Field:

Urology, Neuro-urology

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Description:

Innoventions is developing an efficient and cost effective method and device for applying electrical stimulation to the bladder in a non-surgical, minimally invasive and a reversible manner. The DynaSphere is a small floating balloon containing several electrodes connected to a receiver  in the balloon. The device will be inserted to the bladder in a non-surgical procedure as inserting a catheter. The intravesical receiver will be activated by a remote control for electro-stimulating the detrusor.

 

This multi-contact point  device will  electro-stimulate the detrussor for bladder emptying in atonic or hypotonic bladders on-demand triggered by an external activator.  In addition, the device is intended to be used for increasing the bladder capacity and compliance in neurogenic (or non-neurogenic) patients by the IVES/TEBS  principle.

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StimSphere components

1. The proprietary steerable floating balloon (developed, clinically tried, patented and licensed from Innoventions)

2. The electrodes/antennas on the surface of the balloon

3. The inserting tool (developed, clinically tried)

4. The retrieval tool  (developed, clinically tried)

5. The remote device to charge and command the release of the stimulation energy.

 

The StimSphere™ System

Like in other muscles, bladder contractions are controlled in magnitude and duration by the parameters of electrical stimulation. Bladder pressure increases as the frequency, pulse duration, voltage or stimulation period are increased. The ability of the detrusor to produce a long-lasting work depends on stimulus amplitude, duration and frequency.

 

An electrical stimulator  (usually surgically implanted - until now) can assist emptying of the bladder by stimulating the bladder muscle directly or by stimulating the nerves where they leave the spinal column. The remote controlled StimSphere System which is an intravesical device will be able to induce voluntary bladder contraction or perform bladder function rehabilitation by direct bladder stimulation.

 

The system will be composed of 4 main components: balloon shaped insert, insertion and retrieval kits and a remote control for activating the stimulation by the patient.

 

The insertion and retrieval procedures bear a very familiar resemblance to catheter insertion or cystoscpy procedures commonly used by most health-care professionals and urologists and thus require very little training.

 

Need:

It has been proved that intra-vesical electro-stimulation / Transurethral Electrical Bladder Stimulation (IVES / TEBS) of sufficient intensity induces reproducible detrusor contractions in all animals. IVES is a relatively old technique (direct electrical stimulation started in 1940) which is being resurrected with promising results. There is a need to reactivate the hypotonic, or non-contracting  urinary bladder for providing voluntary bladder emptying.

 

The following are indications in which IVES/TEBS can induce voluntary bladder emptying:

 

In Spinal Cord Injuries

In the USA there are between 11,000 and 12,000 spinal cord injuries each year, caused mostly by car accidents or sports. Many patients do not recover and remain permanently paralysed. Europe has about 300,000 paraplegics, many of them often very young. (Ref: “one Giant Step for the paralysed” Innovation and Technology Transfer. Vol 5/99, Sept. 1999, p. 20). To these can be added war injuries. Most of these patients have serious bladder voiding problems such as non-contracting bladder or  diminished capacity bladder.

 

For these patients there is a need for methods of electrical muscle stimulation to induce voluntary micturition.

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Advantages:

 The method and device being developed is efficient and cost effective for applying electrical stimulation to the bladder in a non-surgical, minimally invasive and a reversible manner. The whole system is  being designed to offer a simple but effective solution to the needs of the “dysfunctional urinary bladder market”. The following are the main advantages of the device:           

• Non-surgical insertion and removal of the StimSphere balloon in an office/clinic/home setting

• Organ-specific stimulation with less pelvic floor musculature stimulatio

• Several stimulation points for improved bladder emptying

• Reversible procedure

• Made of biocompatible materials to remain in the bladder for prolonged periods of time

• Device initially labeled for a simple replacement  once every 29 days (although initial clinical studies with the ContiSphere indicated the possibility for a longer indwelling period)

• Annual cost of using the product expected to be competitively low, compared to existing alternative products or methods

• Insertion and retrieval procedures very similar to existing urological manipulations so will not require more than a basic training program

• Unlike with intermittent catheterization performed a few times a day, the StimSphere will be inserted once a month (or once every 2 or 3 months), entirely into the sterile environment of the bladder

• Completely intravesical without urethral components. Its lack of any contact outside of the body will significantly reduce the risk of ascending infection into the bladder

• Ever changing stimulation points to prevent tissue reaction. Differing from the permanently implanted stimulating electrodes around which a fibrous capsule develops, in the StimSphere device the electrodes constantly will naturally change their contact points because of the floating character of the intravesical balloon. This will prevent even the  remotely possible tissue damage by the electrodes and in case minor damage will occur, there will be enough time for regeneration of the bladder epithelium until the remote possibility of a repeated next contact at the same point

• Detrusor muscle fatigue seen in skeletal muscles during electrostimulation will be less of a problem because bladder emptying only will occur 8-10 times or less during 24 hours

• Acute mechanical or electronic failure of the device or the remote controller can be managed by simple exchange of the intravesical device or the RF charger, or until the failed device is changed, bladder emptying will be managed  by intermittent catheterization, without jeopardizing the patients health

• The StimSphere™ will be a passive device which will be energized by RF connection to a transmitter outside the body which the patient will activate voluntarily by approximating it over the bladder

• The intravesical device will be inserted through the urethra and may be either removed after the desired level of stimulation ability has been achieved; or may be left in the bladder (to be changed periodically – i.e. once every 1-3 months) for selective stimulation for long period

 

IP status:

Multi- Granted and pending patents + Additional patents in preparation

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