Skull slotting positioning device
By using the guide holes and scribing guide edges of the positioning plate during the skull groove process, the problem of low skull groove accuracy is solved, and higher positioning accuracy and safety is achieved, ensuring the accurate implantation of the pulse generator.
Patent Information
- Application Number
- CN202422041581.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-22
- Publication Date
- 2025-07-18
- Estimated Expiration
- 2034-08-22
AI Technical Summary
The prior art has low accuracy during the skull groove process, resulting in the skull groove size not meeting the specifications, increasing the difficulty of surgery, and at risk of brain tissue compression or damage.
A skull groove positioning device including a positioning plate is adopted, and guide holes and scribe guide edges are provided on the positioning plate to guide the opening and outline the grooved contour line to improve positioning accuracy.
It improves the positioning accuracy of skull opening and groove, ensures the accuracy and safety of pulse generator implantation, and reduces the risk of brain tissue damage.
Smart Images
Figure CN223111758U_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of medical tools, and in particular to a skull grooving positioning device. Background Art
[0002] At present, for some nervous system diseases, deep brain stimulation therapy is used to stimulate the corresponding nuclei to play a therapeutic role. The existing deep brain stimulation systems on the market usually use implanted pulse generators to output stimulation to the brain through extension wires and electrode wires. Therefore, it is necessary to create a very long subcutaneous tunnel, and the wires are constantly pulled by soft tissues for a long time, increasing the risks of wound recovery, postoperative infection, and electrode damage. Therefore, existing products implant nerve stimulators through the skull to reduce subcutaneous puncture and reduce the stress on the interface and electrodes. To increase the fixation of the nerve stimulator to the skull, the existing solutions use a fixed base product similar to a prefabricated skull titanium plate, which is installed at the skull grooving position, and the pulse generator is installed in the fixed base to form a relative fixation among the skull, the fixed base, and the pulse generator.
[0003] The skull thicknesses of different patients are inconsistent, and the skull thicknesses in different regions are also inconsistent. How to determine the position of skull grooving during the operation to avoid compressing or damaging the brain tissue is also very important. In the process of placing a pulse generator in the brain in the prior art, first, a groove needs to be cut in the skull. Most doctors manually draw lines on the skull, then manually drill holes along the contour line first, and then use a tool to cut the part between two adjacent holes, so as to cut out a groove with an approximate shape. However, the accuracy of manual drilling and manual drawing is relatively low, resulting in the grooving size of the skull not meeting the specifications and increasing the surgical difficulty.
[0004] Based on this, there is an urgent need for a skull grooving positioning device 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 skull grooving positioning device, which can use a positioning plate to guide the opening of the skull and draw the grooving contour line, improve the positioning accuracy of skull opening and grooving, and ensure the accuracy and safety of implanting the pulse generator.
[0006] To achieve the above object, the present application adopts the following technical solutions:
[0007] A skull grooving positioning device includes a positioning plate, the positioning plate is detachably connected to a preset grooving position of the skull, and a plurality of guiding holes are provided on the positioning plate, and the guiding holes are used to guide an opening tool;
[0008] A scribing guiding edge is provided on the outer periphery of the positioning plate, and the scribing guiding edge is used to assist in drawing the grooving contour line.
[0009] As a preferred technical solution of a skull grooving positioning device, there are four guiding holes, and the four guiding holes are located at the four corners of the positioning plate.
[0010] As a preferred technical solution of a skull grooving positioning device, the scribing guiding edge is a straight edge, the straight edge is located between adjacent guiding holes, and the straight edge is tangent to the inner diameter of the guiding hole.
[0011] As a preferred technical solution of a skull grooving positioning device, the skull grooving positioning device further includes a fastener, the positioning plate is provided with a fixing hole, and the fastener can pass through the fixing hole and be connected to the skull.
[0012] As a preferred technical solution of a skull grooving positioning device, there are at least two fixing holes, and the fasteners correspond to the fixing holes one by one.
[0013] As a preferred technical solution of a skull grooving positioning device, the fixing holes are located on the central axis of the positioning plate.
[0014] As a preferred technical solution of a skull grooving positioning device, the positioning plate is further provided with a hollowing hole.
[0015] As a preferred technical solution of a skull grooving positioning device, there are at least two hollowing holes.
[0016] As a preferred technical solution of a skull grooving positioning device, the shape of the bottom surface of the positioning plate matches the shape of the outer wall of the preset grooving position of the skull, so that the bottom surface of the positioning plate can fit the preset grooving position of the skull.
[0017] As a preferred technical solution of a skull grooving positioning device, the material of the positioning plate is transparent plastic.
[0018] The beneficial effects of this application are:
[0019] This application provides a skull grooving positioning device. During the operation, the preset grooving position of the skull is determined by the relative position between the scribing guiding edge and the anatomical marking points on the skull. The positioning plate is installed at the preset grooving position of the skull, and then the grooving contour line is outlined along the scribing guiding edge. Subsequently, an opening tool is used to perform guiding opening through the guiding holes to form a cutting hole. Finally, a grooving tool is inserted into the opening to process the skull according to the grooving contour line. This application can use the positioning plate to guide both the opening of the skull and the outlining of the grooving contour line, improving the positioning accuracy of the skull opening and grooving, and ensuring the accuracy and safety of the implant of the pulse generator. Description of the Drawings
[0020] To more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the accompanying drawings required for the description of the embodiments 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, without creative efforts, other drawings can also be obtained based on the content of the embodiments of the present application and these drawings.
[0021] Figure 1 It is a schematic structural diagram of the skull grooving positioning device provided by the specific embodiment of the present application installed on the skull;
[0022] Figure 2 It is a schematic structural diagram of the skull grooving positioning device provided by the specific embodiment of the present application.
[0023] The markings in the figure are as follows:
[0024] 1. positioning plate; 11. guiding hole; 12. scribing guiding edge; 13. fixing hole; 14. hollow hole;
[0025] 2. hole-opening tool;
[0026] 3. skull. Specific Embodiments
[0027] The following will further elaborate on the present application in conjunction with the accompanying drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present application, rather than limiting the present application. Additionally, it should be noted that for the sake of convenience of description, only the parts related to the present application rather than all the structures are shown in the accompanying drawings.
[0028] In the description of the present application, unless otherwise clearly defined and limited, the terms "connected", "connected to", and "fixed" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of 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.
[0029] In this application, unless otherwise clearly specified or limited, the first feature being "on" or "under" the second feature may include direct contact between the first and second features, or may include the first and second features not being 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 "under", "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.
[0030] In the description of this embodiment, the orientation or positional relationships such as "upper", "lower", "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 operations, 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 this application. In addition, the terms "first" and "second" are only used for distinction in description and have no special meanings.
[0031] The technical field and related terms of the embodiments of this application will be briefly described below.
[0032] Implantable medical systems include implantable nerve electrical stimulation systems, implantable cardiac electrical stimulation systems (also known as cardiac pacemakers), implantable drug delivery systems (Implantable Drug Delivery System, abbreviated as IDDS), 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.
[0033] An implantable nerve electrical stimulation system includes a stimulator implanted in a patient's body (i.e., an implantable nerve stimulator) 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 tissues 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.
[0034] As an example, DBS includes an IPG (Implantable Pulse Generator, implantable pulse generator), an extension lead, and an electrode lead. The IPG is connected to the electrode lead through the extension lead. The IPG is implanted in the patient's body, for example, implanted in front of the patient's chest or other internal body parts.
[0035] 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.
[0036] 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 tissues 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 tissues through the electrode lead.
[0037] 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.
[0038] In some embodiments, the electrical stimulation can be delivered in the form of a pulse signal or in the form of a non-pulse 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-pulse signal can be a continuous signal, which can have a sine waveform or other continuous waveforms.
[0039] After receiving the electrical stimulation transmitted by the IPG or the extension wire, the electrode lead delivers the electrical stimulation to a specific area of the body tissue through multiple electrode contacts. The stimulator is provided with, for example, one or more electrode leads on one or both sides. Multiple electrode contacts are arranged on the electrode lead, and the electrode contacts can be evenly arranged or unevenly arranged in the circumferential direction of the electrode lead. As an example, the electrode contacts can be arranged in a 4-row and 3-column array (a total of 12 electrode contacts) in the circumferential direction of the electrode lead. The electrode contacts can include stimulation electrode contacts and / or acquisition electrode contacts. The electrode contacts can be in the shape of, for example, a sheet, a ring, a dot, etc.
[0040] In some embodiments, the stimulated body tissue can be the patient's brain tissue, and the stimulated site can be a specific site of the brain tissue. When the patient's disease type is different, the stimulated site is generally 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.
[0041] 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.
[0042] 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 the electrical stimulations corresponding to different stimulation parameters are different), and the stimulator can also sense the patient's electrophysiological activities to collect electrophysiological signals, and the stimulation parameters of the stimulator can be further adjusted through the collected electrophysiological signals to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.
[0043] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact 2# and electrode contact 3#), frequency (e.g., the number of electrical stimulation pulse signals within a unit time of 1 s, with the unit of Hz), pulse width (the duration of each pulse, with the unit of μs), amplitude (generally expressed in voltage, i.e., the intensity of each pulse, with the unit of V), timing sequence (e.g., it can be continuous or bursty, and bursty 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 that the patient can adjust independently).
[0044] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
[0045] 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 (e.g., a charger with programming functions, an electrophysiological acquisition device, etc.).
[0046] As Figure 1 and Figure 2 shown, this embodiment provides a skull slotting positioning device. The skull slotting positioning device includes a positioning plate 1, the positioning plate 1 is detachably connected to a preset slotting position of the skull 3, and a plurality of guiding holes 11 are provided on the positioning plate 1. The guiding holes 11 are used to guide an opening tool 2; a scribing guiding edge 12 is provided on the outer periphery of the positioning plate 1, and the scribing guiding edge 12 is used to assist in drawing a slotting contour line. During the operation, the preset slotting position of the skull 3 is determined by the relative position between the scribing guiding edge 12 and the anatomical marking points on the skull 3. The positioning plate 1 is installed at the preset slotting position of the skull 3, and then the slotting contour line is outlined along the scribing guiding edge 12. Subsequently, the opening tool 2 is used to perform guiding and opening through the guiding holes 11 to form a cutting hole, and finally, a slotting tool is inserted into the opening to process the skull 3 according to the slotting contour line to slot the skull 3. In this application, both the opening of the skull 3 and the outlining of the slotting contour line can be guided by the positioning plate 1, improving the positioning accuracy of the opening and slotting of the skull 3 and ensuring the accuracy and safety of the implantation of the pulse generator.
[0047] In this embodiment, the hole-opening tool 2 includes, but is not limited to, devices such as a craniotome or an ultrasonic osteotome. The grooving tool includes, but is not limited to, devices such as a power tool, an ultrasonic osteotome tool, etc. The anatomical marking points on the skull 3 include, but are not limited to, positions such as the sagittal suture, the coronal suture, and the anterior fontanelle point on the skull 3.
[0048] In this embodiment, there are four guiding holes 11, and the four guiding holes 11 are located at the four corners of the positioning plate 1, and can guide the hole-opening at four positions of the skull 3, facilitating the grooving tool to groove the skull 3.
[0049] Preferably, the scribing guiding edge 12 is a straight edge, the straight edge is located between adjacent guiding holes 11, and the straight edge is tangent to the inner diameter of the guiding hole 11, and the grooving contour line is tangent to the inner diameter of the guiding hole 11, so as to machine a rectangular groove with four rounded corners to meet the surgical requirements.
[0050] In this embodiment, the skull grooving positioning device further includes a fastener. The positioning plate 1 is provided with a fixing hole 13, and the fastener can pass through the fixing hole 13 and be connected to the skull 3. Among them, the fastener is a screw, and the screw passes through the fixing hole 13 and is threadedly connected to the threaded hole on the skull 3, so as to fix the positioning plate 1 on the skull 3 to keep the positioning plate 1 fixed during the hole-opening process.
[0051] Preferably, there are at least two fixing holes 13, and the fasteners correspond to the fixing holes 13 one by one. In this embodiment, there are two fixing holes 13, and the two fasteners fix the positioning plate 1 on the skull 3. On the one hand, the stability of the positioning plate 1 is improved; on the other hand, the positioning plate 1 is prevented from rotating relative to the skull 3.
[0052] In this embodiment, the fixing hole 13 is located on the central axis of the positioning plate 1, and the position of the fixing hole 13 does not affect the position of the guiding hole 11.
[0053] In order for the positioning plate 1 to better fit the surface of the skull 3, the bottom surface shape of the positioning plate 1 matches the outer wall shape of the preset grooving position of the skull 3, so that the bottom surface of the positioning plate 1 can fit the preset grooving position of the skull 3, improving the position accuracy of the positioning plate 1 and the stability of the positioning plate 1.
[0054] In this embodiment, the positioning plate 1 is further provided with a hollowing hole 14, and the fitting condition between the positioning plate 1 and the surface of the skull 3 can be observed through the hollowing hole 14.
[0055] Preferably, there are at least two hollowing holes 14. In this embodiment, there are two hollowing holes 14, and the two hollowing holes 14 are symmetrically arranged on both sides of the fixing hole 13 to facilitate observing the fitting conditions of multiple positions of the positioning plate 1 with the surface of the skull 3.
[0056] In this embodiment, the positioning plate 1 is made of transparent plastic. On the one hand, the plastic positioning plate 1 can deform. When the positioning plate 1 is installed on the surface of the skull 3, the positioning plate 1 deforms to better fit the surface of the skull 3. On the other hand, the transparent positioning plate 1 facilitates observing the fitting condition between the positioning plate 1 and the surface of the skull 3.
[0057] It should be noted that this embodiment also provides a method for positioning skull slotting, and the method for positioning skull slotting includes the following steps:
[0058] S1. Extract the preoperative CT (Computed Tomography) images of the patient;
[0059] S2. Reconstruct the 3D model of the patient's skull 3 based on the CT images to confirm the appropriate implantation position;
[0060] S3. Preoperatively in the 3D data model, combine the scribing guiding edge 12 of the skull slotting positioning device to establish the relative relationship between the implantation position, the intraoperative visible anatomical landmark points and the skull slotting positioning device;
[0061] S4. Intraoperatively position the skull slotting positioning device according to the relative relationship defined preoperatively in step S3;
[0062] S5. Perform osteotomy and slotting through the guidance of the skull slotting positioning device.
[0063] Specifically, in step S5, in this embodiment, the slotting contour line can be outlined along the scribing guiding edge 12 first, and then the opening tool 2 is used to open holes along the guiding holes 11. After removing the skull slotting positioning device, there are two ways to slot the skull 3, specifically as follows:
[0064] Way 1. Directly use the slotting tool to perform edge osteotomy according to the slotting contour line.
[0065] Way 2. Use the slotting tool to perform osteotomy along the centers of the four openings, and then use tools such as a power burr, an ultrasonic bone knife or a rongeur to remove the redundant bone along the slotting contour line.
[0066] Note that the above is only the preferred embodiment of the present application and the applied technical principle. Those skilled in the art will understand that the present application is not limited to the specific embodiments described here. 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 detail through the above embodiments, the present application is not limited to the above embodiments. 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 skull grooving positioning device, characterized in that, It includes a positioning plate (1), the positioning plate (1) is detachably connected to a preset grooving position of the skull (3), and a plurality of guiding holes (11) are provided on the positioning plate (1), and the guiding holes (11) are used to guide an opening tool (2); A scribing guiding edge (12) is provided on the outer periphery of the positioning plate (1), and the scribing guiding edge (12) is used to assist in drawing a grooving contour line.
2. The skull grooving positioning device according to claim 1, wherein There are four guiding holes (11), and the four guiding holes (11) are located at the four corners of the positioning plate (1).
3. The skull grooving positioning device according to claim 2, characterized in that, The scribing guiding edge (12) is a straight edge, the straight edge is located between adjacent guiding holes (11), and the straight edge is tangent to the inner diameter of the guiding holes (11).
4. The skull grooving positioning device according to claim 1, characterized in that, The skull grooving positioning device further includes a fastener, the positioning plate (1) is provided with a fixing hole (13), and the fastener can pass through the fixing hole (13) and be connected to the skull (3).
5. The cranial bone slotting positioning device according to claim 4, characterized in that There are at least two fixing holes (13), and the fasteners correspond to the fixing holes (13) one by one.
6. The skull grooving positioning device according to claim 4, characterized in that, The fixing holes (13) are located on the central axis of the positioning plate (1).
7. The skull grooving positioning device according to claim 1, wherein The positioning plate (1) is further provided with a hollowed-out hole (14).
8. The cranial bone slotting positioning device according to claim 7, wherein, There are at least two hollowed-out holes (14).
9. The skull grooving positioning device according to any one of claims 1-8, characterized in that, The bottom surface shape of the positioning plate (1) matches the outer wall shape of the preset grooving position of the skull (3), so that the bottom surface of the positioning plate (1) can fit on the preset grooving position of the skull (3).
10. The skull grooving positioning device according to any one of claims 1-8, characterized in that, The positioning plate (1) is made of transparent plastic.