CN114404112B - Integrally formed skull and temporo-muscular filling prosthesis and preparation method thereof - Google Patents

Integrally formed skull and temporo-muscular filling prosthesis and preparation method thereof Download PDF

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Publication number
CN114404112B
CN114404112B CN202210095064.9A CN202210095064A CN114404112B CN 114404112 B CN114404112 B CN 114404112B CN 202210095064 A CN202210095064 A CN 202210095064A CN 114404112 B CN114404112 B CN 114404112B
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China
Prior art keywords
skull
temporo
muscular
patient
defect
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CN114404112A (en
Inventor
关俊文
杨靖国
袁轶恺
余杭
孙彤
杨笑语
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West China Hospital of Sichuan University
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West China Hospital of Sichuan University
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2/2875Skull or cranium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]

Abstract

The invention belongs to the technical field of medical equipment, and particularly relates to an integrally formed skull and temporo-muscular filling prosthesis and a preparation method thereof. The skull and temporo-muscular filling prosthesis is made of polyether-ether-ketone as a material by adopting an integrated molding method according to the shape and the size of the missing parts of the skull and the temporo-muscular of a patient. The skull and temporo-muscular filling prosthesis can completely fill the head defect part by only one implantation operation, solves the problem that the patient needs to fill temporo-muscular again after the skull is repaired, can effectively reduce the pain of the patient caused by temporo-muscular atrophy after the skull is repaired, can reduce the risk caused by secondary temporo-muscular filling, and has good application prospect.

Description

Integrally formed skull and temporo-muscular filling prosthesis and preparation method thereof
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to an integrally formed skull and temporo-muscular filling prosthesis and a preparation method thereof.
Background
In patients with skull defects, the forehead, the arch outline and the temporal vertex area of the skull defects account for more than 70 percent. In such craniocerebral injury procedures, it is often necessary to isolate or resect the temporal muscle, resulting in post-operative temporal muscle atrophy or defects and temporal depression. Atrophy or defect of temporal muscle can seriously affect the appearance of the patient and affect the psychological quality of the patient.
Because of the differences in the size and location of the temporo-muscular site that is isolated or resected by different patients during surgery, there is no technique in the prior art that can be readily mass-produced for temporo-muscular implants. In addition, the filling of the temporal muscle also needs to consider the problems of firm combination of the filling material with surrounding tissues such as skull, whether the physical properties after filling can be maintained, whether the filling material has good biocompatibility and the like. Meanwhile, neurosurgeons usually pay attention to the prognosis of the function only and neglect the appearance after operation in the skull repair, so that in the prior art, the problem of atrophy or defect of temporal muscles of patients is not treated when the doctor performs operation on the patients with the skull defects.
Current solutions are directed to implant filling surgery in a patient's own home care professional plastic hospital. The existing cosmetic technique requires the implantation of a filler, which is not known whether it affects brain tissue through gaps and holes of repair material, which brings complication risk and huge economic burden to the patient. Brogan Cynthia M. (US Patent, US 20120259428) discloses a soft tissue filler for temporal fossa filling. But the irritation of the filler to the skin may increase the risk of infection, the abrasion of the bone flap caused by the friction of the filler to the bone flap, the change of the filler itself with time or the external temperature, etc., may affect the life quality of the patient.
It can be seen that in the operation of existing skull defect patients, only functional repair of the skull is generally considered. The filler for temporal area filling is difficult to prepare, the material selection difficulty is high, the technical operation is difficult, and the like, so that the prior operation is difficult to recover the appearance of a postoperative patient. If the patient wishes to correct the temporal depression to restore the appearance, a secondary plastic surgery is required, with additional financial burden and complications risks.
Disclosure of Invention
The invention aims to solve the problems of the prior art and provides a filling prosthesis capable of filling the defect skull and temporal muscle simultaneously.
The utility model provides an integrated skull and temporo muscle filling prosthesis, which is made by using polyether-ether-ketone as material and adopting an integrated molding method according to the shape and the size of the missing parts of the skull and the temporo muscle of a patient.
Preferably, the method of the integrated molding processing is 3D printing.
The invention also provides a preparation method of the skull and temporal muscle filling prosthesis, which comprises the following steps:
step 1, performing head CT thin-layer scanning on a patient to obtain a head three-dimensional image of the patient;
step 2, comparing the defect side and the healthy side of the head three-dimensional image in the step 1, and constructing to obtain three-dimensional images of skull defect, temporo-muscular defect and temporo-muscular atrophy parts;
and 3, integrally molding the three-dimensional image obtained in the step 3 by taking polyether-ether-ketone as a material to obtain the skull and temporo-muscular filling prosthesis.
Preferably, the method of the integrated molding processing is 3D printing.
The invention also provides application of the polyether-ether-ketone material in preparing the integrally formed skull and temporo-muscular filling prosthesis.
The invention also provides the use of the polyetheretherketone material for simultaneously filling the cranium and temporal muscle defects.
The invention combines the design of the three-dimensional image and the integrally formed manufacturing process (such as 3D printing), selects the polyether-ether-ketone with proper performance, provides a new design and manufacturing scheme for the integrated filling prosthesis of the skull and the temporo-muscular, and greatly simplifies the difficulty of repairing the temporo-muscular defect in the operation. Therefore, the skull and temporal muscle filling prosthesis provided by the invention can fill the missing (or atrophic) skull and temporal muscle of a patient at the same time in one operation. The problem that the patient needs to fill the temporal muscles again after filling the skull is solved, the pain of the patient can be effectively reduced, and the risk brought by filling the temporal muscles is reduced.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.
Drawings
FIG. 1 is a schematic illustration of the structure of the cranial and temporal muscle filling prosthesis of example 1 and its combination with a head defect site of a patient;
FIG. 2 is a three-dimensional image construction process of a patient's skull defect, temporo-muscular defect and temporo-muscular atrophy site in example 1;
fig. 3 is a graph comparing the patient of example 1 before and after implantation of the cranial and temporal muscle filling prosthesis.
Detailed Description
Example 1
The embodiment provides an integrally formed skull and temporo-muscular filling prosthesis, which is manufactured by taking polyether ether ketone (PEEK) as a material and adopting an integrally forming method according to the shape and the size of the missing parts of the skull and the temporo-muscular of a patient. The parameters such as molecular weight of the polyether-ether-ketone can be determined according to the existing medical polyether-ether-ketone material, and commercial polyether-ether-ketone (L3W 5-S1T1, L7W7-S1T1, L7W10-S1T1, L9W12-S1T1 or L16W15-S4T 4) purchased by Shenzhen Mich-Mei-p regeneration medical science and technology Co., ltd.
The structure of the cranial and temporal muscle filling prosthesis of this embodiment and its combination with the head defect site of the patient are schematically shown in fig. 1. Wherein 1 is three-dimensional modeling of healthy side temporal muscles; 2. 3, simulating side and front views of the temporal muscle according to the healthy side temporal muscle by mirroring the three-dimensional modeling skull defect area; 4, three-dimensional modeling imaging of unrepaired skull; 5 is a mirror image bone and mirror image temporal muscle integrated filling prosthesis; 6 is a three-dimensional imaging of a repair material comprising a temporal spatial structure; 7 is temporal muscle spatial location filling design.
The preparation method of the skull and temporal muscle filling prosthesis comprises the following steps:
step 1, performing head CT thin-layer scanning on a patient to obtain a head three-dimensional image of the patient;
step 2, comparing the defect side and the healthy side of the three-dimensional image of the head in step 1, and constructing to obtain three-dimensional images of the skull defect, the temporo-muscular defect and the temporo-muscular atrophy part, wherein fig. 2 is a three-dimensional image constructing process of the skull defect, the temporo-muscular defect and the temporo-muscular atrophy part of a patient, and (a) is a patient head CT imaging. The red line is the filling design of the skull defect, and the green line is the design of the temporo-muscular defect. (B) To create a patched three-dimensional image of the healthy lateral skull symmetric to the temporal muscle. Green is healthy side temporal muscle, brown is bony structure to be repaired, and blue is temporal muscle to be repaired. (C) Three-dimensional imaging is designed for repair taking temporal muscle structure into account.
And 3, integrally molding the three-dimensional image obtained in the step 3 by taking polyether-ether-ketone as a material to obtain the skull and temporo-muscular filling prosthesis. The method of the integrated forming processing is 3D printing.
After the skull and temporal muscle filling prosthesis is prepared, the operation of implanting the prosthesis into the head defect part mainly comprises the following steps: (1) sterilizing and spreading towel; (2) cutting the scalp according to the original incision; (3) separating the scalp from the dura mater along the subaponeurosis gap, exposing the dura mater and muscles; (4) careful isolation of temporal muscles, adjustment of temporal muscles according to the experience of the operator; (5) fully exposing the edge of the bone window; (6) embedding PEEK material into the bone window of the defect; (7) fixing PEEK material; (8) placing the drainage tube and suturing the scalp.
Fig. 3 is a graph comparing the anterior and posterior aspects of a patient with the cranial and temporal muscle filling prosthesis according to this embodiment.
According to the embodiment, the skull and temporal muscle filling prosthesis can completely fill the head defect part by only one implantation operation, the head appearance of a patient is bilaterally symmetrical, and the temporal area depression caused by temporal muscle deficiency does not occur. The problem that the patient needs to fill the temporal region again after repairing the skull is solved, the risk brought by secondary operation filling of the temporal region is avoided, the pain of the patient body and mind caused by appearance defects can be effectively reduced, and the method has good application prospect.

Claims (3)

1. An integrally formed cranial and temporal muscle filling prosthesis, characterized in that: the skull and temporal muscle filling prosthesis is made of polyether-ether-ketone as a material by adopting an integrated molding processing method according to the shape and the size of the missing parts of the skull and temporal muscle of a patient, and can fill the missing or atrophic skull and temporal muscle of the patient in one operation; the integrated forming processing method is 3D printing;
the skull and temporal muscle filling prosthesis is prepared according to the following steps:
step 1, performing head CT thin-layer scanning on a patient to obtain a head three-dimensional image of the patient;
step 2, comparing the defect side and the healthy side of the head three-dimensional image in the step 1, and constructing to obtain three-dimensional images of skull defect, temporo-muscular defect and temporo-muscular atrophy parts;
step 3, using polyether-ether-ketone as a material, and performing integrated molding processing according to the three-dimensional image obtained in the step 3 to obtain a skull and temporo-muscular filling prosthesis; the method of the integrated forming processing is 3D printing.
2. A method of preparing a cranial and temporal muscle filling prosthesis according to claim 1, comprising the steps of:
step 1, performing head CT thin-layer scanning on a patient to obtain a head three-dimensional image of the patient;
step 2, comparing the defect side and the healthy side of the head three-dimensional image in the step 1, and constructing to obtain three-dimensional images of skull defect, temporo-muscular defect and temporo-muscular atrophy parts;
step 3, using polyether-ether-ketone as a material, and performing integrated molding processing according to the three-dimensional image obtained in the step 3 to obtain a skull and temporo-muscular filling prosthesis; the method of the integrated forming processing is 3D printing.
3. Use of a polyetheretherketone material for the preparation of an integrally formed cranium and temporo-muscular filling prosthesis according to claim 1.
CN202210095064.9A 2022-01-26 2022-01-26 Integrally formed skull and temporo-muscular filling prosthesis and preparation method thereof Active CN114404112B (en)

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CN103919631A (en) * 2014-04-28 2014-07-16 四川大学 Manufacturing method for jaw defect individual restoration
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CN101019785A (en) * 2007-03-06 2007-08-22 赵亚群 Skull patch and its prepn process
CN103784218A (en) * 2014-01-27 2014-05-14 步星耀 Craniocerebral three-dimensional forming restoration with muscle base window and preparation method thereof
CN103919631A (en) * 2014-04-28 2014-07-16 四川大学 Manufacturing method for jaw defect individual restoration
CN103908358A (en) * 2014-05-03 2014-07-09 王学建 Method for manufacturing artificial skull restoration prosthesis
CN103932823A (en) * 2014-05-03 2014-07-23 王学建 Manufacturing method for artificial skull repair prosthesis
CN107890383A (en) * 2017-12-12 2018-04-10 上海伍健医疗器械有限公司 Temporomandibular joint separates cap and its fixing means
CN108294847A (en) * 2018-01-23 2018-07-20 广州迈普再生医学科技有限公司 A kind of production method of skull repairing prosthese
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