A fixed guide drainage device for intracranial hemorrhage in infants and young children and its preparation and use method

Abstract

The present invention discloses a fixed guided drainage device for intracranial hemorrhage in infants and young children and a preparation and use method thereof. The main body is a shell with the same shape as the head of the child, and the shell is installed on a fine-tuning device, which is placed flat on the child's bed. The device of the present invention improves the accuracy of puncture, overcomes the technical defects that blind puncture cannot puncture in place and repeated puncture will increase brain damage in the child, and the guide plate designed for three-dimensional positioning using the CT data of the child can perfectly avoid more important brain functional areas and structures according to the doctor's requirements, and perfectly guides the puncture needle to the drainage site according to the angle of the guide needle channel; the fixed shell and adjustable position fixer designed based on the CT data of the child can fix the child's head very well into the shell, and by adjusting the angle of the position fixer, the patient's body position is maintained at the ideal drainage position designed by the doctor, avoiding the drainage tube from falling out and the position being unfixed due to the patient's unconscious activities.

Description

Technical Field

[0001] The invention relates to a fixed guiding drainage device for intracranial hemorrhage in infants and young children and a preparation and use method thereof, belonging to the technical field of medical equipment. Background Art

[0002] When infants and young children have intracerebral hemorrhage or ventricular system hemorrhage, the use of minimally invasive extracorporeal puncture to drain the bleeding to the outside of the body is a common clinical method. In actual clinical work, doctors will refer to the CT images of the child, mark the puncture points on the skin outside the body according to experience, and puncture the drainage tube to the bleeding site for drainage. This surgical method is a blind puncture based on the doctor's experience and CT images during the actual puncture, which is uncontrollable in terms of puncture angle and depth, resulting in poor drainage effect or failure. Because the child is unconscious or unable to cooperate with the treatment, it may also cause problems such as the drainage tube not being firmly fixed and falling off. Summary of the invention

[0003] The technical problem to be solved by the present invention is to address the deficiencies in the prior art and to provide a fixed guided drainage device for intracranial hemorrhage in infants and young children and a preparation and use method, thereby solving the problems of low puncture accuracy for cerebral hemorrhage in children, inaccurate surface positioning, and puncture failure and drainage tube falling off caused by the child's lack of cooperation.

[0004] In order to achieve the above purpose, the present invention adopts the following technical solution (the description of the directions "left, right, front, and back" in the present invention refers to our left, right, top of the head, and jaw direction when looking straight ahead and facing the device):

[0005] One of the purposes of the present invention is to provide a method for preparing a fixed guiding drainage device for intracranial hemorrhage in infants and young children, comprising the following steps:

[0006] (1) Scanning and modeling: The patient with cerebral hemorrhage is placed in the position at the time of surgery, and the CT value ranges of the patient's skull, hematoma in the brain and ventricular system, cerebrospinal fluid in the ventricular system, and skin and soft tissue are set. The patient undergoes a full cranial CT scan, and the data generated by the scan of each tissue is imported into the medical 3D modeling software in the format of a formatted image. The CT value range of each tissue in the CT scan is different. Based on this principle, the selected area obtained by extracting the CT value range of different tissues is modeled. The selected area is extracted according to the above CT value range on each two-dimensional thin layer image, and a three-dimensional combination is performed in the order of layer thickness to obtain a three-dimensional skin model, skull model, hematoma model, brain system model, and a full skull model including skin, skull, hematoma, and brain system;

[0007] (2) Generating an outer shell: extracting the outer surface of the skin model in the medical 3D modeling software, and using the offset function to thicken the outer surface of the skin model by 2-3 mm, thereby forming an outer shell. In the device of the present invention, the outer shell is generated in a personalized manner according to the actual CT scan data of different children; extracting the shapes of the eyes, nose, and mouth in the skin model in the medical 3D modeling software and projecting them onto the outer shell for hollowing out to form organ hollowing; extracting the shapes of the unhealed anterior fontanelle and posterior fontanelle in the skull model in the medical 3D modeling software and projecting them onto the outer shell for hollowing out of the skull; and The hollowing out forms a hollowing out of the bone edge, which is used as an auxiliary line for intraoperative positioning, facilitating intraoperative positioning or other operations such as percutaneous puncture; the shell formed at this time has organ hollowing out and bone edge hollowing out, and two bolts with external threads are designed at the positions corresponding to the ears on the left and right sides of the shell in the medical three-dimensional modeling software, and the bolts are equipped with nuts with internal threads, and the shell is divided into two along the top of the head, the ears to the mandible to form an upper shell and a lower shell, and the upper shell and the lower shell each have half of the bolt; after the bolts on the upper shell and the lower shell are aligned, they can be tightened by nuts to form an integral shell;

[0008] (3) Generating a puncture and drainage guide device: In the medical 3D modeling software, the horizontal, coronal, and sagittal whole skull models of the child and the overall whole skull model are simultaneously displayed through a four-grid interface. By combining the above four models for adjustment, the positions that can pass through the scalp and avoid the skull and important brain tissue structures are observed and found. At these positions, a puncture needle catheter that can pass through the scalp to reach the intracranial hematoma or ventricular hemorrhage is designed; a circular through hole is hollowed out on the shell generated in step (2) with the puncture needle catheter as the axis to expose the skin area of ​​the puncture area. The guide post is designed to be vertically arranged with the center of the through hole as the axis, and the guide post has an inner cavity for puncturing the puncture needle catheter, and the inner diameter of the inner cavity of the guide post is the same as the diameter of the puncture needle catheter; with the guide post as the axis, a circular plate is extended outward from the bottom of the guide post and thickened to form a circle, and a fixing plate with a screw hole II is designed on the left and right sides of the circular plate respectively; a screw II is designed as a fixing device, and the screw II can fix the guide post on the shell through the fixing plate; after the design is completed, except for the lower shell, all other parts are printed out by using a 3D printer;

[0009] (4) Fine-tuning and fixation: In the medical 3D modeling software, a fixed base in the shape of a rectangular block is designed as the main body of the fine-tuning device: an arc-shaped groove is designed on the upper surface of the fixed base, and the two arc-shaped edges of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight edge is parallel to the left edge / right edge of the upper surface; two parallel and symmetrical card grooves are respectively arranged on the upper surface of the fixed base near its left edge and right edge, and the card grooves are adjacent to the straight edge of the groove and are located on the outside of the straight edge of the groove; a baffle is designed on the front side wall of the fixed base, and the baffle is designed with a screw hole I; an adjustment plate in the shape of an arc plate matching the groove is designed, and the straight edge of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped edges do not exceed the arc-shaped edge of the groove, and the two straight edges of the adjustment plate can be adjusted along Slide along the card slot, a screw hole I is designed on the arc-shaped edge of the adjustment plate close to the front side wall, and the position corresponds to the screw hole I of the baffle; in the medical three-dimensional modeling software, the outer surface of the lower shell body is combined with the inner surface of the arc-shaped adjustment plate and then printed out by a 3D printer, and then the fixed base designed with a groove and a card slot is printed out by a 3D printer, and the arc-shaped adjustment plate combined with the lower shell body is inserted into the groove of the fixed base, and the adjustment plate slides in the card slot to drive the lower shell body to slide for fine adjustment of the body position. After the body position adjustment is completed, the screw I is used as a fixer to align the screw holes I of the adjustment plate and the baffle, and the adjustment plate is supported by the locking screw I to fix it on the fixed base; then the other parts of the shell are assembled to obtain the fixed guidance drainage device for intracranial hemorrhage in infants and young children.

[0010] In the above technical solution, in step (1), the CT value range of the infant's skull is set between 180 and 2388 Hu (the calcium content of the infant's skull is not as high as that of an adult, and the CT value range of the adult's skull is between 226 and 2388 Hu), the CT value range of the hematoma in the brain and ventricular system is set between 50 and 120 Hu, the CT value range of the cerebrospinal fluid in the ventricular system is set between -5 and 5 Hu, and the CT value range of the skin and soft tissue is set between -202 and 2388 Hu.

[0011] In the above technical solution, in step (1), when performing a whole-cranial CT scan, the scanning layer thickness does not exceed 1 mm, the scanning method is spiral scanning, the scanning FOV (scanning field) is ≤ 24 cm, and the reconstruction format image method is standard or soft tissue reconstruction. The scanned data is imported into the medical 3D modeling software according to the DICOM3.0 format image.

[0012] In the above technical solution, in step (3), the through hole has a diameter of 10 mm; the guide column has a diameter of 5 mm; and the circular plate has a diameter of 15 mm and a thickness of 3 mm.

[0013] In the above technical solution, in step (4), the baffle is in the shape of an arc-shaped plate, the arc-shaped edge of the baffle located in the front is flush with the front side wall of the fixed base, the arc-shaped edge located in the rear is located in the groove, and the two straight edges are respectively flush with the left edge and the right edge of the fixed base; the baffle is provided with a screw hole I through it, and a screw hole I is also provided on one of the arc-shaped edges of the adjustment plate. The screw hole I on the baffle and the screw hole I on the adjustment plate are exactly the same in shape and size and are symmetrical in position. After fine-tuning is completed, the screw holes I on the baffle and the adjustment plate are aligned and then the screws I are tightened to support the adjustment plate to achieve the purpose of fixing.

[0014] The second object of the present invention is to provide a fixed guide drainage device for intracranial hemorrhage in infants and young children prepared by the above method, the main body of which is a shell with the same shape as the head of the child, the shell is installed on a fine-tuning device, and the fine-tuning device is placed flat on the child's bed, characterized in that:

[0015] The shell is hollow inside and can accommodate the head of the child, and includes an upper shell and a lower shell that are connected and fixed together by a shell connection device; the shell connection device is located on the left and right sides of the shell and the position corresponds to the position of the child's ears; the upper shell has organ hollows on its upper surface that are the same shape and corresponding to the eyes, nose and mouth of the child; the lower shell has an inner surface that contacts the back of the child's head, and the outer surface is fixed on the fine-tuning device at a position corresponding to the back of the head; the shell is provided with bone edge hollows on its outer surface that are the same shape and corresponding to the anterior and posterior fontanelles of the child;

[0016] The fine-tuning device is in the shape of a cuboid or a cube as a whole; an arc-shaped groove is dug on the upper surface of the fine-tuning device, and the two arc-shaped edges of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight edge is parallel to the left edge / right edge of the upper surface; the groove is provided with an arc-shaped adjustment plate inside, and the straight edge of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped edges do not exceed the arc-shaped edge of the groove; the lower shell body is installed on the inner arc surface of the adjustment plate at a position corresponding to the back of the head, and the outer surface of the shell body is arranged outside the front side wall of the fine-tuning device corresponding to the top of the child's head; two mutually parallel and mutually symmetrical grooves are respectively provided on the upper surface of the fine-tuning device near its left edge and right edge, and the two straight edges of the adjustment plate can slide along the grooves, and the sliding of the adjustment plate drives the sliding of the shell body to perform fine adjustment of the body position;

[0017] The shell has one or more through holes on its outer surface, a cylindrical guide post is installed in the axial direction of the through hole, a cylindrical guide hole is penetrated from the upper bottom to the lower bottom of the guide post, and the center of the guide hole and the center of the through hole are located on the same axis; the guide hole is equipped with a puncture needle catheter, and the puncture needle catheter is inserted into the through hole after passing through the guide hole; the guide post has a guide plate fixed on the lower bottom, and the guide plate is fixed to the outer surface of the shell by a fixing device.

[0018] In the above technical solution, the shell combination device includes bolts and nuts matching therewith; there are four bolts, two of which are arranged on the left and right sides of the shell; each bolt is divided into two, one half is fixed on the outer surface edge of the upper shell, and the other half is fixed on the outer surface edge of the lower shell, and the bolts are aligned to form a whole and then fixed by rotating the nut.

[0019] In the above technical solution, the fine-tuning device is equipped with a fixer, which includes a screw I and a screw hole I matched therewith; a baffle is fixed upward on the front side wall of the fine-tuning device penetrated by the groove, and the baffle is penetrated by the screw hole I, and the screw hole I is also provided on an arc-shaped edge of the adjustment plate. The screw hole I on the baffle and the screw hole I on the adjustment plate are exactly the same in shape and size and are symmetrical in position. After the fine-tuning is completed, the screw holes I on the baffle and the adjustment plate are aligned and fixed by the screw I to support the adjustment plate to achieve the purpose of fixing.

[0020] In the above technical solution, the baffle is in the shape of an arc-shaped plate, the arc-shaped edge located in the front is flush with the front side wall of the fine-tuning device, the arc-shaped edge located in the rear is located in the groove, and the two straight edges are respectively flush with the left edge and the right edge of the fine-tuning device; the baffle has a thickness the same as that of the adjustment plate, a width less than or equal to one-half of the length of the screw, and a screw hole I is provided on the arc-shaped edge.

[0021] In the above technical solution, the guide plate includes a circular plate located in the center and fixed plates located on both sides of the circular plate that are symmetrical to each other; a circular hole is dug in the center of the circular plate, the inner diameter of the hole is equal to the outer diameter of the guide column, and the outer edge of the lower bottom of the guide column is fixed together with the inner edge of the hole.

[0022] In the above technical solution, a screw hole II is provided through the upper surface of the fixing plate, and a screw hole II is also provided on the outer surface of the shell and does not penetrate the shell. The screw hole II on the fixing plate and the screw hole II on the shell are exactly the same in shape and size and symmetrical in position. The screw hole II on the fixing plate and the screw hole II on the shell are aligned and then rotated and fixed by a fixing device; the fixing device is a screw II.

[0023] In the above technical solution, the shell has a thickness of 2-3 mm and is made of photosensitive resin, which is obtained by printing with an SLA photosensitive resin 3D printer.

[0024] In the above technical solution, the fine-tuning device is made of photosensitive resin and is obtained by printing with a SLA photosensitive resin 3D printer.

[0025] In the above technical solution, the circular plate has a diameter of 15 mm and a thickness of 3 mm.

[0026] In the above technical solution, the through hole has a diameter of 10 mm.

[0027] In the above technical solution, the guide post has a diameter of 5 mm.

[0028] The third object of the present invention is to provide a method for using the above-mentioned fixed guide drainage device for intracranial hemorrhage in infants and young children, comprising the following steps:

[0029] ① Except for the lower shell, each component with the puncture and drainage device is printed out by a 3D printer, and then the adjustment plate combined with the lower shell and other components of the fine-tuning device are printed out by a 3D printer; all components are sterilized by low-temperature plasma;

[0030] ② After assembling the lower shell and the adjustment plate of the fine-tuning device, place them on the bed surface, and adjust and fix the body position angle according to the surgical requirements;

[0031] ③ Place the child's head into the lower shell according to the position angle required for the operation, disinfect the skin on the top of the child's head, and then fix the bolts at the corresponding positions of the upper shell and the lower shell with nuts;

[0032] ④ Fix the guide post on the outer surface of the housing by using the guide plate and the fixing device, and the centers of the guide hole of the guide post and the through hole of the housing are located on the same axis;

[0033] ⑤ Pass the puncture needle catheter through the guide hole in the restricted direction. The depth should be based on the distance calculated during the surgical design. When the specified depth is reached and the accumulated blood flows out, the puncture is successful and the drainage tube is inserted.

[0034] In the above technical solution, if the guide plate is not needed to assist the puncture needle catheter, it can be removed, and the outer shell and fine-tuning device can be used to fix the child's body position and head to maintain the optimal drainage position and prevent the puncture needle catheter from falling off.

[0035] Compared with the prior art, the present invention has the following technical effects in draining intracerebral hematoma in children:

[0036] (1) The device of the present invention improves the accuracy of puncture. Previously, blind puncture was performed according to the general orientation of the CT image, and the probability of failure to puncture in place was very high. Repeated puncture would increase brain damage in children. The guide plate designed by three-dimensional positioning using the CT data of children can perfectly avoid important brain functional areas and structures according to the doctor's requirements, and perfectly guide the puncture needle to the drainage site according to the angle of the guide needle track;

[0037] (2) The fixed shell and adjustable body position fixator designed based on the CT data of the child can fix the child's head in the shell very well. By adjusting the angle of the body position fixator, the patient's body position can be maintained in the ideal drainage position designed by the doctor, thus avoiding the drainage tube from coming out and the body position from being unstable due to the patient's unconscious movement. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a schematic diagram of the overall structure of the fixed guiding drainage device for intracranial hemorrhage in infants and young children of the present invention;

[0039] Figure 2 It is a top view of the device of the present invention;

[0040] Figure 3 A bottom view of the device of the present invention;

[0041] Figure 4 A schematic diagram of a fine-tuning device of the present invention;

[0042] Figure 5 It is an exploded view of the overall structure of the device in the present invention;

[0043] Figure 6 An exploded view of the guide plate, guide post, fixing device and fixing device of the device of the present invention;

[0044] Figure 7 An exploded view of the upper housing, the fixing device, the guide plate and the fixing device of the device of the present invention;

[0045] Figure 8 An exploded view of the lower housing, the fixture and the fixing base of the device of the present invention;

[0046] Among them: 1 is the shell (1.1 is the upper shell, 1.2 is the lower shell), 2 is the guide hole, 3 is the fine-tuning device, 4 is the shell combination device, 5 is the puncture needle catheter, 6 is the fixer, 7 is the fixing device, 8 is the guide plate, 9 is the bone edge hollowing, 10 is the through hole; 11 is the guide column. DETAILED DESCRIPTION

[0047] The specific implementation of the technical solution of the present invention is described in detail below, but the present invention is not limited to the following description:

[0048] The present invention first provides a method for preparing a fixed guiding drainage device for intracranial hemorrhage in infants and young children, comprising the following steps:

[0049] (1) Scanning and modeling: The patient with cerebral hemorrhage is placed in the position at the time of surgery, and the CT value ranges of the patient's skull, hematoma in the brain and ventricular system, cerebrospinal fluid in the ventricular system, and skin and soft tissue are set. The patient undergoes a full cranial CT scan, and the data generated by the scan of each tissue is imported into the medical 3D modeling software in the format of a formatted image. The CT value range of each tissue in the CT scan is different. Based on this principle, the selected area obtained by extracting the CT value range of different tissues is modeled. The selected area is extracted according to the above CT value range on each two-dimensional thin layer image, and a three-dimensional combination is performed in the order of layer thickness to obtain a three-dimensional skin model, skull model, hematoma model, brain system model, and a full skull model including skin, skull, hematoma, and brain system;

[0050] (2) Generating a shell: extracting the outer surface of the skin model in the medical 3D modeling software, and using the offset function to thicken the outer surface of the skin model by 2-3 mm, thereby forming a shell 1. In the device of the present invention, the generation of the shell is personalized according to the actual CT scan data of different children; extracting the shapes of the eyes, nose, and mouth in the skin model in the medical 3D modeling software and projecting them onto the shell for hollowing out to form organ hollowing; the skull of the infant has not yet healed, and extracting the shapes of the unhealed anterior fontanelle and posterior fontanelle in the skull model in the medical 3D modeling software and projecting them onto the shell for hollowing out The hollowing out of the bone edge (9) is used as an auxiliary line for intraoperative positioning, which is convenient for intraoperative positioning or other operations such as percutaneous puncture. At this time, the shell formed has organ hollowing out and bone edge hollowing out. In the medical three-dimensional modeling software, two bolts with external threads are designed at the positions corresponding to the ears on the left and right sides of the shell, and the bolts are equipped with nuts with internal threads. The shell is divided into two parts along the top of the head, the ears to the mandible to form an upper shell and a lower shell. The upper shell and the lower shell each have half of the bolt. After the bolts on the upper shell and the lower shell are aligned, they can be tightened by the nuts to form an integral shell.

[0051] (3) Generating a puncture and drainage guide device: In the medical three-dimensional modeling software, the horizontal, coronal, and sagittal whole skull models of the child and the overall whole skull model are simultaneously displayed through a four-grid interface. By combining the above four models for adjustment, the positions that can pass through the scalp and avoid the skull and important brain tissue structures are observed and found. At these positions, a puncture needle catheter 5 that can pass through the scalp to reach intracranial hematoma or ventricular hemorrhage is designed; a circular through hole 10 is hollowed out on the shell generated in step (2) with the puncture needle catheter as the axis to expose the skin area of ​​the puncture area. Around; a cylindrical vertically arranged guide post 11 is designed with the center of the through hole as the axis, the guide post has an inner cavity for puncturing the puncture needle catheter, and the inner diameter of the inner cavity of the guide post is the same as the diameter of the puncture needle catheter; with the guide post as the axis, a circular plate is extended outward from the bottom of the guide post and thickened to form a circular shape, and a fixing plate with a screw hole II is designed on the left and right sides of the circular plate; a screw II is designed as a fixing device 7, and the screw II can fix the guide post on the shell through the fixing plate; after the design is completed, except for the lower shell, all other parts are printed out using a 3D printer;

[0052] (4) Fine-tuning and fixation: In the medical 3D modeling software, a fixed base in the shape of a rectangular block is designed as the main body of the fine-tuning device 3: an arc-shaped groove is designed on the upper surface of the fixed base, and the two arc-shaped edges of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight edge is parallel to the left edge / right edge of the upper surface; two parallel and symmetrical card grooves are respectively arranged on the upper surface of the fixed base near its left edge and right edge, and the card grooves are adjacent to the straight edge of the groove and are located on the outside of the straight edge of the groove; a baffle is designed on the front side wall of the fixed base, and the baffle is designed with a screw hole I; an adjustment plate in the shape of an arc plate matching the groove is designed, and the straight edge of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped edges do not exceed the arc-shaped edge of the groove, and the two straight edges of the adjustment plate can be along The card slot slides, and a screw hole I is designed on the arc-shaped edge of the adjustment plate close to the front side wall, and the position corresponds to the screw hole I of the baffle; in the medical three-dimensional modeling software, the outer surface of the lower shell is combined with the inner surface of the arc-shaped adjustment plate and then printed out using a 3D printer, and then the fixed base designed with a groove and a card slot is printed out using a 3D printer, and the arc-shaped adjustment plate combined with the lower shell is inserted into the groove of the fixed base 3, and the adjustment plate slides in the card slot to drive the lower shell to slide for fine-tuning the body position. After the body position adjustment is completed, the screw I is used as a fixer 6 to align the screw holes I of the adjustment plate and the baffle, and the adjustment plate 2 is supported by the locking screw I to fix it on the fixed base; then the other parts of the shell are assembled to obtain the fixed guidance drainage device for intracranial hemorrhage in infants and young children.

[0053] Secondly, the present invention provides a fixed guide drainage device for intracranial hemorrhage in infants and young children prepared by the above method, the main body of which is a shell 1 with the same shape as the head of the child, the shell is installed on a fine-tuning device 3, and the fine-tuning device is placed flat on the child's bed, and the characteristics are:

[0054] The shell is hollow inside and can accommodate the head of the child, and includes an upper shell 1.1 and a lower shell 1.2 that are connected and fixed together by a shell connection device 4; the shell connection device is located on the left and right sides of the shell and the position corresponds to the position of the ears of the child; the upper shell has organ hollows on its upper surface that are the same shape and corresponding to the eyes, nose and mouth of the child; the lower shell has an inner surface that contacts the back of the child's head, and the outer surface is fixed on the fine-tuning device 3 at a position corresponding to the back of the head; the outer surface of the shell is provided with bone edge hollows 9 that are the same shape and corresponding to the anterior and posterior fontanelles of the child;

[0055] The shell combination device 4 includes bolts and nuts matched therewith; there are four bolts, two of which are arranged on the left and right sides of the shell; each bolt is divided into two, one half is fixed on the outer surface edge of the upper shell, and the other half is fixed on the outer surface edge of the lower shell, and the bolts are aligned to form a whole and then fixed by rotating through the nut;

[0056] The fine-tuning device 3 is in the shape of a cuboid or a cube as a whole; an arc-shaped groove is dug on the upper surface of the fine-tuning device, and the two arc-shaped edges of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight edge is parallel to the left edge / right edge of the upper surface; the groove is provided with an arc-shaped adjustment plate inside, and the straight edge of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped edges do not exceed the arc-shaped edge of the groove; the lower shell body is installed on the inner arc surface of the adjustment plate at a position corresponding to the back of the head, and the outer surface of the shell body is arranged outside the front side wall of the fine-tuning device corresponding to the top of the child's head; two mutually parallel and mutually symmetrical grooves are respectively provided on the upper surface of the fine-tuning device near its left edge and right edge, and the two straight edges of the adjustment plate can slide along the grooves, and the sliding of the adjustment plate drives the sliding of the shell body to perform fine adjustment of the body position;

[0057] The fine-tuning device is equipped with a fixer 6, which includes a screw I and a screw hole I matched therewith; a baffle is fixed upwardly on the front side wall of the fine-tuning device penetrated by the groove, and the baffle is penetrated by the screw hole I, and the screw hole I is also provided on an arc-shaped edge of the adjustment plate. The screw hole I on the baffle and the screw hole I on the adjustment plate are exactly the same in shape and size and are symmetrical in position. After the fine-tuning is completed, the baffle and the screw holes I on the adjustment plate are aligned and fixed by the screw I to support the adjustment plate to achieve the purpose of fixing;

[0058] The shell has one or more through holes 10 on its outer surface, and a cylindrical guide column 11 is installed in the axial direction of the through hole. A cylindrical guide hole 2 is penetrated from the upper bottom to the lower bottom of the guide column, and the center of the guide hole and the center of the through hole are located on the same axis; the guide hole is equipped with a puncture needle catheter 5, and the puncture needle catheter passes through the guide hole and is inserted into the through hole; the guide column has a guide plate 8 fixed on the lower bottom, and the guide plate is fixed to the outer surface of the shell by a fixing device 7.

[0059] The present invention will be described below in conjunction with specific embodiments:

[0060] Embodiment 1:

[0061] A method for preparing a fixed guiding drainage device for intracranial hemorrhage in infants and young children comprises the following steps:

[0062] (1) Scanning and modeling: The patient with cerebral hemorrhage is placed in the position at the time of surgery, and the CT value ranges of the patient's skull, hematoma in the brain and ventricular system, cerebrospinal fluid in the ventricular system, and skin and soft tissue are set. The patient's whole skull CT scan is performed, and the data generated by the scan of each tissue is imported into the medical 3D modeling software in the format of the format image. The selected area is extracted according to the above CT value range on each 2D thin layer image, and 3D combination is performed according to the layer thickness order to obtain a 3D skin model, skull model, hematoma model, brain system model, and a whole skull model including skin, skull, hematoma, and brain system;

[0063] The CT value range of the child's skull is set between 180 and 200 Hu, the CT value range of the hematoma in the brain and ventricular system is set between 55 and 70 Hu, the CT value range of the cerebrospinal fluid in the ventricular system is set between -5 and 5 Hu, and the CT value range of the skin and soft tissue is set between -202 and 2388 Hu;

[0064] When performing whole-cranial CT scanning, the scanning layer thickness does not exceed 1mm, the scanning method is spiral scanning, the scanning FOV (scanning field) is ≤24cm, the reconstruction format image method is soft tissue reconstruction, and the scanned data is imported into the medical 3D modeling software according to the DICOM3.0 format image;

[0065] (2) Generating a shell: extracting the outer surface of the skin model in the medical 3D modeling software, and using the offset function to thicken the outer surface of the skin model by 2.5 mm, thereby forming a shell 1. In the device of the present invention, the generation of the shell is personalized according to the actual CT scan data of different children; extracting the shapes of the eyes, nose, and mouth in the skin model in the medical 3D modeling software and projecting them onto the shell for hollowing out to form organ hollowing; extracting the shapes of the unhealed anterior fontanelle and posterior fontanelle in the skull model in the medical 3D modeling software and projecting them onto the shell for hollowing out of the skull; The hollowing out forms a bone edge hollowing out 9, which is used as an auxiliary line for intraoperative positioning, facilitating intraoperative positioning or other operations such as percutaneous puncture; the shell formed at this time has organ hollowing out and bone edge hollowing out, and two bolts with external threads are designed at the positions corresponding to the ears on the left and right sides of the shell in the medical three-dimensional modeling software, and the bolts are equipped with nuts with internal threads, and the shell is divided into two along the top of the head, the ears to the mandible to form an upper shell and a lower shell, and the upper shell and the lower shell each have half of the bolt; after the bolts on the upper shell and the lower shell are aligned, they can be tightened by nuts to form an integral shell;

[0066] (3) Generating a puncture and drainage guide device: In the medical three-dimensional modeling software, the horizontal, coronal, and sagittal whole skull models of the child and the overall whole skull model are simultaneously displayed through a four-grid interface. By combining the above four models for adjustment, the positions that can pass through the scalp and avoid the skull and important brain tissue structures are observed and found. At these positions, a puncture needle catheter 5 that can pass through the scalp to reach intracranial hematoma or ventricular hemorrhage is designed; a circular through hole 10 is hollowed out on the shell generated in step (2) with the puncture needle catheter as the axis to expose the skin range of the puncture area; A cylindrical vertical guide post 11 is designed with the center of the through hole as the axis. The guide post has an inner cavity for puncturing the puncture needle catheter. The inner diameter of the inner cavity of the guide post is the same as the diameter of the puncture needle catheter. With the guide post as the axis, a circular plate is extended outward from the bottom of the guide post and thickened to form a circle. A fixing plate with a screw hole II is designed on the left and right sides of the circular plate respectively. A screw II is designed as a fixing device 7. The screw II can fix the guide post on the shell through the fixing plate. After the design is completed, except for the lower shell, other parts are printed out using a 3D printer and photosensitive resin.

[0067] The through hole has a diameter of 10 mm; the guide post has a diameter of 5 mm; the circular plate has a diameter of 15 mm and a thickness of 3 mm;

[0068] (4) Fine-tuning and fixation: In the medical three-dimensional modeling software, a fixed base in the shape of a rectangular block is designed as the main body of the fine-tuning device 3: an arc-shaped groove is designed on the upper surface of the fixed base, and the two arc-shaped edges of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight edge is parallel to the left edge / right edge of the upper surface; two parallel and symmetrical card grooves are respectively arranged on the upper surface of the fixed base near its left edge and right edge, and the card grooves are adjacent to the straight edge of the groove and are located on the outside of the straight edge of the groove; a baffle is designed on the front side wall of the fixed base, and the baffle is designed with a screw hole I; an adjustment plate in the shape of an arc plate matching the groove is designed, and the straight edge of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped edges do not exceed the arc-shaped edge of the groove, and the two straight edges of the adjustment plate can slide along the card groove A screw hole I is designed on the arc-shaped edge of the adjustment plate close to the front side wall, and its position corresponds to the screw hole I of the baffle; in the medical three-dimensional modeling software, the outer surface of the lower shell body is combined with the inner surface of the arc-shaped adjustment plate and then printed out by a 3D printer, and then the fixed base designed with grooves and card slots is printed out by a 3D printer and photosensitive resin, and the arc-shaped adjustment plate combined with the lower shell body is inserted into the groove of the fixed base 3, and the adjustment plate slides in the card slot to drive the lower shell body to slide for fine adjustment of the body position. After the body position adjustment is completed, the screw I is used as a fixer 6 to align the screw holes I of the adjustment plate and the baffle, and the adjustment plate 2 is supported by the locking screw I to fix it on the fixed base; then the other parts of the shell are assembled to obtain the fixed guide drainage device for intracranial hemorrhage in infants and young children.

[0069] The baffle is in the shape of an arc-shaped plate, the arc-shaped edge of the baffle located in the front is flush with the front side wall of the fixed base, the arc-shaped edge located in the rear is located in the groove, and the two straight edges are respectively flush with the left edge and the right edge of the fixed base; a screw hole I is provided through the baffle, and a screw hole I is also provided on an arc-shaped edge of the adjustment plate. The screw hole I on the baffle and the screw hole I on the adjustment plate are exactly the same in shape and size and are symmetrical in position. After fine-tuning is completed, the screw holes I on the baffle and the adjustment plate are aligned and the screws I are tightened to hold the adjustment plate to achieve the purpose of fixation.

[0070] Embodiment 2:

[0071] A fixed guide drainage device for intracranial hemorrhage in infants and young children is prepared by the method of Example 1. In this embodiment:

[0072] The baffle is in the shape of an arc-shaped plate, the arc-shaped edge at the front is flush with the front side wall of the fine-tuning device, the arc-shaped edge at the rear is located in the groove, and the two straight edges are respectively flush with the left edge and the right edge of the fine-tuning device; the baffle has the same thickness as the adjustment plate, the width is less than or equal to half the length of the screw, and a screw hole I is provided on the arc-shaped edge;

[0073] The shell has a thickness of 2.5 mm and is made of photosensitive resin, and is obtained by printing with an SLA photosensitive resin 3D printer;

[0074] The fine-tuning device is made of photosensitive resin and is obtained by printing with a SLA photosensitive resin 3D printer;

[0075] The circular plate has a diameter of 15 mm and a thickness of 3 mm.

[0076] The through hole has a diameter of 10 mm.

[0077] The guide post has a diameter of 5 mm.

[0078] The method for using the fixed guiding drainage device for intracranial hemorrhage in infants and young children of the present invention comprises the following steps:

[0079] ① Except for the lower shell, each component with the puncture and drainage device is printed out by a 3D printer, and then the adjustment plate combined with the lower shell and other components of the fine-tuning device are printed out by a 3D printer; all components are sterilized by low-temperature plasma;

[0080] ② After assembling the lower shell and the adjustment plate of the fine-tuning device, place them on the bed surface, and adjust and fix the body position angle according to the surgical requirements;

[0081] ③ Place the child's head into the lower shell according to the position angle required for the operation, disinfect the skin on the top of the child's head, and then fix the bolts at the corresponding positions of the upper shell and the lower shell with nuts;

[0082] ④ Fix the guide post on the outer surface of the housing by using the guide plate and the fixing device, and the centers of the guide hole of the guide post and the through hole of the housing are located on the same axis;

[0083] ⑤ Pass the puncture needle catheter through the guide hole in the restricted direction. The depth should be based on the distance calculated during the surgical design. When the specified depth is reached and the accumulated blood flows out, the puncture is successful and the drainage tube is inserted.

[0084] The above examples are only for illustrating the technical concept and technical features of the present invention, and cannot be used to limit the protection scope of the present invention. Any equivalent transformation or modification made according to the essence of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for preparing a fixed guide drainage device for intracranial hemorrhage in infants and young children, characterized in that: The following steps are involved: (1) Scanning and modeling: The patient with cerebral hemorrhage is placed in the position of the operation, and the CT value range of the patient's skull, hematoma in the brain and ventricular system, cerebrospinal fluid in the ventricular system, and skin and soft tissue is set. The patient undergoes a full cranial CT scan, and the data generated by the scan of each tissue is modeled in the format of the formatted image to obtain a three-dimensional skin model, skull model, hematoma model, brain system model, and a full cranial model including the skin, skull, hematoma, and brain system; (2) Generating a shell: extracting the outer surface of the skin model, and thickening the outer surface of the skin model by 2-3 mm, thereby forming a shell (1); extracting the shapes of the eyes, nose, and mouth in the skin model and projecting them onto the shell to hollow out the organs; The shapes of the unhealed anterior fontanelle and posterior fontanelle in the skull model are extracted and projected onto the shell for hollowing out to form a bone edge hollowing (9) to be used as an auxiliary line for positioning during surgery; the shell formed at this time has organ hollowing and bone edge hollowing, and two bolts with external threads are designed at positions corresponding to the ears on the left and right sides of the shell, and the bolts are equipped with nuts with internal threads. The shell is divided into two parts along the top of the head, the ears to the mandible to form an upper shell and a lower shell, and the upper shell and the lower shell each have half of the bolt; after the bolts on the upper shell and the lower shell are aligned, they can be tightened by the nuts to form an integral shell; (3) Generating puncture and drainage guide devices: When modeling, display the horizontal, coronal, and sagittal whole skull models of the child and the overall whole skull model at the same time. By combining the above four models and making adjustments, observe and find the positions that can pass through the scalp and avoid the skull and important brain tissue structures. At these positions, design a puncture needle catheter (5) that can pass through the scalp to reach intracranial hematoma or ventricular hemorrhage; hollow out the outer shell generated in step (2) with the puncture needle catheter as the axis to form a circular through hole (10) for exposing the skin range of the puncture area; use the circular shape of the through hole as the axis. A cylindrical vertically arranged guide post (11) is designed with the center as the axis, the guide post having an inner cavity for puncturing the puncture needle catheter, and the inner diameter of the inner cavity of the guide post is the same as the diameter of the puncture needle catheter; with the guide post as the axis, a circular plate is extended outward from the bottom of the guide post and thickened to form a circular shape, and a fixing plate with a screw hole II is designed on the left and right sides of the circular plate respectively; a screw II is designed as a fixing device (7), and the screw II can fix the guide post on the shell through the fixing plate; after the design is completed, except for the lower shell, all other parts are printed out by using a 3D printer; (4) Fine-tuning and fixing: When modeling, design a fixed base in the shape of a rectangular block as the main body of the fine-tuning device (3): design an arc-shaped groove on the upper surface of the fixed base, the two arc-shaped sides of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight side is parallel to the left edge / right edge of the upper surface; set two parallel and symmetrical card grooves on the upper surface of the fixed base near its left edge and right edge, respectively, the card grooves are adjacent to the straight edge of the groove and are located on the outside of the straight edge of the groove; design a baffle on the front side wall of the fixed base, and the baffle is designed with a screw hole I; design an adjustment plate in the shape of an arc plate matching the groove, the straight side of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped sides do not exceed the arc-shaped side of the groove, and the two straight sides of the adjustment plate can The adjusting plate is capable of sliding along the card slot; a screw hole I is designed on the arc-shaped edge of the adjusting plate close to the front side wall, and the position corresponds to the screw hole I of the baffle plate; the outer surface of the lower shell body is combined with the inner surface of the arc-shaped adjusting plate and then printed out by a 3D printer; a fixed base designed with a groove and a card slot is then printed out by a 3D printer; the arc-shaped adjusting plate combined with the lower shell body is inserted into the groove of the fixed base; the adjusting plate slides in the card slot, thereby driving the lower shell body to slide for fine adjustment of the body position; after the body position adjustment is completed, the screw I is used as a fixer (6) to align the screw holes I of the adjusting plate and the baffle plate, and the adjusting plate is fixed to the fixed base by tightening the screw I; and the other parts of the shell are assembled to obtain the fixed guide drainage device for intracranial hemorrhage in infants and young children.

2. The preparation method according to claim 1, characterized in that: In step (1), the CT value range of the child's skull is set between 180 and 2388 Hu, the CT value range of the hematoma in the brain and ventricular system is set between 50 and 120 Hu, the CT value range of the cerebrospinal fluid in the ventricular system is set between -5 and 5 Hu, and the CT value range of the skin and soft tissue is set between -202 and 2388 Hu.

3. The preparation method according to claim 1, characterized in that: In step (1), when performing a whole-cranial CT scan, the scanning layer thickness does not exceed 1 mm, the scanning method is spiral scanning, the scanning FOV is ≤ 24 cm, the reconstruction format image method is standard or soft tissue reconstruction, and the data generated by the scan is modeled according to the DICOM3.0 format image.

4. The preparation method according to claim 1, characterized in that: In step (3), the through hole has a diameter of 10 mm; the guide column has a diameter of 5 mm; the circular plate has a diameter of 15 mm and a thickness of 3 mm.

5. The preparation method according to claim 1, characterized in that: In step (4), the baffle is in the shape of an arc-shaped plate, the arc-shaped edge of the baffle located in the front is flush with the front side wall of the fixed base, the arc-shaped edge located in the rear is located in the groove, and the two straight edges are respectively flush with the left edge and the right edge of the fixed base; the baffle is provided with a screw hole I through it, and a screw hole I is also provided on one arc-shaped edge of the adjustment plate. The screw hole I on the baffle and the screw hole I on the adjustment plate are exactly the same in shape and size and are symmetrical in position. After fine-tuning is completed, the screw holes I on the baffle and the adjustment plate are aligned and the screws I are tightened to hold the adjustment plate to achieve the purpose of fixing.

6. A fixed guide drainage device for intracranial hemorrhage in infants prepared by the preparation method according to any one of claims 1 to 5, wherein the main body is a shell (1) having the same shape as the head of the child, the shell is mounted on a fine-tuning device (3), and the fine-tuning device is placed flat on the child's bed, characterized in that: The shell is hollow inside and can accommodate the head of the child, and comprises an upper shell (1.1) and a lower shell (1.2) which are connected and fixed together by a shell connection device (4); the shell connection device is located on the left and right sides of the shell and the position corresponds to the position of the ears of the child; the upper shell has organ hollows on its upper surface which are the same shape and corresponding to the eyes, nose and mouth of the child; the lower shell has an inner surface which contacts the back of the child's head, and the outer surface is fixed on the fine-tuning device (3) at a position corresponding to the back of the head; the outer surface of the shell is provided with bone edge hollows (9) which are the same shape and corresponding to the anterior and posterior fontanelles of the child; The shell combination device (4) comprises bolts and nuts matched therewith; there are four bolts, two of which are arranged on the left and right sides of the shell; each bolt is divided into two, one half is fixed to the outer surface edge of the upper shell, and the other half is fixed to the outer surface edge of the lower shell, and the bolts are aligned to form a whole and then fixed by rotating through the nut; The fine-tuning device (3) is in the shape of a cuboid or a cube as a whole; an arc-shaped groove is excavated on the upper surface of the fine-tuning device, the two arc-shaped sides of the groove penetrate the front side wall and the rear side wall of the fine-tuning device, and the straight side is parallel to the left edge / right edge of the upper surface; the groove is provided with an adjustment plate in the shape of an arc plate inside, the straight side of the adjustment plate is parallel to the left edge / right edge of the upper surface, and the two arc-shaped sides do not exceed the arc-shaped sides of the groove; the lower shell body is mounted on the inner arc surface of the adjustment plate at a position corresponding to the back of the head, and the outer surface of the shell body is arranged outside the front side wall of the fine-tuning device corresponding to the top of the child's head; two mutually parallel and mutually symmetrical slots are respectively provided on the upper surface of the fine-tuning device near its left edge and right edge, and the two straight sides of the adjustment plate can slide along the slots, and the sliding of the adjustment plate drives the sliding of the shell body to perform fine adjustment of the body position; The fine-tuning device is provided with a fixing device (6), the fixing device comprising a screw I and a screw hole I matched therewith; a baffle is fixed upwardly to the front side wall of the fine-tuning device penetrated by the groove, the baffle is penetrated by the screw hole I, and the screw hole I is also provided on an arc-shaped edge of the adjustment plate, the screw hole I on the baffle and the screw hole I on the adjustment plate are completely the same in shape and size and are symmetrical in position, after the fine-tuning is completed, the baffle and the screw holes I on the adjustment plate are aligned and fixed by the screw I, so as to support the adjustment plate to achieve the purpose of fixing; The shell has one or more through holes (10) on its outer surface, a cylindrical guide post (11) is installed in the axial direction of the through hole, a cylindrical guide hole (2) is penetrated from the upper bottom to the lower bottom of the guide post, and the center of the guide hole and the center of the through hole are located on the same axis; the guide hole is equipped with a puncture needle catheter (5), and the puncture needle catheter is inserted into the through hole after passing through the guide hole; the guide post has a guide plate (8) fixed on the lower bottom, the guide plate includes a circular plate located in the center and mutually symmetrical fixing plates located on both sides of the circular plate, a circular hole is dug in the center of the circular plate, the inner diameter of the hole is equal to the outer diameter of the guide post, and the outer edge of the lower bottom of the guide post is fixed to the inner edge of the hole; the guide plate is fixed to the outer surface of the shell by a fixing device (7).

7. The fixed guiding drainage device for intracranial hemorrhage in infants according to claim 6, characterized in that: The baffle is in the shape of an arc-shaped plate, the arc-shaped edge at the front is flush with the front side wall of the fine-tuning device, the arc-shaped edge at the rear is located in the groove, and the two straight edges are respectively flush with the left edge and the right edge of the fine-tuning device; the baffle has a thickness the same as that of the adjustment plate, a width less than or equal to one-half of the length of the screw, and a screw hole I is provided on the arc-shaped edge.

8. The fixed guiding drainage device for intracranial hemorrhage in infants according to claim 6, characterized in that: The fixing plate has a screw hole II penetrating through the upper surface, and a screw hole II is also provided on the outer surface of the shell but does not penetrate the shell. The screw hole II on the fixing plate and the screw hole II on the shell are exactly the same in shape and size and are symmetrical in position. The screw hole II on the fixing plate and the screw hole II on the shell are aligned and then rotated and fixed by a fixing device; the fixing device is a screw II.

9. The fixed guiding drainage device for intracranial hemorrhage in infants according to claim 6, characterized in that: The shell has a thickness of 2-3mm and is made of photosensitive resin; the fine-tuning device is made of photosensitive resin; the circular plate has a diameter of 15mm and a thickness of 3mm; the through hole has a diameter of 10mm; and the guide column has a diameter of 5mm.

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