Systems and methods to place one or more leads in tissue for providing functional and/or therapeutic stimulation
a technology of tissue and electrode leads, applied in the field of systems and methods for placing one or more electrode leads in tissue, can solve the problems of reducing the effectiveness of neurostimulation, s standards, and affecting the quality of life of patients, and achieve the effect of shortening the distance between the lead and its connection, and improving the quality of li
Inactive Publication Date: 2015-04-16
SPR THERAPEUTICS
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Benefits of technology
The patent text describes a technique called nerves of passage stimulation, which can help treat chronic or acute pain that occurs when muscles cannot contract or when nerves are damaged. The technique involves placing a lead in a nearby muscle to stimulate a specific nerve that previously innervated the amputated or damaged muscles. This technique can be effective even when the area where the pain is felt does not physically exist. The patent text also describes various uses of the technique, such as treating amputation pain, nerve damage from degenerative diseases or trauma, and cosmetic reasons. The most significant technical effect of the patent text is providing a reliable and effective treatment for pain that results from the absence or damage of nerves or muscles.
Problems solved by technology
While existing systems and methods can provide remarkable benefits to individuals requiring neurostimulation, many quality of life issues still remain.
For example, existing systems include complicated procedures to place electrodes and pulse generators, and issues remain with the migration of electrodes which eventually reduce the effectiveness of the neurostimulation.
Furthermore, these systems are, by today's standards, relatively large and awkward to manipulate, transport, and adhere to the patient.
The pain can be extremely bothersome to amputees, significantly decrease their quality of life, correlate with increased risk of depression, and negatively affect their inter-personal relationships and their ability to return to work (Kashani et al 1983; Blazer et al.
The present methods of treatment, which are primarily medications, are unsatisfactory in reducing amputation-related pain, have unwanted side effects, offer a low success rate, and often lead to addiction.
Stump and phantom pain can be severe and debilitating to a large proportion of persons with amputations, who will unfortunately often progress through a battery of management techniques and procedures without finding relief from their pain (Bonica 1953; Sherman et al.
Severe post-amputation pain often leads to further disability, reduced quality of life, and frequently interferes with the simple activities of daily life more than the amputation itself (Millstein et al.
2003), and no available therapy is sufficient to manage it (Sherman et al.
Many techniques have been developed to treat post-amputation pain, but all of them are ultimately insufficient (Jahangiri et al.
However, they are not specific to stump or phantom pain and are rarely sufficient in managing moderate to severe chronic post-amputation pain (Sherman et al.
The use of narcotic analgesics, such as N-methyl-D-aspartate (NDMA) antagonists, has shown only minor success with inconsistent results.
Narcotics carry the risk of addiction and side effects, such as nausea, confusion, vomiting, hallucinations, drowsiness, dizziness, headache, agitation, and insomnia.
Other physical treatments, including acupuncture, massage, and percussion or heating / cooling of the stump, have few complications but also have limited data to support their use and have not been well accepted clinically (Russell and Spalding 1950; Gillis 1964; Monga and Jaksic 1981; Loeser 2001a).
Psychological strategies, such as biofeedback and psychotherapy, may be used as an adjunct to other therapies but are seldom sufficient, and there are few studies demonstrating efficacy and these approaches are not specific to stump or phantom pain (Dougherty 1980; Sherman 1980).
Furthermore, neuroablative procedures carry the risk of producing deafferentation pain, and any surgical procedure has a greater chance of failure than success (Loser 2001a; Rosenquist and Haider 2008).
Thus, present medical treatments of stump and phantom pain are inadequate, and most sufferers resort to living with pain that is poorly controlled with medications.
Electrical stimulation systems hold promise for relief of post-amputation pain, but widespread use of available systems is limited.
TENS has a low rate of serious complications, but it also has a relatively low (i.e., less than 25%) long-term rate of success.
Application of transcutaneous electrical nerve stimulation (TENS) has been used to treat stump and phantom pain successfully, but it has low long-term patient compliance, because it may cause additional discomfort by generating cutaneous pain signals due to the electrical stimulation being applied through the skin, and the overall system is bulky, cumbersome, and not suited for long-term use (Nashold and Goldner 1975; Sherman 1980; Finsen et al.
Similar to TENS, when SCS evokes paresthesias that cover the region of pain, it confirms that the location of the electrode and the stimulus intensity should be sufficient to provide pain relief and pain relief can be excellent initially, but maintaining sufficient paresthesia coverage is often a problem as the lead migrates along the spinal canal (Krainick et al.
Spinal cord stimulation is limited by the invasive procedure and the decrease in efficacy as the lead migrates.
When it can produce paresthesias in the region of pain, spinal cord stimulation is typically successful initially in reducing stump and phantom pain, but over time the paresthesia coverage and pain reduction is often lost as the lead migrates away from its target (North et al.
Brain stimulation systems are limited by the lack of patient selection criteria and the lack of studies demonstrating long-term efficacy.
Peripheral nerve stimulation may be effective in reducing post-amputation pain, but it previously required specialized surgeons to place cuff- or paddle-style leads around the nerves in a time consuming procedure.
As previously described, electrical stimulation has been used and shown to be effective in treating amputee pain, but present methods of implementation have practical limitations that prevent widespread use.
External systems are too cumbersome, and implanted spinal cord stimulation systems often have problems of lead migration along the spinal canal, resulting in either the need for frequent reprogramming or clinical failure.
While existing systems and methods can provide remarkable benefits to individuals requiring therapeutic relief, many issues and the need for improvements still remain.
Many techniques have been developed to treat pain, but all of them are ultimately insufficient.
However, they are rarely sufficient in managing moderate to severe chronic pain (Sherman et al.
The use of narcotic analgesics, such as N-methyl-D-aspartate (NDMA) antagonists, has shown only minor success with inconsistent results.
Narcotics carry the risk of addiction and side effects, such as nausea, confusion, vomiting, hallucinations, drowsiness, dizziness, headache, agitation, and insomnia.
Psychological strategies, such as biofeedback and psychotherapy, may be used as an adjunct to other therapies but are seldom sufficient, and there are few studies demonstrating efficacy.
Electrical stimulation systems have been used for the relief of pain, but widespread use of available systems is limited.
TENS has a low rate of serious complications, but it also has a relatively low (i.e., less than 25%) long-term rate of success.
Application of TENS has been used to treat pain successfully, but it has low long-term patient compliance, because it may cause additional discomfort by generating cutaneous pain signals due to the electrical stimulation being applied through the skin, and the overall system is bulky, cumbersome, and not suited for long-term use (Nashold and Goldner 1975; Sherman 1980; Finsen et al.
In addition, several clinical and technical issues associated with surface electrical stimulation have prevented it from becoming a widely accepted treatment method.
First, stimulation of cutaneous pain receptors cannot be avoided resulting in stimulation-induced pain that limits patient tolerance and compliance.
Second, electrical stimulation is delivered at a relatively high frequency to prevent stimulation-induced pain, which leads to early onset of muscle fatigue in turn preventing patients from properly using their arm.
Third, it is difficult to stimulate deep nerves and / or muscles with surface electrodes without stimulating overlying, more superficial nerves and / or muscles resulting in unwanted stimulation.
The required daily maintenance and adjustment of a surface electrical stimulation system is a major burden on both patient and caregiver.
Similar to TENS, when SCS evokes paresthesias that cover the region of pain, it confirms that the location of the electrode and the stimulus intensity should be sufficient to provide pain relief and pain relief can be excellent initially, but maintaining sufficient paresthesia coverage is often a problem as the lead migrates along the spinal canal (Krainick et al.
Spinal cord stimulation is limited by the invasive procedure and the decrease in efficacy as the lead migrates.
When it can produce paresthesias in the region of pain, spinal cord stimulation is typically successful initially in reducing pain, but over time the paresthesia coverage and pain reduction is often lost as the lead migrates away from its target (North et al.
Peripheral nerve stimulation may be effective in reducing pain, but it previously required specialized surgeons to place cuff- or paddle-style leads around the nerves in a time consuming procedure.
These methods of implementation have practical limitations that prevent widespread use.
External systems are too cumbersome, and implanted spinal cord stimulation systems often have problems of lead migration along the spinal canal, resulting in either the need for frequent reprogramming or clinical failure.
Method used
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[0084]Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the desired embodiment has been described, the details may be changed without departing from the invention.
[0085]Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with, each other in any combination.
[0086]The various aspects of the invention will be described in connection with the placement of one or more leads 12 having one or more electrodes 14, in ti...
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Systems and methods make possible the placement of one or more electrode leads in a tissue region for providing functional and / or therapeutic stimulation to tissue. The systems and methods are adapted to provide the relief of pain.
Description
RELATED APPLICATIONS[0001]This application is a continuation in part of U.S. patent application Ser. No. 12 / 653,029, filed Dec. 7, 2009, and entitled “Systems and Methods to Place One or More Leads in Tissue for Providing Functional and / or Therapeutic Stimulation,” which claims the benefit of U.S. Provisional Patent Application Ser. No. 61 / 201,030, filed 5 Dec. 2008, and entitled “Systems and Methods to Place One or More Leads in Tissue for Providing Functional and / or Therapeutic Stimulation,” which are both incorporated herein by reference. This application is also a continuation in part of U.S. patent application Ser. No. 12 / 653,023, filed Dec. 7, 2009, and entitled “Systems and Methods to Place One or More Leads in Tissue for Providing Functional and / or Therapeutic Stimulation,” which claims the benefit of U.S. Provisional Patent Application Ser. No. 61 / 201,030, filed 5 Dec. 2008, and entitled “Systems and Methods to Place One or More Leads in Tissue for Providing Functional and / ...
Claims
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Login to View More IPC IPC(8): A61N1/36A61N1/05
CPCA61N1/36071A61N1/0558A61N1/0551A61N1/36017A61N1/36021
InventorBOGGS, II, JOSEPH W.
OwnerSPR THERAPEUTICS