Surgery – Miscellaneous – Methods
Reexamination Certificate
2000-01-21
2002-03-26
McDermott, Corrine (Department: 3738)
Surgery
Miscellaneous
Methods
C623S902000, C607S118000, C600S201000, C600S377000, C600S207000
Reexamination Certificate
active
06360750
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to surgical methods of implanting leads for electrical stimulation and drug delivery therapies to the spinal cord and peripheral nervous system. More specifically, the invention relates to such surgical implant methods directed to leads for sacral nerve stimulation.
Pain
Briefly, the brain, not the point of an injury, registers any sensation of pain. When pain is felt, it is a reaction to signals that are transmitted throughout the body. These signals are sent from the pain source, through the nerves in the spinal cord, to the brain, where they are perceived as pain. Pain can be controlled by preventing the pain signals from reaching the brain. If the pain signals never reach the brain, pain is not felt.
The origin of some pain is neuropathic, while other pain is nociceptive. This is important to know because different treatments will work better for each type of pain. Neuropathic pain is pain that is caused by damage to nerve tissue. It is often felt as a burning or stabbing pain. One example of a neuropathic pain is a “pinched nerve.” Nociceptive pain means pain caused by an injury or disease outside the nervous system. It is often an on-going dull ache or pressure, rather than the sharper, trauma-like pain more characteristic of neuropathic pain. Examples of chronic nociceptive pain include pain from cancer or arthritis. Some people experience mixed pain, which is a combination of neuropathic and nociceptive pain.
Acute pain (such as spraining an ankle) acts as a warning to signal harm or possible damage to tissues in the body. It prevents additional damage by alerting you to react and remove the source of pain. However, when pain lasts a long time (over six months) and is not relieved by standard medical management, it is called “chronic” pain. In chronic pain, the pain signal no longer helps, but hinders the body. Chronic pain may result from a previous injury long since healed. Or it may have an ongoing cause, such as arthritis, cancer, nerve damage, or chronic infection. With chronic pain, normal lifestyles can be restricted or even impossible. Many people suffer with chronic pain, unaware that there are a variety of treatment options that can help them live more normal lives. If a person has chronic pain, that person should seek out information about these various treatment options. Because there are many new ways to treat pain, it is important that patients speak openly with their doctors or with doctors who specializes in treating chronic pain—pain specialists.
Pain is recognized as a major public health problem. In the United States, it is estimated that chronic pain affects 15% to 33% of the U.S. population, or as many as 70 million people. In fact, chronic pain disables more people than cancer or heart disease and costs the American people more than both combined. Pain costs an estimated $70 billion a year in medical costs, lost working days, and workers' compensation.
Many people with chronic pain do not seek pain relief, or even tell their doctors about their pain. Most often, the reasons for keeping pain a secret are based on fears or myths: (1) Fear of being labeled as a “bad patient.” A patient will not find relief if he or she does not speak with a doctor about pain. (2) Fear that increased pain may mean that the disease has worsened. Regardless of the state of disease, the right treatment for pain may improve daily life for the patient and the involved family. (3) Fear of addiction to drugs. Research has shown that the chance of people with chronic pain becoming addicted to pain-relieving drugs is extremely small. When taken properly for pain, drugs can relieve pain without addiction. Needing to take medication to control pain is not addiction. (4) Lack of awareness about pain therapy options. Honesty about how pain feels and how it affects life is required. Inquires are appropriate about the pain therapy options that are available. Often, if one therapy is not effectively controlling pain, another therapy can. (5) Fear of being perceived as “weak.” Some believe that living stoically with pain is a sign of strength, while seeking help often is considered negative or weak. This perception prevents them seeking the best treatment with available therapies. Fears and misconceptions should not keep patients from talking to doctors and other members of health care teams about getting adequate pain relief. Help and relief are possible, but only if symptoms are discussed with a doctor.
Advanced Pain Therapies
APT Neurostimulation (“Advanced Pain Therapy Neurostimulation”) is available from Medtronic, Inc., and commonly used for neuropathic pain. APT Intrathecal treatment, also available from Medtronic, Inc., is commonly used for nociceptive pain.
APT Neurostimulation (including both spinal cord stimulation and peripheral nerve stimulation) uses a small neurostimulation system that is surgically placed under the skin to send mild electrical impulses to the spinal cord. The electrical impulses are delivered through a lead (a special medical wire) that is also surgically placed. These electrical impulses block the signal of pain from reaching the brain. Peripheral nerve stimulation works in the same way, but the lead is placed on the specific nerve that is causing pain rather than the spinal cord. Because APT Neurostimulation works in the area where pain signals travel (the spinal cord or specific nerve), electrical impulses (which are felt as tingling) can be directed to cover the specific sites where pain is felt. APT Neurostimulation can give effective pain relief and decreases the need for pain medications. In addition, APT Neurostimulation is reversible and non-destructive. A doctor can do a screening test, which helps predict whether the therapy will relieve pain. Typically patients who have success with APT Neurostimulation experience a 50%-70% reduction in their pain and improved ability to go about daily activities.
There are two types of Medtronic Neurostimulation systems: (1) A totally implantable system: The Itrel® 3 system includes an implantable pulse generator (IPG), a patient programmer, and an extension and lead(s); and (2) A radio frequency system: The Mattrix® system comprises an external transmitter, an antenna, an implanted receiver, and lead(s). The main difference between the two systems is the battery location. The totally implantable system uses a battery that is placed beneath the skin—no part is outside the body. The patient and the doctor can control the totally implantable system with an external programmer. The radio frequency system uses a battery that is worn outside the body. This system requires the patient to wear an antenna on the skin over the site of the receiver. Approximately 90% of people currently receiving APT Neurostimulation use totally implantable systems.
In the totally implantable system, the implantable pulse generator (IPG) sends precise, electrical pulses to your spinal cord to control pain. The IPG contains a special battery and electronics to create these pulses. The system, which is about 2.25 inches (6 cm) across, less than one-half inch (1 cm) thick and about 2 inches (5.2 cm) high, is most often placed under the skin of the abdomen. The lead is a small medical wire with special insulation. It is placed next to the spinal cord through a needle and contains a set of electrodes (small electrical contacts) through which electrical stimulation is delivered to the spinal cord. This stimulation is often described as tingling. The extension is a small cable about 20 inches (50 cm) long that is placed under the skin and connects the lead to the IPG.
The doctor or a nurse can use an additional programmer to adjust the APT Neurostimulation system so that it most effectively treats pain. This programmer includes a computer, programming head, and a printer. The programming head is placed over the IPG to program the settings using radio waves. This procedure is done through the skin and is painless. There is also a patient programmer, a hand-held device that allows the
Gerber Martin Theodore
Sherman Michael C.
Banner & Witcoff , Ltd.
Koh Choon P.
McDermott Corrine
Medtronic Inc.
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