Intraoperative neuromuscular stimulator

Abstract

The invention discloses an intraoperative neuromuscular stimulator which comprises a shell, an electrode head needle is installed in the center of the front end of the shell, a wire is connected to the lower side of the rear end of the shell, an electrode tail needle is installed at the other end of the wire, a control mechanism and a battery are arranged in the shell, and the electrode head needle and the electrode tail needle are connected with the power supply output end of the control mechanism. A power switch is arranged in the center of the rear end of the shell, an output switch and an adjusting switch are arranged on the surface of the shell, and the power switch, the output switch and the adjusting switch are all electrically connected with the control mechanism. The handheld device powered by the battery is small in size, a host device and an external power source are not needed, a surgeon can complete operation with one hand, use is convenient, functional characters of nerves and muscles are fed back through regular jumping, spasm or stiffness of the muscles after the handheld device is used, the doctor is assisted in clinical judgment, and the operation efficiency is improved. And electrophysiology technicians do not need to interpret a conclusion, and the application range of the neuromuscular electrical stimulation technology in an operation can be better expanded.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an intraoperative neuromuscular stimulator. Background Art

[0002] Neuromuscular electrical stimulation (NMS) technology has a long history of use in clinical medicine, primarily in areas such as nerve stimulation and regeneration, and rehabilitation therapy. However, there is a lack of applications and equipment for nerve exploration and positioning during surgery, and for intuitively determining the functional characteristics of nerves and muscles. Although electrophysiological equipment such as electrophysiological parameter detectors, nerve monitors, and intraoperative EEG / EMG / evoked potential measurement systems can also determine the functional characteristics of nerves and muscles, these all require expensive, large-scale equipment systems and professional electrophysiological technicians to participate in the surgery, connect complex test electrode networks, and interpret EEG and EMG before clinicians can provide conclusions. Currently, clinical applications are limited to central nervous system surgeries, greatly limiting the scope of NMS technology's application in surgery. Summary of the Invention

[0003] The purpose of the present invention is to provide an intraoperative neuromuscular stimulator to solve the deficiencies in the prior art.

[0004] In order to achieve the above-mentioned object of the invention, the technical solution adopted by the present invention is:

[0005] An intraoperative neuromuscular stimulator comprises: a housing, an electrode head needle mounted at the front center of the housing, a wire connected to the lower rear end of the housing, an electrode tail needle mounted at the other end of the wire, a control mechanism and a battery disposed within the housing, the electrode head needle and the electrode tail needle being connected to the power supply output end of the control mechanism, a power switch disposed at the rear center of the housing, an output switch and an adjustment switch disposed on the surface of the housing, the power switch, the output switch, and the adjustment switch being all electrically connected to the control mechanism;

[0006] The housing comprises: a lower housing, the top of which is spliced ​​with an upper housing, and the front ends of the lower housing and the upper housing are connected to a pen cap via a fixing ring;

[0007] Rubber pads are installed on both sides of the shell, and a plurality of anti-skid particles are arranged in an array on the rubber pads.

[0008] Furthermore, a sink is provided at the bottom end of the lower shell, and the battery is installed in the sink.

[0009] Furthermore, the control mechanism includes: a main board, on which a key control board is mounted, and the key control board is electrically connected to the power switch, the output switch and the adjustment switch respectively.

[0010] Furthermore, the adjustment switch includes: an unlock button, a parameter increase button, a parameter decrease button and a mode selection button. The upper shell is provided with an avoidance groove adapted to the unlock button, the parameter increase button, the parameter decrease button and the mode selection button. The upper shell is also embedded with a display screen, and the display screen is electrically connected to the main board.

[0011] Furthermore, the adjustment switch includes: a frequency selection key and a current selection key, and the upper shell is respectively provided with a waist-shaped hole that slides with the frequency selection key and the current selection key, and a scale parameter is marked on one side of the waist-shaped hole.

[0012] Furthermore, an output indicator light is provided on a side of the upper shell close to the fixing ring, and the output indicator light is electrically connected to the mainboard.

[0013] The intraoperative neuromuscular stimulator provided by the present invention has the following advantages compared with the prior art:

[0014] The present invention is a battery-powered handheld device with a compact size. It does not require a host device or an external power supply and can be operated by the surgeon with one hand. It is easy to use. After use, the device uses the regular twitching, spasm or rigidity of the muscles to provide feedback on the functional characteristics of nerves and muscles to assist doctors in making clinical judgments. There is no need for electrophysiological technicians to interpret the conclusions, which can better expand the application scope of neuromuscular electrical stimulation technology in surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0016] Figure 1 This is an axonometric view of Example 1 of the present invention;

[0017] Figure 2 A side view of embodiment 1 of the present invention;

[0018] Figure 3 This is a schematic diagram of the internal structure of Example 1 of the present invention;

[0019] Figure 4 This is an axonometric view of embodiment 2 of the present invention;

[0020] Figure 5 This is a schematic diagram of the internal structure of Example 2 of the present invention;

[0021] Figure 6 This is a side sectional view of Example 2 of the present invention.

[0022] In the figure: 1-housing, 2-electrode head needle, 3-wire, 4-electrode tail needle, 5-battery, 6-power switch, 7-output switch, 8-lower housing, 9-upper housing, 10-fixing ring, 11-pen cap, 12-sink, 13-main board, 14-key control board, 15-unlock button, 16-parameter increase button, 17-parameter decrease button, 18-mode selection button, 19-display screen, 20-frequency selection button, 21-current selection button, 22-waist-shaped hole, 23-rubber pad. DETAILED DESCRIPTION

[0023] The technical solution of the present invention will be further described below with reference to the accompanying drawings and embodiments:

[0024] Example 1

[0025] refer to Figure 1-3 As shown, the present invention provides an intraoperative neuromuscular stimulator, comprising: a shell 1, an electrode head needle 2 is installed at the front center of the shell 1, a wire 3 is connected to the lower side of the rear end of the shell 1, and an electrode tail needle 4 is installed at the other end of the wire 3, a control mechanism and a battery 5 are provided inside the shell 1, the electrode head needle 2 and the electrode tail needle 4 are respectively connected to the power supply output end of the control mechanism, a power switch 6 is provided at the rear center of the shell 1, and an output switch 7 and an adjustment switch are provided on the surface of the shell 1, and the power switch 6, the output switch 7 and the adjustment switch are all electrically connected to the control mechanism.

[0026] As a preferred embodiment, the housing 1 includes: a lower shell 8, the top of the lower shell 8 is spliced ​​with an upper shell 9, and the front ends of the lower shell 8 and the upper shell 9 are connected to a pen cap 11 through a fixing ring 10. A sink 12 is provided at the bottom end of the lower shell 8, and the battery 5 is installed in the sink 12. The control mechanism includes: a main board 13, and a key control board 14 is installed on the main board 13. The key control board 14 is electrically connected to the power switch 6, the output switch 7 and the adjustment switch respectively. Output switch 7: When the product needs to output current, this switch must be pressed continuously to output current. If no current is needed, just release it.

[0027] As a preferred embodiment, the adjustment switch includes: an unlock button 15, a parameter increase button 16, a parameter decrease button 17 and a mode selection button 18. The upper shell 9 is provided with an avoidance groove adapted to the unlock button 15, the parameter increase button 16, the parameter decrease button 17 and the mode selection button 18. The upper shell 9 is also embedded with a display screen 19, and the display screen 19 is electrically connected to the main board 13. Unlock button 15: Press and hold for 5 seconds to unlock. This setting is to prevent parameter changes due to accidental touch during surgery. Parameter increase button 16: Used to adjust the value of increasing output current, frequency, and pulse width. Parameter decrease button 17: Used to adjust the value of decreasing output current, frequency, and pulse width. Mode selection button 18: Press the mode selection button 18. When any of the fonts of frequency, pulse width, and current flashes on the display screen, it means that the flashing font has entered the adjustable state.

[0028] As a preferred embodiment, an output indicator light is provided on the side of the upper housing 9 near the fixing ring 10, and a power indicator light is provided on the side of the upper housing 9 away from the fixing ring 10. Both the output indicator light and the power indicator light are electrically connected to the mainboard 13. The output indicator light flashes orange when the product is outputting current and is off when there is no current output. The power indicator light illuminates green when the instrument is powered on normally.

[0029] As a preferred embodiment, rubber pads 23 are installed on both sides of the housing 1, and a plurality of anti-slip particles are arrayed on the rubber pads 23.

[0030] As a preferred embodiment, the device has a short-circuit detection function. During normal output, a voltage difference is generated between the electrode head needle 2 and the electrode tail needle 4. When a short circuit occurs, the voltage difference between the electrode head needle 2 and the electrode tail needle 4 disappears. The voltage difference signal between the electrode head needle 2 and the electrode tail needle 4 is given to the comparator through the sampling resistor. The comparator gives a high or low level according to whether there is a pressure difference. When there is a pressure difference signal, the high level is a normal output. When there is no pressure difference, the low level is a short-circuit alarm.

[0031] When the output switch 7 is pressed and the electrode head needle 2 and the electrode tail needle 4 are short-circuited, the comparator will recognize the output short circuit and sound a buzzer alarm, and the main board 13 will cut off the output. The output indicator light will also stop flashing and go out. The alarm ends after the output switch 7 is released. If the output switch 7 is continuously pressed, the alarm will continue for 1 minute and then stop. The alarm will be on for 1 minute every 5 minutes to prevent the device from being burned due to the output switch 7 being pressed and short-circuited when unattended. The intermittent alarm can save battery power.

[0032] As a preferred embodiment, the device has a disconnection detection function. A photocoupler is connected in series in the output circuit. When the output switch 7 is pressed and the output is normal, current passes through the photocoupler. At this time, the photocoupler will send a pulse signal to the main board 13. When the output switch 7 is pressed and the electrode is disconnected, the output circuit cannot be formed. At this time, no output current passes through the photocoupler, and the photocoupler has no pulse signal to the main board 13. The main board 13 prompts that the electrode is disconnected.

[0033] If the output switch 7 is pressed and the two electrodes are not in good contact with human tissue, the photoelectric coupler can detect this and alert the surgeon through an output indicator light, preventing the surgeon from making an incorrect diagnosis of the functional characteristics of the nerve or muscle being tested. Judgment criteria: If the electrodes are not in good contact with human tissue, the output indicator light flashes three times and then turns off; if the electrodes are in good contact with human tissue, the output indicator light continues to flash until the output switch 7 is released.

[0034] The working process and principle of this embodiment are:

[0035] S1: Press the power switch 6, then the display screen 19 lights up and displays the startup screen;

[0036] S2: Long press the unlock button 15 to unlock the adjustment switch. The display 19 shows unlocked. Operating the adjustment switch proves that it is activated and can be used.

[0037] S3: Use the mode selection button 18 to select the item to be adjusted: frequency, pulse width, current three adjustable parameter options;

[0038] S4: (Frequency adjustment) Press the mode selection button 18. When the "Frequency" font on the display screen 19 flashes, it means that the parameter adjustment is currently active. The required frequency can be adjusted up and down by pressing the parameter increase button 16 and the parameter decrease button 17. The frequency parameter is adjustable from 1 to 100 Hz, increasing in 1 Hz steps, and the initial value is 15 Hz.

[0039] (Pulse width adjustment) Press the mode selection button 18. When the "Pulse Width" font on the display screen 19 flashes, it means that the parameter adjustment is currently active. The required pulse width can be adjusted up and down by the parameter increase button 16 and the parameter decrease button 17. The pulse width parameter increases in 10μs steps between 10μs and 400μs. The initial value is 200uS.

[0040] (Current adjustment): Press the mode selection button 18. When the "current" font on the display 19 flashes, it means that the parameter adjustment is currently active. Use the parameter increase button 16 and parameter decrease button 17 to adjust the required output current up and down. The eight current options are: 0.5mA, 1mA, 2mA, 5mA, 10mA, 20mA, 30mA, 40mA, and the initial value is 2mA.

[0041] S5: After the three parameters are selected, the stimulator will be in the output state (note: the output state only means that the stimulator is turned on and can stimulate output, but does not provide the required stimulation current);

[0042] S6: Connect the electrode tail needle 4 to the proximal end of the muscle to be tested, and the electrode head needle 2 to the distal end of the muscle to be tested, press the output switch 7, and the output indicator light will flash orange. In this state, it means that the stimulator generates stimulation and reaches the output current.

[0043] Example 2

[0044] refer to Figure 4-6 As shown, the main difference between this embodiment and Example 1 is that the adjustment switch includes a frequency selection key 20 and a current selection key 21. The upper housing 9 is provided with a waist-shaped hole 22 that slides with the frequency selection key 20 and the current selection key 21, respectively. One side of the waist-shaped hole 22 is marked with a scale parameter. Frequency selection key 20: Slide this button to select the frequency value. Current selection key 21: Slide this button to select the current value.

[0045] The working process and principle of this embodiment are:

[0046] S1: Press the power switch 6, and the power indicator light turns green;

[0047] S2: (Frequency adjustment) Slide the frequency selection key 20 up and down to select the output frequency, 2Hz or 15Hz, the initial value is 2Hz;

[0048] (Pulse width adjustment): This model has a fixed pulse width of 200uS and cannot be adjusted;

[0049] (Current adjustment): Slide the current selection key 21 up and down to select the output current. There are five current settings: 1mA, 2mA, 5mA, 10mA, and 20mA. The initial value is 1mA.

[0050] S3: After the three parameters are selected, the stimulator will be in the output state (note: the output state only means that the stimulator is turned on and can stimulate output, but does not provide the required stimulation current);

[0051] S4: Connect the electrode tail needle 4 to the proximal end of the muscle to be tested, and the electrode head needle 2 to the distal end of the muscle to be tested, press the output switch 7, and the output indicator light will flash orange, indicating that the stimulator is stimulating and reaching the output current;

[0052] S5: When use is finished, turn off the power switch 6, cut off the electrode head needle 2 and the electrode tail needle 4, and place them in an appropriate sharps / biohazard container for disposal.

[0053] The present invention is a battery-powered handheld device with a compact size. It does not require a host device or an external power supply and can be operated by the surgeon with one hand. It is easy to use. After use, the device uses the regular twitching, spasm or rigidity of the muscles to provide feedback on the functional characteristics of nerves and muscles to assist doctors in making clinical judgments. There is no need for electrophysiological technicians to interpret the conclusions, which can better expand the application scope of neuromuscular electrical stimulation technology in surgery.

[0054] The device in this invention primarily explores nerves during surgery to locate and identify nerves and test nerve and muscle function to assist physicians in clinical assessment. It is suitable for neuromuscular electrical stimulation in areas beyond the central nervous system and spinal cord, such as hand surgery, orthopedics, foot and ankle surgery, oncology, otolaryngology, head and neck surgery, thyroid and breast surgery, urology, pain management, plastic surgery, and cosmetic surgery, where nerve protection at the surgical site or assessment of nerve and muscle function is required.

[0055] In the description of this application, it should be noted that the terms "upper" and "lower" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application. Unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0056] It should be noted that, in this application, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprising a ..." does not exclude the presence of other identical elements in the process, method, article or device comprising the element.

[0057] The foregoing is merely a list of specific embodiments of the present application, intended to enable those skilled in the art to understand or implement the present application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application is not limited to the embodiments shown herein, but is intended to conform to the broadest scope consistent with the principles and novel features of the present application.

Claims

1. An intraoperative neuromuscular stimulator, characterized in that include: A housing (1), wherein an electrode head needle (2) is installed at the center of the front end of the housing (1), a wire (3) is connected to the lower side of the rear end of the housing (1), and an electrode tail needle (4) is installed at the other end of the wire (3), a control mechanism and a battery (5) are provided inside the housing (1), the electrode head needle (2) and the electrode tail needle (4) are respectively connected to the power supply output end of the control mechanism, a power switch (6) is provided at the center of the rear end of the housing (1), and an output switch (7) and an adjustment switch are provided on the surface of the housing (1), and the power switch (6), the output switch (7) and the adjustment switch are all electrically connected to the control mechanism; The housing (1) comprises: a lower housing (8), the top end of the lower housing (8) is spliced ​​with an upper housing (9), and the front ends of the lower housing (8) and the upper housing (9) are connected to a pen cap (11) via a fixing ring (10); Rubber pads (23) are installed on both sides of the housing (1), and a plurality of anti-skid particles are arranged in an array on the rubber pads (23).

2. The intraoperative neuromuscular stimulator according to claim 1, characterized in that A sink (12) is provided at the bottom end of the lower shell (8), and the battery (5) is installed in the sink (12).

3. The intraoperative neuromuscular stimulator according to claim 1, characterized in that The control mechanism comprises a main board (13), a key control board (14) is mounted on the main board (13), and the key control board (14) is electrically connected to a power switch (6), an output switch (7), and an adjustment switch respectively.

4. The intraoperative neuromuscular stimulator according to claim 3, characterized in that The regulating switch comprises an unlocking button (15), a parameter increasing button (16), a parameter decreasing button (17) and a mode selecting button (18); a clearance groove adapted to the unlocking button (15), the parameter increasing button (16), the parameter decreasing button (17) and the mode selecting button (18) is provided on the upper shell (9); a display screen (19) is also embedded in the upper shell (9); and the display screen (19) is electrically connected to the main board (13).

5. The intraoperative neuromuscular stimulator according to claim 3, characterized in that The regulating switch comprises a frequency selection key (20) and a current selection key (21); the upper housing (9) is provided with waist-shaped holes (22) respectively slidingly engaged with the frequency selection key (20) and the current selection key (21); and one side of the waist-shaped holes (22) is marked with scale parameters.

6. The intraoperative neuromuscular stimulator according to claim 3, characterized in that An output indicator light is provided on one side of the upper housing (9) close to the fixing ring (10), and the output indicator light is electrically connected to the main board (13).

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