Controllable enteral sampling capsule

Abstract

The present invention discloses a controllable intestinal sampling capsule, comprising a shell and a sampling port opening device, wherein: a plurality of sampling ports are arranged on the outer periphery of the shell, and before the controllable intestinal sampling capsule enters the human body, the sampling ports are blocked by the sampling port opening device; the sampling port opening device can produce deformation under the induction of an induction source arranged outside the body when the controllable intestinal sampling capsule is located in the human intestine, so as to open the sampling port. The present invention can accurately control the position of the capsule opening sampling port through the in vitro induction source, and ensure that the sampling port is opened in the intestine.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a controllable intestinal sampling capsule. Background Art

[0002] Small intestinal fluid is secreted by the small intestinal glands in the small intestinal mucosa. It is weakly alkaline with a pH value of about 8-9. The daily secretion volume of an adult is about 1 to 3L. Small intestinal fluid is secreted and absorbed at the same time. This fluid exchange provides a medium for the absorption of nutrients in the small intestine.

[0003] Therefore, the composition and pH value of the fluid extracted from the small intestine are quite different from those of gastric juice. Therefore, the extraction and analysis of small intestinal fluid is of great help in some basic diagnosis.

[0004] There are two existing methods for extracting small intestinal fluid: catheter and capsule. The catheter extraction method is to insert a catheter into the small intestine from the mouth or stomach, and extract the small intestinal fluid by negative pressure suction. This method uses a long catheter to enter the patient's mouth, which makes the patient feel uncomfortable and takes a long time for the doctor to operate. The advantage is that the sampling is accurate and the amount of small intestinal fluid obtained is large.

[0005] The capsule method uses a capsule with a controllable valve to be swallowed. After the capsule enters the small intestine, the valve is opened to collect small intestinal fluid, and the valve is closed before the capsule leaves the small intestine area. After the capsule is excreted by the human body, the small intestinal fluid in the capsule is recovered and obtained. Capsule extraction is more comfortable for patients, but it has two problems: low reliability of valve control and easy failure. The capsule obtains less small intestinal fluid, and there is often a problem of not being able to obtain small intestinal fluid. Summary of the invention

[0006] In view of this, the present invention proposes a controllable intestinal sampling capsule, in which the cover of the sampling port is ensured to fall off in the small intestine under the induction of an in vitro induction source, and the reliability is high.

[0007] The present invention adopts the following technical scheme: a controllable intestinal sampling capsule, including a shell and a sampling port opening device, wherein: a plurality of sampling ports are arranged on the outer periphery of the shell, and before the controllable intestinal sampling capsule enters the human body, the sampling ports are blocked by the sampling port opening device; the sampling port opening device can be deformed under the induction action of an induction source arranged outside the body when the controllable intestinal sampling capsule is located in the small intestine of the human body, thereby opening the sampling port.

[0008] Optionally, the induction source is an induced magnetic field; the sampling port opening device includes a heat-sensitive adhesive and a metal cover plate, wherein: the heat-sensitive adhesive is used to stick the metal cover plate to the sampling port so that the sampling port is blocked; the metal cover plate can generate heat under the induction of the induced magnetic field so that the adhesive fails, and when the adhesive fails, the metal cover plate can be deformed.

[0009] Optionally, the metal cover plate is an elastic metal, and when the adhesive fails, the metal cover plate generates the deformation under the action of elastic force; or, the metal cover plate is a memory alloy, and when the adhesive fails, the metal cover plate generates the deformation due to the shape memory effect when the temperature changes.

[0010] Optionally, the memory alloy is silicon steel or Permalloy material.

[0011] Optionally, the shell is made of martensitic nickel-iron alloy material.

[0012] Optionally, the heat-sensitive adhesive fails when the temperature reaches 40 degrees Celsius.

[0013] Optionally, the controllable intestinal sampling capsule further comprises a sampling port closing device, and the sampling port closing device is used to close the sampling port after the controllable intestinal sampling capsule collects small intestinal fluid.

[0014] Optionally, the sampling port closing device includes a piston, a spring, a soluble retaining ring and a spring release mechanism, wherein: the piston is fitted around the inner wall of the shell and is axially adjacent to the sampling port; the spring is axially located on the side of the piston away from the sampling port and its elastic direction points to the sampling port; the spring release mechanism is used to release the spring after collecting the small intestinal fluid, so that the spring pushes the piston to the position of the sampling port.

[0015] Optionally, the spring release mechanism comprises a soluble snap ring fixed to the inner wall of the housing, the soluble snap ring being located in the annular groove of the piston and being used to clamp the spring in a state to be released;

[0016] The soluble clamp ring is connected with the travel route of the small intestinal fluid in the shell, so that the small intestinal fluid can dissolve the soluble clamp ring.

[0017] Optionally, the soluble clamp ring is connected to the end of the route of the small intestinal fluid in the shell.

[0018] Optionally, a first sealing ring is provided between the piston and the inner wall of the housing.

[0019] Optionally, a sampling channel component is also included, and the sampling channel component is connected to the sampling port.

[0020] Optionally, the sampling channel assembly is cylindrical, including three layers of tubes, namely an inner tube, a middle tube, and an outer tube, which are sequentially sleeved from the inside to the outside, and the middle tube and the outer tube are sealed and connected to the shell at both ends; the three layers of tubes are connected by a partition, and the partition is perpendicular to the axis of the collection channel assembly and is located in the middle of the three layers of tubes; the two ends of the outer tube are respectively provided with a plurality of first through holes, and the first through holes are connected to the sampling port; the middle tube is provided with a plurality of second through holes, and the second through holes are distributed on both sides of the partition.

[0021] Optionally, the sampling channel assembly is located in the middle of the shell, and the piston is arranged between the sampling channel assembly and the inner wall of the shell.

[0022] Optionally, a second sealing ring is provided between the inner side of the piston and the outer wall of the sampling channel assembly.

[0023] Optionally, the shell is composed of a first shell part and a second shell part connected to each other, wherein: an annular protrusion is provided on the edge of the first shell part, a slot extending toward the second shell part is provided on the shell cross-section of the annular protrusion, and the edge of the second shell part is inserted into the slot so that the first shell part and the second shell part are riveted together.

[0024] According to the technical solution of the present invention, the controllable intestinal sampling capsule includes a shell and a sampling port opening device, wherein: a plurality of sampling ports are arranged on the outer periphery of the shell, and the sampling ports are blocked by the sampling port opening device before the controllable intestinal sampling capsule enters the human body; the sampling port opening device can produce deformation under the induction of an induction source arranged outside the body when the controllable intestinal sampling capsule is located in the small intestine of the human body, thereby opening the sampling port. The present invention can accurately control the position of the capsule opening sampling port through the in vitro induction source, ensuring that the sampling port is opened in the small intestine. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] For purposes of illustration and not limitation, the present invention will now be described in terms of preferred embodiments thereof, with particular reference to the accompanying drawings, in which:

[0026] Figure 1 It is a schematic diagram of the external structure of the controllable intestinal sampling capsule (metal cover detached) according to an embodiment of the present invention.

[0027] Figure 2 It is a schematic diagram of the external structure of the controllable intestinal sampling capsule according to an embodiment of the present invention.

[0028] Figure 3 It is a structural schematic diagram of the metal cover plate in the bonding state.

[0029] Figure 4 It is a structural schematic diagram of the metal cover being detached.

[0030] Figure 5 is an exploded view of a controllable intestinal sampling capsule according to an embodiment of the present invention.

[0031] Figure 6 It is a schematic diagram of a controllable intestinal sampling capsule in an embodiment of the present invention, in a state where the sampling window is not opened.

[0032] Figure 7 It is a schematic diagram of the detached state of the metal cover of the controllable intestinal sampling capsule according to an embodiment of the present invention.

[0033] Figure 8 It is a schematic diagram of the sealed state of the controllable intestinal sampling capsule after small intestinal fluid absorption according to an embodiment of the present invention.

[0034] In the figure, 1-shell, 11-annular protrusion, 2-sampling port, 3-metal cover, 4-sampling channel assembly, 41-partition, 42-first through hole, 43-second through hole, 441-inner tube, 442-middle tube, 443-outer tube, 5-piston, 51-annular groove, 6-spring, 7-first sealing ring, 8-soluble retaining ring, 9-second sealing ring. DETAILED DESCRIPTION

[0035] See also Figure 1 , Figure 1 It is a schematic diagram of the external structure of a controllable intestinal sampling capsule (metal cover detached) according to an embodiment of the present invention; the controllable intestinal sampling capsule comprises a shell 1 and a sampling port opening device, wherein: a plurality of sampling ports 2 are arranged on the outer periphery of the shell 1, and the sampling ports 2 are blocked by the sampling port opening device before the controllable intestinal sampling capsule enters the human body; the sampling port opening device can, when the controllable intestinal sampling capsule is located in the small intestine of the human body, be deformed under the induction of an induced magnetic field arranged outside the body, thereby opening the sampling port 2.

[0036] See also Figure 2 , Figure 2 It is a schematic diagram of the external structure of the controllable intestinal sampling capsule according to an embodiment of the present invention; the sampling port opening device includes a heat-sensitive adhesive and a metal cover plate 3, the heat-sensitive adhesive fails when the temperature reaches 40-50 degrees Celsius; the heat-sensitive adhesive is used to stick the metal cover plate 3 to the sampling port 2 so that the sampling port 2 is blocked; the metal cover plate 3 can generate heat under the induction of the induced magnetic field so that the adhesive fails, and when the adhesive fails, the metal cover plate 3 can be deformed; the adhesive failure here means that the adhesive loses its adhesion.

[0037] Please combine Figure 3 , Figure 4 , Figure 3 It is a structural diagram of the metal cover plate in bonding state. Figure 4It is a structural schematic diagram of the metal cover plate detached state; the metal cover plate 3 is made of a metal material with a high magnetic permeability. Under the action of an external magnetic field at the corresponding position of the small intestine in vitro, the temperature of the metal cover plate 3 increases. There are two ways to implement the metal cover plate of the intestinal sampling capsule. One is to use elastic metal to make the metal cover plate elastically deform under the action of external force and then glue it to the sampling port of the capsule shell, and overcome the elastic force through the adhesive force of the glue; after the temperature of the metal cover plate increases, the glue temperature reaches more than 40° and the adhesive fails, and the elastic force of the cover plate is released, so that the cover plate is separated from the shell. The other is to use memory alloy, such as silicon steel or permalloy material with a high magnetic permeability. When the adhesive fails, the metal cover plate 3 is deformed under the shape memory effect when the temperature changes. Here, the shape memory effect refers to the memory alloy being able to completely eliminate its deformation at a lower temperature after heating and temperature rise, and restore its original shape before deformation. At room temperature, the shape of the memory alloy cover plate corresponds to the sampling port, and it can be easily glued to the shell. After entering the small intestine, under the action of the in vitro magnetic field, the temperature of the memory alloy cover plate rises. Under the shape memory effect, the memory alloy cover plate deforms and generates elastic force. At the same time, when the glue temperature reaches above 40°, the adhesive fails and the elastic force of the cover plate is released, causing the cover plate to detach from the shell. The second method is more convenient when bonding the cover plate, and no force is required to overcome the elasticity of the cover plate.

[0038] The magnetic permeability of the shell 1 is much lower than that of the metal cover 3. For example, the shell 1 is made of a martensitic nickel-iron alloy material, so that under the same alternating magnetic field, the metal cover 3 can generate heat significantly, while the shell 1 basically does not generate heat, thereby preventing the shell 1 from heating up and affecting the collected intestinal fluid, such as small intestinal fluid.

[0039] The shell 1 of the sampling capsule is made of magnetic metal material, and compared with the plastic shell, the wall thickness is thinner and the inner cavity is larger.

[0040] Please combine Figure 5 , Figure 6 , Figure 5 is an exploded view of a controllable intestinal sampling capsule according to an embodiment of the present invention, Figure 6It is a structural schematic diagram of the metal cover plate in a bonding state; the sampling channel assembly 4 is cylindrical, and has a circuitous collection channel therein; the collection channel assembly 4 is composed of three layers of tubes which are nested with each other, namely an inner layer tube 441, a middle layer tube 442, and an outer layer tube 443, and the three layers of tubes are connected in the middle by a partition 41 which is perpendicular to the axis of the collection channel assembly, and the middle layer tube 442 and the outer layer tube 443 are sealed and connected to the shell 1 at both ends; in the embodiment of the present invention, four first through holes 42 are respectively provided at both ends of the outer layer tube 443 of the sampling channel assembly 4, and the four first through holes 42 are located at four quadrants of a circle (according to the viewing angle in the figure), and four second through holes 43 are respectively provided on the middle layer 442 tube of the sampling channel assembly 4 on both sides of the partition 41, and the first through holes 42 and the second through holes 43 are located on the same longitudinal section of the sampling channel assembly 4 passing through the axis of the sampling channel assembly 4.

[0041] See also Figure 7 , Figure 8 , Figure 7 is a schematic diagram of a detached state of a metal cover plate of a controllable intestinal sampling capsule according to an embodiment of the present invention, Figure 8 It is a schematic diagram of the sealed state of the controllable enteral sampling capsule after the intestinal fluid is absorbed according to an embodiment of the present invention; the piston 5 is annular and slidably arranged between the housing 1 and the sampling channel assembly 4, and can close the sampling port 2 under the action of the spring 6. Before the sampling is completed, the soluble snap ring 8 limits the movement of the piston 5, thereby keeping the sampling port 2 open. When the intestinal fluid enters the collection channel and flows from one end of the channel to the other end (it can be judged that the intestinal fluid fills the collection channel), the intestinal fluid then dissolves the soluble snap ring 8 connected to the collection channel. After the soluble snap ring 8 is dissolved and destroyed, the spring 6 pushes the piston 5, and the sampling port 2 is closed by the piston 5.

[0042] The piston 5 is provided with three sealing rings. The two first sealing rings 7 close to the housing 1 are used to seal the sampling port 2, and the second sealing ring 9 close to the sampling channel assembly 4 is used to separate the two ends of the collection channel.

[0043] The soluble snap ring 8 is located inside the housing 1 , in the annular groove 51 of the piston 5 , and is connected to the small intestinal fluid coming out of the sampling channel assembly 4 through a tiny gap between the piston 5 and the housing 1 .

[0044] See also Figure 6 The shell 1 is composed of two parts riveted together. The shell 1 has two annular protrusions 11. With the help of tools, the shell 1 can be disassembled at the two annular protrusions 11 to take out the sampling channel assembly 4 in the shell 1.

[0045] Directions:

[0046] 1. The patient swallows the sampling capsule, which passes through the esophagus and stomach and then enters the small intestine. At this time, the sampling window is not open. Figure 6 shown.

[0047] 2. Use detection instruments (strong magnetism, ultrasound, X-ray, CT, etc.) to determine the position where the sampling capsule enters the small intestine, and then apply an induced magnetic field to the abdomen to heat the metal cover plate 3 of the sampling port 2, thereby causing the metal cover plate 3 to deform and detach from the shell 1, and the sampling port 2 is opened. The results are as follows: Figure 7 As shown; the metal cover plate 3 is finally discharged from the body.

[0048] 3. The small intestinal fluid enters the capsule from the sampling port 2 and passes through the collection channel of the sampling channel assembly 4; Figure 7 The path of the small intestinal fluid is shown. As shown by the dotted line with arrows in the figure, the small intestinal fluid passes through the first through hole 42 and the second through hole 43 in sequence, enters the inner tube of the sampling channel assembly 4, and then reaches the other end of the sampling channel assembly 4, and then passes through the second through hole 43 and the first through hole 42 in sequence.

[0049] 4. After the intestinal fluid comes out of the sampling channel assembly 4 through the first through hole 42, it is connected with the soluble snap ring 8 provided on the inner wall of the housing 1, and the soluble snap ring 8 is dissolved and destroyed. The spring 6 pushes the piston 5 to close the sampling port 2. The result is as follows: Figure 8 shown.

[0050] 5. The capsule leaves the digestive tract and is discharged from the body along with the excrement. The shell 1 is then recovered from the excrement by strong magnetic attraction. The shell 1 is disassembled through the two annular protrusions 11 on the shell 1, and the sampling channel assembly 4 is taken out to obtain the small intestinal fluid therein.

[0051] According to the technical solution of the embodiment of the present invention, the metal cover 3 is made of a metal material with high magnetic permeability. The metal cover 3 is adhered to the sampling port 2 by a heat-sensitive polymer adhesive and the sampling port 2 is sealed. The position of the capsule opening the sampling port can be accurately controlled by an external induced magnetic field to ensure that the sampling port is opened in the small intestine.

[0052] In the embodiment of the present invention, the magnetic permeability of the shell 1 is much lower than that of the metal cover 3. Under the same alternating magnetic field, the metal cover 3 can generate heat obviously, while the shell 1 does not generate heat at all. This can avoid the problem that the heat of the shell 1 affects the collected small intestinal fluid.

[0053] According to the technical solution of the embodiment of the present invention, the sampling channel assembly 4 has a circuitous collection channel. When the small intestinal fluid enters the collection channel and flows from one end of the channel to the other end, it can be judged that the small intestinal fluid fills the collection channel. Then the small intestinal fluid dissolves the soluble snap ring 8 connected to the collection channel. After the soluble snap ring 8 is dissolved and destroyed, the spring 6 pushes the piston 5 and the sampling port 2 is closed. The circuitous collection channel can ensure that the small intestinal fluid is collected and then the sampling port is closed.

[0054] The above specific implementations do not constitute a limitation on the protection scope of the present invention. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may occur depending on design requirements and other factors. Any modification, equivalent substitution and improvement made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A controllable intestinal sampling capsule, characterized in that: It comprises a housing (1), a sampling port opening device, and a sampling port closing device, wherein: A plurality of sampling ports (2) are arranged on the outer periphery of the shell (1); before the controllable intestinal sampling capsule enters the human body, the sampling ports (2) are blocked by a sampling port opening device; The sampling port opening device can be deformed under the induction of an induction source arranged outside the body when the controllable intestinal sampling capsule is located in the small intestine of the human body, thereby opening the sampling port (2); The induction source is an induced magnetic field; The sampling port opening device comprises a metal cover plate (3) and a heat-sensitive adhesive, wherein: The heat-sensitive adhesive is used to adhere the metal cover plate (3) to the sampling port (2) so that the sampling port (2) is blocked; The metal cover plate (3) can generate heat under the induction effect of the induced magnetic field so as to render the adhesive ineffective, and in the case where the adhesive fails, the metal cover plate (3) can be deformed; The sampling port closing device is used to close the sampling port (2) after the controllable intestinal sampling capsule collects the small intestinal fluid; The sampling port closing device comprises a piston (5), a spring (6), a soluble snap ring (8) and a spring release mechanism, wherein: The piston (5) is circumferentially fitted to the inner wall of the housing (1) and is axially adjacent to the sampling port (2); The spring (6) is axially located on a side of the piston (5) away from the sampling port (2) and its elastic direction points toward the sampling port (2); The spring release mechanism is used to release the spring (6) after collecting the small intestinal fluid, so that the spring (6) pushes the piston (5) to the position of the sampling port (2).

2. The controllable intestinal sampling capsule according to claim 1, characterized in that: The metal cover plate (3) is an elastic metal, and when the adhesive fails, the metal cover plate (3) generates the deformation under the action of the elastic force; Alternatively, the metal cover plate (3) is a memory alloy, and when the adhesive fails, the metal cover plate (3) generates the deformation due to the shape memory effect when the temperature changes.

3. The controllable intestinal sampling capsule according to claim 2, characterized in that: The memory alloy is silicon steel or permalloy material.

4. The controllable intestinal sampling capsule according to any one of claims 1 to 3, characterized in that: The shell (1) is made of a martensitic nickel-iron alloy material.

5. The controllable intestinal sampling capsule according to any one of claims 1 to 3, characterized in that: The heat-sensitive adhesive fails when the temperature reaches 40 degrees Celsius.

6. The controllable intestinal sampling capsule according to claim 1, characterized in that: The spring release mechanism comprises a soluble snap ring (8) fixed to the inner wall of the housing (1), the soluble snap ring (8) being located in the annular groove (51) of the piston (5) and being used to clamp the spring (6) in a state to be released; The soluble clamp ring (8) is connected to the path of the small intestinal fluid in the housing (1), so that the small intestinal fluid can dissolve the soluble clamp ring (8).

7. The controllable intestinal sampling capsule according to claim 6, characterized in that: The soluble clamp ring (8) is connected to the end of the path of the small intestinal fluid in the housing (1).

8. The controllable intestinal sampling capsule according to claim 1, characterized in that: A first sealing ring (7) is provided between the piston (5) and the inner wall of the housing (1).

9. The controllable intestinal sampling capsule according to claim 1, characterized in that: It also comprises a sampling channel component (4), wherein the sampling channel component (4) is connected to the sampling port (2).

10. The controllable intestinal sampling capsule according to claim 9, characterized in that: The sampling channel assembly (4) is cylindrical and comprises three layers of tubes, an inner tube (441), a middle tube (442), and an outer tube (443), which are sequentially sleeved from the inside to the outside. The middle tube (442) and the outer tube (443) are sealed and connected to the housing (1) at both ends. The three-layer tubes are connected by a partition (41), and the partition (41) is perpendicular to the axis of the collection channel assembly (4) and is located in the middle of the three-layer tube; A plurality of first through holes (42) are respectively provided at both ends of the outer tube (443), and the first through holes (42) are connected to the sampling port (2); The intermediate layer tube (442) is provided with a plurality of second through holes (43), and the second through holes (43) are distributed on both sides of the partition plate (41).

11. The controllable intestinal sampling capsule according to claim 9, characterized in that: The sampling channel component (4) is located in the middle of the housing (1), and the piston (5) is arranged between the sampling channel component (4) and the inner wall of the housing (1).

12. The controllable intestinal sampling capsule according to claim 11, characterized in that: A second sealing ring (9) is provided between the inner side of the piston (5) and the outer wall of the sampling channel assembly (4).

13. The controllable intestinal sampling capsule according to any one of claims 1 to 3, characterized in that: The housing (1) is composed of a first housing part and a second housing part connected to each other, wherein: An annular protrusion (11) is provided at the edge of the first shell part, and a slot extending toward the second shell part is provided on the shell cross section of the annular protrusion (11). The edge of the second shell part is inserted into the slot so that the first shell part and the second shell part are riveted together.

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