CN106491197A - A kind of Cranial-bone-flap resets the device and preparation method thereof that is connected - Google Patents

A kind of Cranial-bone-flap resets the device and preparation method thereof that is connected Download PDF

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Publication number
CN106491197A
CN106491197A CN201611137923.7A CN201611137923A CN106491197A CN 106491197 A CN106491197 A CN 106491197A CN 201611137923 A CN201611137923 A CN 201611137923A CN 106491197 A CN106491197 A CN 106491197A
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cylinder
millimeters
bone
cranial
plain film
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CN201611137923.7A
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胡晓予
刘佰运
陈怀萍
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/688Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for reattaching pieces of the skull
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Abstract

The device that is connected the present invention relates to a kind of Cranial-bone-flap resets, described device includes plain film and cylinder, the material of the plain film and cylinder is macromolecular material, the plain film is horizontally disposed, cylinder is symmetrical arranged on the lower surface at the horizontal two ends of the plain film, the bottom of two cylinders internally interior receipts relatively, the angle of interior receipts are 10 an angle of 90 degrees.This fixing device can be connected steadily in the long term Cranial-bone-flap reset, avoided using traditional titanium connection sheet and titanium nail be connected after affect nuclear-magnetism check problem, be equally applicable to child patient, easy to use, safe and effective.

Description

A kind of Cranial-bone-flap resets the device and preparation method thereof that is connected
Technical field
The invention belongs to medicine equipment manufacturing technology field, especially a kind of Cranial-bone-flap reset be connected device and Its preparation method.
Background technology
Neurosurgery operation of opening cranium needs the suitable position drilling on skull using craniotomy drill, then opens cranium using supporting Cranial-bone-flap is separated by milling cutter, then carries out the lesion resection of skull lower floor, then needs Cranial-bone-flap is resetted, after reset Need suitably to fix.Currently, titanium connection sheet and titanium nail support the use for fixed product after Cranial-bone-flap reset.In addition There is titanium skull lock to be used by Clinical Surgery doctor, but skull lock is divided into two panels, stimulate towards dural position occasional and damage Epidural vessel or other tissues, cause local hemorrhage or paradoxical discharge, exactly because such deficiency, in recent years, although The combination fixed form of titanium connection sheet and titanium nail is cumbersome, and can affect nuclear-magnetism inspection in various degree, but its usage amount Also it is more than skull lock.Therefore, a kind of new Cranial-bone-flap reset attachment means are needed badly.
Content of the invention
It is an object of the invention in place of overcoming the technical deficiency of existing product, there is provided a kind of Cranial-bone-flap resets and is connected Device and preparation method thereof, the fixing device can be connected steadily in the long term Cranial-bone-flap reset, avoided using traditional Titanium connection sheet and titanium nail be connected after affect nuclear-magnetism check problem, be equally applicable to child patient, easy to use, safe simultaneously Effectively.
The present invention solves the technical scheme that adopted of technical problem:
A kind of Cranial-bone-flap resets the device that is connected, and described device includes the material of plain film and cylinder, the plain film and cylinder Material is macromolecular material, and the plain film is horizontally disposed, is symmetrical arranged post on the lower surface at the horizontal two ends of the plain film Body, the bottom of two cylinders internally interior receipts relatively, the angle of interior receipts are 10-90 degree angle.
And, the angle of the interior receipts is 45 degree.
And, the plain film is flat cuboid, a length of 3-30 millimeters, a width of 1-15 millimeters, and thickness is 0.1-10 millis Rice;The cylinder is rectangular cylinder or cylinder, the diameter of the width or cylinder of the rectangular cylinder and the width one of plain film Cause, be the actual (tube) length of a diameter of 2-10 millimeters of 1-15 millimeters, rectangular cylinder thickness or cylinder, rectangular cylinder or cylinder Spend for 2-20 millimeters.
And, a length of 10 millimeters of the cuboid of the plain film, a width of 3 millimeters, thickness is 1 millimeter, the side of the plain film Edge has been carried out slope process, can make flat cuboid be covered in skull surface incisura more small;The rectangular cylinder Width or the diameter of cylinder and the width of plain film consistent, be 3 millimeters, rectangular cylinder thickness or cylinder a diameter of 2.5 millimeters, the physical length of rectangular column or cylinder is 5.5 millimeters, and the length is typically smaller than skull thickness 2-3 millimeters.
And, pawl is provided with the interior receipts side of the rectangular cylinder or the surface of cylinder is provided with screw thread, rectangular column There is diminution gradual change at the tip 0.5-3 millimeters of body or cylinder, gradual change angle is 5-35 degree, and tip diameter is 0.5-5 millimeters.
And, there is diminution gradual change at 1.5 millimeters of the tip of the rectangular cylinder or cylinder, gradual change angle is 10 degree, end The tip is a diameter of 2 millimeters.
A kind of Cranial-bone-flap as above resets the preparation method of device of being connected, and step is as follows:
A kind of macromolecular material for meeting medical embedded requirement is selected to form by injection or finishing impression.Select injection or finishing impression Condition be to carry out in the dust proof workshop of ten thousand grades or hundred grades.
And, the macromolecular material is absorbable polymer material or is non-absorbent macromolecular material.
And, the resorbable polymeric materials are polycaprolactone polymer;When making, first according to the making of device Shape need designs female mold, then carries out injection mo(u)lding at temperature 60-85 DEG C.
And, the non-absorbent macromolecular material is ultra-high molecular weight polyethylene;When making, need first according to device Making shape need design 3-D graphic, then by 3-D graphic switch to three-dimensional data import carving machine work computer enterprising Row finishing impression is molded, and needs the finishing impression equipment for selecting four axles or five-axle linkage to carry out product according to the precision of product and space structure Making.
The advantage of present invention acquirement and good effect are:
1st, this device includes plain film and cylinder, is symmetrical arranged cylinder on the lower surface at the horizontal two ends of plain film, two cylinders Bottom internally interior receipts relatively, interior receipts design is using the potential memory characteristic of macromolecular material and rebound characteristics, purpose Be to increase the snap-in force that cylinder is embedded in the aperture that suture edges are drilled in advance, the device use when, first respectively in distance (bore position is selected according to two ends rectangle or cylinder pitch) at about 3.5 millimeters of skull suture edge pre- with pneumatic drill or bone drill Drill diameter is 2.5 millimeters of two apertures tilted towards skull suture;Then will be embedding to the rectangular cylinder of interior receipts or cylinder difference Enter the aperture being drilled, so as to realize the effect being locally connected;The device serves the Cranial-bone-flap of the reset that is connected, and avoids The problem for affecting nuclear-magnetism to check after being connected using traditional titanium connection sheet and titanium nail.
2nd, the material of the plain film and cylinder of this device is resorbable polymeric materials, then the device is equally applicable to Virgin patient, provides a kind of Cranial-bone-flap replacement and fixation product that can be used for children to neurosurgeon, using easy to operate, and The long-term effect of operative treatment is improve, the use range of the device is expanded.
3rd, the main purpose of the diminution gradual design of apparatus of the present invention is easy for embedded and prevents from slipping, and enhances the device Fixed degree of stability, while the Cranial-bone-flap after fixed will not be subject to the pressure of vertical direction, equally it also avoid intracranial pressure Interim resistance when increasing to brain tissue so that fixed result devoid of risk, if the making material of the device for degradable and The macromolecular material of induced osteogenesis, then be exactly the excellent good product of children's neurosurgery.
4th, the condition of this method injection or finishing impression is carried out in the dust proof workshop of ten thousand grades or hundred grades, to ensure in injection or essence Purity and clean level during carving so that the product of formation meets the technical requirements of embedded type medicine equipment.
5th, using absorbable polymer material by being molded, this resorbable polymeric materials can be this method Polycaprolactone (PCL) polymer gradually forms tunnel and micropore in degradation process in vivo, be easy to osteoblastic grow into, long The Gegenbaur's cell secretion ossein for entering, the carrier bracket of the ossein (type i collagen) of secretion as skeletonization, the calcium ion in body fluid And phosphate radical deposits on type i collagen fiber and assembles and be combined into new bone tissue.The reason for selecting injection is at present both at home and abroad The material shape for meeting implantation human body requirement that can be provided is fine particulate, therefore, is first set according to the making shape need of product Female mold has been counted, injection mo(u)lding has then been carried out at appropriate temperatures.
6th, this method is formed using the macromolecular material finishing impression of nonabsorable, and this non-absorbent macromolecular material can be Ultra-high molecular weight polyethylene (PE) is a kind of novel high molecular polymer, and the external beginning of the nineties at the end of the eighties starts to be applied to face Bed, used as Srgery grafting material, there is light weight, good biocompatibility not to be absorbed, not conducted heat for which, satisfactory mechanical property, art Low repressive afterwards, do not affect CT, MRI to check, and titanium material checks there is different degrees of impact to MRI.Finishing impression is selected to make Reason is that the material shape for meeting implantation human body requirement that country's external enwergy is provided at present is plate-like, accordingly, it would be desirable to first basis Then 3-D graphic is switched to the work computer that three-dimensional data imports carving machine by the making shape need design 3-D graphic of product On carry out finishing impression shaping, need the finishing impression equipment for selecting four axles or five-axle linkage to carry out according to the precision of product and space structure The making of product.
Description of the drawings
Fig. 1 is the structure connection diagram of the present invention.
Specific embodiment
For present disclosure, feature and effect can be further appreciated that, following examples are hereby enumerated, and coordinates accompanying drawing detailed It is described as follows.It should be noted that the present embodiment is descriptive, it is not determinate, it is impossible to thus limit the guarantor of the present invention Shield scope.
A kind of Cranial-bone-flap resets the device that is connected, as shown in figure 1, described device includes plain film 1 and cylinder 2, described flat The material of piece and cylinder is macromolecular material, and the plain film is horizontally disposed, the lower surface at the horizontal two ends of the plain film On be symmetrical arranged cylinder, the bottom of two cylinders is relatively internally interior to receive 4, and the angle of interior receipts is 10-90 degree angle, more excellent Ground, the angle of the interior receipts are 45 degree.
This device includes plain film and cylinder, is symmetrical arranged cylinder on the lower surface at the horizontal two ends of plain film, two cylinders Bottom internally interior receipts relatively, interior receipts design is using the potential memory characteristic of macromolecular material and rebound characteristics, it is therefore an objective to Increase cylinder be embedded in the snap-in force in the aperture that suture edges are drilled in advance, the device use when, first respectively apart from cranium (bore position is selected according to two ends rectangle or cylinder pitch) at about 3.5 millimeters of suture edges with pneumatic drill or bone drill preboring A diameter of 2.5 millimeters of two apertures tilted towards skull suture;Then the rectangular cylinder or cylinder of interior receipts are respectively embedded into The aperture being drilled, so that realize the effect being locally connected;The device serves the Cranial-bone-flap of the reset that is connected, and avoids The problem for affecting nuclear-magnetism to check after being connected using traditional titanium connection sheet and titanium nail.
The material of the plain film and cylinder of this device is resorbable polymeric materials, then the device is equally applicable to children Patient, provides a kind of Cranial-bone-flap replacement and fixation product that can be used for children to neurosurgeon, using easy to operate, and carries The high long-term effect of operative treatment, expands the use range of the device.
In the present embodiment, the plain film is flat cuboid, a length of 3-30 millimeters, a width of 1-15 millimeters, and thickness is 0.1-10 millimeters;The cylinder is rectangular cylinder or cylinder, the diameter and plain film of the width or cylinder of the rectangular cylinder Width consistent, be a diameter of 2-10 millimeters of 1-15 millimeters, rectangular cylinder thickness or cylinder, rectangular cylinder or cylinder Physical length be 2-20 millimeters.
More preferably, a length of 10 millimeters of the cuboid of the plain film, a width of 3 millimeters, thickness is 1 millimeter, 1 millimeter of thickness Certain intensity can be both reached, and had been covered on skull surface and will not also seem that projection was felt, the edge of the plain film had been carried out Slope process, can make flat cuboid be covered in skull surface incisura more small;The width of the rectangular cylinder or The diameter of cylinder is consistent with the width of plain film, is 3 millimeters, a diameter of 2.5 millimeters of rectangular cylinder thickness or cylinder, square The physical length of shape post or cylinder is 5.5 millimeters, and the length is typically smaller than skull thickness 2-3 millimeters, prevents embedded cylinder from dashing forward Broken skull and stimulate Epidural cavity organize.
In the present embodiment, pawl is provided with the interior receipts side of the rectangular cylinder or the surface of cylinder is provided with screw thread 3, there is diminution gradual change at the tip 0.5-3 millimeters of rectangular cylinder or cylinder, gradual change angle is 5-35 degree, and tip diameter is 0.5- 5 millimeters.
More preferably, there is diminution gradual change at 1.5 millimeters of the tip of the rectangular cylinder or cylinder, gradual change angle is 10 degree, Tip diameter is 2 millimeters.
The main purpose of the diminution gradual design of apparatus of the present invention is easy for embedded and prevents from slipping, and enhances the device solid Fixed degree of stability, while the Cranial-bone-flap after fixed will not be subject to the pressure of vertical direction, equally it also avoid intracranial pressure and faces Resistance during Shi Zengjia to brain tissue so that fixed result devoid of risk, if the making material of the device is degradable and lures Lead the macromolecular material of skeletonization, then be exactly the excellent good product of children's neurosurgery.
Reset the be connected preparation method of device of above-mentioned Cranial-bone-flap is:Select a kind of high score for meeting medical embedded requirement Sub- material is formed by injection or finishing impression.The condition for selecting injection or finishing impression is carried out in the dust proof workshop of ten thousand grades or hundred grades, with Ensure the purity and clean level during injection or finishing impression so that the product of formation meets the technology of embedded type medicine equipment Require.
1st, a kind of absorbable polymer material that meet medical embedded requirement is selected by being molded.This absorbable Macromolecular material can be that polycaprolactone (PCL) polymer gradually forms tunnel and micropore in degradation process in vivo, be easy to Gegenbaur's cell, the Gegenbaur's cell secretion ossein for growing into, the carrier bracket of the ossein (type i collagen) of secretion as skeletonization, body Calcium ion and phosphate radical in liquid deposits on type i collagen fiber and assembles and be combined into new bone tissue.The reason for selecting injection exists The material shape for meeting implantation human body requirement provided in current country's external enwergy is fine particulate, therefore, first according to the system of product Female mold is designed as shape need, at temperature 60-85 DEG C, then carries out injection mo(u)lding.
2nd, a kind of macromolecular material finishing impression of the nonabsorable for meeting medical embedded requirement is selected to form.This non-absorbent Macromolecular material can be a kind of novel high molecular polymer for ultra-high molecular weight polyethylene (PE), the external nineties at the end of the eighties Just start to be applied to clinic, used as Srgery grafting material, there is light weight, good biocompatibility not to be absorbed, not conducted heat for which, Satisfactory mechanical property, postoperative low repressive, do not affect CT, MRI to check, and titanium material checks there is different degrees of impact to MRI. The material shape for being implanted into meeting of selecting that finishing impression is that country's external enwergy at present provides the reason for make human body requirement be plate-like, because This, needs first to design 3-D graphic according to the making shape need of product, 3-D graphic is switched to three-dimensional data then and imports essence Finishing impression shaping is carried out in the work computer of carving machine, is needed to select four axles or five-axle linkage according to the precision of product and space structure Finishing impression equipment carry out the making of product.

Claims (10)

1. a kind of Cranial-bone-flap resets the device that is connected, it is characterised in that:Described device includes plain film and cylinder, the plain film and The material of cylinder is macromolecular material, and the plain film is horizontally disposed, right on the lower surface at the horizontal two ends of the plain film Claim to arrange cylinder, the bottom of two cylinders internally interior receipts relatively, the angle of interior receipts are 10-90 degree angle.
2. Cranial-bone-flap according to claim 1 resets the device that is connected, it is characterised in that:The angle of the interior receipts is 45 degree.
3. Cranial-bone-flap according to claim 1 resets the device that is connected, it is characterised in that:The plain film is flat square Body, a length of 3-30 millimeters, a width of 1-15 millimeters, thickness are 0.1-10 millimeters;The cylinder is rectangular cylinder or cylinder, institute The diameter for stating the width or cylinder of rectangular cylinder is consistent with the width of plain film, is 1-15 millimeters, rectangular cylinder thickness or circle The physical length of a diameter of 2-10 millimeters of cylinder, rectangular cylinder or cylinder is 2-20 millimeters.
4. Cranial-bone-flap according to claim 3 resets the device that is connected, it is characterised in that:The cuboid of the plain film A length of 10 millimeters, a width of 3 millimeters, thickness is 1 millimeter, and the edge of the plain film has been carried out slope process, can be made flat The incisura that cuboid is covered in skull surface is more small;The diameter of the width or cylinder of the rectangular cylinder and the width of plain film Unanimously, 3 millimeters are, and a diameter of 2.5 millimeters of rectangular cylinder thickness or cylinder, the physical length of rectangular column or cylinder is 5.5 millimeters, the length is typically smaller than skull thickness 2-3 millimeters.
5. Cranial-bone-flap according to any one of Claims 1-4 resets the device that is connected, it is characterised in that:The rectangle The surface for being provided with pawl or cylinder on the interior receipts side of cylinder is provided with the tip 0.5-3 of screw thread, rectangular cylinder or cylinder There is diminution gradual change at millimeter, gradual change angle is 5-35 degree, and tip diameter is 0.5-5 millimeters.
6. Cranial-bone-flap according to claim 5 resets the device that is connected, it is characterised in that:The rectangular cylinder or cylinder There is diminution gradual change at 1.5 millimeters of the tip of body, gradual change angle is 10 degree, and tip diameter is 2 millimeters.
7. a kind of Cranial-bone-flap as described in any one of claim 1 to 6 resets the preparation method of device of being connected, and its feature exists In:Step is as follows:
A kind of macromolecular material for meeting medical embedded requirement is selected to form by injection or finishing impression.Select the bar of injection or finishing impression Part is carried out in the dust proof workshop of ten thousand grades or hundred grades.
8. Cranial-bone-flap according to claim 7 resets the preparation method of device of being connected, it is characterised in that:The high score Sub- material is absorbable polymer material or is non-absorbent macromolecular material.
9. Cranial-bone-flap according to claim 8 resets the preparation method of device of being connected, it is characterised in that:Described inhale Receipts macromolecular material is polycaprolactone polymer;When making, female is designed according to the making shape need of device first Tool, then carries out injection mo(u)lding at temperature 60-85 DEG C.
10. Cranial-bone-flap according to claim 8 resets the preparation method of device of being connected, it is characterised in that:Described not The macromolecular material of absorption is ultra-high molecular weight polyethylene;When making, need first to be designed according to the making shape need of device 3-D graphic, carries out finishing impression shaping in the work computer that then 3-D graphic is switched to three-dimensional data importing carving machine, according to product The precision of product and space structure need the finishing impression equipment for selecting four axles or five-axle linkage to carry out the making of product.
CN201611137923.7A 2016-12-12 2016-12-12 A kind of Cranial-bone-flap resets the device and preparation method thereof that is connected Pending CN106491197A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109953807A (en) * 2019-04-04 2019-07-02 中国人民解放军北部战区总医院 One kind can one-way expansion skull fixator

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5246443A (en) * 1990-10-30 1993-09-21 Christian Mai Clip and osteosynthesis plate with dynamic compression and self-retention
US5779707A (en) * 1992-11-13 1998-07-14 Bertholet; Maurice Link piece for bony elements
CN2458994Y (en) * 2000-12-25 2001-11-14 天津市和平区蛇鹰记忆合金研制中心 Nickel-titanium shape memory alloy bone screw
CN101360461A (en) * 2006-01-17 2009-02-04 生物动力有限责任公司 Craniotomy closures and plugs
US20090062800A1 (en) * 2006-02-11 2009-03-05 Majid Shano Clip-Like Implant for Osteosynthesis
US20100094428A1 (en) * 2008-10-10 2010-04-15 Ralph James D Craniotomy Closure Systems
CN103393486A (en) * 2013-08-13 2013-11-20 华中科技大学同济医学院附属同济医院 Method for preparing to-be-repaired skull flap by 3D printing
CN104546098A (en) * 2013-10-10 2015-04-29 卢明 Autonomous skull repairing material fixing device
CN206964669U (en) * 2016-12-12 2018-02-06 胡晓予 A kind of Cranial-bone-flap resets the device that is connected

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5246443A (en) * 1990-10-30 1993-09-21 Christian Mai Clip and osteosynthesis plate with dynamic compression and self-retention
US5779707A (en) * 1992-11-13 1998-07-14 Bertholet; Maurice Link piece for bony elements
CN2458994Y (en) * 2000-12-25 2001-11-14 天津市和平区蛇鹰记忆合金研制中心 Nickel-titanium shape memory alloy bone screw
CN101360461A (en) * 2006-01-17 2009-02-04 生物动力有限责任公司 Craniotomy closures and plugs
US20090062800A1 (en) * 2006-02-11 2009-03-05 Majid Shano Clip-Like Implant for Osteosynthesis
US20100094428A1 (en) * 2008-10-10 2010-04-15 Ralph James D Craniotomy Closure Systems
CN103393486A (en) * 2013-08-13 2013-11-20 华中科技大学同济医学院附属同济医院 Method for preparing to-be-repaired skull flap by 3D printing
CN104546098A (en) * 2013-10-10 2015-04-29 卢明 Autonomous skull repairing material fixing device
CN206964669U (en) * 2016-12-12 2018-02-06 胡晓予 A kind of Cranial-bone-flap resets the device that is connected

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109953807A (en) * 2019-04-04 2019-07-02 中国人民解放军北部战区总医院 One kind can one-way expansion skull fixator

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Application publication date: 20170315