Hydraulic urethral occlusive device

• US 9,301,824 B2
• Filed: 04/16/2013
• Issued: 04/05/2016
• Est. Priority Date: 04/16/2012
• Status: Expired due to Fees

• Current Assignee: GT Urological, LLC
• Original Assignee: GT Urological, LLC
• Inventors: Anderson, David W., Esarey, Bernard J.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): COX, THADDEUS B
• Application Number:
  US13/863,459
• Publication Number:
  US 20130274546A1
• Time in Patent Office: 1,085 Days
• Field of Search: 600/31
• US Class Current: 1/1
• CPC Class Codes: A61F 2/004 inflatable

Abstract

A totally implantable method for occluding the urethra or bladder neck utilizing an occlusive cuff connected to a control mechanism via a conduit tube. The occlusive cuff is reversibly changed from an activated (occlusive condition) to a de-activated (non-occlusive) condition by depressing a deactivation button contained within a resilient, elastomeric sheath surrounding the control mechanism. The occlusive condition is once again obtained by depressing an activation button also situated within the resilient sheath. In the occlusive condition, a preset tension is applied to a flexible diaphragm through a tensioning suture by a constant force spring contained within the control mechanism. This tension is translated into an occlusive pressure applied to the urethra or bladder neck sufficient to prevent urinary leakage.

Claims

1. An implantable occlusive device, comprising:

an occlusive cuff;

a control mechanism;

a pressure compensator; and

a tension cord that travels from the control mechanism to a diaphragm defining a filling media volume inside the pressure compensator, the diaphragm is configured to operate between an expanded condition and a collapsed condition,

the control mechanism is in fluid communication with the occlusive cuff, through attachment via a flexible tube,

the control mechanism is in fluid communication with an inner portion of the pressure compensator, through attachment via a flexible conduit,

the control mechanism including an activation button and a deactivation button, the activation button upon depression, hydraulically inflates with hydraulic fluid the occlusive cuff to apply a preset occlusive pressure on a tubular body, the deactivation button upon depression, hydraulically evacuates the hydraulic fluid from the occlusive cuff to remove the preset occlusive pressure on the tubular body, wherein

the control mechanism is configured to apply tension to the tension cord to collapse the diaphragm and the filling media volume into the collapsed condition, where the hydraulic fluid transfers to the occlusive cuff to inflate the occlusive cuff, and the control mechanism is configured to release tension from the tension cord to evacuate the hydraulic fluid from the occlusive cuff, where the hydraulic fluid transfers to the pressure compensator to expand the diaphragm and the filling media volume to the expanded condition.

2. The device of claim 1, wherein the occlusive cuff is adjustable to encircle a urethra.

3. The device of claim 2, wherein the occlusive cuff comprises an expandable pouch affixed to a cuff backing strip, the expandable pouch is inflatable when the hydraulic fluid enters the expandable pouch through the flexible tube so as to apply a preset urethral pressure, and the expandable pouch is deflatable when the hydraulic fluid evacuates from the expandable pouch through the flexible tube so as to remove the preset urethral pressure.

4. The device of claim 1, wherein the occlusive cuff comprises sizing detents, a free end, and a locking clip, the free end is insertable through the locking clip to lock the occlusive cuff to one of the sizing detents.

5. The device of claim 1, wherein the control mechanism is encapsulated by a silicone boot.

6. The device of claim 1, wherein the control mechanism comprises a septum.

7. The device of claim 1, wherein the pressure compensator further comprises a shell, a fluid volume contained within the shell and that surrounds and is separated from the filling media volume, as the diaphragm is collapsed, fluid transfers into the fluid volume, and as the diaphragm expands, fluid transfers out of the fluid volume.

8. The device of claim 7, wherein the pressure compensator further comprises a dome, the dome is configured to allow fluid to transfer into the fluid volume when the diaphragm collapses and allow fluid to transfer out of the fluid volume when the diaphragm expands.

9. The device of claim 7, wherein the inner portion of the pressure compensator contains a fluid different from a fluid in the fluid volume.

10. The device of claim 1, wherein the pressure compensator comprises a septum.

11. The device of claim 1, wherein the control mechanism includes an electro mechanical control.

12. The device of claim 1, wherein the control mechanism is configured to incrementally increase occlusive pressure on the tubular body.

13. A method of tubular body occlusion, comprising:

applying a tension to a tension cord to collapse a diaphragm inside a pressure compensator shell to transfer hydraulic fluid to an occlusive cuff, the transfer of hydraulic fluid being via first and second conduits in fluid communication with a control mechanism, wherein the first conduit is connected to the control mechanism and the occlusive cuff and the second conduit is connected to the control mechanism and the pressure compensator, wherein the pressure compensator is physically separated from the control mechanism by the second conduit;

pressurizing the occlusive cuff as a result of the transfer of hydraulic fluid from the collapsing of the diaphragm inside the pressure compensator shell;

occluding a tubular body surrounded by the occlusive cuff as a result of pressurizing of the occlusive cuff; and

during a desired state of non-occlusion, releasing the tension from the tension cord to depressurize the occlusive cuff to transfer the hydraulic fluid from the occlusive cuff to the inside of the pressure compensator to thereby expand the diaphragm, and during a desired state of occlusion, repressurizing the occlusive cuff, by repeating the steps of applying, pressurizing, and occluding.

14. The method of claim 13, wherein the control mechanism is a mechanical control mechanism.

15. The method of claim 13, wherein the control mechanism is an electro mechanical control mechanism.

16. The method of claim 13, further comprising incrementally increasing pressure on the tubular body.

17. An implantable occlusive device, comprising:

an occlusive cuff;

a control mechanism;

a pressure compensator; and

a tension cord that travels from the control mechanism to a diaphragm defining a filling media volume inside the pressure compensator, the diaphragm is configured to operate between an expanded condition and a collapsed condition,

the control mechanism is in fluid communication with the occlusive cuff, through attachment via a flexible tube,

the control mechanism is in fluid communication with an inner portion of the pressure compensator, through attachment via a flexible conduit,

the control mechanism including an activation button and a deactivation button, the activation button upon depression, receives hydraulic fluid from the pressure compensator and hydraulically inflates the occlusive cuff with the hydraulic fluid to apply a preset occlusive pressure on a tubular body, the deactivation button upon depression, hydraulically evacuates the hydraulic fluid from the occlusive cuff to the control mechanism to remove the preset occlusive pressure on the tubular body and provides the hydraulic fluid from the control mechanism to the pressure compensator, wherein

the control mechanism is configured to apply tension to the tension cord to collapse the diaphragm and the filling media volume into the collapsed condition, where the hydraulic fluid transfers to the occlusive cuff to inflate the occlusive cuff, and the control mechanism is configured to release tension from the tension cord to evacuate the hydraulic fluid from the occlusive cuff, where the hydraulic fluid transfers to the pressure compensator to expand the diaphragm and the filling media volume to the expanded condition.