Devices and methods for intraluminal retention and drug delivery

• US 9,744,341 B2
• Filed: 01/15/2013
• Issued: 08/29/2017
• Est. Priority Date: 01/15/2013
• Status: Active Grant

• Current Assignee: Xerox Corporation (Xerox Holdings Corp.)
• Original Assignee: Palo Alto Research Center, Inc. (Xerox Holdings Corp.)
• Inventors: Johnson, David Mathew, Sheridan, Martin, Uhland, Scott A., Abhishek, Ramkumar, Peeters, Eric, Curley, Timothy J., Linn, Felicia, Schmaelzle, Philipp H.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Koo, Benjamin
• Application Number:
  US13/742,203
• Publication Number:
  US 20140200553A1
• Time in Patent Office: 1,687 Days
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• CPC Class Codes: A61M 2210/1433 Uterus
• CPC Class Codes: A61M 2210/1475 Vagina
• CPC Class Codes: 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
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

Retention devices and methods are provided for drug delivery. The device may include a housing configured for intraluminal deployment into a human or animal subject and at least one reservoir contained within the housing. The at least one reservoir may have an actuation end and a release end and contain at least one drug formulation. A plug may be contained within the at least one reservoir and be moveable from the actuation end toward the release end. The device may also include an actuation system operably connected to the actuation end of the at least one reservoir and configured to drive the at least one drug formulation from the reservoir. The device may also include at least one retention member affixed to the housing and movable between a non-stressed position, a deployment position, and a retention position for retaining the device in an intraluminal location in the subject.

Claims

1. A device for drug delivery comprising:

a housing configured for intravaginal or intrauterine deployment into a human or animal subject;

at least one reservoir contained within the housing, the at least one reservoir having an actuation end and a release end and containing at least one drug formulation;

a plug within the at least one reservoir and moveable from the actuation end toward the release end;

an actuation system operably connected to the actuation end of the at least one reservoir and configured to drive the plug and displace the at least one drug formulation from the reservoir; and

at least one retention member affixed to the housing and movable between a non-stressed position, a deployment position, and a retention position for retaining the device in an intravaginal or intrauterine location in the subject, wherein the at least one retention member comprises a spiral member having a first end and a second end, the first end being affixed to the housing and the second end being distal to the housing, wherein the spiral member comprises a central axis about which the spiral member turns, and wherein the first end is affixed to the housing such that the central axis is parallel to a longitudinal axis of the housing.

2. The device of claim 1, wherein the at least one retention member is in substantially the same position in the deployment position and in the retention position.

3. The device of claim 1, wherein the device is configured to be deployed in a vaginal or uterine lumen of the human or animal subject by twisting the device such that the spiral member exerts a spring force against walls of the vaginal or uterine lumen in the retention position.

4. The device of claim 1, wherein the spiral member is configured to be straightened in the deployment position.

5. The device of claim 1, wherein the spiral member is configured such that a twisting motion of the device facilitates insertion and removal of the device.

6. The device of claim 1, wherein the spiral member is substantially planar.

7. The device of claim 1, wherein the spiral member is a three-dimensional spiral.

8. The device of claim 1, where the spiral member includes a shape memory material.

9. The device of claim 8, where the shape memory material is nitinol.

10. The device of claim 1, wherein the actuation system comprises a power source, a microcontroller, and an actuation mechanism configured to drive the plug and displace the at least one drug formulation from the reservoir by positive displacement.