# US 12,214,148 B2 · Multi-lumen drug delivery devices and methods

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- Number: US 12,214,148 B2
- Document ID: US12214148B2
- Status: Granted
- Kind: B2
- Application number: 17/505,897
- Filed: 2021-10-20
- Published: 2022-02-10
- Granted: 2025-02-04
- Earliest claimed: 2016-01-26
- Assignees: TARIS Biomedical LLC
- Applicants: TARIS Biomedical LLC
- Inventors: Heejin Lee
- Web page: https://patentgrep.com/patent/US12214148B2

## CPC

- 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)}
- A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas}
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61F 2/042: {Urinary bladders}
- 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)}
- 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)
- 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)

## Abstract

Drug delivery devices are provided herein and include an elongated, elastic body extending between a first end and a second end, wherein the elastic body comprises a water permeable wall structure having defining an elongated drug reservoir lumen extending between the first and second ends. One or more secondary lumens are structured (e.g., positioned, sized, shaped, and optionally filled) to be effective to retard or prevent in vivo diffusion of (i) water into the drug reservoir lumen and/or (ii) solubilized drug out of the drug reservoir lumen.

## Claims

### Claim 1

A drug delivery device for controlled release of drug into the urinary bladder of a patient comprising:
an elongated, elastic body extending between a closed first end and a closed second end, wherein the elastic body comprises a water permeable outer wall structure having a cylindrical shaped external surface extending between the first and second ends;
an elongated hub structure located within, and coaxial with, the outer wall structure and extending between the first and second ends;
two or more spoke structures extending between and connecting the outer wall structure and the hub structure, the spoke, outer wall, and hub structures defining at least one elongate drug reservoir lumen and at least one air lumen; and
a drug payload disposed in the at least one drug reservoir lumen,
wherein the device is elastically deformable between a relatively straightened shape suited for insertion of the device through a urethra and into the urinary bladder of the patient and a coiled retention shape which is suited to retain the device within the urinary bladder.

### Claim 2 (depends on 1)

The device of claim 1, wherein the hub structure comprises an annulus in which the lumen of the annulus includes an elastic retention frame disposed therein, the elastic retention frame imparting the coiled retention shape to the device.

### Claim 3 (depends on 1)

The device of claim 1, wherein the hub structure is shape set to impart the coiled retention shape to the device.

### Claim 4 (depends on 1)

The device of claim 1, wherein the at least one air lumen is filled with a gas.

### Claim 5 (depends on 1)

The device of claim 1, wherein the spoke, outer wall, and hub structures comprise silicone, a polyurethane, or a combination thereof.

### Claim 6 (depends on 1)

The device of claim 1, wherein the drug payload is in a solid or semi-solid form.

### Claim 7 (depends on 6)

The device of claim 6, wherein the device is operable in vivo to permit water to diffuse into the at least one drug reservoir lumen and solubilize the drug payload and to controllably release solubilized drug from the device by osmotic pressure.

### Claim 8 (depends on 7)

The device of claim 7, wherein the outer wall structure, at a portion thereof defining the drug reservoir lumen, comprises an orifice for the release of the solubilized drug.

### Claim 9 (depends on 1)

The device of claim 1, wherein the drug payload is the form of a plurality of tablets.

### Claim 10 (depends on 9)

The device of claim 9, wherein the tablets are cylindrical and the at least one drug reservoir lumen is not cylindrical, such that open spaces are provided in the drug reservoir lumen between portions of the tablets and portions of the outer wall, spoke, and hub structures.

### Claim 11 (depends on 1)

The device of claim 1, wherein the device is operable in vivo to permit water to diffuse into the at least one drug reservoir lumen and solubilize the drug payload and to controllably release solubilized drug from the device by diffusion.

### Claim 12 (depends on 1)

The device of claim 1, which has exactly two spoke structures, the device having exactly one drug reservoir lumen and exactly one air lumen.

### Claim 13 (depends on 12)

The device of claim 12, wherein the two spoke structures are positioned to define an obtuse angle bounding the drug reservoir lumen and a reflex angle bounding the air lumen.

### Claim 14 (depends on 1)

The device of claim 1, which has exactly three spoke structures.

### Claim 15 (depends on 14)

The device of claim 14, wherein the device has exactly one drug reservoir lumen and exactly two air lumen, and the three spoke structures are positioned to define an obtuse angle bounding each of the drug reservoir lumen and the two air lumen.

### Claim 16 (depends on 1)

The device of claim 1, which the drug payload comprises a high solubility drug.

### Claim 17 (depends on 1)

The device of claim 1, wherein the spoke, outer wall, and hub structures are coextruded and integrally connected.

### Claim 18

A drug delivery device comprising:
an elongated, elastic body extending between a first end and a second end, wherein the elastic body comprises a water permeable first wall structure having an external surface and an internal surface defining an elongated drug reservoir lumen extending between the first and second ends; and
a drug payload disposed in the drug reservoir lumen,
wherein the elastic body comprises a second wall structure which in part defines one or more secondary lumens extending between the first and second ends and located between the second wall structure and the first wall structure, wherein the one or more secondary lumens are effective to retard or prevent in vivo diffusion of (i) water into the drug reservoir lumen and/or (ii) solubilized drug out of the drug reservoir lumen,
wherein the first wall structure comprises an annulus in which the drug reservoir lumen is the central lumen of the annulus.

### Claim 19 (depends on 18)

The device of claim 18, wherein the one or more secondary lumens are filled with a gas.

### Claim 20 (depends on 18)

The device of claim 18, wherein the one or more secondary lumens are filled with a diffusion-resistant polymeric material.

### Claim 21 (depends on 18)

The device of claim 18, wherein the first or second wall structure further comprises a retention frame lumen in which an elastic retention frame is disposed.

### Claim 22 (depends on 18)

The device of claim 18, wherein the first wall structure comprises silicone, a polyurethane, ethylene-vinyl acetate (EVA), or a combination thereof.

### Claim 23 (depends on 18)

The device of claim 18, wherein the second wall structure comprises a high durometer silicone.

### Claim 24 (depends on 18)

The device of claim 18, wherein the device is elastically deformable between a relatively straightened shape suited for insertion of the device through a urethra and into the urinary bladder of a patient and a coiled retention shape which is suited to retain the device within the urinary bladder.

### Claim 25 (depends on 18)

The device of claim 18, wherein the drug payload is in a solid or semi-solid form.

### Claim 26 (depends on 25)

The device of claim 25, wherein the device is operable in vivo to permit water to diffuse into the drug reservoir lumen and solubilize the drug payload and to controllably release solubilized drug from the device by osmotic pressure.

### Claim 27 (depends on 25)

The device of claim 25, wherein the device is operable in vivo to permit water to diffuse into the drug reservoir lumen and solubilize the drug payload and to controllably release solubilized drug from the device by diffusion through the first wall structure.

### Claim 28 (depends on 18)

The device of claim 18, wherein the drug payload is the form of a plurality of tablets.

### Claim 29 (depends on 18)

The device of claim 18, wherein:
the first wall structure is an elongated, extruded tube having two separate lumen, which consist of the drug reservoir lumen and a retention frame lumen, and
the second wall structure is an elongated, extruded C-shaped tube segment connected to, and offset to one side of, the first wall structure.

### Claim 30 (depends on 29)

The device of claim 29, wherein the drug reservoir lumen has a circular cross-sectional shape and the secondary lumen has a non-circular cross-sectional shape.

### Claim 31 (depends on 29)

The device of claim 29, wherein the first and second wall structures are coextruded and integrally connected.