Drug delivery system for treating erectile dysfunction

• US 20110137114A1
• Filed: 11/15/2010
• Published: 06/09/2011
• Est. Priority Date: 11/15/2009
• Status: Active Grant

• Current Assignee: Matthew Zane Schwartz, Robert Matthew Douglas
• Original Assignee: Matthew Zane Schwartz, Robert Matthew Douglas
• Inventors: Douglas, Robert Matthew, Schwartz, Matthew Zane
• Granted Patent: US 8,702,685 B2
• Time in Patent Office: Days
• US Class Current: 600/38
• CPC Class Codes: A61F 5/41 Devices for promoting penis erection penis implants A61F2/26; massage of the genitals A61H19/00
• CPC Class Codes: A61K 31/417 Imidazole-alkylamines, e.g. histamine, phentolamine
• CPC Class Codes: A61K 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2210/1021 Abdominal cavity
• CPC Class Codes: A61M 2210/167 Penis
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61N 1/0521 Genital electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

Drug delivery systems, apparatus and methods to treat erectile dysfunction via an implanted drug infusion pump. The drug delivery system incorporates a passively pressurized drug infusion pump, one or more catheters, one or more microfluidic valves, a microcontroller, and one or more patient input mechanisms to deliver therapeutic solutions to the erectile tissues of a patient. The system in operation is entirely implanted and provides for moderated patient control over dosage via subcutaneously implanted input mechanisms, including in certain embodiments, neural control.

Claims

1. An implantable drug delivery system for the treatment of erectile dysfunction, comprising:

a passively pressurized drug infusion pump, one or more catheters, one or more microfluidic valves, a microcontroller, and one or more patient input mechanisms.

2. The drug delivery system of claim 1 wherein the one or more microfluidic valves are under operative control of the microcontroller.

3. The drug delivery system of claim 2 wherein the microcontroller opens the one or more microfluidic valves to dispense a discrete dosage of therapeutic in response to a signal from the one or more patient input mechanisms.

4. The drug delivery system of claim 3 wherein the passively pressurized drug infusion pump and microcontroller are enclosed within a single housing.

5. The drug delivery system of claim 4 wherein the housing is adapted to be implanted within a subject'"'"'s abdomen and wherein the system is configured to allow one-way fluid communication from the drug infusion pump to the subject'"'"'s penile tissue via the implantable catheters and implantable microfluidic valves.

6. The drug delivery system of claim 1 wherein the passively pressurized drug infusion pump further comprises:

a propellant chamber, a drug reservoir, and a flexible bellows that allows the propellant chamber to exert a pressure on the drug reservoir, wherein the propellant chamber contains a two-phase fluid that has a significant vapor pressure at body temperature.

7. The drug delivery system of claim 6 wherein the passively pressurized drug infusion pump further comprises a filter and a capillary flow restrictor disposed in the fluid path.

8. The drug delivery system of claim 6 further comprising a drug reservoir fill port and a catheter outlet port arranged on the surface of the housing.

9. The drug delivery system of claim 1 wherein the one or more patient input mechanisms are selected from the group consisting of:

an implantable subcutaneous button, an implantable subcutaneous RFID tag, an implantable subcutaneous RFID reader, an implantable subcutaneous capacitive touch sensor, an implantable subcutaneous vibration sensor, an implantable subcutaneous radio frequency control module, and an implantable neural interface.

10. The drug delivery system of claim 3 wherein the one or more patient input mechanisms comprise a neural interface in electrical communication with nerves associated with a subject penis.

11. The drug delivery system of claim 10 wherein the microcontroller is programmed to interpret signals registered by the neural interface, the signal interpretation further comprising requiring that the registered signal exceed a selected threshold stimulus frequency for a defined duration within a predetermined time window prior to release of the therapeutic.

12. An implantable medical apparatus for the treatment of erectile dysfunction, comprising a passively pressurized drug infusion pump containing a therapeutic that stimulates erection, one or more microfluidic valves, one or more catheters for fluid communication with penile tissue, a microcontroller, and one or more patient input mechanisms, wherein the apparatus is configured such that a signal received by the patient input mechanism is transmitted to the microcontroller, which signals the microfluidic valves to switch to an open state, thereby allowing the pressure within the drug infusion pump to propel the therapeutic, via the catheters, to the penile tissue.

13. The implantable medical apparatus of claim 12, wherein the microcontroller is programmed to enter a defined refractory period after each administration of therapeutic, during which refractory period no further administration of therapeutic is permitted regardless of any subsequent signal received by the patient input mechanism.

14. The medical apparatus of claim 13, wherein the microcontroller is programmed to allow administration of the therapeutic after the refractory period has concluded.

15. A method for the treatment of erectile dysfunction consisting essentially of:

implanting a drug delivery system within the body of a patient wherein

(a) the drug delivery system comprises a housing, one or more catheters, one or more microfluidic valves, and one or more patient input mechanisms;

(b) the housing encloses a propellant chamber, a drug reservoir containing a therapeutic selected to stimulate an erection, a microcontroller and a power source, and the housing further provides (i) a drug refill port in fluid communication with the drug reservoir and (ii) one or more outlet ports allowing fluid communication between the drug reservoir and the catheters;

(c) the drug delivery system further provides that the catheters have a proximal end in fluid communication with the housing outlet port and a distal end positioned in fluid communication with the corpora cavernosa of a subject, and wherein the one or more microfluidic valves are situated proximal to each catheter distal end;

wherein the method comprises implanting the housing and one or more patient input mechanisms within the abdomen of the subject, wherein the patient input mechanisms are positioned subcutaneously so that they may register electrical, radio frequency or physical signals from outside the body of the subject;

and wherein the method further comprises the release of the therapeutic in response to a signal received by the patient input mechanism from outside the body of the subject, subject to the further condition that the microcontroller is not within a refractory period prohibiting delivery of a dosage of the therapeutic.