Sampling capsule

A sampling capsule is provided. The sampling capsule includes an enclosure, a sampling assembly, a sample drawing assembly and a control module. The sampling assembly includes a sample chamber arranged in the enclosure, an outer sampling port on the enclosure, a sampling tube connecting the outer sampling port and the sample chamber, and a sampling switch for opening or closing the connecting tube. The sample drawing assembly includes a sample drawing port on the enclosure and connected to the sample chamber, and a silicone plug fitted in the sample discharging port. The control module includes a microprocessor communicating with the sampling switch.

CROSS-REFERENCE OF RELATED APPLICATIONS

The application claims priority to Chinese Patent Application No. 201910636328.5 filed on Jul. 15, 2019, the contents of which are incorporated by reference herein.

FIELD OF INVENTION

The present invention relates to a medical device, and more particularly to a sampling capsule.

BACKGROUND

Due to high reliability and high safety, sampling capsule has become an effective device for the diagnosis of gastrointestinal diseases and has obtained high recognition in international medical device field. Generally, a sampling capsule comprises an enclosure, a sample chamber in the enclosure, and a sampling tube connected to the sample chamber. When the sampling capsule reaches a predetermined position in the gastrointestinal tract, the sampling tube is opened, and digestive fluids flow into the sample chamber. And after the sampling capsule is discharged, medical staff can take the digestive fluids out of the sample chamber for pathological analysis.

Before use of the existing sampling capsule, the sample chamber is under vacuum condition, and after the sampling tube is open, the digestive fluids enter the sample chamber under the pressure difference between inside and outside. However, if air leak occurs during transportation and storage, the sampling capsule can be scrapped, and sample drawing is cumbersome after completion of sampling.

In consideration of this, it is necessary to provide an improved sampling capsule to solve the problem.

SUMMARY OF THE INVENTION

The present invention provides a sampling capsule which can improve sampling effectiveness.

In order to achieve the object, the following technical solutions are employed.

an enclosure; a sampling assembly comprising a sample chamber disposed in the enclosure, an outer sampling port on the enclosure, a sampling tube connecting the outer sampling port and the sample chamber, and a sampling switch for opening or closing the sampling tube;

a sample drawing assembly comprising a sample drawing port on the enclosure and connected to the sample chamber, and a silicone plug fitted in the sample drawing port; and

a control module comprising a microprocessor in communication with the sampling switch.

In one embodiment, the sample drawing assembly further comprises a fixing member corresponding to the sample drawing port, and the silicone plug is fitted in the fixing member.

In one embodiment, the inner diameter of the fixing member gradually decreases from a first end to a second end, one end of the silicone plug protrudes from the second end of the fixing member, and the diameter of the protruding end of the silicone plug is greater than the diameter of the second end of the fixing member;

or both two ends of the silicone plug protrude from the fixing member, and both two ends of the silicone plug have a diameter greater than the inner diameter of the fixing member;

or the fixing member comprises a snap-on portion and a fixing portion adjacent to the snap-on portion, the inner diameter of the snap-on portion is smaller than the inner diameter of the fixing portion, and the inner diameter of the fixing portion gradually decreases from one end of the snap-on portion to the other end.

In one embodiment, when one end of the silicone plug protrudes from the fixing member, the end of the silicone plug near the sample chamber protrudes from the fixing member, and the diameter of the protruding end is greater than the inner diameter of the fixing member, and the inner diameter of the fixing member gradually decreases from outside to inside; or when the fixing member comprises the snap-on portion, the fixing member extends from the snap-on portion toward the sample chamber, the inner diameter of the snap-on portion is smaller than the inner diameter of the fixing portion, and the inner diameter of the fixing portion gradually decreases from outside to inside.

In one embodiment, the sample chamber is under vacuum condition with an absolute pressure between 0 hPa and 260 hPa.

In one embodiment, the control module further comprises a pressure sensor disposed in the sample chamber.

In one embodiment, the sampling tube comprises a flexible tube, and the sampling switch comprises a clamping ring for clamping at least part of the flexible tube and a heating element in communication with the microprocessor and capable of fusing the clamping ring.

In one embodiment, the sampling capsule further comprises a partition wall within the enclosure, and the partition wall together with the enclosure on a first side of the partition wall forms the sample chamber, and the outer sampling port is on a second side of the partition wall; and the sampling assembly further comprises an inner sampling port cut in the partition wall, one end of the flexible tube is connected to the inner sampling port and the flexible tube extends along the axis of the sampling capsule; and wherein the sampling tube further comprises a sample access tube connecting the flexible tube to the outer sampling port;

and the sampling capsule comprises a plurality of the outer sampling ports and the sample access tube comprises a multi-way tube connecting the plurality of outer sampling ports to the flexible tube.

In one embodiment, the plurality of the outer sampling ports are distributed along the circumference of the sampling capsule, and the sample access tube further comprises an annular tube connected to the plurality of the outer sampling ports, and the inlet of the multi-way tube is connected to the annular tube.

In one embodiment, the microprocessor and the flexible tube are disposed on opposite sides of the sample access tube, and the sample access tube comprises a penetration portion through which a wire passes, and the wire is communicatively connected to the heating element and the microprocessor.

Compared with the prior art, the present invention has the following beneficial effects: by the silicone plug, for one thing, if the sampling capsule leaks during transportation and storage, a syringe can be used to pierce the silicone plug to pump air out of the sample chamber again to achieve the desired vacuum, so as not to cause product waste; in addition, according to the shrinkage of the silicone plug, the needle eye is sealed after the syringe is pulled out, so that subsequent use is not be affected. For another, the sampling capsule can be produced without evacuating the sample chamber, but a syringe or the like is used to produce a desired vacuum in the sample chamber through the silicone plug.

DETAILED DESCRIPTION

The present invention can be described in detail below with reference to the accompanying drawings and preferred embodiments. Refer toFIGS.1to5for preferred embodiments of the present invention. However, it should be noted that these embodiments are not a limitation of the present invention, and that equivalent alterations or substitutions on function, method, or structure made by those of ordinary skill in the art according to these embodiments are all within the scope of protection of the present invention. In addition, “and/or” as used herein denotes “or” or “and”, e.g., “M and/or N” comprises M, or N, or M and N.

Referring toFIGS.1˜5, showing a sampling capsule100and an internal structure thereof according to the preferred embodiments of the present invention.

The sampling capsule100comprises an enclosure1, a sampling assembly2, and a sample drawing assembly3and a control module4. The control module4comprises a microprocessor in communication with one or more structures of the assemblies to control and/or coordinate the working state thereof.

The material of the enclosure1can be the material of the enclosure1of the existing sampling capsule100, or can be additionally designed. It should be understood that the material of the enclosure1is acceptable as long as it is harmless to humans and cannot be corroded by digestive fluids.

Further, the enclosure1is constructed by at least two parts joined together to facilitate arrangement of internal components inside the enclosure1. For example, as shown inFIG.1, the enclosure1comprises a first enclosure11, a second enclosure12, and a third enclosure13, and is formed by splicing the first enclosure11, the second enclosure12, and the third enclosure13together.

The sampling assembly2comprises a sample chamber21disposed in the enclosure1, an outer sampling port22on the enclosure1, a sampling tube23connecting the outer sampling port22and the sample chamber21, and a sampling switch24for opening or closing the sampling tube23.

Specifically, the sampling capsule100further comprises a partition wall14within the enclosure1, and the partition wall14together with the enclosure1on a first side of the partition wall14forms the sample chamber21. The outer sampling port22, the sampling tube23and the sampling switch24are arranged on a second side of the partition wall14.

Preferably, the enclosure1on the first side of the partition wall14is transparent to facilitate observation of sampling and sample drawing by a healthcare professional, and specifically observation of the amount of sampling and the remaining amount of sample after drawing.

The partition wall14is designed integrally with the enclosure1on the first side of the partition wall14to form the sample chamber21with a good leak tightness, or the partition wall14and the enclosure1on the first side of the partition wall14have a split-type design and the tightness at the junction of the two ensures that the sample chamber21can maintain its required vacuum degree.

Before use, the sample chamber21is sterilized, and the sample chamber21is under vacuum condition with an absolute pressure between 0 hPa and 260 hPa. When the sampling capsule100reaches a desired region in the gastrointestinal tract, the sampling tube23is opened, allowing the digestive fluid to enter the sample chamber21through the sampling tube23due to internal and external pressure difference.

Methods of evacuating the sample chamber21comprises, but are not limited to, opening the sampling tube23before completion of manufacturing, extracting air from the sample chamber21through the outer sampling port22by a pumping device, and after achieving a desired vacuum, closing the sampling tube23so that the sample chamber21maintains the desired vacuum; or, after completion of manufacturing, extracting air from the sample chamber21through the sample drawing assembly3by a pumping device to achieve a desired vacuum; or, before use, extracting air from the sample chamber21through the sample drawing assembly3by a pumping device to achieve a desired vacuum.

The sampling tube23comprises a flexible tube231, and the sampling switch24comprises a clamping ring241for clamping at least part of the flexible tube231, and a heating element242in communication with the microprocessor and capable of fusing the clamping ring241. The sampling switch24opens or closes the flexible tube231to enable the opening or closing of the sampling tube23.

Specifically, the sampling assembly2further comprises an inner sampling port25cut in the partition wall14. One end of the flexible tube231is connected to the inner sampling port25and the flexible tube231extends along the axis of the sampling capsule100. The sampling tube23further comprises a sample access tube232connecting the flexible tube231to the outer sampling port22. The sampling capsule comprises a plurality of the outer sampling ports22and the sample access tube232comprises a multi-way tube2321connecting the plurality of outer sampling ports22to the flexible tube231.

The end of the flexible tube231close to the inner sampling port25is inserted into the inner sampling port25, and the other end of the flexible tube231away from the inner sampling port25is connected to the outlet of the sample access tube232, so that after the heating element242fuses the clamping ring241, the sample access tube232, the flexible tube231, and the sample chamber21are in an interconnected state, allowing the digestive fluids to enter the sample chamber21through the outer sampling port22, the sample access tube232, the flexible tube231, and the inner sampling port25.

In one embodiment, the sampling tube23further comprises a connecting tube233for connecting the outlet of the sample access tube232to the flexible tube231to facilitate the installation of the flexible tube231and to simplify the process of making the sampling tube23. In addition, the flexible tube231can also be inserted directly into the outlet of the sample access tube232to provide connection and connectivity between the flexible tube231and the sample access tube232.

Specifically, the connecting tube233is a rigid tube. One end of the connecting tube233is inserted into the outlet of the sample access tube232and has an interference fit to the outlet, and the other end of the connecting tube233is inserted into an end of the flexible tube231away from the inner sampling port25and has an interference fit to the flexible tube231. The connecting tube233can connect the sample access tube232to the flexible tube231, to facilitate the installation of the flexible tube231, and to ensure the stability of the connection between the sample access tube232and the flexible tube231and the sealing of the connection between the two.

Further, the sampling capsule comprises a plurality of the outer sampling ports22and the sample access tube232comprises a multi-way tube2321connecting the plurality of outer sampling ports22and the flexible tube231, to improve sampling efficiency and save time.

Specifically, the multi-way tube2321comprises a plurality of sub-tubes2322, the plurality of sub-tubes2322being connected to the outlet of the sample access tube232.

Further, the plurality of the outer sampling ports22are distributed along the circumference of the sampling capsule100, the sample access tube232further comprises an annular tube2323connected to the plurality of the outer sampling ports22, and the inlet of the multi-way tube2321is connected to the annular tube2323. The digestive fluids entering from the outer sampling ports22flows first into the annular tube2323and then flows into the sample chamber21through the multi-way tube2321, the flexible tube231, and the inner sampling port25.

It can be understood that, in the embodiment with the annular tube2323, the number of the sub-tubes2322of the multi-way tube2321can be different from the number of the outer sampling ports22. In the embodiment without the annular tube2323, i.e., where the sub-tubes2322are directly connected to the corresponding outer sampling ports22, the number of the sub-tubes2322of the multi-way tube2321is the same as the number of the outer sampling ports22, that is, each sub-tube2322correspond to one outer sampling port22.

Further, the microprocessor and the flexible231are disposed on opposite sides of the sample access tube232to rationalize the layout of the components within the sampling capsule100.

In the embodiment where the microprocessor and the flexible tube231are disposed on opposite sides of the sample access tube232, the sample access tube232comprises a penetration portion2324through which a wire43passes. The wire43can be communicatively connected to the heating element242and the microprocessor, so that the heating element242can communicate with the microprocessor through the wire43.

It can be understood that in the embodiment where the sample access tube232comprises a multi-way tube2321, the penetration portion2324is a gap between two adjacent sub-tubes2322.

When the sampling capsule100is not in use or does not reach the desired region in the gastrointestinal tract, the clamping ring241clamps the corresponding flexible tube231to close the sampling tube23and maintain a vacuum in the sampling capsule21. When the sampling capsule100reaches the desired region in the gastrointestinal tract, the clamping ring241is fused by the heating element242, and the flexible tube231under the action of its own elastic recovery force recovers to tubular shape to open the sampling tube23, so that the digestive fluids enter the sample chamber21through the outer sampling port22, the sampling tube23and the inner sampling port25due to internal and external pressure difference. Actively controlled opening of the sampling tube23by the heating element242is independent of the particular environment in the gastrointestinal tract. Therefore, the invention has high versatility, and simplifies the internal structure of the sampling capsule100to reduce cost.

As sampling ends, the internal and external pressures of the sample chamber21are balanced. Also, the sampling tube23has a small diameter, such as 0.5 mm, so that, when the sampling tube23is in an open state, the digestive fluids in the sample chamber21has difficulty flowing out of the sampling capsule100through the sampling tube23, ensuring that the collected digestive fluids can be maintained within the sample chamber21.

In an embodiment, the clamping ring241is an alloy ring with a melting point between 42° C. and 55° C. In one aspect, the alloy ring has a hardness that allows it to be able to clamp the flexible tube231while bending, and the elastic recovery force of the flexible tube231is not sufficient to cause the alloy ring to deform, so that the alloy ring can remain tightly clamping the flexible tube231at all times to keep the sampling tube23closed and maintain a vacuum in the sample chamber21. In other aspect, the alloy ring has a melting point between 42° C. and 55° C., which protects the alloy ring from being affected by the temperature in human body, and protects the human body from being harmed during fusing of the alloy ring by the heating element242. But, it is not limited to this, provided that the clamping ring241can keep clamping the flexible tube231while bending and has a melting point between 42° C. and 55° C.

In the embodiment, the clamping ring241is in the shape of a closed ring, similar to a waist, and the clamping ring241has two opposite clamping portions to clamp the flexible tube231. The heating element242is disposed on the outer periphery of the clamping portions to fuse the clamping portions, i.e. to fuse the clamping ring241, so that the flexible tube231is able to recover to a tubular shape under the action of its own elastic recovery force and make the sampling tube23in an open state. Then, the digestive fluids enter the sample chamber21through the outer sampling port22, the sampling tube23and the inner sampling port25under the pressure difference between inside and outside.

In other embodiments, the clamping ring241can also be non-closed. For example, the clamping ring241comprises two opposite clamping portions to clamp the flexible tube231, and a connecting portion connecting the two clamping portions at an end of the same side. In this structure, the heating element242can be disposed on one of the clamping portions or on the connecting portion, provided that the flexible tube231can recover to a tubular shape under its own elastic recovery force after the heating element242fuses the clamping ring241.

In an embodiment, the heating element242is a heating resistor, but is not limited thereto.

The sample drawing assembly3comprises a sample drawing port on the enclosure1and connected to the sample chamber21, and a silicone plug31fitted in the sample drawing port. If the method of evacuating before the completion of manufacturing, when it is detected that the sampling capsule100leaks during transportation and storage, a syringe can be used to pierce the silicone plug31to pump air out of the sample chamber21again to achieve the desired vacuum, so as not to cause product waste. In addition, according to the shrinkage of the silicone plug, the needle eye is sealed after the syringe is pulled out, so that subsequent use cannot be affected. In one aspect, the sampling capsule100can be produced without evacuating the sample chamber21, but before use, a syringe or the like is used to produce a desired vacuum in the sample chamber21through the silicone plug31. All of the above methods ensure that the sample chamber21is used under the desired vacuum conditions to achieve optimum sampling of the sampling capsule100.

Further, the sample drawing assembly3further comprises a fixing member32corresponding to the sample drawing port, and the silicone plug31is fitted in the fixing member32. The fixing member32extends in the thickness direction of the enclosure1, that is, the fixing member32extends into the sample chamber21. The fixing member32fixes the silicone plug31to the sample drawing port, making up for the instability existing in the direct fixing of the thin enclosure1and the silicone plug31, and maintaining a seal between the two when the silicone plug31is pierced by a syringe or the like.

Specifically, the fixing member32integrates with the enclosure1, or the fixing member32is separate from the enclosure1, and the two are sealed.

In addition, the silicone plug31has an interference fit to the fixture32, easy for assembly.

The fixing member32comprises a first end and a second end. The inner diameter of the fixing member32gradually decreases from the first end to the second end, one end of the silicone plug31protrudes from the second end of the fixing member32, and the diameter of the protruding end of the silicone plug31is greater than the diameter of the second end thereof. Specifically, in the embodiment shown inFIG.1, the end of the silicone plug32close to the sample chamber21protrudes from the fixing member32and the diameter of the protruding end is greater than the inner diameter of the fixing member32, and in the process of sampling, after the digestive fluids enter the sample chamber21, the silicone plug31cannot be pushed out of the fixing member32. In addition, the inner diameter of the fixing member32gradually decreases from outside to inside, which also prevents the silicone plug31from falling off during evacuating or sample drawing.

Or, both two ends of the silicone plug31protrude from the fixing member32, and both two ends of the silicone plug31have a diameter greater than the inner diameter of the fixing member32, which can prevent the silicone plug31from falling off during sampling, evacuating or sample drawing.

Or, the fixing member32comprises a snap-on portion321and a fixing portion322adjacent to the snap-on portion321, the inner diameter of the snap-on portion321is smaller than the inner diameter of the fixing portion322, and the inner diameter of the fixing portion322gradually decreases from one end of the snap-on portion321to the other end. As shown inFIG.5, the fixing member32has a snap-on portion321and a fixing portion322extending from the snap-on portion321toward the sample chamber21, where the inner diameter of the snap-on portion321is smaller than the inner diameter of the fixing portion322, and the inner diameter of the fixing portion322gradually decreases from outside to inside. Such structure can prevent the silicone plug31from falling off during sampling, evacuating or sample drawing.

In addition, the difference between the embodiment shown inFIG.5and the embodiment shown inFIG.1only lies in the sample drawing assembly3, while the other structures are the same, and the sectional views along the A-A and B-B directions inFIG.5are also consistent with the sectional views along these two directions inFIG.1, and is not repeated herein.

The control module4further comprises a pressure sensor42disposed within the sample chamber21, and the pressure sensor42detects pressure within the sample chamber21. The control module4determines whether the sampling capsule100is valid based on the pressure before taking the sampling capsule100. The control module4can also determine whether the sampling capsule100is valid based on the pressure before sending sampling commands. The control module4can also determine whether the sampling is proceeding properly, and determine whether the sampling ends.

Further, the control module4further comprises a sensor42for collecting physiological parameters and/or image information in the gastrointestinal tract, and the sensor42communicates with the microprocessor. The sensor42can be one or more sensors selected from an image sensor, a pH sensor, or an ultrasonic sensor. When the sensor42comprises an image sensor, part of the enclosure1is transparent, and when the sensor42comprises a pH sensor, the enclosure1comprises a window. The specific method of determining which region of the gastrointestinal tract the sampling capsule100is in, based on the picture and pH value obtained by the sensor42, can be any method in the prior art, and is not be repeated herein.

While the control module4comprises the sensor42, the control module4can further comprise a storage module for storing normal physiological parameters or image information and physiological parameters or image information in case of possible lesions in different regions of the gastrointestinal tract, where the storage module communicates with the microprocessor. After the sensor42collects physiological parameters and/or image information in the gastrointestinal tract, the microprocessor compares the collected information with the stored information in the storage module to determine whether the sampling capsule100reaches the position at which the sample is to be taken.

Or, while the control module4comprises the sensor42, the control module4further comprises a wireless transmission module for communicating with an external processing terminal. When the sensor42collects physiological parameters and/or image information in the gastrointestinal tract, it transmits the collected information to an external processing terminal, and the external processing terminal analyzes the collected information and determines whether the sampling capsule100reaches the position at which the sample is to be taken.

In addition, the control module4further comprises a battery that provides power to other components of the sampling capsule100. The sampling capsule100further comprises a circuit board41, and the microprocessor and the wireless transmission module are all integrated on the same circuit board41.

The following can describe the operating process of the sampling capsule100of the present invention with an image sensor as an example.

The image sensor transmits the acquired images of the gastrointestinal tract to the external processing terminal, and the external processing terminal analyzes the acquired images of the gastrointestinal tract and identifies the position of the sampling capsule100in the gastrointestinal tract by means of visual check or a computer vision algorithm. In addition, a physician or the computer vision algorithm can identify the existence of some lesions by means of the images of the gastrointestinal tract, and thus determine whether sampling is required. If sampling is required, the external processing terminal sends a command to the microprocessor via the wireless transmission module, and when the microprocessor receives the command, the microprocessor controls the heating element242to heat and fuse the clamping ring241to open the sampling tube23for sampling.

Specifically, after determining that the sampling capsule100reaches a position where sampling is required, the external processing terminal can send an reminder message to the physician for confirmation, or can also directly send a need-to-sample command to the microprocessor via the wireless transmission module to start sampling.

Once the sampling is complete, the healthcare professional draws the sample fluids from the sample chamber21using a syringe or the like that is pierced into the sample chamber21through the silicone plug31for subsequent analysis and testing.

In summary, the sampling capsule100of the present invention comprises a silicone plug31connected to the sample chamber21. Based on the silicone plug31, for one thing, if the sampling capsule100leaks during transportation and storage, a syringe can be used to pierce the silicone plug31to pump air out of the sample chamber21again to achieve the desired vacuum, so as not to cause product waste. In addition, according to the shrinkage of the silicone plug31, the needle eye is sealed after the syringe is pulled out, so that subsequent use is not be affected. For another, the sampling capsule100can be produced without evacuating the sample chamber, but a syringe or the like is used to produce the desired vacuum in the sample chamber21through the silicone plug31.

It should be understood that, although the specification is described in terms of embodiments, not every embodiment merely includes an independent technical solution. Those skilled in the art should have the specification as a whole, and the technical solutions in each embodiment may also be combined as appropriate to form other embodiments that can be understood by those skilled in the art.

The present invention by no means is limited to the preferred embodiments described above. On the contrary, many modifications and variations are possible within the scope of the appended claims.