# US 10,765,782 B2 · Hemostatic devices and methods of use

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- Number: US 10,765,782 B2
- Document ID: US10765782B2
- Status: Granted
- Kind: B2
- Application number: 15/582,935
- Filed: 2017-05-01
- Published: 2019-01-31
- Granted: 2020-09-08
- Earliest claimed: 2016-05-03
- Assignees: Medtronic, Inc.
- Applicants: TYRX, Inc.
- Inventors: Satish Pulapura; Fatima Buevich; Jorie S. Soskin; Franklin R. Mansfield; Kai R. Worrell; Charlie Wood; Jorge Alberto Trevino Blanco
- Web page: https://patentgrep.com/patent/US10765782B2

## CPC

- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61L 31/04: Macromolecular materials
- A61L 31/10: Macromolecular materials
- A61L 31/146: {Porous materials, e.g. foams or sponges}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61N 1/0575: {with drug delivery}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61K 31/65: Tetracyclines
- A61L 31/042: {Polysaccharides}
- A61L 2300/214: Amino acids
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An anchorage device is provided that is configured to surround an implantable medical device. The anchorage device includes a substrate and a hemostatic agent. The substrate includes a first piece and a second piece that is joined with the first piece. The first piece includes the hemostatic agent and the second piece includes an active pharmaceutical ingredient. Kits, systems and methods are disclosed.

## Claims

### Claim 1

An anchorage device configured to surround an implantable medical device, the anchorage device comprising:
a substrate comprising a first piece and a second piece that is joined with the first piece, the first piece being made entirely of a hemostatic agent and the second piece comprising an active pharmaceutical ingredient,
wherein the hemostatic agent is tranexamic acid.

### Claim 2 (depends on 1)

An anchorage device as recited in claim 1, wherein the second piece comprises a polymer, the polymer comprising the active pharmaceutical ingredient.

### Claim 3 (depends on 2)

An anchorage device as recited in claim 2, wherein the polymer coats the second piece.

### Claim 4 (depends on 2)

An anchorage device as recited in claim 2, wherein the polymer is selected from a group consisting of polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide)polyglycolic acid[polyglycolide], poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D, L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, copolymers of polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptides, maleic anhydride copolymers, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylates, tyrosine-derived polycarbonates, tyrosine-derived polyiminocarbonates, tyrosine-derived polyphosphonates, polyethylene oxide, polyethylene glycol, polyalkylene oxides, hydroxypropylmethylcellulose, polysaccharides, hyaluronic acid, chitosan, regenerate cellulose and mixtures thereof.

### Claim 5 (depends on 1)

An anchorage device as recited in claim 1, wherein the active pharmaceutical ingredient is selected from a group consisting of anesthetics, antibiotics, anti-inflammatory agents, procoagulant agents, fibrosis-inhibiting agents, anti-scarring agents, leukotriene inhibitors/antagonists, cell growth inhibitors and mixtures thereof.

### Claim 6 (depends on 1)

An anchorage device as recited in claim 1, wherein the first piece and the second piece form a pocket having a cavity and an opening that is in communication with the cavity, the implantable medical device being configured to be inserted through the opening and into the cavity.

### Claim 7 (depends on 1)

An anchorage device as recited in claim 1, wherein the first piece is a mesh and the second piece is a mesh.

### Claim 8 (depends on 7)

An anchorage device as recited in claim 7, further comprising a polymer that is applied to the substrate, the polymer comprising the active pharmaceutical ingredient.

### Claim 9 (depends on 8)

An anchorage device as recited in claim 8, wherein the polymer is selected from a group consisting of polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide)polyglycolic acid[polyglycolide], poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D, L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D, L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, copolymers of polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptides, maleic anhydride copolymers, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylates, tyrosine-derived polycarbonates, tyrosine-derived polyiminocarbonates, tyrosine-derived polyphosphonates, polyethylene oxide, polyethylene glycol, polyalkylene oxides, hydroxypropylmethylcellulose, polysaccharides, hyaluronic acid, chitosan, regenerate cellulose and mixtures thereof.

### Claim 10 (depends on 8)

An anchorage device as recited in claim 8, wherein the active pharmaceutical ingredient is selected from a group consisting of anesthetics, antibiotics, anti-inflammatory agents, procoagulant agents, fibrosis-inhibiting agents, anti-scarring agents, leukotriene inhibitors/antagonists, cell growth inhibitors and mixtures thereof.

### Claim 11 (depends on 10)

An anchorage device as recited in claim 10, wherein the active pharmaceutical ingredient comprises rifampin and minocycline.

### Claim 12 (depends on 1)

An anchorage device as recited in claim 1, wherein the substrate is biodegradable.

### Claim 13 (depends on 1)

An anchorage device as recited in claim 1, wherein the substrate is non-biodegradable.

### Claim 14 (depends on 1)

An anchorage device as recited in claim 1, wherein the anchorage device is monolithically formed using a 3D printer.

### Claim 15 (depends on 1)

An anchorage device as recited in claim 1, wherein the active pharmaceutical ingredient is printed onto the second piece using a 3D printer.

### Claim 16 (depends on 1)

An anchorage device as recited in claim 1, wherein the active pharmaceutical ingredient is selected from the group consisting of rifampin and minocycline and mixtures thereof.

### Claim 17

An anchorage device configured to surround an implantable medical device, the anchorage device comprising a non-biodegradable substrate including a first piece and a second piece that is joined with the first piece to form a pocket, inner surfaces of the pieces defining a cavity of the pocket configured for disposal of the implantable medical device, the first piece being formed entirely by a hemostatic agent and the second piece being coated with a polymer, the polymer comprising a tyrosine-derived polyarylate, rifampin and minocycline, wherein the hemostatic agent is tranexamic acid.

### Claim 18

An anchorage device comprising:
a biodegradable substrate including a first piece and a second piece that is joined with the first piece to form a pocket, inner surfaces of the pieces defining a cavity of the pocket, the first piece being formed entirely from a hemostatic agent and the second piece being coated with a polymer, the polymer comprising a tyrosine-derived polyarylate, rifampin and minocycline, wherein the hemostatic agent is tranexamic acid; and
an implantable medical device positioned within the cavity, the implantable medical device being selected from a group consisting of neurostimulators, pacemakers and implantable cardioverter defibrillators.
