CN114246615A

CN114246615A - HPV sampling device and sampling training device

Info

Publication number: CN114246615A
Application number: CN202111249007.3A
Authority: CN
Inventors: 杨惠; 毛萌
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-10-26
Filing date: 2021-10-26
Publication date: 2022-03-29

Abstract

The invention provides an HPV biopsy device and a sampling training device, comprising a handle with a handle near end and a handle far end; the sampling brush bundle is provided with bristles and a bristle seat, and the bristles are fixed on the bristle seat and are in a bundle shape; the brush bundle expanding component is provided with a first posture and a second posture, the brush bundle is in a bundle-shaped furling state under the first posture, and the brush bundle is in a blossom-shaped unfolding state under the second posture. The method has the advantages that the skills and standards of the special technical examination sampling personnel are presented in the newly designed sampling device by the formation of technical limits and technical standards, so that a general inexperienced examiner can understand and execute the HPV professional sampling process, and the success rate of obtaining the primary sample of the non-professional HPV self-sampling is obviously improved. The aim of realizing wide coverage, periodicity/periodicity and high reliability (low omission factor) of HPV detection on a macroscopic scale can be comprehensively executed.

Description

HPV sampling device and sampling training device

Technical Field

The invention belongs to the technical field of HPV (human papillomavirus) auxiliary diagnosis and treatment, relates to an HPV detection sample sampling technology, and particularly relates to an HPV sampling device and a device use skill training device corresponding to the sampling device.

Background

HPV (human papilloma virus) is a papilloma vacuolatum virus A genus belonging to papovaviridae family, is a spherical DNA virus and can cause squamous epithelial proliferation of human skin mucosa. More than 130 types have been isolated, with different types leading to different clinical manifestations. The tissue invasion can be classified into the following types according to different tissue sites: (1) low-risk skin type: including HPV1, 2, 3, 4, 7, 10, 12, 15, etc., associated with common warts, flat warts, plantar warts, etc.; (2) skin high risk type: including HPV5,8, 14, 17,20,36,38, are associated with epidermodysplasia verruciformis, and other malignancies that are also associated with possible HPV infections include: vulvar, penile, anal, prostate, bladder cancer; (3) mucosal low risk types such as HPV-6, 11, 13, 32, 34, 40, 42, 43, 44, 54, etc. and infected genital, anal, oropharyngeal, and esophageal mucosa; (4) mucosa high-risk HPV-16, 18, 30, 31, 33, 35, 53 and 39 and cervical cancer, rectal cancer, oral cancer, tonsil cancer and the like.

Studies have shown that the probability of HPV infection in women during their lifetime is as high as 80%. Persistent infection with high-risk HPV types is a major risk factor for cervical cancer. More than 90% of cervical cancers are accompanied by high-risk HPV infection.

In cases of cervical cancer caused by HPV infection, the period of the cases from infection to onset is generally long, which can last for ten years. Therefore, the detection and management of HPV virus infection conditions in a continuous and periodic manner are carried out to achieve the goal of cervical cancer prevention and treatment, and the detection and management become one of effective solutions for cervical cancer prevention and treatment.

In practice, for most inconclusive subjects (subjects in general), the prevention and treatment of cervical cancer is mainly based on periodic detection of HPV infections. And infection (positive result) is still a very small probability event for each test. The positive probability of the HPV result in each detection is very small, so that most people are difficult to actively and regularly detect HPV virus. In general, various daily and sporadic factors such as work, business trips, even small activities such as travel, parties and the like are reasons why the examinee gives up or delays examination. The time, flow and privacy required by the hospital examination are the main factors for the rejected examination of the examinee and also are important factors for the low macroscopic coverage rate of the overall periodic examination.

In order to solve the problem, a self-sampling logistics inspection technology relying on logistics inspection and home self-sampling is developed. The person who should examine buys/obtains the sampling device for detection by oneself, and through the commodity circulation censorship after sampling by oneself, detection mechanism feeds back the result to the person who should examine.

The core goal of periodic, comprehensive detection is to achieve early detection/screening of HPV infection, and thus sampling success is a prerequisite for this goal. In the traditional hospital detection mode, since the doctor who performs the examination and sampling receives the professional sampling training, the success rate of sampling can be ensured by using a common tool and combining with professional knowledge such as sampling depth (position), sampling methods corresponding to different sampling brush shapes and the like. However, in the self-sampling process, the sampling action is completed by the examiner himself, so that specialized sampling education is difficult to realize, and the low success rate caused by the sampling specialty becomes an important factor for restricting the realization of the self-detection purpose.

Disclosure of Invention

The invention designs an HPV sampling device according to the conception of the invention, which aims to solve the problem of sampling failure caused by insufficient sampling professional technology of a person to be detected during HPV self-detection and self-sampling, and designs a sampling training device for rapidly improving the sampling skill of the person to be detected, wherein one of the specifically adopted technical schemes is as follows:

an HPV biopsy device comprising a handle having a proximal handle end and a distal handle end;

which is characterized by comprising the following steps of,

the sampling brush bundle is provided with bristles and a bristle seat, and the bristles are fixed on the bristle seat and are in a bundle shape;

the brush bundle expanding component is provided with a first posture and a second posture, the brush bundle is in a bundle-shaped furling state under the first posture, and the brush bundle is in a blossom-shaped unfolding state under the second posture.

An alternative solution is:

the brush bundle-expanding member includes a brush bundle-expanding member,

the attitude control assembly A is provided with a control end A1 arranged at the proximal end of the handle, a transmission part A2 and an execution part A3.

An alternative solution is:

the executing part A3 is provided with an air bag;

the transmission part A2 is provided with an air channel;

the control end A1 has a pressing part;

the pressing part, the air channel and the air bag are connected to form an airtight space, and external force acts on the pressing part to enable the air bag to be changed from the first posture to the second posture.

An alternative solution is:

the air bag is provided with a recovery concave part, the recovery concave part is provided with prestress, and the prestress acts on the concave part to enable the concave part to have the tendency of maintaining the first posture;

and the restoring recessed portion is convertible from a recessed state to an expanded state by an increased air pressure from the inside of the airbag, and generates an outward thrust on the edge of the restoring recessed portion.

An alternative solution is:

the brush hair seat is a flexible membrane, has an outer surface and is used for fixing brush hair;

the transmission part A2 is provided with an air passage which is provided with a near end B1 and a far end B2;

the control end A1 has a pressing portion connected to the proximal end B1;

the flexible diaphragm is provided with an inner surface, and the inner surface covers the far end B2 of the air passage; the flexible membrane, the air channel and the extrusion part are closed to form an airtight space; the external force acts on the pressing part to enable the flexible diaphragm to be changed from the first posture to the second posture.

An alternative solution is:

the executing part A3 is provided with an umbrella-shaped push rod and an expanding ring;

the umbrella-shaped push rod is folded into a first posture, and the umbrella-shaped push rod is pushed out into a second posture.

An HPV biopsy device according to claim 6,

the umbrella push rod and the expansion ring are connected to form a prestress, and the prestress has an action tendency of enabling the umbrella push rod to be in a first posture.

An alternative solution is:

the control end has a locking assembly that provides a continuous force to maintain the implement a3 in the second position.

An alternative solution is:

the control end is provided with a locking releasing assembly, and the locking releasing assembly can release the locking state of the locking assembly.

An alternative solution is:

a tube L having an open tube proximal end and an open tube distal end;

the handle and the sampling brush bundle are arranged in the tube L;

wherein the sampling brush bundle is close to the distal end of the tube, and the proximal end of the handle is close to the proximal end of the tube;

wherein the handle has a degree of freedom of reciprocating motion in the tube L along the axial direction of the tube L, and the sampling position can be extended towards the far end of the tube and the introduction position can be retracted towards the near end of the tube;

wherein, when the handle extends to the sampling position, the sampling brush bundle is positioned outside the tube L and near the far end of the tube.

An alternative solution is:

an extension limiting member for providing an extension position of the handle in a direction of the reciprocating degree of freedom and having a degree of freedom of rotation about the axis of the tube L when the handle is extended to the sampling position; and, a degree of freedom of reciprocation under defined conditions.

An alternative solution is:

a threshold force condition having a threshold force F0;

when the external force acting on the handle is larger than F0, the handle can retract towards the near end of the tube;

and when the external force acting on the handle is not more than F0, the handle only has the freedom of rotating around the axis of the tube L.

An alternative solution is:

and the cap can cover the far end of the tube L when the tube L is positioned at the guiding position and can block the open port at the far end of the tube.

An alternative solution is:

the cap lock catch can be used for locking the cap in a covering posture.

An alternative solution is:

a handle thrust member having a thrust attitude and a free attitude;

when the cap is in a covering state, the handle thrust piece is in a thrust posture;

when the cap is in a non-covering state, the handle thrust piece is in a free posture;

the thrust attitude is provided with a limit bulge, and the limit bulge is used for limiting the handle to extend and move to the sampling position on the reciprocating motion degree of freedom;

the free posture can release the limiting protrusion, and the limitation of the limiting protrusion on the extension motion of the handle is released;

wherein, the handle extension motion is the motion of handle to sample position direction on the reciprocating motion degree of freedom.

An alternative solution is:

a depth stop assembly having a means for limiting the maximum depth to which the sampling device, and in particular the sampling brush bundle, extends toward the sampling location.

An alternative solution is:

the cap lock catch is a bidirectional elastic buckle and has an elastic threshold force F1;

wherein, when the external reverse acting force is larger than F1, the cover lock catch can be released and unlocked.

An alternative solution is:

the cap lock catch comprises a cover body and a cover body,

a secondary latch having an unlocking force direction different from the external counter force.

An alternative solution is:

the secondary locking member comprises a first locking member and a second locking member,

and a rotation locking part which can rotate and unlock by applying unlocking force.

A sampling training device is characterized by comprising,

a handle of any of the above described HPV biopsy devices; and the combination of (a) and (b),

control end a1 of any of the above described HPV biopsy device.

An alternative solution is:

the sampling training device comprises a locking component of the HPV biopsy device;

wherein, a locking component is arranged at the control end, and the locking component can provide continuous acting force to maintain the executing part A3 at the second posture.

An alternative solution is:

the sampling training device comprises a locking release component of the HPV biopsy device;

the locking releasing assembly is arranged at the control end and can release the locking state of the locking assembly.

An alternative solution is:

the sampling training device comprises a tube L in the HPV biopsy device; and/or the presence of a gas in the gas,

an extension limiting member for providing an extended position of the handle in the direction of the degree of freedom of the reciprocating movement and having a degree of freedom of rotation about the axis of the tube L when the handle is extended to the sampling position; and, a degree of freedom of reciprocation under defined conditions; and/or the presence of a gas in the gas,

Wherein tube L has an open tube proximal end and an open tube distal end;

the handle and the sampling brush bundle are arranged in the tube L;

The locking device comprises a cover cap lock catch and can be used for locking the cover cap in a covering posture.

Wherein the method comprises the following steps of,

a handle thrust member having a thrust attitude and a free attitude;

An alternative solution is:

the cap latch may be a bi-directional resilient latch having a resilient threshold force F1;

An alternative solution is:

the cap lock catch comprises a cover body and a cover body,

An alternative solution is:

the sampling training device comprises a depth limiting component of the HPV biopsy device;

the depth stop assembly has a means for limiting the maximum depth to which the sampling device, and in particular the sampling brush bundle, extends toward the sampling location.

The method has the advantages that the skill and the standard of a person who has special technology and tests the sample are presented in the newly designed sampling device by the formation of technical limitation and technical standard, so that a general inexperienced person who needs to test can understand and execute the HPV professional sampling process, and the success rate of obtaining the primary sample of the non-professional HPV by self-sampling is obviously improved. The aim of realizing wide coverage, periodicity/periodicity and high reliability (low omission factor) of HPV detection on a macroscopic scale can be comprehensively executed.

Drawings

FIG. 1 is a schematic diagram of the construction of an HPV biopsy device;

FIG. 2 is a schematic view of the connection of the handle and the sampling brush bundle;

FIG. 3 is a schematic view of the connection of the tube L to the handle;

FIG. 4 is a schematic view of a brush bundle in a bundle state;

FIG. 5 is a schematic view of a brush bundle in a flower-like deployed state;

FIG. 6 is a cross-sectional view of one embodiment of the handle with the brush bundle in a flower-like deployed configuration;

FIG. 7 is a cross-sectional view of an embodiment of the handle with the brush bundles in a bundled state;

FIG. 8 is a comparison of a bunched up configuration and a bloomed up configuration of an embodiment;

FIG. 9 is a comparison of a bunched up configuration and a bloomed up configuration of an alternative embodiment;

FIG. 10 is a schematic view of the cap attachment;

FIG. 11 is a schematic view of a cap attachment process;

FIG. 12 is a schematic illustration of the locking and unlocking process of the secondary latch;

FIG. 13 is a schematic view of the limit projection and the handle thrust piece;

FIG. 14 is a schematic view of another perspective of FIG. 3;

FIG. 15 is a schematic diagram of a sample training device;

fig. 16 is a schematic structural diagram of a sampling training apparatus in another state.

Reference numerals:

the handle comprises a handle 10, a handle near end 11, a handle far end 12 and a limiting bulge 13;

a sampling brush bundle 20, bristles 21 and a bristle base 22;

the control end A1, the locking component 31, the locking release component 32, the squeezing part 33, the transmission part A2, the air channel 34, the proximal end B1, the distal end B2, the execution part A3, the air bag 35, the umbrella-shaped push rod 36 and the expanding ring 361;

tube L, tube proximal end 41, tube distal end 42, depth stop assembly 43;

an extension limiting member 40;

cap 50, bidirectional elastic buckle 51, rotation locking part 52 and handle thrust piece 53.

Detailed Description

For the purpose of facilitating an understanding of the concepts claimed herein, the following specific embodiments designed according to the concepts of the present invention are provided. It should be understood that the specific structures and techniques designed and illustrated in the following schemes to illustrate the inventive concepts are not intended to limit the scope of the present invention, but should not be construed as limiting the scope of the invention.

Example 1:

referring to fig. 1-14, an HPV biopsy device includes a handle 10 having a proximal handle end 11 and a distal handle end, wherein the proximal end is adapted to be manually held by an examiner during use. The sampling brush bundle 20 is provided with bristles 21 and a bristle seat 22, and the bristles 21 are fixed on the bristle seat 22 and are in a bundle shape. Since the bristles 21 have a soft structure, the state of the bunched bristles 21 is also a specific state in a general state (e.g., a transportation and storage state after production), and is not an absolute state.

The expansion of the brush bundle can be established by the ordinary skilled person according to the structure and function realization principle. The bristle holder 22 is provided with two controllably switchable poses, enabling subjective control of the macroscopic pose of the bristles.

In the above embodiments, the main purpose of the tuft structure design of the bristles is: the sampling position of the device is in a cavity-like structure of the human body, such as uterus/body cavity. The cavity structure and depth, as well as safety indicators and risk control schemes, should be well known to the professional sampling personnel. However, even if the general self-tester informs the sampling requirement, the self-tester may insert too deeply due to the personal understanding deviation, the operation process tension, the misoperation and the like, and may cause the injury. Most of the existing sampling devices are of a structure that bristles are clamped by twisted iron wires, and the bristles of the structure are always in an unfolded state in the process of entering a body cavity to reach a target position (usually a cervical orifice), so that the body cavity wall of the non-target position is stimulated, non-target sampling objects can be brushed down, and the sampling result can be interfered; meanwhile, the foremost end of the sampling brush in the body cavity entering direction is the tail end of the twisted pair iron wire for fixing the brush hair, which belongs to a sharp hard object, and even if the prior product is subjected to material coating passivation treatment, the force transmitted by the hardness is large, so that the tail end can be injured.

In comparison, the front end of the bundle-shaped bristles in the direction that the brush body is sent into the body cavity is the bristles, the softness of the bristles meets the sampling standard and naturally meets the safety stimulation standard, and the bundle-shaped bristles have a good safety protection effect. Specifically, the safe distance can reach the complete length (1-3cm) of the bristles, and the safe length can meet the misoperation allowable range of an ordinary inexperienced person, so that the inexperienced operator can safely use the brush under conventional misoperation with high probability.

The brush hair is arranged on the brush hair seat with multiple states, so that the brush hair bundle has two states of bunchy furling and flower spreading. When the body cavity sampler is used, the bristles can be in a bundle shape in the process of entering the body cavity to reach a target sampling position, so that the stimulation of the body cavity wall in the entering process is reduced, the safety is improved, and the bristle function is protected; after reaching the sampling position, the bristles are controlled to be in a flower-shaped unfolding shape, and the omnibearing effective sampling including the position of the cervical orifice can be realized by rotating the handle 10.

Example 2:

referring to fig. 6-9, an alternative approach:

the brush bundle-expanding member includes a brush bundle-expanding member,

the attitude control assembly A is provided with a control end A1 arranged at the proximal end 11 of the handle bar, a transmission part A2 and an execution part A3.

This embodiment specifically discloses a solution to the spreading mechanism, which is designed to solve the problem of brush bundle spreading with the attitude control assembly a consisting of the control end a1, the transmission part a2 and the actuator part A3, which are disposed at the proximal end 11 of the handle grip. Wherein the control end is arranged at the proximal end 11 of the handle grip to allow free control of the expansion of the brush bundle. The separation of the insertion process and the state control of reaching the destination position is realized.

Example 3:

an alternative solution is:

referring to fig. 6 to 8, the actuating portion a3 has an air bag 35;

the transmission part A2 has an air passage 34;

the control end a1 has a pressing portion 33;

the pressing portion 33, the air passage 34 and the air bag 35 are connected to form an airtight space, and an external force acts on the pressing portion 33 to change the air bag 35 from the first posture to the second posture.

Specifically, the air bag 35 may be a homogeneous elastic air bag, and the inflatable volume is variable; the direction of the preferential unfolding direction of the air bag can be set according to the direction of the force required by the unfolding of the brush bundle, and the direction of the expansion of the air bag is guided by setting the non-homogeneous weak track; or a pre-formed folding state is set, and the folding state is unfolded to form a second posture when the air pressure is increased. The scheme of driving the air bag by pneumatic transmission is adopted, the control structure is simple, the transmission part only needs an airtight cavity, and the product design freedom degree is high; the air transmission is equivalent to 'no transmission part', the product cost can be reduced, and the air transmission system also has positive effects on the aspects of medical antibiosis and system reliability.

Example 4:

an alternative solution is:

referring to fig. 6-7, the bladder has a restoring indentation with a pre-stress that acts on the indentation to cause the indentation to have a tendency to maintain the first position;

This embodiment may be one of the above embodiments in which the folded state is formed in advance.

Example 5:

an alternative solution is:

referring to fig. 6-7, the bristle holder is a flexible membrane having an outer surface for holding bristles;

the transmission part A2 is provided with an air passage 34, and the air passage 34 is provided with a near end B1 and a far end B2;

the control end A1 has a pressing portion 33, the pressing portion 33 is connected with the proximal end B1;

The flexible membrane solution is different from the above air bag solution, which mainly depends on the change of the air bag posture to squeeze the bundle-shaped bristles to expand, and the bristles are required to be deformed essentially. However, the bristles made of most materials are difficult to recover normally after being bent and deformed, so that when the sampling device is withdrawn after sampling is finished, the bristles which are not recovered normally into a bundle shape are in contact friction with the body cavity wall, so that the obtained sample falls on the body cavity wall due to friction, and the sampling success rate is influenced. In this embodiment, the principle that the bristles on the membrane are expanded from a bunch shape to a flower shape is that the back surface of the membrane is pressed (in this embodiment, air pressure is used, and it can be understood that mechanical force applied by a push rod is also extended) and protrudes (bulges) toward the front surface, the planar membrane is changed into a spherical surface, and the bristles distributed on the spherical surface radially extend along the spherical surface and are expanded (second posture). The deformation object of the unfolding process is a membrane, and the membrane has good recovery property, so the scheme can solve the defects of the airbag scheme.

Example 6:

an alternative solution is:

referring to fig. 9, the actuating portion a3 has an umbrella shaped push rod 36 and an expanding ring;

the umbrella-shaped push rod 36 is folded into a first posture, and the umbrella-shaped push rod 36 is pushed out into a second posture.

The proposal is a proposal of mechanical transmission and umbrella-shaped structure design for bristle expansion. The scheme is stable and reliable, and compared with air pressure transmission, the stability and reliability of mechanical transmission have outstanding advantages under different processes. Meanwhile, if the airtight transmission channel is difficult to realize due to other designs of the product, the scheme is also an ideal alternative scheme, and the design space of the product is larger. Is also a preferred alternative under the limited conditions of the production process.

Example 7:

referring to fig. 9, the umbrella push rod 36 and the expanding ring are connected to form a prestress having a tendency to bring the umbrella push rod 36 into the first posture.

After the prestress is set, the operation process of changing the posture is simplified. One-handed posture change operations are generally possible. This application is significant because when self-sampling, especially HPV self-sampling, is usually done without hands, any one more or one more complicated operation will affect the sampling success rate (unlike sampling by trained professionals).

Example 8:

an alternative solution is:

referring to fig. 10-12, the control end has a locking assembly 31, and the locking assembly 31 can provide a continuous force to maintain the actuator a3 in the second position.

The sampling process has a number of steps including feeding the sampling device into a sampling location; spreading the sampling brush 20; the rotating deployed sampling brush at a constant speed typically requires five or more revolutions. After the brush bundle is unfolded, if the force for maintaining the unfolding of the brush bundle is provided by hands under the condition of reverse-hand operation, the unfolding of the brush bundle is unstable in the rotary sampling process, the sample is not sufficiently obtained, and the success rate of sampling is influenced. This problem is solved by the locking assembly 31.

The locking assembly 31 is provided depending on the particular tuft spreading assembly used. For example, if the piston is driven by pressing air pressure, a mechanical locking structure for the piston is required, or an air pressure one-way valve is arranged, and an unlocking component for unlocking the air pressure one-way valve is arranged. In the case of mechanical constructions, a lock may be provided for the respective moving end, typically at the end of the movement.

Example 9:

an alternative solution is:

referring to fig. 6-7, the control end has a latch release assembly 32, and the latch release assembly 32 can release the latched state of the latch assembly.

The locking subassembly is used for maintaining the brush bundle and is in the expanded state, and the brush bundle expandes stably when being convenient for rotate the sample brush, and the sample is abundant. The primary reason for the latch release assembly 32 is that the sampling device needs to be removed from the body after sampling is completed, and the brush bundle is kept in the closed position to protect the sample being taken. And is beneficial to the collection and storage of samples after the sampling is finished.

Example 10:

referring to fig. 3-5, an alternative approach:

a tube L having an open tube proximal end 41 and an open tube distal end 42;

the handle and the sampling brush bundle 20 are arranged in the tube L;

wherein the sampling brush bundle 20 is adjacent the distal tube end 42 and the proximal handle end is adjacent the proximal tube end 41;

wherein the handle has a degree of freedom of reciprocating movement within the tube L in the axial direction of the tube L, and extends to a sampling position towards the distal end 42 of the tube and retracts to an introduction position towards the proximal end 41 of the tube;

wherein the sampling brush bundle is positioned outside the tube L adjacent the distal end 42 of the tube when the handle is extended to the sampling position.

In the embodiment, a pipe L structure is added on the basis of the plurality of embodiments, the pipe L is connected with the handle in a sleeved mode, and the handle can rotate in the pipe L. The sampling brush bundle can be extended or retracted from the other end of the tube L, and can be used for sampling when extended, and can be protected by the tube L when retracted. The tube L may also be held in the other hand while the handle is rotated for the sampling process. For the purpose of assisting the fixing, the handle and the brush bundle have as far as possible only a rotational freedom with respect to the axis of the handle itself. The introduction of the tube L has important significance for uniform sampling of the cervical orifice/uterus/vagina in the whole circumferential direction after the sampling process posture of the sampling brush bundle is relatively fixed; moreover, overstimulation of a single direction/position by a brush bundle or a brush handle/handle due to unstable sampling gestures of a person with limited training and examination can be avoided. In addition, the tube L can provide protection for the brush bundle, which is of great importance during insertion of the device into a body cavity, i.e. during insertion of the brush bundle into the body cavity, the brush bundle is in a protected state, and the problem of deformation caused by the brush bundle touching the body cavity is solved compared to direct use of a brush into the body cavity; the specific application method is that the brush bundle is pushed out and unfolded after entering the sampling position.

Example 11:

referring to fig. 3, an alternative scheme:

an extension limiting member 40, wherein the extension limiting member 40 is used for providing an extension position of the handle in the direction of the reciprocating freedom degree and enabling the handle to have a freedom degree of rotating around the axis of the pipe L when the handle is extended to the sampling position; and, a degree of freedom of reciprocation under defined conditions.

By this solution provision is made for a standard position, i.e. a sampling position, in which the sampling brush bundle extends outwards in the tube L. The limiting piece is arranged in a way that after the using mode is simply explained, a general examiner can accurately extend the sampling brush bundle to the sampling standard position. This arrangement of standardized positions is more effective in combination with the use of embodiment 10 described above: in the embodiment 10, the brush bundle needs to be extended from the tube L after entering the sampling position, and the examiner/operator cannot visually observe the brush bundle, so that the structure can provide a standard position indication under blind operation, and the position is accurate and safe.

Example 12:

an alternative solution is:

the limiting condition is a threshold force condition with a threshold force F0;

and when the external force acting on the handle is larger than F0, the handle can retract towards the proximal end 41 of the tube;

A threshold force F0 is set for limiting the reciprocating movement of the handle within the tube L, the magnitude of this force setting the standard reference: the pressing force against the extension restriction member 40 is generally rotated by mistake. And can be optimized as follows: with less force to accommodate longer range. Such as a withdrawal/retraction resistance of 3-5N, while the force action distance is set to 3-6 mm. The small resistance makes the sampling brush retract more easily after sampling is finished, no obvious resistance feeling exists, and the sample can not fall off due to vibration caused by overlarge force; the longer acting distance can ensure that the needle is not easy to return accidentally during misoperation, and ensure the stability of the sampling process.

Example 13:

referring to fig. 10-14, an alternative approach:

includes a cap 50 that covers the distal end of the tube L when it is in the introduction position and blocks the open end of the distal end of the tube.

The cap 50 is provided to protect the sampling brush from damage during transport or before use after removal. And after the sampling is finished, the sampling brush bundle with the sample is retracted into the tube L to provide protection for the sample and the sampling brush bundle.

Example 14:

referring to fig. 10-14, an alternative approach:

and the cap lock catch can be used for locking the cap 50 in the covering posture.

This device need the censorship to detect the detection mechanism after the sample is accomplished, and the middle long-distance logistics transportation that probably exists, the block hasp can provide reliable and stable block lock state.

Example 15:

referring to fig. 13-14, an alternative approach:

includes a handle thrust piece 53 having a thrust attitude and a free attitude;

when the cap is in a covering state, the handle thrust piece 53 is in a thrust posture;

wherein, when the cap is in a non-covering state, the handle thrust piece 53 is in a free posture;

the thrust posture is provided with a limit bulge 13, and the limit bulge 13 is used for limiting the handle to extend and move to the sampling position on the reciprocating motion degree of freedom;

In the existing design, the situation that the sampling brush bundle is seriously deformed due to extrusion with the cap when the handle is pushed forward when the cap is opened is often caused, and the sampling brush bundle is damaged and is unusable when the sampling brush bundle is serious. The purpose of self-sampling is to provide privacy premise to reduce the complexity of the detection process so as to realize wide coverage of corresponding detected people, and if the sampled brush bundle waiting for hands is damaged and needs to wait for new brush bundle mailing again, the complexity of the event can be obviously increased. The design thrust piece has realized the block in the technique and has taken off the unable forward promotion of front handle, just also can not lead to the condition of sample brush bunch damage because of the operator is not professional or the maloperation.

Example 16:

referring to fig. 15, an alternative approach:

including a depth stop assembly 43 having a maximum depth that limits the extension of the sampling device, and in particular the sampling brush bundle, to the sampling position.

The depth stop assembly 43 provides non-professional operational safety.

Example 17:

an alternative solution is:

referring to fig. 10, the cap latch is a bi-directional resilient latch 51 having a resilient threshold force F1;

It appears that the cap cannot be removed under a force less than F1, but is free to be removed or closed under a force greater than F1. Provides a structure which is easy to operate and has the function of locking.

Example 18:

referring to fig. 10, an alternative scheme:

the cap lock catch comprises a cover body and a cover body,

The secondary locking piece reinforces the function of the lock catch. The unlocking acting force directions of the secondary locking piece and the lock catch are different, the acting force provided by accidental violence/misoperation in the daily process is usually unidirectional although possibly large, and the design of different unlocking directions can ensure effective response to accidental violence.

Example 19:

referring to fig. 12, an alternative approach:

the rotation locking portion 52 is rotatably unlocked by applying an unlocking force.

The design is unlocked in a rotating mode, and the unlocking safety is obviously improved relative to the unlocking in a common single direction. If the single-direction secondary unlocking is adopted, if two accidental violences occur in the whole process (including the whole logistics process) and the direction of the force required by the secondary unlocking is exactly consistent, the cap can be separated due to mistaken unlocking, and the sample is not protected. But the probability of a sustained, rotational incident force is significantly lower than an incident force in a single direction (which may be a transient force).

Example 20:

referring to fig. 15-16, a sample training device, comprising,

control end a1 of any of the above described HPV biopsy device.

The training device simulates the handle, i.e. the control end, of the device of the above embodiments, without the presence of other functional components. The device can be used for familiarizing the operation method of the sampling device of each embodiment, particularly the operation touch and hand feeling, so that the strange feeling when the sampling device is used is experienced and sensed in advance, and the device has obvious positive effects on eliminating the psychological fear (uncertainty) of a person to be detected and improving the sampling quality.

Example 21:

an alternative solution is:

The training device increases the operation training of the locking component, the locking component is not a key link of sampling operation but is one of necessary links, and the touch feeling of the operable part of the device familiar to the examinee can further eliminate the strange/fear feeling of the examinee.

Example 22:

an alternative solution is:

the sampling training device comprises a latch release assembly 32 of the HPV biopsy device;

the locking release assembly 32 is disposed at the control end, and the locking release assembly can release the locking state of the locking assembly.

Example 23:

an alternative solution is:

an extension limiting member 40 for providing an extended position of the handle in the direction of the reciprocating degree of freedom and having a degree of freedom of rotation about the axis of the tube L when the handle is extended to the sampling position; and, a degree of freedom of reciprocation under defined conditions; and/or the presence of a gas in the gas,

Wherein tube L has an open tube proximal end 41 and an open tube distal end;

the handle and the sampling brush bundle are arranged in the tube L;

wherein the sampling brush bundle is adjacent the distal end of the tube and the proximal handle end is adjacent the proximal tube end 41;

Wherein the method comprises the following steps of,

a handle thrust piece 53 having a thrust attitude and a free attitude;

Example 24:

an alternative solution is:

the cap latch may be a bi-directional resilient latch 51 having a resilient threshold force F1;

An alternative solution is:

the cap lock catch comprises a cover body and a cover body,

An alternative solution is:

the sampling training device comprises a depth stop assembly 43 of the HPV biopsy device;

the depth stop assembly 43 has the ability to limit the maximum depth to which the sampling device, and in particular the sampling brush bundle, extends to the sampling position.

The above three embodiments provide simulated training in different aspects and to different degrees for each operational stage in the operation of the sampling device.

In the description of the embodiments of the present invention, it should be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "center", "top", "bottom", "inner", "outer", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for the purpose of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present invention. Where "inside" refers to an interior or enclosed area or space. "periphery" refers to an area around a particular component or a particular area.

In the description of the embodiments of the present invention, the terms "first", "second", "third", and "fourth" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", "third", "fourth" may explicitly or implicitly include one or more of the features. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "assembled" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the description of the embodiments of the invention, the particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.

In the description of the embodiments of the present invention, it should be understood that "-" and "-" indicate the same range of two numerical values, and the range includes the endpoints. For example, "A-B" means a range greater than or equal to A and less than or equal to B. "A to B" means a range of not less than A and not more than B.

In the description of the embodiments of the present invention, the term "and/or" herein is only one kind of association relationship describing an associated object, and means that there may be three kinds of relationships, for example, a and/or B, and may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. An HPV biopsy device comprising a handle having a proximal handle end and a distal handle end;

which is characterized by comprising the following steps of,

2. The HPV biopsy device of claim 1, wherein the brush bundle expansion member comprises,

3. An HPV biopsy device according to claim 2,

the executing part A3 is provided with an air bag;

the transmission part A2 is provided with an air channel;

the control end A1 has a pressing part;

4. An HPV biopsy device according to claim 3,

5. An HPV biopsy device according to claim 2,

the control end A1 has a pressing portion connected to the proximal end B1;

6. An HPV biopsy device according to claim 2,

7. An HPV biopsy device according to claim 6,

8. A HPV biopsy device according to any one of claims 2-7,

9. An HPV biopsy device according to claim 8,

10. An HPV biopsy device according to any one of claims 1-9,

a tube L having an open tube proximal end and an open tube distal end;

the handle and the sampling brush bundle are arranged in the tube L;

11. An HPV biopsy device according to claim 10 comprising,

12. The HPV biopsy device of claim 11, wherein the defined conditions comprise,

a threshold force condition having a threshold force F0;

13. An HPV biopsy device according to any one of claims 10-12 comprising,

14. An HPV biopsy device according to claim 13 comprising,

the cap lock catch can be used for locking the cap in a covering posture.

15. An HPV biopsy device according to claim 13 or 14 comprising,

a handle thrust member having a thrust attitude and a free attitude;

16. An HPV biopsy device according to any one of claims 1-15 comprising,

17. The HPV biopsy sampling device of claim 14, wherein the cap latch is a bi-directional resilient latch having a resilient threshold force F1;

18. The HPV biopsy device of claim 17, wherein the cap latch comprises,

19. The HPV biopsy device of claim 18, wherein the secondary lock comprises,

20. A sampling training device is characterized by comprising,

a handle for an HPV biopsy device according to any one of claims 1-19; and the combination of (a) and (b),

the control end a1 of the HPV biopsy device of any one of claims 2-19.

21. The sample training device of claim 20, comprising,

a locking assembly of the HPV biopsy device of claim 8.

22. The sample training device of claim 21, comprising,

the latch release assembly of an HPV biopsy device of claim 9.

23. A sample training device as claimed in claims 20 to 22, comprising,

the tube L in the HPV biopsy device of claim 10; and/or the presence of a gas in the gas,

an extension limiting condition in the HPV biopsy device of claim 11; and/or the presence of a gas in the gas,

a cap for use in an HPV biopsy device according to any one of claims 13-15, 17-19.

24. A sample training device according to any one of claims 20-23, comprising,

the depth stop assembly in an HPV biopsy device of claim 16.