A wearable medical device for treating peripheral pain

Abstract

The present invention discloses a wearable medical device for treating peripheral pain, including a stimulation strategy unit, an electrode array unit, a pulse excitation unit, an impedance measurement unit, an adaptive threshold anchoring unit, an interference intensity detection unit, and a solution unit. Through lightweight wearable technology and non-invasive deep neural regulation technology, specific intervention and regulation are performed on peripheral nerves to achieve effective relief of peripheral pain. The present invention combines non-invasive wearable technology, spatial interference electrical technology, spatial electrode arrays, and neural decoding stimulation strategies to achieve non-invasive treatment of peripheral pain.

Description

Technical Field

[0001] The present invention belongs to the field of nerve stimulation, and in particular relates to a wearable medical device for treating peripheral pain. Background Art

[0002] The International Society for the Study of Pain defines neuropathic pain as "pain caused by damage or disease of the somatic sensory system" and divides it into peripheral neuropathic pain and central neuropathic pain. Peripheral neuropathic pain is more common clinically and seriously affects the quality of life of patients.

[0003] The pain may manifest as tingling, tingling, lightning, burning, tearing, piercing, pulling, shooting, deep or superficial, often with more than two types of pain. It may be aggravated by activity, fatigue, mental stress, environmental or climatic changes.

[0004] Conventional drug treatments include anticonvulsants and antidepressants, which mainly selectively inhibit the reuptake of serotonin and norepinephrine, increase their concentrations in the synaptic cleft, and act on the descending pathway of the pain conduction pathway; or opioid analgesics.

[0005] Non-drug treatments mainly include neurotomy, which involves locating the puncture around the nerve that needs treatment under image guidance, and blocking the conduction of pain through physical thermal coagulation or drug neurotomy.

[0006] Neuromodulation is an innovative minimally invasive and non-invasive analgesia method in recent years. It does not damage nerves and has the advantages of being programmable and reversible. The analgesic mechanism of peripheral neuropathy is related to the activation of the gate control mechanism. Stimulating peripheral nerve fibers inhibits the activity of C fibers, thereby reducing the response of the dorsal horn neurons of the spinal cord to noxious stimuli. Summary of the invention

[0007] In order to solve the above problems, the technical solution of the present invention is as follows: A wearable medical device for treating peripheral pain, comprising a stimulation strategy unit and an electrode array unit, a pulse excitation unit, an impedance measurement unit, an adaptive threshold anchoring unit, an interference intensity detection unit and a solution unit, all of which are connected to the stimulation strategy unit, wherein:

[0008] The stimulation strategy unit determines and decides which stimulation parameters to use;

[0009] The electrode array unit is an interactive channel composed of multiple electrodes;

[0010] The pulse excitation unit generates a specific frequency carrier and a specific amplitude modulated electric pulse or electric field or magnetic field pulse;

[0011] The impedance measurement unit is also connected to the electrode array unit to detect and identify the electrical impedance corresponding to the excitation frequency between the electrode array unit and the peripheral skin tissue, and calculates the impedance distribution trend of the area to be stimulated and the surrounding area through the impedance measurement results between the electrodes, and provides information input for the stimulation strategy unit based on the discontinuity of the impedance distribution;

[0012] The adaptive threshold anchoring unit marks the impedance characteristics of different areas based on impedance measurement and transmits them to the stimulation strategy unit. The stimulation strategy unit selects the corresponding electrodes and pulse excitation parameters to act on the area, and adaptively marks the impedance characteristics and threshold characteristics of different sites according to the discontinuity of impedance distribution, and provides different stimulation doses for each area. The whole process changes dynamically to maximize the adaptation to the outcome changes of body conditions;

[0013] The interference intensity detection unit is also connected to the pulse excitation unit to detect the validity of the stimulation signal output by the pulse excitation unit, and by monitoring the output result, the feedback is fed back to the stimulation strategy unit to optimize the pulse excitation parameters and select the electrode array;

[0014] The solving unit solves the complex physiological information acquired by the interference intensity detection unit.

[0015] Preferably, the stimulation strategy unit is a processor or a microprocessor that executes a specific algorithm.

[0016] Preferably, the stimulation strategy unit judges and determines the stimulation parameters to be used including stimulation amplitude, carrier characteristics, frequency modulation characteristics, amplitude modulation characteristics and stimulation electrode array combination.

[0017] Preferably, the electrodes in the electrode array unit are circular, square or polygonal.

[0018] Preferably, the electrode array units are arranged in a ring-shaped space with an interval of (0°-180°) when in use.

[0019] Preferably, the electrodes in the electrode array unit are in direct contact with the skin of the peripheral area or not in contact with the skin of the peripheral area, and energy and signals are transmitted through electric fields or magnetic fields.

[0020] Preferably, the pulses output by the pulse excitation unit are constant frequency outputs or non-constant frequency outputs.

[0021] Preferably, the pulse excitation unit adopts a random amplitude modulation method with controllable modulation depth.

[0022] Preferably, the relationship between the pulse excitation parameters in the adaptive threshold anchoring unit is:

[0023] The pulse equation is Pulse (t) =f 0(t,E,Z,I,F,Pw,Cy,N,K k )

[0024] Impedance Distribution Matrix

[0025] Normalized specific electrode impedance Z 0 =|Z*A|

[0026] The electrical stimulation constraint equation is f 1 ∝ρ 0 *[(E,N,I,Pw) / (Z 0 *S)]

[0027] The specific stimulation pulse is Pulse_out = K 0 *Pulse (t) *K 1 *f 1 *P fb

[0028] Where t is time, E is electrode, Z 0 is the specific electrode impedance, I is the current, F is the frequency, Pw is the pulse width, Cy is the pulse period, N is the number of electrode pairs, K k is the calibration coefficient, Ez1-EzN is the mutual impedance matrix element between N electrode pairs, To select any two electrodes from N electrodes, f 0 is the pulse parameter equation, f 1 is the electrical stimulation constraint equation, K 0 is the specific stimulus pulse calibration factor, K 1 is the feedback coefficient calibration value, A is the electrode gating position matrix with the same number of columns as the Z matrix, ρ 0 is the constraint equation coefficient, S is the electrode area, P fb is the feedback coefficient.

[0029] Preferably, the solving unit performs the solving including signal separation, feature extraction and signal cluster analysis, and extracts feature information including neural induced feedback and stimulation loss.

[0030] In order to improve the traumatic defects of minimally invasive and invasive therapies, the present invention innovatively proposes electric pulses or electric fields or magnetic field pulses with specific frequency carriers and specific amplitude modulation based on spatial electrode distribution, which can achieve non-invasive penetration of deep tissues, allowing the stimulation energy to reach deep parts, and modulate the depth of the random amplitude modulation technology to control the controllable random amplitude modulation technology, which can ensure the stimulation dose while reducing the tolerance fatigue of nerves and muscles and improve the treatment efficiency; this technology is non-invasive and wearable, which is very important for the treatment of peripheral neuralgia.

[0031] The beneficial effects of the present invention include at least:

[0032] 1. A wearable medical device for treating peripheral pain, which uses a specific frequency carrier distributed by spatial electrodes and electric pulses or electric or magnetic field pulses modulated by a specific amplitude, can achieve non-invasive penetration of deep tissues, so that the stimulation energy reaches deep parts and has focus.

[0033] 2. The innovative neural feedback monitoring and solution unit can realize quantitative neural stimulation regulation and achieve targeted and precise regulatory intervention.

[0034] 3. The random amplitude modulation technology with controllable modulation depth can ensure the stimulation dose while reducing the tolerance fatigue of nerves and muscles, thereby improving the treatment efficiency.

[0035] 4. The use of non-invasive and wearable technology improves the inherent defects of trauma and the inconvenience of use of traditional minimally invasive and invasive therapies, and can be used in both home and medical environments. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This is a structural block diagram of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention;

[0037] Figure 2 A sagittal schematic diagram of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention when worn on a limb;

[0038] Figure 3 for Figure 2 A schematic diagram of a planar spread-out electrode array unit of four electrodes of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention;

[0039] Figure 4 for Figure 2 A schematic diagram of a combination strategy of stimulation of electrodes of a 4-electrode electrode array unit of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention;

[0040] Figure 5 A schematic diagram of the application of a 6-electrode electrode array unit of a wearable medical device for treating peripheral pain in a specific embodiment of the present invention at a peripheral trunk;

[0041] Figure 6 for Figure 5 A schematic diagram of a planar spread-out electrode array unit of 6 electrodes of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention;

[0042] Figure 7 for Figure 5 A schematic diagram of a combination strategy for stimulating electrodes of a 6-electrode electrode array unit of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention;

[0043] Figure 8 A schematic diagram of the application of an 8-electrode electrode array unit of a wearable medical device for treating peripheral pain in a specific embodiment of the present invention at a peripheral trunk;

[0044] Fig. 9 for Figure 8 A schematic diagram of a planar spread-out electrode array unit of 8 electrodes of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention;

[0045] Fig.10 for Figure 8 A schematic diagram of a unit electrode stimulation combination strategy of an 8-electrode electrode array of a wearable medical device for treating peripheral pain according to a specific embodiment of the present invention. DETAILED DESCRIPTION

[0046] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0047] See also Figure 1 A wearable medical device for treating peripheral pain includes a stimulation strategy unit 10, an electrode array unit 20, a pulse excitation unit 30, an impedance measurement unit 40, an adaptive threshold anchoring unit 50, an interference intensity detection unit 60, and a solution unit 70, all of which are connected to the stimulation strategy unit 10. Through lightweight wearable technology, non-invasive deep neural regulation technology, spatial electrode array and neural decoding stimulation strategy technology, specific intervention and regulation of peripheral nerves are formed to effectively relieve peripheral pain.

[0048] The stimulation strategy unit 10 is used to judge and decide which stimulation parameters to use, including stimulation amplitude, carrier characteristics, frequency modulation characteristics, amplitude modulation characteristics and stimulation electrode array combination, etc. It is the central control part of the treatment system, usually a processor or microprocessor that executes a specific algorithm.

[0049] The electrode array unit 20 is an interactive channel composed of multiple electrodes 201. The electrodes are arranged in a spatial manner with an interval of 20°-180°. The electrodes can be circular, square or other special shapes. The electrodes can directly contact the skin of the peripheral area or not contact the peripheral skin, and energy and signals are transmitted through electric fields or magnetic fields. Figure 2-Figure 4 The diagram is a sagittal diagram of a device when four electrodes 201 (E1-P and E1-N form a pair of positive and negative stimulation electrodes, and E2-P and E2-N form another pair of positive and negative stimulation electrodes) are worn at the end of a limb, a diagram of electrodes spread out along a plane, and a diagram of electrode stimulation combination strategy. The electrodes 201 can be combined into different stimulation pairs to form different signal flow circuits. Figure 5-Figure 7The diagram is a sagittal diagram of the electrode 201 when it is worn on the end of a limb when there are 6 electrodes 201 (E1-P and E1-N form a pair of positive and negative stimulation electrodes, E2-P and E2-N form another pair of positive and negative stimulation electrodes, and E3-P and E3-N form another pair of positive and negative stimulation electrodes). The electrodes 201 can be combined into different stimulation pairs to form different signal flow circuits. Figure 8-Figure 10 The diagram is a sagittal diagram of the electrode 201 when it is worn at the end of a limb when there are 8 electrodes 201 (E1-P and E1-N form a pair of positive and negative stimulation electrodes, E2-P and E2-N form another pair of positive and negative stimulation electrodes, E3-P and E3-N form another pair of positive and negative stimulation electrodes, and E4-P and E4-N form another pair of positive and negative stimulation electrodes). The electrodes 201 can be combined into different stimulation pairs to form different signal flow circuits.

[0050] The pulse excitation unit 30 is used to generate electric pulses or electric field or magnetic field pulses after KHz-level specific frequency carrier and specific amplitude modulation, which can achieve non-invasive penetration of deep tissues, so that the stimulation energy reaches the deep part, and the pulses can be output at a constant frequency or a non-constant frequency; the random amplitude modulation technology with controllable modulation depth is adopted to ensure the stimulation dose while reducing the tolerance fatigue of nerves and muscles, thereby improving the treatment efficiency.

[0051] The impedance measurement unit 40 is used to detect and identify the electrical impedance between the electrode array unit 20 and the peripheral skin tissue, and to obtain the impedance distribution trend of the area to be stimulated. Based on the discontinuity of the impedance distribution, it provides information input for the stimulation strategy unit. The electrode array can be in the shape of a ring that surrounds a complete circle, or it can be in the shape of a planar electrode placed opposite and parallel in the peripheral area.

[0052] The adaptive threshold anchoring unit 50 marks the impedance characteristics of different areas based on the impedance measurement of the peripheral area, and the stimulation strategy unit 10 selects the corresponding electrode array and specific pulse excitation parameters to act on the area. According to the discontinuity of the impedance distribution, the system can adaptively mark the impedance characteristics and threshold characteristics of different sites, and provide different stimulation doses for each area. The whole process changes dynamically, maximally adapting to the changes in the outcome of the body's conditions, and improving the treatment efficiency and comfort of use.

[0053] The interference intensity detection unit 60 is used to detect the validity of the stimulation signal output by the pulse excitation unit 30. By monitoring the output result, negative feedback can be given to the input end of the system to facilitate the stimulation strategy unit to optimize the pulse excitation parameters and select the electrode array.

[0054] The solving unit 70 is used to solve the complex physiological information obtained by the interference intensity detection unit 60, including signal separation, feature extraction and signal clustering analysis, etc., to extract characteristic information such as neural induced feedback and stimulation loss.

[0055] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present invention.

Claims

1. A wearable medical device for treating peripheral pain, characterized in that: It includes a stimulation strategy unit and an electrode array unit, a pulse excitation unit, an impedance determination unit, an adaptive threshold anchoring unit, an interference intensity detection unit and a solution unit, all of which are connected to the stimulation strategy unit, wherein: The stimulation strategy unit determines and decides which stimulation parameters to use; The electrode array unit is an interactive channel composed of multiple electrodes; The pulse excitation unit generates a specific frequency carrier and a specific amplitude modulated electric pulse or electric field or magnetic field pulse; The impedance measurement unit is also connected to the electrode array unit to detect and identify the electrical impedance corresponding to the excitation frequency between the electrode array unit and the peripheral skin tissue, and calculates the impedance distribution trend of the area to be stimulated and the surrounding area through the impedance measurement results between the electrodes, and provides information input for the stimulation strategy unit based on the discontinuity of the impedance distribution; The adaptive threshold anchoring unit marks the impedance characteristics of different areas based on impedance measurement and transmits them to the stimulation strategy unit. The stimulation strategy unit selects the corresponding electrodes and pulse excitation parameters to act on the area, and adaptively marks the impedance characteristics and threshold characteristics of different sites according to the discontinuity of impedance distribution, and provides different stimulation doses for each area. The whole process changes dynamically to maximize the adaptation to the outcome changes of body conditions; The interference intensity detection unit is also connected to the pulse excitation unit to detect the validity of the stimulation signal output by the pulse excitation unit, and by monitoring the output result, the feedback is fed back to the stimulation strategy unit to optimize the pulse excitation parameters and select the electrode array; The solving unit solves the complex physiological information acquired by the interference intensity detection unit; The relationship between the pulse excitation parameters in the adaptive threshold anchoring unit is: The pulse equation is Pulse (t) = f0(t,E,Z,I,F,Pw,Cy,N,K k ) ; Impedance Distribution Matrix ; Normalized specific electrode impedance ; The electrical stimulation constraint equation is ; The specific stimulation pulse is ; Where t is time, E is electrode, Z0 is specific electrode impedance, I is current, F is frequency, Pw is pulse width, Cy is pulse period, N is number of electrode pairs, K k is the calibration coefficient, Ez1-EzN are the mutual impedance matrix elements between N electrode pairs, is a combination of any two electrodes selected from N electrodes, f0 is the pulse parameter equation, f1 is the electrical stimulation constraint equation, K0 is the specific stimulation pulse calibration coefficient, K1 is the feedback coefficient calibration value, A is the electrode gating position matrix and the Z matrix has the same number of columns, is the constraint equation coefficient, S is the electrode area, P fb is the feedback coefficient.

2. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The stimulation strategy unit is a processor or microprocessor that executes a specific algorithm.

3. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The stimulation strategy unit judges and determines the stimulation parameters to be used, including stimulation amplitude, carrier characteristics, frequency modulation characteristics, amplitude modulation characteristics and stimulation electrode array combination.

4. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The electrodes in the electrode array unit are circular or polygonal.

5. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The electrode array units are arranged in a circular space when in use, with an interval of (0°-180°].

6. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The electrodes in the electrode array unit are in direct contact with the skin of the peripheral area or not in contact with the skin of the peripheral area, and energy and signals are transmitted through electric fields or magnetic fields.

7. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The pulses output by the pulse excitation unit are constant frequency outputs or non-constant frequency outputs.

8. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The pulse excitation unit adopts a random amplitude modulation method with controllable modulation depth.

9. The wearable medical device for treating peripheral pain according to claim 1, characterized in that: The calculation of the calculation unit includes signal separation, feature extraction and signal cluster analysis, and extracts feature information, including neural induced feedback and stimulation loss.

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