CN113995447A

CN113995447A - Saccular biological sampler

Info

Publication number: CN113995447A
Application number: CN202111307220.5A
Authority: CN
Inventors: 汝成韬; 张智超; 赵陈列
Original assignee: Shanghai Kegang Medical Technology Co ltd
Current assignee: Shanghai Kegang Medical Technology Co ltd
Priority date: 2021-11-05
Filing date: 2021-11-05
Publication date: 2022-02-01

Abstract

The invention provides a saccule-shaped biological sampler, which comprises a sampling part, a catheter part and an interface part, wherein the sampling part, the catheter part and the interface part are sequentially connected; the sampling part is spherical, can expand after being filled with fluid, can recover to an original state or contract to a state with smaller volume after the fluid is pumped out, and the flocking treatment is carried out on the whole surface of the sampling part; the interface portion is connected to the syringe pump to inflate or evacuate the sampling portion through the conduit portion. Can collect biological samples of deeper cavities of human bodies and has high collection efficiency and elution efficiency.

Description

Saccular biological sampler

Technical Field

The invention relates to the field of medical instruments or biological experimental equipment, in particular to a sacculus-shaped biological sampler.

Background

The incidence of esophageal tumors in china is always at a high level, with potential causes possibly related to dietary structure and geographical environment. Due to unhealthy work and rest habits and dietary structures in modern life, the age group of high-incidence people tends to shift to the low age group. Meanwhile, the five-year survival rate of patients with early esophageal cancer after excision of lesions under an endoscope can reach 80% -90%, but the five-year survival rate of patients with late esophageal cancer is less than 10%. Therefore, there is a need for early esophageal tumor screening. At present, many hospitals adopt endoscopy, but the cost of endoscopy is too high, the pain of patients is too great, and the method cannot be popularized on a large scale. Large-scale targeted early screening of esophageal tumors cannot be effectively deployed. Currently investigated, there are the following solutions for this application.

US10327742B2 discloses a novel esophageal wall cell sampler and method. It is made up by filling sponge in capsule and drawing sponge by wire rope. When in use, the patient swallows the capsule, and the sponge is wetted and expanded when the capsule is dissolved. The sponge is pulled up again, and the tissue sample is obtained by rubbing the sponge and the esophageal tissue. The disadvantage of this technique is that the sponge easily falls off the string during use. And the capsule is required to be melted in the stomach before sampling. The biggest shortcoming is that the device melts at the capsule after, the sponge rises after, unable initiative shrink, and this just leads to gathering behind the cell of esophagus target location, when narrow parts such as throat, can rub the esophagus cell who gathers off, has the difficulty even when passing through these narrow parts, causes painful impression to the patient.

Another product is a product known as EsoCheck Device, owned by Pavmed corporation. The device is a sacculus with a scraping structure on the surface. The product is used by extending the product into a tissue to be sampled, inflating the tissue, scraping and sucking the tissue surface, and retracting the balloon, so that the sampled cells can be protected from being influenced. Can directly collect tissue cells (lesion high-incidence area) of the stomach cardia and protect the stomach cardia from being polluted. The disadvantage of this solution is that the sampled structures (bulges) are not densely distributed enough and are of a single thin-walled structure, and the collected cell tissue cannot be densely collected and stored.

For the collection and detection of cells, cotton swabs and nylon flocked swabs are generally available in the market at present, and literature researches show that the collection efficiency and the elution efficiency of the nylon flocked swabs are superior to those of the cotton swabs, so that the nylon flocked swabs occupy most of the market at present. The flocked swab is generally composed of a hard plastic rod and a head end flocked part, and generally the sampling target part is the throat, nasal cavity or anus and other parts of the superficial body channels. Such swabs do not reach the deep body cavities such as the esophagus and cardia.

In view of the shortcomings of the above solutions, there is a need for a method of collecting cells from a specific part of the human body (e.g., the esophagus) for in vitro testing. Can be used more conveniently, has higher sampling and elution efficiency and lower production cost, and can be produced and used on a large scale.

Disclosure of Invention

The invention aims to provide a balloon-shaped biological sampler based on flocking technology, which is used for collecting cells of a human body deep cavity, and the surface of the balloon adopts flocking technology, so that the sampling efficiency and the elution efficiency are high.

In order to realize the aim, the invention provides a sacculus-shaped biological sampler which comprises a sampling part, a catheter part and an interface part, wherein the three parts are connected in sequence; the sampling part is spherical, can expand after being filled with fluid, can recover to an original state or contract to a state with smaller volume after the fluid is pumped out, and the flocking treatment is carried out on the whole surface of the sampling part; the interface portion is connected to the syringe pump to inflate or evacuate the sampling portion through the conduit portion.

Wherein, the surface of the sampling part is distributed with bulges. The projection is a cylinder with the diameter of 0.1mm-3mm, and the length range is within 5 mm. The distribution density of the bulges at the saccular middle part of the sampling part is higher. The thickness of the balloon of the sampling part is 0.1mm-2mm, and the diameter is about 2mm-30 mm. And a developing device is arranged at the tail part of the sampling part. The fiber length range of the flocking layer is 0.1-5.0mm, the fiber fineness of the flocking layer is 0.1-10.0dtex, and the fiber density of the flocking layer is 1-350 mu g/mm ^ 2.

Wherein the conduit portion has a scale. The catheter is a single-cavity tube and is extruded in a co-extrusion mode, and one or more high polymer wires are embedded in the middle of the catheter. The catheter is a braided tube or a co-extruded tube, and the wires of the braided layer or the co-extruded tube are nylon wires. The conduit has a thickness in the range of 0.1mm to 5mm and a length of about 20 to 50 cm.

Further, the interface portion has blocking means to prevent swallowing by the patient. The interface portion has a one-way valve to facilitate filling and evacuation of fluid.

The invention has the beneficial effect of providing a new mode for sampling cells in the deep cavity of the human body. Meanwhile, a new scheme (combining flocking and a balloon) is adopted, so that the device is more convenient to use, higher in sampling and eluting efficiency and lower in production cost, and can be produced and used on a large scale.

In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic diagram of one embodiment of the present invention;

FIG. 2 is a schematic view of the structure of the sampling portion of the present invention;

FIG. 3 is a schematic view of the construction of a portion of the catheter of the present invention;

fig. 4 is a schematic structural diagram of an interface portion of the present invention.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

The present invention is described in further detail below to enable those skilled in the art to practice the invention with reference to the description.

Referring first to fig. 1, fig. 1 is a schematic diagram of an embodiment of the invention. In fig. 1. The main structure of the saccule-shaped biological sampler is divided into three parts, namely a sampling part 1, a catheter part 2 and an interface part 3 which are connected in sequence.

Fig. 1 is a sacculus-shaped biological sampler based on flocking technology, the sampling part 1 is sacculus-shaped, the material uses silica gel material with 20A hardness, the surface is completely flocked, and the flocking fiber material is nylon. The catheter part 2 is a single-lumen tube and is embedded with two nylon wires, the catheter is made of silica gel, the length of the catheter is about 50cm, marks are arranged on the catheter, and the marks are arranged at intervals of 10cm to assist a doctor to identify. The interface part 3 is made of high polymer material and can be connected with a syringe pump.

When the esophagus of a patient needs to be sampled, the balloon is firstly sucked to be flat by the injection pump, and the patient puts the sampling part 1 into the mouth and swallows the sampling part after drinking water. The physician can then see his specific position by X-rays or can roughly judge the position of the sampling part 1 by means of a ruler of the catheter part 2. At this time, the sampling part 1 is filled through the interface part 3, after the saccule is filled, the sampling part 1 is slowly pulled up, and at this time, the sampling part is contacted with the esophagus wall in the esophagus for sampling. When the patient is about to reach the laryngeal part of the pharynx, the patient sucks the flat sacculus to facilitate the sampling part to pass through the narrow part. After being taken out from the mouth, the cells collected by the sampling part 1 can be eluted for the relevant detection.

Referring to fig. 2, fig. 2 is a schematic structural diagram of a sampling portion according to the present invention. The sampling part 1 is mainly used for sampling cells in a deep human body, is saccule-shaped in appearance, can be expanded after being filled with liquid or gas, adapts to the shape and size of the human body sampling part, is convenient for more efficient sampling, can be recovered to an original state or contracted to a state with a smaller volume after the liquid or the gas is pumped out, is beneficial to the convenience of retraction, and simultaneously avoids the collected cells from falling off or being polluted. The thickness of the balloon of the sampling portion 1 is 0.3mm, the diameter is about 10mm, the surface is distributed with the protrusions 4, the protrusions 4 have a cylindrical shape with the diameter of 1mm, and the distribution density of the protrusions 4 in the spherical middle portion of the balloon 1 is higher because the portion most likely contacts the sampling site after being inflated. The tail part 5 is provided with a developing line or a metal developing ring, which can assist a doctor to see the position of the instrument on a human body under the assistance of an X-ray machine. While the tail end is connected to the pipe section 2.

The basic requirement of the sampling part 1 is that it can be expanded arbitrarily, and the shape can be spherical, ellipsoidal, annular, rod-like, etc. The shape in the original state may be any shape, and the size is preferably a size that can be swallowed by a human body. The material of the sampling part 1 has high elongation at break, namely can bear large volume expansion, and can be silica gel, thermoplastic elastomer (TPE), Thermoplastic Polyurethane (TPU), latex and the like.

The surface of the balloon of the sampling part 1 is subjected to flocking treatment, the fiber length of the flocking layer ranges from 0.1mm to 5.0mm, the fiber fineness of the flocking layer ranges from 0.1 dtex to 10.0dtex, and the fiber density of the flocking layer ranges from 1 mug/mm ^2 to 350 mug/mm. The shape of the bare balloon surface may be rounded, but preferably the surface should be provided with protrusions 4, or grooves, or tentacles, or sharp corners. This arch 4 is because thicker than the sacculus other places, and when the sacculus inflation, the outside surface of this part can not enlarge other places relatively, because the surface area can not enlarge, the flocking density of this part can keep ideal density always, can not reduce flocking density because of the expansion of sacculus, consequently when the sacculus inflation, protruding department flocking surface still can keep better flocking density, obtains good sampling efficiency. The tail end 5 of the saccule is of a closed structure and is connected with the catheter part. And the closing-in structure can be provided with developing substances, so that a doctor can observe the position of the part on a human body under developing equipment conveniently.

Referring next to fig. 3, fig. 3 is a schematic structural view of a catheter portion according to the present invention. The catheter 2 is shown in detail, with the catheter 2 being approximately 1mm in diameter and the balloon 1 being inflated or released of liquid or gas through the hollow lumen 7. The wall of the catheter is embedded with two nylon filaments 7, which has very soft and tensile properties.

The length of the catheter portion 2 is preferably such that it covers the distance from the oral cavity to the cardia (20-50 cm). The material of the catheter section 2 may be any polymeric material (nylon, polyethylene, TPU, etc.), silicone, latex, etc. The thickness of the catheter ranges from 0.1mm to 5mm, and the inner lumen can be a single-lumen tube or a multi-lumen tube. The catheter part 2 needs to have high tensile strength and tear resistance, cannot stretch when stressed, and is internally provided with a cavity for filling or relieving pressure of the balloon part through liquid or gas. The catheter is preferably a braided tube or a co-extruded tube, and the soft degree of the pipeline can be kept due to the fact that the filaments with high tensile strength are embedded in the wall of the pipeline, and meanwhile, the catheter can have high tensile strength. Is very suitable for patients to swallow, and can ensure that the catheter is not stretched and broken when the sampler is pulled out. The filaments of the braided layer or the co-extruded tube can be polymer filaments (such as Dammar wires, nylon wires and the like) or metal filaments, and are preferably nylon filaments. The catheter may be provided with visualization lines to assist the physician in visualizing the position of the catheter within the body under the visualization device. Meanwhile, the distance from the catheter to the balloon can be marked by a ruler, so that a user can observe the distance from the catheter to the human body.

Details of the mouthpiece section 3 are shown in figure 4, with the forward end connected to the conduit section 2 and the baffle 8 being about 30mm in diameter forward of the mouthpiece section 3. Preventing the patient from swallowing all of the instruments while swallowing the sampling portion. The one-way valve 9 is in the fluid or gas path and maintains the balloon during inflation and deflation. The interface 10 may be connected to a syringe for filling or venting.

The front end of the interface part 3 is connected with a catheter, and the rear end is provided with an interface connected with an injector (used for filling or decompressing a balloon). The mouthpiece portion 3 has blocking means to prevent the patient from swallowing the whole apparatus. A one-way valve can be arranged in the interface part 3, so that the filling and pressure relief of the instrument are facilitated.

While embodiments of the invention have been disclosed above, it is not intended to be limited to the uses set forth in the specification and examples. It can be applied to all kinds of fields suitable for the present invention. Additional modifications will readily occur to those skilled in the art. Therefore, the invention is not to be limited to the specific details and illustrations shown and described herein, without departing from the general concept defined by the claims and their equivalents.

Claims

1. The saccular biological sampler is characterized by comprising a sampling part, a conduit part and an interface part which are sequentially connected;

the sampling part is spherical, can expand after being filled with fluid, can recover to an original state or contract to a state with smaller volume after the fluid is pumped out, and the flocking treatment is carried out on the whole surface of the sampling part;

the interface portion is connected to the syringe pump to inflate or evacuate the sampling portion through the conduit portion.

2. The balloon-like biological sampler as defined in claim 1 wherein the surface of the sampling portion is provided with protrusions.

3. The balloon-like biological sampler as defined in claim 2 wherein said protuberances are cylinders having a diameter of 0.1mm to 3mm and a length within 5 mm.

4. The balloon-like biological sampler as defined in claim 2 wherein said projections are distributed in a greater density in the balloon-like central portion of the sampling portion.

5. The balloon-like biological sampler as recited in claim 1, wherein the balloon of the sampling portion has a thickness of 0.1mm to 2mm and a diameter of about 2mm to 30 mm.

6. The balloon-like biological sampler as recited in claim 1, wherein the tail of the sampling portion has a visualization device.

7. The balloon-like biological sampler as claimed in claim 1 wherein the flocked layer has a fiber length in the range of 0.1 to 5.0mm, a fiber fineness of 0.1 to 10.0dtex, and a fiber density of 1 to 350 μ g/mm ^ 2.

8. The balloon-like biosampler of claim 1, wherein said catheter portion has a scale.

9. The balloon-like biological sampler as claimed in claim 1 wherein the catheter is a single lumen tube and is extruded by co-extrusion with one or more polymeric filaments embedded therein.

10. The balloon-like biological sampler as claimed in claim 1 wherein the catheter is a braided or co-extruded tube, the filaments of the braided or co-extruded tube being nylon filaments.

11. The balloon-like biosampler of claim 1, wherein said catheter has a diameter in the range of 0.1mm to 5mm and a length of about 20 cm to about 50 cm.

12. The balloon-like biological sampler as defined in claim 1 wherein said interface portion has a stop means.

13. The balloon-like biological sampler as defined in claim 1 wherein said interface portion has a one-way valve to facilitate filling and evacuation of fluid.