# US 11,109,856 B2 · Sutures and related medical devices

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- Number: US 11,109,856 B2
- Document ID: US11109856B2
- Status: Granted
- Kind: B2
- Application number: 16/227,954
- Filed: 2018-12-20
- Published: 2019-06-20
- Granted: 2021-09-07
- Earliest claimed: 2017-12-20
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Tiffany Gemetta; Rachel Radspinner; Elena Ten; Franklin C. Wetherell
- Web page: https://patentgrep.com/patent/US11109856B2

## CPC

- A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61F 2/2457: {Chordae tendineae prostheses}
- A61L 17/145: {Coating}
- C08F 114/26: Tetrafluoroethene
- C08F 214/262: {with fluorinated vinyl ethers}
- C08F 216/1408: {Monomers containing halogen}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/06057: {Double-armed sutures, i.e. sutures having a needle attached to each end}
- A61B 2017/06171: {helically or spirally coiled}
- A61B 2017/06176: {with protrusions, e.g. barbs}
- A61B 2017/0619: {thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2002/0081: {directly machined on the prosthetic surface, e.g. holes, grooves (A61F2/30771 takes precedence)}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0024: made from both porous and non-porous parts, e.g. adjacent parts
- A61L 2400/02: Treatment of implants to prevent calcification or mineralisation in vivo
- C08F 2800/20: as weight or mass percentages
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C08F: MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS

## Abstract

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a cord that is flexible and elongated defining a length. The cord may include a core having a porous surface and a porosity-reducing element on at least a portion of the core.

## Claims

### Claim 1

A suture device comprising:
a cord that is flexible and elongated defining a length, a first end and a second end opposite the first end, the cord including a core extending from the first end to the second end and having a porous surface, the cord further including a porosity-reducing element on at least a portion of the core configured to eliminate a porosity or cover the pores of the surface of the portion of the core and the porosity-reducing element is a non-permeable film that is wrapped around and coupled to the portion of the core and the non-permeable film includes an ePTFE film having a micro-structure that has smaller pores than a microstructure of the surface of the core.

### Claim 2 (depends on 1)

The suture device of claim 1, wherein the porosity-reducing element includes an elastomer TFE-PMVE copolymer, elastomeric material TFE-PMVE copolymer, or non-elastomeric TFE-PMVE copolymer coating on the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 3 (depends on 2)

The suture device of claim 2, wherein the core comprises a fluoropolymer.

### Claim 4 (depends on 3)

The suture device of claim 3, wherein the TFE-PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and from about 60 to about 20 weight percent tetrafluoroethylene, or wherein the TFE-PMVE copolymer comprises from about 33 to about 39 weight percent perfluoromethyl vinyl ether and respectively from about 72 to about 61 weight percent tetrafluoroethylene, or wherein the TFE-PMVE copolymer comprises from about 27 to about 32 weight percent perfluoromethyl vinyl ether and respectively from about 73 to about 68 weight percent tetrafluoroethylene and the TFE-PMVE copolymer is present in pores of the fluoropolymer such that the pores are covered or imbibed.

### Claim 5 (depends on 3)

The suture device of claim 3, wherein the TFE-PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and from about 60 to about 20 weight percent tetrafluoroethylene or wherein a TFE-PMVE copolymer comprising from about 33 to about 39 weight percent perfluoromethyl vinyl ether and respectively from about 72 to about 61 weight percent tetrafluoroethylene is imbibed into the pores of the portion of the core, and further including a coating of TFE-PMVE copolymer comprising from about 27 to about 32 weight percent perfluoromethyl vinyl ether and respectively from about 73 to about 68 weight percent tetrafluoroethylene on the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 6 (depends on 2)

The suture device of claim 2, wherein the elastomer or elastomeric material is configured to increase the tackiness of the core for improved knot holding.

### Claim 7 (depends on 1)

The suture device of claim 1, wherein the porosity-reducing element includes an elastomer, elastomeric material, or non-elastomeric TFE-PMVE copolymer imbibed into the pores of the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 8 (depends on 1)

The suture device of claim 1, wherein the porosity-reducing element includes an elastomer or elastomeric material imbibed into the pores of the portion of the core further including a non-elastomeric TFE-PMVE copolymer coating on the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 9 (depends on 1)

The suture device of claim 1, wherein the porosity-reducing element is a composite film wrapped around and coupled to the portion of the core, the composite film comprising:
a porous film; and
an elastomer, elastomeric material, or non-elastomeric TFE-PMVE copolymer coating on or imbibed into the pores of the porous film rendering the porous film non-porous.

### Claim 10 (depends on 1)

The suture device of claim 1, wherein the porosity-reducing element includes an elastomer, elastomeric material, or non-elastomeric TFE-PMVE copolymer coating on and imbibed into the pores of the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 11 (depends on 1)

The suture device of claim 1, wherein the core comprises ePTFE.

### Claim 12 (depends on 1)

The suture device of claim 1, further comprising a first attachment element at the first end of the cord configured to attach to a first location at a first tissue; and a second attachment element at the second end of the cord configured to attach to a second location at a second tissue.

### Claim 13 (depends on 12)

The suture device of claim 12, wherein the porosity-reducing element is a composite film wrapped around and coupled to the portion of the core and the composite film is helically wrapped about the core.

### Claim 14 (depends on 13)

The suture device of claim 13, wherein the cord includes a length and the composite film is formed of a first portion and a second portion helically wrapped about the core, and the first portion and the second portion are wound in opposite directions along the length of the cord.

### Claim 15 (depends on 1)

The suture device of claim 1, wherein the core comprises ePTFE, and
wherein the porosity-reducing element includes a TFE-PMVE copolymer comprising from about 40 to about 80 weight percent perfluoromethyl vinyl ether and from about 60 to about 20 weight percent tetrafluoroethylene or a TFE-PMVE copolymer comprising from about 33 to about 39 weight percent perfluoromethyl vinyl ether and respectively from about 72 to about 61 weight percent tetrafluoroethylene which is imbibed into the pores of the portion of the core, and further including a coating of TFE-PMVE copolymer comprising from about 27 to about 32 weight percent perfluoromethyl vinyl ether and respectively from about 73 to about 68 weight percent tetrafluoroethylene on the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 16 (depends on 1)

A chordae tendineae repair or replacement device, comprising: the cord of claim 1, further comprising:
a first attachment element coupled to the first end of the cord configured to attach to a first location at a first tissue; and
a second attachment element coupled to the second end of the cord configured to attach to a second location at a second tissue.

### Claim 17 (depends on 16)

The chordae tendineae repair or replacement device of claim 16, wherein the first attachment element is releasably coupled to a first tissue piercing member that is configured to pierce through tissue, and wherein the second attachment element is releasably coupled to a second tissue piercing member that is configured to pierce through the tissue.

### Claim 18 (depends on 16)

The chordae tendineae repair or replacement device of claim 16, wherein at least a first portion of the cord between the first end and the second end is configured to be secured to a second tissue and further comprising a pledget fixed in position on the first portion and configured to engage the second tissue.

### Claim 19 (depends on 1)

A method for treating a defective mitral or tricuspid valve, the method comprising:
percutaneously accessing a region of a heart with a catheter-based device; and
repairing a cardiac valve by use of the device, wherein the repairing comprises augmenting or replacing at least one chordae tendineae with the suture device of claim 1.

### Claim 20 (depends on 1)

A method for reducing or avoiding calcification of sutures utilized as replacement chordae tendineae, the method comprising:
percutaneously accessing a region of a heart with a catheter-based device; and
repairing a cardiac valve by use of said device, wherein the repairing comprises augmenting or replacing at least one chordae tendineae with the suture device of claim 1.

### Claim 21

A suture device comprising:
a cord that is flexible and elongated defining a length, a first end and a second end opposite the first end, the cord including a core extending from the first end to the second end and having a porous surface, the cord further including a porosity-reducing element on at least a portion of the core configured to eliminate a porosity or cover the pores of the surface of the portion of the core and the porosity-reducing element is an elastomer or elastomeric material imbibed into the pores of the portion of the core further including a non-elastomeric TFE-PMVE copolymer coating on the portion of the core rendering the surface of the core at the portion of the core non-porous.

### Claim 22 (depends on 21)

A chordae tendineae repair or replacement device, comprising: the cord of claim 21, further comprising:
a first attachment element coupled to the first end of the cord configured to attach to a first location at a first tissue; and
a second attachment element coupled to the second end of the cord configured to attach to a second location at a second tissue.

### Claim 23 (depends on 22)

The chordae tendineae repair or replacement device of claim 22, wherein the first attachment element is releasably coupled to a first tissue piercing member that is configured to pierce through tissue, and wherein the second attachment element is releasably coupled to a second tissue piercing member that is configured to pierce through the tissue.
