Stimulating electrode and implantation device

Abstract

The utility model provides a stimulating electrode and an implantation device, and the stimulating electrode comprises an insulating film which is cylindrical and has flexibility, and two ends of the insulating film are communicated to form an accommodating cavity; the electrode contacts are arranged on the surface of the outer side of the insulating film, the number of the electrode contacts is multiple, and the multiple electrode contacts are distributed at intervals; and the wires are arranged on the inner side surface of the insulating film, the wires are not communicated with one another, and the wires are electrically connected to the electrode contacts in a one-to-one correspondence manner. Due to the fact that the insulating film has flexibility, the stimulating electrode can have Young modulus and bending rigidity matched with the brain tissue and is not prone to generating micro-movement in the brain tissue, and therefore it is guaranteed that small damage is caused to the brain tissue. Moreover, the periphery of the stimulating electrode is provided with a plurality of electrode contacts, the contact area between the stimulating electrode and the brain nuclei is large, each electrode contact can be independently controlled, neural electrophysiological signal collection and stimulation at different point positions can be carried out, and the purpose of precise treatment is achieved.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical equipment technical field especially, and it is a kind of stimulating electrode and implantation device. BACKGROUND

[0002] Traditional treatment method of neurological disease includes early and middle period drug therapy and late operation treatment, patient needs to take medicine perennially even for life, this not only causes great economic burden to patient, and the effect of drug therapy can weaken with the different degree of patient physiological drug resistance enhancement. With the development of science and technology, brain deep stimulation (Deep Brain Stimulation, DBS) therapy gradually becomes important neurological disease treatment means, DBS is implanted electrode in brain through operation, and this invasive therapy carries out electric stimulation to brain deep nerve tissue nuclear group through electrode.

[0003] In related art, stimulating electrode is usually long strip rigid insulator, four cylindrical metal contacts are provided on long strip rigid insulator, to form four stimulation modes of monopole to four pole. However, rigid insulator has great difference with cerebral cortex, is easy to produce micro movement in brain tissue, causes greater immune response;And, monopole mode of minimum stimulation area also stimulates surrounding non-target nerve nuclear group to produce side effect, to cause stimulating electrode to easily cause damage to brain tissue, and stimulation precision and flexibility are insufficient. SUMMARY

[0004] The technical problem to be solved by the utility model lies in providing a stimulating electrode and implantation device, to solve the problems of stimulating electrode in related art that easily causes damage to brain tissue, and insufficient stimulation precision and flexibility.

[0005] To solve the above technical problem, the utility model provides a stimulating electrode in the first aspect, which comprises:

[0006] Insulating film, which is cylindrical and has flexibility, the two ends of the insulating film are connected to form a receiving cavity;

[0007] Electrode contact, provided on the outer surface of the insulating film, the electrode contact is provided with a plurality of electrode contacts, and the plurality of electrode contacts are distributed at intervals;And,

[0008] Wire, provided on the inner surface of the insulating film, the wire is provided with a plurality of wires, the plurality of wires are not connected to each other, and the plurality of wires are electrically connected to the plurality of electrode contacts one by one.

[0009] Optionally, part of the electrode contacts are arranged along the circumferential direction of the insulating film to form a group of electrode contacts, and a plurality of groups of electrode contacts are distributed at intervals along the axial direction of the insulating film.

[0010] Optionally, the electrode contact is arc-shaped.

[0011] Optionally, the stimulating electrode further comprises a wire band and a connector, the wire band is connected to the insulating film and the connector respectively, and a plurality of the conductive wires are arranged in the wire band and electrically connected to the connector.

[0012] Optionally, the end of the insulating film is provided with a connecting area, and the connection between the wire band and the insulating film is located in the connecting area.

[0013] The utility model discloses a second aspect provides an implant device, comprising:

[0014] The fixed inner core is arranged in the accommodating cavity of the stimulating electrode in any one of the above aspects; and,

[0015] The sheath is arranged on the outer side of the fixed inner core, the insulating film is in contact with the fixed inner core and the sheath respectively, and the insulating film is in a squeezed state.

[0016] Optionally, the outer side surface of the fixed inner core is provided with a positioning groove in the form of a ring, and the insulating film is assembled in the positioning groove.

[0017] Optionally, the middle part of the sheath is provided with a tearable seam.

[0018] Optionally, the implant device further comprises a handle, and the handle is connected to the end of the fixed inner core away from the sheath.

[0019] Optionally, the outer side surface of the sheath is provided with a scale line, and the starting position of the scale line is flush with the end surface of the fixed inner core away from the handle.

[0020] Compared with the related art, the stimulating electrode and the implant device have the beneficial effects that: the insulating film is flexible, so that the stimulating electrode can have a Young's modulus and bending stiffness matched with the brain tissue, and is not easy to produce micro-movement in the brain tissue, thereby ensuring that the brain tissue is less damaged, and the service life of the electrode is prolonged. Moreover, the insulating film is in the form of a cylinder, so that the stimulating electrode has a plurality of electrode contacts around the circumference, the contact surface with the brain nucleus is large, each electrode contact can be controlled independently, and the nerve electrophysiological signal collection and stimulation of different points can be performed, so that the purpose of precise treatment is achieved. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the related art, the drawings needed to be used in the embodiments or the related art description will be briefly introduced. Obviously, the drawings in the following description only constitute some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained from these drawings without creative labor.

[0022] Figure 1 is an assembly schematic diagram between the implanting device and the stimulating electrode provided by the embodiment of the present application;

[0023] Figure 2 is a structural schematic diagram of the stimulating electrode provided by the embodiment of the present application;

[0024] Figure 3 is a structural schematic diagram of the implanting device provided by the embodiment of the present application;

[0025] Figure 4 is a structural schematic diagram of one direction of the sheath tube provided by the embodiment of the present application;

[0026] Figure 5 is a structural schematic diagram of another direction of the sheath tube provided by the embodiment of the present application;

[0027] Figure 6 is a state schematic diagram when the implanting device is inserted into a predetermined position provided by the embodiment of the present application;

[0028] Figure 7 is a state schematic diagram when the sheath tube is withdrawn to completely expose the stimulating electrode provided by the embodiment of the present application;

[0029] Figure 8 is a state schematic diagram after the fixed inner core is withdrawn provided by the embodiment of the present application;

[0030] Figure 9 is a state schematic diagram when the sheath tube is withdrawn provided by the embodiment of the present application;

[0031] Figure 10 is a state schematic diagram when the stimulating electrode is inserted into a predetermined position provided by the embodiment of the present application.

[0032] In the drawings, various reference signs represent:

[0033] 1, fixed inner core; 11, positioning groove; 12, conveying mark; 13, ball head; 2, sheath tube; 21, tearable seam; 22, scale line; 3, handle; 4, insulating film; 41, accommodating cavity; 42, connecting area; 5, electrode contact; 6, wire belt; 7, connector. DETAILED DESCRIPTION

[0034] The embodiments of the present application are described in detail below, examples of which are shown in the drawings, wherein the same or similar notations represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by reference to the drawings are exemplary and are intended to explain the present application, and cannot be understood as a limitation of the present application, and all other embodiments obtained by those skilled in the art without creative labor on the basis of the embodiments in the present application belong to the scope of protection of the present application.

[0035] In the description of the present application, 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" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements indicated must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation of the present application.

[0036] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "multiple", "several" is two or more, unless otherwise explicitly specified.

[0037] Embodiment:

[0038] Please refer to Figures 1 to 5 The embodiment of the present application provides an implant device, which comprises a fixed inner core 1 and a sheath 2. The fixed inner core 1 is arranged in the accommodating cavity 41 of the stimulating electrode; the sheath 2 is arranged outside the fixed inner core 1, the stimulating electrode is in contact with the fixed inner core 1 and the sheath 2 respectively, and the stimulating electrode is at least partially in a squeezed state, so as to fix the stimulating electrode and complete the assembly between the implant device and the stimulating electrode, so that the implant device can implant the stimulating electrode into the brain tissue. The implant device is used in combination with the stimulating electrode, which can quickly and accurately implant the stimulating electrode into the target position, so that the implanting process of the stimulating electrode is accurate and convenient.

[0039] Please refer to Figure 1 and Figure 2The stimulating electrode comprises an insulating film 4, electrode contacts 5 and wires. The insulating film 4 is cylindrical and flexible, and has two ends in communication to form a receiving cavity 41; the electrode contacts 5 are arranged on the outer side surface of the insulating film 4, and are provided in plurality and spaced apart; the wires are arranged on the inner side surface of the insulating film 4, and are provided in plurality and not in communication with each other, and are electrically connected to the plurality of electrode contacts 5 in one-to-one correspondence. The fixed inner core 1 is arranged in the receiving cavity 41 of the insulating film 4, the insulating film 4 is in contact with the fixed inner core 1 and the sheath tube 2 respectively, and the insulating film 4 is in a squeezed state, so as to fix the stimulating electrode between the fixed inner core 1 and the sheath tube 2.

[0040] The insulating film 4 is flexible, so that the stimulating electrode can have a Young's modulus and bending stiffness matched with the brain tissue, and is not easy to produce micro-movement in the brain tissue, thereby ensuring that the brain tissue is less damaged and prolonging the service life of the electrode. Moreover, the insulating film 4 is cylindrical, so that the stimulating electrode has a plurality of electrode contacts 5 on the circumference, has a large contact surface with the brain nucleus, each electrode contact 5 can be controlled individually, and can collect and stimulate neural electrophysiological signals at different points to achieve the purpose of precise treatment.

[0041] It should be noted that the insulating film 4 can be made of a biocompatible flexible material, such as polyether ether ketone, polylactic acid, polydimethylsiloxane, etc. The insulating film 4 can be provided in multiple layers, and the multiple layers of the insulating film 4 are stacked. The plurality of wires are not in communication with each other, and are electrically connected to the plurality of electrode contacts 5 in one-to-one correspondence, so that each electrode contact 5 can be controlled individually.

[0042] Please refer to Figure 2 Some of the electrode contacts 5 are arranged along the circumferential direction of the insulating film 4 to form a group of electrode contacts 5, and multiple groups of electrode contacts 5 are spaced apart along the axial direction of the insulating film 4, i.e. the electrode contacts 5 are arrayed on the circumferential surface of the insulating film 4, preferably uniformly distributed, so that the contact positions of the electrode contacts 5 with the brain nucleus are more uniform, and the purpose of precise treatment is more easily achieved. The electrode contacts 5 are arc-shaped, preferably circular arc-shaped, which is beneficial to the attachment of the electrode contacts 5 on the circumferential surface of the insulating film 4, and the electrode contacts 5 can be prepared by MEMS technology.

[0043] According to actual needs, the electrode contacts 5 can be made of platinum-iridium alloy which has biocompatibility, high corrosion resistance and low contact resistance. The electrode contacts 5 can be provided in eight groups, and the eight groups of electrode contacts 5 are uniformly and spaced apart along the axial direction of the insulating film 4.

[0044] Please refer to Figure 2The stimulating electrode further comprises a wire belt 6 and a connector 7, the wire belt 6 is connected to the insulating film 4 and the connector 7 respectively, a plurality of wires are arranged in the wire belt 6 and are electrically connected to the connector 7, so that the connector 7 can supply power to the electrode contact 5 through the wires. The wire belt 6 can be made of plastic film, the cross-sectional shape of the wire belt 6 can be rectangular or circular, and the wires can be wrapped in the plastic film through a heat shrink process. The connector 7 can be made of stainless steel, nickel-based alloy or gold-plated material with good electrical conductivity, and the connector 7 and the wires can be fixedly connected through welding.

[0045] Please refer to Figure 2 The end of the insulating film 4 is provided with a connecting area 42, and the connection between the wire belt 6 and the insulating film 4 is located in the connecting area 42, that is, each electrode contact 5 is led out to the connecting area 42 through independent wires, and is uniformly concentrated in the wire belt 6. Among them, the tail end of the insulating film 4 is provided with a connecting area 42, that is, the wire belt 6 is connected to the tail end of the insulating film 4.

[0046] Please refer to Figure 3 The outer surface of the fixed inner core 1 is provided with a positioning groove 11 in the form of a ring, and the insulating film 4 is assembled in the positioning groove 11. The positioning groove 11 can position the stimulating electrode on the fixed inner core 1, so that the stimulating electrode remains stationary during the process of sleeving the sheath tube 2 on the outer side of the fixed inner core 1.

[0047] According to actual needs, the fixed inner core 1 can be made of austenitic stainless steel or titanium alloy with good rigidity. The fixed inner core 1 is provided with a proximal end and a distal end arranged oppositely, the proximal end of the fixed inner core 1 is closer to the operator, and the distal end is farther away from the operator. Among them, as shown in Figure 3 The proximal end of the fixed inner core 1 is provided with a delivery mark 12, which can be printed by laser or processed by heat shrinkage of a plastic tube with a different color from the fixed inner core 1, and the plastic tube material is PEEK, PA, PVC, PET or silicone, etc. The distal end of the fixed inner core 1 is provided with a positioning groove 11. The distal end of the fixed inner core 1 is provided with a ball head 13, which is beneficial to the insertion of the fixed inner core into the sheath tube 2 and the accommodation cavity 41.

[0048] Please refer to Figure 2 The implant device further comprises a handle 3 connected to the end of the fixed inner core 1 away from the sheath tube 2, that is, the handle 3 is connected to the proximal end of the fixed inner core 1, and the handle 3 is beneficial to the fixation of the fixed inner core 1. Among them, the handle 3 can be made of PC or PC+ABS, the proximal end of the handle 3 is provided with a mounting hole, the proximal end of the fixed inner core 1 is inserted into the mounting hole, and the fixed inner core 1 and the handle 3 are fixed by adhesion.

[0049] Please refer to Figure 4 and Figure 5The outer surface of the sheath tube 2 is provided with a scale line 22, the starting position of the scale line 22 is flush with the end face of the fixed inner core 1 away from the handle 3, that is, the starting position of the scale line 22 is flush with the distal end face of the fixed inner core 1; the middle part of the sheath tube 2 is provided with a tearable seam 21, which can be used to detach the sheath tube 2 from the fixed inner core 1.

[0050] According to actual needs, the sheath tube 2 can be made of FEP, the scale line 22 can be made by laser printing process, and the distal end of the sheath tube 2 is provided with a rounded corner, which can reduce the damage of the sheath tube 2 to the brain tissue. The ball head 13 at the distal end of the fixed inner core 1 is flush with the distal end face of the sheath tube 2.

[0051] When the insulating film 4 of the stimulating electrode is positioned in the positioning groove 11, the sheath tube 2 is sleeved on the outside of the fixed inner core 1, at this time the insulating film 4 abuts against the fixed inner core 1 and the sheath tube 2 respectively, and the insulating film 4 is in a squeezed state, completing the assembly between the stimulating electrode and the implanting device (as shown in Figure 1 ). Then move the sheath tube 2 to make the proximal end face of the sheath tube 2 exit to be flush with the distal end line of the delivery mark 12, at this time the insulating film 4 will completely expose the distal end face of the sheath tube 2, the insulating film 4 is out of the squeezed state, and the insulating film 4 expands to a diameter greater than the diameter of the fixed inner core 1 (as shown in Figure 7 ). Then move the fixed inner core 1 to make it completely withdrawn from the sheath tube 2, and then tear it along the tearable seam 21 of the sheath tube 2, so that the fixed inner core 1 can be separated from the sheath tube 2 (as shown in Figure 8 ), and then remove the sheath tube 2 (as shown in Figure 9 ), so as to remove the implanting device (as shown in Figure 10 ), and complete the implantation of the stimulating electrode. In this process, the stimulating electrode is used with the implanting device, which can quickly and accurately implant the stimulating electrode into the target position, so that the implantation process of the stimulating electrode is accurate and convenient.

[0052] The following examples are used to illustrate the implantation surgery of the stimulating electrode.

[0053] Before the surgery, a comprehensive assessment is made on the patient, including medical history, physical examination and imaging examination, etc., to determine whether the patient is suitable for DBS surgery. The doctor also needs to determine the position of the stimulating electrode implantation and the stimulation parameters, etc. The doctor obtains the position parameters of the nucleus group where the stimulating electrode needs to be implanted through CT or MRI image, so as to locate the target point. After the target point positioning is completed, the implantation channel is designed in the software and the sheath tube 2 insertion process is simulated, and a complete and careful preoperative surgical plan is made to increase the safety of the surgery and avoid damaging blood vessels or unnecessary brain tissue.

[0054] First, the stimulating electrode and the implanting device are assembled perfectly, and then taken out for standby.

[0055] During the operation, the method of tracheal intubation is used for general anesthesia, the patient takes a prone position, then disinfection, single laying, 1-2cm before the coronary suture, 2-3cm right to the center line as the center, make a straight incision about 3cm long, cut the skin, subcutaneous and galea in turn, thoroughly stop bleeding in this part, drill the skull, and expand the bone window to 1cm. Coagulate the dura mater, cross the dura mater. Coagulate the brain surface arachnoid membrane, connect the puncture by the brain needle according to the preoperative design of the implantation channel, and pull out the brain needle after the puncture is completed.

[0056] Please refer to Figures 6 to 10 The distal end of the sheath tube 2 is inserted along the puncture hole, the implantation depth is confirmed in real time through the scale line 22 on the sheath tube 2, and the nucleus position planned in advance is reached. The inner core 1 is fixed by the handle 3, then the sheath tube 2 is slowly pulled out until the proximal end face of the sheath tube 2 is flush with the distal end line of the delivery mark 12, at this time the insulating film 4 is out of the extrusion state, and the diameter of the insulating film 4 will expand to be greater than the diameter of the fixed inner core 1. Then the sheath tube 2 is kept stationary, the fixed inner core 1 is pulled out slowly to make the insulating film 4 completely separate from the positioning groove 11, and then the fixed inner core 1 is slowly pulled out from the sheath tube 2. The sheath tube 2 is completely pulled out to the outside of the body, and then the sheath tube 2 is torn along the tearable seam 21, so that the implantation device can be removed. The bone hole is closed, and finally the scalp is sutured and the incision is bandaged.

[0057] After the stimulation electrode is implanted, the doctor first performs a preliminary test, adjusts the parameters, and observes and checks the improvement of the patient's symptoms. After the operation, the patient needs to be in the hospital for a period of rehabilitation training to adapt to the stimulation of the deep brain electrode. The doctor will also regularly adjust the deep brain electrode system of the patient to optimize the treatment effect.

[0058] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A stimulating electrode, characterized by The stimulation electrode comprises: an insulating film in a cylindrical shape and having flexibility, two ends of the insulating film being communicated to form a receiving cavity; electrode contacts arranged on an outer surface of the insulating film, the electrode contacts being provided in a plurality, the electrode contacts being spaced apart from each other; and wires arranged on an inner surface of the insulating film, the wires being provided in a plurality, the wires being not communicated with each other, and the wires being electrically connected to the electrode contacts one by one.

2. The stimulating electrode according to claim 1, characterized in that Some of the electrode contacts are arranged along a circumferential direction of the insulating film to form a group of electrode contacts, and a plurality of groups of the electrode contacts are spaced apart along an axial direction of the insulating film.

3. The stimulating electrode according to claim 1, characterized in that The electrode contacts are in an arc shape.

4. The stimulating electrode of claim 1, wherein The stimulation electrode further comprises a wire band and a connector, the wire band being connected to the insulating film and the connector respectively, the wires being arranged in the wire band and being electrically connected to the connector.

5. The stimulating electrode according to claim 4, characterized in that An end of the insulating film is provided with a connecting area, and a connection between the wire band and the insulating film is located in the connecting area.

6. An implant device, characterized by The stimulation electrode further comprises: a fixed inner core arranged in the receiving cavity of the stimulation electrode; and a sheath arranged outside the fixed inner core, the insulating film being in contact with the fixed inner core and the sheath respectively, and the insulating film being in a squeezed state.

7. The implant device of claim 6, wherein, An outer surface of the fixed inner core is provided with a positioning groove in a ring shape, and the insulating film is arranged in the positioning groove.

8. The implant device of claim 6, wherein, A middle part of the sheath is provided with a tearable seam.

9. The implant device of claim 6, wherein, The implanting device further comprises a handle connected to an end of the fixed inner core away from the sheath.

10. The implant device of claim 9, wherein, An outer surface of the sheath is provided with a scale line, and a starting position of the scale line is flush with an end surface of the fixed inner core away from the handle.

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