Distributed pressure fenestrated urethral compression apparatus for treatment of male urinary sphincter deficiency with preservation of blood flow

• US 11,135,048 B2
• Filed: 06/16/2017
• Issued: 10/05/2021
• Est. Priority Date: 01/25/2017
• Status: Active Grant

• Current Assignee: Pacey MedTech Ltd.
• Original Assignee: Pacey MedTech Ltd.
• Inventors: Pacey, John Allen
• Primary Examiner(s): Lee, Michelle J
• Application Number:
  US16/473,277
• Publication Number:
  US 20190314129A1
• Time in Patent Office: 1,572 Days
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6802 Sensor mounted on worn items
• CPC Class Codes: A61B 5/6813 Specially adapted to be attached to a specific body part A61B5/6802 takes precedence
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61F 2/0054 with pressure applied to urethra by an element placed around the penis, e.g. penis clamp
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

An urethral compression apparatus is defined by a semi-cylindrical fenestrated dorsal hood that is worn dorsally on the penis and which is interconnected with a strap to a urethral compressor that is oriented ventrally to apply compressive pressure on the urethra to prevent urine leakage. The dorsal hood and the urethral compressor apply distributed pressure that prevents compromised venous and arterial circulation but eliminate incontinence. The device may be worn continually and is easily removed to allow voiding, then reattached. The fenestration in the dorsal hood (or plural fenestrations as the case may be) allows distribution of pressure to avoid venous and arterial blood flow interruption. The dorsal hood partially encircles the penile shaft and the urethral compressor is oriented ventrally and applies the desired pressure to the soft ventral tissues and the urethra. A strap applies tension between the dorsal hood and the urethral compressor, and thus the necessary compression between these two components.

Claims

1. Urinary incontinence control apparatus, comprising:

a semi-cylindrical dorsal hood adapted for positioning on a dorsal aspect of a penis and defining a semi-cylindrical channel and having an exterior surface, an interior surface facing the semi-cylindrical channel, and at least one bounded fenestration defining an opening extending through the dorsal hood from the exterior surface through the interior surface between first and second ends of the dorsal hood, the at least one bounded fenestration positioned above dorsal arteries and dorsal veins of the penis when the dorsal hood is positioned on the dorsal aspect;

a urethral compressor positioned on a ventral aspect of the penis below the at least one bounded fenestration when the dorsal hood is positioned on the dorsal aspect;

a strap interconnecting the dorsal hood and the urethral compressor such that the dorsal hood, urethral compressor, and the strap is configured to encircle the penis and such that the urethral compressor is retained 180 degrees from the at least one bounded fenestration to thereby decrease pressure applied to the dorsal arteries and dorsal veins of the penis, wherein the strap extends from the first end of the dorsal hood, over the at least one bounded fenestration, past the second end, under the urethral compressor and over the first end.

2. The urinary incontinence control apparatus according to claim 1 in which the urethral compressor includes a ridge facing the semi-cylindrical channel and extending transverse to a longitudinal axis of the dorsal hood.

3. The urinary incontinence control apparatus according to claim 2 in which the urethral compressor includes a main body and a first loop at a first end of the main body and a second loop at a second end of the main body, wherein each loop defines a space between the respective loop and the main body.

4. The urinary incontinence control apparatus according to claim 3 in which the strap extends from the dorsal hood through the space between the first loop and the main body, beneath the urethral compressor, through the space between the second loop and the main body, and over the dorsal hood.

5. The urinary incontinence control apparatus according to claim 4 in which the dorsal hood further defines a strap channel on the exterior surface and the strap extends over the strap channel.

6. The urinary incontinence control apparatus according to claim 5 wherein a first end of the strap is connected to the dorsal hood and a second end of the strap is a free end, and wherein the second end of the strap is connectable to the dorsal hood.

7. The urinary incontinence control apparatus according to claim 6 wherein the strap extends through the strap channel and over the at least one fenestration such that there is a space in the at least one fenestration between the interior surface and the strap.

8. The urinary incontinence control apparatus according to claim 1 including a pulse oximeter adapted for measuring oxygen saturation.

9. The urinary incontinence control apparatus according to claim 8 in which the pulse oximeter generates oxygen saturation data, and the apparatus further including means for transmitting the oxygen saturation data to a remote monitoring station.

10. The urinary incontinence control apparatus according to claim 1 including a pressure sensor adapted for transmission of pressure data to a remote monitoring station.

11. The urinary incontinence control apparatus according to claim 1 including a temperature sensor adapted for transmission of temperature data to a remote monitoring station.

12. Urinary incontinence control apparatus, comprising:

a substantially C-shaped dorsal hood having an interior surface adapted for positioning on a dorsal aspect of a penis and at least partially surrounding the penile shaft, and an exterior surface, the dorsal hood having at least one bounded opening extending through the dorsal hood, the at least one bounded opening located on the C-shaped dorsal hood between first and second ends of the C-shaped dorsal hood so that the at least one bounded opening is configured to be positioned on the dorsal aspect of the penile shaft above dorsal arteries and dorsal veins;

a urethral compressor caudad to the dorsal hood and the at least one bounded opening and having a urethral compressing component facing the interior surface of the dorsal hood below the at least one bounded opening such that the urethral compressing component is configured to apply pressure to a ventral aspect of the penile shaft to thereby occlude the urethra, wherein the at least one bounded opening is configured to be positioned on the dorsal aspect of the penile shaft to minimize pressure on the dorsal aspect of the penile shaft and the dorsal arteries and dorsal veins; and

a connector interconnecting the dorsal hood with the urethral compressor so that the urethral compressor is configured to be retained on the ventral aspect of the penile shaft and for varying the pressure applied to thereto, the connector extending from the first end of the C-shaped dorsal hood, over the at least one bounded opening, past the second end, beneath the urethral compressor and over the first end.

13. The urinary incontinence control apparatus according to claim 12 in which the connector is defined by a strap having a first end attached to the C-shaped dorsal hood and a second free end and wherein the urethral compressor is movable relative to the strap.

14. The urinary incontinence control apparatus according to claim 12 further comprising an oximeter for generating penis blood oxygen saturation data.

15. The urinary incontinence control apparatus according to claim 13 further including means for transmitting the penis blood oxygen saturation data to a monitoring station.

16. Urinary incontinence control apparatus, comprising:

a semi-cylindrical component adapted for at least partially encircling a penile shaft in a semi-cylindrical channel extending therethrough and having at least one bounded fenestration configured to correspond to a dorsal aspect of the penis, the at least one bounded fenestration extending through the semi-cylindrical component between first and second ends of the semi-cylindrical component;

a urethra compressor having a urethral compression component facing the semi-cylindrical channel inferiorly to the at least one bounded fenestration; and

strap means for connecting the semi-cylindrical component to the urethra compressor, wherein the semi-cylindrical component, urethra compressor and strap means combine to encircle the penile shaft with the strap means extending from the first end of the semi-cylindrical component, over the at least one bounded fenestration, past the second end, under the urethra compressor and over the first end;

wherein the at least one bounded fenestration is configured to be positioned on the dorsal aspect of the penis 180 degrees from the urethra compressor to minimize pressure thereon from the semi-cylindrical component.

17. The urinary incontinence control apparatus according to claim 16 in which the urethral compression component is defined by a ridge extending transverse to a longitudinal axis of the semi-cylindrical channel.

18. The urinary incontinence control apparatus according to claim 17 including an oximeter.