Gastrointestinal fistula structure with sensing unit

Abstract

This invention discloses a gastrostomy fistula structure with a sensing unit, comprising a fistula body having a first end and a second end, and the fistula body including an outer surface, an inner surface, and a fistula hole penetrating the fistula body; an outer fixing plate disposed near the first end, the outer fixing plate including an outer contact surface; an inner fixing member disposed at the second end, the inner fixing member including an inner contact surface; at least one sensing unit disposed at any one, any two, any three, or all four locations of the outer surface, the inner surface, the outer contact surface, and the inner contact surface, the sensing unit including a sensing surface that is exposed; a processing unit signal-connected to the sensing unit to receive sensing information from the sensing unit; and a power supply unit electrically connected to the sensing unit and the processing unit to provide the required power.

Description

Technical Field

[0001] This invention relates to a digestive tract stoma structure with a sensing unit, specifically an invention that provides a sensing unit on the stoma body of a digestive tract stoma to sense the state of the digestive tract or stoma at regular intervals or at any time. Background Technology

[0002] Depending on the patient's condition (e.g., difficulty swallowing), a doctor may assess the patient and place a stoma in the digestive tract. A fistula can then be inserted directly into the digestive tract from the outside through the stoma to form a fistula, allowing medication or feeding to be administered directly through the fistula.

[0003] Since the stoma extends directly from the body surface into the digestive tract, it usually needs to be covered with gauze or other medical dressings and changed frequently to prevent acidic or inflammatory substances in the digestive tract from leaking out and eroding or damaging the tissues or skin near the stoma. In addition, regular follow-up visits are required for medical personnel to check the condition of the stoma.

[0004] Automated detection of stoma status includes prior art such as Chinese Patent No. CN114080204, "Leakage Detection System for Stoma Instruments," US Patent No. US20220031495, "OSTOMY MONITORING SYSTEM AND METHOD," and US Patent No. US20220079803, "A SENSOR PATCH FOR AN OSTOMY APPLIANCE." All of these prior art involve placing detectors on the body surface to detect stoma status, such as whether digestive fluids are leaking or the temperature near the stoma.

[0005] However, when a detector is placed on the body surface to detect the leakage of digestive fluids, the digestive fluids have usually already been leaking from the digestive tract for some time, making it impossible to deal with the problem of digestive fluid leakage in real time. In addition, the detection device in the previous case could not detect the wound on the stoma incision or the condition inside the digestive tract. Summary of the Invention

[0006] Unlike the prior art, the purpose of this invention is to provide a digestive tract fistula structure with a sensing unit.

[0007] This invention proposes a gastrostomy structure with a sensing unit, comprising:

[0008] A fistula, comprising a first end and a second end, the fistula comprising an outer surface, an inner surface, and a fistula opening penetrating the fistula. An external fixing plate, comprising an outer contact surface, the external fixing plate being disposed near the first end. An internal fixing member, comprising an inner contact surface, the internal fixing member being disposed at the second end. At least one sensing unit, the sensing unit comprising a sensing surface, the sensing unit being disposed at any one, two, three, or all four of the following four locations: the outer surface, the inner surface, the outer contact surface, and the inner contact surface; the sensing surface being exposed above the aforementioned outer contact surface, the aforementioned inner surface, the aforementioned outer surface, or the aforementioned inner contact surface. A processing unit, signal-connected to the sensing unit, receiving sensing information from the sensing unit. A power supply unit, electrically connected to the sensing unit and the processing unit.

[0009] Furthermore, the sensing units are arranged in a ring on the outer contact surface.

[0010] Furthermore, the sensing units are arranged in a ring on the inner contact surface.

[0011] Furthermore, the sensing units are distributed in a ring on the outer surface.

[0012] Furthermore, the sensing units are distributed in a ring on the inner surface.

[0013] Furthermore, the sensing unit is one of the following: a blood glucose sensor, a pH sensor, a tension sensor, a blood oxygen sensor, a temperature sensor, or a flow rate sensor.

[0014] Furthermore, an ultrasonic unit is disposed on the fistula, the ultrasonic unit being electrically connected to the power supply unit and signal-connected to the processing unit.

[0015] Furthermore, it includes a wireless unit that is signal-connected to the processing unit and electrically connected to the power supply unit. Both the wireless unit and the processing unit are disposed in the fistula. The processing unit receives a sensing signal from the sensing unit and transmits the sensing signal through the wireless unit.

[0016] Furthermore, it includes an alarm unit that is signal-connected to the processing unit and electrically connected to the power supply unit.

[0017] Furthermore, the processing unit and the power supply unit are located outside the fistula. The power supply unit is connected to the sensing unit via a wire, and the processing unit is connected to the sensing unit via a signal line.

[0018] Furthermore, the sensing surface is flush with or recessed within the aforementioned outer contact surface, the aforementioned inner surface, the aforementioned outer surface, or the aforementioned inner contact surface; or the sensing surface may protrude from the aforementioned outer contact surface.

[0019] Furthermore, the sensing unit is disposed in an inner groove channel. Even further, an extending axis of the inner groove channel is perpendicular or inclined to the outer contact surface, the inner surface, the outer surface, or the inner contact surface. Even further, the inner groove channel is annular.

[0020] Furthermore, the sensing unit is ring-shaped.

[0021] The following effects can be achieved based on the above technical features:

[0022] 1. The present invention provides sensing units on the outer surface, inner surface, outer contact surface and inner contact surface of the fistula, which can detect the condition of the inside of the digestive tract, the wound of the stoma incision and the body surface; especially when digestive fluid or inflammatory substances leak from the digestive tract, it can detect and deal with it in real time.

[0023] 2. The sensing unit can be placed in the inner groove channel on the surface of the fistula. When a slight leak of digestive fluid is not detected by the sensing unit on the surface of the fistula, the digestive fluid accumulated in the inner groove channel can be detected by the sensing unit in the inner groove channel, making the detection of digestive fluid leakage more real-time and accurate. Furthermore, if the inner groove channel is made into a ring, it can sense leaks from all directions.

[0024] 3. The sensing unit can use different sensors such as blood glucose sensor, pH sensor, tension sensor, blood oxygen sensor, temperature sensor, flow rate sensor, etc., to sense various states of the stoma.

[0025] 4. The additional ultrasound unit can be used to detect the suture status after the stoma surgery, whether the stoma is suppurating, and whether there are residual blood clots in the digestive tract.

[0026] 5. The sensing unit is set to a ring shape, which can sense the state of the digestive tract stoma in all directions. Attached Figure Description

[0027] Figure 1 This is a three-dimensional view of the digestive tract fistula from one perspective of the first embodiment of the present invention.

[0028] Figure 2 This is a three-dimensional view of the digestive tract fistula of the first embodiment of the present invention from another perspective.

[0029] Figure 3 This is a cross-sectional view of a digestive tract fistula according to the first embodiment of the present invention.

[0030] Figure 4 This is a functional block diagram showing the connection relationships of various electronic components in a gastrointestinal fistula according to the first embodiment of the present invention.

[0031] Figure 5 This is a diagram illustrating the usage of a gastrostomy system in the digestive tract according to the first embodiment of the present invention.

[0032] Figure 6 This is a schematic diagram of a digestive tract fistula according to a second embodiment of the present invention, showing that each electronic component is disposed outside the fistula.

[0033] Figure 7 This is a schematic diagram of a digestive tract fistula according to the third embodiment of the present invention, showing that an ultrasound unit is also provided on the fistula.

[0034] Figure 8 This is a functional block diagram showing the connection relationships of various electronic components in a gastrointestinal fistula according to the third embodiment of the present invention.

[0035] Figure 9 This is a schematic diagram of a digestive tract fistula according to the fourth embodiment of the present invention, showing that the sensing surface of the sensing unit protrudes from the aforementioned outer contact surface.

[0036] Figure 10 This is a cross-sectional view of a gastrointestinal fistula according to the fifth embodiment of the present invention.

[0037] Figure 11 for Figure 10 The cross-sectional view shows the sensing unit positioned within the annular groove of the fistula.

[0038] Figure 12 for Figure 10 A cross-sectional view showing an annular sensing unit disposed on the outer surface of the fistula.

[0039] Explanation of reference numerals in the attached drawings: 1-Fistula; 11-First end; 12-Second end; 13-Outer surface; 131-Internal groove channel; 132-Annular internal groove channel; 14-Inner surface; 15-Fistula opening; 2-External fixation plate; 21-External contact surface; 3-Internal fixation component; 31-Inner contact surface; 4-Sensing unit; 41-Sensing surface; 4A-Annular sensing unit; 5-Processing unit; 6-Alarm unit; 7-Wireless unit; 8-Power supply unit; 9-Wire; 9A-Signal line; 10-Ultrasound unit; A-Gastrostomy; B-Gastric wall; C-Skin surface. Detailed Implementation

[0040] Based on the above technical features, the main functions of the digestive tract fistula structure with sensing unit of the present invention will be clearly demonstrated in the following embodiments.

[0041] The first embodiment of the present invention is described below. Figures 1 to 3 As shown, the gastrointestinal fistula structure in this embodiment includes:

[0042] A fistula 1 includes a first end 11 and a second end 12. The fistula 1 includes an outer surface 13, an inner surface 14 and a fistula hole 15 passing through the fistula 1. An outer fixing plate 2 includes an outer contact surface 21 and is disposed near the first end 11. An inner fixing member 3 includes an inner contact surface 31 and is disposed at the second end 12.

[0043] At least one sensing unit 4 is disposed at any one, two, three, or all four of the following four locations: the outer surface 13, the inner surface 14, the outer contact surface 21, and the inner contact surface 31. In this embodiment, a plurality of sensing units 4 are disposed at each of the above four locations, and the sensing units 4 are distributed in a ring on the outer surface 13, the inner surface 14, the outer contact surface 21, and the inner contact surface 31. The sensing unit 4 includes a sensing surface 41, which is exposed on the outer surface 13, the inner surface 14, the outer contact surface 21, and the inner contact surface 31. In this embodiment, the sensing surface 41 is flush with the inner surface 14, the outer contact surface 21, and the inner contact surface 31. The sensing unit 4 located on the outer surface 13 is partially flush with the outer surface 13 and partially recessed into the outer surface 13. For example, there is a ring of inner groove channels 131 on the outer surface 13, and the sensing unit 4 is disposed in the inner groove channels 131. An extension axis of the inner groove channels 131 may be perpendicular or inclined to the outer surface 13.

[0044] See also Figure 4 As shown, a processing unit 5, an alarm unit 6, a wireless unit 7, and a power supply unit 8 are provided in the fistula 1. The processing unit 5 is signal-connected to the sensing unit 4, the alarm unit 6 and the wireless unit 7 are signal-connected to the processing unit 5, and the power supply unit 8 is electrically connected to the sensing unit 4, the processing unit 5, the alarm unit 6 and the wireless unit 7.

[0045] See Figure 5 As shown, the fistula structure of this embodiment is set in, for example, a gastrostomy A. The internal fixation member 3 is located inside the stomach and the internal contact surface 31 abuts against the stomach wall B. The fistula body 1 is located in the gastrostomy A and the outer surface 13 is supported against the cut surface of the gastrostomy A. The external fixation plate 2 is located on the body surface and the outer contact surface 21 abuts against the skin C of the body surface.

[0046] The aforementioned sensing unit 4 can continuously sense the status of the gastrostomy A and transmit the sensing signal to the processing unit 5. When the sensing signal is abnormal, the processing unit 5 controls the warning unit 6 to issue a warning to remind personnel to handle the situation. The processing unit 5 can also transmit the sensing signal through the wireless unit 7, which can be used for remote care. Figure 5The sensing unit 4, processing unit 5, warning unit 6 and wireless unit 7 shown are separate entities, but integrating any two, any three or all of the sensing unit 4, processing unit 5, warning unit 6 and wireless unit 7 into a single composite unit is also a feasible embodiment of the present invention.

[0047] In this embodiment, the aforementioned sensing unit 4 uses a blood glucose sensor, a pH sensor, a tension sensor, a blood oxygen sensor, a temperature sensor, and a flow rate sensor. The blood glucose sensor and blood oxygen sensor are, for example, located on the outer surface 13 of the fistula 1, allowing blood glucose and blood oxygen levels to be detected from the blood at the gastrostomy A incision site. The pH sensor is, for example, located on the outer surface 13 and inner surface 14 of the fistula 1, the outer contact surface 21 of the outer fixation plate 2, and the inner contact surface 31 of the inner fixation member 3, respectively, enabling detection of whether digestive fluid leaks and the extent of leakage. The pH sensor can be located in the inner groove 131 of the outer surface 13. When digestive fluid leaks continuously in small amounts, and the pH sensors at other locations (flush with the outer surface 13, the inner surface 14, the outer contact surface 21, and the inner contact surface 31) do not detect leakage due to the rapid passage of digestive fluid, the digestive fluid accumulated in the inner groove 131 can be detected by the pH sensor in the inner groove 131. The detection allows for real-time leak detection. The tension sensor can be symmetrically positioned on the outer surface 13 of the fistula 1, the outer contact surface 21 of the outer fixation plate 2, and the inner contact surface 31 of the inner fixation member 3, allowing for judgment of correct installation of the stoma structure based on pressure balance. The temperature sensor can be positioned at any position on the outer surface 13 and inner surface 14 of the fistula 1, the outer contact surface 21 of the outer fixation plate 2, and the inner contact surface 31 of the inner fixation member 3, to sense whether the body temperature around the gastrostomy A is normal. The flow rate sensor can be positioned on the outer surface 13 and inner surface 14 of the fistula 1, the outer contact surface 21 of the outer fixation plate 2, and the inner contact surface 31 of the inner fixation member 3, to sense the rate of digestive fluid leakage. The flow rate sensor on the inner surface 14 can also sense the feeding rate.

[0048] Please refer to the second embodiment of the present invention. Figure 4 and Figure 6 As shown, unlike the first embodiment, the processing unit 5, the warning unit 6, the wireless unit 7 and the power supply unit 8 are disposed outside the fistula 1. The power supply unit 8 is connected to the sensing unit 4 by a wire 9, and the processing unit 5 is connected to the sensing unit 4 by a signal line 9A.

[0049] Please refer to the third embodiment of the present invention. Figure 7 and Figure 8As shown, unlike the first embodiment, an ultrasonic unit 10 is further included on the fistula 1. The ultrasonic unit 10 is electrically connected to the power supply unit 8 and signal-connected to the processing unit 5. The ultrasonic unit 10 can detect the suturing status of the fistula surgery, as well as subsequent issues such as whether the wound has become infected or whether there are residual blood clots at the stoma site.

[0050] Please refer to the fourth embodiment of the present invention. Figure 9 As shown, unlike the first embodiment, in this embodiment, the sensing unit 4, which is disposed on the outer contact surface 21 of the outer fixing plate 2, has a sensing surface 41 that protrudes from the aforementioned outer contact surface 21. Since the outer contact surface 21 rests against the skin C, the protruding sensing surface 41 will not cause discomfort and can still accurately detect whether digestive fluid has leaked to the skin surface.

[0051] Please refer to the fifth embodiment of the present invention. Figures 10 to 12 As shown, unlike the first embodiment, as Figure 10 and Figure 11 The fistula 1 has an annular inner groove channel 132 on its outer surface 13, and the aforementioned sensing unit 4 is disposed in the annular inner groove channel 132. Thus, when digestive fluid leaks from the outer surface 13 of the fistula 1, the leaked digestive fluid accumulates in the annular inner groove channel 132. Therefore, only a single sensing unit 4 is needed to sense leakage from all directions of the outer surface 13. For example... Figure 10 and Figure 12 For example, an annular sensing unit 4A is provided on the outer surface 13 of the fistula 1, so that the state of the gastrostomy A in each direction can be sensed through the annular sensing unit 4A.

[0052] Based on the above description of the embodiments, one can fully understand the operation, use, and effects of the present invention. The above embodiments are only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Simple equivalent changes and modifications made in accordance with the claims and description of the invention are all within the scope of the present invention.

Claims

1. A gastrointestinal fistula structure with a sensing unit, characterized in that, Including: A fistula includes a first end and a second end, the fistula includes an outer surface, an inner surface and a fistula opening through the fistula; An outer fixing plate includes an outer contact surface, the outer fixing plate being disposed near the first end; An internal fastener includes an inner contact surface, and the internal fastener is disposed at the second end; At least one sensing unit, the sensing unit comprising a sensing surface, the sensing unit being disposed at any one, two, three, or all four of the following locations: the outer surface, the inner surface, the outer contact surface, and the inner contact surface; the sensing surface being exposed to the aforementioned outer contact surface, the aforementioned inner surface, the aforementioned outer surface, or the aforementioned inner contact surface; the sensing surface being flush with or recessed into the outer contact surface, the inner surface, the outer surface, or the inner contact surface; or the sensing surface protruding from the outer contact surface; the sensing unit being disposed in an inner groove channel, an extension axis of the inner groove channel being perpendicular or inclined to the outer contact surface, the inner surface, the outer surface, or the inner contact surface; A processing unit is connected to the sensing unit and receives sensing information from the sensing unit; A power supply unit is electrically connected to the sensing unit and the processing unit.

2. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The sensing units are distributed in a ring on the outer contact surface.

3. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The sensing units are distributed in a ring on the inner contact surface.

4. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The sensing units are distributed in a ring on the outer surface.

5. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The sensing units are distributed in a ring on the inner surface.

6. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The sensing unit is one of the following: blood glucose sensor, pH sensor, tension sensor, blood oxygen sensor, temperature sensor, or flow rate sensor.

7. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The device further includes an ultrasonic unit disposed on the fistula, which is electrically connected to the power supply unit and signal-connected to the processing unit.

8. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, It further includes a wireless unit that is signal-connected to the processing unit and electrically connected to the power supply unit. Both the wireless unit and the processing unit are disposed in the fistula. The processing unit receives a sensing signal from the sensing unit and transmits the sensing signal through the wireless unit.

9. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, It further includes an alarm unit that is signal-connected to the processing unit and electrically connected to the power supply unit.

10. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The processing unit and the power supply unit are located outside the fistula. The power supply unit is connected to the sensing unit by a wire, and the processing unit is connected to the sensing unit by a signal line.

11. The gastrointestinal fistula structure with a sensing unit as described in claim 10, characterized in that, The groove is annular.

12. The gastrointestinal fistula structure with a sensing unit as described in claim 1, characterized in that, The sensing unit is ring-shaped.

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