Craniotomy in situ pressure visualization scalp compression hemostasis device

Abstract

The application discloses a craniotomy pressure visualization scalp pressing positioning hemostasis equipment, which comprises two groups of pressure touchers, is arranged on both sides of a surgical incision, a scalp nail is arranged on one side of the pressure touchers close to the incision, a pressure sensing assembly is arranged on the end of the pressure touchers in contact with the scalp, a control host is connected with the two groups of pressure touchers, the pressure touchers maintain the scalp in a pulled-apart state through the scalp nail, and the pressing force on the scalp is detected in real time through the pressure sensing assembly, so that the incision is in a non-bleeding state. Advantages: the pressure sensing assembly and the scalp nail for pulling the scalp are integrated in the C-shaped pressure arm to form the pressure toucher, the scalp is pulled to form an operation space through the scalp nail, the tissues around the surgical incision are pressed through the pressure toucher, the pressing force is monitored in real time through the control host, the surgeon can adjust the hemostasis force, bleeding and tissue damage are avoided, and the problems of unquantifiable pressure, functional separation and lack of feedback during the operation are solved.

Description

Technical Field

[0001] This invention relates to the medical field, specifically to a device for visualizing scalp pressure application and positioning for hemostasis during craniotomy. Background Technology

[0002] Craniotomy is one of the most common surgical procedures in neurosurgery. With advancements in technology and the increasing adoption of minimally invasive techniques, most intracranial hematomas and small intracranial lesions can be removed with a small 3-5cm scalp incision. During the procedure, the scalp needs to be incised to expose the skull and facilitate subsequent procedures. The common sequence for scalp incision is as follows: the surgeon and assistant press down on both sides of the skin with their hands, the blade cuts through the skin or the full thickness, the subcutaneous tissue is cut with an electrocautery knife, bipolar electrocoagulation is used to stop bleeding at major bleeding points, and scalp clamps are applied. After the scalp is incised, in order to obtain sufficient surgical space, a scalp retractor is usually used to push and pull the scalp outward from both sides of the incision.

[0003] Currently, existing technologies have the following shortcomings: 1. Inability to provide real-time pressure feedback, hindering adjustment of scalp pressure: After scalp incision, continuous pressure is applied to the scalp on both sides of the incision to reduce intraoperative bleeding and maintain a clear surgical field. During the surgery, the pressure applied to the scalp will dynamically change due to factors such as surgeon's operation, changes in patient position, and tissue elasticity. With current equipment, the surgeon cannot know the specific pressure value applied to the scalp and can only make subjective judgments based on feel and experience. When the pressure is insufficient, bleeding will continue at the incision site, and excessive electrocoagulation and thermal burns often affect incision healing or delay suture removal. When the pressure is too high, it may cause complications such as ischemic damage to scalp tissue and postoperative scalp necrosis.

[0004] 2. The retraction and hemostasis functions are independent and the operation is cumbersome: In the existing technology, scalp retraction and compression hemostasis are usually completed by two different sets of instruments. After using the retractor to create operating space, gauze, cotton pads, etc. are also needed for manual compression hemostasis. This not only increases the number of surgical steps, but also reduces the efficiency of the operation due to the need for frequent adjustments.

[0005] In summary, there is an urgent clinical need for a scalp retraction device that can assist in opening the scalp, creating more space for operation, while also detecting and displaying the pressure applied in real time, thus ensuring that the incision remains free of bleeding. Summary of the Invention

[0006] The technical problem to be solved by the present invention is that, as mentioned in the background art, existing head surgeries cannot quantify and display the scalp pressure, the separation of traction and hemostasis functions, and lack real-time pressure feedback, which makes it difficult for the surgeon to conveniently control the pressure for hemostasis, and the incision is prone to bleeding or scalp tissue damage.

[0007] To address the aforementioned technical issues, a pressure visualization scalp pressure positioning and hemostasis device for craniotomy is proposed; it is achieved through the following technical solution: a pressure visualization scalp pressure positioning and hemostasis device for craniotomy, comprising two sets of pressure contactor bodies, respectively placed on both sides of the surgical incision; Scalp tacks are placed on one side of the pressure device near the incision. They can pull the scalp on both sides of the surgical incision to keep the scalp open and create operating space. A pressure sensing component is located at the end of the pressure sensor body that contacts the scalp, and is used to monitor the pressure of the pressure sensor body on the scalp in real time; The control unit is quick-release connected to two sets of pressure sensors to display the pressure value of the pressure sensing components in real time. The pressure device body maintains the scalp in a pulled-open state through scalp clips, and detects the pressure applied to the scalp in real time through a pressure sensing component to achieve hemostasis and keep the incision in a bleeding-free state.

[0008] In a preferred embodiment of the present invention, the pressure device body includes a hollow C-shaped pressure arm, a scalp clip is set on the side of the C-shaped pressure arm pointing towards the incision, and a pressure sensing component is set inside the C-shaped pressure arm. The scalp clip facilitates pulling the patient's scalp through the scalp clip, which is convenient for creating operating space and easy to use.

[0009] In a preferred embodiment of the present invention, the pressure sensing component includes a base plate, a PCB board, and a silicone contact plate. The pressure sensor is mounted on the PCB board, corresponding to the turning points of the C-shaped pressure arm near both ends in the pressure body of the pressure device. The PCB board is positioned between the silicone contact plate and the base plate. The base plate is placed inside the C-shaped pressure arm in the pressure device body. The silicone contact plate is in contact with the skin. The configuration of the pressure sensing component facilitates the sensing of the pressure applied to the scalp, making it convenient to coordinate with the control host to display the pressure value in real time, and allowing the operator to adjust the pressure in real time according to the displayed pressure value.

[0010] In a preferred embodiment of the present invention, the pressure sensor protrudes from the surface of the PCB board and is connected to the silicone contact plate. The silicone contact plate does not contact any other part of the PCB board except the pressure sensor. This arrangement ensures that all pressure applied to the silicone contact plate is directly and without loss transmitted to the pressure sensor, effectively avoiding the diversion effect caused by the support of other parts of the PCB board on the silicone contact plate. This ensures the accuracy of the pressure measurement and makes the feedback pressure value truly reflect the actual compressive force.

[0011] In a preferred embodiment of the present invention, the silicone contact plate is made of silicone, and the size of the silicone contact plate is smaller than the internal size of the C-shaped pressure arm in the pressure sensor body. The silicone contact plate does not contact the inner wall of the C-shaped pressure arm. The silicone contact plate is lower than the scalp clip, and the scalp clip contacts the scalp before the silicone contact plate. The silicone contact plate does not contact the C-shaped pressure arm, thus avoiding interference of the shell stress with the pressure measurement. Its size is smaller than the C-shaped pressure arm, ensuring that it can float freely and transmit pressure in the vertical direction without affecting the contact between the scalp clip and the scalp.

[0012] A preferred embodiment of the present invention further includes a pressure point fixing device for fixing and adjusting the position of the pressure point body. The pressure point fixing device includes a head cover, a pressure point mounting assembly, and a pressure point adjustment assembly. The pressure point mounting assembly and the pressure point adjustment assembly are disposed on the head cover, which is fixed to the patient's head. The pressure point body is detachably installed in the pressure point mounting assembly, which is connected to the pressure point adjustment assembly. The pressure point adjustment assembly and the pressure point mounting assembly can controllably adjust the position of the pressure point body on the head and the pressure applied to the scalp. The setting of the pressure point fixing device facilitates the adjustment of the position of the pressure point body on the patient's head and automatic pressing, avoiding manual pressing by the operator and making it convenient to use.

[0013] In a preferred embodiment of the present invention, the pressure point mounting assembly includes a mounting base, a pressure point mounting plate, and an adjustment plate. The mounting base is mounted on the headgear, and the pressure point mounting plate is mounted inside the mounting base via a pressure point adjustment assembly. The pressure point body is detachably mounted inside the pressure point mounting plate, and the adjustment plate is connected to the pressure point mounting plate. The adjustment plate can controllably adjust the distance between the pressure point mounting plate and the head. This configuration facilitates adjustment of the pressure applied by the pressure point body to the patient's head, avoids manual handling, and is convenient to use.

[0014] In a preferred embodiment of the present invention, the pressure-sensitive device adjustment assembly includes an X-axis moving mechanism, a Y-axis moving mechanism, and a locking mechanism. The X-axis moving mechanism and the Y-axis moving mechanism are connected to the adjustment plate. The X-axis moving mechanism and the Y-axis moving mechanism adjust the position of the adjustment plate and the pressure-sensitive device mounting plate in the X and Y directions, respectively. There are two sets of locking mechanisms, which are set on the mounting base. The two sets of locking mechanisms are respectively connected to the X-axis moving mechanism and the Y-axis moving mechanism to restrict the adjustment of the X-axis moving mechanism and the Y-axis moving mechanism. The setting of the pressure-sensitive device adjustment assembly facilitates the adjustment of the position of the pressure-sensitive device body through the pressure-sensitive device adjustment assembly, which is suitable for different head positions and avoids the user holding it by hand, making it convenient to use.

[0015] In a preferred embodiment of the present invention, the X-axis moving mechanism includes a sliding rod, a sliding sleeve, and a first adjusting screw. The sliding sleeve is disposed on the adjusting plate, the sliding rod is connected to the sliding sleeve, and the first adjusting screw is disposed in the mounting base and connected to the adjusting plate. The Y-axis moving mechanism includes a Y-axis slide, a connecting rod, and a second adjusting screw. The Y-axis slide is set inside the mounting base. The connecting rod is connected to the slide rod. The second adjusting screw is connected to the connecting rod. The second adjusting screw drives the connecting rod to move along the Y-axis slide. The locking mechanism includes a gear, a gear limit block, and a lifting screw. The gear is mounted on the first and second adjusting screws of the X-axis and Y-axis moving mechanisms. The gear limit block engages with the gear via the lifting screw. The locking mechanism facilitates locking the X-axis and Y-axis moving mechanisms, preventing accidental movement of the pressure contactor body during use and ensuring operational stability.

[0016] In a preferred embodiment of the present invention, auxiliary drawing lines are provided at both ends of the C-shaped pressure arm in the pressure device body. The auxiliary drawing lines assist in the preoperative incision of the scalp. The setting of the auxiliary drawing lines facilitates the operation of the surgeon during the operation by assisting the surgeon in the incision of the scalp.

[0017] The beneficial effects of this invention compared to the prior art are: The technical solution of this invention integrates a pressure sensing component for pressure detection and a scalp tack for pulling the scalp into a C-shaped pressure arm to form a pressure device body. In use, the scalp tack pulls the scalp to form a stable surgical operating space, and the pressure device body is used to press on the tissue around the surgical incision. The pressure intensity is monitored in real time by a control host connected to the pressure sensing component. The surgeon can accurately adjust the pressure hemostasis intensity according to the displayed data to avoid bleeding and tissue damage, thus realizing precise operation in surgery. It solves the problems of unquantifiable pressure, functional separation, and lack of feedback in surgery, and achieves safe and controllable surgical operation, effectively reducing surgical risks and tissue damage. Furthermore, by setting up a pressure point fixing device that includes a headgear, a pressure point mounting component, and a pressure point adjustment component, the pressure point mounting component serves as the carrier for mounting the pressure point body. During use, the headgear is stably fixed to the patient's head. The pressure point mounting component and the pressure point adjustment component allow for adjustment of the position of the pressure point body on the patient's head, as well as adjustment of the pressure of the pressure point body on the patient's head. This avoids the user having to manually press and hold the pressure point body, making it convenient to use. Attached Figure Description

[0018] Figure 1 This is a three-dimensional schematic diagram of the present application; Figure 2 This is a three-dimensional schematic diagram of the main body of the pressure contactor; Figure 3 A three-dimensional schematic diagram of a C-shaped pressure arm; Figure 4 This is a three-dimensional schematic diagram of the pressure sensing component; Figure 5 This is a partial sectional view of the main body of the pressure contactor; Figure 6 This is an exploded view of the main body of the pressure contactor; Figure 7 This is a schematic diagram showing the main body of the pressure contactor in use. Figure 8 for Figure 7 Enlarged view of point A in the middle; Figure 9 A three-dimensional schematic diagram of the pressure contactor fixing device; Figure 10 Partial cross-sectional view of the pressure contactor mounting assembly; Figure 11 Exploded view of the pressure contactor mounting assembly (including the pressure contactor adjustment mechanism); Figure 12 Exploded view of the pressure contactor mounting plate (including the adjustment plate); Figure 13 A three-dimensional schematic diagram of the pressure contactor adjustment assembly; Figure 14 Exploded view of the pressure contactor fixing device; Figure labeling: 1-Presser body, 11-C-type pressure arm, 12-Headpiece clip, 13-Clip step, 14-Press handle, 15-Mounting insert, 16-Auxiliary drawing line, 2-Pressure sensing component, 21-Base plate, 22-PCB board, 23-Pressure sensor, 24-Silicone contact plate, 26-Connecting wire, 27-Quick-release terminal block, 3-Control host, 31-Display screen, 32-Power cord, 4-Presser fixing device, 41-Headpiece cover, 42-Strap, 43-Top fixing platform, 44-Operating port, 5-Presser mounting component, 51-Mounting base, 52-Mounting substrate 53-Pressor mounting plate, 54-Mounting groove, 55-Leaning opening, 56-Adjusting plate, 57-Triangular connecting plate, 58-Lifting block, 59-Lifting adjusting screw, 6-Pressor adjusting assembly, 7-X-axis moving mechanism, 71-Slide rod, 72-Slide sleeve, 73-First adjusting screw, 74-Screw mounting block, 75-Mounting block sliding hole, 76-Flange nut, 8-Y-axis moving mechanism, 81-Y-axis slide rail, 82-Slide rod connecting slider, 83-Connecting rod, 84-Second adjusting screw, 9-Locking mechanism, 91-Gear, 92-Gear limit block, 93-Lifting screw, 94-Lifting guide rod. Detailed Implementation

[0019] The following will refer to the appendices in the embodiments of the present invention. Figure 1-14 The technical solutions in the embodiments of the present invention will be described in detail below. Example

[0020] like Figure 1 and 2As shown, a pressure visualization scalp pressure positioning and hemostasis device for craniotomy includes two sets of pressure contact body 1 and a control host 3 connected to the two sets of pressure contact body 1.

[0021] The main function of the pressure device body 1 is to hold it by the surgeon or assistant and press the skin at the incision site on both sides of the incision to achieve hemostasis. At the same time, the scalp clips 12 on the pressure device body 1 can also pull the scalp at the incision site from both sides of the incision to keep the scalp in a pulled state and create surgical operation space.

[0022] The main function of the control host 3 is to connect with the pressure device body 1, and the control host 3 can display the pressure of the pressure device body 1 on the skin at the incision site in real time. The surgeon can accurately adjust the pressure hemostasis force according to the displayed data to avoid bleeding and tissue damage, realize the fine operation in the operation, and solve the problems of unquantifiable pressure, functional separation and lack of feedback in the operation.

[0023] like Figure 2 and 3 As shown, the main body 1 of the pressure sensor includes a C-shaped pressure arm 11, a scalp clip 12, and a pressing handle 14.

[0024] The C-shaped pressure arm 11 is a C-shaped metal cover made of stainless steel bent into shape. One side of the C-shaped pressure arm 11 is open, and its interior has space for installing the pressure sensing component 2.

[0025] To facilitate scalp traction, three rectangular protrusions protrude perpendicularly outward from the inner arc of the C-shaped pressure arm 11. These protrusions are named scalp clips 12. The three scalp clips 12 are evenly spaced along the inner arc of the C-shaped pressure arm 11. To ensure that the scalp clips 12 can stably hook onto the scalp, the cross-sectional area of ​​the end of the scalp clip 12 that contacts the scalp is smaller than the cross-sectional area of ​​the end that is furthest away from the scalp. Furthermore, a clip step 13 is provided on the end face of the scalp clip 12, which contacts the scalp. This design increases the contact area and friction between the scalp clips 12 and the scalp tissue, allowing them to hook onto the scalp more securely. This prevents the clips from loosening or damaging the deep tissues of the scalp during traction, thus enhancing the reliability of the scalp fixation.

[0026] In order to facilitate the application of force to the C-shaped pressure arm 11 and make it easier to press the C-shaped pressure arm 11, thereby improving the user's comfort, a pressing handle 14 is fixed on the front of the C-shaped pressure arm 11. The pressing handle 14 is arc-shaped, which makes it easy to hold and operate, and makes it easy for the user to pinch and apply force.

[0027] Definition: In this embodiment, the patient is the reference, and the side of the pressure device body 1 that contacts the patient is the back (also the bottom), and the other side is the front (also the top).

[0028] like Figure 1 ,4 As shown in Figures 5, 6, 7 and 8, the pressure sensing assembly 2 includes a base plate 21, a PCB board 22 and a silicone contact plate 24. The base plate 21 is installed inside the C-shaped pressure arm 11, the PCB board 22 is installed on the base plate 21, and the silicone contact plate 24 is connected to the pressure sensor 23 in the PCB board 22.

[0029] The base plate 21 is a C-shaped plate made of a rigid material. In this embodiment, it is preferably made of stainless steel. The outline of the base plate 21 is the same as the outline of the C-shaped pressure arm 11. The base plate 21 can be fixed in the C-shaped pressure arm 11 with screws.

[0030] The PCB board 22 is an existing integrated circuit control board. The outline shape of the PCB board 22 is the same as that of the base plate 21, and its size is slightly smaller than that of the base plate 21. Two pressure sensors 23 are installed on both sides of the PCB board 22 at the bends at both ends of the C-shaped pressure arm 11. The pressure sensors 23 protrude from the PCB board 22 and can collect the pressure applied by the surgeon to the patient's scalp.

[0031] The silicone contact plate 24 is a C-shaped plate made of silicone. The outline shape of the silicone contact plate 24 is the same as that of the base plate 21, and the size of the silicone contact plate 24 is slightly smaller than the size of the installation space of the C-shaped pressure arm 11. That is, the outer side wall of the silicone contact plate 24 does not contact the inner side wall of the C-shaped pressure arm 11. This setting avoids interference with pressure measurement due to the side wall of the C-shaped pressure arm 11 contacting the silicone contact plate 24. At the same time, it also ensures that the silicone contact plate 24 can float freely and transmit vertical pressure only to the pressure sensor 23, reducing interference during pressure detection and improving accuracy.

[0032] Two mounting slots are provided on the surface of the silicone contact plate 24 at one end of the C-shaped pressure arm 11. The pressure sensor 23 on the PCB board 22 can be placed in the mounting slots and fixedly connected to the pressure sensor 23 with glue. The silicone contact plate 24 does not contact the PCB board 22 or any other parts thereon except for the pressure sensor 23. In this way, the pressure on the silicone contact plate 24 can be transmitted to the pressure sensor 23 most accurately, thus improving the accuracy of pressure detection.

[0033] Regarding the connection between the pressure sensing component 2 and the control host 3, in this embodiment, it is preferred that the PCB board 22 in the pressure contactor body 1 is connected to the control host 3 by connecting wire 26.

[0034] In this embodiment, the pressure sensor body 1 is preferably a disposable item. Before use, the pressure sensor body 1 is sterilized and packaged (this is the prior art). In order to facilitate the replacement of the pressure sensor body 1, a quick-release terminal 27 is also installed at the connection between the pressure sensor body 1 and the connecting wire 26. The quick-release terminal 27 is an existing two-pin quick-release terminal. The quick-release terminal 27 can realize the quick disassembly and assembly of the pressure sensor body 1 and the connecting wire 26, which facilitates the replacement of the pressure sensor body 1 after use.

[0035] To avoid interference, the height of the end of the silicone contact plate 24 that contacts the patient's scalp is lower than the height of the scalp clip 12. That is, the scalp clip 12 takes precedence over the silicone contact plate 24 and contacts the patient's scalp first. This arrangement ensures that the silicone contact plate 24 does not affect the contact between the scalp clip 12 and the patient's scalp, thus avoiding affecting the normal traction effect of the scalp clip 12 on the patient's scalp.

[0036] like Figure 1 As shown, the control host 3 includes a display screen 31 and a power cord 32. The power cord 32 is installed inside the display screen 31, and the control host 3 is connected to an external power source through the power cord 32.

[0037] The control host 3 is a host with a display screen 31 and a control circuit board. The display screen 31 is a conventional touch screen and is connected to the control circuit board. The pressure plate body 1 is connected to the control circuit board in the control host 3 through the connecting wire 26. The display screen 31 can display the pressure detected by the two pressure sensors 23 at different positions on the two pressure plate bodies 1 in real time, and calculate the average pressure of the entire silicone contact plate 24 (this calculation method is existing technology, and the contact area between the silicone contact plate 24 and the patient is preferably 17.2 square centimeters). This allows the user to view the pressure applied to the pressure plate body 1 in real time and make adjustments based on the data to avoid bleeding.

[0038] Regarding the magnitude of the force applied to the pressure plate 1: Tests have shown that during normal surgery, the silicone contact plate 24 in the pressure plate 1 applies a pressure of 15 kPa to the scalp, which is sufficient to prevent bleeding from the incision. Therefore, when applying pressure to the scalp at the incision site by pressing the pressure plate 1, it is important to ensure that the pressure is greater than 15 kPa.

[0039] like Figure 9 , 10 As shown in Figures 1 and 14, in order to reduce the user's workload and avoid applying pressure to the patient's scalp by holding the pressure device body 1, this application can also fix and adjust the position of the pressure device body 1 on the patient's head by the pressure device fixing device 4.

[0040] The pressure point fixing device 4 includes a head cover 41, a pressure point mounting assembly 5, and a pressure point adjusting assembly 6. The pressure point mounting assembly 5 and the pressure point adjusting assembly 6 are mounted on the head cover 41. The pressure point body 1 is detachably mounted in the pressure point mounting assembly 5. The pressure point mounting assembly 5 and the pressure point adjusting assembly 6 can adjust the position of the pressure point body 1 in the X and Y directions, as well as adjust the pressure of the pressure point body 1 on the head.

[0041] The main function of the headgear 41 is to serve as a carrier for mounting the pressure sensor mounting assembly 5 and the pressure sensor adjustment assembly 6, while the headgear 41 can be stably fixed on the patient's head.

[0042] The main function of the pressure plate mounting assembly 5 is to serve as a carrier for mounting the pressure plate body 1 and the pressure plate adjustment assembly 6. At the same time, the pressure plate mounting assembly 5 can also adjust the distance between the pressure plate body 1 and the patient's head, thereby adjusting the pressure of the pressure plate body 1 on the head.

[0043] The main function of the pressure sensor adjustment component 6 is to adjust the position of the pressure sensor body 1 relative to the head in the X and Y directions, making it convenient to use.

[0044] The headgear 41 is a circular cover made of existing high-density polyester fiber (the same material as the surgical gown currently in use). The headgear 41 can be put on the patient's head, and there are openings at the corresponding face and back of the head to facilitate ventilation and fixation. In order to make it easier to press the handle 14 to fix it stably on the patient's head, there are also straps 42 sewn on the headgear 41 at the corresponding neck and forehead of the patient. The straps 42 are attached to the headgear 41 with Velcro to achieve stable fixation of the headgear 41 on the patient's head.

[0045] To facilitate the installation of the pressure device mounting assembly 5, a circular plate made of PP plastic is fixed to the top of the head of the headgear 41 in an existing manner. This plate is named the top fixing platform 43. A circular operating port 44 is provided in the middle of the top fixing platform 43 to facilitate the operator to operate through the operating port 44. Nuts are also pre-embedded on the top fixing platform 43 to facilitate the installation of the pressure device mounting assembly 5 on the headgear 41.

[0046] To improve the stability of the fixation, the part of the top fixation platform 43 that contacts the patient's head is an arc shape that conforms to the shape of the head.

[0047] like Figure 10 , 11 As shown in Figures 1 and 12, the pressure contactor mounting assembly 5 includes a mounting base 51 and a mounting substrate 52, with the mounting base 51 mounted on the top fixed platform 43 via the mounting substrate 52.

[0048] Mounting base 51 is a rectangular metal platform made of stainless steel. A cavity for mounting the pressure contactor adjustment assembly 6 is milled on the mounting base 51, and the cavity extends through the mounting base 51.

[0049] The mounting base 52 is a stainless steel metal plate with the same outer contour as the mounting platform 51. There are two mounting bases 52. The two mounting bases 52 are respectively installed on the upper and lower sides of the mounting platform 51 with screws to seal the cavity of the mounting platform 51. The lower one of the two mounting bases 52 is connected to the top fixing platform 43 with screws to fix the mounting platform 51 on the headgear 41. In order to facilitate the operation of the user, an operation port is also provided in the middle of the mounting base 52 corresponding to the operation port 44, which is convenient for the operator to operate.

[0050] To facilitate the installation of the pressure contactor body 1 within the mounting base 51, a pressure contactor mounting plate 53 is also provided within the mounting base 52. The pressure contactor mounting plate 53 is a rectangular metal plate, and a mounting groove 54 for installing the pressure contactor body 1 is provided on the side of the pressure contactor mounting plate 53. The pressure contactor body 1 can be inserted into the mounting groove 54. In addition, to facilitate the routing of wires on the pressure contactor body 1, a clearance opening 55 communicating with the mounting groove 54 is provided on the pressure contactor mounting plate 53 for easy insertion into the pressure contactor. The pressure contact body 1 is routed within the mounting plate 53. In addition, to improve the stability of the pressure contact body 1 within the pressure contact mounting plate 53, triangular inserts are welded to both sides of the C-shaped pressure arm 11 on the pressure contact body 1. These inserts are named mounting inserts 15. Threaded holes are provided on the mounting inserts 15. Circular mounting holes are also provided on the pressure contact mounting plate 53. The mounting holes and threaded holes enable the pressure contact body 1 to be stably fixed within the pressure contact mounting plate 53.

[0051] To facilitate the installation of the pressure plate 53 within the mounting base 51 and to allow for easy adjustment of the pressure applied to the patient's head by the pressure plate 1, an adjustment plate 56 is also installed within the mounting base 51. The adjustment plate 56 is installed within the mounting base 51 via the pressure plate adjustment assembly 6. The adjustment plate 56 is a rectangular metal plate and is connected to the pressure plate 53 via a triangular connecting plate 57.

[0052] The triangular connecting plate 57 is a metal plate with a triangular cross-section. The triangular connecting plate 57 is connected to the middle and two ends of the pressure contactor mounting plate 53 by screws. These three points correspond to the middle and two ends of the C-shaped pressure arm 11, which improves the stability of pressure monitoring. In addition, in order to further enhance pressure monitoring and ensure the stability of pressure adjustment of the C-shaped pressure arm 11, protrusions are provided on the pressure contactor mounting plate 53 at the three connection points. The triangular connecting plate 57 is connected to the pressure contactor mounting plate 53 through the protrusions and does not contact other positions on the pressure contactor mounting plate 53, thus avoiding position interference.

[0053] To facilitate adjustment of the distance between the pressure plate 53 and the adjusting plate 56, thereby adjusting the pressure on the patient's head, an "L"-shaped lifting block 58 is welded to the middle of the triangular connecting plate 57. The vertical end of the lifting block 58 is inserted into the adjusting plate 56 and can slide as the distance between the pressure plate 53 and the adjusting plate 56 is adjusted. To facilitate adjustment of the distance between the adjusting plate 56 and the pressure plate 53, a lifting adjusting screw 59 is screwed onto the adjusting plate 56. One end of the lifting adjusting screw 59 passes through the triangular connecting plate 57 and is connected to the triangular connecting plate 57 using existing technology (in this embodiment, a commonly used C-shaped spring clip connection is preferred). In this way, when the lifting adjusting screw 59 is rotated, the lifting adjusting screw 59 will not fall off the triangular connecting plate 57, but it can drive the triangular connecting plate 57 to move closer to or further away from the adjusting plate 56, thereby adjusting the pressure on the patient's head by the pressure plate body 1.

[0054] like Figure 10 , 11 As shown in Figure 13, the pressure contactor adjustment assembly 6 includes an X-axis moving mechanism 7, a Y-axis moving mechanism 8, and a locking mechanism 9. The X-axis moving mechanism 7 can adjust the position of the adjusting plate 56 together with the pressure contactor mounting plate 53 in the X direction, and the Y-axis moving mechanism 8 can adjust the position of the adjusting plate 56 together with the pressure contactor mounting plate 53 in the Y direction. There are two sets of locking mechanisms 9, which are connected to the X-axis moving mechanism 7 and the Y-axis moving mechanism 8 respectively, to restrict the adjustment of the X-axis moving mechanism 7 and the Y-axis moving mechanism 8 and prevent unplanned movement.

[0055] The X-axis moving mechanism 7 includes a slide rod 71, a sliding sleeve 72, and a first adjusting screw 73. The slide rod 71 is a plastic rod with a rectangular cross-section, and the sliding sleeve 72 is a plastic tube with a rectangular cross-section. The slide rod 71 can be inserted into the sliding sleeve 72 and slide freely within the sliding sleeve 72 (in this example, the slide rod 71 and the sliding sleeve 72 are preferably made of Teflon material that meets medical standards and has self-lubricating ability). The sliding sleeve 72 is fixed to the lower surface of the adjusting plate 56 using existing technology.

[0056] The first adjusting screw 73 is an existing screw. A flange nut 76 is fixed to the lower surface of the adjusting plate 56 near the first adjusting screw 73 by screws. The first adjusting screw 73 passes through the flange nut 76 and is connected to the adjusting plate 56. The two ends of the first adjusting screw 73 are respectively connected to the two opposite side walls of the mounting base 51. Rotating the first adjusting screw 73 can drive the adjusting plate 56 to move, thereby adjusting the position of the pressure contactor body 1 in the X direction.

[0057] Regarding the mounting method of the first adjusting screw 73 on the mounting base plate 52: In this example, a screw mounting block 74 is used for mounting. The screw mounting block 74 is a rectangular metal block. A bearing is installed in the middle of the screw mounting block 74. The first adjusting screw 73 passes through the bearing and is interference-fitted with the inner ring of the bearing. A circular mounting hole is opened at each of the four corners of the screw mounting block 74. The screw mounting block 74 is connected to the mounting base plate 52 using existing locking screws. Rotating the first adjusting screw 73 can drive the adjusting plate 56 to move. In order to facilitate the movement of the adjusting plate 56 in the Y direction, an oblong mounting block sliding hole 75 is opened on the side of the mounting base plate 52 corresponding to the mounting positions of the screw mounting block 74 and the first adjusting screw 73. The locking screw on the screw mounting block 74 and the first adjusting screw 73 can move along the mounting block sliding hole 75 under the action of the Y-axis moving mechanism 8 to achieve movement in the Y direction.

[0058] like Figure 11 and 13 As shown, the Y-axis moving mechanism 8 includes a Y-axis slide 81, a sliding rod connecting slider 82, a connecting rod 83, and a second adjusting screw 84. The Y-axis slide 81 is fixed on the mounting base 52 at the bottom of the mounting base 51. The sliding rod connecting slider 82, which is connected to both ends of the sliding rod 71, is slidably disposed in the Y-axis slide 81. The connecting rod 83 connects the two sliding rod connecting sliders 82. The second adjusting screw 84 passes through the mounting base 51 and is rotatably connected to the connecting rod 83. Rotating the second adjusting screw 84 drives the connecting rod 83 and the X-axis moving mechanism 7 to move in the Y direction.

[0059] The Y-axis slide 81 is a plastic slide with a rectangular cross-section. A U-shaped groove is provided on the Y-axis slide 81 along the extension direction. The slider connecting the slide rod 82 is a rectangular plastic block. One end of the slider connecting the slide rod 82 can cooperate with the Y-axis slide 81 and slide inside the Y-axis slide 81. The other end is connected to the end of the slide rod 71 by a screw.

[0060] Two sets of Y-axis slide rails 81 and slide rod connecting sliders 82 are provided, located at both ends of slide rod 71 respectively. In order to ensure the stability of sliding, in this example, Y-axis slide rails 81 and slide rod connecting sliders 82 are preferably made of Teflon material that meets medical standards and has self-lubricating ability.

[0061] The connecting rod 83 is a rectangular rod made of plastic. Its main function is to connect the two sliding rods, the connecting slider 82 and the second adjusting screw 84. The sliding rod connecting slider 82 is connected to the connecting rod 83 by screws.

[0062] The second adjusting screw 84 is an existing threaded rod. One end of the second adjusting screw 84 passes through the side wall of the mounting base 51 and is rotatably connected to the connecting rod 83. A flange nut is fixed to the mounting base 51 where the second adjusting screw 84 passes through the mounting base 51 with screws. Rotating the second adjusting screw 84 can drive the connecting rod 83 and the X-axis moving mechanism 7 to move in the Y direction.

[0063] Regarding the connection method between the end of the second adjusting screw 84 and the connecting rod 83, this embodiment preferably adopts the commonly used C-shaped spring clip connection. In this way, when the second adjusting screw 84 is rotated, the second adjusting screw 84 will not fall off the connecting rod 83, but can drive the connecting rod 83 to move in the Y direction.

[0064] like Figure 11 and 13 As shown, the locking mechanism 9 includes a gear 91, a gear limiting block 92, a lifting screw 93, and a lifting guide rod 94. The lifting screw 93 is installed on the mounting base 52 above the mounting base 51. One end of the lifting screw 93 is screwed to the gear limiting block 92. The gear limiting block 92 can engage with the gear 91 to limit the rotation of the gear 91. Rotating the lifting screw 93 can adjust the engagement between the gear limiting block 92 and the gear 91.

[0065] Gear 91 is an existing gear, gear limiting block 92 is a rectangular block that can mesh with gear 91 at one end, lifting screw 93 is an existing screw, lifting screw 93 is mounted on mounting base plate 52 through a circular mounting platform, lifting screw 93 passes through the mounting platform and is screwed to gear limiting block 92, lifting guide rod 94 has two ends inserted into gear limiting block 92, and the other end is fixed on the circular mounting platform. Rotating lifting screw 93 can drive gear limiting block 92 to move upward along lifting guide rod 94, disengaging from gear 91.

[0066] Regarding the connection between the locking mechanism 9 and the X-axis moving mechanism 7 and the Y-axis moving mechanism 8, the locking mechanism 9 has two sets. When the locking mechanism 9 is connected to the X-axis moving mechanism 7, the gear 91 is fixed on the first adjusting screw 73, and the gear limit block 92 is connected to the gear 91. When the locking mechanism 9 is connected to the Y-axis moving mechanism 8, the gear 91 is fixed on the second adjusting screw 84, and the gear limit block 92 is connected to the gear 91.

[0067] In order to ensure that the locking mechanism 9 connected to the X-axis moving mechanism 7 can move under the action of the Y-axis moving mechanism 8, an elongated sliding hole is also provided on the mounting base plate 52 on which the locking mechanism 9 is mounted, so as to facilitate the movement of the locking mechanism 9 connected to the X-axis moving mechanism 7 along the Y direction.

[0068] Two sets of pressure contactor adjustment components 6 and pressure contactor mounting plates 53 and 56 for fixing pressure contactor bodies 1 are provided and are distributed opposite to each other on the mounting base plate 52 to realize the installation and adjustment of the two pressure contactor bodies 1.

[0069] like Figure 11 As shown, in order to facilitate the preoperative incision of the scalp and ensure a straight incision, an auxiliary drawing line 16 can be fixed on the C-shaped pressure arm 11 in the main body 1 of the pressure device. The auxiliary drawing line 16 is a rectangular metal strip, and the two ends of the auxiliary drawing line 16 are fixed to the ends of the C-shaped pressure arm 11 with screws. The auxiliary drawing line 16 can assist the operator in operation.

[0070] Regarding the cleaning and disinfection of the pressure device fixing device 4, this embodiment adopts the existing technology as follows: the head cover 41 (cloth product) can be disinfected in the same way as surgical gowns, or it can be used once. Regarding the pressure plate mounting assembly 5 and the pressure plate adjustment assembly 6, in this embodiment, both the pressure plate mounting assembly 5 and the pressure plate adjustment assembly 6 are detachable and made of stainless steel (some plastics are Teflon). They can be cleaned using ultrasonic cleaning and brushing in multi-enzyme disinfectant solution. After cleaning, the device is rinsed and lubricated to improve its service life. The lubrication is widely used in existing metal surgical instruments and is an existing technology. Then, the existing medical device is sterilized by high-pressure steam at 120°C to ensure that the cleaning and disinfection meet the standards.

[0071] The usage process of this embodiment: How to use the handheld pressure device body 1: First, connect the control host 3 to the power supply, then connect the pressure device body 1 to the control host 3. Then, the user holds one pressure device body 1 in each hand and places it on the scalp to be incised. Then, press the pressure handle 14. At this time, the scalp tack 12 will make contact with the scalp and then make an incision. After the incision, apply pressure to the pressure handle 14 so that the pressure applied by the silicone contact plate 24 to the scalp is slightly greater than 15 kPa. Then, pull the C-shaped pressure arms 11 to both sides. At this time, the scalp tack 12 pulls the scalp, thereby creating an operating space for surgery.

[0072] The method of using the pressure contactor mounting component 5 to fix the pressure contactor body 1: When in use, first move the pressure contactor mounting plate 53 to the opening in the middle of the mounting base plate 52, then insert the pressure contactor body 1 into the mounting groove 54 in the pressure contactor mounting plate 53 and connect it with screws, then pass the quick-release terminal 27 through the relief opening 55 and connect it to the external connecting wire 26. Then, rotate the lifting screw 93 in the locking mechanism 9 on the X-axis moving mechanism 7 to release the engagement between the gear limit block 92 and the gear 91, adjust the pressure contactor body 1 to the designated position, and then rotate the lifting screw 93 to achieve the engagement between the gear limit block 92 and the gear 91. Then, rotate the lifting adjustment screw 59 to adjust the pressure of the pressure contactor body 1 on the patient's head. Then, rotate the lifting screw 93 in the locking mechanism 9 on the Y-axis moving mechanism 8 to release the engagement between the gear limit block 92 and the gear 91. Then, with the assistance of the auxiliary drawing line 16, the scalp can be cut with a scalpel. At this time, the second adjustment screw 84 in the Y-axis moving mechanism 8 can be rotated to move the pressure contactor body 1 to achieve the opening of the scalp. Then, the locking mechanism 9 is used to lock the Y-axis moving mechanism 8, thus completing the maintenance of the scalp opening state and the continuous pressure on the scalp to stop bleeding.

[0073] The above embodiments are merely illustrative of the technical concept of the present invention and should not be construed as limiting the scope of protection of the present invention. Any modifications made to the technical solutions based on the technical concept proposed in this invention shall fall within the scope of protection of this invention.

Claims

1. A pressure-visualized scalp pressure positioning and hemostasis device for craniotomy, characterized in that: The device includes two sets of pressure device bodies (1), which are placed on both sides of the surgical incision; scalp clips (12), which are set on one side of the pressure device body (1) near the incision, and can pull the scalp on both sides of the surgical incision to maintain the scalp in a pulled state and create operating space; pressure sensing component (2), which is set at the end of the pressure device body (1) that contacts the scalp, and is used to monitor the pressure of the pressure device body (1) on the scalp in real time; control host (3), which is quickly connected to the two sets of pressure devices (1) and is used to display the pressure value of the pressure sensing component (2) in real time; the pressure device body (1) maintains the scalp in a pulled state through the scalp clips (12) and detects the pressure on the scalp in real time through the pressure sensing component (2) to achieve hemostasis and keep the incision in a non-bleeding state.

2. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 1, characterized in that: The pressure sensor body (1) includes a hollow C-shaped pressure arm (11), a scalp clip (12) is set on the side of the C-shaped pressure arm (11) pointing towards the cut, and a pressure sensing component (2) is set inside the C-shaped pressure arm (11).

3. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 1, characterized in that: The pressure sensing component (2) includes a base plate (21), a PCB board (22) and a silicone contact plate (24). The pressure sensor (23) is set on the PCB board (22) and corresponds to the turning point of the C-shaped pressure arm (11) in the pressure body (1) near both ends. The PCB board (22) is set between the silicone contact plate (24) and the base plate (21). The base plate (21) is placed inside the C-shaped pressure arm (11) in the pressure body (1). The silicone contact plate (24) is in contact with the skin.

4. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 3, characterized in that: The pressure sensor (23) protrudes from the surface of the PCB board (22) and is connected to the silicone contact plate (24), and the silicone contact plate (24) does not contact any other position on the PCB board (22) except for the pressure sensor (23).

5. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 3, characterized in that: The silicone contact plate (24) is made of silicone, and the size of the silicone contact plate (24) is smaller than the internal size of the C-shaped pressure arm (11) in the pressure body (1). The silicone contact plate (24) does not contact the inner wall of the C-shaped pressure arm (11). The silicone contact plate (24) is lower than the scalp clip (12). The scalp clip (12) contacts the scalp before the silicone contact plate (24).

6. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 1, characterized in that: It also includes a pressure device fixing device (4) for fixing and adjusting the position of the pressure device body (1). The pressure device fixing device (4) includes a head cover (41), a pressure device mounting assembly (5) and a pressure device adjustment assembly (6). The pressure device mounting assembly (5) and the pressure device adjustment assembly (6) are mounted on the head cover (41). The head cover (41) is fixed to the patient's head. The pressure device body (1) is detachably mounted in the pressure device mounting assembly (5). The pressure device mounting assembly (5) is connected to the pressure device adjustment assembly (6). The pressure device adjustment assembly (6) and the pressure device mounting assembly (5) can controllably adjust the position of the pressure device body (1) on the head and adjust the pressure on the scalp.

7. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 6, characterized in that: The pressure sensor mounting assembly (5) includes a mounting base (51), a pressure sensor mounting plate (53), and an adjustment plate (56). The mounting base (51) is mounted on the headgear (41). The pressure sensor mounting plate (53) is mounted inside the mounting base (51) via the pressure sensor adjustment assembly (6). The pressure sensor body (1) is detachably mounted inside the pressure sensor mounting plate (53). The adjustment plate (56) is connected to the pressure sensor mounting plate (53). The adjustment plate (56) can controllably adjust the distance between the pressure sensor mounting plate (53) and the head.

8. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 6, characterized in that: The pressure contactor adjustment assembly (6) includes an X-axis moving mechanism (7), a Y-axis moving mechanism (8), and a locking mechanism (9). The X-axis moving mechanism (7) and the Y-axis moving mechanism (8) are connected to the adjustment plate (56). The X-axis moving mechanism (7) and the Y-axis moving mechanism (8) adjust the position of the adjustment plate (56) and the pressure contactor mounting plate (53) in the X and Y directions. There are two sets of locking mechanisms (9), which are set on the mounting base (51). The two sets of locking mechanisms (9) are connected to the X-axis moving mechanism (7) and the Y-axis moving mechanism (8) respectively, and restrict the adjustment of the X-axis moving mechanism (7) and the Y-axis moving mechanism (8).

9. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 6, characterized in that: The X-axis moving mechanism (7) includes a slide rod (71), a sliding sleeve (72) and a first adjusting screw (73). The sliding sleeve (72) is set on the adjusting plate (56), the slide rod (71) is connected to the sliding sleeve (72), and the first adjusting screw (73) is set in the mounting base (51) and connected to the adjusting plate (56). The Y-axis moving mechanism (8) includes a Y-axis slide (81), a connecting rod (83), and a second adjusting screw (84). The Y-axis slide (81) is set inside the mounting base (51). The connecting rod (83) is connected to the slide rod (71). The second adjusting screw (84) is connected to the connecting rod (83). The second adjusting screw (84) drives the connecting rod (83) to move along the Y-axis slide (81). The locking mechanism (9) includes a gear (91), a gear limit block (92) and a lifting screw (93). The gear (91) is mounted on the first adjusting screw (73) and the second adjusting screw (84) of the X-axis moving mechanism (7) and the Y-axis moving mechanism (8). The gear limit block (92) cooperates with the gear (91) through the lifting screw (93).

10. The intracranial pressure visualization scalp pressure positioning and hemostasis device according to claim 1, characterized in that: In the body of the pressure device (1), auxiliary drawing lines (16) are provided at both ends of the C-shaped pressure arm (11), and the auxiliary drawing lines (16) assist in the preoperative incision of the scalp.

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