Implantation depth measuring jig for pulse generator

Abstract

The utility model relates to the technical field of medical tools, and discloses a tool for measuring the implantation depth of a pulse generator. The tool for measuring the implantation depth of the pulse generator comprises a fixing device and a measuring device. The fixing device can be detachably connected to an open groove of a skull and comprises a cross beam, and a guide hole is formed in the cross beam; the measuring device comprises a guide rod and a bottom plate, the guide rod is slidably connected to the guide hole, one end of the guide rod is connected to the bottom plate, and the bottom plate can penetrate through the open groove and extend into a preset position in the skull. The pulse generator implantation depth measuring jig is used for simulating the fixed base and measuring the implantation depth of the pulse generator to select the proper fixed base, so that the waste of implantation consumables caused by detaching a plurality of fixed bases at a time is avoided, a doctor can know and evaluate the implantation state of the fixed base and the pulse generator in advance, and the accuracy of the doctor is improved. And the implantation safety is ensured.

Description

Technical Field

[0001] The present application relates to the technical field of medical tools, and in particular, to a jig for measuring the implantation depth of a pulse generator. Background Art

[0002] Currently, for some neurological diseases, deep brain stimulation therapy is used to stimulate the corresponding nerve nuclei for treatment. The existing deep brain stimulation systems on the market usually use an implanted pulse generator to output stimulation to the brain through an extension wire and an electrode wire. Therefore, a very long subcutaneous tunnel needs to be created, and the wire is continuously pulled by soft tissues for a long time, increasing the risks of wound recovery, postoperative infection, and electrode damage. Therefore, existing products implant a nerve stimulator through the skull to reduce subcutaneous puncture and reduce the stress on the interface and the electrode. To increase the fixation of the nerve stimulator to the skull, the existing solution uses a fixing base similar to a prefabricated skull titanium plate, which is installed at the grooved opening of the skull, and the pulse generator is installed in the fixing base to form a relative fixation among the skull, the fixing base, and the pulse generator.

[0003] However, the skull thicknesses of different patients are inconsistent. Although a better match can be achieved by setting fixing bases with different implantation depth specifications, testing the matching situation of the fixing bases one by one by opening the sterilization package during the operation not only takes time and effort but also easily increases the risk of intraoperative infection.

[0004] Based on this, there is an urgent need for a jig for measuring the implantation depth of a pulse generator to solve the above problems. Summary of the Utility Model

[0005] Based on the above, the purpose of the present application is to provide a jig for measuring the implantation depth of a pulse generator, which can avoid waste of implantation consumables of multiple fixing bases at one time, enable doctors to understand and evaluate the implantation status of the fixing base and the pulse generator in advance, and ensure the safety of implantation.

[0006] To achieve the above object, the present application adopts the following technical solutions:

[0007] A jig for measuring the implantation depth of a pulse generator, comprising:

[0008] A fixing device, which can be detachably connected to the grooved opening of the skull. The fixing device includes a cross beam, and the cross beam is provided with a guiding hole;

[0009] A measuring device, which includes a guiding rod and a bottom plate. The guiding rod is slidably connected to the guiding hole, and one end of the guiding rod is connected to the bottom plate. The bottom plate can pass through the grooved opening and extend into a preset position inside the skull.

[0010] As a preferred technical solution of a pulse generator implantation depth measuring fixture, a reading hole is provided on the side wall of the guiding hole, and a scale is provided on one side of the guiding rod facing the reading hole.

[0011] As a preferred technical solution of a pulse generator implantation depth measuring fixture, a distance sensor is installed on the side wall of the guiding hole, and the distance sensor is used to measure the displacement of the guiding rod relative to the guiding hole.

[0012] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the fixing device further includes a contour ring and a plurality of fixing pieces. The plurality of fixing pieces are arranged at intervals in the circumferential direction of the contour ring. The fixing pieces are rotatably connected to the contour ring. The fixing pieces are detachably connected to the surface of the skull, and both ends of the cross beam are connected to the contour ring.

[0013] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the fixing piece is rotatably connected to the contour ring through a damping shaft.

[0014] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the pulse generator implantation depth measuring fixture further includes a fastener. The fixing piece is provided with a fixing hole, and the fastener can pass through the fixing hole and be fixed to the skull.

[0015] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the cross beam is arc-shaped, and the cross beam protrudes away from the bottom plate.

[0016] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the axis of the guiding hole is coaxial with the center line of the contour ring.

[0017] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the bottom surface shape of the bottom plate is the same as the bottom surface shape of the fixed base of the pulse generator.

[0018] As a preferred technical solution of a pulse generator implantation depth measuring fixture, the bottom plate is provided with a hollow hole.

[0019] The beneficial effects of this application are:

[0020] The present application provides a fixture for measuring the implantation depth of a pulse generator. Before implanting the pulse generator, the fixing device is connected to the grooved opening of the skull, and then the guiding rod slides relative to the guiding hole, and the bottom plate is moved up and down to adjust the implantation depth of the bottom plate until the bottom plate penetrates the grooved opening and extends into the preset position inside the skull, and the data of the implantation depth is obtained through the relative position between the bottom plate and the fixing device. The present application uses the fixture for measuring the implantation depth of the pulse generator to simulate the fixing base, measures the implantation depth of the pulse generator, selects a suitable fixing base, avoids waste of the implantation consumables of multiple fixing bases being disassembled at one time, enables the doctor to understand and evaluate the status of the fixing base and the pulse generator implantation in advance, and ensures the safety of the implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for the description of the embodiments of the present application. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on the content of the embodiments of the present application and these drawings.

[0022] Figure 1 FIG. is a schematic structural diagram of the fixture for measuring the implantation depth of the pulse generator provided by the specific embodiment of the present application installed in the grooved opening of the skull;

[0023] Figure 2 FIG. is a schematic structural diagram of the fixture for measuring the implantation depth of the pulse generator provided by the specific embodiment of the present application.

[0024] The labels in the figure are as follows:

[0025] 1. Fixing device; 11. Cross beam; 111. Guiding hole; 112. Reading hole; 12. Contour ring; 13. Fixing piece; 131. Fixing hole; 14. Damping shaft;

[0026] 2. Measuring device; 21. Guiding rod; 22. Bottom plate; 221. Hollow hole;

[0027] 3. Skull; 31. Grooved opening. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0028] The following will further elaborate on the present application in conjunction with the drawings and embodiments. It can be understood that the specific embodiments described herein are only for explaining the present application and not for limiting the present application. Additionally, it should be noted that for the sake of description, only the parts related to the present application are shown in the drawings rather than all the structures.

[0029] In the description of the present application, unless otherwise clearly defined and limited, the terms "connected", "connected to", and "fixed" shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0030] In the present application, unless otherwise clearly defined and limited, the first feature being "above" or "below" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through additional features therebetween. Moreover, the first feature being "above", "over", and "on top of" the second feature includes the first feature being directly above and obliquely above the second feature, or merely indicating that the horizontal height of the first feature is higher than that of the second feature. The first feature being "below", "beneath", and "underneath" the second feature includes the first feature being directly below and obliquely below the second feature, or merely indicating that the horizontal height of the first feature is lower than that of the second feature.

[0031] In the description of this embodiment, the orientation or positional relationships such as "above", "below", "left", and "right" are based on the orientation or positional relationships shown in the drawings, and are only for the convenience of description and simplifying the operation, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present application. In addition, the terms "first" and "second" are only used for distinction in description and have no special meanings.

[0032] The technical field and related terms of the embodiments of the present application will be briefly described below.

[0033] Implantable medical systems include implantable nerve electrical stimulation systems, implantable cardiac electrical stimulation systems (also known as cardiac pacemakers), implantable drug infusion systems (Implantable Drug Delivery System, abbreviated as IDDS), and lead transfer systems, etc. Implantable nerve electrical stimulation systems are, for example, deep brain stimulation systems (Deep Brain Stimulation, abbreviated as DBS), implantable cerebral cortex stimulation systems (Cortical Nerve Stimulation, abbreviated as CNS), implantable spinal cord stimulation systems (Spinal Cord Stimulation, abbreviated as SCS), implantable sacral nerve stimulation systems (Sacral Nerve Stimulation, abbreviated as SNS), implantable vagus nerve stimulation systems (Vagus Nerve Stimulation, abbreviated as VNS), etc.

[0034] The implantable nerve electrical stimulation system includes a stimulator (i.e., an implantable nerve stimulator) implanted in a patient's body and a programming device arranged outside the patient's body. That is to say, the stimulator is a medical device, or rather, the medical device includes the stimulator. The related nerve regulation technology mainly implants electrodes (the electrodes are in the form of electrode leads, for example) at specific sites (i.e., target points) of the tissue of an organism through stereotactic surgery, and sends electrical pulses to the target points through the electrodes to regulate the electrical activities and functions of the corresponding nerve structures and networks, thereby improving symptoms and relieving pain.

[0035] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension lead, and an electrode lead, and the IPG is connected to the electrode lead through the extension lead. The IPG is implanted in the patient's body, for example, in front of the patient's chest or other internal body parts.

[0036] As another example, DBS includes an IPG and an electrode lead, and the IPG is directly connected to the electrode lead. The IPG is implanted in the patient's head. For example, a slot is cut in the patient's skull, and then the IPG is installed in the slot of the skull. In this case, the IPG may not protrude from the outer surface of the skull, or may partially protrude from the outer surface of the skull.

[0037] Among them, the IPG responds to the programming instructions sent by the programming device and provides controllable electrical stimulation therapy (or electrical stimulation energy) to the internal tissue by relying on a sealed battery and a circuit. The IPG delivers one or more channels of controllable specific electrical stimulation to a specific area of the internal tissue through the electrode lead.

[0038] In some embodiments, the extension lead is used in cooperation with the IPG as a transmission medium for electrical stimulation to transmit the electrical stimulation generated by the IPG to the electrode lead.

[0039] In some embodiments, the electrical stimulation can be delivered in the form of a pulsed signal or in the form of a non-pulsed signal. For example, the electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, the electrical stimulation in the form of a non-pulsed signal can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.

[0040] After receiving the electrical stimulation transmitted by the IPG or the extension lead, the electrode lead delivers electrical stimulation to a specific area of the body tissue through multiple electrode contacts. For example, the stimulator is provided with one or more electrode leads on one or both sides, and multiple electrode contacts are arranged on the electrode lead. The electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode lead. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode lead. The electrode contacts can include stimulating electrode contacts and / or acquisition electrode contacts. The electrode contacts can be in the shape of, for example, flakes, rings, dots, etc.

[0041] In some embodiments, the body tissue to be stimulated can be the patient's brain tissue, and the stimulated site can be a specific site of the brain tissue. When the disease types of the patient are different, generally the stimulated sites are different, and the number of stimulated contacts (single-source or multi-source), the application of one or more (single-channel or multi-channel) specific electrical stimulations, and the stimulation parameters (values) are also different.

[0042] The embodiments of the present application do not limit the applicable disease types, which can be the disease types applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the disease types that DBS can be used to treat or manage include but are not limited to: spastic diseases (such as epilepsy), pain, migraine, mental diseases (such as major depressive disorder (MDD)), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymia, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (such as essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.

[0043] In the embodiments of the present application, when the programming device and the stimulator establish a programming connection, the programming device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, and different electrical stimulations correspond to different stimulation parameters), and the stimulator can also sense the patient's electrophysiological activities to collect electrophysiological signals, and the stimulation parameters of the stimulator can be continuously adjusted through the collected electrophysiological signals to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0044] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (such as electrode contact 2# and electrode contact 3#), frequency (such as the number of electrical stimulation pulse signals within a unit time of 1 s, with the unit being Hz), pulse width (the duration of each pulse, with the unit being μs), amplitude (generally expressed in voltage, i.e., the intensity of each pulse, with the unit being V), timing sequence (such as continuous or burst, where burst refers to a discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), upper and lower limits controlled by the doctor (the adjustable range by the doctor), and upper and lower limits controlled by the patient (the adjustable range by the patient).

[0045] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0046] The programming device may include a doctor programming device (i.e., the programming device used by the doctor) and / or a patient programming device (i.e., the programming device used by the patient). The doctor programming device is, for example, an intelligent terminal device such as a tablet computer, a notebook computer, a desktop computer, a mobile phone, etc. equipped with programming software. The patient programming device is, for example, an intelligent terminal device such as a tablet computer, a notebook computer, a desktop computer, a mobile phone, etc. equipped with programming software. The patient programming device may also be other electronic devices with programming functions (such as a charger with programming functions, an electrophysiological acquisition device, etc.).

[0047] As Figure 1 and Figure 2 As shown, this embodiment provides a pulse generator implantation depth measurement fixture, which includes a fixing device 1 and a measuring device 2. Specifically, the fixing device 1 can be detachably connected to the slot 31 of the skull 3. The fixing device 1 includes a cross beam 11, and the cross beam 11 is provided with a guiding hole 111; the measuring device 2 includes a guiding rod 21 and a bottom plate 22. The guiding rod 21 is slidably connected to the guiding hole 111, and one end of the guiding rod 21 is connected to the bottom plate 22. The bottom plate 22 can pass through the slot 31 and extend into a preset position inside the skull 3.

[0048] Before implanting the pulse generator, connect the fixing device 1 to the grooved portion 31 of the skull 3. Then, the guiding rod 21 slides relative to the guiding hole 111, and the bottom plate 22 is moved up and down to adjust the implanting depth of the bottom plate 22 until the bottom plate 22 penetrates through the grooved portion 31 and extends into the preset position inside the skull 3. The data of the implanting depth is obtained based on the relative position between the bottom plate 22 and the fixing device 1. In this application, a pulse generator implanting depth measuring jig is used to simulate the fixing base to measure the implanting depth of the pulse generator, so as to select a suitable fixing base, avoid waste of implanting consumables by disassembling multiple fixing bases at one time, enable doctors to understand and evaluate the implanting status of the fixing base and the pulse generator in advance, and ensure the safety of implantation.

[0049] Preferably, a reading hole 112 is provided on the side wall of the guiding hole 111, a scale is provided on the side of the guiding rod 21 facing the reading hole 112. The scale on the guiding rod 21 is engraved or laser-printed, and the scale reading can be read through the reading hole 112 to judge the implanting depth value, improving the convenience of depth measurement. In other embodiments, a distance sensor is installed on the side wall of the guiding hole 111. The distance sensor is used to measure the displacement of the guiding rod 21 relative to the guiding hole 111, and the reading is displayed on a digital display screen to improve the measurement convenience.

[0050] Furthermore, the fixing device 1 further includes a contour ring 12 and a plurality of fixing pieces 13. The plurality of fixing pieces 13 are arranged at intervals in the circumferential direction of the contour ring 12. The fixing pieces 13 are rotatably connected to the contour ring 12, and the fixing pieces 13 are detachably connected to the surface of the skull 3. Both ends of the cross beam 11 are connected to the contour ring 12. When the fixing device 1 is connected to the grooved portion 31 of the skull 3, the contour ring 12 is embedded in the grooved portion 31, and the fixing pieces 13 rotate relative to the contour ring 12 so that the fixing pieces 13 fit the surface of the skull 3. Finally, the fixing pieces 13 are connected to the surface of the skull 3, realizing the connection of the fixing device 1 to the grooved portion 31 of the skull 3. In this embodiment, the shape of the contour ring 12 matches the shape of the grooved portion 31 of the skull 3. The shape of the contour ring 12 is a rectangle with four rounded corners, and there are three fixing pieces 13. Two fixing pieces 13 are rotatably connected to the two long sides of the contour ring 12, and one fixing piece 13 is rotatably connected to one short side of the contour ring 12.

[0051] Preferably, the fixing piece 13 is rotatably connected to the contour ring 12 through a damping shaft 14, and the fixing piece 13 can maintain a preset angle after rotating relative to the contour ring 12. Therefore, after the measurement is completed, the pulse generator implanting depth measuring jig is disassembled, and the fixing base is orthopedically corrected to a certain extent according to the relative angle between the fixing piece 13 and the contour ring 12 to ensure that the fixing base can be firmly connected to the grooved portion 31 of the skull 3.

[0052] In this embodiment, the pulse generator implantation depth measuring jig further includes a fastener. The fixing plate 13 is provided with a fixing hole 131. The fastener can pass through the fixing hole 131 and be fixed to the skull 3. Wherein, the fastener is a screw, and the screw passes through the fixing hole 131 and is threadedly connected to the threaded hole on the surface of the skull 3, so that the fixing plate 13 is detachably connected to the surface of the skull 3.

[0053] In this embodiment, the contour ring 12 and the cross beam 11 are integrally formed, and the guide rod 21 and the bottom plate 22 are integrally formed.

[0054] Preferably, the cross beam 11 is arc-shaped and protrudes away from the bottom plate 22. In this embodiment, the two ends of the cross beam 11 are connected to the two long sides of the contour ring 12, and the reading holes 112 on the side walls of the guide holes 111 are higher than the contour ring 12, which is convenient for doctors to observe the scales on the guide rod 21 through the reading holes 112 and improve the operation convenience.

[0055] Further preferably, the axis of the guide hole 111 is coaxial with the center line of the contour ring 12. When the fixing device 1 guides the measuring device 2 through the guide hole 111, the force balance of the fixing device 1 is ensured, and the stability is improved.

[0056] In this embodiment, the bottom surface shape of the bottom plate 22 is the same as the bottom surface shape of the fixing base of the pulse generator. When the bottom plate 22 extends into the preset position in the skull 3, the bottom surface of the bottom plate 22 fits against the dura mater in the skull 3.

[0057] Preferably, the bottom plate 22 is provided with a hollow hole 221. Through this hollow hole 221, it is ensured that the user can visually judge the fitting condition of the bottom surface of the bottom plate 22 and the dura mater. In this embodiment, there are two hollow holes 221, and the two hollow holes 221 are symmetrically arranged on both sides of the guide rod 21, so as to facilitate observing the fitting conditions of multiple positions of the bottom plate 22 and the dura mater.

[0058] This application can obtain the reading of the implantation depth and the angular position of the fixing plate 13 fitting on the surface of the skull 3 by using the pulse generator implantation depth measuring jig, which can facilitate doctors to select a fixing base with a suitable specification and perform a certain degree of orthopedic correction on the fixing base with reference to the shape and position of the fixing plate 13, ensuring the safety of pulse generator implantation.

[0059] Note that the above is only the preferred embodiment of the present application and the technical principles applied. Those skilled in the art will understand that the present application is not limited to the specific embodiments described herein, and various obvious changes, re-adjustments and substitutions can be made by those skilled in the art without departing from the protection scope of the present application. Therefore, although the present application has been described in more detail through the above embodiments, the present application is not limited to the above embodiments only. Without departing from the concept of the present application, more other equivalent embodiments can be included, and the scope of the present application is determined by the scope of the appended claims.

Claims

1. A fixture for measuring the implantation depth of a pulse generator, characterized in that, Comprising: A fixing device (1) capable of being detachably connected to a slot (31) of a skull (3), the fixing device (1) comprising a cross beam (11), and the cross beam (11) being provided with a guiding hole (111); A measuring device (2) comprising a guiding rod (21) and a bottom plate (22), the guiding rod (21) being slidably connected to the guiding hole (111), and one end of the guiding rod (21) being connected to the bottom plate (22), the bottom plate (22) being capable of passing through the slot (31) and extending into a preset position inside the skull (3).

2. The pulse generator implantation depth measurement jig according to claim 1, characterized in that, A reading hole (112) is provided on the side wall of the guiding hole (111), and a scale is provided on the side of the guiding rod (21) facing the reading hole (112).

3. The pulse generator implantation depth measurement jig according to claim 1, characterized in that, A distance sensor is installed on the side wall of the guiding hole (111), and the distance sensor is used to measure the displacement of the guiding rod (21) relative to the guiding hole (111).

4. The pulse generator implantation depth measurement fixture according to claim 1, characterized in that, The fixing device (1) further comprises a contour ring (12) and a plurality of fixing pieces (13), the plurality of fixing pieces (13) being arranged at intervals in the circumferential direction of the contour ring (12), the fixing pieces (13) being rotatably connected to the contour ring (12), the fixing pieces (13) being detachably connected to the surface of the skull (3), and both ends of the cross beam (11) being connected to the contour ring (12).

5. The pulse generator implantation depth measurement fixture according to claim 4, wherein The fixing piece (13) is rotatably connected to the contour ring (12) through a damping shaft (14).

6. The pulse generator implantation depth measurement fixture according to claim 4, characterized in that The pulse generator implantation depth measuring jig further comprises a fastener, the fixing piece (13) being provided with a fixing hole (131), and the fastener being capable of passing through the fixing hole (131) and being fixed to the skull (3).

7. The pulse generator implantation depth measurement fixture according to claim 1, characterized in that, The cross beam (11) is arc-shaped, and the cross beam (11) protrudes in a direction away from the bottom plate (22).

8. The pulse generator implantation depth measurement jig according to claim 4, characterized in that The axis of the guiding hole (111) is coaxial with the center line of the contour ring (12).

9. The pulse generator implantation depth measurement fixture according to claim 1, wherein The bottom surface shape of the bottom plate (22) is the same as the bottom surface shape of the fixing base of the pulse generator.

10. The pulse generator implantation depth measurement fixture according to claim 9, characterized in that, The bottom plate (22) is provided with a hollowed-out hole (221).

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