Medical instrument for inducing intestinal motion, and method for inducing intestinal motion

Abstract

[Problem] To provide a medical instrument for inducing intestinal motion and a method for inducing intestinal motion that enable a patient to live a comfortable daily life without worrying about leakage of excrement. [Solution] A medical device 100 comprising: stimulation-applying parts 110A, 110B for applying stimulation, from the outside of a living body B, to the intestinal tract S of a human (or a non-human animal); heating parts 120A, 120B for heating the intestinal tract from the outside of the living body when the stimulation-applying parts apply the stimulation; and an attachment part 130 for allowing the stimulation-applying parts and the heating parts to be attached to the living body.

Description

Medical device for inducing intestinal motility and method for inducing intestinal motility

[0001] The present invention relates to a medical device for inducing intestinal motility and a method for inducing intestinal motility.

[0002] There is known an ostomy device that is attached to a patient who has an ostomy created (see, for example, Patent Document 1). In general, the ostomy device includes a base plate that is fixed to the patient's skin in a state where it is arranged so as to surround the periphery of the ostomy, and a bag-shaped stoma pouch attached to the base plate.

[0003] When a patient wearing an artificial anus device suddenly needs to defecate while out and about, they can discharge waste into the stoma pouch, which allows them to temporarily store the waste without leaking out. Once a predetermined amount of waste has been discharged into the storage space of the stoma pouch, the patient discards the used stoma pouch and replaces it with an unused one. In their daily lives, patients must constantly be aware of the stoma pouch's storage capacity to prevent waste from overflowing.

[0004] JP 2010-57932 A

[0005] However, when large intestinal peristalsis occurs, which is said to occur several times a day, more waste than expected is forcefully carried to the anus. In particular, patients who have undergone rectal resection are unable to adequately block this waste, which raises concerns that the waste may leak out.

[0006] As a result of extensive research, the inventors of the present invention have invented a medical device for inducing intestinal motility and a method for inducing intestinal motility that can induce intestinal motility at any timing desired by the patient, thereby promoting the excretion of waste accumulated in the intestines and enabling patients to live comfortable daily lives without worrying about excrement leakage.

[0007] The present invention can be achieved by any one of the following means (1) to (11).

[0008] (1) A medical device for inducing intestinal motility, comprising: a stimulating unit that applies a stimulus to the intestinal tract of a human or non-human animal from outside the living body; a heating unit that heats the intestinal tract from outside the living body when the stimulating unit applies the stimulus; and an attachment unit that enables the stimulating unit and the heating unit to be attached to the living body.

[0009] (2) The medical device for inducing intestinal motility according to (1), wherein the stimulation unit is configured to be able to apply ultrasound waves of a frequency of 0.1 MHz to 5 MHz to the intestinal tract, and the heating unit is configured to be able to heat the intestinal tract to a temperature of 37° to 41°.

[0010] (3) The stimulation unit has an ultrasonic energy of 0.2 W / cm2 of an effective irradiation area. ２ The medical device for inducing intestinal motility according to (2), which also functions as the heating section that heats the intestinal tract in association with application of the ultrasound to the living body.

[0011] (4) As energy for heating, the ultrasonic energy (W / cm) of the effective irradiation area ２ ) and irradiation time (sec) is 60 (W / cm ２ The medical device for inducing intestinal motility according to (3), wherein the time required for the induction of intestinal motility is 100 sec or more.

[0012] (5) The stimulation unit has an ultrasonic energy of 0.2 W / cm2 of an effective irradiation area. ２ The medical device for inducing intestinal motility according to (1) or (2), wherein a burst wave having a fundamental frequency of 0.1 MHz to 5 MHz is applied for a predetermined period of time at a repetition frequency of 1 to 1000 Hz.

[0013] (6) A method for inducing intestinal motility, comprising applying a stimulus to the intestinal tract of a human or non-human animal from outside the living body while heating the intestinal tract from outside the living body.

[0014] (7) The method for inducing intestinal motility according to (6), wherein the intestinal tract is heated to a temperature of 37° to 41° while applying ultrasound having a frequency of 0.1 MHz to 5 MHz to the intestinal tract as the stimulation.

[0015] (8) The method for inducing intestinal motility according to (6), wherein the intestinal tract is heated in conjunction with the application of ultrasound.

[0016] (9) The ultrasonic energy of the effective irradiation area is 0.2 W / cm ２ The method for inducing intestinal motility according to (8), wherein the stimulation is given as described above.

[0017] (10) Ultrasonic energy (W / cm) of the effective irradiation area ２ ) and irradiation time (sec) to 60 (W / cm ２ The method for inducing intestinal motility according to (9), wherein the duration is 10 seconds or more.

[0018] (11) The ultrasonic energy of the effective irradiation area is 0.2 W / cm ２ The method for inducing intestinal motility according to any one of (6) to (8), wherein the stimulation is applied as described above, and a burst wave having a fundamental frequency of 0.1 MHz to 5 MHz is applied at a repetition frequency of 1 to 1000 Hz for a predetermined time.

[0019] According to the medical device for inducing intestinal motility and the method for inducing intestinal motility, intestinal motility can be induced in humans or non-human animals at any timing, thereby promoting the excretion of waste accumulated in the intestines, thereby enabling humans or non-human animals to live a comfortable life without worrying about excrement leakage.

[0020] FIG. 1 is a perspective view showing a medical device for inducing intestinal motility according to an embodiment. FIG. 2 is a flowchart for explaining a method for inducing intestinal motility according to an embodiment. FIG. 3 is a diagram schematically showing an example of use of a medical device for inducing intestinal motility according to an embodiment. FIG. 4 is a diagram schematically showing a waveform pattern of ultrasound used in a method for inducing intestinal motility according to an embodiment. FIG. 5 is a diagram for explaining an example. FIG. 6 is a diagram for explaining an example. FIG. 7 is a diagram for explaining intestinal motility in an example.

[0021] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Also, the dimensional proportions in the drawings are exaggerated for the convenience of explanation and may differ from the actual proportions.

[0022] As shown in Figures 1 and 3, a medical device 100 for inducing intestinal motility according to this embodiment (hereinafter simply referred to as "medical device 100") includes stimulating units 110A, 110B that apply stimuli to the intestinal tract S of a human (or non-human animal) from outside the living body B, heating units 120A, 120B that heat the intestinal tract from outside the living body B when the stimulating units 110A, 110B apply stimuli, and an attachment unit 130 that enables the stimulating units 110A, 110B and the heating units 120A, 120B to be attached to the living body B.

[0023] The attachment unit 130 has a belt-shaped main body 131 having a predetermined length that can be attached by wrapping it around the abdomen of the patient's body, for example.

[0024] Two stimulating units 110A and 110B are arranged in a pair at predetermined positions on the main body 131 so as to face each other.

[0025] The attachment unit 130 can be configured to have a fixing member 132 for fixing the main body unit 131 to the patient's body. The fixing member 132 can be configured, for example, with a hook-and-loop fastener, a snap button, or a fitting mechanism (such as a protrusion or hole) provided at one end and the other end in the longitudinal direction of the main body unit 131. Note that there are no particular limitations on the specific configuration of the attachment unit 130, as long as it is possible to attach the stimulating units 110A, 110B and the heating units 120A, 120B to the patient's body.

[0026] As shown in FIG. 3, when the medical device 100 is attached to the abdomen of the patient's body, the stimulating units 110A and 110B can be arranged at positions facing each other with the colon between them.

[0027] The "intestinal tract S" to which the medical device 100 of this embodiment is applied can be selected from any part of the large intestine (or the entirety) and / or any part of the small intestine (or the entirety). The medical device 100 can also be widely applied to non-human animals (e.g., rats, mice, and other laboratory animals).

[0028] As shown in Figure 2, the method for inducing intestinal movement using medical device 100 (hereinafter simply referred to as the "inducing method") includes applying a stimulus to the intestinal tract S of a human (or non-human animal) from outside the living body B while heating the intestinal tract S from outside the living body B.

[0029] According to the above-described induction method, applying mechanical stimulation and heat to the intestinal tract S excites the central nervous system via various mechanoreceptor channels (afferent pathways), thereby creating a parasympathetic dominant state. This induces large peristaltic movements in the intestinal tract S, thereby inducing defecation in the patient. Therefore, a patient (e.g., a patient after rectal resection) can induce defecation at any time they wish by using the medical device 100 to simultaneously apply the above-described stimulation and heat at any time they wish. This prevents problems such as unintended large amounts of excrement and excrement leakage while out and about, for example, when using an artificial anus device.

[0030] The stimulating units 110A and 110B can be configured to apply ultrasound waves with a repetition frequency of, for example, 1 Hz to 1000 Hz to the intestinal tract S. Furthermore, the heating units 120A and 120B can be configured to heat the intestinal tract S to a temperature of, for example, 37° to 41° (preferably 38° to 41°). By setting the magnitude of the ultrasound waves applied by the stimulating units 110A and 110B as described above and setting the temperature range during heating by the heating units 120A and 120B, it becomes possible to efficiently induce large peristaltic movements in the intestinal tract S.

[0031] The stimulating units 110A, 110B can be configured to function as heating units 120A, 120B that heat the intestinal tract S by applying ultrasound to the living body B, for example. In other words, the stimulating units 110A, 110B can be configured as heating units 120A, 120B so that the intestinal tract S can be heated by heat generated by vibrations caused by the ultrasound when the stimulating units 110A, 110B emit ultrasound as a stimulus. Note that each stimulating unit 110A, 110B and each heating unit 120A, 120B can also be configured as independent elements having different functions.

[0032] The stimulating units 110A and 110B can be configured to apply burst waves Wb having a fundamental frequency of 0.1 MHz to 5 MHz (preferably 0.5 to 2 MHz, more preferably 0.8 to 1.4 MHz) at a frequency of 1 to 1000 Hz for a predetermined period of time, as shown in Fig. 4. By applying the above-described stimulation to the intestinal tract S, it becomes possible to efficiently induce large peristaltic movements of the intestinal tract S.

[0033] There are no particular restrictions on the number, arrangement, specific structure, etc. of the stimulating parts provided in the medical device 100, and the number, arrangement, specific structure, etc. of the heating parts, and these can be changed as desired.

[0034] The operation of the medical device 100 can be controlled, for example, via a controller (control device) 200 .

[0035] The controller 200 can be configured, for example, as a known control device (e.g., a portable or non-portable information terminal device) equipped with a CPU and a memory unit. The memory unit includes a ROM for storing various programs and data, a RAM for temporarily storing programs and data as a working area, and a hard disk capable of storing various programs and data. The memory unit can store a series of programs necessary for controlling the operation of the medical device 100. Operational commands can be transmitted from the controller 200 to the medical device 100 via, for example, a wired connection via an electric communication line, a wireless connection without an electric communication line, a transmission based on input from a patient or the like via an operation unit incorporated in the controller 200, or a transmission and reception of control commands based on input from an external communication means or the like provided as a device separate from the controller 200.

[0036] Figure 5 shows a schematic diagram of an example of an induction method for experimental animals (rats). In this example, stimuli of the following five parameters (A, B, C, D, E) were applied to 10 rats (5 groups of 2 rats each). The output energy during stimulation was constant for each parameter A to E. Parameter A: 1 Hz Parameter B: 3 Hz Parameter C: 10 Hz Parameter D: 100 Hz Parameter E: 1000 Hz

[0037] The above stimulation and cessation of stimulation were repeated (9 stimulations, 9 cessation of stimulation, a total of 18 times), and the differences between 5 groups x 2 groups were evaluated. The evaluation was based on the expulsion time of beads 300 placed in the intestinal tract Sa (colon) of the experimental animals. As a result of the evaluation, it was confirmed that the expulsion time was significantly shorter than that of the non-stimulated group, based on the results of parameters C and D.

[0038] Figure 6 shows a schematic example of an example of an induction method for a laboratory animal (dog). In this example, ultrasonic stimulation with the aforementioned "parameter D" was applied. The ultrasonic output was set to ultrasonic energy per effective irradiation area (ISTPA) = 2 to 3.5 W / cm. ２ It was decided.

[0039] Figure 7 also shows the waveform of intestinal peristalsis after stimulation. The vertical axis in Figure 7 represents the contractile activity of the circular muscle, which is a value obtained from a strain gauge force transducer sewn onto the surface of the serosal muscle of the colon. The horizontal axis in Figure 7 represents the time that stimulation was continued. It was confirmed that application of stimulation under the above conditions induced large peristalsis and defecation.

[0040] It was also confirmed that peristalsis was enhanced within 30 seconds after the start of stimulation (time A in FIG. 7). At this time, the ultrasonic energy of the effective irradiation area at the time of defecation (time C in FIG. 7), ISTPA (W / cm ２ The product of the power and irradiation time (sec) is approximately 60 (W / cm ２ This means that the product is 60 (W / cm ２ sec) or more, it can be confirmed that defecation can be effectively induced.

[0041] Furthermore, when the above-mentioned parameter D was applied to humans, defecation was observed 20 minutes after the start of stimulation.

[0042] From the above, the ultrasonic energy is calculated as 0.1 W / cm in ISPTA terms. ２ or more (0.2W / cm ２ By setting the product of ultrasonic energy and time (sec) to 60 or more (more preferably 120 or more), it becomes possible to effectively induce defecation.

[0043] In addition, ultrasound was irradiated onto living tissue under conditions similar to those of the intestinal tract (gas simulating a living lumen was placed on the other side of the ultrasound transducer, sandwiching the living tissue), and the number of seconds it took for the tissue to be heated to 38°C or higher was summarized for each output, resulting in the following (1) to (3): (1) ISPTA 0.5 W / cm ２ (2) ISPTA 0.75 W / cm for approximately 120 seconds (product of ultrasonic energy and irradiation time = 67.5) ２ for approximately 60 seconds (product of ultrasonic energy and irradiation time = 45) (3) ISPTA 1 W / cm ２ for approximately 60 seconds (product of ultrasonic energy and irradiation time = 60).

[0044] The medical device for inducing intestinal motility and the method for inducing intestinal motility according to the present invention have been described above through embodiments and examples. However, the present invention is not limited to the content described in the specification, and can be modified as appropriate based on the claims.

[0045] This application is based on International Patent Application PCT / JP2024 / 4157, filed February 7, 2024, the disclosure of which is incorporated by reference in its entirety.

[0046] 100 Medical device for inducing intestinal motility 110A Stimulation unit 110B Stimulation unit 120A Heating unit 120B Heating unit 130 Wearing unit 131 Main unit 200 Controller S Intestinal tract B Living body

Claims

1. A medical device for inducing intestinal motility, comprising: a stimulating unit that applies a stimulus to the intestinal tract of a human or non-human animal from outside the living body; a heating unit that heats the intestinal tract from outside the living body when the stimulating unit applies the stimulus; and an attachment unit that enables the stimulating unit and the heating unit to be attached to the living body.

2. A medical device for inducing intestinal motility as described in claim 1, wherein the stimulation unit is configured to be able to apply ultrasound waves of a frequency of 0.1 MHz to 5 MHz to the intestinal tract, and the heating unit is configured to be able to heat the intestinal tract to a temperature of 37° to 41°.

3. The stimulation unit has an ultrasonic energy of 0.2 W / cm2 in the effective irradiation area. ２ The medical device for inducing intestinal motility according to claim 2 , further functioning as the heating section for heating the intestinal tract in association with application of the ultrasound to the living body.

4. As the energy for heating, the ultrasonic energy (W / cm) of the effective irradiation area ２ ) and irradiation time (sec) is 60 (W / cm ２ 4. The medical device for inducing intestinal motility according to claim 3, wherein the time required for the intestinal motility induction is 100 s or more.

5. The stimulation unit has an ultrasonic energy of 0.2 W / cm2 in the effective irradiation area. ２ 3. The medical device for inducing intestinal motility according to claim 1 or 2, wherein a burst wave having a fundamental frequency of 0.1 MHz to 5 MHz is applied for a predetermined period of time at a repetition frequency of 1 to 1000 Hz.

6. A method for inducing intestinal motility, which comprises applying a stimulus to the intestinal tract of a human or non-human animal from outside the living body while heating the intestinal tract from outside the living body.

7. A method for inducing intestinal motility according to claim 6, wherein the intestinal tract is heated to a temperature of 37° to 41° while applying ultrasound of a frequency of 0.1 MHz to 5 MHz to the intestinal tract as the stimulation.

8. The method for inducing intestinal motility according to claim 6, wherein the intestinal tract is heated in conjunction with the application of ultrasound.

9. The ultrasonic energy of the effective irradiation area is 0.2 W / cm ２ The method for inducing intestinal motility according to claim 8, wherein the stimulation is given by the above.

10. Ultrasonic energy (W / cm) of the effective irradiation area ２ ) and irradiation time (sec) to 60 (W / cm ２ 10. The method for inducing intestinal motility according to claim 9, wherein the duration of the stimulation is 10 seconds or more.

11. The ultrasonic energy of the effective irradiation area is 0.2 W / cm ２ The method for inducing intestinal motility according to any one of claims 6 to 8, wherein the stimulation is applied as described above, and a burst wave having a fundamental frequency of 0.1 MHz to 5 MHz is applied at a repetition frequency of 1 to 1000 Hz for a predetermined time.

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