Urethral catheter device and method of using

• US 7,410,481 B1
• Filed: 04/06/2004
• Issued: 08/12/2008
• Est. Priority Date: 04/06/2004
• Status: Active Grant

• Current Assignee: Cheryl A. Mitts, Lawrence E. Klecka
• Original Assignee: Cheryl A. Mitts, Lawrence E. Klecka
• Inventors: Mitts, Cheryl A., Klecka, Lawrence E.
• Primary Examiner(s): Lucchesi; Nicholas D.
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/819,068
• Time in Patent Office: 1,589 Days
• Field of Search: 604/540, 604/264, 604/265, 604/275, 604/276, 604/103.02, 604/523, 604/544, 604/533, 604349-350, 604/321, 604/317, 604/96.01, 604/244, 604246-247
• US Class Current: 604/544
• CPC Class Codes: A61F 5/44 Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aidsabsorbent pads, e.g. sanitary towels, A61F13/15; drainage appliances for wounds A61M27/00; emptying devices for urine bags B65B69/0016; Colostomy devices adhesives for colostomy devices A61L24/00; materials for colostomy devices A61L28/00
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A urethral catheter device and an associated method of using the device are disclosed. The device comprises a catheter probe and at least one receiving unit attachable to the probe for receiving and collecting urine. The catheter probe comprises: an elongated shaft, a valve, a drainage lumen, a drainage inlet, a tapered cone, a collar, an elongated protuberance, a saline inlet, a saline lumen, a sheath, and a fluid lock. Each receiving unit comprises: a sterile membrane, a sleeve, and a collection bag. When the sleeve of the receiving unit is attached to the collar of the catheter probe, then the tapered cone of the catheter probe ruptures the membrane of the receiving unit, whereby the drainage inlet of the proximate end of the catheter probe is fluidly connected to the collection bag of the catheter probe and the valve is thereby opened. The sheath attached at the proximate end of the elongated shaft is inflatable into a donut shaped balloon which is capable of being retained within a bladder of a patient. The method of using the device comprises the steps of aligning, forcing, holding, injecting, inserting, lubricating, positioning, releasing, removing, sliding, slipping, turning, and twisting.

Claims

1. A urethral catheter device comprising:

a catheter probe comprising;

an elongated shaft including;

an interior side wall;

an exterior side wall;

a middle section;

a proximate end for insertion into a bladder of a patient;

a distal end comprising a valve for pending outside the bladder of the patient; and

an internal wall disposed between said interior side wall and said exterior side wall, wherein said internal wall of said shaft defining a lip disposed at the exterior side wall of said shaft, said lip defining a saline outlet disposed in said proximate end of said shaft;

a drainage lumen defined by said interior side wall of said shaft, said drainage lumen providing fluid communication between said proximate end of said shaft and said distal end of said shaft;

a drainage inlet comprising a drainage opening defined by said drainage lumen at said proximate end of said shaft, said drainage inlet for receiving urine from the bladder;

a tapered cone attached to the distal end of said shaft, said cone having a pointed head and a side port drainage outlet, said drainage outlet of said cone in fluid communication with said drainage inlet, said drainage outlet for discharging urine;

a collar attached to the distal end of said shaft, said collar having an annular interior wall, said interior wall of said collar having two ridges defining an annular channel disposed around said interior wall of said collar;

an elongated protuberance attached to said middle section of said shaft, said protuberance including;

a distal end, the distal end of said protuberance is attached to said middle section of said shaft;

a proximate end;

an inner side wall, said inner side wall of said protuberance connected to said internal wall of said shaft; and

an outer side wall;

a saline inlet defined by said inner side wall of said protuberance, said saline inlet disposed at said proximate end of said protuberance, said saline inlet for receiving saline;

a saline lumen defined by said internal wall of said shaft and said inner side wall of said protuberance, said saline lumen in fluid communications with said saline inlet of said protuberance and said saline outlet of said shaft;

a sheath circumferentially attached around said proximate end of said shaft, said sheath defining a void space between said sheath and said proximate end of said shaft, said void space in fluid communications with saline outlet disposed of said shaft, wherein when said void space is empty then said sheath is collapsed around said proximate end of said shaft, when said void space is filled with saline then said sheath expands into a donut shaped balloon, said drainage inlet disposed outside of said balloon; and

a fluid lock pivotally attached to said proximate end of said protuberance, said fluid lock is in fluid communications with said saline inlet, when said fluid lock is turned in a given direction then said fluid lock is placed in an open position so that said saline inlet is in fluid communications with the surrounding environment of the device, when said fluid lock is rotated in an opposite direction relative to said given direction then said fluid lock is in a closed position wherein said saline inlet is not in fluid communications with the surrounding environment of the device; and

at least one receiving unit attachable to said probe, each receiving unit of said at least one receiving unit comprising;

a sterile membrane;

a sleeve attached to said membrane, said sleeve having

rim attached to said membrane;

an annular outside wall, said annular outside wall having an annular ring attached around said outside wall, said annular outside wall is proportioned to slidably insert within said collar of said distal end of said shaft, said ring of said outside wall of said sleeve is shaped to slidably lock within said annular channel disposed around said interior wall of said collar of said distal end of said shaft, wherein when said sleeve is inserted within said collar of said distal end of said shaft then said membrane is punctured with said pointed head of said cone of said shaft; and

an annular inside wall, said annular inside wall defining a urine collection inlet; and

a collection bag attached to the sleeve, said collection bag in fluid communications with said urine collection inlet of said sleeve.

2. The device of claim 1 further comprising at least one cap, each cap of said at least one cap is attached to said outside wall of said sleeve of each receiving unit of said at least one receiving unit, wherein said sterile membrane of each receiving unit of said at least one receiving unit is disposed between said cap and said rim of said sleeve.

3. The device of claim 1 wherein said void space between said sheath and said proximate end of said shaft having a volumetric capacity of at least five milliliters of saline.

4. The device of claim 1 wherein said void space between said sheath and said proximate end of said shaft having a volumetric capacity of up to ten milliliters of saline.

5. The device of claim 1 wherein said device is made of an elastomer plastic selected from the group consisting of polyester, polypropylene, polyurethanes, polyacryls, polymethacryls, cellulosic polymers, styrene-acryl copolymers, polystyrene-polyacryl mixtures, polysiloxanes, urethane-acryl copolymers, siloxane-urethane copolymers, polyurethane-polymethacryl mixtures, silicone-acryl copolymers, vinyl acetate polymers, and mixtures thereof.

6. The device of claim 1 wherein said device is sterile.

7. The device of claim 1 wherein said collection bag having a capacity of approximately one half liter.

8. The device of claim 1 wherein said collection bag having a capacity of approximately one liter.

9. The device of claim 1 wherein said collection bag having a capacity of approximately two liters.

10. The device of claim 1 wherein said collection bag having a capacity of approximately four liters.

13. The device of claim 1 wherein said void space between said sheath and said proximate end of said shaft having a volumetric capacity of up to ten milliliters of saline.

19. The device of claim 1I wherein said collection bag having a capacity of approximately four liters.

11. A urethral catheter device consisting essentially of:

a catheter probe comprising;

an elongated shaft including;

an interior side wall;

an exterior side wall;

a middle section;

a proximate end for insertion into a bladder of a patient;

a distal end comprising a valve for pending outside the bladder of the patient; and

an internal wall disposed between said interior side wall and said exterior side wall, wherein said internal wall of said shaft defining a lip disposed at the exterior side wall of said shaft, said lip defining a saline outlet disposed in said proximate end of said shaft;

a drainage lumen defined by said interior side wall of said shaft, said drainage lumen providing fluid communication between said proximate end of said shaft and said distal end of said shaft;

a drainage inlet comprising a drainage opening defined by said drainage lumen at said proximate end of said shaft, said drainage inlet for receiving urine from the bladder;

a tapered cone attached to the distal end of said shaft, said cone having a pointed head and a side port drainage outlet, said drainage outlet of said cone in fluid communication with said drainage inlet, said drainage outlet for discharging urine;

a collar attached to the distal end of said shaft, said collar having an annular interior wall, said interior wall of said collar having two ridges defining an annular channel disposed around said interior wall of said collar;

an elongated protuberance attached to said middle section of said shaft, said protuberance including;

a distal end, comprising a valve, said distal end attached to said middle section of said shaft;

a proximate end;

an inner side wall, said inner side wall of said protuberance connected to said internal wall of said shaft; and

an outer side wall;

a saline inlet defined by said inner side wall of said protuberance, said saline inlet disposed at said proximate end of said protuberance, said saline inlet for receiving saline;

a saline lumen defined by said internal wall of said shaft and said inner side wall of said protuberance, said saline lumen in fluid communications with said saline inlet of said protuberance and said saline outlet of said shaft;

a sheath circumferentially attached around said proximate end of said shaft, said sheath defining a void space between said sheath and said proximate end of said shaft, said void space in fluid communications with saline outlet disposed of said shaft, wherein when said void space is empty then said sheath is collapsed around said proximate end of said shaft, when said void space is filled with saline then said sheath expands into a donut shaped balloon, said drainage inlet disposed outside of said balloon; and

a fluid lock pivotally attached to said proximate end of said protuberance, said fluid lock is in fluid communications with said saline inlet, when said fluid lock is turned in a given direction then said fluid lock is placed in an open position so that said saline inlet is in fluid communications with the surrounding environment of the device, when said fluid lock is rotated in an opposite direction relative to said given direction then said fluid lock is in a closed position wherein said saline inlet is not in fluid communications with the surrounding environment of the device;

at least one receiving unit attachable to said probe, each receiving unit of said at least one receiving unit comprising;

a sterile membrane;

a sleeve attached to said membrane, said sleeve having

rim attached to said membrane;

an annular outside wall, said annular outside wall having an annular ring attached around said outside wall, said annular outside wall is proportioned to slidably insert within said collar of said distal end of said shaft, said ring of said outside wall of said sleeve is shaped to slidably lock within said annular channel disposed around said interior wall of said collar of said distal end of said shaft, wherein when said sleeve is inserted within said collar of said distal end of said shaft then said membrane is punctured with said pointed head of said cone of said shaft; and

an annular inside wall, said annular inside wall defining a urine collection inlet; and

a collection bag attached to the sleeve, said collection bag in fluid communications with said urine collection inlet of said sleeve; and

at least one cap, each cap of said at least one cap is attached to said outside wall of said sleeve of each receiving unit of said at least one receiving unit, wherein said sterile membrane of each receiving unit of said at least one receiving unit is disposed between said cap and said rim of said sleeve.

12. The device of claim 11 wherein said void space between said sheath and said proximate end of said shaft having a volumetric capacity of at least five milliliters of saline.

14. The device of claim 11 wherein said device is made of an elastomer plastic selected from the group consisting of polyester, polypropylene, polyurethanes, polyacryls, polymethacryls, cellulosic polymers, styrene-acryl copolymers, polystyrene-polyacryl mixtures, polysiloxanes, urethane-acryl copolymers, siloxane-urethane copolymers, polyurethane-polymethacryl mixtures, silicone-acryl copolymers, vinyl acetate polymers, and mixtures thereof.

15. The device of claim 11 wherein said device is sterile.

16. The device of claim 11 wherein said collection bag having a capacity of approximately one half liter.

17. The device of claim 11 wherein said collection bag having a capacity of approximately one liter.

18. The device of claim 11 wherein said collection bag having a capacity of approximately two liters.

20. A method of using a urethral catheter device, said method comprising the steps of:

obtaining the device comprising;

a catheter probe comprising;

an elongated shaft including;

an interior side wall;

an exterior side wall;

a middle section;

a proximate end for insertion into a bladder of a patient;

a distal end having a valve therein; and

an internal wall disposed between the interior side wall and the exterior side wall, wherein the internal wall of the shaft defining a lip disposed at the exterior side wall of the shaft, the lip defining a saline outlet disposed in the proximate end of the shaft;

a drainage lumen defined by the interior side wall of the shaft, the drainage lumen providing fluid communication between the proximate end of the shaft and the distal end of the shaft;

a drainage inlet comprising a drainage opening defined by the drainage lumen at the proximate end of the shaft, the drainage inlet for receiving urine from the bladder;

a tapered cone attached to the distal end of the shaft, the cone having a pointed head and a side port drainage outlet, the drainage outlet of the cone in fluid communication with the drainage inlet, the drainage outlet for discharging urine;

a collar attached to the distal end of the shaft, the collar having an annular interior wall, the interior wall of the collar having two ridges defining an annular channel disposed around the interior wall of the collar;

an elongated protuberance attached to the middle section of the shaft, the protuberance including;

a distal end, the distal end of the protuberance having a valve therein and attached to the middle section of the shaft;

a proximate end;

an inner side wall, the inner side wall of the protuberance connected to the internal wall of the shaft; and

an outer side wall;

a saline inlet defined by the inner side wall of the protuberance, the saline inlet disposed at the proximate end of the protuberance, the saline inlet for receiving saline;

a saline lumen defined by the internal wall of the shaft and the inner side wall of the protuberance, the saline lumen in fluid communications with the saline inlet of the protuberance and the saline outlet of the shaft;

a sheath circumferentially attached around the proximate end of the shaft, the sheath defining a void space between the sheath and the proximate end of the shaft, the void space in fluid communications with saline outlet disposed of the shaft, wherein when the void space is empty then the sheath is collapsed around the proximate end of the shaft, when the void space is filled with saline then the sheath expands into a donut shaped balloon, the drainage inlet disposed outside of the balloon; and

a fluid lock pivotally attached to the proximate end of the protuberance, the fluid lock is in fluid communications with the saline inlet, when the fluid lock is turned in a given direction then the fluid lock is placed in an open position so that the saline inlet is in fluid communications with the surrounding environment of the device, when the fluid lock is rotated in an opposite direction relative to the given direction then the fluid lock is in a closed position wherein the saline inlet is not in fluid communications with the surrounding environment of the device;

at least one receiving unit attachable to the probe, each receiving unit of the at least one receiving unit comprising;

a sterile membrane;

a sleeve attached to the membrane, the sleeve having

rim attached to the membrane;

an annular outside wall, the annular outside wall having an annular ring attached around the outside wall, the annular outside wall is proportioned to slidably insert within the collar of the distal end of the shaft, the ring of the outside wall of the sleeve is shaped to slidably lock within the annular channel disposed around the interior wall of the collar of the distal end of the shaft, wherein when the sleeve is inserted within the collar of the distal end of the shaft then the membrane is punctured with the pointed head of the cone of the shaft; and

an annular inside wall, the annular inside wall defining a urine collection inlet; and

a collection bag attached to the sleeve, the collection bag in fluid communications with the urine collection inlet of the sleeve; and

a cap attached to the outside wall of the sleeve of each receiving unit of the at least one receiving unit, wherein the sterile membrane of each receiving unit of the at least one receiving unit is disposed between the cap and the rim of the sleeve;

holding with a hand onto a penis of the patient;

lubricating the proximate end of the shaft of the probe with a gel;

aligning the lubricated proximate end of the shaft of the probe with the external urethral orifice of the held penis of the patient;

inserting the lubricated proximate end of the shaft of the probe into the external urethral orifice of the held penis of the patient;

slipping the lubricated proximate end of the shaft of the probe through the urethra of the held penis of the patient;

forcing the lubricated proximate end of the shaft of the probe through the prostate gland of the patient;

positioning the lubricated proximate end of the shaft of the probe in the bladder of the patient;

releasing with the hand from the penis of the patient;

turning the fluid lock in the given direction so that the fluid lock is placed in the open position;

injecting about five to ten milliliters of saline into the saline inlet when the fluid lock is placed in the open position so that the sheath is allowed to expand into the donut shaped balloon when the

lubricated proximate end of the shaft of the probe is positioned in the bladder of the patient;

twisting the fluid lock in the opposite direction relative to the given direction so that the fluid lock is placed in the closed position, said twisting step performed subsequent to said injecting step;

removing away the cap from the outside wall of the sleeve of the receiving unit; and

sliding the sleeve within the collar of the distal end of the shaft, so that the ring of the outside wall of the sleeve locks within the annular channel disposed around the interior wall of the collar of the distal end of the shaft, wherein said pointed head of said tapered cone punctures the membrane, thereby establishing a fluid communications between the drainage inlet at the proximate end of the shaft with the collection bag of the receiving unit.