cranial repair components

Abstract

This invention relates to a prosthesis for implantation into bone defects. Specifically, it discloses a cranioplasty component, comprising: a bone flap body for filling a defect in the skull, the bone flap body including a disc-shaped filling body and multiple stimulation units arranged circumferentially between the outer and inner disc surfaces of the filling body, and each stimulation unit being capable of protruding from the sidewall of the filling body through radial movement; a force-applying component for driving each stimulation unit to protrude radially from the sidewall of the filling body, thereby, after the bone flap body fills the defect, the force-applying component drives each stimulation unit to protrude from the sidewall of the filling body, causing the radially outer ends of the stimulation units to press against the sidewall of the defect to stimulate the bone of the sidewall of the defect; and a positioning component for attaching and positioning the bone flap body to the skull.

Description

Technical Field

[0001] This invention relates to a prosthesis for implantation in areas of bone defects, and more particularly to a cranial repair component. Background Technology

[0002] Postoperative craniotomy for various reasons (such as decompressive craniectomy or brain tumor resection) requires cranioplasty to repair the skull defects caused by the removal of bone, in order to re-establish a physical barrier between the brain tissue within the ventricles and the external environment. The main filler for repairing the skull defects can be autologous skull bone removed during craniotomy (or autologous bone flap), or artificial bone flaps made of titanium alloys or polymer compounds (such as PEEK material) through 3D printing, injection molding, and / or machining processes.

[0003] When repairing skull defects, relevant connecting and fixing elements are also needed to connect and fix the main filling component to the skull, such as... Figure 1 and Figure 2 As shown, the prior art provides a typical method for fixing a main filling component to the skull using connecting and fixing elements. Specifically, the connecting and fixing elements include multiple connecting strips 300 and multiple clamping components 400. The clamping components 400 include two opposing clamping plates 401 connected in series by screws 402. After the main filling component 200 is placed in the defect area 1001 of the skull 1000, on the one hand, the connecting strips 300 simultaneously span the outer surface of the main filling component 200 and the skull 1000. The outer surface of the main filling component 200 is fixed to both the main filling component 200 and the missing area 1001 (edge ​​sidewall) by means of bone screws. On the other hand, the screw 402 of the clamping component 400 passes through the inherent gap or active perforation between the main filling component 200 (edge ​​sidewall) and the missing area 1001 (edge ​​sidewall). Two clamps 401 connected in series on the screw 402 are located on the inner and outer sides of the skull 1000, respectively. By tightening the screw 402, the two clamps 401 simultaneously clamp the edge of the main filling component 200 and the edge of the skull 1000. In this way, the main filling component 200 and the skull 1000 can be fixed by the above-described fixation method, and in particular, the main filling component 200 can be prevented from shifting into the ventricles and compressing the brain tissue.

[0004] The existing methods for repairing the skull described above have the following problems regarding their impact on the repair effect:

[0005] 1. It is easy to understand that, regardless of whether an autologous bone flap or an artificial bone flap is used as the main filling component to fill the defect area, the main filling component needs to be slightly smaller than the defect area. This allows the main filling component to fill the defect area smoothly through a gap formed between its edge and the edge of the defect area (for autologous bone flaps, this gap is naturally formed when the autologous bone flap is refilled due to the cutting suture during craniotomy; for artificial bone flaps, this gap needs to be obtained through processing based on set size parameters). However, this "gap" that facilitates filling has the following adverse consequences for postoperative recovery: the bone on the sidewall of the defect area lacks guidance and stimulation due to the gap, resulting in slower growth of new bone from the sidewall towards the main filling component and insufficient strength of the new bone. This leads to a longer fusion time between the main filling component and the skull, and poor fusion results, especially when using an artificial bone flap.

[0006] 2. Postoperatively, the splint located inside the skull in the clamping device inevitably protrudes from the inner surface of the skull, which may irritate the dura mater.

[0007] 3. After filling the defect area with an artificial bone flap, especially after filling the defect area with an artificial bone flap made of titanium alloy, stress may be generated between the artificial bone flap and the skull during the fusion process of the artificial bone flap and the skull due to factors such as new bone growth. Summary of the Invention

[0008] In view of the above-mentioned technical problems existing in the prior art, the present invention provides a cranial repair component.

[0009] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0010] A cranial repair component, comprising:

[0011] A bone flap body for filling a defect area in the skull, the bone flap body comprising a disc-shaped filling body and a plurality of stimulation units, the filling body having an outer disc surface facing outward after the bone flap body fills the defect area, an inner disc surface facing the ventricle, and a sidewall facing the sidewall of the defect area, the plurality of stimulation units being arranged circumferentially in the filling body between the outer disc surface and the inner disc surface, and each stimulation unit being able to protrude from the sidewall of the filling body by radial movement;

[0012] The force-applying component is used to drive each stimulation unit to protrude radially from the sidewall of the filling body, so that after the bone flap body fills the defect area, the force-applying component drives each stimulation unit to protrude from the sidewall of the filling body, causing the radially outer end of the stimulation unit to press against the sidewall of the defect area to stimulate the bone body of the sidewall of the defect area.

[0013] Positioning components are used to attach and position the bone flap body to the skull.

[0014] Preferably,

[0015] Each stimulation unit includes an integrally formed stimulation part located on the radially outer side and a guide part located on the radially inner side; the circumferentially arranged stimulation units are formed by cutting a ring, and the stimulation parts of each two adjacent stimulation units are elastically connected by staggered cutting seams.

[0016] The filling body is configured with an annular receiving groove penetrating its sidewalls and multiple guide grooves located radially inside the receiving groove, arranged circumferentially and extending radially through the receiving groove. The stimulation part of each stimulation unit on the annular body is located in the receiving groove, and the guide part is correspondingly embedded in each guide groove; wherein:

[0017] Each stimulation unit has a honeycomb structure configured on the end face of its stimulation part.

[0018] Preferably, an annular recess is formed on the radially inner side of the guide groove, the guide groove extends into the recess, and a wedge-shaped groove extending circumferentially and with a gradually changing bottom depth is formed on the inner end face of the guide portion of each stimulation unit; wherein:

[0019] The force-applying component includes:

[0020] A drive ring is disposed in the sink groove. The outer wall of the drive ring is provided with a plurality of radially protruding and circumferentially arranged ribs, which are used to slide into the wedge-shaped groove. The inner wall of the drive ring is provided with a section of internal teeth.

[0021] A gear is disposed in a mounting hole located radially inside the drive ring and meshes with the internal teeth of the drive ring. The axial end of the gear is provided with an operating part for screwing, and the operating part is exposed on the outer disk surface of the filling body.

[0022] A locking pin extends from the outer disk surface of the filling body to restrict the rotation of the gear.

[0023] Preferably,

[0024] The bone flap body is provided with a plurality of radial holes arranged in a circumferential direction. The radial holes extend from the radial inner side of the filling body to its sidewall and penetrate the stimulation unit.

[0025] The positioning component includes:

[0026] The bone screws include a plurality of them, each bone screw being disposed in a plurality of radial holes, wherein the head of the bone screw can extend out to fill the sidewall of the body by moving along the radial holes;

[0027] A push screw is screwed into a radial hole at the tail of the bone screw. By screwing the push screw, the head of the bone screw extends out of the side wall of the filling body and is inserted laterally into the bone body of the skull through the side wall of the defect area.

[0028] Preferably, a circular window is provided in the central region of the filling body, and the radial hole extends through the side wall of the circular window to form an entrance end. The bone nail is inserted into the radial hole from the entrance end of the side wall of the circular window; a sealing plug is screwed into the circular window.

[0029] Preferably, the edge region of the filling body is configured with a honeycomb structure.

[0030] Preferably, the filling body includes an inner disc and an outer disc that interlock; an annular step is formed on the radially outer side of the inner disc, and the inner disc and the outer disc define an annular receiving groove; the guide groove and the receiving groove are formed on the inner disc; wherein:

[0031] The outer disc is fixed to the inner disc by screws that are screwed into the solid portion between each pair of adjacent guide slots;

[0032] The height of the solid portion between each pair of adjacent guide grooves is less than the thickness of the stimulation unit, so that the outer disc body presses against the stimulation unit by tightening the screw.

[0033] Preferably, the cranial repair component further includes a limiting component, which includes a plurality of circumferentially arranged strips on the outer disc surface of the filling body, the radial inner end of the strips being connected to the filling body, and the outer end of the strips being connected to the skull.

[0034] Preferably, the filling body is made of PEEK material, and the stimulating unit is made of titanium alloy material.

[0035] Preferably, a bone growth promoting material is coated in the honeycomb structure of the stimulation unit and in the honeycomb structure at the edge of the filling body.

[0036] Compared with the prior art, the beneficial effects of the cranial repair component disclosed in this invention are:

[0037] 1. The cranioplasty component provided by the present invention has circumferentially arranged stimulation units arranged in the bone flap body that can radially protrude from the side wall of the bone flap body. Thus, when the bone flap body is placed in the defect area, the stimulation units are retracted within the side wall of the bone flap body to facilitate the bone flap body filling the defect area. After the bone flap body is placed in the defect area, the stimulation units protrude from the side wall of the bone flap body and abut against the bone body of the side wall of the defect area to stimulate the bone body. This can induce the bone body to grow new bone more rapidly so that the skull and the bone flap body can fuse more quickly. Furthermore, by arranging a honeycomb structure on the stimulation part of the stimulation unit, the growth rate of new bone is induced to be further accelerated. And by cooperating with the honeycomb structure arranged at the edge of the filling body, the new bone can grow into the edge of the bone flap body, thereby improving the fusion effect.

[0038] 2. When the cranial repair component provided by the present invention is placed in the defect area and the stimulation unit abuts against the side wall of the defect area, the gaps between the side wall of the filling body and the side wall of the defect area are basically equal at each circumferential position. This facilitates the fusion of the skull and the bone flap body at each circumferential position in a basically synchronous manner, thereby avoiding inconsistent fusion speed and effect at different positions.

[0039] 3. In the cranial repair component provided by the present invention, after the stimulation unit abuts against the side wall of the defect area, each bone screw extends radially out of the side wall of the bone flap body and is inserted laterally into the bone body near the defect area, thereby achieving the positioning of the bone flap body. After the bone flap body is positioned, the repair component does not have any structures or components protruding from the inner surface of the skull in the thickness direction, thereby reducing the stimulation of the skull tissue to a certain extent.

[0040] 4. The bone flap body, composed of a stimulation unit made of titanium alloy and a filling body made of PEEK material, can both induce and stimulate rapid bone growth and reduce the stress between the bone flap body and the skull.

[0041] 5. Other advantages of the cranial repair component provided by the present invention are described in the specific implementation method.

[0042] The overview of various implementations or examples of the technology described in this invention is not a complete disclosure of the full scope or all features of the disclosed technology. Attached Figure Description

[0043] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and, together with the description and claims, serve to explain embodiments of the invention. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0044] Figure 1 A state view of a skull repair component in the prior art when it is positioned to fill a skull defect area.

[0045] Figure 2 for Figure 1 A sectional view along line AA.

[0046] Figure 3 A three-dimensional structural diagram of the cranioplasty component provided in an embodiment of the present invention (both the stimulation unit and the bone screw are in a retracted state).

[0047] Figure 4 A three-dimensional structural diagram of a cranial repair component with the outer disc body hidden, provided for an embodiment of the present invention (both the stimulation unit and the bone screw are in a retracted state).

[0048] Figure 5 A three-dimensional perspective view of the inner disc in a cranial repair component provided for an embodiment of the present invention.

[0049] Figure 6 This is a three-dimensional structural diagram of the stimulation component in the cranial repair component provided in an embodiment of the present invention.

[0050] Figure 7 This is a three-dimensional structural diagram of the drive ring in the cranial repair component provided in an embodiment of the present invention.

[0051] Figure 8 This is a three-dimensional structural diagram of the assembly state of the drive ring and the stimulation component in the cranial repair component provided in an embodiment of the present invention.

[0052] Figure 9 A top view of a cranioplasty component provided for an embodiment of the present invention (both the stimulation unit and the bone screw are in a retracted state).

[0053] Figure 10 for Figure 9 BB-direction sectional view.

[0054] Figure 11A top view of a cranioplasty component provided for an embodiment of the present invention (both the stimulation unit and the bone screw are in the extended state).

[0055] Figure 12 for Figure 11 CC-direction sectional view.

[0056] Figure label:

[0057] 100-Repair component; 10-Bone flap body; 20-Filling body; 21-Inner disc; 211-Inner disc surface; 22-Outer disc; 221-Outer disc surface; 23-Side wall; 231-Receiving groove; 2311-L-shaped step; 24-Guide groove; 241-Solid part; 25-Sink; 26-Mounting hole; 27-Circular window; 28-Radial hole; 281-Inlet end; 29-Sealing plug; 291-Sealing ring; 30- Stimulating component; 31-Stimulating unit; 311-Stimulating part; 312-Guide part; 32-Cutting slit; 33-Wedge groove; 40-Force-applying component; 41-Drive ring; 411-Protruding rib; 412-Internal tooth; 413-Oblong hole; 42-Gear; 421-Operating head; 43-Setting pin; 50-Positioning component; 51-Bone nail; 52-Push screw rod; 53-Locking screw rod; 54-Spring; 60-Screw; 70-Strip.

[0058] 1000 - Skull; 1001 - Defect area; 1002 - Lateral wall. Detailed Implementation

[0059] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0060] To keep the following description of the embodiments of the present invention clear and concise, detailed descriptions of known functions and known components are omitted.

[0061] The cranial repair component 100 disclosed in this invention is used to close a defect area 1001 on the skull 1000 caused by craniotomy. The cranial repair component 100 is particularly suitable for closing circular or near-circular defect areas 1001 with a small area, such as those created by trephine cutting through the skull 1000. After closing the defect area 1001 using the repair component 100 provided by this invention, the bone body of the sidewall 1002 of the defect area 1001 is stimulated by the repair component 100, which accelerates new bone growth, thereby accelerating the fusion of the repair component 100 with the human skull 1000 and achieving a better fusion effect.

[0062] like Figures 3 to 12 As shown, the cranioplasty component 100 disclosed in this embodiment of the invention includes: a bone flap body 10, a force-applying component 40, a positioning component 50, and a limiting component.

[0063] like Figure 10 As shown, the bone flap body 10 is used to fill the area enclosed by the sidewall 1002 of the defect region 1001. The bone flap body 10 includes two parts: a filling body 20 and a stimulation component 30. The filling body 20 is configured to be the same thickness as or slightly smaller than the thickness of the skull 1000 and has an overall curvature adapted to the skull 1000 or a disc-shaped shape that may not have curvature (if it does not have curvature, its thickness is minimized to avoid protruding from the exposed inner and outer surfaces of the skull 1000). The edge of the filling body 20 defines the edge of the bone flap body 10. When the bone flap body 10 is not fixed in the defect region 1001, the edge of the filling body 20 is the edge of the bone flap body 10. Thus, by making the external dimensions of the filling body 20 slightly smaller than the dimensions of the defect region 1001, the bone flap body 10 can be smoothly placed in the defect region 1001. It is readily understood that the disc-shaped filling body 20 has an outer disc surface 221 facing outwards from the skull, an inner disc surface 211 facing the intracranial brain tissue (e.g., the dura mater) and a side wall 23 facing the side wall 1002 of the defect area 1001 after the bone flap body 10 is placed in the defect area 1001. The outer disc surface 221, inner disc surface 211 and side wall 23 of the filling body 20 may also be referred to as the outer surface, inner surface and side wall of the bone flap body 10.

[0064] The stimulating component 30 is placed in the area between the outer disc surface 221 and the inner disc surface 211 of the filling body 20, and before the bone flap body 10 is fixed to the skull 1000, such as Figure 10 As shown, the stimulation component 30 is located within the sidewall 23 of the filling body 20, as... Figure 12 As shown, when it is necessary to fix the bone flap body 10, the stimulating component 30 protrudes radially from the sidewall 23 of the filling body 20. Specifically, as... Figure 4 and combined Figure 5 and Figure 6 As shown, an annular receiving groove 231 is disposed in the radial edge region between the outer disk surface 221 and the inner disk surface 211 of the filling body 20, and axially arranged guide grooves 24 are disposed on the radially inner side of the annular receiving groove 231. Each guide groove 24 extends radially and penetrates into the receiving groove 231. The stimulation component 30 is generally annular in structure, that is, the stimulation component 30 is a ring body. Multiple stimulation units 31 are obtained by cutting the stimulation component 30. Each stimulation unit 31 is cut to have a stimulation part 311 located on the radially outer side and a guide part 312 located on the radially inner side. The width of the guide part 312 is smaller than the width of the stimulation part 311. The stimulation portions 311 of two adjacent stimulation units 31 are elastically connected by staggered cutting slits 32, so that the stimulation portions 311 of each stimulation unit 31 are elastically connected to each other and are embedded in the receiving groove 231 of the filling body 20, and the guide portions 312 of each stimulation unit 31 are correspondingly embedded in each guide groove 24. Thus, after the bone flap body 10 is placed in the defect area 1001, the radial inner end of the guide portion 312 of each stimulation unit 31 is applied by the force application member 40, so that the stimulation portion 311 of each stimulation unit 31 protrudes out of the side wall 23 of the filling body 20 and abuts against the bone body of the side wall 1002 of the defect area 1001 for stimulating the bone body.

[0065] A honeycomb structure is configured on the radial edge of the stimulation component 30, so that the end region of the stimulation part 311 of each stimulation unit 31 or the entire stimulation part 311 forms a honeycomb structure. In this way, after the stimulation part 311 abuts against the bone body of the side wall 1002 of the defect area 1001, the honeycomb structure guides the new bone on the bone body to grow towards the interior of the stimulation component 30. This not only helps to make the new bone grow quickly, but also improves the fusion effect of the skull 1000 and the bone flap body 10.

[0066] In some preferred configurations, a honeycomb structure is also configured in the radial edge regions of the filling body 20 above and below the stimulating component 30, so that after the new bone enters the honeycomb structure of the stimulating component 30, the new bone grows toward the edge interior of the filling body 20 with the permission of the honeycomb structure of the stimulating component 30, thereby causing the skull 1000 to fuse with the entire edge region of the bone flap body 10.

[0067] The stimulation component 30 is preferably made of titanium alloy. The titanium alloy stimulation component 30 provides better stimulation to the skull 1000, and its honeycomb structure has a better guiding effect, thus allowing the skull 1000 to preferentially fuse with the stimulation component 30. The honeycomb structure on the stimulation component 30 can be obtained through laser engraving and 3D printing. The filling body 20 is preferably made of PEEK material. PEEK material has mechanical properties closer to those of bone, thereby reducing the stress between the skull 1000 and the bone flap body 10 after fusion. The honeycomb structure can be obtained by mixing PEEK material with a pore-forming agent (such as sodium chloride) during printing, and then washing off the pore-forming agent later.

[0068] like Figures 6 to 8 and combined Figure 4 As shown, the force-applying component 40 is used to drive each stimulation unit 31 of the stimulation component 30 to protrude radially from the sidewall 23 of the filling body 20 and press against the sidewall 1002 of the defect area 1001 and remain in the state of pressing against the sidewall 1002. Specifically, an annular groove 25 is arranged in the filling body 20 on the radial inner side of each guide groove 24, and a mounting hole 26 is arranged on the radial inner side of the annular groove 25, so that the mounting hole 26 and the groove 25 are connected to form a gap; a wedge-shaped groove 33 is opened on the inner end face of the guide portion 312 of each stimulation unit 31. The wedge-shaped groove 33 extends circumferentially and the depth of the bottom of the wedge-shaped groove 33 gradually becomes shallower in the extension direction, and the deeper end of the wedge-shaped groove 33 penetrates the sidewall of the guide portion 312. The wedge-shaped groove 33 can be machined by a cutting tool and a milling cutter; the force-applying component 40 includes a drive ring 41, a gear 42 and a locking pin. 43. The drive ring 41 is installed in the recess 25 and allows the drive ring 41 to rotate. Multiple radially protruding ribs 411 are arranged on the outer wall of the drive ring 41. These ribs 411 are circumferentially arranged and correspond to the wedge-shaped grooves 33 of the guide portion 312 of each stimulation unit 31, allowing each rib 411 to slide from the side wall of the guide portion 312 into the wedge-shaped groove 33. An internal tooth 412 is arranged on the inner wall of the drive ring 41, and this internal tooth 412 corresponds to the circumferential position of the mounting hole 26. The gear 42 is installed in the mounting hole 26, and the teeth of the gear 42 mesh with the internal teeth 412 of the drive ring 41. An operating head 421 is arranged at the outer end of the gear 42. Figure 3As shown, the operating head 421 passes through the filling body 20 and is exposed on the outer disk surface 221 of the filling body 20 for screwing the workpiece. By screwing the operating head 421, the gear 42 rotates. The gear 42 rotates with the inner ring of the inner tooth 412 of the drive ring 41, causing the drive ring 41 to rotate. This causes the rib 411 on the drive ring 41 to slide toward the side of the shallower wedge-shaped groove 33, thereby synchronously driving each stimulation unit 31 to move radially outward, that is, causing the annular stimulation component 3 to move radially outward. The radial expansion causes the stimulation portion 311 of the stimulation unit 31 to abut against the bone of the sidewall 1002 of the defect area 1001. Furthermore, the stimulation portions 311 of each stimulation unit 31 extend out of the sidewall 23 of the filling body 20 by approximately the same amount. Therefore, after each stimulation unit 31 abuts against the bone of the sidewall 1002 of the defect area 1001, the gaps at various circumferential positions between the sidewall 23 of the bone flap body 10 and the sidewall 1002 of the defect area 1001 are essentially consistent. The locking pin 43 is screwed into the end face of the tooth groove from the outer disk surface 221 of the filling body 20 where the gear 42 is located. After each stimulation unit 31 protrudes from the sidewall 23 of the filling body 20 and abuts against the sidewall 1002 of the defect area 1001 with reasonable force, the locking pin 43 is tightened so that its head presses firmly against the gear 42, restricting the rotation of the gear 42, thereby keeping each stimulation unit 31 in its extended state.

[0069] The positioning component 50 is used to fix the bone flap body 10 to the skull 1000, thereby limiting the displacement of the bone flap body 10 in the thickness direction before the skull 1000 and the bone flap body 10 fuse. The positioning method of the positioning component 50 for the bone flap body 10 is completely different from the positioning method of the clamping component in the prior art. After the bone flap body 10 is positioned, none of the elements in the positioning component 50 protrude from the inner surface of the skull 1000, and therefore will not irritate the intracranial tissues. Specifically, as shown in the figure... Figure 3 , Figure 5 , Figure 10 , Figure 12As shown, the bone flap body 10 has multiple radial holes 28 arranged circumferentially, each corresponding to a stimulation unit 31. A circular window 27, penetrating the thickness, is opened in the central region of the filling body 20, so that the inner end of the radial hole 28 extends to the side wall of the circular window 27 to form an entrance end 281. The positioning component 50 includes a bone screw 51, a push screw screw 52, ​​and a locking screw 53. A bone screw 51 is installed in each radial hole 28, so that the bone screws 51 are arranged circumferentially. The bone screw 51 is inserted into the radial hole 28 from the entrance end 281 of the side wall of the circular window 27. The head of the bone screw 51 is equipped with a pointed tip to facilitate insertion into the bone body. To avoid When the drive ring 41 rotates, it interferes with the bone screw 51. A circumferentially extending elongated hole 413 is opened on the drive ring 41, through which the bone screw 51 passes. The push screw 52 is screwed into the radial hole 28 from the inlet end 281. By turning the push screw 52, ​​the push screw 52 is moved radially outward. Thus, when the stimulation unit 31 protrudes from the side wall 23 of the filling body 20 and abuts against the bone body of the side wall 1002 of the defect area 1001, the head of the bone screw 51 extends from the end face of the stimulation part 311 of the stimulation unit 31 and is inserted into the bone body of the side wall 1002 of the defect area 1001 to fix the bone flap body 10. To prevent the push screw 52 from loosening, after the head of the bone screw 51 is inserted into the bone body by screwing the push screw 52, ​​the locking screw 53 is screwed into the radial hole 28 from the inlet end 281 to abut against the tail of the push screw 52 to restrict the push screw 52 from loosening, thereby restricting the retraction of the bone screw 51. To prevent the head of the bone screw 51 from protruding from the side wall 23 of the filling body 20 and interfering with the placement process when the bone flap body 10 is placed in the defect area 1001, a spring 54 is installed in the radial hole 28. The spring 54 applies elastic force to the bone screw 51 so that the head of the bone screw 51 is located within the side wall 23 of the filling body 20.

[0070] like Figure 11 and Figure 12As shown, a sealing plug 29 is detachably arranged in the circular window 27. Specifically, a stepped surface and internal threads are configured inside the circular window 27, and an external thread and stepped surface are configured inside the sealing plug 29, so that the sealing plug 29 screws into the circular window 27. A sealing ring 291 (which can be made of medical-grade silicone) is installed on the stepped surface of the sealing plug 29 to provide a sealing effect. After the bone flap body 10 is fixed to the skull 1000, the sealing plug 29 is screwed into the circular window 27 to finally close the skull 1000. The significant function of the sealing plug 29 is that, postoperatively, if it is necessary to re-explore brain tissue or perform minimally invasive surgery on brain tissue, the sealing plug 29 can be removed, and medical treatment tools such as neuroendoscopy or ultrasonic emulsification scalpel can be used to enter the ventricle through the circular window 27 for medical treatment operations. Preferably, the sealing plug 29 is made of PEEK material. Preferably, the outer end face of the sealing plug 29 is provided with an operating groove for screwing tools.

[0071] like Figure 3 and combined Figure 10 and Figure 12 As shown, the limiting component is used to prevent the bone flap body 10 from shifting towards the skull 1000 due to unforeseen impacts and static forces after surgery, thus preventing permanent collapse of the defect area 1001, especially in the early postoperative period before fusion. The limiting component includes multiple strips 70 arranged circumferentially. Each strip 70 simultaneously spans the outer disc surface 221 of the filling body 20 and the outer surface of the skull 1000 near the defect area 1001. Screws are used to fix the radially inner end of the strip 70 to the filling body 20 and the radially outer end to the skull 1000, thereby limiting the intracranial displacement of the bone flap body 10. Furthermore, during the operation, the pre-installed limiting component can effectively prevent the bone flap body 10 from misaligning with the side wall 1002 of the defect area 1001 and entering the intracranial cavity during the filling operation.

[0072] The bone nail 51 in the positioning component 50 is preferably made of titanium alloy, and the push screw 52 and locking screw 53 are made of stainless steel; the slat 70 in the limiting component is preferably made of titanium alloy.

[0073] In some preferred configurations, the filling body 20 is configured as a split structure to accommodate the aforementioned stimulation component 30 and mounting components for installation. Specifically, such as... Figure 5 and Figure 3As shown, the filling body 20 includes an outer disc 22 and an inner disc 21. The outer disc 22 is fastened to the inner disc 21. The aforementioned structures, such as the receiving groove 231, guide groove 24, and sink 25, are mainly obtained by machining on the inner disc 21. Therefore, the thickness of the blank used to machine the inner disc 21 is greater than the thickness of the outer disc 22. An annular L-shaped step 2311 is machined on the edge of the inner disc 21. After the outer disc 22 is fastened to the inner disc 21, the edge of the outer disc 22 and the L-shaped step 2311 surround each other. The aforementioned receiving groove 231 and guide groove 24 are machined on the inner disc 21. A solid portion 241 is provided between each pair of adjacent guide grooves 24. After the outer disc 22 and inner disc 21 are fastened together, screws 60 are used to pass through the area corresponding to the solid portion 241 of the outer disc 22 and the solid portion 241 to fix the outer disc 22 and inner disc 21. An annular recess 25 and mounting holes 26 are both formed on the inner disc 21. The main body of the circular window 27 is formed on the inner disc 21. Honeycomb structures are provided on the edges of both the outer disc 22 and the inner disc 21 to fill the edges of the main body 20.

[0074] In some preferred configurations, the height of the solid portion 241 on the inner disc 21 used to connect the outer disc 22 is slightly less than the thickness of the stimulation unit 31. Thus, when the stimulation unit 31 is driven to extend radially out of the side wall 23 of the filling body 20, the screw 60 used to fix the two discs is loosened, allowing the stimulation unit 31 to smoothly protrude from the side wall 23 of the filling body 20. After the stimulation unit 31 protrudes from the side wall 23 of the filling body 20 and abuts against the side wall 1002 of the defect area 1001 with reasonable force, the screw 60 is tightened, so that the outer disc 22 presses against each stimulation unit 31, and each stimulation unit 31 and the filling body 20 are integrated into a whole at the edge, so as to avoid the stimulation unit 31 becoming loose and affecting the growth of new bone in the honeycomb structure of the stimulation unit 31 into the honeycomb structure at the edge of the filling body 20.

[0075] It should be noted that:

[0076] The shape of the processed and assembled bone flap body 10 is not necessarily... Figures 1 to 8The strictly circular shape of the bone flap body 10 is determined based on the specific outline of the defect area 1001 generated by craniotomy. However, without excessive removal of the skull 1000, the outline of the defect area 1001 is repaired to a near-circular shape before repair. If the outline of the defect area 1001 generated by craniotomy is elongated or irregular, it is not suitable to use the repair component 100 provided by this invention for closure. When customizing the filling body 20 and the stimulation component 30, their outline dimensions are made larger than the size of the defect area 1001, and the radial dimension of the honeycomb structure intruding into the filling body 20 and the stimulation component 30 is made as large as possible. Then, by removing material from the edges of the filling body 20 and the stimulation component 30, a bone flap body 10 that fits the defect area 1001 and is slightly smaller than its size is obtained, for example, repaired as shown. Figure 9 and Figure 11 The outline shown is adapted to the defective area 1001.

[0077] The following describes the method for assembling the various components of the skull repair component 100 described above:

[0078] First, axially align the drive ring 41 with the annular stimulation component 30. Then, align the protrusion 411 on the drive ring 41 with the notch between the guide portion 312 of each pair of adjacent stimulation units 31 of the stimulation component 30. The protrusion 411 is inserted into the notch by axially moving the drive ring 41 and the stimulation component 30. Then, as... Figure 8 As shown, by slightly rotating the drive ring 41, the rib 411 slides from the side wall of the guide portion 312 into the wedge groove 33, thus completing the assembly of the drive ring 41 and the stimulation component 30.

[0079] Then, as Figure 4 As shown, the drive and stimulation components 30 in the assembled state are embedded into the recess 25, guide groove 24 and L-shaped step 2311 of the inner disc 21, and then the gear 42 is installed into the mounting hole 26 of the inner disc 21.

[0080] Then, spring 54, bone nail 51, and push screw 52 are inserted one by one into radial hole 28 from the inlet end 281 on the side wall of circular window 27, while avoiding the head of bone nail 51 from protruding from the side wall of inner disc 21.

[0081] Then, the outer disc 22 is fastened onto the inner disc 21, and screws 60 are screwed into each solid part 241 of the inner disc 21 through the outer disc 22 one by one. Before the outer disc 22 is inserted, the inner end of each strip 70 is inserted by the screw 60 and connected to the upper surface at the same time, so that the screw 60 is kept slightly loose, thereby allowing each stimulation unit 31 of the stimulation component 30 to move radially; the set pin 43 is inserted into the outer disc 22 and kept loose to allow the gear 42 to rotate.

[0082] Finally, the circular window 27 remains open, and the sealing plug 29 is kept in reserve.

[0083] The following describes the procedure for using the aforementioned skull repair component 100 to close the defect area 1001 of the skull 1000:

[0084] First, the sidewall 1002 of the defective area 1001 is repaired to obtain a flat sidewall 1002.

[0085] Then, the repair component 100 is placed in the defective area 1001, such as... Figure 10 As shown, this causes the sidewall of the bone flap body 10 to face the sidewall 1002 of the defect area 1001. At this time, the outer end of the strip 70 overlaps the skull 1000, thereby preventing the repair component 100 from entering the cranium due to the gap between it and the sidewall 1002 of the defect area 1001.

[0086] Then, using a special screw-twisting tool, the operating head 421 of gear 42 is screwed to drive gear 42 to rotate. This causes the driving ring 41 to drive each stimulation unit 31 of the stimulation component 30 to protrude radially from the sidewall of the bone flap body 10 and simultaneously press against the sidewall 1002 of the defect area 1001. Since the amount of protrusion of the stimulation unit 31 from the sidewall 23 at each circumferential position is approximately the same, the circumferential positions of the edge of the filling body 20 are basically consistent with the sidewall 1002 of the defect area 1001. This is beneficial for the synchronous fusion of the skull 1000 at each circumferential position of the defect area 1001 with the bone flap body 10. Then, the locking pin 43 is screwed so that the head of the locking pin 43 presses against gear 42 to restrict the rotation of gear 42, thereby restricting the retraction of stimulation unit 31.

[0087] Then, as Figure 12 As shown, a special screw-tightening tool is used to screw the push screw 52 one by one so that the head of each bone screw 51 is inserted into the bone body of the side wall 1002 of the defect area 1001. Then, the locking screw 53 is screwed in and tightened one by one to restrict the retraction of the bone screw 51.

[0088] Then, tighten all screws 60 so that the outer disc 22 presses against the stimulation element 30, thereby making the stimulation unit 31 of the stimulation element 30 form a whole with the edge of the outer disc 22 and the edge of the inner disc 21 to prevent the stimulation element 30 from loosening.

[0089] Then, the pointed short bone nails 51 are inserted through the outer ends of each strip 70 and screwed into the skull 1000 to fix the outer ends of the strips 70.

[0090] Finally, the sealing plug 29 is screwed into the circular bone window to finally close the skull 1000.

[0091] Postoperatively, if excessive stress is observed between the skull 1000 and the repair component 100 through manual or imaging observation, such as the skull 1000 of the repair component 100 being observed to bulge and deform, the repair component 100 can be exposed by cutting the scalp, and then the stress of the stimulation unit 31 can be released by slightly loosening each screw 60.

[0092] Furthermore, although exemplary embodiments have been described in this invention, their scope includes any and all embodiments based on the invention that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, and such examples will be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered illustrative only, and the true scope and spirit are indicated by the full scope of the following claims and their equivalents.

[0093] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments may be used by those skilled in the art upon reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the invention. This should not be construed as an intention that a disclosed feature, which is not claimed, is necessary for any claim. Rather, the subject matter of the invention may be less than all the features of the particular disclosed embodiment. Thus, the following claims are incorporated herein by reference as examples or embodiments, wherein each claim is independently considered as a separate embodiment, and these embodiments are contemplated as being possible in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

[0094] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within its spirit and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of the present invention.

Claims

1. A cranial repair component, characterized in that, include: A bone flap body for filling a defect area in the skull, the bone flap body comprising a disc-shaped filling body and a plurality of stimulation units, the filling body having an outer disc surface facing outward after the bone flap body fills the defect area, an inner disc surface facing the ventricle, and a sidewall facing the defect area, the plurality of stimulation units being arranged circumferentially in the filling body between the outer disc surface and the inner disc surface, and each stimulation unit being able to protrude from the sidewall of the filling body by radial movement; The force-applying component is used to drive each stimulation unit to protrude radially from the sidewall of the filling body, so that after the bone flap body fills the defect area, the force-applying component drives each stimulation unit to protrude from the sidewall of the filling body, causing the radially outer end of the stimulation unit to press against the sidewall of the defect area to stimulate the bone body of the sidewall of the defect area. Positioning components are used to attach and position the bone flap body to the skull. Each stimulation unit includes an integrally formed stimulation part located on the radially outer side and a guide part located on the radially inner side. Each circumferentially arranged stimulation unit is formed by cutting a ring, and the stimulation parts of each two adjacent stimulation units are elastically connected by staggered cutting seams. The filling body is configured with an annular receiving groove penetrating its sidewalls and multiple guide grooves located radially inside the receiving groove, arranged circumferentially and extending radially through the receiving groove. The stimulation part of each stimulation unit on the annular body is located in the receiving groove, and the guide part is correspondingly embedded in each guide groove; wherein: Each stimulation unit has a honeycomb structure configured on the end face of its stimulation part; An annular recess is formed on the radially inner side of the guide groove, and the guide groove extends into the recess. A wedge-shaped groove extending circumferentially and with a gradually changing bottom depth is formed on the inner end face of the guide portion of each stimulation unit; wherein: The force-applying component includes: A drive ring is disposed in the sink groove. The outer wall of the drive ring is provided with a plurality of radially protruding and circumferentially arranged ribs, which are used to slide into the wedge-shaped groove. The inner wall of the drive ring is provided with a section of internal teeth. A gear is disposed in a mounting hole located radially inside the drive ring and meshes with the internal teeth of the drive ring. The axial end of the gear is provided with an operating part for screwing, and the operating part is exposed on the outer disk surface of the filling body. A locking pin extends from the outer disk surface of the filling body to restrict the rotation of the gear.

2. The cranial repair component according to claim 1, characterized in that, The bone flap body is provided with a plurality of radial holes arranged in a circumferential direction. The radial holes extend from the radial inner side of the filling body to its sidewall and penetrate the stimulation unit. The positioning component includes: The bone screws include a plurality of them, each bone screw being disposed in a plurality of radial holes, wherein the head of the bone screw can extend out to fill the sidewall of the body by moving along the radial holes; A push screw is screwed into a radial hole at the tail of the bone screw. By screwing the push screw, the head of the bone screw extends out of the side wall of the filling body and is inserted laterally into the bone body of the skull through the side wall of the defect area.

3. The cranial repair component according to claim 2, characterized in that, A circular window is provided in the central region of the filling body, and the radial hole extends through the side wall of the circular window to form an entrance end. The bone nail is inserted into the radial hole from the entrance end of the side wall of the circular window; a sealing plug is screwed into the circular window.

4. The cranial repair component according to claim 1, characterized in that, The edge regions of the filling body are configured with a honeycomb structure.

5. The cranial repair component according to claim 1, characterized in that, The filling body includes an inner disc and an outer disc that interlock; an annular step is formed on the radially outer side of the inner disc, and the inner disc and the outer disc define an annular receiving groove; the guide groove and the receiving groove are formed on the inner disc; wherein: The outer disc is fixed to the inner disc by screws that are screwed into the solid portion between each pair of adjacent guide slots; The height of the solid portion between each pair of adjacent guide grooves is less than the thickness of the stimulation unit, so that the outer disc body presses against the stimulation unit by tightening the screw.

6. The cranial repair component according to claim 1, characterized in that, The cranial repair component further includes a limiting component, which includes a plurality of circumferentially arranged strips on the outer disc surface of the filling body. The radial inner ends of the strips are connected to the filling body, and the outer ends of the strips are connected to the skull.

7. The cranial repair component according to claim 1, characterized in that, The filling body is made of PEEK material, and the stimulation unit is made of titanium alloy material.

8. The cranial repair component according to claim 4, characterized in that, Bone growth promoting material is coated in the honeycomb structure of the stimulation unit and in the honeycomb structure at the edge of the filling body.

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