CN108852484B - 3D printing skull bone flap-removing decompression postoperative bone window protection device and preparation method - Google Patents
3D printing skull bone flap-removing decompression postoperative bone window protection device and preparation method Download PDFInfo
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- CN108852484B CN108852484B CN201810247440.5A CN201810247440A CN108852484B CN 108852484 B CN108852484 B CN 108852484B CN 201810247440 A CN201810247440 A CN 201810247440A CN 108852484 B CN108852484 B CN 108852484B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
Abstract
The invention discloses a 3D printing skull bone flap-removing decompression postoperative bone window protection device and a preparation method, which solve the problems of poor adhesion between the bone window protection device and the scalp, easy movement, unbalanced stress distribution, inconvenient wearing and the like in the prior art, have exact, safe and good adaptability to the body surface morphological structure of a patient, and have the advantages of convenience in wearing, good adhesion, uniform stress, high comfort, good stability, attractiveness, economy, environmental protection and the like; the technical scheme is as follows: the device comprises a protection plate and a fixing device, wherein the protection plate comprises an outer surface layer and an inner core layer which are formed by 3D printing, and the inner core layer is arranged inside the outer surface layer; the shape of the outer surface layer is matched with the bone window area, and the outer side surface of the outer surface layer is provided with a fixing device for stabilizing the bone window protection plate; thickening the edge of the outer surface layer; the outer surface layer and the inner core layer are both provided with a plurality of vent holes, and the inner core layer is additionally provided with a plurality of small holes so as to strengthen the combination between the inner core layer and the outer surface layer.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a 3D printing skull bone flap-removing and decompression postoperative bone window protection device and a preparation method thereof.
Background
Skull flap-removing decompression is one of the common operation modes of neurosurgery, and is mainly applied to patients with severe craniocerebral trauma, cerebral hemorrhage and cerebral hernia or infarction after cerebral artery occlusion and the like. A large bone window remains after surgery, while the early bone window for decompression becomes the cause of secondary brain damage to the later stages. If not protected, this can have a number of undesirable effects: the intracranial pressure is difficult to maintain stably, the brain tissue in the range of the bone window can be directly injured by external force, the brain tissue loses external support and is damaged due to position change or cough and frequent displacement during breath holding, the cerebrospinal fluid circulatory disturbance is secondary effusion and hydrocephalus, the brain tissue is hernial and is damaged by clamping pressure, and the venous blood reflux disturbance caused by the clamping pressure of veins on the surface of the brain aggravates the brain swelling. The expanded brain tissue brings troubles to cranioplasty, and sometimes the ventricular puncture is needed to release cerebrospinal fluid to promote the brain tissue to reset in the operation, and sometimes even the necrotic and softened brain tissue of the part of the dura mater resection needs to be opened, so that the wound is increased, the operation time is prolonged, and the operation risk is increased.
In addition, the condition of some patients in the state of low intracranial pressure for a long time is aggravated due to the fact that intracranial pressure quickly rises after skull repair, and especially, the skull repair is carried out by taking volume reduction measures in the preoperative cerebral bulge obvious operation. And the hydrocephalus shunt operation is implemented in advance or during cranioplasty on the patients with part of the hydrocephalus after the bone flap removing and pressure reducing operation, and the hydrocephalus shunt operation can be automatically relieved and is not needed after the cranioplasty on the patients with the part of the patients after the cranioplasty, so that the operation risk and the economic burden are increased. If the patient wears the protective devices such as the bone window protective plate and the like in the early stage, the hydrocephalus shunt operation can be avoided when the hydrocephalus happens, and the intracranial pressure adjusting rebalance period after the cranioplasty is smoothly spent by the patient receiving the cranioplasty is facilitated.
The bone window has a large influence on the appearance, which is particularly significant for the patients with restored consciousness to further restore, and a part of patients possibly need a protective measure ideal for the appearance correction effect for a long time due to reasons or even no longer carry out cranioplasty for the whole life, and wearing a proper bone window protective device is a practical and effective choice. In a word, the skull bone window protection device has important significance for the intracranial pressure reduction after the bone flap reduction operation to the normal state, before the skull repairing operation and after the skull repairing operation.
The existing head bone window protection device has the defects of poor application property with local scalp, poor stability, easy movement, large external force for fixation, unbalanced stress distribution, difficult tolerance and even damage to the local scalp, so the safety and the reliability are poor; in addition, some pressure measurement and control devices and helmet-shaped skull bone window protection devices have the defects of high manufacturing cost, complex operation, inconvenient wearing, complex maintenance, large appearance influence and the like, and are poor in practicability. The tension change of the skull bone window is the result of the comprehensive effect of the intracranial pressure change and the self mechanical tension of the scalp, muscle, dura mater and other soft tissues at the bone window. The intracranial pressure has established new balance gradually after removing the bone flap decompression, if not the intracranial new pathological change or the bone window suddenly receives external force, position sudden change, respiration that epilepsy leads to suppresses intracranial venous return stasis or acute cough etc. lead to the brain swing usually can not have the obvious change of intracranial pressure without accident, with the bone window edge, the head shape pastes the protective plate that applies well and is in fact the best pressure balancing unit that accords with normal skull protection effect, can effectively avoid the brain to shift and keep intracranial pressure steady, so these take the protective device structure of pressure observing and controlling complicated manufacturing cost high, use inconvenient, unreliable so the practicality is not high. These protective devices have resulted in little clinical practice due to the above drawbacks.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides a 3D printing skull bone flap-removing and decompression postoperative bone window protection device and a preparation method thereof, which have good adaptability with the body surface morphological structure of a patient, and have the advantages of good application property, uniform stress, high comfort, good stability and the like during wearing.
The invention adopts the following technical scheme:
A3D printing skull bone flap-removing decompression postoperative bone window protection device comprises a protection plate and a fixing device, wherein the protection plate comprises an outer surface layer and an inner core layer which are formed through 3D printing, and the outer surface layer is provided with an inner side surface and an outer side surface; the inner core layer is arranged inside the outer surface layer; the shape of the outer surface layer is matched with the bone window area, and the outer side surface of the outer surface layer is provided with a fixing device for stabilizing the bone window; the edge of the outer surface layer is thickened so as to improve the comfort when the garment is worn; the outer surface layer and the inner core layer are both provided with a plurality of vent holes, and the inner core layer is additionally provided with a plurality of small holes, so that the air permeability can be increased, and the combination firmness between different layers of the protection plate can be increased.
Furthermore, the inner core layer is a high-strength core layer and is made of metal or high-strength synthetic materials, and the inner core layer plays a supporting role.
Further, the thickness range of the inner core layer is 0.5 mm-1.5 mm.
Further, the outer surface layer is made of a soft material, such as silica gel, plastic, etc.
Furthermore, the thickness range of the inner side surface of the outer surface layer is 0.5 mm-1.5 mm.
Furthermore, the edge of the outer surface layer exceeds the edge of the bone window by 2-3 cm.
Further, the adaptive trim is applied when approaching the protruding structure.
Furthermore, the outer surface of the outer surface layer is provided with a plurality of fixing holes, and fixing devices penetrate through the fixing holes.
Further, the fixing device is an elastic bandage or an elastic cap.
A preparation method of a 3D printing skull bone flap-removing decompression postoperative bone window protection device comprises the following steps:
step (1), performing CT-3D scanning reconstruction on the skull of a patient after a bone flap removing and decompression operation, and collecting 3D scanning information;
performing left and right mirror image processing according to the body surface data information of the body window range and the edge of the operating side corresponding to the healthy side to obtain the data information of the anatomical features of the body surface of the body window range and the edge of the operating side;
and (3) manufacturing a protection device covering the range of the bone window by adopting a 3D printing technology according to the data information.
Compared with the prior art, the invention has the beneficial effects that:
(1) according to the bone window protection plate manufactured by the 3D printing technology according to the CT scan data of the skull of the patient, the manufacturing shape is derived from the skull scan data of the patient, and the protection plate can be accurately matched with the anatomy of the bone window region, so that the protection plate is tightly and properly attached to the body surface structure of the wearing region, and is uniform, stable and safe in stress during wearing;
(2) the outer surface layer of the skull bone window protective device is made of softer and tough materials such as silica gel and has sufficient air holes, so that the comfort level and the tolerance of the skull bone window protective device are obviously improved compared with other skull bone window protective devices;
(3) as most of the current comprehensive hospitals with more than two hundred and twenty meters all have craniocerebral 3D scanning conditions, when a patient needs to review craniocerebral CT examination, the patient only needs to scan in a line, and does not need special examination; with the increasing maturity and popularization of the 3D printing technology, the possible technical requirements are easy to solve;
(4) the protective plate, the elastic bandage for fixing the protective plate, the elastic cap and the like can be cleaned and reused, and the maintenance is easy; the protective plate has the characteristics of simple treatment flow, low manufacturing cost, less used consumables, environmental protection, simple maintenance, long service life, good effect and the like.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the application and, together with the description, serve to explain the application and are not intended to limit the application.
FIG. 1 is a schematic cross-sectional view of the present invention;
FIG. 2 is a schematic structural view of the present invention;
FIG. 3 is an example of a 3D image reconstructed after a CT scan of a patient's skull;
wherein, 1-outer surface layer, 2-inner core layer, 3-vent hole, 4-fixing hole.
Detailed Description
It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
As introduced by the background art, the defects of poor adhesion between the bone window protection device and the scalp, easiness in movement, unbalanced stress distribution, inconvenience in wearing and the like exist in the prior art, and in order to solve the technical problems, the application provides the bone window protection device after the skull bone flap removing and pressure reducing operation through 3D printing and the preparation method.
In an exemplary embodiment of the present application, as shown in fig. 1-2, a 3D printed bone window protection device after a skull flap-removing decompression operation is provided, which is a body surface protection plate conforming to a patient and manufactured by 3D printing technology according to the imaging examination data of the patient.
The protection shield covers patient's bone window scope, for individualized customized irregular arc, and it has good suitability, when wearing with body surface morphological structure and applies the nature good, the even comfort level of atress is high, stability is good.
The protective plate comprises an outer surface layer 1 and an inner core layer 2, and the inner core layer 2 is arranged inside the outer surface layer 1; the outer surface layer 1 is divided into an inner side surface which is contacted with the scalp of a human body and an outer side surface which is exposed outside, and the wearing is realized by the joint of the inner side surface of the outer surface layer 1 and the edge position of a bone window; when the external bone-setting mask is worn, the internal core layer 2 and the external surface layer 1 which cross the bone window extend outwards for a certain range.
The edge of the outer surface layer 1 extends 2-3 cm beyond the edge of the bone window, so that the outer surface layer is conveniently and stably attached to the scalp; if the device is close to the protruding structures such as ears, proper avoidance, shearing and modification are carried out.
The outer surface layer 1 is made of soft materials which are well pasted with the scalp and have good hand feeling, such as silica gel, plastic and other materials; the thickness of the inner side surface of the outer surface layer 1 is 1 +/-0.5 mm, and the soft material of the part, which is contacted with the edges and the scalp of the bone window, of the outer surface layer is thickened and extended to improve the wearing comfort.
The inner core layer 2 is a high-strength core layer and can be made of metal or high-strength synthetic materials; the inner core layer 2 plays a supporting role; the thickness is in the range of 1 + -0.5 mm.
The whole thickness of protection shield is about 3 ~ 4 mm.
The outer surface layer 2 and the inner core layer 2 are both provided with a plurality of vent holes 3, so that the air permeability can be improved, and the bonding firmness between different layers can be improved.
The outer surface of the outer surface layer 1 is provided with a plurality of fixing holes 4, the specific number of the fixing holes 4 is determined according to the range of a patient bone window, and the requirement that the protection plate can be stably fixed is met.
The fixing hole 4 is an arched flat hole with the height of about 3mm formed by the protrusion of the outer side surface of the outer surface layer and used for a strip-shaped fixing device to pass through; the arrangement position and the direction of the arched flat hole are determined according to the actual wearing mode.
The fixing device is an elastic bandage, an elastic cap or other elastic components, the elastic bandage or the elastic cap penetrates through the fixing hole 4 to surround the head or be fixed at the chin or other positions which do not affect the normal life of the patient, and the wearing stability of the protective plate is improved.
The exposed portion of the protective plate may be further modified in appearance by decoration, such as by coloring the skin or hair at the location of the head.
The preparation method of the protective plate comprises the following steps:
the method comprises the following steps:
step (1) performing CT-3D scanning reconstruction on the skull of a patient after a bone flap removing and decompression operation by adopting the conventional CT equipment, and collecting 3D scanning information;
the 3D image reconstructed after CT scan of the patient's skull is shown in FIG. 3, where part A represents a left lateral view of the skull CT-3D skull external surface imaging, which accurately shows details of the bone window; the range of the arc arrow at the top of the skull represents the approximate anteroposterior range of the bone window; part B shows a left side view of the skull CT-3D body surface imaging, and the arc arrow range in the figure shows the approximate anterior-posterior range of the body surface corresponding to the bone window; part C shows a right lateral view of skull CT-3D skull external surface imaging, and the arc arrow range in the figure shows the approximate anteroposterior range of the healthy side (non-operation side) and the operation side bone window; the part D shows the right side view of the skull CT-3D body surface imaging, and the arc arrow range in the figure shows the approximate anteroposterior range of the body surface corresponding to the bone window on the healthy side (non-operation side) and the operation side.
Step (2) performing left and right mirror image processing according to CT scanning body surface data information of a bone window range and an edge of a side of health corresponding to an operation to obtain data information of anatomical features of the bone window range and the edge body surface of the side of the operation;
and (3) preparing the inner core layer 2 and the outer surface layer 1 by adopting a 3D printing technology according to the data information obtained after the mirror image processing, thereby manufacturing the body surface protection plate covering the range of the bone window.
This application is according to the bone window protection shield of patient's skull CT scan data through the preparation of 3D printing technique, because the preparation shape derives from patient self skull scanning data, the protection shield can match with bone window regional dissection more accurately, consequently the protection shield with wear regional body surface structure laminating closely, properly, the atress is even and stable, so the exact and safety of acting on.
The outer surface layer 1 is made of soft and tough materials such as silica gel and is provided with sufficient air holes 3, so that the comfort level and the tolerance of the protective plate are obviously improved compared with other skull bone window protective devices.
At present, most of the more than two-second comprehensive hospitals have craniocerebral 3D scanning conditions, and when a patient needs to review craniocerebral CT examination, the patient only needs to scan in a line mode without special examination. And with the increasing maturity and popularization of 3D printing technology, the technical requirements which may exist are easier to solve.
The protective plate, the elastic bandage for fixing the protective plate, the elastic cap and the like can be cleaned and reused, and the maintenance is easy; the protective plate has the characteristics of simple treatment flow, low manufacturing cost, less used consumables, simple maintenance, long service life, good effect and the like.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims (8)
1. A3D printing skull bone flap-removing decompression postoperative bone window protection device is characterized in that the device is applied to a skull repair preoperative after intracranial pressure is reduced to normal after a flap-removing decompression operation, and comprises a protection plate and a fixing device, wherein the protection plate comprises an outer surface layer and an inner core layer which are formed through 3D printing, and the inner core layer is arranged inside the outer surface layer; the shape of the outer surface layer is matched with the bone window area, and the outer side surface of the outer surface layer is provided with a fixing device for stabilizing the bone window protection plate; thickening the edge of the outer surface layer; the outer surface layer and the inner core layer are both provided with a plurality of vent holes, and the inner core layer is additionally provided with a plurality of small holes so as to strengthen the combination between the inner core layer and the outer surface layer; the outer surface layer comprises an inner side surface and an outer side surface, the inner side surface can be contacted with the scalp of a human body, the outer side surface is exposed outside, and the wearing is realized by the joint of the inner side surface of the outer surface layer and the edge position of the bone window; when the bone window is worn, the inner core layer and the outer surface layer which span the bone window extend outwards to a set range;
the edge of the outer surface layer exceeds the edge of the bone window by 2-3 cm; the outer surface of the outer surface layer is provided with a plurality of fixing holes, and fixing devices penetrate through the fixing holes.
2. The post-3D printed skull flap-removing and decompression bone window protection device according to claim 1, wherein the inner core layer is a high-strength core layer and is made of metal or a high-strength synthetic material.
3. The post-surgical bone window protection device for 3D printing of the skull bone flap reduction according to claim 2, wherein the thickness of the inner core layer ranges from 0.5mm to 1.5 mm.
4. The post-surgical bone window protection device for 3D printing of a skull flap-reducing surgery according to claim 1, wherein the outer surface layer is made of a soft material.
5. The post-surgical bone window protection device for 3D printing of the skull bone flap reduction according to claim 4, wherein the thickness of the inner side surface of the outer surface layer ranges from 0.5mm to 1.5 mm.
6. The post-3D printed skull flap-removing decompression bone window protection device according to claim 1, wherein an adaptive trim is made near the protruding structure.
7. The 3D printing post-skull flap-removing decompression post-operative bone window protection device according to claim 1, wherein the fixing device is an elastic bandage or an elastic cap.
8. A method of manufacturing a device according to any one of claims 1 to 7, comprising the steps of:
step (1), performing CT-3D scanning reconstruction on the skull of a patient after a bone flap removing and decompression operation, and collecting 3D scanning information;
performing left and right mirror image processing according to the body surface data information of the body window range and the edge of the operating side corresponding to the healthy side to obtain the data information of the anatomical features of the body surface of the body window range and the edge of the operating side;
and (3) manufacturing a protection device covering the range of the bone window by adopting a 3D printing technology according to the data information.
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| CN201810247440.5A CN108852484B (en) | 2018-03-23 | 2018-03-23 | 3D printing skull bone flap-removing decompression postoperative bone window protection device and preparation method |
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| CN109480981B (en) * | 2018-12-25 | 2021-06-15 | 朱成伟 | Skull breaking and repairing device suitable for neurosurgery clinic |
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| CN108852484A (en) | 2018-11-23 |
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