The LION procedure ®
Discovery of the LION procedure
LION: Laparoscopic Implantation Of Neuroprothesis
There are an awful lot of people in the world who are suffering from intractable chronic pelvic, genital or low lumbar pain radiating into the legs, in who no spinal or orthopedics etiologies are found. When no etiology is found, such patients are irrevocably treated on long term by pain killers, antipsychotic or anticonvulsants. That pathologies of the pelvic nerves might also explain such pain conditions, is often omitted. The most probable reason for the omission of the pelvic nerves in the field of the neurosurgery but also in the field of the pelvic surgery may be associated with the anatomy of the pelvic nervous system which is difficult to understand, and the limitations of open surgery which is inadequate to dissect pelvic nerves which are hidden deep in the retroperitoneal space behind the pelvic vessels. All these limitations were overcome with the introduction of laparoscopy into this field. Advances in video endoscopy and microsurgical instruments enable good access to all areas in the retroperitoneal pelvic space (3), providing the necessary visibility with magnification of the structures and possibility to work with appropriate instruments for adequate neurofunctional procedures such as nerve decompression and neurolysis. Laparoscopy is also the only technique that enables selective placement of electrodes to all pelvic nerves and plexuses. This technique of Laparoscopic Implantation Of Neuroprothesis, also called “LION procedure”, enables the selective placement of electrodes in direct contact with the nerves under direct visualization. The LION procedure to the pelvic somatic nerves allows for control of neurogenic pain syndromes and pelvic organ dysfunction and may also represent a potent alternative to current methods for neuromodulation in the treatment of visceral pain mediated by the autonomous nerve system
Main current indications for the LION procedure
Pelvic Neuropathic Pain Syndromes
Chronic pelvic pain is a commonly encountered problem for GP´s and gynecologists in daily practice. It is estimated that 12 % of the general population around the world suffer from chronic pelvic pain. The LION procedure has been succefully employed in non-gynecologic applications such as treatment of:
- Stump residual pain and phantom pain after amputation of the lower limb(s).
- Polyneuropathy of the lower limbs (prevalence in general population 1 % and rises to up to 7 % in the elderly
- Inguinal pain secondary to groin surgery for hernia (40 % of the patients)
- „Chronic Pelvic Pain syndrome“ which condition affect about 6.9 Million patients in Europe
Spinal Cord Injury – The Possover’s Procedure
Researchers have estimated that, as of 2019, 17,730 new SCI cases occur each year and between 249,000 and 363,000 people are currently living with SCI in the United States. In a recent study, Prof. Possover reported on 30 consecutive cases of people with chronic Spinal Cord Injury underwent a LION procedure for the recovery of standing and walking motion: 70 % of the patient recovery a voluntary walking for more than 10 meters. The best of these patients can walk 2.6 km using crutches.
See publication: “Possover M. 10-years experience with continuous low-frequency pelvic somatic nerves stimulation for recovery of voluntary walking in chronic spinal cord injured peoples: a prospective case series of 28 consecutive patients“
Children with Spina Bifida („open back“)
Spina bifida is a birth defect that occurs when a baby’s backbone (spine) does not develop normally. Each year, about 1,645 babies are born in the USA with spina bifida. A 2013 study using data from the NIS showed that hospitalizations related to spina bifida cost more than $1.6 billion in 2013 for people of all ages.
In two large cohort studies of U.S. men 40 to 83 years of age, the overall incidence was 4.5 to 6.8 per 1,000 men per year. In the USA, investigators estimated the annual direct costs for urinary incontinence in 2007 for adults over 25 years old, not necessarily just those with neurogenic bladder, was $65.9 billion.
From the LION Procedure to the Mars Mission
Neuromodulation affect every area of the body and treat nearly every disease or symptom from headaches to tremors to spinal cord damage to pelvic organs dysfunctions. The main objective of Prof. Possover is to revolutionize standard treatment options for several further special medical conditions with high reputational aspects by using the same pacemaker while the implantation is obtained by laparoscopic approach – the LION procedure (Laparaoscopic Implantation Of Neuroprothesis):
Treatment & prevention of Osteoporosis and Arteriosclerosis
Because sympathetic trunks travel downward outside the spinal cord and first anastomose to the sacral plexus which nerves build the sciatic nerve, the LION procedure permits neuromodulation of the sympathetic nervous system of the lower extremities and of the bottom. This continuous stimulation of the pelvic nerves induces a peripheral cutaneous vasodilatation resulting in a powerful decubitus and arteritis prophylaxis. Muscle training and pelvic sympathetic nerves stimulation offer a treatment and prophylaxis of osteoporosis. Osteoporosis is a global health problem whose importance is going to increase with the aging of the population: Worldwide, osteoporosis causes more than 8.9 million fractures annually, resulting in an osteoporotic fracture every 3 seconds. Osteoporosis is estimated to affect 200 million women worldwide – approximately one-tenth of women aged 60, one-fifth of women age 70, two-fifths of women aged 80 and two-thirds of women aged 90 (Cost in the US: $13.8 billion/year). Osteoporosis affects an estimated 75 million people in Europe, USA and Japan (International Osteoporosis Foundation). While less common in men than women, approximately 1.5 million men over age 65 years in the United States have osteoporosis, and another 3.5 million men are at risk.
Prevention & treatment of decubitus (Bedsores)
Pressure ulcers (PUs) are one of the most common and challenging public health problems affecting patients with spinal cord injury (SCI). Approximately 30–40% of SCI patients develop pressure ulcers during the acute and rehabilitation phases, and over 85% of patients will develop at least one pressure sore in their lifetime 1. Poor management after the appearance of pressure ulcers as well as waiting too long can limit the success of conservative therapy, leading to the necessity for plastic surgery. Pus become often super-infected and can lead to sepsis, whose management is a major concern in SCI patients already highly exposed to antimicrobial treatment and multidrug-resistant organisms’ colonization. PUs occurrence is potentially associated with several hospitalizations, even in intensive care units, and a longer length of stay. In addition to secondary infections that have been the traditional focus of prevention efforts, secondary amputations, fractures, and depressive symptoms are associated with a higher risk of mortality as well. Consequently, PUs are a major medico-economic burden for providers, with a US-national economic burden of about $26.8 billion/year. PUs among SCI individuals remains an unrelenting problem and a major issue in nursing care across the globe. The high rate of complications and the associated costs suggest the importance of evaluating the efficacy of prophylaxis and treatment options.
It is well known that trophism and blood supply are improved by electrostimulation, which is used in the treatment of decubital ulcers. In vivo studies involving animal models have even revealed that electric stimulation of wound healing processes results in more collagen deposition, enhanced angiogenesis, greater wound tensile strength, and a faster wound contraction rate. In addition, electric stimulation has been shown to improve tissue perfusion and reduce edema formation that results in a significant increase in transcutaneous oxygen pressures.
The US-patented LION Procedure (Neurogyn AG) enables such a pelvic nerves stimulation which in combination with electrically assisted standing and walking exercises in patients with disability for standing/working induce an increase in muscle mass at the thigh (femoral nerve stimulation) as well as in the gluteal and calf muscles (sciatic nerve stimulation). Because the gluteal region is one of the most common localizations of pressure-caused ulcers, the stimulation’s induced building of the muscles in the gluteal regions might have a good effect not only for treatment but even in the prophylactic treatment of paraplegic patients and further patients exposed to PU’s. The LION procedure presents unique advantages compared to all other techniques of stimulation (Fig.1):
- The combination of three therapeutic/prophylactic effects together—vasodilation, muscle building (gluteal pads), and gluteal pressure relief—during electrically assisted voluntary standing/walking training “on demand.”
- Recovery of some independence with voluntary electrically assisted gait (crutches/walker assisted) in 70% of SCI individuals.
- Because the neuroprosthesis is implanted within the body and the generator is rechargeable, continuous PU prophylaxis can be provided passively, nonstop, 24/7, and for life.
- Passive continuous low-frequency pelvic stimulation has been shown to improve bone density, a sine quantum condition for resuming walking in SCI individuals without risk of bone fractures in the lower limbs.
Today it is imperative to extend LION’s indications to the treatment and prevention of bedsores in arteritis patients and long-term bedridden patients. The costs of the LION procedure and the neuroprosthesis are not negligible, but the medical costs of every ulcer are, for the most part, much higher. Proactive care to prevent the development of pressure ulcers proves both cost- and time-effective when compared to reactive care for treating already-developed pressure sores.
„In-body-ENS“ as anti-aging control and improve QoL
Sarcopenia refers to the gradual decline in muscle mass and quality noted with advancing age. Functional losses in strength and balance capacity as well as increasing gait uncertainties are the result. The risk of acute problems owing to falls and injuries and chronic recurrent and degenerative illnesses rises. Prevention of the aging process mainly focuses on the control and treatment of such muscle atrophy. A crucial factor in this is sustaining a high individual strength capacity. The „in-body-ENS“ avoid all disadvantages of external techniques for muscles stimulation (EMS), and enable both continuous passive and a voluntary active muscle trainings. Passive continuous “in-body-ENS” for muscle training is especially appropriate in elderly people who are not capable of fitness training and sport activities because of pain, motoric limitations, or subcortical pathologies (dementia, comatose patients, Parkinson’s, etc. Thus, it should be appreciated that the capability of the implantation of micro stimulators within the body to nerves for muscle stimulation opens the door to a whole new area of humanity, the „e-control-body“ in which implanted electronics may help the human body to better performance and a longer life as a result . By reversing the process of sarcopenia, the “in-body-ENS” can be considered as an anti-aging treatment.
„In-body-FES“ on Mars Mission to avoid osteoporosis and muscles loss due to microgravity
Space is a dangerous, unfriendly place that required daily exercise to keep muscles and bones from deteriorating. On Mars, if the astronauts don’t exercise and eat properly, they will lose muscle strength, endurance, and experience cardiovascular deconditioning since it does not take effort to float through space. Exercise is an important part of the daily routine for astronauts aboard the station to prevent bone (osteoporosis) and muscle loss. On average, astronauts exercise two to six hours per day. Maintaining strong muscles is a big enough challenge on earth, but it is much harder to do in space where there is no gravity. Calf muscles biopsies before flight and after a six months mission on the ISS show that even when crew members did aerobic exercise five hours a week and resistance exercise three to six days per week, muscle volume and peak power both still decrease significantly. The second main issu in space is the osteoporosis which conditions will decide whether the Mars mission will be successful or not. Peggy Whitson, a NASA astronaut and biochemist, said even those who went on short 18 day space shuttle flights had been found to be affected by osteoporosis. During space flight, crew members lose bone density while the calcium that’s released ends up in the urine. The higher calcium levels are contributing to the increased calcium-stone forming potential. Such Ca-stones can move from the kidney towards the bladder causing a number of problems including excruciating pain. If the stone completely blocks the tube draining the kidney, the kidney could stop functioning. Kidney stones could prove to be the „final frontier“ astronauts embarking on long distance missions have to tackle. Scientists say they must find ways of preventing space travellers developing the stones on long trips. Affected astronauts could become incapacitated, and missions may have to be aborted. Development stones in the kidney would build a catastrophe on Mars.
In addressing the physical disadvantages the astronaut faces when weightless in space by the introduction of the “in-body-FES, which allows muscle mass to be maintained even whilst the astronaut is sleeping, provides an extremely effective and time-saving strength-training program. Continuous passive “in-body-ENS” enables continuous muscle training without the need of active participation of the person who can at same time absolve some other activities. Such a passive “e-training” may reduce considerably the intensity of body training required in the current conditions on the ISS, allowing more time for the astronauts to rest and work. This training can also be continued during the night, when the astronaut is in a deep sleep. Active “in-body-FES” can be combined with the usual muscle training program is space, if required. Locomotor training and stimulation of the pelvic nerves with both isometric and eccentric gluteal muscles contractions induces an increase of gluteal muscle mass. The advantages of the LION-Procedure (Laparoscopic Implantation of Neuroprothesis) are profound when it comes to counteracting the effects of prolonged micro-gravity on the human body.
Fitness training and Body Building through “In-body-ENS“
One of LION’s most ambitious indications, even though it is not directly a purely medical indication, but rather „medical prevention“ or QoL, is the introduction of „in-body-ENS“ into the world of fitness industrie and body building – with various training forms:
- Passive continuous low-energy stimulation’s training which allows long-term muscle training in the background without any visible muscle contractions or movement and without the patient feeling anything. This is a passive extremely effective form of Fitness Training for all peoples who not have the time and opportunity to go to Gym. In-body-ENS train their body wherever and whenever they want, without affecting their professional and private life: the trainer is inside the body!
- Active training with induction of muscle contractions (body building). This active form of training can also be divided into two distinct forms: the patient may actively support the training of the specific muscles he/she wishes to train through the electrical stimulation or the opposite muscles are activated and a form of resistance training is generated.