Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
  • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
  • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
  • A61B2018/1861—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
  • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1002—Balloon catheters characterised by balloon shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1011—Multiple balloon catheters

Definitions

• the invention relates to a method for the diagnosis, treatment and prophylaxis of premature ejaculation and to a catheter for the diagnosis, treatment and prophylaxis of premature ejaculation.
• the catheter in particular constitutes a determinant feature in making use of this method and in resolving the problem of premature ejaculation.
• This kind of therapy is often accompanied by treatment with anaesthetic creams, antidepressive cyclic drugs, behaviour and relax techniques and more recently by the rehabilitation of the pelvic floor.
• the invention presented here designed to solve this problem, is based on the hypothesis that one of the main pathogenic mechanisms of premature ejaculation lies within the prosthatic urethra, still not thoroughly understood.
• the sperm accumulation chamber is comprised of the prosthatic urethra, the bladder neck which closes above the accumulation chamber and the outer urethra sphincter which closes it at the other end.
• the sperm gathers in this chamber causing an increase in pressure inside the urethra.
• the ejaculatory reflex is induced when a certain amount of pressure is built up within this chamber.
• the ejaculatory reflex is induced before the patient wishes with only a small amount of seminal fluid either because the urethra wall is not very elastic or because the threshold for reaction to increased pressure is low, or because the patient is unable to make the ejaculation inhibition mechanism perform properly.
• the so-called accumulation chamber has no vent for releasing the pressure generated as the sperm accumulates because the bladder neck and/or the preprosthatic sphincter does not open at the right time. Therefore the pressure required to trigger off the ejaculatory reflex is reached very quickly.
• This invention is therefore based on the discovery that during sexual intercourse in males with premature ejaculation the opening of the bladder neck and/or the preprosthatic sphincter which acts as a vent fails to occur.
• the bladder neck and/or the preprosthatic sphincter fails to open either because the person is unable to perform correctly the pelvic floor relaxation movement which opens the bladder neck and/or the preprosthatic sphincter or because the bladder neck and/or the preprosthatic sphincter cannot open.
• This inability can be caused either by a spastic or sclerotic condition or by insufficient neuromodulation, or by the insufficient activation or functioning of the alfalytic system.
• the amount of seminal fluid produced during the second sexual intercourse is highly less than the amount produced during the first one.
• a number of solutions using inflatable catheters are available for the treatment of the prostate. For the most part, they consist of a balloon elliptical in shape, positioned inside the urethra and inflatable from outside.
• the action of the catheter presented here is not to squeeze the prosthatic urethra as the other balloon-shaped prosthatic dilators do, but rather, thanks to its shape, to create an effect similar to that which occurs after the surgical operation described above.
• the solution obtained through this invention ensures the reversibility of the phenomenon, allowing the patient to procreate if he wishes.
• the specific aim of this invention is to permit the diagnosis, treatment and prophylaxis of premature ejaculation by inducing a dilation, opening or relaxation of the bladder neck and/or the preprosthatic sphincter.
• Dilation, opening or relaxation may be effected through mechanical means, hyperthermia, microwaves or other kind of energy, or by pharmacological therapy.
• pharmaceuticals antagonist of the alpha-adrenergic receptors particularly anti alpha 1 a, b, c, d, alpha 2, and their salts, are preferable.
• a catheter for the diagnosis, treatment and prophylaxis of premature ejaculation comprising an inflation passage and an inflatable means on the outside of the tube, suitably positioned to interact with the bladder neck and/or the preprosthatic sphincter which can be inflated through the inflation passage which constitutes the invention.
• the inflatable means is frustro- conical in shape with the wider end towards the bladder neck and the narrower end towards the urethral meatus.
• a second inflatable means fitted with a second inflation passage, which serves to anchor the tube in the bladder.
• first frustro-conical-shaped inflatable means with the larger base towards the bladder, may be 2 -7 cm in length and 3
• the first inflatable means is inflated for 10 -20 minutes to attain a pressure of 2 - 6 atmospheres.
• the second inflatable means positioned at about 2 cm. from the tip of the catheter can inflate to a volume of about 5 - 30 cc;
• the components of the catheter can be echo and/or radio reflecting.
• figure 1 is a schematic view of one embodiment of the catheter
• figure 2 is an enlarged view of the catheter shown in figure 1
• figure 3 shows the outer end of the catheter shown in Figure
• figure 4 is a cross section view taken along line IV-IV of figure
• the figures show a catheter 1 with a plastic tube 2, a first inflatable balloon 3 and a second inflatable balloon 4 for anchoring the catheter.
• the tube 2 has three different inlets 5, 6 and 7, respectively for the guide wire or for the passage of water or urine, for the inflating first balloon 3 and for the second inflating balloon 4.
• the second balloon 4 is positioned about 0.5 cm from the first 3 and can be inflated to a volume of 5 to 50 c ⁇ , as is normal for catheters. It serves to hold the catheter 1 in the bladder during treatment and to ensure that the action of the first balloon 3 occurs in the neck.
• the anchoring element is a not new feature in bladder catheters.
• the first balloon 3 is positioned on the tube 2 of the catheter 1 just below the second balloon 4.
• the first balloon 3 too is inflated from the outside through the tube 6, using water, air or other means.
• the first balloon 3 is frustro-conical in shape which makes it particularly suitable for acting on the bladder neck. The wider part of the cone faces the inner tip of the catheter 1 and the narrower, the point of insertion of catheter 1.
• the length varies according to the length of the prostate urethra. It is usually 4-6 cm. long but can be shorter or longer. The length is measured by echography through a transrectal probe.
• the diameter of the larger base of the first balloon 3 can vary from 3 - 5 cm.
• the width of the narrow end can also vary but the first balloon 3 usually protrudes from catheter 1 only 0.5 cm.
• the first balloon 3 is connected to a pump or similar device by which it can be inflated to a pressure of about 2 - 6 atmospheres so as to dilate the bladder neck (and if necessary, also the prosthatic urethra and/or the preprosthatic sphincter). In this way the bladder neck remains open allowing the sperm to flow back into the bladder in the sperm accumulation stage during sexual activity.
• the catheter On the outer edge of the narrow end of the frustro-conical balloon 3 the catheter has a marker bulge 8 which is identifiable through rectal digital or echographical examination.
• the catheter 1 is inserted into the urethra after the patient has had a local or loco regional anaesthesia, neuroleptoanalgesia or other kind of anaesthetic.
• the anchor balloon 4 is inflated and the catheter 1 is put in traction.
• the frustro- conical balloon 3 is inflated to a pressure of about 4-6 atmospheres although this pressure may be lower or higher. Dilation, opening or relaxation time may vary; it generally takes
• the first balloon 3 makes it possible to achieve greater dilation, opening or relaxation at the neck of the bladder and/or the preprosthatic sphincter without risk of damaging the sphincter of the urethra causing incontinence.
• the dilation, opening or relaxation of the first balloon 3 makes it possible to position the same well above the sphincter.
• the sperm By dilating the bladder neck and/or the preprosthatic sphincter (and partially the prosthatic urethra) it is possible for the sperm to flow back into the bladder as it accumulates in the prosthatic urethra during sexual intercourse. This means that there will be a lengthening of ejaculation time and even better control of the ejaculatory reflex.
• a multi-channel catheter is introduced through the urethra and the prosthatic urethra is measured. Measurement can be made by echographic or radiological means or by using a graduated measuring catheter at the distal end of which there is an anchoring device such as a balloon.
• the inflatable means is inflated and the catheter is slightly withdrawn until it engages the inflated means to the bladder neck.
• the distance between the inflatable means and the external sphincter of the urethra is measured.
• a graduated catheter can also be inserted through one of the channels of an optical fibre instrument.
• the catheter fitted with an anchoring device is inserted through the urethra and it is inflated.
• the catheter is then withdrawn slightly until the anchoring means engages the walls of the bladder neck and then the inflatable means is inflated. Dilation, opening or relaxation time varies according to the different cases; it may be rapid, progressive or slow - it may even last a few weeks in which case the means of inflation may comprise expanders.
• the catheter may even be fitted with a positioning device, consisting of a third inflatable means located closer to the dilating device or may consist of a bulge in the catheter, detectable by digital rectal examination during the positioning procedure.
• this method also comprises pharmacological treatment.
• this drug determines an opening in the bladder neck and a reduction in the obstruction of the urinary flow caused by the prostate.
• a drug which causes such an effect in the context of this invention provides an outlet for the semen with a lowering of the pressure within the prostate urethra during sexual intercourse. Consequently the ejaculatory reflex may be delayed.

Landscapes

• Health & Medical Sciences (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Electromagnetism (AREA)
• Engineering & Computer Science (AREA)
• Physics & Mathematics (AREA)
• Heart & Thoracic Surgery (AREA)
• Otolaryngology (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• External Artificial Organs (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

Family

ID=11404999

Family Applications (1)

Country Status (3)

Cited By (2)

Citations (5)

• 1997
  • 1997-04-23 IT IT97RM000235A patent/IT1291890B1/it active IP Right Grant
• 1998
  • 1998-04-15 WO PCT/IT1998/000088 patent/WO1998047557A1/en active Application Filing
  • 1998-04-15 AU AU70782/98A patent/AU7078298A/en not_active Abandoned

Patent Citations (5)

Also Published As

Similar Documents

Legal Events