CN113425398A - Manufacturing method of skull lock - Google Patents

Abstract

A method for manufacturing a skull lock comprises the following steps: heating the first material to a molten state; mixing the second material into the first material in a molten state, and uniformly mixing; waiting for the mixture in the molten state to cool and solidify; preparing an osteogenic part by adopting a molding method, wherein the osteogenic part is matched with a locking part to form a skull lock, and after the locking part fixes a bone flap and an opening of a skull along a first direction, a plurality of induction holes which are formed on the osteogenic part of a gap between the osteogenic part and the locking part in a penetrating way along a second direction different from the first direction induce bone cells at two ends of the bone flap and the opening of the skull to grow towards each other to form the bone anchor.

Description

Manufacturing method of skull lock

Technical Field

The invention relates to the medical field related to neurosurgery skull, in particular to a manufacturing method of a skull lock.

Background

In neurosurgery, under some commonly used surgical methods, the skull of a patient needs to be cut, the cut bone is called a bone flap, the bone flap needs to be placed back to the original position after surgery to realize subsequent bone healing, and a certain fixing device needs to be used before the bone healing is completed to prevent the bone flap from displacing.

CN209564187U relates to the technical field of medical instruments for neurosurgery, in particular to a skull lock, which comprises a fixed locking plate, a movable locking plate, a binding belt, a handle, a tightening column and a return spring; the lower end and the upper end of the binding belt are respectively fixedly connected with the fixed locking plate and the handle; the movable locking plate is provided with a locking hole matched with the binding belt, the movable locking plate is sleeved on the binding belt through the locking hole and is arranged between the fixed locking plate and the handle, the binding belt is provided with a first stopping tooth, and the movable locking plate is provided with a second stopping tooth matched with the first stopping tooth; the puller column is slidably mounted on the handle, a limiting flange is arranged at the upper end of the puller column, and the reset spring is sleeved outside the puller column and located between the handle and the limiting flange. Through the skull lock of the utility model, the locking of the bone lamella can be accomplished to doctor's one hand, can simplify the operating procedure and improve skull lock installation rate.

It can be seen that prior art only can realize the fixed to the bone lamella, the process that increases for the bone guides, the arbitrary irregular growth of bone can cause bone healing back sclerotin inhomogeneous, intensity distribution is scattered indiscriminate scheduling problem, if adopt absorbable material design in addition, skull lock will not provide sufficient stable support and guarantee the position of bone lamella and prescribe a limit to at the later stage of bone healing, the bone lamella still produces the displacement easily this moment, make the bone healing achievement lack one and for one time, the technology can't realize the bone lamella stable support of whole bone healing period and the even formation guide of the direction and the intensity that grow into the sclerotin now.

Furthermore, on the one hand, due to the differences in understanding to the person skilled in the art; on the other hand, since the inventor has studied a lot of documents and patents when making the present invention, but the space is not limited to the details and contents listed in the above, however, the present invention is by no means free of the features of the prior art, but the present invention has been provided with all the features of the prior art, and the applicant reserves the right to increase the related prior art in the background.

Disclosure of Invention

In order to solve at least a part of problems in the prior art, the invention provides a method for manufacturing a skull lock, which comprises the following steps: s1 heating PLGA to a molten state; s2, mixing the TCP powder and the magnesium powder or the magnesium alloy powder into the molten PLGA, and uniformly mixing; s3 waiting for the mixture in the molten state to cool and solidify; s4 is to prepare an osteogenic part using a molding method, the osteogenic part being provided in a gap between the flap and the opening edge of the skull and guiding bone cells at both ends of the flap and the opening edge of the skull to grow toward each other to form a bone connection, the locking part fixing the flap and the opening edge of the skull in a first direction, the bone connection being performed based on a second direction different from the first direction, wherein the osteogenic part is provided with a plurality of inducing holes throughout the second direction for facilitating the bone connection to form a bone anchor during a post-operative bone healing period.

Preferably, the osteogenic part cooperates with the locking part to form a skull lock, and after the locking part fixes the bone flap and the skull opening along a first direction, a plurality of induction holes which are formed through along a second direction different from the first direction and exist on the osteogenic part of the gap between the two parts induce bone cells at two ends of the bone flap and the skull opening to grow towards each other to form the bone anchor.

The existence of the induction holes provides a growth channel towards each other for the bone cells at the edge of the bone flap and the opening of the skull, the bone cells will grow towards each other through the induction holes preferentially to form the bone anchors in a period of postoperative healing, a plurality of bone anchors arranged at different positions form auxiliary fixing on the positions of the bone flap and the opening of the skull in at least three dimensions, especially for the time after the bone anchors are formed, when the bone forming part disappears due to self decomposition, if other objects participating in the auxiliary fixing do not exist, only the skull is locked to participate in the fixing, and the bone anchors growing to the right positions in the invention play a role in the auxiliary fixing. And the bone substance in the range defined by a plurality of adjacent bone anchors can grow towards the expected direction and position due to the limiting and guiding action of the surrounding bone anchors in the process of growing towards each other, and finally, a complete skull with high uniformity and direction consistency degree is obtained, the possibility of fracture caused by insufficient subsequent strength is prevented, and the effect of skull healing is greatly improved. The bone anchors obtained by the induction holes which are arranged in a system form not only have certain auxiliary effect on fixing bone flaps, but also can limit the growth direction and the growth range of bone in the process of guiding the growth of the bone, so that the bone reconstruction effect is greatly improved. Compared with the bone anchor which adopts massive open holes and amorphous random bone growth induction, the bone anchor which adopts the arrangement of the plurality of induction holes to guide the growth of the bone to ensure that the volume of the plurality of bone anchors is small enough and the strength is ensured has stronger regularity, the growth process and the growth trend of the bone are controllable, the problems of uneven bone caused by the disordered and random growth of the bone to any direction and the scattered distribution of the bone strength after healing can be avoided. The skull lock is applied with the osteogenesis part at the same time, at the early stage of postoperative healing, the skull lock forms stable limitation on the position of the osteogenesis part and the osteogenesis direction, the bone anchoring direction formed by the osteogenesis piece in the later stage of healing forms an auxiliary fixing effect on the process of fixing the bone flap by the skull lock, the skull lock and the osteogenesis part are stable and smooth in the whole skull healing process under the bidirectional feedback stabilizing effect in different periods, particularly, an absorbable skull lock scheme is adopted, and at the later stage of bone reconstruction, because the skull lock is gradually absorbed, the skull lock cannot provide sufficient supporting effect at the moment, the bone anchor generated by the introduction of the osteogenesis part can continue to uniformly fix the bone flap with high strength under the action of the skull lock at the moment, and meanwhile, uniform growth guide on the residual bone can be formed.

Preferably, the plurality of induction holes are arranged in a matrix on the locking part at intervals along the first direction and the third direction.

Preferably, the plurality of induction holes are arranged on the locking part in such a manner as to be spaced apart in the first direction and the third direction, respectively.

Preferably, the bone anchors defined by the guide holes form a matrix arrangement in two dimensions at a plurality of points formed on a projection plane along the second direction.

Preferably, the bone anchors in the smallest matrix arrangement in the matrix arrangement are able to circumscribe a rectangular area, and the bone anchors around the rectangular area provide marginal guidance for bone cell growth in the center of the area after the osteogenic section is decomposed.

Under the technical scheme, the stability of the formed bone anchor structure is further improved, and the stress conditions in three directions described in three dimensions are considered, the bone anchor structure formed under the scheme can uniformly and stably disperse the acting forces from the three directions, so that the movement or shaking of the bone flap relative to the opening of the skull under the influence of the gravity or the external acting forces such as the inertia force generated by the autonomous or non-autonomous movement of the patient is greatly reduced. Meanwhile, from the view of the minimum unit matrix forming the large matrix, the bone anchors contained in each unit matrix can induce the growth of other bone substances in the range defined by the bone anchors, so that a plurality of bone minimum units with relatively high consistency degree are formed, and the result evaluation after bone healing is further improved.

Preferably, the osteogenic part is made of a polymer material which can be absorbed by the human body, and the locking part is made of the same material, wherein the molecular weight of the polymer material is adjusted to ensure that the dissolution time of the osteogenic part is shorter than that of the locking part.

Preferably, the interval arrangement of the inducing holes formed in the first direction and the third direction respectively is performed according to a uniform arrangement mode, and when viewed in the third direction, any four inducing holes in the dot matrix projection formed by the inducing holes can define a rectangular range, and the smallest rectangular range is defined by four adjacent inducing holes.

Preferably, the thickness of the osteogenic section extending in the second direction is configured to match the width of the gap created by the craniotomy tool selected for use in craniotomy of the patient, and the height of the osteogenic section extending in the first direction is configured to match the length of the thickness of the skull of the patient.

Preferably, the osteogenic part is provided with at least two threading holes in a first direction, the threading holes are used for penetrating and guiding the locking wires to move in the osteogenic part, wherein the locking part comprises an intracranial locking sheet and an extracranial locking sheet, and when the locking wires move up and down due to locking operation of the intracranial locking sheet and the extracranial locking sheet, the osteogenic part respectively penetrates through the corresponding locking wires through the at least two threading holes arranged in the first direction.

Preferably, the locking portion comprises an intracranial locking tab and an extracranial locking tab which abut against the inner and face sides of the skull of the patient, respectively, when the flap and the opening of the skull are brought into fixed alignment, and the directions in which the two approach and depart from each other are configured in a first direction.

Preferably, the osteogenesis part is provided with at least two threading holes along the first direction in a penetrating way, and the intracranial locking piece and the extracranial locking piece are also respectively provided with two lead holes.

Preferably, one end of the locking wire passes through one of the lead holes of the extracranial locking piece and enters one of the lead holes at the end close to the face side, passes through one of the lead holes of the intracranial locking piece after passing out to the inner side, passes out from the other lead hole in the reverse direction, then passes through the other lead hole on the inner side face, passes out from the other lead hole on the face side, and finally passes out from the other lead hole of the extracranial locking piece.

Preferably, the side surfaces of the osteogenic part respectively contacting the bone flap and the edge of the skull opening and the induction hole are provided with growth induction powder containing magnesium.

Preferably, the lead hole aperture is larger than the induction hole aperture.

Drawings

Fig. 1 is a flow chart of a method for making an osteogenesis part according to the present invention;

FIG. 2 is a schematic structural view of the present invention;

FIG. 3 is a schematic representation of the cross-sectional configuration and resulting bone anchor of the present invention after use on a skull bone;

FIG. 4 is a top view of the osteogenic section and two locking tabs of the present invention;

fig. 5 is a schematic view of the bone formation recess and groove portion and the resulting bone pin and bone plate configuration of the present invention;

in the figure: 100. a bone flap; 200. a cranial opening; 300. a locking portion; 310. an intracranial locking tab; 320. an extracranial locking tab; 330. a wire hole; 400. an osteogenic section; 410. a guide hole; 420. threading holes; 430. a recess; 440. a groove part; 500. a bone anchor; 600. a bone pin; 700. a bone support; 800. locking the wire; 001. a first direction; 002. a second direction; 003. and a third direction.

Detailed Description

In the description of the present invention, it should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" in the specification should be interpreted broadly, and may be, for example, a fixed connection, a detachable connection, or an integral connection; the connection can be mechanical connection or electric connection, and also can be a combination of mechanical connection and electric connection; the electronic components can be installed by using a circuit of a lead, and can also be designed by using a simplified circuit board in modes of integration and the like. The specific meaning of the above terms in the present invention can be understood by those skilled in the art according to specific applications.

FIG. 1 provides a method of making a skull lock. The method is used for manufacturing the bone part and comprises the following specific steps:

s1 heating the first material to a molten state;

s2, mixing the second material into the first material in a molten state, and uniformly mixing;

s3 waiting for the mixture in the molten state to cool and solidify;

s4, preparing the osteogenic part 400 by adopting a molding method;

the first material can be a material which is non-toxic and harmless to human bodies and can be degraded in human bodies, for example, PLGA can be adopted, PLGA is polylactic acid-glycolic acid copolymer which is commonly used as a manufacturing raw material of absorbable medical devices, and the first material can be widely used as a substance which is non-toxic and harmless to human bodies and can be decomposed into lactic acid or a complex thereof in human bodies along with time, and besides, PHA and other materials can be utilized. The second material can be selected from one or a combination of any one of TCP ceramic powder and magnesium powder or magnesium alloy powder, and both the TCP ceramic powder and the magnesium powder or the magnesium alloy powder have excellent biocompatibility, osteoinduction and can induce the growth of bones. Mixing the inducing material and the explaining material harmless to the human body to prepare the osteogenesis part can fill the gap when the gap is formed in the early stage of bone healing, slowly turn to the later stage of bone healing along with the time, and the explanation accompanying the osteogenesis part per se disappears when the growth of the inducing bone is carried out, so that the gap has different supporting functions of an action main body in the whole course, the osteogenesis stability is good, the bone is uniform after osteogenesis, and the direction consistency is good. The molding method can utilize a prefabricated mold to cool and solidify the mixture to form the bone forming part in one step, and can also adopt schemes such as subsequent grinding and hole opening to form the structure of the bone forming part.

Fig. 2 and 3 provide a method of making a skull lock for fixation of a patient's bone flap 100 after neurosurgery or craniotomy performed by a medical or related head or brain department. To facilitate the description of the following embodiments, the procedure of fixing the previously removed bone flap 100 back to the opened portion of the patient's skull after the craniotomy is described. In the craniotomy, since the brain part of the patient protected by the skull is often operated, a part of the bone of the skull is often cut off to expose the brain inside the skull to the operating range of the operator, the cut-off part of the skull is called a bone flap 100, and the craniotomy determines the surgical parameters such as the cutting-off position of the bone flap 100, the size of the cut-off bone flap 100 and the like according to the surgical requirements and the condition of the patient. Generally, the opened bone flap 100 is generally in a regular shape such as a circle or a square, and has at least one or more longer edges or side lengths, such as a circular perimeter portion or a polygonal side length portion, which are also edges separated from the peripheral skull bone caused by cutting with a surgical hand saw or an electric saw during the operation. After the operation on the brain of the patient is finished, the open part on the skull of the patient needs to be refilled with a solid body to protect the brain therein from the external environment and maintain the normal physiological environment of the brain of the patient, and an optional scheme is to refill the open part with a 3D printed artificial bone flap 100 or fill the open part with other materials capable of being solidified quickly, which is mostly used in the case that the patient has skull injury, and another common scheme is to directly refill the open part with the bone flap 100 removed from the skull of the patient to form a complete skull, because the bone flap 100 and the open part removed from the skull of the patient have double-fit, which can almost perfectly fit the edge part of the opening. During a healing period of bone at one end after operation, osteoblasts between the bone flap 100 and the open portion of the skull are regenerated and slowly proliferate from the fractured portion of the bone flap 100 and the fractured portion of the skull opening 200 to each other, during which the proliferated bone at both ends gradually merges at the middle portion and finally fuses to form a complete junction, and the healing of the bone flap 100 filled in the complete skull is substantially completed at this time. The reason for the clearance between the flap 100 and the edge of the skull opening 200 is that the hand saw or electric saw used in surgery has a certain blade thickness, typically 1-3mm wide, in order to ensure a certain operational rigidity, and the bone material of the skull is lost by the abrasion of a knife or saw disc of this width, so that a certain clearance is usually formed between the flap 100 and the edge of the skull when the flap 100 is filled back, and this clearance width is typically determined according to the width of the knife, e.g. a knife 3mm wide is used, and the resulting clearance width is also typically about 3mm, and the clearance can be regarded as a space defined by the edges with two ends being substantially parallel, viewed in cross section. However, during post-operative bone healing, the edges of the flap 100 will not normally be perfectly aligned with the edges of the skull opening 200 due to patient movement or other external forces, and if the bone is left to heal in this situation, it may cause misalignment, surface irregularity, and even some problems affecting the patient's brain function after healing. Some fixation means may be required to forcibly align the split bone flap 100 with the skull opening 200.

Therefore, the invention provides a manufacturing method of a skull lock, which at least comprises a locking part 300 and an osteogenesis part 400, wherein the locking part 300 is used for enabling the edges of the parts of a patient's bone flap 100 and a skull opening 200 to simultaneously contact the two sides of the parts of the patient's bone flap 100 and the skull opening 200 in a mode of forcibly fixing and aligning thickness sides, for the convenience of description, the skull of the patient is divided into two approximately observation side surfaces, the first side surface is the inner side of the skull facing the brain direction of the patient, and can be called as the inner side, and the other side surface is the outer side of the skull far away from the brain direction of the patient, and can be called as the surface side. In addition, since the skull region of the human body exhibits a certain curvature and does not form a flat plane, the locking directions of the plurality of locking portions 300 used in fixing the bone flap 100 are not spatially oriented, and only by describing one of the locking portions 300 in detail, the other locking portions 300 have structures substantially identical to the locking portions 300 mainly described in the present embodiment when they have no other function or are not placed in a specific position or in a specific state. While a single locking portion 300 is described, in general, the overall size of the locking portion 300 may be configured to be a smaller volume, depending on the size of the human skull and the size of the gap created by the surgical tool, so that when the user's skull or the portion of the bone flap 100 is acted upon, the action portion may be generally considered to be a generally flat tangent plane formed by cutting a tangent line at the curved region of the skull. It will be appreciated that this does not mean that the face of the locking portion 300 in contact with the patient's skull could only or preferably be configured as a planar structure, but rather that the contact face could correspond to or generally follow a pre-formed planar structure curved in a similar arc depending on the curvature of the physiologically occurring part of the skull corresponding to the location of the cover on the user's skull as set by itself, or could be adapted to overlie a curved portion of the user's skull in the case of a deformable material, soft material, actuated deformable material or deformable structure. The contact plane is here considered for simplicity of analysis as a plane, as is shown in the cross-section in fig. 3, which is a two-dimensional image in which the direction across the gap is referred to as the second direction 002, i.e. the direction in which the left arrow points. This direction may also be referred to as the radial direction of the cut bone flap 100 in a circular shape, and in general this direction also describes the direction in which bone material at the ends of the gap grows and heals toward one another, i.e. may also be described as the positive-negative direction of the second direction 002. It is understood that the direction of bone cell regeneration, i.e. the direction of bone growth, may be along an oblique direction different from the second direction 002 in non-ideal cases, or the growth direction of a certain part of the bone cell regeneration process is observed, and the growth direction is usually a fan-shaped or annular plane or body diffusion process, but in the set of these two-dimensional or three-dimensional direction vectors, at least the second direction 002 should be included, so the second direction 002 may be substantially the growth direction of the bone in the present embodiment.

To achieve fixation of bone flap 100, it is desirable to apply at least one external force to bone flap 100 to counter the tendency of bone flap 100 to fall toward the brain of the patient due to its own weight, and preferably locking portion 300 comprises at least intracranial locking tabs 310 and extracranial locking tabs 320, wherein intracranial locking tabs 310 contact the inside of the skull of the patient and extracranial locking tabs 320 contact the face side of the skull of the patient when locking portion 300 is activated. It can be seen from the above that the surface of the extracranial locking piece 320 and/or the intracranial locking piece 310 contacting the skull is arranged to be flat or can be bent equally according to the corresponding radian of the skull contacting part, and preferably, both locking pieces are approximately sheet-shaped structures, which may refer to not only sheet-shaped structures with a certain area in the two-dimensional meaning, but also sheet-shaped structures with a certain thickness and even a certain radian in the three-dimensional meaning, that is, three-dimensional structures with a thickness smaller than or substantially smaller than at least one other side length can be generally regarded as sheet-shaped structures.

According to a common usage, the two locking tabs of the locking portion 300 are forced to align the bone flap 100 and the skull opening 200 in a manner of clipping at both ends, specifically, the direction of the connecting line of the centers of the shapes of the intracranial locking tab 310 and the extracranial locking tab 320 or the moving direction of the two locking tabs toward each other without the centers of the other shapes being in the regular position is configured as a first direction 001, as shown by the upward arrow in fig. 3. It can be seen from the schematic cross-sectional view that the first direction 001 and the second direction 002 of the bone growth are not at least in the same direction, even the included angle between the vectors has a large value, when the two locking plates are driven by the external driving force and the first direction 001 generated along the physical limit of the transmission part is arranged along the plane direction which is perpendicular to the tangent direction of the small part of the skull bone and is approximately flat, the first direction 001 can be said to be approximately perpendicular to the second direction 002. The intracranial locking piece 310 and the extracranial locking piece 320 are moved towards each other along the first direction 001 by external force operation to reduce the linear distance between the two, when moving to a certain distance, the two are respectively contacted with the inner side and the face side of the skull, at least one part of the two contact surfaces is contacted with the skull opening 200, the other part is contacted with the bone flap 100, therefore, under the action of the supporting and fixing limit, the bone flap 100 can be approximately aligned with the thickness side of the skull opening 200.

Preferably, in order to achieve the effects of continuously accelerating the healing of the bone flap 100 and further controlling the bone growth direction and the final healing effect when the bone flap 100 is healed on the premise of fixing the bone flap 100, an osteogenic part 400 is provided at the position of the gap formed between the bone flap 100 and the edge of the skull opening 200, and the osteogenic part 400 may be configured to be substantially a sheet shape due to the spatial shape filling the gap or a sheet shape bent with a certain radian according to the opening scheme of the bone flap 100, and from the configuration of the length of the side thereof, the thickness side thereof in the general sense is substantially arranged along the second direction 002, and the height direction thereof is arranged along the first direction 001. Preferably, in case of mass-producing bone formation portions 400 of various sizes adapted to different thicknesses of patient's skull and widths of gaps caused by a craniotomy tool used at the time of surgery, the height at which the bone formation portions 400 extend in the first direction 001 may be set in a manner to fit the length of the thickness of the patient's skull, the thickness of the skull at most positions of general personnel is between 10-15mm, the thickness of parietal bone portions frequently operated at the time of craniotomy is approximately between 5-10mm, and the height of the bone formation portions 400 may be set to be, for example, 10mm long; accordingly, the thickness established by the extension of the osteogenic section 400 in the second direction 002 may be configured to match the width of the gap created by a craniotomy tool selected for use in craniotomy procedures on a patient, such as a typical craniotome, for example, a craniotome, which creates a gap width generally close to its own blade width, between 1-3 mm.

The osteogenic part 400 is provided at the gap portion not to affect the healing of the bone located at the edges of the bone flap 100 and the skull opening 200, but on the contrary, the osteogenic part 400 plays a role of guiding the growth direction and fixing the growth position for the growth of the bone at both ends at the sacrifice of a certain growth rate. Preferably, a plurality of growth inducing holes 410 are formed on the surfaces of the osteogenesis part 400 contacting the edges of the bone flap 100 and the skull opening 200 in the first direction 001, respectively, and the inducing holes 410 on the two surfaces are preferably communicated with each other inside the osteogenesis part 400, and preferably, the channel formed by the communication is substantially linearly directed, in other words, a plurality of inducing holes 410 are formed on the osteogenesis part 400 in a certain arrangement. The presence of the induction holes 410 provides a channel for bone cells at the edge of the bone flap 100 and the skull opening 200 to grow toward each other, bone cells will preferentially grow toward each other through the induction holes 410 during a period of post-operative healing, and ideally, will grow and combine with each other inside the channel of the induction holes 410 to form a stronger and complete bone connection, since other bone parts not facing the induction holes 410 are blocked by the solid body of the osteogenic part 400 and grow slower and do not form a bone connection, if the osteogenic part 400 is withdrawn from the gap in an imaginary manner without destroying the bone connection parts already formed, it can be observed that the bone connections formed at several positions through the several induction holes 410 form a structure for connecting and fixing the edge of the bone flap 100 and the skull opening 200, which functions like an anchor for anchoring the bone flap 100 to the edge of the skull opening 200, the bone connection site formed at this time may therefore be referred to as a bone anchor 500.

As can be seen from the above, the position of the inducing hole 410 determines the position of the bone anchor 500, and the bone anchor 500 plays a role of supporting the bone flap 100 and orienting the bone growth position of other parts for a certain period of time after the disappearance of the osteogenic part 400. The disappearance of the osteogenic part 400 is achieved by designing the entire material of the osteogenic part 400, and materials absorbable by the human body have been widely studied, such as polylactic acid polymer materials, which are gradually decomposed in the environment of the human body and then harmlessly absorbed by the human body, in other words, the osteogenic part 400 made of such materials can be gradually "melted" inside the human body and finally completely disappeared. Preferably, the two locking tabs of the locking portion 300 can also be made of the materials described above.

After the osteogenic part 400 is decomposed by itself and absorbed by the human body to disappear, the bone materials existing at the edges of the bone flap 100 and the skull opening 200 in the range defined by the adjacent bone anchors 500 grow toward each other under the orientation and guidance of the adjacent bone anchors 500 to form a bone connection lagging behind the bone anchors 500.

Preferably, the present embodiment provides some beneficial results for the process of supporting and orienting bony growth of the bone flap 100 at other sites where bone connection has not previously been created by specifying the location of the induction hole 410 to create a specific alignment of the locations of the bone anchors 500. Specifically, in the present embodiment, the inducing holes 410 are arranged at intervals along the first direction 001 and the third direction 003 respectively to form a matrix structure similar to a chessboard or a Chinese character jing, and when viewed from one of the inducing holes 410 arbitrarily selected, the inducing holes respectively have at least one other inducing hole 410 which has a certain interval distance with each other along the first direction 001 and the third direction 003, and preferably, the interval lengths arranged along the first direction 001 are all equal, and correspondingly, the interval lengths arranged along the third direction 003 are also equal, and the interval length in the first direction 001 is equal to or not equal to the interval length in the third direction 003. The third direction 003 here refers to a direction spatially perpendicular to a plane formed by the first direction 001 and the second direction 002, and is shown in fig. 3 as a direction vertically inward or outward along the plane of the paper, and the extension of the bone formation portion 400 in this direction also establishes its length.

The plurality of bone anchors 500 formed as defined by the inducing holes 410 in the matrix structure as described above are formed in the matrix structure of the spots, as viewed in a projection plane along the second direction 002, and the bone anchors 500 in the matrix structure have advantages in at least supporting stability and uniformly directing other bone growth. Specifically, the bone anchors 500 arranged in a matrix at least can provide relatively uniform and stable support for the bone flap 100 and the skull opening 200 at least in three dimensional directions, and when viewed along the first direction 001, the bone anchors 500 arranged in a matrix are arranged at intervals on the side surface, so that a strong and uniform limitation is provided for the stability of the bone flap 100 fixed on the skull opening 200 in the first direction 001, that is, the freedom of up-and-down displacement of the bone flap 100 and the skull opening 200 under the action of gravity and the like is limited. If the uniform arrangement is not adopted, some positions in the first direction 001 may have low support property, and other positions may have high support property, and since the newly grown bone anchors 500 may not reach full hardness for a while, the non-uniform arrangement may cause a problem that the bone anchors 500 are broken at the portions having low support property. Similarly, the uniform arrangement of the bone anchors 500 provides, viewed in the third direction 003, a limited relative movement of the bone flap 100 and the skull opening 200 in the third direction 003, i.e. the rotational freedom of the bone flap 100 within the skull opening 200 is limited. Viewed in the second direction 002, the bone anchors 500 in the lattice provide a freedom of movement defining the relative movement of the bone flap 100 and the skull opening 200 in the second direction 002, i.e. the movement of the edge of the bone flap 100 closer to or further away from the edge of the skull opening 200. The matrixed bone anchor 500 formed by matrixing the inducing holes 410 is capable of uniformly fixing the bone flap 100 on the skull opening 200 edge in at least three dimensions and in the freedom of displacement in other direction vectors formed by the combination of the three direction vectors.

In addition, as seen from the second direction 002, the lattice-shaped bone anchors 500 form a checkerboard-like or # -like structure, at least one bone anchor 500 exists at the intersection of each imaginary line, in other words, every four bone anchors 500 arranged in a minimum matrix can define a rectangular range, which is similar to each lattice on the checkerboard, the lattices cannot form bone connection until the bone formation portion 400 is absorbed, after the bone formation portion 400 is decomposed and disappeared, the defined rectangular range provides guidance and limitation for the bone growth of the portion, according to the bone cell participating bone reconstruction process, the bone anchors 500 which are stable around provide marginal guidance for the new bone cell proliferation, the proliferated bone cells fill the lattices one by one, and the overall bone reconstruction process is finally completed with time. The bone anchors 500 in the matrix have well-controlled direction in the whole bone healing process due to the limitation and marginal guiding process, so that the problems of uneven bone and delayed bone healing time caused by the fact that the bone grows in other directions randomly are solved.

Preferably, growth inducing powders containing magnesium capable of promoting bone growth are provided on both sides of the osteogenic part 400 contacting the edge of the flap 100 and the skull opening 200, and bone cells can be more rapidly proliferated by the powders.

Preferably, as shown in fig. 5, two structures are provided in the matrix defined by the inducing holes 410 opened in the bone forming portion 400 in the matrix form, one of the two structures faces the edge of the bone flap 100, the other faces the edge of the skull opening 200, one of the two structures is a concave portion 430 formed by sinking towards the interior of the bone forming portion 400 along the second direction 002, the other structure is a groove portion 440 firstly grooved towards the interior of the bone forming portion 400 along the second direction 002 and provided with a protrusion along the opposite direction of the grooving direction at the groove bottom, wherein preferably, the protrusion radian of the groove portion 440 is consistent with the depression radian of the concave portion 430, the groove portion 440 and the concave portion 430 are both provided in the bone forming portion 400, and the two structures are not communicated with each other but have a cut-off distance between the deepest portions of the two recesses. Under the scheme, when the bone anchor 500 is formed, bone substances positioned in the middle position of a matrix defined by the bone anchor 500 grow into the concave part 430 and the groove part 440 respectively under the influence of growth inducing powder, the bone pins 600 with one ends protruding in an arc shape and the bone supports 700 with one ends recessed inwards are formed due to the shaping of the shapes of the bone pins and the groove part, the protruding ends of the bone pins 600 can be approximately matched with the concave parts of the bone supports 700, after the bone forming parts 400 are decomposed and disappear, the bone pins 600 and the bone supports 700 form a bearing matching relation, the bone pins 600 and the bone supports 700 in the matching relation are combined to form a second fixing position except the bone anchor 500, the stability of the bone reconstruction process is further improved, the coated bone pins 600 and the bone supports 700 can be combined together more quickly, and the bone connection process of the part is finally completed.

Preferably, the two locking pieces of the locking portion 300 are also made of a material that can be absorbed and decomposed by human body, for example, polylactic acid polymer material as described above, and the absorption time of the osteogenic piece is configured to be shorter than that of the skull lock by selecting materials with different molecular weights during the manufacturing or raw material, so that in this case, the osteogenic piece will decompose and disappear faster relative to the skull lock, so that the locking effect of the skull lock between the bone flap 100 and the skull opening 200 can be achieved and the undesired displacement can be prevented at least in a period of time before the bone anchor 500 is completely formed and the combination of the bone pin 600 and the bone bracket 700 is completed and after the above structure is achieved in the process of inducing bone reconstruction by using the osteogenic portion 400.

The process of controlling the relative movement of the intracranial locking plate 310 and the extracranial locking plate 320 is realized by the driving of the locking wire 800, and as shown in fig. 4, at least two threading holes 420 are penetratingly formed in the osteogenesis part 400 along the first direction 001. Two lead holes 330 are also provided on the intracranial locking plate 310 and the extracranial locking plate 320, respectively. One end of the locking wire 800 passes through one of the thread holes 330 of the extracranial locking piece 320 and enters one of the thread holes 420 at the end near the face side, passes through one of the thread holes 330 of the intracranial locking piece 310 after reaching the inside and passing out, and passes through the other thread hole 330 in the reverse direction, then passes through the other thread hole 420 on the inside face side, and passes out of the other thread hole 420 on the face side, and finally passes out of the other thread hole 330 of the extracranial locking piece 320. Thereby forming an actuating structure for the two locking tabs. The wire hole 330 has a larger aperture than the inducing hole 410.

It should be noted that the above-mentioned embodiments are exemplary, and that those skilled in the art, having benefit of the present disclosure, may devise various arrangements that are within the scope of the present disclosure and that fall within the scope of the invention. It should be understood by those skilled in the art that the present specification and figures are illustrative only and are not limiting upon the claims. The scope of the invention is defined by the claims and their equivalents.

Claims (10)

1. A method for manufacturing a skull lock, which comprises the steps of,

it is characterized in that the preparation method is characterized in that,

the method comprises the following steps:

heating the first material to a molten state; mixing the second material into the first material in a molten state, and uniformly mixing; waiting for the mixture in the molten state to cool and solidify; the osteogenic part (400) is prepared by a molding method,

the osteogenic part (400) is matched with a locking part (300) to form the skull lock, and after the locking part fixes a bone flap (100) and a skull opening (200) along a first direction (001), a plurality of induction holes (410) which are formed on the osteogenic part (400) in a gap between the osteogenic part and the skull opening in a penetrating way along a second direction (002) different from the first direction (001) induce the bone cells at two ends of the bone flap and the skull opening to grow towards each other to form a bone anchor (500).

2. The method according to any of the preceding claims, wherein a plurality of the induction holes (410) are arranged on the locking part (300) in a manner to form intervals in the first direction (001) and the third direction (003), respectively.

3. The method according to any of the preceding claims, wherein the osteogenic section (400) and the locking section (300) are made of a polymeric material that is absorbable by the human body, wherein the molecular weight of the polymeric material is adjusted such that the osteogenic section (400) has a shorter decomposition time than the locking section (300).

4. The method according to one of the preceding claims, wherein the bone anchor (500) defined by the guide hole (410) forms a matrix arrangement in two dimensions of a plurality of points formed on a projection plane along the second direction (002).

5. The method according to one of the preceding claims, wherein the bone anchors (500) in the smallest matrix arrangement of the matrix arrangement are able to circumscribe a rectangular area, the bone anchors (500) around the rectangular area providing marginal guidance for bone cell growth in the center of the area after the osteogenic section (400) is decomposed.

6. The method according to one of the preceding claims, wherein the osteogenic section (400) is threaded with the respective locking wire (800) through at least two threading holes (420) provided in the first direction (001) when the intracranial locking tab (310) and the extracranial locking tab (320) of the locking section (300) cause the locking wire (800) to move up and down due to the locking operation.

7. The method according to one of the preceding claims, wherein the intracranial locking tab (310) and the extracranial locking tab (320) are provided with a lead hole (330), respectively.

8. The method according to one of the preceding claims, wherein the locking wire (800) threaded and defined by the threading aperture (420) is capable of defining the direction of movement of the intracranial locking tab (310) and extracranial locking tab (320) in a first direction (001).

9. Method according to one of the preceding claims, characterized in that the osteogenic section (400) is in contact with the side of the edge of the flap (100) and the skull opening (200), respectively, and that the induction holes (410) are provided with growth inducing powders containing magnesium.

10. The method according to one of the preceding claims, wherein the locking wire (800) limiting the movement of the intracranial locking plate (310) and extracranial locking plate (320) is achieved by means of a wire feed hole (330) threaded onto both.

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