# US 2013/0158675 A1 · Ureteral stent drug delivery device, kit, and method

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- Number: US 2013/0158675 A1
- Document ID: US20130158675A1
- Status: Published application
- Kind: A1
- Application number: 13/813,973
- Filed: 2011-08-05
- Published: 2013-06-20
- Earliest claimed: 2010-08-05
- Assignees: TARIS Biomedical LLC
- Inventors: Burleigh M. Hutchins, III; Cheryl Larrivee-Elkins; Heejin Lee; Jim Boyko
- Web page: https://patentgrep.com/patent/US20130158675A1

## 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)}
- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 27/008: {pre-shaped, for use in the urethral or ureteral tract}
- A61F 2002/048: {Ureters}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/09: Guide wires
- A61M 2025/0057: {Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings}
- Y10T 29/49826: Assembling or joining
- 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)}
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Ureteral stent devices having improved drug delivery capabilities are provided. The ureteral stent device includes a ureteral stent comprising two opposed ends, and a drug delivery component associated with at least one end of the ureteral stent. The drug delivery component includes a drug housing defining a drug reservoir containing a drug, wherein the drug housing is configured to release the drug in-vivo.

## Claims

### Claim 1

An implantable medical device, comprising:
a ureteral stent comprising two opposed ends; and
a drug delivery component associated with at least one end of the ureteral stent, the drug delivery component comprising a drug housing defining a drug reservoir containing a drug in solid or semi-solid form, wherein the drug housing is configured to release the drug in vivo.

### Claim 2 (depends on 1)

The implantable medical device of claim 1, wherein:
the two opposed ends of the ureteral stent include a kidney-residing end and a bladder-residing end; and
the drug delivery component is associated with the bladder-residing end.

### Claim 3 (depends on 2)

The implantable medical device of claim 2, wherein the bladder-residing end comprises a pigtail configuration,

### Claim 4 (depends on 1)

The implantable medical device of claim 1, wherein
the drug housing of the drug delivery component comprises a tube; and
the drug comprises a plurality of solid drug tablets aligned in a row in the tube.

### Claim 5 (depends on 1)

The implantable medical device of claim 1, wherein the housing comprises a water-permeable material.

### Claim 6 (depends on 1)

The implantable medical device of claim 1, wherein the housing comprises a silicone.

### Claim 7 (depends on 1)

The implantable medical device of claim 1, wherein the device is adapted to release the drug in-vivo at a controlled rate for an extended period.

### Claim 8 (depends on 1)

The implantable medical device of claim 1 wherein:
the drug housing comprises a release aperture; and
the drug comprises a water soluble salt form of lidocaine.

### Claim 9 (depends on 1)

The implantable medical device of claim 1, wherein:
the drug comprises a lidocaine base; and
the housing comprises a material that is permeable to the lidocaine base.

### Claim 10 (depends on 1)

The implantable medical device of claim 1, wherein the drug housing of the drug delivery component comprises a tube that is aligned with and coupled to the ureteral stent along the at least one end.

### Claim 11 (depends on 1)

The implantable medical device of claim 1 wherein:
the at least one end of the ureteral stent comprises a pigtail configuration; and
the drug delivery component is parallel and adjacent to the at least one end.

### Claim 12 (depends on 11)

The implantable medical device of claim 11, wherein the drug delivery component is configured to lie inside the at least one end when in the pigtail configuration.

### Claim 13 (depends on 1)

The implantable medical device of claim 1, wherein:
the at least one end of the ureteral stent comprises a pigtail configuration; and
the drug delivery component extends from a distal tip of the at least one end.

### Claim 14 (depends on 13)

The implantable medical device of claim 13, further comprising a urine outflow aperture.

### Claim 15 (depends on 13)

The implantable medical device of claim 13, wherein the drug delivery component is deformable between a retention shape and a deployment shape.

### Claim 16 (depends on 15)

The implantable medical device of claim 15, wherein the drug delivery component includes a retention frame operable to cause the drug delivery component to assume the retention shape upon deployment of the drug delivery component within the bladder.

### Claim 17 (depends on 1)

The implantable medical device of claim 1, wherein:
the drug delivery component extends from the at least one end of the ureteral stent and comprises a pigtail configuration.

### Claim 18 (depends on 17)

The implantable medical device of claim 17, wherein:
the ureteral stern comprises a central lumen; and
the drug delivery component comprises a central lumen fluidly connected with the central lumen of the ureteral stent.

### Claim 19 (depends on 17)

The implantable medical device of claim 17, wherein:
the ureteral stent comprises a central lumen and an aperture proximal to the at least one end of the ureteral stem; and
the drug delivery component comprises a central lumen defining the drug housing reservoir.

### Claim 20 (depends on 1)

The implantable medical device of claim 1, further comprising a tether linking the drug delivery component to the at least one end of the ureteral stent.

### Claim 21

A method of delivering a drug from a ureteral stent device, comprising:
implanting a ureteral stent device in a ureter of a patient, the ureteral stent device including a drug delivery component comprising a drug housing defining a drug reservoir containing a drug in solid or semi-solid form; and
releasing the drug from the drug delivery component into the patient's body.

### Claim 22 (depends on 21)

The method of claim 21, wherein the drug is selected from the group consisting of: a local anesthetic agent, an anti-muscarinic, an alpha-blocker, a narcotic, phenazopyridine, an antibiotic, an anticholineraic, and combinations thereof.

### Claim 23 (depends on 22)

The method of claim 22, wherein the drug is a local anesthetic agent, which is lidocaine.

### Claim 24

A method of treating one or more side effects associated with placement of the ureteral stent in the body, comprising:
implanting a ureteral stent device in a ureter of a patient, the ureteral stem device including a drug delivery component comprising a drug housing defining a drug reservoir containing a drug in solid or semi-solid form; and
releasing the drug from the ureteral stoat device into the patient, the drug being selected from the group consisting of: a local anesthetic agent, an anti-muscarinic, an alpha-blocker, a narcotic, phenazopyridine and combinations thereof.

### Claim 25 (depends on 24)

The method of claim 24, wherein the drug consists of a local anesthetic agent, which is lidocaine.

### Claim 26

A medical procedure kit comprising:
a ureteral stent having a bladder end and a kidney end; and
at least one drug delivery portion with means for attachment to one of the ends of the ureteral stent in-vivo, the drug delivery portion comprising a drug housing defining a drug reservoir containing a drug in solid or semi-solid form.

### Claim 27 (depends on 26)

The kit of claim 26, further comprising one or more of a guidewire, a dialator, and deployment sheath.
