Apparatus and method for the controlled hydrodistention of the urinary bladder

• US 7,615,046 B2
• Filed: 10/25/2006
• Issued: 11/10/2009
• Est. Priority Date: 10/25/2006
• Status: Expired due to Fees

• Current Assignee: Sobhy Shehata
• Original Assignee: Sobhy Shehata
• Inventors: Shehata, Sobhy
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Treyger; Ilya Y
• Application Number:
  US11/586,458
• Publication Number:
  US 20080172041A1
• Time in Patent Office: 1,112 Days
• Field of Search: 604/101.1, 604/101.2, 604/101.05, 604/103.01, 604/103.02, 604/544
• US Class Current: 604/544
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61F 2/0013 inflatable
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A urological medical system for performing a controlled hydrodistention of the urinary bladder for treating a bladder dysfunction problem comprised of a programmed CPU with associated computer equipment for facilitating an automatic control of a treatment procedure to be performed on a patient, a saline solution warmer, a saline solution pump, a four-way catheter wherein a channel is provided for monitoring the pressure within the bladder during the procedure, a syringe for infusing a medicine through the catheter and a strapping device to secure the syringe and to slidingly engage the catheter to a leg of the patient. Desired parameters are monitored during the procedure and a desired pressure is maintained in the bladder for a predetermined time to perform the controlled hydrodistention of the urinary bladder.

Claims

1. A procedure for performing a controlled hydrodistention of a urinary bladder for a patient that, after an initial clinical evaluation, is determined to be a candidate for treatment for a bladder dysfunction, the procedure comprising:

treating a bladder dysfunction in a patient by performing a controlled hydrodistention of a urinary bladder of said patient, the procedure further comprising;

premedicating the patient with appropriate predetermined sedation medications such that the patient remains conscious and able to verbally communicate with a physician performing the procedure throughout the procedure;

preparing the patient to be treated by placing the patient in a lithotomy position and performing a flexible cystoscopy with a topical anesthetic;

providing a urological medical system for performing the controlled hydrodistention of the urinary bladder, the system comprising;

central microprocessing means for facilitating an automatic control of a treatment procedure to be performed on a patient, said central microprocessing means further comprising means for entering data related to the treatment procedure, means for printing out desired procedure documentation data, and means for displaying desired parameters related to the procedure;

fluid warmer means in fluid communication with a saline solution fluid source for varying a temperature of said saline solution fluid;

pump means in fluid communication with the fluid warmer means for pumping said saline solution though a corresponding catheter saline solution infusion channel into a bladder of the patient to be treated;

a catheter system comprising a catheter having the saline solution infusion channel having one or more fluid inlet ports at a distal end of the catheter inserted in the bladder, a medicine infusion channel adapted to be connected to a tube in fluid communication with a syringe, a balloon near the distal end of the catheter system and channel means for inflating and deflating said balloon within the bladder, and pressure sensor channel means for monitoring a pressure within the bladder during a treatment procedure, said pressure sensor channel means further including sensor means near the distal end of the catheter system for transmitting bladder pressure data to the central microprocessing means; and

means for securing said syringe, which is adapted to be in fluid communication with the medicine infusion channel of the catheter system, to a limb of a patient being treated;

inserting the catheter in the bladder of the patient and inflating said balloon with about 20 cc of sterile water draining said bladder;

changing the patient'"'"'s position to a more comfortable supine position;

connecting the catheter to corresponding connections on the central microprocessing means and after a tubing from a fluid pump is primed with a warm sterile normal saline, connecting said tubing to the saline solution infusion channel of the catheter system;

mixing a solution of a topical anesthetic, sodium bicarbonate and an anti-clotting drug in a syringe;

securing said syringe in position against the patient'"'"'s limb, slidingly engaging said catheter to said means for securing said syringe against the patients'"'"'s limb, and infusing said mixture into the bladder via a tubing through the medicine infusion port of the medicine infusion channel of the catheter, and allowing said mixture to stay in the bladder for a predetermined time;

adjusting a horizontal level of a tube holder supporting a tube attached to the pump means and holding the saline solution, to a desired level in relation to the patient'"'"'s symphysis pubis;

performing a titration procedure by infusing a warmed normal saline solution at the rate of about 50 cc per minute, wherein the saline solution flows from its source into the warmer means through the pump means and into the bladder;

monitoring desired procedure parameters including procedure time, fluid infusion rate, fluid volume infused and intravesical pressure;

verbally communicating with the patient at all times during the titration procedure wherein the patient is continuously reminded to express his physical sensations, and once the patient indicates there is pressure in the bladder and the sensation of the desire to urinate, the patient is asked to indicate how strong said sensations and once a maximum sensation level is reached, the pump means is stopped and notations are taken of time, infused volume, and intravesical pressure are made in the central microprocessing means, wherein at such time the parameters of volume infused and intravesical pressure are not to be exceeded, and maintaining the intravesical pressure for a predetermined time, at the expiration of which a main catheter port is opened and the bladder is drained and the volume as well as the color is inspected; and

deflating the catheter balloon, and removing the catheter and the procedure is completed.

2. The procedure according to claim 1, wherein after the maximum sensation level is reached, should the patient complain of considerable discomfort, the intravesical pressure can be temporarily lowered by aspiration using the syringe, after which additional sedation means for alleviating discomfort to the patient can be administered.

3. The procedure according to claim 1, wherein the sedation means comprises a mixture of nitrous oxide and oxygen administered to the patient.

4. The procedure according to claim 1, wherein the pump means is in electronic controlled communication with the central microprocessing means so as to pump the saline solution fluid at the desired preset infusion rate, monitor the volume infused into the bladder and to create controlled pressure inside the bladder so that said controlled pressure will not exceed the desired sensation level.

5. The procedure according to claim 1, further comprising:

providing mobile equipment support platform means for supporting the central microprocessing means, said fluid warmer means, and said pump means.

6. The procedure according to claim 5, further comprising:

providing vertically adjustable tube holder means adapted on said mobile equipment support platform means, said vertically adjustable tube holder means for adjusting a height of a tube containing said saline solution fluid being infused in said bladder so that said tube is capable of being located in a generally level orientation at a desired height.

7. The procedure according to claim 1, wherein the central microprocessing means further comprises:

manual override means for stopping the inflow of fluid into the bladder, for increasing fluid volume in the bladder, for terminating the procedure, for changing the infusion rate of the saline solution fluid and for changing an infusion time.

8. The procedure according to claim 1, wherein the means for securing said syringe to the limb of the patient being treated comprises:

a first strap portion being of sufficient length to be wrapped around the patient'"'"'s limb and secured thereon;

a second strap portion, an intermediate portion thereof being fixed to an intermediate portion of the first strap portion, said second strap portion being of sufficient length to be wrapped around said syringe so that said syringe is tangentially secured to said first strap portion;

fastening means for securing said first strap portion to said limb and fastening means for securing said syringe within second strap portion; and

means for slidingly engaging the catheter within the first strap portion.

9. The procedure according to claim 8, wherein said fastening means for securing said first strap portion to said limb and fastening means for securing said syringe within second strap portion are mating hook and loop fasteners.

10. The procedure according to claim 8, wherein said first strap portion includes an intermediate elastic portion for stretching said first strap portion or said second strap portion includes an intermediate elastic portion for stretching said second strap portion or said first and second strap portions each include an intermediate elastic portion for stretching said corresponding first and second strap portions.

11. The procedure according to claim 8, wherein the means for slidingly engaging the catheter within the first strap portion comprises:

a clip fixed to said first strap portion, said clip being adapted to slidingly engage the catheter.

12. The procedure according to claim 1, wherein the central microprocessing means further comprises:

means for the temporary automatic stopping of the pump when the pressure in the bladder reaches a predetermined maximum level.