Sheet electrode and implantation device

Abstract

The utility model provides a sheet-shaped electrode and an implantation device, the sheet-shaped electrode comprises an electrode slice, the surface of the electrode slice is provided with an electrode contact, the electrode slice has flexibility, and the electrode slice can be curled and contracted into a cylindrical shape matched with a pushing catheter, or the electrode slice can be unfolded into a sheet shape outside the pushing catheter; and the electrode wire is connected to one end of the electrode plate, the electrode wire is electrically connected with the electrode contact, the electrode wire can be arranged in the pushing catheter or the withdrawing catheter in a penetrating manner, and the electrode wire is used for dragging the electrode plate, so that the electrode plate and the withdrawing catheter are matched with each other and are curled and contracted in the withdrawing catheter. Surgical operations such as laminectomy or laminotomy are not needed in the implanting operation process, the invasive property is small, trauma and operation risks are reduced, and the sheet-shaped electrode plates are not prone to displacement. In addition, the electrode plate can be withdrawn from the body along with the withdrawing catheter, and withdrawing and recycling of the electrode plate are achieved.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a sheet electrode and implantation device. Background Technology

[0002] Chronic pain is characterized by its complex causes and pathogenesis, long duration, and diverse treatment methods, yet its clinical efficacy remains unsatisfactory, making it a widely concerned medical and social problem. In recent years, neuromodulation techniques, such as spinal cord stimulation (SCS), have gained increasing attention from pain physicians for the treatment of chronic pain.

[0003] In related technologies, surgical electrodes typically have 16 contacts arranged in various patterns, supporting complex stimulation patterns and providing a large lateral stimulation coverage, making them suitable for pain in specific areas. However, surgical electrodes require surgical placement or removal through procedures such as laminectomy or laminatomy, which carries significant surgical risks. Utility Model Content

[0004] The technical problem to be solved by this utility model is to provide a sheet electrode and an implantation device, which aims to solve the problem that surgical electrodes in related technologies need to be placed or retrieved through surgical procedures.

[0005] To address the aforementioned technical problems, the first aspect of this utility model provides a sheet-like electrode for use in conjunction with a push or pull catheter of an implantation device for implantation into or removal from the body. The sheet-like electrode comprises:

[0006] The electrode sheet has electrode contacts on its surface. The electrode sheet is flexible and can be rolled up and contracted into a cylindrical shape adapted to the push-through conduit; alternatively, the electrode sheet can be unfolded into a sheet shape outside the push-through conduit.

[0007] An electrode wire is connected to one end of the electrode plate and is electrically connected to the electrode contact. The electrode wire can be inserted into the push conduit or the retraction conduit. The electrode wire is used to drag the electrode plate so that the electrode plate and the retraction conduit cooperate to curl and retract within the retraction conduit.

[0008] Optionally, the end of the electrode plate connected to the electrode wire is provided with a guide bevel, which is used to guide the electrode plate into the retraction conduit.

[0009] Optionally, the electrode sheet has a first side connected to the electrode wire, a second side connected to one end of the first side, and a third side connected to the other end of the first side and disposed opposite to the second side, wherein the second side is inclined toward the first side and / or the third side is inclined toward the first side to form the guide bevel.

[0010] Optionally, the end of the electrode sheet away from the electrode wire is arc-shaped.

[0011] Optionally, the electrode sheet includes a sheet-shaped flexible circuit board, the electrode contacts are disposed on the surface of the flexible circuit board, and the electrode wires are connected to the flexible circuit board.

[0012] Optionally, the electrode sheet further includes a sheet-shaped substrate, and the flexible circuit board is disposed on the substrate, the substrate being flexible.

[0013] Optionally, the electrode contacts are provided in multiples, and the multiple electrode contacts are distributed at intervals.

[0014] Optionally, the electrode sheet has a stimulation area and a blank area adjacent to the stimulation area, the electrode contact is located within the stimulation area, and the blank area is located at the end of the electrode sheet connected to the electrode wire.

[0015] Optionally, the sheet electrode further includes an electrode contact, which is disposed at the end of the electrode wire away from the electrode sheet, and the electrode contact is electrically connected to the electrode wire.

[0016] The second aspect of this utility model provides an implantation device, comprising:

[0017] The puncture device has a through puncture channel;

[0018] A delivery catheter, which can be inserted into the puncture channel, is used to implant the sheet electrode as described above into the body; and...

[0019] A retraction catheter may be inserted into the puncture channel, and the retraction catheter is used to withdraw the sheet electrode as described above from the body.

[0020] Compared with related technologies, the sheet electrode and implantation device of this invention have the following advantages: During the implantation procedure, the electrode sheet is first rolled and retracted into a cylindrical shape and placed inside the delivery catheter. Then, the delivery catheter is pushed along the puncture channel of the trocar to the spinal nerve distribution area. Afterward, the electrode sheet is pushed outside the delivery catheter, and the electrode sheet naturally unfolds into a sheet shape, completing the implantation of the electrode sheet. This surgical procedure does not require laminectomy or laminatomy, and is less invasive, reducing trauma and surgical risks. Furthermore, the sheet electrode sheet is less prone to displacement. In addition, after the surgery, the retraction catheter can be moved along the puncture channel of the trocar to the spinal nerve distribution area. Then, the electrode sheet is dragged by the electrode wire, so that the electrode sheet and the retraction catheter cooperate to roll and retract within the retraction catheter, thereby being withdrawn from the body along with the retraction catheter, achieving the removal and retrieval of the electrode sheet. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this utility model or related technologies, the drawings used in the description of the embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of the sheet electrode provided in this embodiment of the utility model;

[0023] Figure 2 This is a schematic diagram of the electrode sheet curling and retracting inside the push tube in an embodiment of this utility model;

[0024] Figure 3 yes Figure 2 A schematic diagram of the cross-section;

[0025] Figure 4 This is a schematic diagram of the electrode sheet portion curling and retracting within the retraction conduit in an embodiment of this utility model;

[0026] Figure 5 This is a schematic diagram of the electrode sheet being completely rolled up and retracted inside the retraction conduit in an embodiment of this utility model;

[0027] Figure 6 yes Figure 5 A schematic diagram of the cross-section;

[0028] Figure 7 This is a schematic diagram of the catheter being pushed to the spinal nerve distribution area during the implantation process of this utility model embodiment;

[0029] Figure 8 This is a schematic diagram of the electrode pads unfolding in the spinal nerve distribution area during the implantation process of this utility model embodiment;

[0030] Figure 9 This is a schematic diagram of the electrode pad being implanted according to an embodiment of this utility model;

[0031] Figure 10 This is a schematic diagram of the retraction catheter moving to the spinal nerve distribution area during the retraction process of this utility model embodiment;

[0032] Figure 11 This is a schematic diagram of the electrode sheet being completely rolled up and contracted inside the retraction guide tube during the retraction process of this utility model embodiment.

[0033] In the accompanying drawings, the reference numerals represent: 1. puncture device; 2. push catheter; 3. retraction catheter; 4. sheet electrode; 41. electrode sheet; 411. guide bevel; 412. first side; 413. second side; 414. third side; 415. stimulation area; 416. blank area; 42. electrode lead; 43. electrode contact; 44. electrode tip. Detailed Implementation

[0034] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without inventive effort are within the scope of protection of this utility model.

[0035] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "circumferential", "radial", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0036] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this utility model, "a plurality of" or "several" means two or more, unless otherwise explicitly specified.

[0037] Example:

[0038] Please see Figure 1 , Figures 7 to 11 This utility model provides an implantation device, including a puncture device 1, a pushing catheter 2, and a withdrawing catheter 3. The puncture device 1 has a through puncture channel, used to puncture the spinal nerve distribution area, thereby establishing a puncture channel to the spinal nerve distribution area. The pushing catheter 2 can be inserted into the puncture channel and is used to implant a sheet electrode 4 into the body. The withdrawing catheter 3 can be inserted into the puncture channel and is used to withdraw the sheet electrode 4 from the body, thereby realizing the surgical implantation and postoperative retrieval of the sheet electrode 4. The puncture device 1 can be a percutaneous puncture device, and both the pushing catheter 2 and the withdrawing catheter 3 are flexible tubes with a certain degree of flexibility, ensuring that they can be pushed into the target spinal cord segment.

[0039] Please see Figures 1 to 6 The sheet electrode 4 includes an electrode sheet 41 and an electrode wire 42. The surface of the electrode sheet 41 is provided with electrode contacts 43. The electrode sheet 41 is flexible and can be rolled up and contracted into a cylindrical shape that fits the delivery catheter 2. This allows the electrode sheet 41 to be placed inside the delivery catheter 2 after being rolled up and contracted into a cylindrical shape, thus allowing it to follow the delivery catheter 2 into the spinal nerve distribution area. Alternatively, the electrode sheet 41 can be unfolded into a sheet shape outside the delivery catheter 2, allowing it to automatically unfold after being pushed out of the delivery catheter 2, thus achieving implantation of the electrode sheet 41. The electrode wire 42 is connected to one end of the electrode sheet 41 and is electrically connected to the electrode contacts 43. The electrode wire 42 can be inserted into either the delivery catheter 2 or the retraction catheter 3. The electrode wire 42 is used to drag the electrode sheet 41 so that the electrode sheet 41 cooperates with the retraction catheter 3 to roll up and contract within the retraction catheter 3, thereby withdrawing from the body along with the retraction catheter 3, achieving the withdrawal and retrieval of the electrode sheet 41.

[0040] During the implantation surgery, such as Figure 2 and Figure 3 As shown, the electrode pad 41 is first rolled and retracted into a cylindrical shape and placed inside the delivery catheter 2. Then, the delivery catheter 2 is pushed along the puncture channel of the trocar 1 to the spinal nerve distribution area. Afterward, the electrode pad 41 is pushed outside the delivery catheter 2, and the electrode pad 41 naturally unfolds into a sheet shape, completing the implantation of the electrode pad 41. This surgical procedure does not require laminectomy or laminatomy, and is minimally invasive, reducing trauma and surgical risks. Furthermore, the sheet-shaped electrode pad 41 is less prone to displacement. In addition, after the surgery, the retraction catheter 3 can be moved along the puncture channel of the trocar 1 to the spinal nerve distribution area, such as... Figure 4 , Figure 5 and Figure 6As shown, the electrode plate 41 is then dragged by the electrode wire 42 so that the electrode plate 41 and the retraction conduit 3 cooperate to curl and retract inside the retraction conduit 3, thereby withdrawing from the body along with the retraction conduit 3, realizing the withdrawal and recovery of the electrode plate 41.

[0041] Please see Figure 1 and Figure 4 One end of the electrode plate 41 connected to the electrode wire 42 is provided with a guide bevel 411. The guide bevel 411 is used to guide the electrode plate 41 into the retraction conduit 3. The guide bevel 411 facilitates the curling and retraction of the electrode plate 41 within the retraction conduit 3. For example, Figure 4 As shown, when the electrode wire 42 drags the electrode plate 41 to abut against the contour of the retraction conduit 3, the guide bevel 411 can guide the electrode plate 41 into the retraction conduit 3, reducing the resistance generated when the electrode plate 41 contacts the retraction conduit 3.

[0042] It should be noted that when the electrode wire 42 drags the electrode plate 41 to abut against the contour of the retraction conduit 3, the edge of the electrode plate 41 will rotate and fold along the contour of the retraction conduit 3, thereby curling and shrinking inside the retraction conduit 3.

[0043] Please see Figure 1 and Figure 4 In some embodiments, the electrode sheet 41 has a first side 412 connected to the electrode wire 42, a second side 413 connected to one end of the first side 412, and a third side 414 connected to the other end of the first side 412 and disposed opposite to the second side 413. The second side 413 is inclined toward the first side 412 and / or the third side 414 is inclined toward the first side 412 to form a guide bevel 411. Preferably, the second side 413 is inclined toward the first side 412 and the third side 414 is inclined toward the first side 412 to form the guide bevel 411, that is, the end of the electrode sheet 41 connected to the electrode wire 42 is in the shape of a trumpet, which can further reduce the resistance generated when the electrode sheet 41 contacts the retraction conduit 3.

[0044] Please see Figure 1 The end of the electrode pad 41 away from the electrode wire 42 is arc-shaped, preferably circular arc-shaped, which can reduce the damage to the spinal nerves caused by the electrode pad 41 when the push catheter 2 is pushed out.

[0045] The electrode sheet 41 includes a sheet-shaped flexible circuit board. Electrode contacts 43 are disposed on the surface of the flexible circuit board, which facilitates the fabrication of the electrode contacts 43. Electrode wires 42 are connected to the flexible circuit board, meaning the flexible circuit board is electrically connected to both the electrode wires 42 and the electrode contacts 43, thereby supplying power to the electrode contacts 43. Multiple electrode contacts 43 are provided, spaced apart. Multiple electrode wires 42 are also provided, with each electrode contact 43 electrically connected to a corresponding electrode wire 42 via the flexible circuit board. This ensures that the individual electrode contacts 43 do not interfere with each other, facilitating precise electrical stimulation.

[0046] Depending on actual needs, electrode contacts 43 can be configured with eight, sixteen, etc., for example, Figure 1 As shown, when there are sixteen electrode contacts 43, the electrode contacts 43 can be arranged in three rows, with six in the middle row and five in each of the other two rows.

[0047] The electrode sheet 41 also includes a sheet-shaped substrate, on which a flexible circuit board is disposed. The substrate is flexible to ensure that the electrode sheet 41 can be rolled up and retracted within the push conduit 2 or the retraction conduit 3, and can be unfolded into a sheet shape outside the push conduit 2. The substrate can be made of an insulating, soft film material, for example, silicone. The substrate and the flexible circuit board can be stacked, with the electrode contacts 43 disposed on the surface of the flexible circuit board away from the substrate; alternatively, the flexible circuit board is disposed within the substrate, and the electrode contacts 43 are exposed on the surface of the substrate.

[0048] Please see Figure 1 The electrode sheet 41 has a stimulation area 415 and a blank area 416 adjacent to the stimulation area 415. The electrode contact 43 is located in the stimulation area 415. That is, no electrode contact 43 is set in the blank area 416 of the electrode sheet 41. The blank area 416 is located at the end of the electrode sheet 41 connected to the electrode wire 42. This can avoid setting the electrode contact 43 in the area of ​​the electrode sheet 41 with a high degree of curvature, and improve the service life of the electrode sheet 41.

[0049] Please see Figure 1 The sheet electrode 4 also includes an electrode contact 44, which is located at the end of the electrode wire 42 away from the electrode sheet 41. The electrode contact 44 is electrically connected to the electrode wire 42, and the stimulation source is connected to the sheet electrode 4 through the electrode contact 44. Multiple electrode contacts 44 are provided, and multiple electrode contacts 43 are electrically connected one-to-one to multiple electrode wires 42.

[0050] The following example illustrates in detail the implantation and retrieval process of the sheet electrode 4:

[0051] Before the surgery, puncture localization markings are established. Based on these markings, puncture device 1 is inserted into the spinal nerve distribution area. Anteroposterior and lateral radiographs are taken using C-arm X-rays to confirm the position of puncture device 1. The needle core of puncture device 1 is then withdrawn. Figure 7 and Figure 8 As shown, under C-arm X-ray guidance, the push catheter 2, containing the electrode pad 41, is inserted into the spinal canal through the intersegmental space between the eighth and ninth thoracic vertebrae and along the puncture channel into the epidural space of the spinal cord. After the push catheter 2 reaches the predetermined position, the electrode pad 41 inside the push catheter 2 is slowly withdrawn. After the electrode pad 41 is withdrawn from the push catheter 2, it naturally unfolds into a sheet shape, as shown. Figure 9 As shown, the push catheter 2 is then completely withdrawn, and it is confirmed whether the electrode pad 41 is accurately implanted in the predetermined position and target area.

[0052] Next, prepare a skin incision, withdraw the trocar 1, and insert the electrode lead 42 into the anchoring tool. Gently advance the anchor loader tool by hand until the anchor is in the anchoring position. Push the anchor from the anchor loader tool onto the electrode lead 42 by hand; at this point, the anchor has secured the electrode lead 42.

[0053] Then, the external electrode contact 44 is connected to the external temporary stimulator. The location of stimulation coverage and the degree of pain improvement are observed through the external temporary stimulator. The position of the electrode pad 41 is adjusted according to the test results to achieve the optimal stimulation state. The patient remains awake during the process to cooperate with the test. After a successful test, the patient will return to the ward with the temporary stimulator for a trial period of about two to seven days to observe the improvement in pain and daily life (such as sleep and walking). If the pain relief is good and the patient is satisfied with the treatment effect, a subcutaneous pocket is created during the operation, and the pad electrode 4 is connected to the stimulator through a subcutaneous tunnel. The implantation site of the stimulator is chosen to avoid affecting the patient's function, such as the upper buttock, below the clavicle, or abdomen. After the operation, doctors and professional technicians will use an external programmer to non-invasively set and adjust the spinal cord stimulation system. The patient can also use the configured patient programmer to adjust within the range set by the doctor, which is very convenient and flexible.

[0054] Please see Figure 10 and Figure 11When treatment is completed or electrode pad 41 needs to be replaced, the end of the electrode lead 42 of the sheet electrode 4 is re-punctured through the puncture channel of the puncturist 1 from the original bone hole channel position. After puncture, the end of the electrode lead 42 is passed through the lumen of the retraction catheter 3 and fixed. Then, the retraction catheter 3 enters the spinal nerve distribution area along the puncture channel of the puncturist 1 until it reaches the end where the electrode pad 41 is connected to the electrode lead 42. After that, the fixation of the end of the electrode lead 42 is released, and the end of the electrode lead 42 is dragged so that the electrode pad 41 follows the retraction movement. When the electrode pad 41 moves to abut against the contour of the retraction catheter 3, the edge of the electrode pad 41 will rotate and fold along the contour of the retraction catheter 3, thereby curling and retracting into the retraction catheter 3 until the electrode pad 41 is completely inside the lumen of the retraction catheter 3. Then, the retraction catheter 3 is withdrawn, thereby recovering the sheet electrode 4.

[0055] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A sheet electrode for cooperating with a push or a withdrawal catheter of an implantation device for implantation into or withdrawal from a body, characterized in that The sheet electrode comprises: an electrode sheet provided with electrode contacts on a surface, the electrode sheet being flexible and being capable of being rolled into a cylindrical shape to fit into the push catheter, or being capable of being unfolded into a sheet shape outside the push catheter; and an electrode lead connected to one end of the electrode sheet, the electrode lead being electrically connected to the electrode contacts, the electrode lead being capable of being inserted into the push catheter or the pullback catheter, the electrode lead being used to drag the electrode sheet to be rolled into the pullback catheter together with the pullback catheter.

2. The sheet electrode according to claim 1, characterized by The electrode sheet is provided with a guide bevel at the end connected to the electrode lead, the guide bevel being used to guide the electrode sheet into the pullback catheter.

3. The sheet electrode according to claim 2, characterized by The electrode sheet has a first side connected to the electrode lead, a second side connected to one end of the first side, and a third side connected to the other end of the first side and arranged opposite to the second side, the second side being inclined towards the first side and / or the third side being inclined towards the first side to form the guide bevel.

4. The sheet electrode according to claim 1, characterized by The end of the electrode sheet away from the electrode lead is arc-shaped.

5. The sheet electrode according to claim 1, characterized by The electrode sheet comprises a flexible circuit board in a sheet shape, the electrode contacts being arranged on the surface of the flexible circuit board, and the electrode lead being connected to the flexible circuit board.

6. The sheet electrode according to claim 5, characterized by The electrode sheet further comprises a substrate in a sheet shape, the flexible circuit board being arranged on the substrate, and the substrate being flexible.

7. The sheet electrode according to claim 1, wherein The electrode contacts are provided in a plurality, and the plurality of electrode contacts are arranged at intervals.

8. The sheet electrode according to claim 1, characterized by The electrode sheet is provided with a stimulation area and a blank area adjacent to the stimulation area, the electrode contacts being arranged in the stimulation area, and the blank area being arranged at the end of the electrode sheet connected to the electrode lead.

9. The sheet electrode according to claim 1, characterized by The sheet electrode further comprises an electrode contact head arranged at the end of the electrode lead away from the electrode sheet, the electrode contact head being electrically connected to the electrode lead.

10. An implant device, characterized by The sheet electrode comprises: a puncture device provided with a puncture channel; a push catheter capable of being inserted into the puncture channel, the push catheter being used to implant the sheet electrode into a body according to any one of claims 1-9; and a pullback catheter capable of being inserted into the puncture channel, the pullback catheter being used to withdraw the sheet electrode from the body according to any one of claims 1-9.

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