Spinal cord puncture type electrode and abnormal tissue monitoring system

Abstract

The invention provides a spinal cord puncture type electrode and an abnormal tissue monitoring system, and relates to the technical field of spinal cord dorsal root marrow entering region damage operation treatment, the spinal cord puncture type electrode is used for puncturing to a spinal cord dorsal root marrow entering region in the spinal cord dorsal root marrow entering region damage operation, and the spinal cord puncture type electrode comprises an electrode puncture head; the electrode puncture head is provided with a plurality of detection sites which are distributed in a two-dimensional mode in the transverse axis direction and the longitudinal axis direction, and the detection sites are used for collecting nerve electrophysiological signals in the length direction and the depth direction of a marrow entering area in the spinal cord dorsal root marrow entering area ablation operation; an intraoperative electrophysiology monitoring device in communication connection with the spinal cord puncture type electrode is used for receiving the nerve electrophysiology signals and confirming the abnormal tissue position of the spinal cord dorsal root marrow entering area according to the nerve electrophysiology signals and the positions of the multiple detection sites in the spinal cord dorsal root marrow entering area. Quantifiable, quantifiable and objective guidance of the lesion depth is realized, the surgical curative effect is improved, and complications are slowed down.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and more particularly, to a spinal puncture electrode and an abnormal tissue monitoring system. Background Art

[0002] The commonly used method for treating neuropathic pain is spinal cord stimulation, which is a neuromodulation technique that implants electrodes outside the dura mater of patients and applies a certain current to stimulate the spinal cord. This technique is also widely used in the treatment of spinal cord injuries, strokes and other diseases.

[0003] Although spinal cord stimulation has been clinically applied for many years, existing technologies still have some drawbacks. The electrode is one of the core components of the spinal cord stimulation system, and its performance directly affects the treatment effect. Traditional columnar electrodes have poor flexibility and large volume, which will compress the spinal cord after implantation, affecting the patient's comfort; the conformal contact between the electrode points and the tissue is poor, and it is easy to shift, affecting the accuracy of stimulation, and the biocompatibility is poor. Long-term use may cause biocompatibility reactions, resulting in weakened or ineffective electrode function. Moreover, for some patients with severe injuries, the effective rate of spinal cord stimulation is only 30%, and the cost of this surgery is expensive and the economy is low, and patients are unable to bear the surgery. Therefore, for such patients, spinal dorsal root entry zone lesioning is a good indication, with an effective rate of up to 90%, and the patient's quality of life after surgery has been greatly improved.

[0004] However, because the technique of spinal dorsal root entry zone lesioning is difficult, when performing the lesioning, the depth of the surgery is often judged by the subjective experience of the surgeon. Therefore, there is a risk of improper operation, which will lead to poor surgical efficacy and even serious complications such as hemiplegia. Summary of the Invention

[0005] The purpose of the present application is to provide a spinal puncture electrode and an abnormal tissue monitoring system, aiming to achieve quantifiable, quantitative and objective guidance for the length and depth of lesioning, improve the surgical efficacy and reduce complications.

[0006] Additional aspects and advantages of the present application will be partially described below, and will partially become apparent from the description, or can be learned through the practice of the present application.

[0007] According to a first aspect of the present application, a spinal puncture electrode is used to puncture into the spinal dorsal root entry zone during spinal dorsal root entry zone lesioning. The spinal puncture electrode includes an electrode puncture head, and the electrode puncture head is provided with a plurality of detection sites distributed two-dimensionally along its horizontal axis and vertical axis. The plurality of detection sites are used to collect neuroelectrophysiological signals in the length and depth directions of the spinal dorsal root entry zone during the spinal dorsal root entry zone lesioning.

[0008] The intraoperative electrophysiological monitoring device communicatively connected to the spinal puncture electrode is configured to receive the neuroelectrophysiological signals, and confirm the location of abnormal tissues in the spinal dorsal root entry zone based on the neuroelectrophysiological signals and the positions of the multiple detection sites in the spinal dorsal root entry zone.

[0009] In an exemplary embodiment of the present application, the electrode puncture head includes a plurality of puncture needles arranged at intervals in the horizontal axis direction, and a plurality of the detection sites are arranged at intervals along the longitudinal axis of each puncture needle; when the electrode puncture head penetrates into the spinal dorsal root entry zone, the horizontal axis direction of the electrode puncture head is consistent with the length direction of the spinal dorsal root entry zone, and the longitudinal axis direction of the electrode puncture head is consistent with the depth direction of the spinal dorsal root entry zone.

[0010] In an exemplary embodiment of the present application, the electrode puncture head includes, from bottom to top, a flexible substrate layer, a metal wiring layer, and a first insulating layer; the detection sites are arranged on the metal wiring layer and the metal wiring layer is exposed by etching at corresponding positions on the lower surface of the flexible substrate layer, and the first insulating layer completely covers the upper surface of the metal wiring layer.

[0011] In an exemplary embodiment of the present application, the electrode puncture head further includes a support layer and a second insulating layer, the support layer is arranged above the first insulating layer, and the second insulating layer completely covers the upper surface of the support layer.

[0012] In an exemplary embodiment of the present application,

[0013] the flexible substrate layer is a polyimide substrate;

[0014] and / or, the metal wiring layer includes, from bottom to top, a titanium layer, a platinum layer, and a gold layer, the titanium layer serves as an adhesion layer for the platinum layer, and at the positions where the electrical detection sites are located, the titanium layer is selectively removed to expose the platinum layer for contacting the nerve tissue in the spinal dorsal root entry zone;

[0015] and / or, the first insulating layer is a parylene insulating layer;

[0016] and / or, the support layer is a nickel support layer;

[0017] and / or, the second insulating layer is a parylene passivation layer.

[0018] In an exemplary embodiment of the present application, it further includes a circuit adapter for connecting to the electrophysiological monitoring device, and a flexible extension circuit connected between the electrode puncture head and the circuit adapter.

[0019] In an exemplary embodiment of the present application, the electrode puncturing head further includes a plurality of lead-out pads, and the plurality of lead-out pads are respectively connected to a plurality of the detection sites through the metal wiring layer; the flexible extension circuit includes a plurality of flexible cable pads, and the plurality of lead-out pads are respectively connected to the plurality of flexible cable pads.

[0020] In an exemplary embodiment of the present application, the flexible extension circuit further includes:

[0021] Adapter pads for connecting to the circuit adapter, and a plurality of the adapter pads are provided, and the plurality of adapter pads correspond to the plurality of flexible cable pads one by one;

[0022] Connection circuits for connecting the corresponding flexible cable pads and the adapter pads.

[0023] In an exemplary embodiment of the present application, the circuit adapter includes:

[0024] A circuit board for connecting the adapter pads;

[0025] A flip connector mounted on the circuit board and capable of clamping or loosening the adapter pads;

[0026] A pin header interface mounted on the circuit board, and the pin header interface is electrically connected to the adapter pads through the circuit board;

[0027] Pins fixedly connected to the pin header interface.

[0028] In an exemplary embodiment of the present application, it further includes an electrode protection housing covering the outside of the electrode puncturing head and a converter fixing housing covering the outside of the circuit adapter.

[0029] In an exemplary embodiment of the present application, the electrode protection housing includes a first protection housing and a second protection housing, the lead-out pads and the flexible cable pads are located between the first protection housing and the second protection housing, and the first protection housing and the second protection housing are snap-fitted with each other.

[0030] In an exemplary embodiment of the present application, the converter fixing housing includes a first fixing housing and a second fixing housing, the circuit board and the adapter pads are located between the first fixing housing and the second fixing housing, and the first fixing housing and the second fixing housing are snap-fitted with each other.

[0031] In an exemplary embodiment of the present application, an electrode protection housing sleeve is fixedly provided on the outside of the first fixing housing or the second fixing housing, and the electrode protection housing can be inserted into the electrode protection housing sleeve.

[0032] According to the second aspect of the present application, the abnormal tissue monitoring system is used in spinal cord dorsal root entry zone ablation surgery, and comprises:

[0033] The spinal puncture electrode according to any one of the above;

[0034] An electrophysiological monitoring device, which is in communication connection with the spinal puncture electrode during the operation, and the electrophysiological monitoring device can be equipped with one or more of the spinal puncture electrodes at the same time;

[0035] The adjusting mechanism is used for supporting and adjusting the spinal cord puncture electrode.

[0036] In an exemplary embodiment of the present application, the adjustment mechanism includes a load-bearing member and a support frame;

[0037] The bearing member is used to bear the spinal puncture electrode, and the bearing member comprises: an assembly sleeve, a slider and a pulley, the spinal puncture electrode is mounted on the assembly sleeve, the assembly sleeve is fixedly connected to one side of the slider, and the pulley is rotatably connected to the side of the slider away from the assembly sleeve;

[0038] The support frame comprises: a support column, an adjustable connector, a slide rail fixing rod and a slide rail;

[0039] The support column is arranged along the vertical direction;

[0040] The adjustable connector is installed between the support rod and the slide rail fixing rod, and the adjustable connector can slide and lock along the length direction of the support column;

[0041] The slide rail fixing rod is arranged in the horizontal direction, and the slide rail fixing rod can slide relative to the adjustable connector in the horizontal direction and be locked in position through the adjustable connector;

[0042] The slide rail is installed at one end of the slide rail fixing rod in a horizontal direction, and the pulley is located in the slide rail and can roll along the length direction of the slide rail.

[0043] The exemplary embodiments of the present application may have some or all of the following beneficial effects:

[0044] In a spinal cord puncture electrode provided by an exemplary embodiment of the present application, during a spinal dorsal root entry zone lesioning operation, the operator inserts the electrode puncture head of the spinal cord puncture electrode into the spinal dorsal root entry zone of the patient. Through the detection sites arranged on the electrode puncture head, the neuroelectrophysiological signals in the entry zone can be collected. The collected neuroelectrophysiological signals are then transmitted to an electrophysiological monitoring device. Through real-time monitoring, the operator can clearly understand the specific conditions of the neuroelectrophysiological signals in the spinal dorsal root entry zone in the length and depth directions. Specifically, the detection sites form a two-dimensional distributed detection network in the spinal cord entry zone. Through the detection sites on the horizontal axis, the neuroelectrophysiological signals in the length direction of the entry zone can be collected; while through the detection sites on the vertical axis, the neuroelectrophysiological signals at different depths in the entry zone can be collected, thus ensuring that the spinal cord puncture electrode can fully cover the entry zone and achieve a full-range detection of the neuroelectrophysiological signals in the entry zone. With the above structure, the spinal cord puncture electrode has a plurality of detection sites with a two-dimensional distribution, can monitor the neuroelectrophysiological signals in the length and depth directions of the entry zone, can thus more accurately determine the location of abnormal tissues, can provide a quantifiable, quantitative, and objective guidance for the operator on the lesion location, and further improve the surgical efficacy and reduce complications.

[0045] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The accompanying drawings herein are incorporated into the specification and constitute a part of this specification, showing embodiments consistent with the present application, and are used together with the specification to explain the principles of the present application. Obviously, the accompanying drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0047] Figure 1 Side view of the electrode puncture head in the spinal cord puncture electrode for an application embodiment;

[0048] Figure 2 Stratified structure diagram of the metal wiring layer of the electrode puncture head in an embodiment of the present application;

[0049] Figure 3 Top view of the electrode puncture head in an embodiment of the present application;

[0050] Figure 4 For an embodiment of the present application Figure 3 Partial enlarged view of part A;

[0051] Figure 5 Side view of the flexible extension circuit in an embodiment of the present application;

[0052] Figure 6 Partial top view of the flexible extension circuit in the embodiment of the present application;

[0053] Figure 7 Schematic diagram of the connection method between the electrode puncture head and the flexible extension circuit in the embodiment of the present application;

[0054] Figure 8 Schematic diagram of the structure of the circuit adapter in the embodiment of the present application;

[0055] Figure 9 Schematic diagram of the structure of the lead wire in the embodiment of the present application;

[0056] Figure 10 Schematic diagram of the structure of the electrode protection housing in the embodiment of the present application;

[0057] Figure 11 Schematic diagram of the structure of the adapter fixing housing in the embodiment of the present application;

[0058] Figure 12 Schematic diagram of the assembly method among the electrode puncture head, the flexible extension circuit, the circuit adapter, the electrode protection housing and the adapter fixing housing in the embodiment of the present application;

[0059] Figure 13 Schematic diagram of the structure of the bearing member in the embodiment of the present application;

[0060] Figure 14 Schematic diagram of the assembly result of the spinal puncture electrode installed in the bearing member to form an electrode module in the embodiment of the present application;

[0061] Figure 15 Schematic diagram of the structure of the support frame in the embodiment of the present application.

[0062] Explanation of reference numerals:

[0063] 1. Flexible substrate layer; 2. Detection site; 3. Metal wiring layer; 4. Lead-out pad; 5. First insulating layer; 6. Support layer; 7. Second insulating layer; 8. Titanium; 9. Platinum; 10. Gold; 11. Insulating substrate; 12. Connection circuit; 13. Insulating package; 14. FFC pad; 15. Adapter pad; 16. Reinforcement plate; 17. Anisotropic conductive film; 18. Circuit board; 19. Circuit board positioning hole; 20. Flip connector; 21. Pin header interface; 22. Pin header; 23. Female header interface; 24. Jack; 25. Lead wire; 26. Socket type interface; 27. First protective housing; 28. Limit side wall; 29. Protective housing positioning hole; 30. Positioning groove; 31. Second protective housing; 32. First positioning post; 33. First buckle; 34. First fixed housing; 35. Second positioning post; 36. Second fixed housing; 37. Second buckle; 38. Electrode protective housing sleeve; 39. Assembly sleeve; 40. First screw hole; 41. Sleeve side wall; 42. Slide block; 43. Pulley; 44. Second screw hole; 45. Fixed pedestal; 46. Support column; 47. Adjustable connector; 48. Slide rail fixing rod; 49. Slide rail; 50. Electrode puncture head; 51. Puncture needle body; 52. Flexible extension circuit. Detailed implementation mode

[0064] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the example embodiments to those skilled in the art. Like reference numerals in the figures denote like or similar structures, and thus their detailed description will be omitted. In addition, the drawings are only schematic illustrations of the present application and are not necessarily drawn to scale.

[0065] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of an icon to another component, these terms are used in this specification only for convenience, for example, according to the orientation of the example in the drawings. It can be understood that if the device of the icon is turned upside down, the component described as "upper" will become the component "lower". When a structure is "on" another structure, it may mean that a structure is integrally formed on another structure, or that a structure is "directly" disposed on another structure, or that a structure is "indirectly" disposed on another structure through another structure.

[0066] The terms "a", "an", "the", and "at least one" are used to indicate the presence of one or more elements / components / etc.; the terms "comprising" and "having" are used to mean an open inclusion and refer to the possibility of the existence of additional elements / components / etc. in addition to the listed elements / components / etc.; the terms "first", "second" are used only as labels and do not limit the quantity of their objects.

[0067] Referring to Figure 1 , Figure 2 , Figure 3 and Figure 4 As shown, in an embodiment of the present application, a spinal puncture electrode is provided, which is used to puncture into the spinal dorsal root entry zone during the spinal dorsal root entry zone destruction operation. The spinal puncture electrode includes an electrode puncture head 50, and a plurality of detection sites 2 with two-dimensional distribution are arranged along the horizontal axis and the vertical axis directions of the electrode puncture head 50. The plurality of detection sites 2 are used to collect neuroelectrophysiological signals in the length and depth directions of the entry zone during the spinal dorsal root entry zone destruction operation.

[0068] The intraoperative electrophysiological monitoring device communicatively connected to the spinal puncture electrode is used to receive the neuroelectrophysiological signals, and confirm the position of abnormal tissues in the spinal dorsal root entry zone according to the neuroelectrophysiological signals and the positions of the plurality of detection sites 2 in the spinal dorsal root entry zone.

[0069] In an embodiment of the present application, for the link where the spinal puncture electrode collects neuroelectrophysiological signals and then transmits them to the electrophysiological monitoring device, the present application provides two options for the transmission method: wired and wireless. Considering the stability and real-time nature of the signals, the present application preferably adopts the wired transmission method to ensure the accurate and error-free transmission of neuroelectrophysiological signals, provide stable and reliable monitoring data for the surgeon, and thus facilitate the surgeon's operation. The wired transmission method not only strengthens the reliability of signal transmission, but also provides a solid guarantee for the intraoperative neuroelectrophysiological signal monitoring, further improving the safety and success rate of the operation.

[0070] The electrophysiological monitoring device selected in the present application is a conventional electrophysiological detector in the art. Of course, this is not restrictive. The electrophysiological monitor can display in real time the neuroelectrophysiological signals in the area monitored by the spinal puncture electrode, so as to enable the surgeon to judge this area and find the position of abnormal tissues. Specifically, when finding the position of abnormal tissues, the horizontal position of the abnormal tissue position in the entry zone can be determined through the detection sites 2 distributed along the horizontal axis, and the depth position of the abnormal tissue position in the entry zone can be determined through the detection sites 2 distributed along the vertical axis.

[0071] In an embodiment of the present application, the electrode puncture head 50 includes a plurality of puncture needle bodies 51 arranged at intervals in the lateral direction. A plurality of detection sites 2 are arranged at intervals on the plurality of puncture needle bodies 51. To improve the uniformity and stability of the puncture needle bodies 51 when receiving neuroelectrophysiological signals, the plurality of puncture needle bodies 51 are preferably arranged at uniform intervals. At the same time, the detection sites 2 on each puncture needle body 51 also follow the principle of uniform interval distribution. Of course, this is not restrictive. It should be noted that when the electrode puncture head 50 punctures into the spinal dorsal root entry zone, the transverse axis direction of the electrode puncture head 50 is consistent with the length direction of the spinal dorsal root entry zone, and the longitudinal axis direction of the electrode puncture head 50 is consistent with the depth direction of the spinal dorsal root entry zone.

[0072] Furthermore, there is no limitation on the number of the puncture needle bodies 51 and the number of the detection sites 2 on each puncture needle body 51. In the present application, for example, the puncture needle bodies 51 are set to four, and four detection sites 2 are arranged on each puncture needle body 51.

[0073] When performing spinal dorsal root entry zone ablation, the plurality of puncture needle bodies 51 are all inserted into the dorsal root of the spinal cord along the length direction of the entry zone, and it is ensured that the insertion depth of each puncture needle body 51 is the same. Therefore, it can be understood that the detection sites 2 on the puncture needle bodies 51 form a 4×4 detection network array in the entry zone. In the present application, the distance between adjacent puncture needle bodies 51 is 1 mm, and the distance between adjacent detection sites 2 on the same puncture needle body 51 is also 1 mm. That is to say, the distance between each detection site 2 and its adjacent detection site 2 in the horizontal or vertical direction is 1 mm.

[0074] Therefore, it can be understood that through the above structure, the spinal puncture electrode has 16 detection sites 2 with two-dimensional distribution, which can monitor the neuroelectrophysiological signals in the length and depth directions of the entry zone, so as to accurately determine the position of abnormal tissues, and can provide quantitative and objective guidance for the ablation position for the operator, thereby improving the surgical efficacy and reducing complications.

[0075] In an embodiment of the present application, the electrode puncture head 50 includes a flexible substrate layer 1, detection sites 2 arranged on the puncture needle bodies 51, a metal wiring layer 3, an output pad 4, a first insulating layer 5, a support layer 6, and a second insulating layer 7. Among them, the flexible substrate layer 1, the metal wiring layer 3, the first insulating layer 5, the support layer 6, and the second insulating layer 7 are arranged in sequence from bottom to top.

[0076] Among them, the flexible substrate layer 1 is the first layer of the entire electrode. It has excellent biocompatibility and a thickness between 4 and 6 micrometers. The flexible substrate layer 1 is a polyimide substrate, that is, made of polyimide, which plays an insulating role at the bottom and has good adhesion to the metal wiring layer 3 above it. Detection sites 2 and lead pads 4 are etched at the tails of the puncture needle body 51 and the electrode puncture head 50 respectively, and the metal wiring layer 3 at these positions will be exposed to receive neural electrical signals.

[0077] The metal wiring layer 3 is the second layer of the entire electrode, with an overall thickness range of 75 - 125 nanometers. It plays a role in connecting the detection sites 2 and lead pads 4 of each channel of the electrode in a one-to-one correspondence. The metal used in the metal wiring layer 3 has a three-layer structure, which are a titanium layer 8, a platinum layer 9, and a gold layer 10 from bottom to top, with thicknesses of 10 ± 5 nanometers, 50 ± 10 nanometers, and 50 ± 10 nanometers respectively. Among them, the titanium layer 8 serves as an adhesion layer for the platinum layer 9. At the positions where the detection sites 2 and lead pads 4 expose the metal wiring layer 3, the titanium layer 8 will be selectively removed to enable the platinum layer 9 to be the metal actually in contact with neural tissue, because the interface of the platinum layer 9 has a lower electrochemical impedance and can have a higher signal-to-noise ratio when collecting electrophysiological signals. The topmost gold layer 10 plays a role in reducing the resistance of the metal wiring layer 3 itself, and its good ductility enables the metal wiring layer 3 to still be electrically conductive under certain bending conditions.

[0078] The first insulating layer 5 is the third layer of the entire electrode, with a thickness of 2 micrometers and made of parylene. The first insulating layer 5 completely covers the metal wiring layer 3 to prevent the metal wiring layer 3 from being short-circuited due to contact with body fluids in the body. Parylene has good biosecurity.

[0079] The support layer 6 is the fourth layer of the entire electrode, with a thickness of about 15 to 20 micrometers and made of nickel. The support layer 6 can make the puncture needle body 51 rigid so that it can better penetrate into the spinal cord. At the same time, the support layer 6 has good toughness, so that the puncture needle body 51 will not break under a large-angle bend, greatly reducing the risk of electrode breakage during the operation. The support layer 6 forms a positioning groove 30 at some positions in the electrode puncture head 50 to achieve the positioning and assembly of the electrode with its protective housing.

[0080] The second insulating layer 7 is the fifth layer of the entire electrode, with a thickness of 2 micrometers and made of parylene C. The second insulating layer 7 completely covers the support layer 6 to prevent it from direct contact with body fluids, playing a role in enhancing the biocompatibility of the device.

[0081] Refer to Figure 5 and Figure 6As shown, in the embodiment of the present application, the spinal puncture electrode further includes a circuit adapter for connecting to an electrophysiological monitoring device, and a flexible extension circuit 51 connected between the electrode puncture head 50 and the circuit adapter.

[0082] In the embodiment of the present application, the flexible extension circuit 51 includes an insulating substrate 11, a connection circuit 12, an insulating package 13, a flexible cable pad 14, a transfer pad 15, and a reinforcing plate 16. The length of the flexible extension circuit 51 in the present application is 5 to 10 cm, but this is not restrictive. The flexible extension circuit 51 can also be set to a longer length. By means of the flexible extension circuit 51, the distance between the electrode puncture head 50 and the circuit adapter can be increased, enhancing the flexibility of the operation.

[0083] Among them, both the insulating substrate 11 and the insulating package 13 are 10-μm polyimide films. The two layers of polyimide wrap the connection circuit 12, preventing the connection circuit 12 from short-circuiting when encountering liquid. The flexible cable pad 14 and the transfer pad 15 are provided at both ends of the flexible extension circuit 51. Here, the insulating package 13 will be selectively removed to expose the connection circuit 12, enabling the flexible cable pad 14 and the transfer pad 15 to make their respective connections.

[0084] The reinforcing plate 16 is a polyimide block with a thickness ranging from 200 μm to 1 mm, which can enhance the mechanical strength at the transfer pad 15.

[0085] Refer to Figure 7 As shown, in the embodiment of the present application, when the electrode puncture head 50 is connected to the flexible extension circuit 51, an anisotropic conductive film 17 is provided between the lead-out pad 4 and the flexible cable pad 14. The anisotropic conductive film 17 can achieve electrical interconnection in the vertical direction under the action of heat and pressure, while remaining insulated in the horizontal direction. Therefore, one-to-one connection between the lead-out pad 4 and the flexible cable pad 14 can be achieved. After the anisotropic conductive film 17 is fixed on the flexible cable pad 14 of the flexible extension circuit 51, the lead-out pad 4 of the electrode puncture head 50 and the flexible cable pad 14 of the flexible extension circuit 51 are aligned under a microscope, and finally a hot press is used to make them electrically conductive in the vertical direction.

[0086] Refer to Figure 8 As shown, in the embodiment of the present application, the circuit adapter includes a circuit board 18, a flip connector 20, a pin 22 interface 21, and pins 22. Through the circuit adapter, the transfer pad 15 in the flexible extension circuit 51 can be converted into a DuPont pin interface 21, facilitating connection to an electrophysiological monitoring device.

[0087] The flip connector 20 and the pin header interface 21 are welded on the circuit board 18. The flip connector 20 is a flip device that can be clamped and released to provide a conductive mechanical clamping for the transfer pad 15 in the flexible extension circuit 51, thereby achieving electrical connection between the transfer pad 15 and the flip connector 20. In the embodiment of the present application, the pin header interface 21 is set to a 2.54mm pitch DuPont line pin header commonly seen on a PCB circuit board, which has good mechanical fixing performance and can achieve repeated plug-in and unplug connections.

[0088] Circuit board positioning holes 19 are provided on both sides of the circuit board 18 , and the circuit board positioning holes 19 can be used for positioning and fixing with the circuit board fixing housing.

[0089] Reference Figure 9 As shown, in the embodiment of the present application, the lead wire 25 connected between the spinal puncture electrode and the electrophysiological monitoring device includes a female connector 23, a jack 24, a lead wire 25 cable, and a socket interface 26. The lead wire 25 also plays a role of transfer, and can transfer the pin connector 21 on the circuit board 18 to the socket interface 26 dedicated to various intraoperative electrophysiological monitoring devices. In the present application, the jack 24 is set as a DuPont line jack 24.

[0090] Among them, the female connector 23 realizes a reliable connection that can be plugged and unplugged multiple times with the pin connector 21 on the circuit board 18 through the jack 24 thereon; the lead wire 25 cable is 0.5 meters to 1.5 meters long, and the longer distance can increase the flexibility of intraoperative operation, and the lead wire 25 cable has a shielding layer inside to reduce external electromagnetic interference during long-distance signal transmission.

[0091] Reference Figure 10 , Figure 11 and Figure 12 As shown, in the embodiment of the present application, the spinal puncture electrode also includes an electrode protection shell covering the outside of the electrode puncture head 50 and an adapter fixing shell covering the outside of the circuit adapter; the electrode protection shell and the adapter fixing shell are both manufactured in an integrated manner using a printer.

[0092] In an embodiment of the present application, the electrode protective shell includes a first protective shell 27 and a second protective shell 31 that can form a mutual snap-fit ​​fit. The first protective shell 27 and the second protective shell 31 are arranged opposite to each other, and the lead-out pad 4 and the wiring pad 14 are located between the two. The first protective shell 27 is provided with a limiting side wall 28 and a protective shell positioning hole 29 on the side facing the second protective shell 31, and the limiting side wall 28 is integrally formed with the first protective shell 27; the second protective shell 31 is provided with a first positioning column 32 and a first buckle 33 on the side facing the first protective shell 27, and the first positioning column 32 and the first buckle 33 are both integrally formed with the second protective shell 31, and the first positioning column 32 is plugged and adapted with the protective shell positioning hole 29.

[0093] The first protective shell 27 and the second protective shell 31 are connected to each other through the first buckle 33. The folded portion of the first buckle 33 has a size of 0.5 to 1 mm, and there is a gap of 1 mm between the side wall at the bottom of the first buckle 33 and the limiting side wall 28 of the first protective shell 27. Such a structure allows the friction between the first protective shell 27 and the second protective shell 31 to be small after being connected, so that the first protective shell 27 can be pulled out from the side.

[0094] The first protective shell 27 and the limiting side wall 28 together play a role in positioning the electrode puncture head 50. At the same time, the protective shell positioning hole 29, the first positioning column 32 on the second protective shell 31, and the positioning groove 30 on the electrode puncture head 50 are consistent in size and are nested in each other during assembly to achieve positioning and fixation of the electrode.

[0095] In the embodiment of the present application, the fixed housing of the converter includes a first fixed housing 34 and a second fixed housing 36 that can form a mutually snap-fitting fit, the first fixed housing 34 and the second fixed housing 36 are arranged opposite to each other, the circuit board 18 and the transfer pad 15 are located between the two, the first fixed housing 34 is provided with a second positioning column 35 on the side facing the second fixed housing 36, the second fixed housing 36 is provided with a second buckle 37 on the side facing the first fixed housing 34, and the second fixed housing 36 is provided with an electrode protection shell sleeve 38 on the side away from the second buckle 37, and the second buckle 37 and the electrode protection shell sleeve 38 are both integrally formed with the second fixed housing 36. It is also possible that the electrode protection shell sleeve 38 is arranged on the side of the first fixed housing 34 away from the second fixed housing 36.

[0096] Similarly, the first fixed housing 34 and the second fixed housing 36 are connected to each other through the second buckle 37, but for a more secure connection, the size of the folded portion of the second buckle 37 is 2 mm, and the side wall at the bottom thereof is equivalent to the actual height of the first fixed housing 34, without redundancy. Since the fixed housing of the converter has a certain toughness, the two parts can still be separated from the side under a small deformation.

[0097] The electrode protection shell sleeve 38 is a sleeve with side plates and an opening at the bottom. Its internal dimensions are larger than those of the assembled electrode protection shell, and it can be used to accommodate the electrode puncture head 50 and the electrode protection shell, preventing the electric puncture needle body 51 from being damaged by collisions and the like. The opening at the bottom facilitates the passage of the flexible extension circuit 51.

[0098] When assembling the electrode protection shell, first align the positioning groove 30 of the electrode puncture head 50 with the protection shell positioning hole 29 in the first protection shell 27, and then press the second electrode protection shell from above. The two are fixed to each other through the first buckle 33. At the same time of fixation, the first positioning post 32 on the second electrode protection shell will press the positioning groove 30 on the electrode puncture head 50 to achieve the fixation of the electrode.

[0099] When assembling the converter fixing shell, first align the protection shell positioning hole 29 of the circuit board 18 with the second positioning post 35 on the first fixing shell 34, and then press the second fixing shell 36 from above. The two are fixed to each other through the second buckle 37.

[0100] Refer to Figure 13 、 Figure 14 and Figure 15 As shown in

[0101] In the embodiment of the present application, an abnormal tissue monitoring system is also disclosed, which is used during the spinal dorsal root entry zone lesioning operation. The abnormal tissue monitoring system includes any one of the above-mentioned spinal puncture electrodes;

[0102] An electrophysiological monitoring device, communicatively connected to the spinal puncture electrode, for receiving the neuroelectrophysiological signals in the length and depth directions of the spinal dorsal root entry zone collected by the multiple detection sites, and confirming the location of the abnormal tissue in the spinal dorsal root entry zone according to the neuroelectrophysiological signals and the positions of the multiple detection sites in the spinal dorsal root entry zone; the electrophysiological monitoring device is configured to be able to be equipped with one or more of the spinal puncture electrodes at the same time;

[0103] An adjusting mechanism for supporting and adjusting the spinal puncture electrode.

[0104] Further, the adjusting mechanism includes a bearing member and a support frame for installing the spinal puncture electrode.

[0105] Among them, the assembly sleeve 39 is provided with a first screw hole 40, and sleeve side walls 41 are fixed on both sides. The slider 42 is provided with a second threaded hole.

[0106] Specifically, four first threaded holes and four second threaded holes are provided. The four first screw holes 40 and the four second screw holes 44 can be fixed using M4 screws. The side wall 41 of the sleeve is open in the front to facilitate the insertion and removal of the assembled converter housing, and is open in the lower part to facilitate the exposure of the flip connector 20 and the passage of the flexible extension circuit 51.

[0107] The pulley 43 has a recessed structure to prevent it from slipping out of the slide rail 49 while sliding.

[0108] Furthermore, the support frame includes: a fixed pedestal 45, a support column 46, an adjustable connector 47, a slide rail fixing rod 48, and a slide rail 49. The support frame can adjust the slide rail 49 vertically and horizontally.

[0109] Among them, the fixed pedestal 45 is a steel weight, which can play a role in reducing the center of gravity of the support frame to prevent it from tipping over. The support column 46 is arranged vertically; the adjustable connector 47 is installed between the support rod and the slide rail fixing rod 48. The adjustable connector 47 can slide along the length direction of the support column 46 and be locked. The slide rail fixing rod 48 is arranged horizontally, and the slide rail fixing rod 48 can slide relative to the adjustable connector 47 along the horizontal direction and be position-locked by the adjustable connector 47. The slide rail 49 is installed horizontally at one end of the slide rail fixing rod 48. The adjustable connector 47 has a connecting seat and a hand-tightening screw. Both the support column 46 and the slide rail fixing rod 48 are slidably connected to the connecting seat. After sliding to the appropriate position, tightening the hand-tightening screw can clamp it at this position, thereby realizing the adjustment of the position of the slide rail 49. As for the connection between the slide rail fixing rod 48 and the slide rail 49, they can be connected through the adjustable connector 47 or directly fixedly connected.

[0110] The slide rail 49 is a workpiece made of an aluminum alloy layer 10 with a length of 0.5 to 1 meter. It is relatively light in weight, and even if the slide rail 49 is adjusted to the most front upper position, the support frame will not tip over. Multiple electrode modules can exist on the slide rail 49 at the same time and are allowed to slide left and right to realize the simultaneous detection of multi-position intraoperative neuroelectrophysiological signals.

[0111] Refer to Figure 14 As shown, after fixing the assembled sleeve 39 and the slider 42, the previously assembled spinal puncture electrode is placed into the assembled sleeve 39, which is the electrode module. The electrode protection housing can be placed into the electrode protection shell sleeve 38 to accommodate the electrode.

[0112] In the embodiment of the present application, a preparation method for a spinal puncture electrode is also disclosed, including the following steps: sequentially depositing 10 nanometers of titanium and 500 nanometers of aluminum on a silicon wafer using magnetron sputtering as a sacrificial layer for release;

[0113] Spin-coat a layer of polyimide with a thickness of 4 to 6 microns;

[0114] On the polyimide layer, spin-coat a photoresist, and then successively perform photolithography and development processes to process a photoresist with the same shape as the flexible substrate layer 1 in design, and transfer the pattern to the polyimide layer through reactive ion etching;

[0115] Use acetone to remove the residual photoresist after etching, spin-coat the photoresist again, and then successively perform photolithography and development processes to process a photoresist with the same shape as the designed metal wiring layer 3;

[0116] Using the magnetron sputtering deposition method, successively deposit a 10-nanometer titanium layer 8, a 50-nanometer platinum layer 9, and a 50-nanometer gold layer 10. After the deposition is completed, use acetone to dissolve and strip the photoresist to obtain a conductive pattern on the polyimide layer;

[0117] Chemically vapor deposit parylene to fabricate the first insulating layer 5, and at this time, no patterning is performed;

[0118] Using the magnetron sputtering deposition method, successively deposit 10 nanometers of titanium and 50 nanometers of copper as electroplating seed layers;

[0119] Spin-coat the photoresist again, and then successively perform photolithography and development processes to process a photoresist with the same shape as the designed support layer 6;

[0120] Through the method of direct current electroplating, electroplate about 15 microns of nickel, and then selectively etch away the titanium and copper seed layers to obtain the patterned support layer 6.

[0121] Chemically vapor deposit parylene to coat the exposed support layer 6 for the second insulating layer 7, and cut the chemically vapor deposited parylene twice by laser cutting to define the overall shape of the electrode puncture head 50;

[0122] Use the method of electrolytic aluminum to release the electrode from the silicon wafer.

[0123] The remaining components are processed and manufactured externally using the designed drawings.

[0124] Connect and assemble the prepared electrode puncture head 50, flexible extension circuit 51, circuit converter, electrode protection housing, circuit adapter board fixing housing, assembly sleeve 39, and slider 42 to prepare the electrode module. Multiple electrode modules can be installed on the support frame to complete the construction of the overall device. The overall device is sterilized with ethylene oxide before surgery.

[0125] Those skilled in the art will readily conceive of other embodiments of the present application after considering the specification and practicing the embodiments of the present application. The present application is intended to cover any variations, uses, or adaptations of the present application, which follow the general principles of the present application and include well-known common general knowledge or conventional technical means in the technical field of the present application that are not claimed in the present application. The specification and embodiments are only regarded as exemplary, and the true scope and spirit of the present application are pointed out by the appended claims.

Claims

1. A spinal puncture electrode, characterized in that: Used to puncture the dorsal root insertion area of ​​the spinal cord during spinal cord dorsal root insertion area ablation surgery, the spinal cord puncture electrode includes an electrode puncture head, and the electrode puncture head is provided with a plurality of detection sites distributed in two dimensions along its horizontal axis and longitudinal axis directions, and the plurality of detection sites are used to collect neuroelectrophysiological signals in the length and depth directions of the dorsal root insertion area of ​​the spinal cord during the spinal cord dorsal root insertion area ablation surgery; The intraoperative electrophysiological monitoring device communicatively connected to the spinal puncture electrode is used to receive the neuroelectrophysiological signal and confirm the abnormal tissue position in the spinal dorsal root insertion area according to the neuroelectrophysiological signal and the positions of the multiple detection sites in the spinal dorsal root insertion area.

2. The spinal cord puncture electrode according to claim 1, characterized in that: The electrode puncture head comprises a plurality of puncture needle bodies arranged at intervals along the horizontal axis direction, and each puncture needle body is provided with a plurality of detection sites at intervals along its longitudinal axis; when the electrode puncture head punctures the spinal dorsal root entry area, the horizontal axis direction of the electrode puncture head is consistent with the length direction of the spinal dorsal root entry area, and the longitudinal axis direction of the electrode puncture head is consistent with the depth direction of the spinal dorsal root entry area.

3. The spinal cord puncture electrode according to claim 1, characterized in that: The electrode puncture head includes a flexible substrate layer, a metal wiring layer and a first insulating layer from bottom to top; the detection site is arranged on the metal wiring layer and the metal wiring layer is exposed by etching at a corresponding position on the lower surface of the flexible substrate layer, and the first insulating layer completely covers the upper surface of the metal wiring layer.

4. The spinal cord puncture electrode according to claim 3, characterized in that: The electrode puncture head further comprises a support layer and a second insulating layer, wherein the support layer is arranged on the first insulating layer, and the second insulating layer completely covers the upper surface of the support layer.

5. The spinal cord puncture electrode according to claim 4, characterized in that: The flexible substrate layer is a polyimide substrate; And / or, the metal wiring layer includes a titanium layer, a platinum layer and a gold layer from bottom to top, the titanium layer serves as an adhesion layer for the platinum layer, and at the location of the detection site, the titanium layer is selectively removed to expose the platinum layer for contact with the nerve tissue of the dorsal root insertion area of ​​the spinal cord; And / or, the first insulating layer is a polyparaxylene insulating layer; And / or, the support layer is a nickel support layer; And / or, the second insulating layer is a polyparaxylene passivation layer.

6. The spinal cord puncture electrode according to claim 3, characterized in that: It also includes a circuit adapter, a lead wire connected between the circuit adapter and the electrophysiological monitoring device, and a flexible extension circuit connected between the electrode puncture head and the circuit adapter.

7. The spinal cord puncture electrode according to claim 6, characterized in that: The electrode puncture head also includes a plurality of lead pads, which are connected to the plurality of detection sites in a one-to-one correspondence through the metal wiring layer; the flexible extension circuit includes a plurality of wiring pads, which are connected to the plurality of wiring pads in a one-to-one correspondence.

8. The spinal cord puncture electrode according to claim 7, characterized in that: The flexible extension circuit also includes: A transfer pad, used to connect to the circuit adapter, wherein the transfer pad is provided in plurality, and the plurality of transfer pads correspond one-to-one to the plurality of wiring pads; The connecting circuit is used to connect the corresponding wiring pads and the transfer pads.

9. The spinal cord puncture electrode according to claim 8, characterized in that: The circuit adapter comprises: Circuit boards; A flip connector, mounted on the circuit board, capable of clamping or releasing the transfer pad; A pin header interface is installed on the circuit board, and the pin header interface is electrically connected to the transfer pad through the circuit board; A pin header is fixedly connected to the pin header interface and is used for connecting to the lead wire.

10. The spinal cord puncture electrode according to claim 9, characterized in that: It also includes an electrode protection shell which is covered on the outside of the electrode puncture head and an adapter fixing shell which is covered on the outside of the circuit adapter.

11. The spinal cord puncture electrode according to claim 10, characterized in that: The electrode protection shell comprises a first protection shell and a second protection shell, the lead pad and the wiring pad are located between the first protection shell and the second protection shell, and the first protection shell and the second protection shell are engaged with each other; And / or, the adapter fixed shell includes a first fixed shell and a second fixed shell, the circuit board and the adapter pad are located between the first fixed shell and the second fixed shell, and the first fixed shell and the second fixed shell are snap-fitted with each other.

12. The spinal cord puncture electrode according to claim 11, characterized in that: An electrode protection shell sleeve is fixedly arranged on the outer side of the first fixed shell or the second fixed shell, and the electrode protection shell can be inserted into the electrode protection shell sleeve.

13. An abnormal tissue monitoring system, characterized in that: Used in spinal cord dorsal root entry zone ablation surgery, the abnormal tissue monitoring system comprises: The spinal cord puncture electrode according to any one of claims 1 to 12; an electrophysiological monitoring device, which is in communication connection with the spinal puncture electrode, and is used to receive the neuroelectrophysiological signals of the length and depth direction of the spinal dorsal root insertion area collected by the multiple detection sites, and to confirm the abnormal tissue position of the spinal dorsal root insertion area according to the neuroelectrophysiological signals and the positions of the multiple detection sites in the spinal dorsal root insertion area; the electrophysiological monitoring device is configured to be equipped with one or more of the spinal puncture electrodes at the same time; The adjusting mechanism is used for supporting and adjusting the spinal cord puncture electrode.

14. The abnormal tissue monitoring system according to claim 13, characterized in that: The adjustment mechanism includes a load-bearing member and a support frame; The bearing member is used to bear the spinal puncture electrode, and the bearing member comprises: an assembly sleeve, a slider and a pulley, the spinal puncture electrode is mounted on the assembly sleeve, the assembly sleeve is fixedly connected to one side of the slider, and the pulley is rotatably connected to the side of the slider away from the assembly sleeve; The support frame comprises: a support column, an adjustable connector, a slide rail fixing rod and a slide rail; The support column is arranged along the vertical direction; The adjustable connector is installed between the support column and the slide rail fixing rod, and the adjustable connector can slide and lock along the length direction of the support column; The slide rail fixing rod is arranged in the horizontal direction, and the slide rail fixing rod can slide relative to the adjustable connector in the horizontal direction and be locked in position through the adjustable connector; The slide rail is installed at one end of the slide rail fixing rod in a horizontal direction, and the pulley is located in the slide rail so that the slider can roll along the length direction of the slide rail.

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