CN116407168A - Biopsy device with focus marker imbedding function and application method - Google Patents

Biopsy device with focus marker imbedding function and application method Download PDF

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Publication number
CN116407168A
CN116407168A CN202310548817.1A CN202310548817A CN116407168A CN 116407168 A CN116407168 A CN 116407168A CN 202310548817 A CN202310548817 A CN 202310548817A CN 116407168 A CN116407168 A CN 116407168A
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China
Prior art keywords
needle tube
focus
firing
marker
biopsy device
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CN202310548817.1A
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Chinese (zh)
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CN116407168B (en
Inventor
赵笑峰
王磊
彭震东
马世成
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Hangzhou Likang Medical Technology Co ltd
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Hangzhou Likang Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0041Detection of breast cancer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3908Soft tissue, e.g. breast tissue
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention discloses an application method of a biopsy device with a focus Marker placement function, which comprises a bottom shell and an upper shell arranged on the bottom shell, wherein a needle tube seat is arranged on the bottom shell, an outer needle tube is arranged on the needle tube seat, an inner needle tube which is matched with the outer needle tube and has a hollow structure, a firing structure which is arranged on the bottom shell and enables the needle tube seat to rapidly perform the firing, and a release mechanism which is arranged on the inner needle tube and has a focus Marker placement function are arranged on the bottom shell.

Description

Biopsy device with focus marker imbedding function and application method
Technical Field
The invention relates to the technical field of biopsy sampling, in particular to an application method of a biopsy device with a focus marker imbedding function.
Background
With advances in imaging technology, there is an increasing number of early breast cancers that are negative for clinical palpation, how are "minimally effective" to locate and resect? How are the same lesion to be marked for subsequent follow-up and surgical treatment, with different imaging techniques to perform and classify the lesion? How does a primary tumor lesion or metastatic lymph node change in size morphology after neoadjuvant chemotherapy to achieve complete pathological remission, preoperative imaging assessment and follow-up? How do intraoperative anatomic and histopathological assessment of cutting edges or precise excision of metastatic lymph nodes? The breast focus positioning mark clamp is called as a breast Marker for short, and is expected to solve the series of dilemmas.
The biopsy needle function and Marker placement instrument adopted in clinic at present are two independent instruments, and the clinical requirement that the Marker is placed within 10mm of the focus bulls-eye position is higher than the surgical operation requirement of re-placement of the Marker after biopsy; firstly, puncture again after biopsy cutting sampling is completed to find a focus position to be placed into a Marker, so that secondary injury is caused to a patient; secondly, because the puncture sampling part is displaced due to the accordion effect, the Marker is punctured again, and the original focus bullion is difficult to accurately find;
therefore, in order to solve the technical problems, the invention provides an application method of a biopsy device with a focus Marker embedding function, wherein biopsy sampling and Marker embedding are completed simultaneously in a process of puncturing a patient once, and a biopsy needle at a focus sampling position can be accurately embedded by a Marker.
Disclosure of Invention
The invention aims to solve the problems and provides an application method of a biopsy device with a focus marker embedding function.
In order to achieve the above purpose, the present invention provides the following technical solutions: the needle tube seat is arranged on the bottom shell, an outer needle tube is arranged on the needle tube seat, the needle tube seat is characterized in that an inner needle tube which is matched with the outer needle tube and has a hollow structure, a firing structure which is arranged on the bottom shell and enables the needle tube seat to be rapidly loaded and fired, and a release mechanism which is arranged on the inner needle tube and has a focus marker placement function are arranged on the bottom shell, and the release mechanism comprises a storage part which is arranged on the inner needle tube and is used for storing focus markers, and a firing rod which is arranged on the inner needle tube and is used for placing focus markers in the storage part into focus positions.
Further preferably, the firing structure comprises a spring arranged on the needle tube seat for enabling the needle tube seat to fire forwards, a firing key arranged on the bottom shell for feeding or firing the needle tube seat and a limiting structure arranged on the bottom shell and the needle tube seat for limiting the needle tube seat, and the inner needle tube is movably arranged on the bottom shell and one end of the inner needle tube is connected with the firing key.
Further preferably, the limit structure comprises a limit bar which is integrally formed with the bottom shell and has elasticity, and a limit boss which is arranged on the needle tube seat and is matched with the limit bar, and the firing key is provided with a grabbing rod which is convenient for grabbing the needle tube seat.
Further preferably, the limiting strip is provided with a clamping table matched with the limiting boss, and the limiting strip is also provided with a guide surface matched with the grabbing rod.
Further preferably, the bottom shell is also provided with a finger ring which is convenient for fixing fingers, and the inner needle tube is provided with a sampling groove.
Further preferably, the lesion Marker is selected from a ceramic Marker or a metal Marker.
Further preferably, one end of the firing bar passes through the firing key, and the other end passes through the sampling groove on the inner needle tube, and the height of the firing bar does not exceed the bottom end face of the sampling groove.
Further preferably, the firing key is also provided with an elastic resetting piece which is connected with the firing bar to reset the firing bar after pushing out the focus marker.
Further preferably, the application method comprises the following steps:
the first step: firing and loading, namely pulling a firing key to drive an inner needle bar and an outer needle tube to load, synchronously compressing a spring, and enabling the spring to be in a state to be fired through a limit strip on a bottom shell;
and a second step of: percussion cutting and sampling, namely puncturing the biopsy device to the edge of a focus to be sampled, puncturing a needle core sampling groove into the focus position by pushing a percussion key, then continuously pushing the percussion key, exciting a needle tube seat, and rapidly cutting the focus position by the needle tube to finish sampling;
and a third step of: the focus marker is put into the focus target through pushing the marker in the firing bar storage part;
fourth step: taking out the biopsy device, and completing sampling and marker placement.
It is further preferred that before the marker is placed, the inner needle tube is moved outwards by a specified distance, and the distance is such that the position of the marker after pushing out is not more than 10MM from the position of the focus target when cutting and sampling.
The invention has the beneficial effects that: through the arrangement of the release mechanism, the Marker placement machine is combined with the biopsy needle, after the breast biopsy is cut and sampled, the firing bar is pushed to place the Marker in the sampling focus part, so that the damage to a patient caused by the secondary Marker placement is avoided, the Marker placement accuracy is improved, and good marking and positioning effects are achieved for the follow-up observation before operation, the pathological cutting edge evaluation during operation and the accurate lesion excision;
the inner needle tube is arranged to be of a hollow structure, so that focus marks can be conveniently stored in the storage part, and meanwhile, the firing bar is pushed to place the focus marks into focus bulls centers, so that the operation is simple and convenient;
through the arrangement of the limiting mechanism, when the trigger key pulls the needle tube seat to move backwards, the needle tube seat is limited on the bottom shell by the limiting mechanism, so that the loading is completed, when the trigger key is pushed to move forwards, the trigger key pushes the limiting structure open, and the needle tube seat is rapidly and forwards triggered under the action of the spring, so that the cutting sampling is realized;
the triggering bar is connected with the triggering key through the elastic resetting piece, so that the situation that the focus marker is put in advance and the position deviation of the focus marker is large due to the fact that the triggering bar on the triggering key is pushed out forwards by misoperation when the triggering key is pushed forwards is avoided; the elastic reset piece is utilized to enable the firing bar to synchronously move with the firing key all the time, thereby effectively preventing misoperation and improving the accuracy of the placement of focus markers; meanwhile, the elastic resetting piece enables the firing bar to have the resetting function after firing the focus marker.
Drawings
FIG. 1 is a schematic diagram of the overall structure of the present invention;
FIG. 2 is a schematic diagram of the overall cross-sectional structure of the present invention;
FIG. 3 is an enlarged schematic view of the structure of the present invention at A;
FIG. 4 is a schematic view of the firing bar of the present invention;
FIG. 5 is a schematic view of the bottom shell structure of the present invention;
FIG. 6 is an enlarged schematic view of the structure of the present invention at the position B;
fig. 7 is a schematic structural diagram of embodiment 2 of the present invention.
The marks in the figure are as follows: 1 bottom shell, 11 inner needle tube, 12 needle tube seat, 13 outer needle tube, 14 finger ring, 15 sampling groove, 2 upper shell, 31 storage part, 32 firing bar, 41 spring, 42 firing key, 43 limit bar, 44 limit boss, 45 grabbing bar, 46 clamping table, 47 guide surface and 5 elastic reset piece.
Detailed Description
The following describes in further detail the application method of a biopsy device with lesion marker insertion function according to the present invention with reference to the accompanying drawings.
Referring to fig. 1 to 6, the application method of a biopsy device with function of placing focus markers in this embodiment includes a bottom case 1, an upper case 2 mounted on the bottom case 1 by a buckle, wherein a closed structure is formed between the bottom case 1 and the upper case 2, a needle holder 12 is slidably mounted on the bottom case 1, an outer needle tube 13 is integrally injection-molded on the needle holder 12, and the biopsy device is characterized in that an inner needle tube 11 with hollow structure and adapted to the outer needle tube 13 is movably mounted on the bottom case 1, a firing structure is mounted on the bottom case 1 to enable the needle holder 12 to rapidly perform firing, a release mechanism with function of placing focus markers is mounted on the inner needle tube 11, the release mechanism includes a storage part 31 for storing focus markers mounted on the inner needle tube 11, a firing rod 32 mounted on the inner needle tube 12 for placing focus markers in the storage part 31 at focus positions, a ring 14 for facilitating finger fixation is further mounted on the bottom case 1, and a sampling groove 15 is provided on the inner needle tube 11; through the arrangement of the release mechanism, the Marker placement machine is combined with the biopsy needle, after the breast biopsy is cut and sampled, the firing bar 32 is pushed to place the Marker in the sampling focus part, so that the damage to a patient caused by the secondary Marker placement is avoided, the Marker placement accuracy is improved, and a good marking and positioning effect is also achieved for follow-up observation of the later non-malignant focus; by arranging the inner needle tube 11 into a hollow structure, the focus marker is convenient to store in the storage part 31, and meanwhile, the firing bar 32 is pushed to place the focus marker into the focus target, so that the operation is simple and convenient.
The firing structure comprises a spring 41 arranged on the needle tube seat 12 for forward firing of the needle tube seat 12, a firing key 42 arranged on the bottom shell 1 for loading or firing the needle tube seat 12 and a limiting structure arranged on the bottom shell 1 and the needle tube seat 12 for limiting the needle tube seat 12, and the inner needle tube 11 is movably arranged on the bottom shell 1 and one end of the inner needle tube 11 is connected with the firing key 42; wherein the spring 41 is located between the needle holder 12 and the bottom shell 1; by means of the arrangement of the spring 41, when the needle tube seat 12 is rapidly fired after the bottom shell 1 is loaded, the needle tube seat 12 drives the outer needle tube 13 to be instantaneously fired forward by the aid of resilience force of the spring 41, and therefore cutting and sampling are achieved.
The limiting structure comprises a limiting strip 43 which is integrally formed with the bottom shell 1 and has elasticity, and a limiting boss 44 which is arranged on the needle tube seat 12 and matched with the limiting strip 43, a grabbing rod 45 which is convenient for grabbing the needle tube seat 12 is arranged on the firing key 42, a clamping table 46 matched with the limiting boss 44 is arranged on the limiting strip 43, and a guide surface 47 matched with the grabbing rod 45 is also arranged on the limiting strip 43; through the setting of stop gear, when trigger key 42 pulling needle tube seat 12 moves backward, utilize stop gear to limit needle tube seat 12 on drain pan 1 to accomplish the loading, when pushing trigger key 42 and moving forward, trigger key 42 jack-up spacing 43, the effect of spring 41 is with needle tube seat 12 forward quick percussion, realizes the cutting sample.
The limit structure works as follows: by pulling the trigger key 42 backwards, the grab bar 45 on the trigger key 42 drives the needle tube seat 12 to move backwards in the bottom shell 1 and compress the spring 41, the limit boss 44 presses the clamping table 46 to enable the limit bar 43 to incline downwards in the moving process of the needle tube seat 12 until the limit boss 44 does not press the clamping table 46 any more, the limit bar 43 is restored to be in an original state to enable the clamping table 46 to limit the limit boss 44, so that the needle tube seat 12 is in a loading state, along with forward pushing of the trigger key 42, the grab bar 45 contacts the limit bar 43 and presses the guide surface 47, the guide surface 47 is pressed to enable the elastic limit bar 43 to incline downwards, so that the clamping table 46 is separated from the limit boss 44, at the moment, the needle tube seat 12 is instantly and forwards fired under the resilience force of the spring 41, and the needle tube seat 12 drives the outer needle tube 13 to be quickly and forwards fired at the outer side of the inner needle tube 11, and focal tissues on the sampling groove 15 are quickly cut.
The focus Marker is selected from a ceramic Marker or a metal Marker, one end of the firing bar 32 passes through the firing key 42, the other end passes through the sampling groove 15 on the inner needle tube 11, and the height of the firing bar should not exceed the bottom end surface of the sampling groove 15; wherein the Marker has the function of developing and being positioned fast under medical equipment, firing bar 32 one end terminal surface height is not more than the bottom terminal surface of sampling groove 15 to guarantee that the focus sample of cutting the sample can not receive the influence because of firing bar 32's action.
The application method comprises the following steps:
the first step: the firing and the loading are carried out, the firing key 42 is pulled backwards, the inner needle tube 11 moves backwards along with the firing key 42, meanwhile, the grabbing rod 45 on the firing key 42 drives the needle tube seat 12 to move backwards in the bottom shell 1 and compresses the spring 41, the limiting boss 44 presses the clamping table 46 to enable the limiting bar 43 to incline downwards in the moving process of the needle tube seat 12 until the limiting boss 44 does not press the clamping table 46 any more, the limiting bar 43 is restored to enable the clamping table 46 to limit the limiting boss 44, and therefore the needle tube seat 12 is in the loading state, and at the moment, the biopsy device is in the state to be fired;
and a second step of: the biopsy device is triggered to cut and sample, the biopsy device is penetrated to the edge of a focus to be sampled, then the trigger key 42 is pushed to move forwards, the trigger key 42 drives the inner needle tube 11 to penetrate the focus to be biopsied, focus tissues are left on the sampling groove 15, the grab bar 45 contacts the limit bar 43 at the moment, the trigger key 42 is pushed again, the grab bar 45 contacts and presses the guide surface 47, the elastic limit bar 43 is downwards inclined after the guide surface 47 is pressed, so that the clamping table 46 is separated from the limit boss 44, and the needle tube seat 12 is instantaneously triggered forwards under the resilience force of the spring 41 at the moment, so that focus tissues are cut in the sampling groove 15;
and a third step of: after the sampling and cutting are finished, the biopsy device is controlled to be pulled out outwards to enable the inner needle tube 11 to move outwards, and the firing bar 32 moves forwards along the inner needle tube 11 to push the focus marker out of the inner needle tube 11 and put the focus marker into a focus position by pushing the firing bar 32;
fourth step: taking out the biopsy device, taking out the biopsy device from the patient, and completing biopsy sampling and lesion marker placement.
Implementation of the embodiments example 2:
referring to fig. 7, the difference between the present embodiment and embodiment 1 is that: the firing key 42 is also provided with an elastic reset piece 5 which is connected with the firing bar 32 to reset the firing bar 32 after pushing out the focus marker; the elastic restoring piece 5 refers to a metal piece or a nonmetal piece with elasticity, such as a spring or a rubber or plastic shrapnel; the firing bar 32 and the firing key 42 are connected together through the elastic reset piece 5, so that the situation that the focus marker is put in advance due to the fact that the firing bar 32 on the firing key 42 is pushed out forwards by misoperation when the firing key 42 is pushed forward is avoided, and the position deviation of the focus marker is large; the elastic reset piece 5 is utilized to enable the firing bar 32 to synchronously move with the firing key 42 all the time, thereby effectively preventing misoperation and improving the accuracy of the placement of focus markers; meanwhile, the elastic reset piece 5 enables the firing bar 32 to have a quick reset function after firing the focus marker.
Example 3:
the difference between this embodiment and embodiment 1 is that: the application method of the embodiment further comprises the step of moving the inner needle tube outwards for a specified distance before the focus marker is placed, wherein the distance is such that the superposition deviation between the position of the marker after pushing out and the position of the focus target during cutting and sampling is not more than 10MM; by moving the inner needle tube 11 outwards for a specified distance, the elastic reset piece 5 is pressed to enable the firing bar 32 to push the focus marker in the storage part 31 to be placed into the focus target, and the deviation between the placement position of the focus marker and the focus target of cutting sampling should not exceed 10MM, so that accurate positioning is realized.
The scope of the present invention is not limited to the above embodiments and their modifications, and conventional modifications and substitutions made by those skilled in the art based on the contents of the present embodiments fall within the scope of the present invention.

Claims (10)

1. The utility model provides a biopsy device with focus marker is put into function, includes drain pan (1), installs epitheca (2) on drain pan (1), drain pan (1) on install needle tube seat (12), needle tube seat (12) on be equipped with outer needle tube (13), characterized by still drain pan (1) on install with outer needle tube (13) looks adaptation and have interior needle tube (11) of hollow structure, set up the firing structure that makes needle tube seat (12) bore fast on drain pan (1), install and have focus marker and put into the release mechanism of function on interior needle tube (11), release mechanism including set up in needle tube (11) be used for depositing focus marker storage portion (31), install in needle tube (12) on be used for with the firing bar (32) of the focus marker of putting into focus position in storage portion (31).
2. A biopsy device having lesion marking placement functionality according to claim 1, further characterized by: the firing structure comprises a spring (41) which is arranged on the needle tube seat (12) and enables the needle tube seat (12) to fire forwards, a firing key (42) which is arranged on the bottom shell (1) and used for feeding or firing the needle tube seat (12) and a limiting structure which is arranged on the bottom shell (1) and the needle tube seat (12) and used for limiting the needle tube seat (12), wherein the inner needle tube (11) is movably arranged on the bottom shell (1) and one end of the inner needle tube is connected with the firing key (42).
3. A biopsy device having lesion marking placement functionality according to claim 2, further characterized by: the limiting structure comprises a limiting strip (43) which is integrally formed with the bottom shell (1) and is elastic, and a limiting boss (44) which is arranged on the needle tube seat (12) and is matched with the limiting strip (43), and a grabbing rod (45) which is convenient for grabbing the needle tube seat (12) is arranged on the firing key (42).
4. A biopsy device having lesion marking placement functionality according to claim 3, further characterized by: the limiting strip (43) is provided with a clamping table (46) matched with the limiting boss (44), and the limiting strip (43) is also provided with a guide surface (47) matched with the grabbing rod (45).
5. A biopsy device having lesion marking placement functionality according to claim 2, further characterized by: the bottom shell (1) is also provided with a finger ring (14) which is convenient for fixing fingers, and the inner needle tube (11) is provided with a sampling groove (15).
6. A biopsy device having lesion marking placement functionality according to claim 1, further characterized by: the focus Marker is selected from a ceramic Marker or a metal Marker.
7. A biopsy device having lesion marking placement functionality according to claim 1 or 2, further characterized by: one end of the firing bar (32) passes through the firing key (42), and the other end passes through the sampling groove (15) on the inner needle tube (11), and the height of the firing bar does not exceed the bottom end surface of the sampling groove (15).
8. A biopsy device having lesion marking placement functionality according to claim 7, further characterized by: the firing key (42) is also provided with an elastic reset piece (5) which is connected with the firing bar (32) to enable the firing bar (32) to reset after pushing out the focus marker.
9. The method of using a biopsy device having lesion marking placement functionality according to any of claims 1-9, wherein: the application method comprises the following steps:
the first step: firing and loading, namely pulling a firing key to drive an inner needle bar and an outer needle tube to load, synchronously compressing a spring, and enabling the spring to be in a state to be fired through a limit strip on a bottom shell;
and a second step of: percussion cutting and sampling, namely puncturing the biopsy device to the edge of a focus to be sampled, puncturing a needle core sampling groove into the focus position by pushing a percussion key, then continuously pushing the percussion key, exciting a needle tube seat, and rapidly cutting the focus position by the needle tube to finish sampling;
and a third step of: the focus marker is put into the focus target through pushing the marker in the firing bar storage part;
fourth step: taking out the biopsy device, and completing sampling and marker placement.
10. The method of using a biopsy device having lesion marking placement functionality according to claim 9, wherein: before the focus marker is placed, the inner needle tube can be moved outwards by a specified distance, and the distance is enough to ensure that the position of the marker after pushing out is not more than 10MM from the position of the focus target during cutting and sampling.
CN202310548817.1A 2023-05-16 2023-05-16 Biopsy device with focus marker is put into function Active CN116407168B (en)

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