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Percutaneous lead

a percutaneous lead and nerve fiber technology, applied in the field of percutaneous lead, can solve the problems of difficulty in the useability of high-frequency electrical stimulation, uncomfortable sensation, uncomfortable motor contraction, etc., and achieve the effect of facilitating complete, or near complete, blockage of nerve conduction

Pending Publication Date: 2019-09-19
AVENT INVESTMENT LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a system and method for using electrical stimulation to block nerve conduction and treat pain. The method involves placing electrodes in parallel to a peripheral nerve over an overlapping nerve region of greater than 3 millimeters without direct contact. The block of nerve conduction is complete and consistent, and it ensures that the patient does not feel any pain or discomfort. The method can be performed using conventional percutaneous leads and improved designs for better block efficacy, reliability, and longer treatment periods. The electrical stimulation intensity is delivered for a time period ranging from about 1 to 6 weeks, and a carry-over blocking effect may be observed, wherein the blocking of painful sensations hosted by the target nerve can extend for a time period that is up to about 1000% of the time period during which the desired stimulation intensity is delivered.

Problems solved by technology

Destructive methods, such as radiofrequency ablation, are treatments of last resort, and are typically not used for treating acute (i.e., post-surgical) pain.
Such high-frequency and conventional electrical stimulation treatment do not fully block nerve conduction as a means to treat pain.
Further, the usability of high-frequency electrical stimulation is challenged by “onset activity” and the “co-excitation” of nearby excitable tissues.
Onset response elicited in a peripheral nerve may lead to uncomfortable sensations (i.e., pain), or uncomfortable motor contractions.
However, the investigated techniques have been either impractical for clinical implementation or have not eliminated the onset response to high frequency electrical stimulation.
As a result, the targeted nerve which is in close proximity to electrode may be blocked, but the more distant excitable tissues (i.e., muscles, blood vessels) may be activated, potentially causing motor contraction and / or vasospasm.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example # 1

EXAMPLE #1

[0403]FIG. 27 demonstrates the sensory response in an able-bodied subject to a percutaneously delivered high-frequency electrical stimulation. The sensations are consistent with the onset response elicited by high-frequency stimulation of a sensory nerve. An S8 (Abbott) electrode was used to stimulate the saphenous nerve at a site 5-to-10 cm proximal to the ankle. The stimulation consisted of a constant-current, 10 kHz sinusoidal waveform, and it was delivered for a period of 20 seconds at various amplitudes, including 4 mA (A—see reference number 2704), 6 mA (B—see reference number 2706), 10 mA (C—see reference number 2708), and 15 mA (D—see reference number 2710). The subject verbally described the quality of the evoked sensations (e.g. light-touch or pain) and indicated the intensity of the sensation on an 11-point scale: levels 1 and 2 defined tactile sensation, level 3 defined the pain threshold, and levels 4-10 indicated a mild-to-severe painful sensation.

[0404]FIG. ...

example # 2

EXAMPLE #2

[0413]To determine if the onset response experienced when a 15-mA stimulation was delivered to the saphenous nerve could be minimized or eliminated, various ramping conditions were tested where the amplitude was allowed to gradually increase to the 15-mA level rather than being immediately set to 15-mA, after which time the 15-mA stimulation was delivered for a time period of 20 seconds. Specifically, the data from the 15-mA stimulation from Example #1 where no ramping was utilized was compared to two different ramping rates—(1) 1 milliamp / second and (2) 0.5 milliamps / second.

[0414]The results are shown in FIGS. 28A-28C and Table 2 below.

TABLE 2PeakSensationResponsePeakOnset-Amplitude(0 to 8AreaOnsetLatencyOffsetAmp(mA)Scale)(mA * s)(seconds)(seconds)(seconds)(mA)157.5458.740.392.5210.87NA(no ramp)(±0.27)(±4.82)(±0.03)(±0.67)(±0.36)150.817.085.8916.5620.675.3(1 mA / s(±0.02)(±0.94)(±0.38)(±2.35)(±1.78)(±0.26)ramp)15N / AN / AN / AN / AN / AN / A(0.5 mA / sramp)

[0415]Table 2 shows an averag...

example # 3

EXAMPLE #3

[0420]The following results shows the ability to block acute pain sensations with high-frequency electrical stimulation delivered in a percutaneous fashion.

[0421]FIGS. 29A and 29B are diagrams of experimental results illustrating sensory responses to a sinusoidal waveform at various levels delivered percutaneously to the saphenous nerve, while pain inducing electrical stimulation was concurrently applied to the subject. Specifically, FIGS. 29A and 29B demonstrate the effect of high-frequency electrical stimulation in blocking acute pain sensations in 2 able-bodied subjects. In the experiment corresponding to FIG. 29A, a pain eliciting electrical stimulation (9 pulses train, 500 Hz, 1 millisecond pulse width, about 30 mA amplitude, inter-train interval of 4 seconds) was delivered to the subject's foot over-top of the saphenous nerve to elicit painful sensations to simulate / cause acute pain. Then, and as shown in FIG. 29A, a high-frequency (10 kHz) electrical stimulation was...

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Abstract

The exemplified systems and methods facilitate a nerve conduction block at a target nerve using electrical stimulation applied from one or more electrodes located on a percutaneous lead that are placed in parallel, or substantially in parallel, and without direct contact, to a long axis of the peripheral nerve over an overlapping nerve region of greater than about 3 millimeters. The exemplified system and method can be further configured to block nerve condition without eliciting onset activity and co-excitation of non-targeted structures. The exemplified method and system can be performed using conventional percutaneous leads, though an improved percutaneous lead design is disclosed herein. In an aspect, an introducer is disclosed that facilitates accurate and consistent insertion of the percutaneous lead to the specified or intended position relative to the target nerve. In another aspect, a treatment kit comprising the various system components to treat pain is disclosed.

Description

RELATED APPLICATION[0001]This application claims priority to, and the benefit of, U.S. Provisional Application No. 62 / 643,216, filed Mar. 15, 2018, titled “System and Method to Percutaneously Block Painful Sensations Elicited by a Peripheral Nerve Without Eliciting Non-Targeted Motor and Sensor Activity,” which is incorporated by referenced herein in its entirety.FIELD OF THE INVENTION[0002]The disclosure relates generally to a system and method to block nerve fiber activity, e.g., to treat pain, particularly, to block peripheral nerve activity through electrical stimulation of a lead, e.g., a percutaneous lead.BACKGROUND OF THE INVENTION[0003]Pain can be treated by destructive and non-destructive methods that interfere with the transmission of pain signals sent to the brain. Destructive methods, such as radiofrequency ablation, are treatments of last resort, and are typically not used for treating acute (i.e., post-surgical) pain. Non-destructive methods to treat pain include the u...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61N1/05A61N1/06
CPCA61N1/0551A61N1/0502A61N1/36071A61N1/06A61N1/36021A61N1/36034A61N1/20A61N1/0553A61N1/0556A61N1/36057A61N1/36128A61B17/3468A61N1/36017A61N1/05
Inventor CALDWELL, RYANSCHEPIS, ERIC A.BOYLE, ANTHONYHANSON, TODDOSTER, DANIELSCHORR, PHILLIP A.SASTRY, SHYAMY R.
Owner AVENT INVESTMENT LLC
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