CN106562841A - Fixing device used for packing craniotomy drilled holes and preparation method of fixing device - Google Patents
Fixing device used for packing craniotomy drilled holes and preparation method of fixing device Download PDFInfo
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- CN106562841A CN106562841A CN201611152982.1A CN201611152982A CN106562841A CN 106562841 A CN106562841 A CN 106562841A CN 201611152982 A CN201611152982 A CN 201611152982A CN 106562841 A CN106562841 A CN 106562841A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2875—Skull or cranium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
- A61F2002/2839—Bone plugs or bone graft dowels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30075—Properties of materials and coating materials swellable, e.g. when wetted
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/3097—Designing or manufacturing processes using laser
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
The invention provides a fixing device used for packing craniotomy drilled holes and a preparation method of the fixing device. The fixing device used for packing craniotomy drilled holes is in the shape of a thick rivet in the whole, and comprises a knife edge I, a knife edge II, a knife edge III, a vertical part and a horizontal part, wherein the horizontal part is convex-arc-shaped, and the vertical part is cylinder-shaped; the horizontal part is horizontally arranged, the vertical part is vertically arranged, the horizontal part and the vertical part are coaxially and integrally formed, after the horizontal part and the vertical part are coaxially and integrally formed, the vertical part is thoroughly cut in the horizontal direction, so that a gap is formed, and the gap forms the knife edge I, the knife edge II and the knife edge III. The fixing device is convenient to use, and is safe and effective, the stability of fixing the restored skull flaps can be achieved, meanwhile, the formation of new bone tissues at the skull defect part can be promoted to different degrees, and the functional reconstruction is achieved.
Description
Technical field
The present invention is related to and belongs to medical apparatus and instruments manufacturing field, is related to repair for the filling of skull hole and Cranial-bone-flap resets admittedly
Fixed device, specially a kind of fixing device for the filling of drill for craniotomy hole and preparation method thereof.
Background technology
Neurosurgery operation of opening cranium needs the suitable position drilling on skull using drill for craniotomy (such as pneumatic drill or electric drill),
Then Cranial-bone-flap is separated using supporting miller for craniotomy knife, then carries out the lesion resection of skull lower floor, then needed skull
Lobe carries out replacement and fixation, and the little defect of poroid or other shapes of skull caused because of drill for craniotomy can be also remained after replacement and fixation.Pin
The fixed demand resetted to Cranial-bone-flap and the reparation demand of the little defect of skull, the solution of clinician can be existing according to hospital
Product select fixed or repair mode.For example select titanium connection sheet and titanium nail to carry out the fixation of reset Cranial-bone-flap, need supporting
Instrument twists screw, and operation is relatively not easy enough, and screw is shot skull and has damage in various degree, if child patient titanium material is produced
Product are often avoided, and nuclear-magnetism inspection can be affected after titanium material implants in addition.Bone hole or sutura after Cranial-bone-flap is resetted
Reparation demand brings a new difficult problem to doctor, and usual doctor has to select the broken bone or medical collagen of some residuals extra large
Silk floss is used cooperatively, and in addition to skeletonization effect on driving birds is not good, increased the risk of infection on the contrary.Certainly, with indivedual artificial bones
Clinical practice, different degrees of solve the problems, such as Bone Defect Repari, but or artificial bone hardness is exactly greatly very much too crisp, almost
Without toughness, so being difficult to moulding, and the immunologic rejection risk of potential animal derived materials.
The content of the invention
In order to solve the above problems, the present invention provides a kind of fixing device for the filling of drill for craniotomy hole and its making side
Method, it is easy to use, safe effective, in addition to it can reach the stability of fixed reset Cranial-bone-flap, it is also possible to different degrees of rush
Enter defect of skull position new bone tissue to be formed, reach reconstruction.
The present invention is adopted the following technical scheme that:
A kind of fixing device for the filling of drill for craniotomy hole, the thick rivet shape of fixing device generally class of drill for craniotomy hole filling
Shape, including the edge of a knife one, the edge of a knife two, the edge of a knife three, vertical component and horizontal component;The horizontal component is convex surface arc, described to hang down
Straight part is cylinder;Horizontal component is horizontally disposed with, and vertical component is vertically arranged, the coaxial one of horizontal component and vertical component into
After type, horizontal component and vertical component are coaxially integrally formed, the penetrating cutting of horizontal direction are carried out to vertical component and forms gap, stitched
Gap forms the edge of a knife one, the edge of a knife two and the edge of a knife three.
After the horizontal component and vertical component are coaxially integrally formed, penetrating cutting are carried out to vertical component and forms " Lv " word
Capitiform, " well " font, " X " font, " two " font or " three " font gap.
The edge thickness of the horizontal component is 0.1-10 millimeters, and boss thickness is 0.3-5 millimeters, and vertical component is straight
Footpath is 5-30 millimeters, and horizontal component is 1-10 millimeters with diameter greater than the length of vertical component, the radian of convex surface arc is 179 degree-
100 degree, horizontal component marginal portion has carried out the slope modification of gradual change, it is ensured that edge is attractive in appearance with skull surface to be connected.
The height of the vertical component is 1-10 millimeters, and this is highly approximately less than skull thickness 3-6 millimeters, vertical component it is straight
Footpath is 5-30 millimeters, and the conventional bit diameter for opening cranium is 5-7 millimeters, and bit diameter is 3-15 millimeters, and the surface of vertical component sets
It is set to smooth, coarse, coarse-pitch thread or unidirectional anti-slip texture.
Carry out to vertical component that horizontal direction is penetrating to cut that to form the spacing in gap be 0.1-5 millimeters, the depth of cutting is
Less than the height 0.5-5 millimeters of vertical component, after penetrating cutting gap, vertical component can be carried out according to boring sites in curing skull thickness
Cut out short.
At least two and above product are packed to the bone hole opened by drill for craniotomy when using for the present invention, using macromolecular material
Horizontal exapnsion power behind cut gap reaches and the Cranial-bone-flap for resetting is fixed.Penetrating cutting can more preferably embody macromolecule
The horizontal exapnsion power of material.
For the manufacture method of the fixing device of drill for craniotomy hole filling, comprise the steps:One kind is selected to meet medical plant
The resorbable polymeric materials for entering requirement pass through first injection, three D printings or finishing impression by horizontal component and the coaxial one of vertical component
Molding, then carries out penetrating cutting and forms gap to vertical component.
The resorbable polymeric materials are polycaprolactone (PCL) polymer, and polycaprolactone (PCL) polymer is in body
Tunnel and micropore are inside gradually formed in degradation process, is easy to osteoblast to grow into, the osteoblast secretion ossein for growing into, secretion
Type i collagen as skeletonization carrier bracket, the calcium ion and phosphate radical in body fluid deposit on type i collagen fiber and assemble and multiple
Synthesis new bone tissue.
The injection moulding process is:Spill is designed according to the making shape need of the fixing device in the filling of drill for craniotomy hole first
Mould, then under such as 35-95 degree Celsius carries out injection mo(u)lding, the semi-finished product of injection mo(u)lding is carried out machine cuts then or is swashed
The penetrating cutting in light level direction.
The three D print procedures are:The resorbable polymeric materials for meeting medical embedded requirement are carried out with three D printers
Then the semi-finished product made are carried out the penetrating cutting of machine cuts or laser level direction by molding.
The finishing impression process is:According to the making shape need design 3-D graphic of the fixing device of drill for craniotomy hole filling,
Finishing impression molding is carried out in the work computer that then 3-D graphic is switched to three-dimensional data importing carving machine, according to the precision of product
And space structure needs the finishing impression equipment for selecting four axles or five-axle linkage to carry out the making of product, then by the semi-finished product made
Carry out the penetrating cutting of machine cuts or laser level direction.
Select that injection, three D are printed or the condition of finishing impression is carried out in the dust proof workshop of ten thousand grades or hundred grades, to ensure making
During purity and clean level so that the product of formation meets the technical requirements of embedded type medical apparatus and instruments.
The Advantageous Effects of the present invention:It is easy to use, safe effective, except the steady of fixed reset Cranial-bone-flap can be reached
It is qualitative outer, it is also possible to which that different degrees of promotion defect of skull position new bone tissue is formed, and reaches reconstruction.The fixation of this device
Mode instead of traditional silk suture fix or titanium nail and titanium connection sheet fixed form, saved operation time, kept away
Bleeding caused by stubborn titanium nail has been exempted from, has alleviated patient suffering, and the use for titanium metal material being substituted using macromolecular material has kept away
Exempt from postoperative patient to be not easy to carry out the problem of nuclear-magnetism inspection.
Description of the drawings
Fig. 1 is the structure chart of the fixing device for the filling of drill for craniotomy hole.
Description of reference numerals
1 edge of a knife one;2 edges of a knife two;3 edges of a knife three;4 vertical components;5 horizontal components.
Specific embodiment
The present invention is further illustrated with the preferred embodiments of the present invention below in conjunction with the accompanying drawings.
Embodiment 1
As shown in figure 1, a kind of fixing device for the filling of drill for craniotomy hole, the fixing device of drill for craniotomy hole filling is generally
The thick rivet shape of class, including the edge of a knife 1, the edge of a knife 22, the edge of a knife 33, vertical component 4 and horizontal component 5;The horizontal component 5 is
Convex surface arc, the vertical component 4 are cylinder;Horizontal component 5 is horizontally disposed with, and vertical component 4 is vertically arranged, horizontal component 5
Coaxially it is integrally formed with vertical component 4, after horizontal component 5 and vertical component 4 are coaxially integrally formed, water-filling is entered to vertical component 4
Square gap is formed to penetrating cutting, gap forms the edge of a knife 1, the edge of a knife 22 and the edge of a knife 33.
After the horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out to vertical component 4 that horizontal direction is penetrating to cut
Cut to form " Lv " prefix shape, " well " font, " X " font, " two " font or " three " font gap.
The edge thickness of the horizontal component 5 is 0.1-10 millimeters, and boss thickness is 0.3-5 millimeters, and vertical component effect is straight
Footpath is 5-30 millimeters, and horizontal component is 1-10 millimeters with diameter greater than the length of vertical component 4, the radian of convex surface arc is 179 degree-
100 degree, horizontal component marginal portion has carried out the slope modification of gradual change, it is ensured that edge is attractive in appearance with skull surface to be connected.
The height of the vertical component 4 is 1-10 millimeters, and this is highly approximately less than skull thickness 3-6 millimeters, vertical component 4
A diameter of 5-30 millimeters, the conventional bit diameter for opening cranium is 5-7 millimeters, and bit diameter is 3-15 millimeters, the surface of vertical component 4
It is set to smooth, coarse, coarse-pitch thread or unidirectional anti-slip texture.
Carry out to vertical component 4 that horizontal direction is penetrating to cut that to form the spacing in gap be 0.1-5 millimeters, the depth of cutting is
Less than the height 0.5-5 millimeters of vertical component 4, after penetrating cutting gap, vertical component 4 can enter according to boring sites in curing skull thickness
Row is cut out short.
At least two and above product are packed to the bone hole opened by drill for craniotomy when using for the present invention, using macromolecular material
Horizontal exapnsion power behind cut gap reaches and the Cranial-bone-flap for resetting is fixed.Penetrating cutting can more preferably embody macromolecule
The horizontal exapnsion power of material.The present invention is easy to use, safe effectively, the stability except reaching fixed reset Cranial-bone-flap
Outward, it is also possible to which different degrees of promotion defect of skull position new bone tissue is formed, and reaches reconstruction.The fixed form of this device
Instead of traditional silk suture fix or titanium nail and titanium connection sheet fixed form, saved operation time, it is to avoid
Bleeding caused by stubborn titanium nail, alleviates patient suffering, and the use for substituting titanium metal material using macromolecular material is avoided
Postoperative patient is not easy to the problem for carrying out nuclear-magnetism inspection.
Embodiment 2
A kind of fixing device for the filling of drill for craniotomy hole, the thick rivet shape of fixing device generally class of drill for craniotomy hole filling
Shape, including the edge of a knife 1, the edge of a knife 22, the edge of a knife 33, vertical component 4 and horizontal component 5;The horizontal component 5 is convex surface arc,
The vertical component 4 is cylinder;Horizontal component 5 is horizontally disposed with, and vertical component 4 is vertically arranged, horizontal component 5 and vertical component
4 are coaxially integrally formed, and after horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out horizontal direction to vertical component 4 penetrating
Cutting forms gap, and gap forms the edge of a knife 1, the edge of a knife 22 and the edge of a knife 33.
After the horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out to vertical component 4 that horizontal direction is penetrating to cut
Cut to form " Lv " prefix shape, " well " font, " X " font, " two " font or " three " font gap.
The edge thickness of the horizontal component 5 be 0.1 millimeter, boss thickness be 0.3 millimeter, vertical component 4 it is straight
Footpath is 5 millimeters, and horizontal component is 1 millimeter with diameter greater than the length of vertical component 4, and the radian of convex surface arc is 179 degree, horizontal part
Point marginal portion has carried out the slope modification of gradual change, it is ensured that edge is attractive in appearance with skull surface to be connected.
The height of the vertical component 4 is 1 millimeter, and this is highly approximately less than 3 millimeters of skull thickness, the diameter of vertical component 4
For 5 millimeters, the conventional bit diameter for opening cranium is 5 millimeters, and bit diameter is 3 millimeters, the surface of vertical component 4 be set to it is smooth,
Coarse, coarse-pitch thread or unidirectional anti-slip texture.
Carry out to vertical component 4 that horizontal direction is penetrating to cut that to form the spacing in gap be 0.1 millimeter, the depth of cutting is little
In 0.5 millimeter of the height of vertical component 4, after penetrating cutting gap, vertical component 4 can be cut out according to boring sites in curing skull thickness
It is short.
At least two and above product are packed to the bone hole opened by drill for craniotomy when using for the present invention, using macromolecular material
Horizontal exapnsion power behind cut gap reaches and the Cranial-bone-flap for resetting is fixed.Penetrating cutting can more preferably embody macromolecule
The horizontal exapnsion power of material.The present invention is easy to use, safe effectively, the stability except reaching fixed reset Cranial-bone-flap
Outward, it is also possible to which different degrees of promotion defect of skull position new bone tissue is formed, and reaches reconstruction.The fixed form of this device
Instead of traditional silk suture fix or titanium nail and titanium connection sheet fixed form, saved operation time, it is to avoid
Bleeding caused by stubborn titanium nail, alleviates patient suffering, and the use for substituting titanium metal material using macromolecular material is avoided
Postoperative patient is not easy to the problem for carrying out nuclear-magnetism inspection.
Embodiment 3
The present embodiment is highly preferred embodiment of the present invention.
A kind of fixing device for the filling of drill for craniotomy hole, the thick rivet shape of fixing device generally class of drill for craniotomy hole filling
Shape, including the edge of a knife 1, the edge of a knife 22, the edge of a knife 33, vertical component 4 and horizontal component 5;The horizontal component 5 is convex surface arc,
The vertical component 4 is cylinder;Horizontal component 5 is horizontally disposed with, and vertical component 4 is vertically arranged, horizontal component 5 and vertical component
4 are coaxially integrally formed, and after horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out horizontal direction to vertical component 4 penetrating
Cutting forms gap, and gap forms the edge of a knife 1, the edge of a knife 22 and the edge of a knife 33.
After the horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out to vertical component 4 that horizontal direction is penetrating to cut
Cut to form " Lv " prefix shape, " well " font, " X " font, " two " font or " three " font gap.
The edge thickness of the horizontal component 5 be 10 millimeters, boss thickness be 5 millimeters, vertical component it is a diameter of
30 millimeters, the length with diameter greater than vertical component 4 of horizontal component is 10 millimeters, and the radian of convex surface arc is 100 degree, horizontal part
The marginal portion divided has carried out the slope modification of gradual change, it is ensured that edge is attractive in appearance with skull surface to be connected.
The height of the vertical component 4 is 10 millimeters, and this is highly approximately less than 6 millimeters of skull thickness, the diameter of vertical component 4
For 25 millimeters, the conventional bit diameter for opening cranium is 7 millimeters, and bit diameter is 15 millimeters, and the surface of vertical component 4 is set to light
Sliding, coarse, coarse-pitch thread or unidirectional anti-slip texture.
Carry out to vertical component 4 that horizontal direction is penetrating to cut that to form the spacing in gap be 5 millimeters, the depth of cutting be less than
5 millimeters of the height of vertical component 4, after penetrating cutting gap, vertical component 4 can carry out cutting out short according to boring sites in curing skull thickness.
At least two and above product are packed to the bone hole opened by drill for craniotomy when using for the present invention, using macromolecular material
Horizontal exapnsion power behind cut gap reaches and the Cranial-bone-flap for resetting is fixed.Penetrating cutting can more preferably embody macromolecule
The horizontal exapnsion power of material.The present invention is easy to use, safe effectively, the stability except reaching fixed reset Cranial-bone-flap
Outward, it is also possible to which different degrees of promotion defect of skull position new bone tissue is formed, and reaches reconstruction.The fixed form of this device
Instead of traditional silk suture fix or titanium nail and titanium connection sheet fixed form, saved operation time, it is to avoid
Bleeding caused by stubborn titanium nail, alleviates patient suffering, and the use for substituting titanium metal material using macromolecular material is avoided
Postoperative patient is not easy to the problem for carrying out nuclear-magnetism inspection.
Embodiment 4
A kind of fixing device for the filling of drill for craniotomy hole, the thick rivet shape of fixing device generally class of drill for craniotomy hole filling
Shape, including the edge of a knife 1, the edge of a knife 22, the edge of a knife 33, vertical component 4 and horizontal component 5;The horizontal component 5 is convex surface arc,
The vertical component 4 is cylinder;Horizontal component 5 is horizontally disposed with, and vertical component 4 is vertically arranged, horizontal component 5 and vertical component
4 are coaxially integrally formed, and after horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out horizontal direction to vertical component 4 penetrating
Cutting forms gap, and gap forms the edge of a knife 1, the edge of a knife 22 and the edge of a knife 33.
After the horizontal component 5 and vertical component 4 are coaxially integrally formed, carry out to vertical component 4 that horizontal direction is penetrating to cut
Cut to form " Lv " prefix shape, " well " font, " X " font, " two " font or " three " font gap.
The edge thickness of the horizontal component 5 is 0.6 millimeter, and boss thickness is 1.3 millimeters, and vertical component is a diameter of
17 millimeters, the length with diameter greater than vertical component 4 of horizontal component is 7 millimeters, and the radian of convex surface arc is 175 degree, horizontal part
The marginal portion divided has carried out the slope modification of gradual change, it is ensured that edge is attractive in appearance with skull surface to be connected.
The height of the vertical component 4 is 5 millimeters, and this is highly approximately less than 4.5 millimeters of skull thickness, vertical component 4 it is straight
Footpath is 10 millimeters, and the conventional bit diameter for opening cranium is 6 millimeters, and bit diameter is 13 millimeters, and the surface of vertical component 4 is set to light
Sliding, coarse, coarse-pitch thread or unidirectional anti-slip texture.
Carry out to vertical component 4 that horizontal direction is penetrating to cut that to form the spacing in gap be 1.5 millimeters, the depth of cutting is little
In 1.5 millimeters of the height of vertical component 4, after penetrating cutting gap, vertical component 4 can be cut out according to boring sites in curing skull thickness
It is short.
At least two and above product are packed to the bone hole opened by drill for craniotomy when using for the present invention, using macromolecular material
Horizontal exapnsion power behind cut gap reaches and the Cranial-bone-flap for resetting is fixed.Penetrating cutting can more preferably embody macromolecule
The horizontal exapnsion power of material.The present invention is easy to use, safe effectively, the stability except reaching fixed reset Cranial-bone-flap
Outward, it is also possible to which different degrees of promotion defect of skull position new bone tissue is formed, and reaches reconstruction.The fixed form of this device
Instead of traditional silk suture fix or titanium nail and titanium connection sheet fixed form, saved operation time, it is to avoid
Bleeding caused by stubborn titanium nail, alleviates patient suffering, and the use for substituting titanium metal material using macromolecular material is avoided
Postoperative patient is not easy to the problem for carrying out nuclear-magnetism inspection.
Embodiment 5
For the manufacture method of the fixing device of drill for craniotomy hole filling, comprise the steps:One kind is selected to meet medical plant
The resorbable polymeric materials for entering requirement pass through first injection, three D printings or finishing impression by horizontal component and the coaxial one of vertical component
Molding, then carries out penetrating cutting and forms gap to vertical component.
The resorbable polymeric materials are polycaprolactone (PCL) polymer, and polycaprolactone (PCL) polymer is in body
Tunnel and micropore are inside gradually formed in degradation process, is easy to osteoblast to grow into, the osteoblast secretion ossein for growing into, secretion
Type i collagen as skeletonization carrier bracket, the calcium ion and phosphate radical in body fluid deposit on type i collagen fiber and assemble and multiple
Synthesis new bone tissue.
The injection moulding process is:Spill is designed according to the making shape need of the fixing device in the filling of drill for craniotomy hole first
Mould, then under such as 35-95 degree Celsius carries out injection mo(u)lding, the semi-finished product of injection mo(u)lding is carried out machine cuts then or is swashed
The penetrating cutting in light level direction.
The three D print procedures are:The resorbable polymeric materials for meeting medical embedded requirement are carried out with three D printers
Then the semi-finished product made are carried out the penetrating cutting of machine cuts or laser level direction by molding.
The finishing impression process is:According to the making shape need design 3-D graphic of the fixing device of drill for craniotomy hole filling,
Finishing impression molding is carried out in the work computer that then 3-D graphic is switched to three-dimensional data importing carving machine, according to the precision of product
And space structure needs the finishing impression equipment for selecting four axles or five-axle linkage to carry out the making of product, then by the semi-finished product made
Carry out the penetrating cutting of machine cuts or laser level direction.
Select that injection, three D are printed or the condition of finishing impression is carried out in the dust proof workshop of ten thousand grades or hundred grades, to ensure making
During purity and clean level so that the product of formation meets the technical requirements of embedded type medical apparatus and instruments.
Present pre-ferred embodiments, therefore the scope of present invention enforcement can not be limited according to this, i.e., according to patent model of the present invention
Enclose and equivalence changes that description is made and modification, all still should belong in the range of present invention lid.
Claims (11)
1. it is a kind of for drill for craniotomy hole filling fixing device, it is characterised in that:The fixing device of drill for craniotomy hole filling is generally
The thick rivet shape of class, including the edge of a knife one, the edge of a knife two, the edge of a knife three, vertical component and horizontal component;The horizontal component is convex surface arc
Shape, the vertical component are cylinder;Horizontal component is horizontally disposed with, and vertical component is vertically arranged, horizontal component and vertical component
Coaxially it is integrally formed, after horizontal component and vertical component are coaxially integrally formed, the penetrating cutting of horizontal direction is carried out to vertical component
Gap is formed, gap forms the edge of a knife one, the edge of a knife two and the edge of a knife three.
2. it is according to claim 1 for drill for craniotomy hole filling fixing device, it is characterised in that:The horizontal component and
After vertical component is coaxially integrally formed, penetrating cutting is carried out to vertical component and forms " Lv " prefix shape, " well " font, " X " font,
" two " font or " three " font gap.
3. it is according to claim 1 for drill for craniotomy hole filling fixing device, it is characterised in that:The horizontal component
Edge thickness be 0.1-10 millimeters, boss thickness be 0.3-5 millimeters, a diameter of 5-30 millimeters of vertical component, horizontal part
Point it is 1-10 millimeters with diameter greater than the length of vertical component, the radian of convex surface arc is 179 degree of -100 degree, horizontal component edge part
Dividing has carried out the slope modification of gradual change, it is ensured that edge is attractive in appearance with skull surface to be connected.
4. it is according to claim 1 for drill for craniotomy hole filling fixing device, it is characterised in that:The vertical component
It is highly 1-10 millimeters, this is highly approximately less than skull thickness 3-6 millimeters, a diameter of 5-30 millimeters of vertical component, vertical component
Surface be set to smooth, coarse, coarse-pitch thread or unidirectional anti-slip texture.
5. it is according to claim 1 for drill for craniotomy hole filling fixing device, it is characterised in that:Vertical component is carried out
It is 0.1-5 millimeters that the penetrating cutting of horizontal direction forms the spacing in gap, and the depth of cutting is the height 0.5-5 less than vertical component
Millimeter, after penetrating cutting gap, vertical component can carry out cutting out short according to boring sites in curing skull thickness.
6. described in claim 1 for drill for craniotomy hole filling fixing device manufacture method, it is characterised in that including as follows
Step:A kind of resorbable polymeric materials for meeting medical embedded requirement are selected to pass through first injection, three D printings or finishing impression by level
Part and vertical component are coaxially integrally formed, and penetrating cutting is then carried out to vertical component and forms gap.
7. described in claim 6 for drill for craniotomy hole filling fixing device manufacture method, it is characterised in that:It is described to inhale
Receipts macromolecular material is polycaprolactone (PCL) polymer, and polycaprolactone (PCL) polymer is in vivo gradually in degradation process
Form tunnel and micropore, be easy to osteoblast to grow into, the osteoblast secretion ossein for growing into, the type i collagen of secretion as into
The carrier bracket of bone, the calcium ion and phosphate radical in body fluid deposit on type i collagen fiber and assemble and be combined into new bone tissue.
8. described in claim 6 for drill for craniotomy hole filling fixing device manufacture method, it is characterised in that the injection
Process is:Female mold is designed according to the making shape need of the fixing device in the filling of drill for craniotomy hole first, then in such as 35-
Injection mo(u)lding is carried out under 95 degrees Celsius, the semi-finished product of injection mo(u)lding is carried out into machine cuts then or laser level direction is penetrating cuts
Cut.
9. described in claim 6 for drill for craniotomy hole filling fixing device manufacture method, it is characterised in that three D
Print procedure is:The resorbable polymeric materials for meeting medical embedded requirement are carried out into molding with three D printers, then will be made
Good semi-finished product carry out the penetrating cutting of machine cuts or laser level direction.
10. described in claim 6 for drill for craniotomy hole filling fixing device manufacture method, it is characterised in that the essence
Carving process is:According to the making shape need design 3-D graphic of the fixing device of drill for craniotomy hole filling, then by 3-D graphic
Finishing impression molding is carried out in the work computer for switching to three-dimensional data importing carving machine, according to the precision and space structure needs of product
Select the finishing impression equipment of four axles or five-axle linkage to carry out the making of product, then by the semi-finished product made carry out machine cuts or
The penetrating cutting in laser level direction.
The manufacture method of 11. fixing devices for the filling of drill for craniotomy hole according to claim 6-10 any one, its
It is characterised by, selects that injection, three D are printed or the condition of finishing impression is carried out in the dust proof workshop of ten thousand grades or hundred grades, ensures in system
Purity and clean level during work so that the product of formation meets the technical requirements of embedded type medical apparatus and instruments.
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CN201611152982.1A CN106562841A (en) | 2016-12-14 | 2016-12-14 | Fixing device used for packing craniotomy drilled holes and preparation method of fixing device |
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CN201611152982.1A CN106562841A (en) | 2016-12-14 | 2016-12-14 | Fixing device used for packing craniotomy drilled holes and preparation method of fixing device |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110742711A (en) * | 2019-06-05 | 2020-02-04 | 湖南普林特医疗器械有限公司 | Manufacturing method of medical bone-like small-beam-structure porous tantalum bone implant prosthesis through laser additive manufacturing and high-temperature vacuum sintering |
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