# US 11,992,583 B2 · Drug delivery devices and methods

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,992,583 B2
- Document ID: US11992583B2
- Status: Granted
- Kind: B2
- Application number: 17/158,322
- Filed: 2021-01-26
- Published: 2021-05-20
- Granted: 2024-05-28
- Earliest claimed: 2014-05-12
- Assignees: TARIS Biomedical LLC
- Applicants: TARIS Biomedical LLC
- Inventors: Heejin Lee; Karen Daniel; Cheryl Larrivee-Elkins; Vikas Agarwal; Hong Linh Ho Duc
- Web page: https://patentgrep.com/patent/US11992583B2

## CPC

- A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- 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 31/007: {Injectors for solid bodies, e.g. suppositories}
- A61L 2300/402: Anaestetics, analgesics, e.g. lidocaine
- A61M 2205/04: implanted
- A61M 2210/16: Male reproductive, genital organs
- 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)
- 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

Drug delivery devices are provided in which much of a drug payload within the device remains within an area proximal to a wall of the device through which the drug must pass for release of the drug from the device into a patient. In one case, the device may include a drug reservoir portion which has a drug reservoir lumen bounded by a reservoir wall having an inner surface; a drug located in the drug reservoir lumen; and a core region which does not comprise the drug, wherein the drug is disposed between the inner surface of the reservoir wall and the core region. The device may be elastically deformable between a first shape suited for insertion through a lumen into a body cavity of the patient and a second shape suited to retain the device within the body cavity.

## Claims

### Claim 1

A drug delivery device for insertion into the body of a patient, the drug delivery device comprising:
a drug reservoir portion which comprises a drug reservoir lumen bounded by reservoir walls which comprise a drug permeable and water permeable polymeric material;
a retention frame lumen in which a retention frame is disposed; and
a drug formulation which comprises a drug and which substantially fills the drug reservoir lumen,
wherein the drug reservoir lumen has a ribbon shape such that a substantial portion of the drug formulation is adjacent to the reservoir walls to facilitate trans-wall diffusion of the drug through the reservoir walls, and
wherein the drug delivery device is elastically deformable between a first shape configured to be inserted through a urethra into a bladder of the patient and a second shape, induced by the retention frame, configured to retain the entire drug delivery device within the bladder.

### Claim 2 (depends on 1)

The drug delivery device of claim 1, wherein the reservoir walls are dimensioned to define the ribbon-shaped drug reservoir lumen to have a maximum width:maximum height ratio of at least 4:1.

### Claim 3 (depends on 1)

The drug delivery device of claim 1, wherein the reservoir walls are dimensioned to define the ribbon-shaped drug reservoir lumen to have a maximum width:maximum height ratio of at least 7:1.

### Claim 4 (depends on 1)

The drug delivery device of claim 1, wherein the reservoir walls are dimensioned to define the ribbon-shaped drug reservoir lumen to have a maximum width:maximum height ratio of at least 10:1.

### Claim 5 (depends on 1)

The drug delivery device of claim 1, wherein the second shape is a coil shape, a spiral shape, or a serpentine shape.

### Claim 6 (depends on 1)

The drug delivery device of claim 1, wherein the drug formulation is in the form of a powder or granules.

### Claim 7 (depends on 1)

The drug delivery device of claim 1, wherein the reservoir walls comprise a water-permeable elastomeric material.

### Claim 8 (depends on 7)

The drug delivery device of claim 7, wherein the water-permeable elastomeric material comprises silicone, a polyurethane, or a combination thereof.

### Claim 9 (depends on 1)

The drug delivery device of claim 1, wherein the drug formulation is in the form of a powder or granules, and the reservoir walls comprise a water-permeable elastomeric material and are dimensioned to define the ribbon-shaped drug reservoir lumen having a maximum width:maximum height ratio of at least 4:1.

### Claim 10 (depends on 1)

The drug delivery device of claim 1, wherein the reservoir walls comprise the retention frame lumen in which the retention frame is disposed.

### Claim 11 (depends on 1)

The drug delivery device of claim 1, wherein the reservoir walls define an exterior surface of the drug delivery device.

### Claim 12 (depends on 1)

A method of administering a drug to a patient in need thereof, comprising:
inserting into the patient the drug delivery device of claim 1; and
permitting the drug to be released from the drug delivery device.

### Claim 13 (depends on 12)

The method of claim 12, wherein the drug delivery device is inserted into the patient's urinary bladder via through the patient's urethra.

### Claim 14

An intravesical drug delivery device, the intravesical drug delivery device comprising:
a drug reservoir portion which comprises a drug reservoir lumen bounded by reservoir walls which comprise a drug permeable and water permeable elastomeric material; and
a drug formulation in a solid form, which comprises a drug and which substantially fills the drug reservoir lumen,
wherein the drug reservoir lumen has a ribbon shape such that a substantial portion of the drug formulation is adjacent to the reservoir walls to facilitate trans-wall diffusion of the drug through the reservoir walls,
wherein the intravesical drug delivery device is elastically deformable between a first shape, which is a relatively straightened shape configured to be inserted through a patient's urethra, and a second shape, which is configured to retain the intravesical drug delivery device within the patient's bladder, and
wherein the reservoir walls are dimensioned to define the ribbon-shaped drug reservoir lumen to have a maximum width:maximum height ratio of at least 4:1.

### Claim 15 (depends on 14)

The intravesical drug delivery device of claim 14, wherein the second shape is a coil shape, a spiral shape, or a serpentine shape.

### Claim 16 (depends on 14)

The intravesical drug delivery device of claim 14, wherein the reservoir walls define an exterior surface of the intravesical drug delivery device.

### Claim 17 (depends on 14)

The intravesical drug delivery device of claim 14, further comprising a retention frame lumen in which a retention frame is disposed.
