Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
2000-05-02
2001-04-17
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
C482S008000, C482S112000, C482S113000, C600S587000, C073S379010, C606S192000
Reexamination Certificate
active
06217529
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to an apparatus for strengthening the pubococcygeal muscles (i.e., pelvic floor muscles) for improved sphincter or urinary control, and improving erectile dysfunction. More particularly, this invention relates to a biofeedback device that guides a user through an exercise program for the pelvic floor muscles.
BACKGROUND OF THE INVENTION
Over 18 million people in the US suffer from urinary incontinence. Many forms of incontinence have been linked to poor muscle tone in the pubococcygeus or pelvic floor muscles. The pelvic floor muscles originate from the symphysis pubis and extend posteriorly encompassing the urethra, the vagina, and the rectum. The pelvic floor muscles often work in conjunction with other muscles, such as the sphincter urethrae, to control urination. Many pathological conditions, such as cystocoel (hernial protrusion of the urinary bladder through the vaginal wall), rectocoel (hernial protrusion of part of the rectum into the vagina), uterine prolapse (protrusion of the uterus through the vaginal orifice), and bladder and sexual dysfunctions, may be caused by a weakened condition of the pelvic floor muscles. It is widely known that treatment of these pathological conditions generally includes development of muscle tone in the pelvic floor muscles.
One procedure for improving tone in the pelvic floor muscles is for the patient to exercise these muscles through voluntary contractions. Many patients find it difficult to perform such exercises because of an unfamiliarity with how to control the pelvic floor muscles or due to the weakened state of the muscles. Some types of voluntary exercises have been prescribed, such as the exercises developed by Dr. Arnold Kegel. To perform these exercises properly requires instruction, such as the insertion of an instructor's finger into the vagina or anus to determine when the correct muscles have been contracted. Once the patient has learned to contract the correct muscle group, the patient repeats the contractions many times per day. The requirement for personal instruction is often an impediment to a patient seeking care for incontinence or other conditions caused by pelvic muscular dysfunction.
Many training devices have therefore been developed for assistance in exercising the pelvic floor muscles. For example, U.S. Pat. No. 4,167,938 to Remih discloses a vaginal muscle exerciser having an inflatable, compressible body connected to an air cell. The air cell houses a piston connected to a tongue which raises and lowers a U-shaped pointer riding along a numerical scale to indicate the pressure. As a user applies pressure to the body by contraction of the pelvic muscles, air is forced out of the body, through a tube and into the air cell. As air enters or leaves the air cell, the piston moves upwardly or downwardly to approximately indicate on the scale the amount of applied pressure. A digital readout of the total pressure applied to the compressible body is also disclosed.
U.S. Pat. No. 2,541,520 to Kegel discloses another device for exercising injured sphincter muscles. The device includes a resilient member that is inserted within a sphincter muscle. A hose connects the device to a mechanical pressure gauge and an externally located pump. As pressure is applied to the inflatable member by the user's sphincter muscles, air is forced from the resilient member, through the hose and toward the mechanical pressure gauge, where the pressure is approximately indicated by a needle on the pressure gauge.
None of these prior devices, however, have been able to provide a fully effective exercise regimen.
SUMMARY OF THE INVENTION
The present invention has taken advantage of the recognition of several previously unappreciated drawbacks of the prior art. Although both Remih and Kegel provide devices for exercising the pelvic floor muscles, they do not guide the user through the exercises. For example, the present inventors have found that a drawback of the prior devices is that they do not direct a user when to flex the pelvic floor muscles and for how long. Additionally, these prior devices do not prevent the user from over-inflating or under-inflating the inflatable member, nor did they recognize that under-inflation reduces the effectiveness of the exercises. Furthermore, the pressure gauges of these prior devices show the total pressure in the inflatable member, rather than increased pressure due to contraction of the pelvic floor muscles. The present inventors have also found that users have difficulty judging contractile strength based on the readout of the calibrated pressure gauges. The analog and digital displays are difficult for a user to correlate with the subjective experience of the contraction.
The present invention has overcome these previously unappreciated problems, by providing a device having embodiments which present an intuitively helpful display to the user that more effectively correlates with the subjective sensations associated with pelvic floor muscle contractions. The intuitive display may for example be a series of arcs, concentric rings, or portions of concentric rings, that mimic the tightening of the muscles of the pelvic floor around a probe inserted in the vagina or rectum. The number, color, or brightness of the concentric rings or arcs may increase or decrease to signify tightening or loosening of the pubococcygeal muscles. Some embodiments of the invention also function as training devices that guide a user through an exercise routine, detect and correct improper or injurious pressurization of an inflatable probe, detect subtle contractile pressures, and/or have a central pump bladder and display.
In particular embodiments, the present invention includes a biofeedback training unit for exercising the pelvic floor muscles by guiding a user through an exercise routine. The training unit tracks the overall exercise time and the time between flexing and relaxation cycles. The training unit also monitors pressure in a probe to ensure the pressure remains within predetermined limits. If an error is detected due to improper pressure, the training unit automatically prompts the user to take corrective action.
In one aspect of the invention, the training unit includes an inflatable, elongated, cylindrical probe for insertion into an orifice such as the vagina or rectum. The probe is a sensitively designed balloon sensor that adjusts to the user's anatomy. Additionally, the probe's pneumatic design ensures that electrical components are not placed in the user's body. The training unit houses a controller, such as a microcontroller or microprocessor, which is coupled to the inflatable probe for detecting the pressure in the probe. A display is coupled to the controller and includes a pressure indicator portion that displays information associated with the contraction and relaxation of the user's pelvic floor muscles. The pressure indicator portion displays the pressure increase due to contraction of the pelvic floor muscles, rather than a total pressure within the probe. Displaying the pressure increase due to muscle contraction allows the user to accurately assess muscle strength. The controller also tracks the timing of the exercises and guides the user through alternating flexing and relaxation cycles to provide a safe and effective urinary control regimen.
In another aspect of the invention, the controller monitors the pressure and determines whether the pressure is above or below a predetermined threshold. If a pressure problem is detected, the controller automatically takes corrective action. For example, if the pressure is below a predetermined limit, the controller automatically terminates the workout cycle and advises the user to increase the pressure in the probe. If the pressure is above a predetermined limit, the controller automatically warns the user and suspends further exercises until the pressure decreases.
These and other features of the present invention will be more readily apparent from the foll
Boileau Michel A.
Clem William E.
Hoffman Gary L.
Hoskins Matthew W.
McCoy William G.
Deschutes Medical Products, Inc.
Klarquist Sparkman Campbell & Leigh & Whinston, LLP
Marmor II Charles
O'Connor Cary
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