Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
  • A61B5/4519—Muscles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
  • A61B5/224—Measuring muscular strength
  • A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B23/00—Exercising apparatus specially adapted for particular parts of the body
  • A63B23/20—Exercising apparatus specially adapted for particular parts of the body for vaginal muscles or other sphincter-type muscles

Definitions

• the invention relates to method and device for assessing the status of the pelvic floor musculature of a patient in connection with incontinence evaluation or for another purpose .
• urinary incontinence is a person's inability to keep back the urine, which means that repeated involuntary urine passages occur. It is distinguished between two main types of urinary incontinence, urge incontinence and stress incontinence. Urge incontinence is considered to be caused above all by uncontrolled contractions of the bladder during the filling thereof. At stress incontinence urine leakage arises in connection with increased abdominal pressure which occurs at laughing, straining, coughing, lifting, jumping, and other physical activities. Stress incontinence affects principally middle- aged women with whom the symptoms rather often make their debut in connection with a childbirth.
• Urge incontinence generally is treated pharmacologically.
• electrical stimulation has been developed to be an alternative course of treatment for this type of incontinence.
• Electrical stimulation has also been tested for treating stress incontinence.
• the traditional treatment of stress incontinence generally comprises surgical reconstruction or physiotherapeutic training of the pelvic floor.
• the surgical treatment provides permanent continence of 60 to 80 % of the patients depending on the method. Many patients with unsatisfactory result after training of the pelvic floor are cured after a surgical operation. Unfortunately, there are at present no diagnostic methods for assigning the individual patient to the optimal treatment method, physiotherapy or surgery.
• the functional evaluation of the pelvic floor usually is made by a physiotherapist or urotherapist .
• Several methods have been used in order to estimate the condition of the pelvic floor musculature.
• One method is to subjectively estimate the squeezing ability of the patient by manual vaginal palpation.
• Another method is to measure the patient's ability to carry conical weights in vagina, cf . e.g. US-A-4 895 363 and US-A-5 213 557.
• the purpose of the invention is to provide method and device of the kind referred to above, eliminating the drawbacks of prior art methods and devices accounted for above. Then, one focuses on the upward force of parts of the pelvic floor musculature at squeezing and on the downward force at straining.
• the pelvic floor is in fact shaped as an open cone with muscles which surround urethra, vagina, and rectum and extend upwards and outwards to the attachment at the pelvic bone.
• the anatomic extension of the muscles causes lifting of these organs at an active contraction (squeezing movement) , and this obligatory lifting movement is now utilized in order to effect an objective, quantitative estimation of the pelvic floor function by measuring the depression force (downward force) exerted by the abdominal pressure on the pelvic floor at straining and providing a measure of the need of muscular carrying capacity, as well as the lifting force (upward force) exerted by the pelvic floor musculature at squeezing and indicating the power of the musculature in order that one will be able to choose the optimal treatment method for incontinence by guidance of the measuring result obtained thereby.
• FIG. 1 is a side view of the device and illustrates diagrammatically the use thereof
• FIG. 2 is a side view of an expendable set included in the device
• FIG. 3 is an enlarged cross-sectional view along line
• Support arm 14 is adjustable vertically by means of a servo motor in unit 13, and the adjustment is controlled from a control unit 15.
• Support arm 14 is attached to unit 13 at 16, and this attachment can be of a type allowing support arm 14 to be swung to different positions but the support arm can also be mounted in a fixed position.
• In the outer free end of support arm 14 there is means 17 for attaching a yoke 18 having a stem 19.
• Stem 19 can be inserted into a slot 20 in a head 21, FIG. 3, and can be fixed in the slot by means of a clamp screw 22.
• Head 21 can be rotated to different positions on support arm 14.
• a pressure sensor 24 is mounted between the limbs of the yoke, said sensor comprising an elastically stretchable resistance element the electric resistance of which is altered by stretching of the resistance element.
• a catheter with an expandable restrainer shown here as a balloon 25 which may be coated with an antiglidant and has a tubular stem 26 is mounted at said stem in sensor 24 and is connected by a hose 27 to an air pump 28 by means of which balloon 25 can be inflated.
• a wire 29 and a contact pin 30 sensor 24 can be connected to a contact socket 31 on support arm 14 in order to be connected with electronic means in support unit 13 via electric wiring in support arm 14 signals from the electronic means being transmitted to a display 32 on control unit 15 via a wire connection 33 between support unit 13 and control unit 15.
• yoke 18 with attachment stem 19, sensor 24, balloon catheter 25, 26, and pump 28 with connection hose 27 as well as wire 29 with pin 30 shall be included in an expendable set, FIG. 2, which includes also a pair of scissors 34 or a scalpel.
• a floor 35 forms adjacent wall 10 a standing accommodation for a patient fragmentarily disclosed at 36 in a diagrammatic vertical cross-sectional view for whom the status of the pelvic floor musculature shall be estimated e.g. in connection with evaluation of incontinence.
• this evaluation is performed as described below.
• the patient shall be in upright position in order to imitate everyday situations when a stress incontinent patient typically is affected by involuntary urinary leakage. Therefore, the patient shall be standing with straight legs on floor 35 straddling support arm 14 which is adjusted by means of support and control unit 13 to a position vertically, which is adapted to the size of the patient. Also the position vertically of sacrum rest 12 is adapted to the size of the patient.
• Yoke 18 is fixed in a suitable displaced and angular position on support arm 14 by means of attachment means 17 (FIG. 3) in order that balloon catheter 25, 26 can be inserted into vagina.
• balloon 25 is inflated inside vagina and then one pulls gently in the catheter in distal direction until the patient registers a retention of the catheter in vagina.
• Yoke 18 is now adjusted in such a way that the sensor with the catheter in said position has some bias (for example 0.5 N) , and the indication on display 32 is zeroed at said bias.
• some bias for example 0.5 N
• measuring is made at three maximal squeezings, strains, and coughs.
• the possible fatigue of the musculature can also be measured by means of one prolonged maximal squeezing.
• the electronic means in the support unit 13 can be connected not only to control unit 15 with display 32 but also to a printer for presentation of the patient's momentary squeeze/strain parameters for positive and negative maximal values and analogue registration of a complete sequence at squeezing, straining, and coughing.
• a minor pilot study including continent and stress incontinent women has shown that the method according to the invention has a good reproductivity.
• the variability of the measuring procedure is equivalent to or less than the ability of the individual patient to generate actively repeated maximal squeeze movements of the same amplitude. This variability in turn can be neglected in relation to the interindividual difference in pelvis floor power (which varies with a factor of 6) .
• the stress incontinent women had a definitely lower relative lifting power than the continent women, i.e. lower muscle power in relation to the individual need of active contraction ability. The difference was particularly pronounced at coughing, the situation when the majority of stress incontinent women leak.
• the pilot study referred to above indicates that the actual measuring method functions as expected: it distinguishes unequivocally between squeeze and strain movements of the pelvic floor, provides reproducible quantitative measure values in easily comprehensible units, and can be used to choosing an optimal treatment procedure at stress incontinence.
• hose 27 is cut by means of the pair of scissors 34 in order that the air shall leave balloon 25 so that the balloon catheter can be withdrawn from vagina.
• the device described for working the method of the invention can be modified as far as the constructive details are concerned.
• Another type of pressure sensor can be provided, for example a strain gauge on a flexible element which is connected with the balloon catheter and is bent in one direction or the other at squeezing or straining, respectively.
• the balloon catheter can be replaced by another type of catheter which is shaped in order to be retained in vagina.
• the catheter can be inserted into another body opening in the pelvic region also of men, viz. rectum or urethra. In that case the catheter must of course be constructed in order to be fit for the actual body opening.

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• Animal Behavior & Ethology (AREA)
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• Pathology (AREA)
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• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Physics & Mathematics (AREA)
• Physical Education & Sports Medicine (AREA)
• Biophysics (AREA)
• Veterinary Medicine (AREA)
• Gynecology & Obstetrics (AREA)
• Reproductive Health (AREA)
• Dentistry (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Rheumatology (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

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Cited By (16)

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Citations (4)

• 1998
  • 1998-08-13 SE SE9802716A patent/SE514665C2/sv not_active IP Right Cessation
• 1999
  • 1999-08-10 JP JP2000564521A patent/JP2002522147A/ja active Pending
  • 1999-08-10 EP EP99943565A patent/EP1105040A1/en not_active Withdrawn
  • 1999-08-10 WO PCT/SE1999/001357 patent/WO2000009013A1/en not_active Application Discontinuation
  • 1999-08-10 AU AU56635/99A patent/AU5663599A/en not_active Abandoned

Patent Citations (4)

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