CN206675577U - A kind of external assisted biopsy/positioner of 3D printing - Google Patents

A kind of external assisted biopsy/positioner of 3D printing Download PDF

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Publication number
CN206675577U
CN206675577U CN201620899497.XU CN201620899497U CN206675577U CN 206675577 U CN206675577 U CN 206675577U CN 201620899497 U CN201620899497 U CN 201620899497U CN 206675577 U CN206675577 U CN 206675577U
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biopsy
printed
base
needle
positioning module
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范子文
西尔买买提·卡德尔
李泽遥
李牧
王龙
顾亚伟
陈昶
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Shanghai Lanhui Medical Technology Co ltd
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Shanghai Pulmonary Hospital
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Abstract

The utility model discloses a kind of external assisted biopsy/positioner of 3D printing, the biopsy/positioner is formed by 3D printing, and it includes:Centralized positioning module, the inserting needle duct for puncture needle inserting needle is offered in the centralized positioning module, the first neck is offered on the surface of the centralized positioning module;Feeler, its one end are provided with the first bayonet lock snapped connection with first neck, and the other end of the feeler is provided with the second bayonet lock;And fixed foot stool, including base and the leg being arranged on the base, the leg is set at an angle with the plane where the base, and the one end of the leg away from the base is provided with the second neck, and second neck snaps connection with second bayonet lock.The utility model biopsy/positioner use range is wide, the operating time shorten, mitigate patient suffering significantly, realize lump it is preoperative be accurately positioned and aspiration biopsy.

Description

3D prints external supplementary biopsy/positioner
Technical Field
The utility model relates to a positioner that is arranged in the tumour of lung of laparoscopic surgery especially relates to an external supplementary biopsy/positioner that 3D printed.
Background
In clinical work, clinical problems are often encountered that require the use of needle biopsy techniques or preoperative localization techniques. The puncture biopsy can define the histological type of the focus, determine the pathological diagnosis and guide the clinical treatment. The preoperative localization technology of the tumor is important for determining the resection range in the operation.
The above clinical problems include lesions of lung tumor needle biopsy and preoperative localization, thyroid needle biopsy, breast needle biopsy, liver area needle biopsy.
The prior art of preoperative localization and needle biopsy will be described below:
firstly, preoperative positioning: taking lung tumor as an example, when a thoracoscopic lung operation is required, for the condition that the tumor is too small and the position is deep, the judgment of the resection part is affected because the position of the tumor cannot be directly seen in the operation. Currently, to address this clinical problem, there are three main methods for locating a lung mass: 1. probing and positioning in the operation: in the operation, the lung nodule part is determined by touching the chest CT in a hand touch method in the approximate range of the lung nodule; 2. lung nodules were located via a chest wall hook-wire locator needle under preoperative CT guidance: before surgery, lung puncture was performed through the chest wall using a hook-wire pilot needle under CT guidance. The needle head is gradually close to the position of the lung lump through repeated adjustment and groping, and hook-shaped metal hook-wire filaments are released to stay near the lump to position the position of the lung lump. In the operation, the position of the tumor can be determined in an auxiliary way by searching the hook needle position of hook-wire, and the range of the excised lung tissue is further determined; 3. the pulmonary nodules are positioned by a chest wall micro-coil microcoil coil under the guidance of preoperative CT: similar to the hook-wire procedure described above, the lung position was located preoperatively by transthoracic lung puncture with a micro-coil microcoil under CT guidance. The main difference is that the foreign body released after the puncture is in place is not a metal hook, but a microcoil. The main physician determines the extent of lung tissue that needs to be excised by palpating the location of the coil.
However, the prior art preoperative localization technology has the following problems: 1. the postoperative method cannot touch the tumor: confirming the position of the tumor by touching in the operation is theoretically the most direct and accurate method, but in many cases, the lung tumor cannot be completely removed due to the fact that the lung tumor is tough in texture, too small in volume, deep in position, insufficient in doctor experience and other reasons in the operation, and the lung tumor cannot be touched or touched accurately by hand touching; 2. effect of radiation irradiation: before operation, the puncture positioning is guided by a hook-wire positioning needle or a micro-coil microcoil through CT, and the patient needs to receive CT for many times in a short period so as to determine the positioning part and cause radiation influence on the patient; 3. staffing and cost: before operation, the puncture positioning is guided by a hook-wire positioning needle or a micro-coil microcoil through a CT, and at least two experienced medical staff are needed for operation. On one hand, the learning curve of the medical staff training is gentle, and the culture period is long; on the other hand, the workload and the medical cost of medical staff are increased, and the economic burden of patients is increased; 4. the existing preoperative positioning method is long in time consumption, and requires a patient to lie on the CT bed in a fixed posture for a long time, so that the patient suffers from repeated adjustment and repeated puncture of a puncture needle, and is very painful. The prior art is completely impossible for unconscious or severe patients who cannot be matched.
Secondly, puncture biopsy: taking lung tumor as an example, the current percutaneous aspiration biopsy technology under ultrasound guidance has become a main means for obtaining lung periphery space occupying lesion tissue specimen, and the lesion size, internal echo and blood supply condition are known by conventional ultrasound before operation. For the part of the focus without or with little blood supply, contrast medium is injected through the elbow vein before puncture, and materials are obtained by using a biopsy needle or a biopsy gun. For the lung tumor of a comparatively superficial, the tumor position is determined by directly touching the lung tumor with a manipulation, and puncture is carried out. For deep tumor mass located in lung far away from skin, puncture biopsy needs to be performed under CT guidance, and the puncture needle can be accurately positioned in tumor by means of multiple CT guidance during operation.
However, the existing needle biopsy technique has the following problems: 1. the puncture biopsy of the occupation lesion at the periphery of the lung is operated through the intercostal space, the movable range of a probe and a puncture needle is limited, the rib, nerves and blood vessels of the rib are easy to be injured by inserting the needle, and complications such as pneumothorax, hemorrhage and the like can be increased by repeatedly puncturing; 2. when the focus has no blood flow or little blood flow, the injection of the contrast medium is not suitable for patients with liver and kidney insufficiency; 3. personnel allocation and cost, the success rate of the operation can be improved only after the puncture biopsy operation needs to be mastered, the learning curve of the training of medical personnel is mild, and the discontented patients can be caused when inexperienced doctors puncture, so that the mental burden of the patients is increased.
SUMMERY OF THE UTILITY MODEL
The utility model provides a 3D printing external auxiliary biopsy/positioning device, which solves the problems in the prior art. The utility model discloses a biopsy/positioner is according to the data that patient's image CT and human three-dimensional scanner obtained, utilizes the individualized external location/biopsy device of 3D printing technique preparation, has realized accurate positioning or puncture biopsy before the lump art.
In order to achieve the above purpose, the utility model adopts the following technical scheme:
a first aspect of the present invention provides an external auxiliary biopsy/positioning device for 3D printing, which is formed by 3D printing and comprises:
the central positioning module is internally provided with a needle inserting pore passage for inserting a puncture needle, and the surface of the central positioning module is provided with a first clamping groove;
one end of the antenna is provided with a first clamping pin in clamping connection with the first clamping groove so as to upwards support the central positioning module, and the other end of the antenna is provided with a second clamping pin; and
the fixed foot rest comprises a base and support legs arranged on the base, the support legs and a plane where the base is located are arranged at a certain angle, one end, far away from the base, of each support leg is provided with a second clamping groove, and the second clamping grooves are connected with second clamping pins in a buckled mode.
Further, the centering module is cylindrical, cubic or spherical.
Furthermore, the number of the antennae and the fixed foot frames is more than or equal to 3;
preferably, the central positioning module is a cube, the number of the antennae is 4, the antennae are respectively located on 4 side surfaces of the cube, and the number of the fixed foot frames is 4.
Furthermore, a clamping device for fixing the puncture needle in the needle inserting pore channel is arranged on the central positioning module.
Furthermore, the near end of the second clamping groove is connected with the base in a matched and movable manner through a round groove arranged on the base and a spherical near end buckle of the second clamping groove.
Furthermore, the material of the central positioning module, the antenna and the fixed foot rest is selected from one or more of ABS resin, polylactic acid, polyvinyl alcohol and nylon.
Furthermore, scales are arranged at the joint of the second clamping pin and the second clamping groove so as to determine the inclination angle and the vertical height of the antenna.
Further, the lower surface of the base is a curved surface, and the shape of the curved surface is consistent with the shape of the surface of the thorax.
The second aspect of the present invention is a method for preparing a 3D-printed in vitro biopsy/positioning device, comprising the steps of:
(1) according to the preprocessed positioning sheet image with the tumor in the lung, model reconstruction is carried out on the chest cavity and the lung with the tumor of the patient by utilizing modeling software, and the projection position of the tumor in the body surface of the lung is determined on the chest cavity model and the lung model;
(2) constructing an umbrella-shaped biopsy/positioning model which is attached to the thoracic cavity model and the lung model and comprises a central positioning module model, an antenna model and a fixed foot stand model by utilizing modeling software again according to the pre-calculated needle inserting angle and depth;
(3) respectively guiding the positioning module model, the antenna model and the fixed foot rest model into a printer and performing 3D printing to obtain a central positioning module, an antenna and a fixed foot rest;
(4) and assembling the positioning module die, the antenna and the fixed foot stand which are printed in the 3D mode to obtain the biopsy/positioning device.
Furthermore, a needle inserting hole is formed in the central positioning module model, and the needle inserting hole and the lung tumor on the chest cavity and the lung model are located on the same straight line.
The above technical scheme is adopted in the utility model, compared with the prior art, following technological effect has:
the utility model discloses an in vitro auxiliary biopsy/positioning device with 3D printing, which is an individualized in vitro positioning and biopsy device manufactured by 3D printing technology according to the image CT of a patient and the data obtained by a human body three-dimensional scanner, thereby realizing the accurate positioning and the puncture biopsy before the tumor operation; the nodules cannot be touched by hand touch; the exposure of CT of a patient is reduced, and the radiation damage is reduced; 3D printing is customized according to the data of the patient, so that the puncture accuracy is improved, the operation time is shortened, and the pain of the patient is greatly relieved; the requirement on the patient adaptability is low, and the method is suitable for patients who cannot be well matched; the training time of operators is shortened, and medical resources are effectively utilized; accurate puncture and reduced risk of complications.
Drawings
Fig. 1 is a schematic view of the overall structure of a 3D-printed in-vitro auxiliary biopsy/positioning device according to the present invention;
fig. 2 is an assembly schematic view of an antenna of the 3D printed in-vitro assisted biopsy/positioning device of the present invention;
fig. 3 is a schematic view of a center positioning module of a 3D-printed in-vitro assisted biopsy/positioning device according to the present invention;
fig. 4 is a schematic view of an antenna of a 3D printed in-vitro assisted biopsy/positioning device according to the present invention;
fig. 5 is a schematic view of a fixed foot stand of a 3D-printed in-vitro assisted biopsy/positioning device according to the present invention;
fig. 6 is a CT scan during the use of the 3D printed in vitro assisted biopsy/positioning device of the present invention; 6-1 is a physical examination CT image, 6-2 is a CT image during puncture positioning, and 6-3 is a CT image after puncture positioning;
the puncture needle comprises a central positioning module 1, a needle inserting hole 11, a first clamping groove 12, an antenna 2, a first clamping pin 21, a second clamping pin 22, a fixed foot stand 3, a base 31, a support leg 32, a second clamping groove 33, a thorax surface 4, a puncture needle 5, a puncture point 6 and a tumor 7.
Detailed Description
The present invention will be described in detail and specifically with reference to the following examples for better understanding, but the scope of the present invention is not limited by the following examples.
As shown in fig. 1-5, the utility model provides an external supplementary biopsy/positioner that 3D printed, biopsy/positioner is printed by 3D and forms, and it includes: as shown in fig. 3, the central positioning module 1 is provided with a needle insertion hole 11 for inserting a puncture needle 5 in the central positioning module 1, and the surface of the central positioning module 1 is provided with a first clamping groove 12; the antenna 2 is provided with a first clamping pin 21 buckled with the first clamping groove 12 at one end thereof as shown in fig. 4 so as to upwards support the central positioning module 1, and a second clamping pin 22 at the other end of the antenna 2; and the fixed foot stand 3 comprises a base 31 and a support leg 32 arranged on the base 31, the support leg 32 and the plane where the base 31 is located are arranged at a certain angle, one end, far away from the base 31, of the support leg 32 is provided with a second clamping groove 33, and the second clamping groove 33 is connected with the second clamping pin 22 in a buckling mode.
In the biopsy/positioning device of the present invention, the central positioning module 1 is cylindrical, cubic or spherical; the number of the antennae 2 is more than or equal to 3. Preferably, as shown in fig. 1 or 3, the centering module 1 is a cube, and the number of the antennas 2 is 4 and is located on 4 sides of the cube respectively. The centering module 1 is provided with a clamping device for fixing the puncture needle 5 in the needle inlet duct 11.
Preferably, the connection between the legs 32 and the base 31 is a snap-fit movable connection with the spherical proximal ends of the legs 32 via circular grooves provided on the base 31. The central positioning module 1, the antenna 2 and the fixed foot rest 3 are made of one or more of ABS resin, polylactic acid, polyvinyl alcohol and nylon. The joint of the second clamping pin 22 and the second clamping groove 33 is provided with scales so as to determine the inclination angle and the vertical height of the antenna 2. The lower surface of the base 31 is a curved surface having a shape conforming to the shape of the thoracic surface 4.
The utility model also provides a 3D prints in vitro supplementary biopsy/positioner's preparation method, including following step:
(1) according to the preprocessed positioning sheet image with the tumor in the lung, model reconstruction is carried out on the chest cavity and the lung with the tumor of the patient by utilizing modeling software, and the projection position of the tumor in the lung on the body surface is determined on the chest cavity and the lung model;
(2) constructing an umbrella-shaped biopsy/positioning model which is attached to the thoracic cavity model and the lung model and comprises a central positioning module model, an antenna model and a fixed foot stand model by utilizing modeling software again according to the pre-calculated needle inserting angle and depth;
(3) respectively guiding the central positioning module, the antenna model and the fixed foot rest model into a printer and performing 3D printing to obtain a positioning module, an antenna and a fixed foot rest;
(4) and assembling the positioning module die, the antenna and the fixed foot stand which are printed in the 3D mode to obtain the biopsy/positioning device.
Wherein, the central positioning module model is provided with a needle inserting hole which is positioned on the same straight line with the chest cavity and the lung tumor on the lung model.
As above-mentioned preparation method, the utility model discloses biopsy/positioner utilizes 3D printing technique, according to the body surface location mark of patient, the body surface projection position of focus, the needle inserting angle and the degree of depth of the pjncture needle of precalculating, prints individualized biopsy/positioner including central positioning module, corner contact mould and fixed foot rest, and the device possesses following characteristic:
the biopsy/positioning device is in a spider shape, an octopus shape or an umbrella shape in appearance, and is formed by combining a plurality of fixed foot frames 3, antennae 2 and a central positioning module 1 (shown in figures 1-3); wherein,
as shown in fig. 2 and 3, the "central positioning module 1" is a cylinder, a cube or a sphere with a first slot 12, and can be printed into a biopsy module or a preoperative positioning module by 3D printing; the relative position relation between the locating point and the antennal 2 on the surface 4 of the thorax is determined according to the body surface projection of the tumor 7; a designed needle inserting hole 11 is reserved in the central positioning module 1 of the cube, the position and the angle of the inner needle inserting hole 11 are designed according to the computer three-dimensional reconstruction of the CT of a patient, the shielding and the error area caused by the dissection are avoided, 3D printing and manufacturing are carried out, and the entering depth of a positioning needle is calculated; the fixed foot rest, the antenna and the central positioning module are combined into a functional unit;
as shown in fig. 4, the antenna 2 is also a supporting structure which can be recycled for multiple times, and is made of stainless steel material or plastic material; two ends of the fixing frame are respectively provided with a first clamping pin 21 and a second clamping pin 22 so as to connect the fixing foot rest 3 and the central positioning module 1; scales are arranged at the connecting part (the second clamping pin 22 and the second clamping groove 33) of the antenna 2 and the fixed foot stand 3 so as to determine the angle and the height of the antenna;
as shown in fig. 5, the "fixed foot stand 3" is formed by 3D printing, corresponds to body surface markers of a patient, such as the suprasternal fossa, the sternal horn, the xiphoid process, the seventh cervical vertebra, the twelfth rib of the affected chest wall, and the like, meets individual requirements of the patient, is used for determining the placement position of the positioning device, and is provided with a second clamping groove 33 connected with the tentacle 2, and the inclination angle of the second clamping groove 33 can be adjusted and fixed during printing or during use. The parameters of curvature, radian and the like of the bottom surface of the fixed foot rest part are determined according to the actual situation of the thorax surface 4 of the patient.
The utility model discloses a biopsy/positioner's application method does:
firstly, the part of a fixed foot rest 3 is attached to the body surface 4 of the thorax of a patient in a climbing manner, the patient is ordered to inhale deeply and hold breath, and the lower surface of a base 31 of the fixed foot rest 3 of the device is printed according to the individuation of the positioning area of the body surface of the patient, so that the body position of the patient is correct and the device is installed in place under the condition that the part of the fixed foot rest 3 of the device is tightly attached to the thorax of the patient and no local stress/deformation exists;
after the biopsy/positioning device is placed in place, the position of the needle insertion hole 11 in the central positioning module 1 is the position of the needle insertion part for puncture, the puncture needle 5 is inserted through the needle insertion hole 1 reserved on the central positioning module, and the needle is inserted into the corresponding depth along the hole track according to the pre-calculated data by taking the mark point on the central positioning module as a reference, so that the needle point reaches the position of the tumor mass or the position close to the tumor mass, as shown in fig. 1;
preoperative positioning: CT proves that the puncture needle is good in position, after the patient has no obvious complication, hook-wire or a spring ring is manually released, the puncture needle 5 is pulled out, and the puncture positioning is completed after the puncture needle is disinfected and bound; in the operation, the position of a hook-wire or a spring ring is searched, so that the position of a focus can be determined, and lesion tissues can be accurately resected;
puncture biopsy: after CT confirms that the puncture needle is in a good position and the patient has no obvious sign of complication, the biopsy needle core is pulled out and a tissue specimen is extracted.
Application examples
One male patient, age 65, was examined for CT and had one frosted glass nodule shadow in the right lung as shown in figure 6-1 (CT 1).
And reconstructing a chest digital three-dimensional model by using CT before the operation of the patient. Measuring and designing according to the digital model, wherein the body surface projection of the nodule is positioned between the 4 th and 5 th ribs of the right anterior axillary line; a plane tangent to the thorax of the patient is taken as a reference horizontal plane, a body surface projection point is taken as an origin, and a three-dimensional coordinate system is specified: wherein the positive direction of the x-axis is approximately directed from the tail end of the patient to the head end of the patient, the positive direction of the y-axis is approximately directed from the back side of the patient to the ventral side of the patient, and the positive direction of the z-axis is approximately directed from the inner side of the patient to the outer side of the patient. The narrowing angles of the needle insertion angle and the positive directions of the x axis, the y axis and the z axis are respectively 41 degrees, 49 degrees and 7 degrees, and the needle insertion depth is 5cm relative to the projection point.
Drawing a sketch of the device by using 3D Max software, wherein five fixed foot stands of the device are attached to the surface of the chest wall of a patient to run, and the width and the height of the fixed foot stands are 1.5cm and 1cm respectively; the tail ends of the cervical vertebrae respectively correspond to the suprasternal fossa, the sternum angle, the xiphoid process, the seventh cervical vertebra spinous process and the intersection angle of the twelfth rib on the right side and the spine; the 5 tentacles converge on the body surface projection point, namely the center positioning module.
The central positioning module is cylindrical, 3cm in height and 3cm in diameter, and is connected with 5 tentacles into a whole. The central positioning module is provided with a through hole channel with the diameter of 21G from the upper surface to the lower surface, the angle of the through hole channel is the same as the needle inserting angle, the lower end of the through hole channel corresponds to the projection point of the surface of the nodule, and the upper end of the through hole channel is a needle inserting hole.
And (3) importing the generated three-dimensional digital model into a printer driver, performing layered analysis and internal structure calculation, and printing a finished product model by using a rigid transparent hard material as a raw material and using a hot melting layered stacking method. Sterilized by epoxy ethane in hospital supply room, and packed in sterile bag for use.
The patient lies flat on the CT machine examination bed, the thorax is fully exposed, and the right thorax is disinfected before the routine operation. The operating doctor takes the sterile glove, takes the auxiliary positioning device out of the sterile bag, and places and fixes the positioning device on the right chest wall of the patient. After the patient is ordered to inhale deeply, the doctor checks that the alignment of each positioning point is good, the antenna does not receive the influence of abnormal stress, and the whole device can be closely attached to the thorax of the affected side.
And taking one puncture needle, checking the position of the auxiliary positioner again before the operation of the doctor, and determining that the central positioning module is not positioned above the rib or the lower edge of the rib is close to the vascular nerve by using a palpation method. Slowly inserting the puncture needle along the angle of the reserved pore channel until the depth of the puncture needle is preset. After the positioning device is taken down, CT examination is carried out, as shown in figure 6-2, the ideal position of the puncture needle is determined through examination, no adjustment is needed, so that the spring ring is released, as shown in figure 6-3, the puncture needle is pulled out, and the puncture needle is disinfected and bandaged conventionally. After observing the appearance of no complication for half an hour, the patient is sent back to the ward to wait for the period-selecting operation.
The above detailed description of the embodiments of the present invention is only for exemplary purposes, and the present invention is not limited to the above described embodiments. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, variations and modifications in equivalents may be made without departing from the spirit and scope of the invention, which is intended to be covered by the following claims.

Claims (9)

1. A 3D printed extracorporeal assisted biopsy/localization apparatus, wherein the biopsy/localization apparatus is formed by 3D printing, comprising:
the central positioning module is internally provided with a needle inserting pore passage for inserting a puncture needle, and the surface of the central positioning module is provided with a first clamping groove;
one end of the antenna is provided with a first clamping pin in clamping connection with the first clamping groove so as to upwards support the central positioning module, and the other end of the antenna is provided with a second clamping pin; and
the fixed foot rest comprises a base and support legs arranged on the base, the support legs and a plane where the base is located are arranged at a certain angle, one end, far away from the base, of each support leg is provided with a second clamping groove, and the second clamping grooves are connected with second clamping pins in a buckled mode.
2. The 3D printed in vitro assisted biopsy/localization device according to claim 1, wherein the central localization module is cylindrical, cubic or spherical.
3. The 3D printed in vitro assisted biopsy/localization device according to claim 1, wherein the number of the antennae and the fixed foot stands is equal to or greater than 3.
4. The 3D printed in vitro assisted biopsy/localization device according to claim 1, wherein the central localization module is provided with a clamping device for fixing the puncture needle in the needle access hole channel.
5. The 3D printed in vitro assisted biopsy/positioning device according to claim 1, wherein the connection of the proximal end of the second slot to the base is a snap fit movable connection with the spherical proximal end of the second slot through a circular groove provided on the base.
6. The 3D-printed in-vitro auxiliary biopsy/positioning device according to claim 1, wherein the central positioning module, the antenna and the fixed foot rest are made of one or more of ABS resin, polylactic acid, polyvinyl alcohol and nylon.
7. The 3D printed in vitro auxiliary biopsy/positioning device according to claim 1, wherein the connection of the second bayonet lock and the second bayonet lock is provided with a scale to determine the inclination angle and vertical height of the antenna.
8. The 3D printed in vitro assisted biopsy/localization device according to claim 1, wherein the lower surface of the base is a curved surface, the shape of the curved surface conforming to the shape of the thoracic surface.
9. The 3D printed in vitro assisted biopsy/localization device according to claim 1, wherein the needle access port is in line with lung tumors on the thoracic cavity and lung model.
CN201620899497.XU 2016-08-18 2016-08-18 A kind of external assisted biopsy/positioner of 3D printing Active CN206675577U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106073865A (en) * 2016-08-18 2016-11-09 上海市肺科医院 External assisted biopsy/positioner that a kind of 3D prints and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106073865A (en) * 2016-08-18 2016-11-09 上海市肺科医院 External assisted biopsy/positioner that a kind of 3D prints and preparation method thereof
CN106073865B (en) * 2016-08-18 2019-09-10 上海市肺科医院 A kind of external assisted biopsy/positioning device of 3D printing and preparation method thereof

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Effective date of registration: 20210728

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Patentee before: SHANGHAI PULMONARY Hospital