Veinoplus

Last updated

Veinoplus is a class IIa medical device with CE marking. It is indicated for the treatment of vascular diseases. This is a neuromuscular stimulator developed by an American scientist, Jozef Cywinski.

Contents

Veinoplus DEVICE-VI-vue de face-electrodes-ombre.jpg
Veinoplus

History

Description

Veinoplus is composed of a pocket-size device linked to two electrodes. The device has three buttons: a central one to turn on and off the device and two buttons marked “+” and “-” to adjust the intensity of stimulation. The electrodes have to be placed on the calf: either both electrodes on one calf if the venous disease affects only one leg, or one electrode on each calf if the pathology concerns both legs.

Veinoplus technology

Veinoplus technology is based on the principle of electrostimulation. Thanks to a 9V battery, the device delivers electrical impulses with low frequency and low voltage. Input power is below 0.3W and output power is under 0.05W. The difference between Veinoplus and others electrical muscle stimulators is due to the waveform of the impulses. With this unique waveform, the electrical field can deeply get through the calf and so stimulate an important volume of tissue. As a consequence, Veinoplus triggers deep muscular contractions even if both electrodes are over one meter apart, for instance with one electrode on each calf. [2]

Veinoplus produces safe and painless electrical impulses. Actually, the signal's intensity is below limits authorized by the Association for the Advancement of Medical Instrumentation and American National Standards Institute (AAMI / ANSI ; NS-4; 1986/2002). Moreover, the device doesn't generate excessive electromagnetic interference. [3] Thus it can be used in a plane, except during take-off and landing. Finally, a study on pregnant women [4] has proven that Veinoplus has no side effects on foetus and pregnancy.

Clinical data

Physiological properties

Veinoplus activates the calf muscular pump which is responsible for 80% of the venous return. The pulsating calf contractions compress deep veins and pump the venous blood against gravity towards the heart.

We can highlight 3 principal hemodynamic effects: [1] [5] [6]

Indications

Veinoplus is indicated for the treatment of chronic venous insufficiency symptoms: [1] [6] [7]

Veinoplus could also ease chronic venous ulcer healing. [9]

Veinoplus can be used either by patients suffering from venous disease or at risk of venous disorders:

Contra-indications

The only contra-indication of Veinoplus is wearing a pacemaker. [3]

Related Research Articles

<span class="mw-page-title-main">Varicose veins</span> Medical condition in which superficial veins become large and twisted

Varicose veins, also known as varicoses, are a medical condition in which superficial veins become enlarged and twisted. Although usually just a cosmetic ailment, in some cases they cause fatigue, pain, itching, and nighttime leg cramps. These veins typically develop in the legs, just under the skin. Their complications can include bleeding, skin ulcers, and superficial thrombophlebitis. Varices in the scrotum are known as a varicocele, while those around the anus are known as hemorrhoids. The physical, social, and psychological effects of varicose veins can lower their bearers' quality of life.

<span class="mw-page-title-main">Vein</span> Blood vessels that carry blood towards the heart

Veins are blood vessels in the circulatory system of humans and most other animals that carry blood towards the heart. Most veins carry deoxygenated blood from the tissues back to the heart; exceptions are those of the pulmonary and fetal circulations which carry oxygenated blood to the heart. In the systemic circulation, arteries carry oxygenated blood away from the heart, and veins return deoxygenated blood to the heart, in the deep veins.

<span class="mw-page-title-main">Artificial cardiac pacemaker</span> Medical device

An artificial cardiac pacemaker, commonly referred to as simply a pacemaker, is an implanted medical device that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart. Each pulse causes the targeted chamber(s) to contract and pump blood, thus regulating the function of the electrical conduction system of the heart.

<span class="mw-page-title-main">Thrombosis</span> Medical condition caused by blood clots

Thrombosis is the formation of a blood clot inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets (thrombocytes) and fibrin to form a blood clot to prevent blood loss. Even when a blood vessel is not injured, blood clots may form in the body under certain conditions. A clot, or a piece of the clot, that breaks free and begins to travel around the body is known as an embolus.

<span class="mw-page-title-main">Deep vein thrombosis</span> Formation of a blood clot (thrombus) in a deep vein

Deep vein thrombosis (DVT) is a type of venous thrombosis involving the formation of a blood clot in a deep vein, most commonly in the legs or pelvis. A minority of DVTs occur in the arms. Symptoms can include pain, swelling, redness, and enlarged veins in the affected area, but some DVTs have no symptoms.

<span class="mw-page-title-main">Transcutaneous electrical nerve stimulation</span> Therapeutic technique

A transcutaneous electrical nerve stimulation is a device that produces mild electric current to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation, but the term is often used with a more restrictive intent—namely, to describe the kind of pulses produced by portable stimulators used to reduce pain. The unit is usually connected to the skin using two or more electrodes which are typically conductive gel pads. A typical battery-operated TENS unit is able to modulate pulse width, frequency, and intensity. Generally, TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction or low frequency (<10 Hz) with an intensity that produces motor contraction. More recently, many TENS units use a mixed frequency mode which alleviates tolerance to repeated use. Intensity of stimulation should be strong but comfortable with greater intensities, regardless of frequency, producing the greatest analgesia. While the use of TENS has proved effective in clinical studies, there is controversy over which conditions the device should be used to treat.

<span class="mw-page-title-main">Electrotherapy</span> Use of electricity for medical purposes, and to stimulate Muscle for more strength.

Electrotherapy is the use of electrical energy as a medical treatment. In medicine, the term electrotherapy can apply to a variety of treatments, including the use of electrical devices such as deep brain stimulators for neurological disease. The term has also been applied specifically to the use of electric current to speed wound healing. The use of EMS is also very wide for managing muscular pain. Additionally, the term "electrotherapy" or "electromagnetic therapy" has also been applied to a range of alternative medical devices and treatments. Evidence supporting the effectiveness of electrotherapy is limited.

<span class="mw-page-title-main">Sclerotherapy</span> Shrinking of the varicose blood vessels by the injection of medicine

Sclerotherapy is a procedure used to treat blood vessel malformations and also malformations of the lymphatic system. A medication is injected into the vessels, which makes them shrink. It is used for children and young adults with vascular or lymphatic malformations. In adults, sclerotherapy is often used to treat spider veins, smaller varicose veins, hemorrhoids, and hydroceles.

<span class="mw-page-title-main">Venous ulcer</span> Medical condition

Venous ulcer is defined by the American Venous Forum as "a full-thickness defect of skin, most frequently in the ankle region, that fails to heal spontaneously and is sustained by chronic venous disease, based on venous duplex ultrasound testing." Venous ulcers are wounds that are thought to occur due to improper functioning of venous valves, usually of the legs. They are an important cause of chronic wounds, affecting 1% of the population. Venous ulcers develop mostly along the medial distal leg, and can be painful with negative effects on quality of life.

<span class="mw-page-title-main">Electrosurgery</span> Use of high-frequency, alternating polarity, electrical current in medical operations

Electrosurgery is the application of a high-frequency alternating polarity, electrical current to biological tissue as a means to cut, coagulate, desiccate, or fulgurate tissue. Its benefits include the ability to make precise cuts with limited blood loss. Electrosurgical devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms or in outpatient procedures.

Electrical muscle stimulation (EMS), also known as neuromuscular electrical stimulation (NMES) or electromyostimulation, is the elicitation of muscle contraction using electric impulses. EMS has received an increasing amount of attention in the last few years for many reasons: it can be utilized as a strength training tool for healthy subjects and athletes; it could be used as a rehabilitation and preventive tool for people who are partially or totally immobilized; it could be utilized as a testing tool for evaluating the neural and/or muscular function in vivo. EMS has been proven to be more beneficial before exercise and activity due to early muscle activation. Recent studies have found that electrostimulation has been proven to be ineffective during post exercise recovery and can even lead to an increase in Delayed onset muscle soreness (DOMS).

<span class="mw-page-title-main">Compression stockings</span> Compression garment

Compression stockings are a specialized hosiery designed to help prevent the occurrence of, and guard against further progression of, venous disorders such as edema, phlebitis and thrombosis. Compression stockings are elastic compression garments worn around the leg, compressing the limb. This reduces the diameter of distended veins and increases venous blood flow velocity and valve effectiveness. Compression therapy helps decrease venous pressure, prevents venous stasis and impairments of venous walls, and relieves heavy and aching legs.

<span class="mw-page-title-main">Post-thrombotic syndrome</span> Medical condition

Post-thrombotic syndrome (PTS), also called postphlebitic syndrome and venous stress disorder is a medical condition that may occur as a long-term complication of deep vein thrombosis (DVT).

The term venous translucence has been used in phlebology since 1996 by surgeon Pedro Fernandes Neto during ambulatory clinical exams in Brazil. His results were published in the annals of the national and international congresses of angiology. Venous translucence is the process of reflective image visualization of veins by light, which reaches up to the superficial venous system. It is a non-invasive method. Since it is a simple, low-cost technique it can be repeated as needed, which is useful in disease-process monitoring. It is a new diagnostic procedure, still undergoing investigation; more analysis is necessary to hone its technical aspects. Venous translucence is based on optical physics. It is caused by the refraction, absorption and reflection of light. The color which is not absorbed is reflected, and is the one that is seen. Therefore, venous translumination is based on the incidence of luminosity on the vein, where part of the light is absorbed and another reflected.

Andrew Nicolaides is a British-Greek Cypriot surgeon, and an expert in cardiovascular disease and stroke prevention.

Electroanalgesia is a form of analgesia, or pain relief, that uses electricity to ease pain. Electrical devices can be internal or external, at the site of pain (local) or delocalized throughout the whole body. It works by interfering with the electric currents of pain signals, inhibiting them from reaching the brain and inducing a response; different from traditional analgesics, such as opiates which mimic natural endorphins and NSAIDs that help relieve inflammation and stop pain at the source. Electroanalgesia has a lower addictive potential and poses less health threats to the general public, but can cause serious health problems, even death, in people with other electrical devices such as pacemakers or internal hearing aids, or with heart problems.

John H. Saringer is a professional engineer who graduated from the University of Toronto in 1977 and specializes in biomechanics and the development of products to accelerate healing and mitigate the effects of immobility.

<span class="mw-page-title-main">Jozef Cywinski</span> Polish bioengineer (born 1936)

Jozef Cywinski is a Polish-American scientist, a specialist in the field of biomedical engineering and specifically in electrical stimulation of living organisms. His work has been the subject of 12 patents, two books and over 100 scientific publications. He developed several first-on-the-market electro-medical devices like cardiac stimulators pacemakers, train-of-four nerve stimulators, PACS, EMS, TENS and Veinoplus calf pump stimulators.

<span class="mw-page-title-main">Ultrasonography of chronic venous insufficiency of the legs</span> Non-invasive medical procedure

Ultrasonography of suspected or previously confirmed chronic venous insufficiency of leg veins is a risk-free, non-invasive procedure. It gives information about the anatomy, physiology and pathology of mainly superficial veins. As with heart ultrasound (echocardiography) studies, venous ultrasonography requires an understanding of hemodynamics in order to give useful examination reports. In chronic venous insufficiency, sonographic examination is of most benefit; in confirming varicose disease, making an assessment of the hemodynamics, and charting the progression of the disease and its response to treatment. It has become the reference standard for examining the condition and hemodynamics of the lower limb veins. Particular veins of the deep venous system (DVS), and the superficial venous system (SVS) are looked at. The great saphenous vein (GSV), and the small saphenous vein (SSV) are superficial veins which drain into respectively, the common femoral vein and the popliteal vein. These veins are deep veins. Perforator veins drain superficial veins into the deep veins. Three anatomic compartments are described, (N1) containing the deep veins, (N2) containing the perforator veins, and (N3) containing the superficial veins, known as the saphenous compartment. This compartmentalisation makes it easier for the examiner to systematize and map. The GSV can be located in the saphenous compartment where together with the Giacomini vein and the accessory saphenous vein (ASV) an image resembling an eye, known as the 'eye sign' can be seen. The ASV which is often responsible for varicose veins, can be located at the 'alignment sign', where it is seen to align with the femoral vessels.

<span class="mw-page-title-main">Thrombosis prevention</span> Medical treatment

Thrombosis prevention or thromboprophylaxis is medical treatment to prevent the development of thrombosis in those considered at risk for developing thrombosis. Some people are at a higher risk for the formation of blood clots than others, such as those with cancer undergoing a surgical procedure. Prevention measures or interventions are usually begun after surgery as the associated immobility will increase a person's risk.

References

  1. 1 2 3 Dr F. Zuccarelli, Dr J. Launay, Dr J. Lemagrex, Pr R. Mollard, P Fargier, M. Pujo. Activation de la pompe musculaire du mollet par électrostimulation Veinoplus®. Angéiologie. 2005; 57:48-54
  2. Marquage CE 0535.
  3. 1 2 International Standard IEC 60601-2-10 Medical electrical equipment. Particular requirements for the safety of nerve and muscle stimulators
  4. 1 2 A. Le Tohic, H. Bastian, M. Pujo, P. Beslot, R. Mollard, P. Madelenat. Effets de l’électrostimulation par Veinoplus® sur les troubles circulatoires des membres inférieurs chez la femme enceinte, Gynécologie Obstétrique & Fertilité, 2009, volume 37, n°1 p.18-24.
  5. 1 2 Nicolaides AN, Griffin M, Bond D et al. The Efficacy of New Veinoplus Stimulation Technology to Increase Venous Flow and Prevent Venous Stasis. Journal of Vascular Surgery Volume 51, issue 3, page 790, March 2010
  6. 1 2 Griffin M, Nicolaides AN, Bond D, Geroulakos G, Kalodiki E. The efficacy of a new stimulation technology to increase venous flow and prevent venous stasis in Eur J Vasc Endovasc Surg.2010 Dec; 40(6):766-71.
  7. Bogachev V. Y., Golovanova O.V., Kuznietzov A.H., Stchekoian A.O. Electrostimulation par Veinoplus, une nouvelle méthode pour le traitement de l'insuffisance veineuse chronique des membres inférieurs. Phlebology (Russ. Assoc. of Phlebology & IUP) 2010; Volume 1, Issue 4 pages 22-25
  8. Soriano C., Moll S., Deal A. Efficacy and optimal use of a portable electrical muscle stimulator (Veinoplus) to improve symptoms of post-thrombotic syndrome. Poster presented at the Annual scientific Symposium 2010 of the Hemophilia and Thrombosis Research Society (HTRS). Abstract (page 30) published by HTRS
  9. Dr F. Zuccarelli, J. Lemagrex, M. Pujo. Sur un cas de guérison d’une ulcération chronique de 50 ans d’âge, par utilisation de Veinoplus. Angéiologie. 2006 Vol. 58, n°4