk fibroin yarn in a first course direction using a knit pattern 3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-1/1-1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5 or a portion thereof; and

(iv) knitting a fourth silk fibroin yarn in a second course direction using the knit pattern 1/1-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-7/7-7/7-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3-3/3-5/5-5/5-3/3 or a portion thereof.