A cranial repair component

Abstract

This invention relates to a cranial repair component, comprising a repair module and an injection mechanism. The repair module includes a repair block and an impermeable membrane. The repair block has a shape consistent with the shape of the skull to be repaired and is a mesh structure woven from nickel-titanium alloy wire. The impermeable membrane covers the lower surface of the repair block, and its edge is sewn to the side of the repair block. A filling channel is pre-set within the repair block, spiraling within it, with its entrance located on the side of the repair block. Within the repair block, the distance between any point and the filling channel is less than a preset distance. The injection mechanism includes an adjustable conduit and a bone cement delivery device connected to the tail end of the adjustable conduit. The adjustable conduit is controlled to bend and enters the filling channel from its entrance, such that the distal end of the adjustable conduit reaches the blind end of the filling channel. This effectively fills the repair block with bone cement, improving the post-repair outcome of the cranial repair.

Description

Technical Field

[0001] This invention belongs to the field of medical technology, specifically relating to a cranial repair component. Background Technology

[0002] The applicant filed an application on July 31, 2024, with publication number CN118557338A, entitled "A Skull Repair Component", which discloses a repair block formed by weaving nickel-titanium alloy wire. When repairing a patient's skull, the repair block is implanted into a bone window, and then bone cement is injected and hardened to replace the missing skull, thereby achieving the purpose of skull repair.

[0003] However, in practical applications, the inventors discovered that after the repair block is implanted into the bone window, when injecting bone cement into the repair block, a long needle needs to be inserted into the repair block through the incision. However, since the repair block is made of woven nickel-titanium alloy wire, the needle cannot move laterally inside the repair block. This requires frequent insertion and removal of the needle to fill the bone cement. Moreover, when filling the bone cement, medical staff cannot directly observe the injection of bone cement, which often results in some repair blocks not being filled with bone cement, leading to unsatisfactory surgical results. Summary of the Invention

[0004] In view of this, the present invention provides a cranial repair component that can effectively fill the inside of the repair block with bone cement, thereby improving the effect of cranial repair.

[0005] The technical solution adopted in this invention is as follows:

[0006] A cranial repair component includes a repair module and an injection mechanism. The repair module includes a repair block and an impermeable membrane. The shape of the repair block is consistent with the shape of the cranium to be repaired. The repair block is a mesh structure woven from nickel-titanium alloy wire. The impermeable membrane covers the lower surface of the repair block, and the edge of the impermeable membrane is sewn to the side of the repair block.

[0007] The repair block has a pre-set filling channel that spirals within it, with the entrance to the filling channel located on the side of the repair block. Within the repair block, the distance between any point within the repair block and the filling channel is less than a preset distance.

[0008] The injection mechanism includes an adjustable conduit and a bone cement delivery device connected to the tail end of the adjustable conduit. The adjustable conduit is controlled to bend and passes through the inlet into the filling channel, such that the distal end of the adjustable conduit extends to the blind end of the filling channel.

[0009] Preferably, the preset distance is 1 cm.

[0010] Preferably, the filling channel is S-shaped or spiral-shaped.

[0011] Preferably, the repair block is prepared using the following method:

[0012] S100. Scan to obtain the patient's skull and obtain the first three-dimensional data of the bone window; the first three-dimensional data corresponds to the shape of the repair block;

[0013] S200: Generate second three-dimensional data corresponding to the filling channel based on the three-dimensional data;

[0014] S300. Obtain a prefabricated hose, the outer diameter of which is consistent with the inner diameter of the filling channel;

[0015] S400. Place the prefabricated hoses according to the second three-dimensional data;

[0016] S500, around the hose, according to the first three-dimensional data, is woven using nickel-titanium alloy wire to form an initial repair block;

[0017] S600, Heat-set the initial repair block;

[0018] S700, remove the hose to obtain the repair block.

[0019] Preferably, the adjustable bendable conduit includes a skeleton body, a first polymer layer disposed inside the skeleton body, and a second polymer layer disposed outside the skeleton body;

[0020] The skeleton body is tubular, and a bending control wire is connected to the skeleton body. The bending control wire is connected to the far end of the skeleton body. The skeleton body has several deformation openings that penetrate the side wall of the skeleton body. The deformation openings extend to both sides along the circumference of the skeleton body, and the several deformation openings are spaced apart along the axial direction of the skeleton body. On the skeleton body, the portion located between two adjacent deformation openings is a connecting ring. The connecting ring has an opening and closing slit that extends along the circumference of the skeleton body and is radially opposite to the deformation opening.

[0021] Preferably, the adjustable bendable conduit includes a first part and a second part connected to each other, the first part being located at the distal end of the second part, the first part having a length of 3 cm, and the skeleton body being located in the first part, so that the first part can be bent in a controlled manner.

[0022] Preferably, the tail end of the adjustable bendable conduit is detachably connected to the bone cement delivery device.

[0023] Preferably, it also includes a visualization structure, which includes an inner sheath, a camera, and an LED light. The camera and the LED light are arranged side by side inside the inner sheath and located on the distal side of the inner sheath. The wires of the camera and the LED light pass through the inside of the inner sheath and extend from the proximal side of the inner sheath.

[0024] The visualization structure is inserted inside the adjustable bend conduit, and the distal end of the visualization structure is aligned with the distal end of the adjustable bend conduit.

[0025] Preferably, the visualization structure and the adjustable bend conduit are fitted with a clearance.

[0026] The beneficial effects of this invention are:

[0027] The repair block is woven from nickel-titanium alloy wire. In its natural state, the repair block unfolds, but it can deform under external force. The repair block has a mesh structure, which makes the interior and surface of the module porous, so the repair block can be compressed and its size reduced. At the same time, the impermeable membrane is made of soft material, so it can also be deformed, allowing the entire repair module to be compressed and reduced in size. During the operation, only a 2-3 cm incision is made on the scalp, and the repair module can be inserted into the bone window. The repair module fits the bone window perfectly, and the impermeable membrane faces downward and contacts the pseudodura mater. Bone cement is injected into the repair module to fill each module body, thus replacing the missing skull. After the bone cement hardens, the repair block is fixed to the original skull, and then the incision is sutured.

[0028] During the above-mentioned surgery, only a 2-3cm incision is needed on the scalp to repair the skull, resulting in a smaller surgical wound, which facilitates the patient's later recovery and reduces the risk of postoperative infection.

[0029] After the repair module is placed into the bone window, the entrance on the repair module is located directly at the incision site. This means that medical staff can directly see the entrance. The distal end of the adjustable catheter is inserted into the filling channel through the entrance. The adjustable catheter is then inserted along the filling channel, so that the distal end of the adjustable catheter reaches the blind end of the filling channel. Bone cement is pumped into the adjustable catheter through the bone cement delivery device, and the bone cement is ejected from the distal end of the adjustable catheter. There are many gaps within the repair block, and these gaps are connected to the filling channel. Therefore, bone cement can diffuse outward through these gaps. While retracting the adjustable catheter, bone cement is injected through the adjustable catheter, thus allowing bone cement to be injected along the entire filling channel. In other words, bone cement diffuses outward from the filling channel. The distance between any point in the repair block and the filling channel is less than the preset distance, so any point in the repair block can be filled with bone cement. This ensures that the entire repair module is filled with bone cement. After the bone cement hardens, it fills the entire bone window, thus ensuring the effectiveness of skull repair and improving the surgical outcome. Attached Figure Description

[0030] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which:

[0031] Figure 1 This is a schematic diagram of the skull repair component;

[0032] Figure 2 This is a schematic diagram of a repair module with a spiral filling channel;

[0033] Figure 3 This is a structural diagram of the skeleton body;

[0034] Figure 4 It is a cross-sectional view of the skeleton body.

[0035] In the diagram: 1. Repair module; 2. Adjustable bendable conduit;

[0036] 11. Fill channel; 12. Inlet; 13. Blind end;

[0037] 21. Skeleton body; 201. Deformation opening; 202. Opening and closing seam. Detailed Implementation

[0038] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail, but well-known methods, processes, procedures, and elements are not described in detail in order to avoid obscuring the essence of the present invention.

[0039] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0040] Unless the context explicitly requires it, the words "comprising," "including," and similar terms throughout the specification and claims should be interpreted as encompassing rather than being exclusive or exhaustive; that is, meaning "including but not limited to."

[0041] In the description of this invention, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0042] See Figures 1-4 This invention provides a cranioplasty component for use in cranioplasty, enabling minimally invasive cranioplasty. The cranioplasty component includes a repair module 1 and an injection mechanism. The repair module 1 includes a repair block and an impermeable membrane. The shape of the repair block is consistent with the shape of the skull to be repaired. The repair block is a mesh structure woven from nickel-titanium alloy wire. The impermeable membrane covers the lower surface of the repair block, and the edge of the impermeable membrane is sutured to the side of the repair block.

[0043] The repair block has a pre-set filling channel 11, which rotates within the repair block. The entrance 12 of the filling channel 11 is located on the side of the repair block. Within the repair block, the distance between any point within the repair block and the filling channel 11 is less than a preset distance.

[0044] The injection mechanism includes an adjustable bendable catheter 2 and a bone cement delivery device connected to the tail end of the adjustable bendable catheter 2. The adjustable bendable catheter 2 is controlled to bend and enters the filling channel 11 from the inlet 12, such that the distal end of the adjustable bendable catheter 2 extends to the blind end 13 of the filling channel 11.

[0045] The shape of the repair patch can be obtained by scanning the bone window of the patient's head. In other words, the shape of the repair patch is specific for each patient, and the specific shape and size are determined by the actual situation of the bone window of the patient's head.

[0046] The repair block can be prepared according to the following method.

[0047] S100. Scan to obtain the patient's skull and obtain the first three-dimensional data of the bone window; the first three-dimensional data corresponds to the shape of the repair block;

[0048] S200: Generate second three-dimensional data corresponding to the filling channel 11 based on the three-dimensional data;

[0049] S300. Obtain a prefabricated hose, the outer diameter of which is consistent with the inner diameter of the filling channel 11;

[0050] S400. Place the prefabricated hoses according to the second three-dimensional data;

[0051] S500, around the hose, according to the first three-dimensional data, is woven using nickel-titanium alloy wire to form an initial repair block;

[0052] S600, Heat-set the initial repair block;

[0053] S700, remove the hose to obtain the repair block.

[0054] Then, an impermeable membrane is sewn onto the underside of the repair block to obtain repair module 1.

[0055] Nickel-titanium alloy wire is a shape memory metal that can deform under external force. After the external force is removed, the nickel-titanium alloy wire will return to its initial state. In other words, under natural conditions, the shape of repair module 1 basically corresponds to the first three-dimensional data (the anti-permeability membrane is a thin film, so the shape of repair module 1 is basically the same as the shape of the repair block). Therefore, under no external force, repair module 1 can fit perfectly with the bone window.

[0056] During the surgery, a 2-3 cm incision is made on the patient's scalp. Surgical instruments are then inserted through this incision to separate the myocutaneous flap from the pseudodura mater until the complete bone margin is exposed. A cavity is formed between the myocutaneous flap, the pseudodura mater, and the bone margin. Saline solution is injected into the cavity to inflate the myocutaneous flap. Repair module 1 is then inserted into the cavity through the incision. The position of repair module 1 is adjusted so that the repair block precisely fills the bone window, with the inlet 12 facing the incision. Saline solution in the cavity is drained. Surgical instruments are inserted into the cavity and push the myocutaneous flap upwards from the inside of the cavity to prevent the local myocutaneous flap from compressing the repair module 1. The distal end of the adjustable bendable catheter 2 is inserted into the filling channel 11 through the inlet 12. The adjustable bendable catheter 2 is inserted along the filling channel 11 so that the distal end of the adjustable bendable catheter 2 reaches the blind end of the filling channel 11. 13. Bone cement is pumped into the adjustable conduit 2 through the bone cement delivery device, and the bone cement is ejected from the distal end of the adjustable conduit 2. Since there are many gaps within the repair block, and these gaps communicate with the filling channel 11, the bone cement can diffuse outwards through these gaps. While retracting the adjustable conduit 2, bone cement is injected through it, thus allowing it to be injected along the entire filling channel 11. In other words, the bone cement diffuses outwards from the filling channel 11, and the distance between any point within the repair block and the filling channel 11 is less than a preset distance. Therefore, any point within the repair block can be filled with bone cement, making the entire repair module 1 completely filled with bone cement. After the bone cement hardens, it fills the entire bone window, ensuring the effectiveness of the cranial repair and improving the surgical outcome. Finally, the hardened repair module 1 (filled with hardened bone cement) is fixed to the original skull, and the incision is sutured.

[0057] It should be noted that when the repair module 1 is placed in the cavity, the impermeable membrane on the repair module 1 faces downward, so that the impermeable membrane is in contact with the pseudodura mater. Therefore, when the bone cement is injected, it can prevent the bone cement from contacting the pseudodura mater, prevent the bone cement from affecting the patient's brain tissue downward, and improve the safety of the operation.

[0058] The geomembrane can be a biological valve, such as a porcine valve or a bovine valve.

[0059] During the above-mentioned surgery, only a 2-3cm incision is needed on the scalp to repair the skull, resulting in a smaller surgical wound, which facilitates the patient's later recovery and reduces the risk of postoperative infection.

[0060] A filling channel 11 is provided within the repair block to facilitate the entry of the adjustable catheter 2 into the repair block. The filling channel 11 rotates within the repair block, ensuring that the closest distance between any point within the repair block and the filling channel 11 is within a preset distance. Therefore, when bone cement is pumped out through the adjustable catheter 2, the distal end of the adjustable catheter 2 sprays out bone cement while retracting backward, allowing the bone cement to spread throughout the entire filling channel 11. At the same time, it ensures that the pumped amount of bone cement is greater than the space formed by the retraction of the adjustable catheter 2 within the filling channel 11, allowing the bone cement to diffuse outward through the gaps. Since the distance between any point within the repair block and the filling channel 11 is less than the preset distance, it ensures that any point within the repair block can be filled with bone cement, thereby ensuring the effectiveness of cranioplasty and improving surgical outcomes.

[0061] Of course, when filling bone cement, the adjustable catheter 2 can be retracted a certain distance (e.g., 2cm), then the retraction is stopped and the bone cement is pumped to ensure that the bone cement can fill the repair module 1. This operation is then repeated until the adjustable catheter 2 is completely withdrawn from the repair module 1.

[0062] The preset distance is 1cm. The preset distance is controlled within 1cm to ensure that the bone cement can reach any point on the repair block.

[0063] The filling channel 11 is S-shaped or spiral-shaped. This allows the channel to rotate within the repair block with only one filling channel 11, and during filling, it can be moved backward while simultaneously filling with bone cement to achieve the purpose of filling the repair module 1 with bone cement.

[0064] During the fabrication of the repair block, a filling channel 11 is formed within the initial braided repair block by prefabricating a flexible tube. Then, heat setting is performed to shape the repair block. Since the flexible tube is not removed during the heat setting process, the nickel-titanium alloy wire in the repair block will not encroach on the flexible tube (filling channel 11). Therefore, after the shaping is completed, the flexible tube is removed, and the filling channel 11 is formed within the repair block. Since the nickel-titanium alloy wire has been shaped, the nickel-titanium alloy wire in the repair block will not encroach on the filling channel 11, thereby ensuring that the adjustable bendable catheter 2 can be smoothly inserted along the filling channel 11 during surgery.

[0065] The adjustable bendable conduit 2 includes a skeleton body 21, a first polymer layer disposed on the inner side of the skeleton body 21, and a second polymer layer disposed on the outer side of the skeleton body 21.

[0066] The skeleton body 21 is tubular, and a bending control wire is connected to the skeleton body 21. The bending control wire is connected to the far end of the skeleton body 21. The skeleton body 21 has a plurality of deformation openings 201 penetrating the side wall of the skeleton body 21. The deformation openings 201 extend to both sides along the circumference of the skeleton body 21, and the plurality of deformation openings 201 are spaced apart along the axial direction of the skeleton body 21. On the skeleton body 21, the portion between two adjacent deformation openings 201 is a connecting ring. The connecting ring has an opening and closing slit 202. The opening and closing slit 202 extends along the circumference of the skeleton body 21, and the opening and closing slit 202 is radially opposite to the deformation opening 201.

[0067] Because the filling channel 11 is curved and its wall is made of nickel-titanium alloy wire, when the adjustable bendable conduit 2 enters the filling channel 11 from the inlet 12, the distal end of the adjustable bendable conduit 2 may come into contact with the wall of the filling channel 11. Since there are pores in the wall (and the nickel-titanium alloy wire will deform when compressed), the distal end of the adjustable bendable conduit 2 may be inserted into the wall through the pores, making it impossible for the adjustable bendable conduit 2 to pass through the filling channel 11.

[0068] The adjustable bending conduit 2 is embedded with a skeleton body 21, which is made of nickel-titanium alloy tube. The skeleton body 21 has axially spaced deformation ports 201. The deformation ports 201 are located on one side of the skeleton body 21, while the other side has an opening and closing slit 202. Therefore, when the skeleton body 21 is pulled by the bending control wire, the opening of the deformation port 201 will become smaller and the opening and closing slit 202 will open, thereby causing the skeleton body 21 to bend towards the side of the deformation port 201. In this way, the adjustable bending conduit 2 can be bent in a controlled manner.

[0069] Therefore, when the adjustable bendable conduit 2 is inserted into the filling channel 11, when the distal end of the adjustable bendable conduit 2 passes through the bend position, the angle of the distal end of the adjustable bendable conduit 2 is adjusted by pulling the bending control wire, so that the distal end of the adjustable bendable conduit 2 can smoothly pass through the bend, thus enabling the adjustable bendable conduit 2 to be transported along the filling channel 11.

[0070] The adjustable bendable conduit 2 includes a first part and a second part connected to each other. The first part is located at the distal end of the second part. The length of the first part is 3 cm. The skeleton body 21 is located in the first part, so that the first part can be bent in a controlled manner.

[0071] By simply adjusting the bending of this portion at the distal end of the adjustable bend conduit 2, the adjustable bend conduit 2 can be smoothly conveyed along the filling channel 11.

[0072] The tail end of the adjustable bendable conduit 2 is detachably connected to the bone cement delivery device.

[0073] It also includes a visualization structure, which includes an inner sheath, a camera, and an LED light. The camera and the LED light are arranged side by side inside the inner sheath and located at the distal end of the inner sheath. The wires of the camera and the LED light pass through the inside of the inner sheath and extend out from the proximal end of the inner sheath.

[0074] The visualization structure is inserted inside the adjustable bend conduit 2, and the distal end of the visualization structure is aligned with the distal end of the adjustable bend conduit 2.

[0075] When the adjustable bendable catheter 2 is transported along the filling channel 11, the tail end of the adjustable bendable catheter 2 is separated from the bone cement delivery device. The adjustable bendable catheter 2 has a pre-set visualization structure. Through this visualization structure, the front side of the distal end of the adjustable bendable catheter 2 can be observed. Thus, the bending control wire is pulled under visual conditions, so that the adjustable bendable catheter 2 can smoothly pass through the bend. When the distal end of the adjustable bendable catheter 2 reaches the blind end 13 of the filling channel 11, the visualization structure is removed, and the tail end of the adjustable bendable catheter 2 is connected to the bone cement delivery device. In this way, bone cement can be filled into the repair module 1.

[0076] When the visualization structure is in operation, the front side of the distal end of the adjustable bendable conduit 2 is illuminated by an LED light, and the camera captures an image, thus allowing the relevant scene to be observed and facilitating the operation of the adjustable bendable conduit 2.

[0077] The visible structure and the adjustable bendable conduit 2 are fitted with a gap.

[0078] The inner sheath and the adjustable bend catheter 2 are fitted with a gap, which facilitates the removal of the entire visible structure from the adjustable bend catheter 2.

[0079] It should be understood that the above embodiments are merely exemplary and not restrictive. Various obvious or equivalent modifications or substitutions that can be made by those skilled in the art regarding the above details without departing from the basic principles of the present invention will be included within the scope of the claims of the present invention.

Claims

1. A cranial repair component, characterized in that, The device includes a repair module and an injection mechanism. The repair module includes a repair block and an impermeable membrane. The shape of the repair block is consistent with the shape of the skull to be repaired. The repair block is a mesh structure woven from nickel-titanium alloy wire. The impermeable membrane covers the lower surface of the repair block, and the edge of the impermeable membrane is sewn to the side of the repair block. The repair block has a pre-set filling channel that spirals within it, with the entrance to the filling channel located on the side of the repair block. Within the repair block, the distance between any point within the repair block and the filling channel is less than a preset distance. The injection mechanism includes an adjustable bendable catheter and a bone cement delivery device connected to the tail end of the adjustable bendable catheter. The adjustable bendable catheter is controlled to bend and enters the filling channel from the inlet, such that the distal end of the adjustable bendable catheter extends to the blind end of the filling channel. The adjustable bendable conduit includes a skeleton body, a first polymer layer disposed inside the skeleton body, and a second polymer layer disposed outside the skeleton body; The skeleton body is tubular, and a bending control wire is connected to the skeleton body. The bending control wire is connected to the far end of the skeleton body. The skeleton body has several deformation openings that penetrate the side wall of the skeleton body. The deformation openings extend to both sides along the circumference of the skeleton body, and the several deformation openings are spaced apart along the axial direction of the skeleton body. On the skeleton body, the portion located between two adjacent deformation openings is a connecting ring. The connecting ring has an opening and closing slit that extends along the circumference of the skeleton body and is radially opposite to the deformation opening.

2. The cranial repair component according to claim 1, characterized in that, The preset distance is 1cm.

3. The cranial repair component according to claim 1, characterized in that, The filling channel is S-shaped or spiral-shaped.

4. The cranial repair component according to claim 1, characterized in that, The repair block is prepared using the following method: S100. Scan to obtain the patient's skull and obtain the first three-dimensional data of the bone window; the first three-dimensional data corresponds to the shape of the repair block; S200: Generate second three-dimensional data corresponding to the filling channel based on the three-dimensional data; S300. Obtain a prefabricated hose, the outer diameter of which is consistent with the inner diameter of the filling channel; S400. Place the prefabricated hoses according to the second three-dimensional data; S500, around the hose, according to the first three-dimensional data, is woven using nickel-titanium alloy wire to form an initial repair block; S600, Heat-set the initial repair block; S700, remove the hose to obtain the repair block.

5. The cranial repair component according to claim 1, characterized in that, The adjustable bendable conduit includes a first part and a second part connected to each other. The first part is located at the distal end of the second part and has a length of 3 cm. The skeleton body is located in the first part, so that the first part can be bent in a controlled manner.

6. The cranial repair component according to claim 5, characterized in that, The tail end of the adjustable bendable conduit is detachably connected to the bone cement delivery device.

7. The cranial repair component according to claim 6, characterized in that, It also includes a visualization structure, which includes an inner sheath, a camera, and an LED light. The camera and the LED light are arranged side by side inside the inner sheath and located on the distal side of the inner sheath. The wires of the camera and the LED light pass through the inside of the inner sheath and extend out from the proximal side of the inner sheath. The visualization structure is inserted inside the adjustable bend conduit, and the distal end of the visualization structure is aligned with the distal end of the adjustable bend conduit.

8. The cranial repair component according to claim 7, characterized in that, The visible structure and the adjustable bendable conduit are fitted with a clearance.

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