Guide screw and coordinate system alignment method

Abstract

The present invention provides a guide screw and a coordinate system alignment method, which relates to the technical field of medical devices. The guide screw provided by the present invention comprises: a screw body, one end of the screw body is provided with a skull connection part, the other end is provided with an instrument connection part, the screw body is provided with a matching through hole, and the matching through hole extends along the axial direction of the screw body; the outer peripheral wall of the screw body is provided with a marking structure, and the marking structure is located at the end of the screw body close to the instrument connection part. The guide screw provided by the present invention alleviates the technical problem that when a patient with a stereotactic electrode installed in the related art needs to place a medical device in the brain for the second or even third time through a stereotactic surgical robot or a neuronavigation device, the patient needs to repeat the installation of the marker point for the alignment process each time, thereby causing pain to the patient, complicating the treatment process, and reducing the surgical efficiency.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a guide screw and a coordinate system alignment method. Background Art

[0002] Stereotactic electrode implantation is a new method for diagnosing epilepsy both domestically and internationally in recent years. This method has the advantages of minimally invasive, wide monitoring range and multiple monitoring points, and is gradually replacing the original intracranial cortical electrodes and deep intracranial electrodes. Stereotactic electrodes are generally fixed to the patient's head with the assistance of stereotactic equipment and guide screws fixed on the skull until the long-term EEG monitoring is completed.

[0003] According to the existing surgical procedures, when a stereotactic surgical robot or neuronavigation equipment is used to place a medical device in the patient's brain, the patient coordinate system and the software coordinate system need to be aligned, so the following are required:

[0004] 1. Install bone markers after drilling holes in the patient's skull.

[0005] 2. The patient undergoes a CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) scan with marker points installed to generate patient images with marker points and import them into the stereotactic surgical robot or neuronavigation equipment software system.

[0006] 3. After the patient is pushed into the operating room, operate the registration needle or navigation stick of the stereotactic surgical robot or neuronavigation device to actually point to the marker point on the patient's body, and register the marker point in the software.

[0007] 4. Register at least 3 marker points to complete patient registration.

[0008] 5. The path planned by the software system can then be called up to insert the device to be placed into the skull according to the preset path.

[0009] 6. Depending on the needs of the operation, the doctor may choose to remove the marker from the patient at a certain time between the completion of the patient registration and the end of the operation.

[0010] Whenever a patient needs to precisely place a medical device inside the skull, they need to go through the process of "installing marker points - taking CT or MRI - software image fusion reconstruction - registering marker points in the operating room". In the actual treatment process, patients may need to undergo a second or even third surgery to place a medical device.

[0011] When a patient with stereotactic electrodes installed needs to undergo a second or even third operation to place medical devices (including but not limited to stereotactic electrodes, radiofrequency electrodes, laser ablation probes, puncture biopsy needles, drainage tubes, and intracranial pressure monitoring catheters) in the brain through a stereotactic surgical robot or neuronavigation equipment, the patient needs to repeat the installation of marker points for the alignment process each time, causing pain to the patient, complicating the treatment process, and reducing surgical efficiency. Summary of the invention

[0012] The purpose of the present invention is to provide a guide screw and a coordinate system alignment method to alleviate the technical problem in the related art that when a patient with stereotactic electrodes installed needs to undergo a second or even third operation to place a medical device in the brain through a stereotactic surgical robot or a neuronavigation device, the patient needs to repeat the installation of marker points for the alignment process each time, thereby causing pain to the patient, complicating the treatment process, and reducing the surgical efficiency.

[0013] The guide screw provided by the present invention comprises: a screw body, one end of the screw body is provided with a skull connection part, the other end is provided with an instrument connection part, the screw body is provided with a matching through hole, and the matching through hole extends along the axial direction of the screw body;

[0014] The outer peripheral wall of the screw body is provided with a marking structure, and the marking structure is located at the end of the screw body close to the instrument connecting part.

[0015] Optionally, the screw body is made of metal material.

[0016] Optionally, the marking structure includes a protrusion protruding from the peripheral wall of the screw body.

[0017] Optionally, the marking structure includes a recessed portion recessed in the outer peripheral wall of the screw body, and a side wall of the recessed portion is bent.

[0018] Optionally, the screw body is made of non-metallic material.

[0019] Optionally, the marking structure is made of metal material, and the marking structure is embedded in the outer peripheral wall of the screw body.

[0020] Optionally, the marking structure is in the form of dots or lines.

[0021] Optionally, the screw body includes a first supporting portion and a second supporting portion connected to the first supporting portion, the skull connecting portion is arranged on the first supporting portion, the instrument connecting portion is arranged on the second supporting portion, the first supporting portion is made of non-metallic or metallic material, and the second supporting portion is correspondingly made of metallic material or non-metallic material.

[0022] Optionally, a boundary line between the first supporting portion and the second supporting portion is bent.

[0023] The coordinate system registration method provided by the present invention comprises:

[0024] Pre-enter the guide screw and the marking structure on the guide screw into the device;

[0025] When it is necessary to place a medical device on the patient's head for the Nth time (N is greater than or equal to 2), the image data obtained by scanning the patient's head after the electrodes are buried is retrieved;

[0026] Identify and mark the specific position of the marking structure of each guide screw on the retrieved image, so that the guide screw can be used as a bone marker point during N surgeries;

[0027] Register at least 3 marker points.

[0028] The guide screw provided by the present invention comprises: a screw body, one end of the screw body is provided with a skull connection part, the other end is provided with an instrument connection part, the screw body is provided with a matching through hole, and the matching through hole extends along the axial direction of the screw body; the outer peripheral wall of the screw body is provided with a marking structure, and the marking structure is located at the end of the screw body close to the instrument connection part. The screw body is installed on the patient's head through the skull connection part, and the medical device can enter the patient's skull through the matching through hole. The medical device is connected to the screw body through the instrument connection part to fix the device; when it is necessary to place the medical device in the patient's brain for the second or third time, the image data obtained by scanning the patient's head after the buried electrode is retrieved, and each marking structure in the image marks the position of the corresponding guide screw, and the guide screw can be used as a bone marker point during the second operation. Compared with the related art, the guide screw provided by the present invention can be used as a bone marker point during the second operation. When the medical device is placed in the patient's brain for the second or third time, there is no need to install the marker point again, which reduces the patient's pain, simplifies the treatment process, and thus improves the efficiency of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the related technologies, the drawings required for use in the specific embodiments or the related technical descriptions will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0030] Figure 1 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 1 ;

[0031] Figure 2A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 2 ;

[0032] Figure 3 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 2 A top view of

[0033] Figure 4 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 3 ;

[0034] Figure 5 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 4 ;

[0035] Figure 6 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 5 ;

[0036] Figure 7 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 6 ;

[0037] Figure 8 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 7 ;

[0038] Fig. 9 A schematic diagram of the structure of the guide screw provided in the embodiment of the present invention Figure 8 .

[0039] Icons: 100 - screw body; 101 - mating through hole; 110 - first supporting portion; 120 - second supporting portion; 210 - skull connecting portion; 220 - instrument connecting portion; 211 - tapered end; 230 - mating interface; 240 - mating surface; 300 - marking structure; 310 - protrusion; 320 - recessed portion. DETAILED DESCRIPTION

[0040] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0041] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, 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 therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0042] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0043] like Figures 1 to 9 As shown, the guide screw provided by the embodiment of the present invention includes: a screw body 100, one end of the screw body 100 is provided with a skull connection part 210, the other end is provided with an instrument connection part 220, the screw body 100 is provided with a matching through hole 101, and the matching through hole 101 extends along the axial direction of the screw body 100; the outer peripheral wall of the screw body 100 is provided with a marking structure 300, and the marking structure 300 is located at the end of the screw body 100 close to the instrument connection part 220.

[0044] The skull connection part 210 is provided with a self-tapping external thread, and the end of the skull connection part 210 is provided with a conical closing 211 to facilitate the insertion of the skull connection part 210 into the skull hole of the patient. When the screw body 100 is installed on the skull, the screw body 100 is rotated around the axis of the screw body 100, and the skull connection part 210 taps the internal thread on the inner wall of the skull hole, and the screw body 100 is installed on the skull at the same time.

[0045] Specifically, the matching through hole 101 penetrates the screw body 100 along the axis of the screw body 100, and medical devices (such as stereotactic electrodes, radiofrequency electrodes, laser destruction probes, puncture biopsy needles, drainage tubes, and intracranial pressure monitoring catheters, etc.) can enter the patient's skull through the matching through hole 101. The instrument connection part 220 can be connected to the medical device by means of a snap connection or a threaded connection. In this embodiment, the instrument connection part 220 is connected to the medical device by means of a threaded connection. Specifically, the instrument connection part 220 is provided with an external thread, and the medical device can be connected to the instrument connection part 220 through its own internal thread, thereby improving the stability of the connection, and at the same time improving the sealing between the guide screw and the medical device to prevent cerebrospinal fluid from leaking from the matching through hole 101.

[0046] Furthermore, a mating interface 230 is provided at the end of the instrument connection part 220 away from the skull connection part 210, and the mating interface 230 has a groove that cooperates with the installation tool. When the screw body 100 is installed on the skull, the screw body 100 is installed on the skull by cooperating with the mating interface 230 through the screwdriver, thereby improving the tightness of the installation. A wrench mating part is provided on the outer peripheral wall of the screw body 100. Specifically, the wrench mating part is located between the skull connection part 210 and the instrument connection part 220, and is close to the instrument connection part 220. The wrench mating part includes two mating surfaces 240 parallel to each other, and the distance between the two mating surfaces 240 is less than the diameter of the screw body 100. When the screw body 100 is removed from the skull, the wrench cooperates with the two mating surfaces 240, which facilitates the removal of the screw body 100.

[0047] Optionally, the screw body 100 is made of a metal material. Specifically, the screw body 100 can be made of a metal material such as stainless steel, titanium alloy, titanium, aluminum alloy or platinum-iridium alloy.

[0048] Furthermore, the marking structure 300 includes a protrusion 310 protruding from the outer peripheral wall of the screw body 100. Specifically, the protrusion 310 can be provided on the arc-shaped outer side surface of the screw body 100, or on the mating surface 240 that cooperates with the wrench. In this embodiment, the protrusion 310 is provided on the arc-shaped outer side surface of the screw body 100. Figure 1 As shown, the protrusion 310 is located between the mating surface 240 and the instrument connecting portion 220. The cross-section of the protrusion 310 perpendicular to the mating surface 240 is circular or polygonal, etc., which can be used for robot or navigation registration. In addition, other shapes that can form obvious features on CT or MRI images and facilitate precise pointing during robot or navigation registration are also acceptable.

[0049] As another embodiment, the marking structure 300 includes a recessed portion 320 recessed in the outer peripheral wall of the screw body 100, and the side wall of the recessed portion 320 is bent. Specifically, the recessed portion 320 can be provided on the arc-shaped outer side surface of the screw body 100, or on the mating surface 240 that cooperates with the wrench. Taking the recessed portion 320 provided on the arc-shaped outer side surface of the screw body 100 as an example, as shown in FIG. Figure 2 As shown, the cross section of the recessed portion 320 perpendicular to the mating surface 240 is V-shaped, and the recessed portion 320 includes two inclined surfaces with opposite inclined directions, such as Figure 3 As shown, the intersection of the two inclined surfaces can be used as a registration mark structure 300 for registration. Further, the cross section of the recessed portion 320 perpendicular to the mating surface 240 is W-shaped, or has more bending points, and the intersection of two adjacent inclined surfaces can be used as a registration point.

[0050] Optionally, the screw body 100 is made of a non-metallic material. Specifically, the screw body 100 can be made of polyoxymethylene, PEEK (polyetheretherketone), polysulfone, PE (polyethylene), PP (polypropylene), PPSU (polyphenylene sulfone resins), and the like.

[0051] Furthermore, the marking structure 300 is made of metal material, and the marking structure 300 is embedded in the outer peripheral wall of the screw body 100. Specifically, the marking structure 300 can be embedded in the arc-shaped outer side surface of the screw body 100, or embedded in the mating surface 240 that cooperates with the wrench. In some embodiments, the marking structure 300 is in the shape of a dot. Figure 4 As shown, a dot-shaped marking structure 300 is embedded between the mating surface 240 and the instrument connecting portion 220, and the marking structure 300 protrudes from the outer peripheral surface of the screw body 100, or is flush with the outer peripheral surface of the screw body 100. The surface of the marking structure 300 exposed outside the screw body 100 is a circular or polygonal shape that can be identified on CT or MRI images and is convenient for accurate pointing during robot or navigation registration.

[0052] In some other embodiments, the marking structure 300 is in a linear shape. Figure 5 and Figure 6 As shown, the marking structure 300 is cross-shaped and is disposed between the mating surface 240 and the instrument connecting portion 220, or is disposed on the mating surface 240. The intersection of the two straight lines can be used as a marking point for CT or MRI imaging. In other embodiments, the marking structure 300 is bent, and the inflection point of the bending line can be used as a marking point for CT or MRI imaging.

[0053] As another embodiment, the outer peripheral surface of the screw body 100 made of non-metallic material is provided with Figure 2 In the recessed portion 320 shown, the intersection line of two adjacent inclined surfaces of the recessed portion 320 can be used as a marking point for CT or MRI imaging.

[0054] Optionally, the screw body 100 includes a first support portion 110 and a second support portion 120 connected to the first support portion 110, the skull connection portion 210 is disposed on the first support portion 110, and the instrument connection portion 220 is disposed on the second support portion 120, the first support portion 110 is made of non-metallic or metallic material, and the second support portion 120 is correspondingly made of metallic material or non-metallic material.

[0055] In this embodiment, the first support portion 110 is made of a metal material, and the second support portion 120 is made of a non-metal material. Figure 1 The protrusion 310 shown, or the first support portion 110 is provided Figure 2 The recessed portion 320 shown is used as a marking point for CT or MRI imaging; as another embodiment, a marking structure 300 supported by a metal material can be embedded on the first support portion 110, or a recessed portion 320 can be set on the first support portion 110 as a marking point for CT or MRI imaging.

[0056] like Figure 7 As shown, the angle between the intersection line of the first support portion 110 and the second support portion 120 and the axis of the screw body 100 is less than 90 degrees. Specifically, the first support portion 110 is provided with a first inclined surface, and the second support portion 120 is provided with a second inclined surface that matches the first inclined surface. The first inclined surface and the second inclined surface are fixedly connected. The intersection line of the first support portion 110 and the second support portion 120 is inclined, and the endpoints of the intersection line can be used as robot or navigation registration points. In other embodiments, the intersection line of the first support portion 110 and the second support portion 120 is bent. Figure 8 As shown, one end of the first support portion 110 is provided with a connecting protrusion with a V-shaped cross section, and one end of the second support portion 120 is provided with a connecting groove that matches the connecting protrusion. The connecting protrusion is inserted into the connecting groove. The intersection line between the first support portion 110 and the second support portion 120 is V-shaped, and the inflection point of the V-shaped intersection line can be used as a robot or navigation registration point. Further, as Fig. 9 As shown, the boundary line between the first support portion 110 and the second support portion 120 is sawtooth-shaped, and the sawtooth-shaped boundary line has multiple inflection points. Appropriate inflection points can be selected as robot or navigation registration points as needed.

[0057] The marking structure in the guide screw provided in the embodiment of the present invention is not limited to the above-mentioned setting method. A structure that can be easily identified on CT or MRI images and can be easily and accurately selected during actual operation registration can be used as a marking structure.

[0058] The coordinate system registration method provided by the embodiment of the present invention includes:

[0059] Pre-enter the guide screw and the marking structure 300 on the guide screw into the device;

[0060] When it is necessary to place a medical device on the patient's head for the Nth time (N is greater than or equal to 2), the image data obtained by scanning the patient's head after the electrodes are buried is retrieved;

[0061] Identify and mark the specific position of the marking structure 300 of each guide screw on the retrieved image, so that the guide screw serves as a bone marker point during N operations;

[0062] Register at least 3 marker points.

[0063] Specifically, when placing a medical device on the patient's head for the first time, the registration operation can be performed according to the operation method of the prior art, and the guide screw provided in the embodiment of the present invention is installed on the patient's head, and the electrode is fixed to the patient's head through the guide screw. After the electrode is buried, the patient's head is scanned by CT or MRI to determine the actual position of the electrode. When the medical device needs to be placed for the second or even third time, the image data obtained by scanning the patient's head after the electrode is buried is retrieved, and the specific position of each guide screw marking structure 300 is identified and marked on the retrieved image. The guide screw installed on the patient's skull is used as a registration marker point, and the registration needle or navigation stick of the stereotactic surgical robot or neuronavigation device is operated to actually point to the marker point on the patient's body, and the marker point is registered in the software. The patient registration can be completed by registering at least 3 marker points.

[0064] The guide screw provided by the embodiment of the present invention comprises: a screw body 100, one end of the screw body 100 is provided with a skull connection part 210, the other end is provided with an instrument connection part 220, the screw body 100 is provided with a matching through hole 101, and the matching through hole 101 extends along the axial direction of the screw body 100; the outer peripheral wall of the screw body 100 is provided with a marking structure 300, and the marking structure 300 is located at the end of the screw body 100 close to the instrument connection part 220. The screw body 100 is installed on the patient's head through the skull connection part 210, and the medical device can enter the patient's skull through the matching through hole 101, and the medical device is connected to the screw body 100 through the instrument connection part 220 to fix the device; when it is necessary to place the medical device into the patient's brain for the second or third time, the image data obtained by scanning the patient's head after the buried electrode is retrieved, and each marking structure 300 in the image marks the position of the corresponding guide screw, and the guide screw can be used as a bone marker point during the secondary surgery. Compared with the related art, the guide screw provided in the embodiment of the present invention can be used as a bone marker point during secondary surgery. When placing medical devices in the patient's brain for the second or third time, there is no need to install the marker point again, which reduces the patient's pain, simplifies the treatment process, and thus improves surgical efficiency.

[0065] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A guide screw, It is characterized in that include: A screw body, wherein one end of the screw body is provided with a skull connection portion, the other end of the screw body is provided with an instrument connection portion, and the screw body is provided with a matching through hole, and the matching through hole extends along the axial direction of the screw body; The outer peripheral wall of the screw body is provided with a marking structure, and the marking structure is located at the end of the screw body close to the instrument connection part. The marking structure is configured to form a shape that can form obvious features on CT or MRI images and can be accurately indicated during robot or navigation registration; the marking structure provides one or more registration points.

2. The guide screw according to claim 1, It is characterized in that The screw body is made of metal material.

3. The guide screw according to claim 2, It is characterized in that The marking structure includes a protruding portion protruding from the outer peripheral wall of the screw body.

4. The guide screw according to claim 2, It is characterized in that The marking structure comprises a recessed portion recessed in the outer peripheral wall of the screw body, and the side wall of the recessed portion is bent.

5. The guide screw according to claim 1, It is characterized in that The screw body is made of non-metallic material.

6. The guide screw according to claim 5, It is characterized in that The marking structure is made of metal material and is embedded in the outer peripheral wall of the screw body.

7. The guide screw according to claim 6, It is characterized in that The marking structure is in the form of dots or lines.

8. The guide screw according to claim 1, It is characterized in that The screw body includes a first supporting part and a second supporting part connected to the first supporting part, the skull connecting part is arranged on the first supporting part, and the instrument connecting part is arranged on the second supporting part. The first supporting part is made of non-metallic or metallic material, and the second supporting part is correspondingly made of metallic material or non-metallic material.

9. The guide screw according to claim 8, It is characterized in that A boundary line between the first supporting portion and the second supporting portion is in a bent shape.

10. A coordinate system registration method, It is characterized in that The guide screw according to any one of claims 1 to 9 comprises: Pre-enter the guide screw and the marking structure on the guide screw into the device; When it is necessary to place a medical device on the patient's head for the Nth time, the image data obtained by scanning the patient's head after the electrodes are buried is retrieved, where N is greater than or equal to 2; Identify and record the specific position of the marking structure of each guide screw on the retrieved image, so that the guide screw can be used as a bone marker point during N surgeries; Register at least 3 marker points.

Images