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G-Sphere
Remote Bladder Filling Monitor

Field:

Urology, UroGynecology, Gerontology.

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Description:

Urinary incontinence is a condition with severe economical and psychological impact. It may occur at any age and in any sex. It is estimated that over 12 million Americans suffer from lack of bladder control, but only one fourth seek help. The most common approach to geriatric incontinence is using disposable adult diapers. This approach deals with the symptom rather than the cause. As a result of chronic use of diapers, the “diaper rash” is the most common skin problem found in adult incontinent sufferers. In addition, the use of adult diapers cause also an environmental problem because these diapers ends in the municipal waste at the level of one million tons a year.( S. P. Wallace. The Public Health Perspective on Aging. Generations 2005; 29(2): 5-10. © 2005 American Society on Aging)

 

Eight to 34% of community-dwelling elderly persons suffer from urinary incontinence; rates are higher in women than in men, and urinary incontinence affects > 50% of elderly patients in hospitals and in nursing homes.( Merck Manual of Geriatrics)

 

Restricted mobility can prevent a patient from reaching the toilet and may result from physical limitations. If mobility of the person cannot be improved, the new approach of the G-Sphere can help to resolve the problems of using diapers and its related complications.

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The G-Sphere project is a combination/modification of the ContiSphere and the DynaSphere devices of Innoventions to dedect and wirelessly communicate the bladder filling events

In this modification the intravesical balloon will be the carrier of a bladder volume / pressure sensor and transmitter for bladder filling monitoring to allow the nursing home residents  to empty the bladder before full bladder capacity is reached. The device (system) shall detect and wirelessly communicate the bladder filling events to the nursing staff and cause an encouragement to the incontinent residents.

 

The system comprises of three components:

  • The intravesical device based on the insertable balloon with electronics, a magnet, including pressure sensor and wireless communication to the patient monitor.

    1. The operation of the intravesical  device will be as following:

      • The device (balloon) will include the magnet, and it will seal the bladder urethral outlet, when attracted to an external magnet placed in the patient underwear.

      • Once the balloon electronics will detect the urge, the alarm signal will be sent from the balloon, via the patient monitor to the nurse monitor.

      • The nurse then will give the bed pan, remove the external magnet, opening the bladder outlet and allow spontaneous urination.

    2. The communication shall have the following parameters

      • Range shall be at least 3 meters.

      • The communication shall include urge alarms, battery status, and failure alarms.

    3. The COGS of the intravesical device and of insertion/removal tools shall be not higher than $50 in production quantities of 10,000 units or higher per year.

      • Note: current COGS of the ContiSphere with a magnet and of the insertion/removal set of tools from Innoventions is app. $20.

    4. The durability of the intravesical device shall be 3 months.

    5. The intravesical device and the insertion/removal kits shall be disposable, for a single insertion/removal.

    6. The intravesical device and the insertion/removal kits shall be supplied sterile.

    7. The sterility expiration shall be at least 2 years.

    8. The intravesical device shall be insertable using tools and methods developed by, based on, or similar to the ContiSphere.

    9. The intravesical device shall be removable using tools and methods developed by, based on, or similar to the ContiSphere.

    10. The intravesical device shall be replaceable by a nurse.

  • Patient monitor.

    1. The patient monitor shall receive the communication from the intravesical device and deliver audio/visual indication of the urge event.

    2. The patient monitor shall serve as a communication hub, delivering the urge alarm to the nurse monitor either via proprietary protocol, or via standard communication protocols (wifi, cell phone, etc.)

    3. The COGS of the patient monitor shall be not higher than $50 in production quantities of 500 units or higher per year.

    4. The patient monitor shall have a non-rechargeable battery.

    5. The battery shall be sufficient for at least 6 months of operation.

    6. The patient monitor shall have a use life of at least 2 years.

  • Nurse monitor. This is an optional device; the effort should be used to incorporate the standard monitor, already available at the nurse station.

 

Need:

Current practice in geriatric institutions is using pads, resulting in costs of $1,500-$3,000 per patient per year. The need to wear and to replace the pads is inconvenient both for the patient and for the nurses, as well as can cause patient skin irritation.

 

Advantages:

  • An alternative to indwelling catheters inserted to control incontinence

  • An alternative to absorbent pads that cause skin irritations and sores

  • Ambulatory, easy to perform procedure

  • Very low risk of infections or other medical complications

  • Discreet – Concealed completely inside thepatient’s body

  • Variable indwelling period (according  the indications and local regulations)

 

IP status:

Multi patented intravesical balloon technology + Additional patents in preparation

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