# US 10,369,098 B2 · Methods for localized drug delivery

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- Number: US 10,369,098 B2
- Document ID: US10369098B2
- Status: Granted
- Kind: B2
- Application number: 15/421,253
- Filed: 2017-01-31
- Published: 2017-05-18
- Granted: 2019-08-06
- Earliest claimed: 2008-10-15
- Assignees: DTherapeutics, LLC
- Applicants: DTherapeutics, LLC
- Inventors: Ghassan S. Kassab; Jose A. Navia, Sr.
- Web page: https://patentgrep.com/patent/US10369098B2

## CPC

- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61M 25/0082: {Catheter tip comprising a tool}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61L 2430/20: for reconstruction of the heart, e.g. heart valves
- A61M 2210/122: Pericardium
- 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)
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Devices, systems, and methods for localized drug delivery. In at least one embodiment of a method of localized drug delivery, the method comprises the steps of placing a resorbable device within a tube, introducing the tube within a mammalian body at or near a tissue and/or organ within the mammalian body, and anchoring the resorbable device to the tissue and/or organ. Devices and systems useful for performing such a method are also disclosed herein, wherein an exemplary device comprises at least one drug release portion having at least one drug to be released over time and a binder intermixed with the at least one drug, and at least one resorbable anchor portion coupled to the at least one drug release portion.

## Claims

### Claim 1

A method for localized drug delivery, the method comprising the step of positioning a resorbable device at least partially into a mammalian tissue of a mammalian body, the resorbable device comprising:
at least one drug release portion comprising at least one drug and a binder intermixed with the at least one drug; and
at least one resorbable anchor portion forming the device with the at least one drug release portion and configured to actively engage and anchor to the mammalian tissue;
wherein when the resorbable device is positioned within the mammalian body, the binder is biologically degradable within the mammalian body at a first rate of degradation, and the at least one resorbable anchor portion biologically degradable within the mammalian body at a second rate of degradation that is slower than the first rate of degradation.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of positioning comprises the steps of:
placing the resorbable device within a tube;
introducing the tube into the mammalian body; and
anchoring the resorbable device to the mammalian tissue.

### Claim 3 (depends on 2)

The method of claim 2, wherein the step of anchoring the resorbable device to the mammalian tissue is performed using a shaft positioned within the tube.

### Claim 4 (depends on 2)

The method of claim 2, wherein the step of anchoring the resorbable device to the mammalian tissue is performed using a gas from a gas source introduced into the tube to facilitate placement of the resorbable device.

### Claim 5 (depends on 2)

The method of claim 2, wherein the step of introducing is performed to introduce the tube into the mammalian body so that at least part of the tube is positioned within a pericardial space surrounding a heart.

### Claim 6 (depends on 5)

The method of claim 5, wherein the step of anchoring is performed to anchor the resorbable device to the heart.

### Claim 7 (depends on 1)

The method of claim 1, wherein the mammalian tissue comprises a heart, and wherein the step of positioning is performed to position the resorbable device at least partially into the heart.

### Claim 8 (depends on 1)

The method of claim 1, performed so that the at least one drug can be released over time within the mammalian body.

### Claim 9

A method for localized drug delivery, the method comprising the step of positioning a resorbable device at least partially into a mammalian tissue of a mammalian body, the resorbable device comprising:
at least one drug release portion comprising at least one drug and a binder intermixed with the at least one drug, the binder biologically degradable within the mammalian body at a first rate of degradation; and
at least one resorbable anchor portion forming the device with the at least one drug release portion and configured to actively engage and anchor to the mammalian tissue, the at least one resorbable anchor portion biologically degradable within the mammalian body at a second rate of degradation that is slower than the first rate of degradation.

### Claim 10 (depends on 9)

The method of claim 9, wherein the step of positioning the resorbable device comprises the steps of:
placing the resorbable device within a tube;
introducing the tube into the mammalian body; and
anchoring the resorbable device to the mammalian tissue.

### Claim 11 (depends on 10)

The method of claim 10, wherein the step of anchoring the resorbable device to the mammalian tissue is performed using a shaft positioned within the tube.

### Claim 12 (depends on 10)

The method of claim 10, wherein the step of anchoring the resorbable device to the mammalian tissue is performed using a gas from a gas source introduced into the tube to facilitate placement of the resorbable device.

### Claim 13 (depends on 10)

The method of claim 10, wherein the step of introducing is performed to introduce the tube into the mammalian body so that at least part of the tube is positioned within a pericardial space surrounding a heart.

### Claim 14 (depends on 13)

The method of claim 13, wherein the step of anchoring is performed to anchor the resorbable device to the heart.

### Claim 15 (depends on 9)

The method of claim 9, wherein the mammalian tissue comprises a heart, and wherein the step of positioning is performed to position the resorbable device at least partially into the heart.

### Claim 16 (depends on 9)

The method of claim 9, performed so that the at least one drug can be released over time within the mammalian body.

### Claim 17

A method for localized drug delivery, the method comprising the step of anchoring a resorbable device to a surface of a mammalian tissue or organ of a mammalian body, wherein the resorbable device comprises:
at least one drug release portion comprising at least one drug and a binder intermixed with the at least one drug; and
at least one resorbable anchor portion forming the device with the at least one drug release portion and configured to actively engage and anchor to the surface of the mammalian tissue or organ;
wherein the binder biologically degrades within the mammalian body faster than the at least one resorbable anchor portion.

### Claim 18 (depends on 17)

The method of claim 17, wherein the step of positioning the resorbable device within the mammalian body comprises the steps of:
placing the resorbable device within a tube;
introducing the tube into the mammalian body; and
anchoring the resorbable device to the mammalian tissue.

### Claim 19 (depends on 18)

The method of claim 18, wherein the step of introducing is performed to introduce the tube into the mammalian body so that at least part of the tube is positioned within a pericardial space surrounding a heart.

### Claim 20 (depends on 17)

The method of claim 17, wherein the step of anchoring the resorbable device to the mammalian tissue is performed using a shaft positioned within the tube.
