Medical instrument and system

Abstract

A medical instrument according to the present invention comprises: a structure configured to be capable of being inserted into a luminal organ having a smooth muscle; and a stimulus generation unit configured to be capable of applying a stimulus produced using at least one of heat, vibration, light, and electricity to the luminal organ in a state in which the structure is inserted into the luminal organ.

Description

Medical Devices and Systems

[0001] The present invention relates to a medical device and system. This invention claims priority to Japanese Patent Application No. 2024-015136, filed on February 2, 2024, the contents of which are incorporated herein by reference.

[0002] Nasogastric ileus tubes have been known as a conservative treatment for intestinal obstruction. For example, ileus tubes are configured to enable treatment by suctioning intestinal fluids and gas near the obstruction. Patent Document 1 discloses a medical tube used as an ileus tube. This medical tube has a guide device insertion section at a predetermined longitudinal midpoint through which a guide device can be inserted, and a lubricant lumen through which lubricant can be sprayed inside the tube. Patent Document 2 discloses a medical catheter having a guider section at the distal end of the catheter body and a first balloon disposed on the catheter body posterior to the guider section. In this medical catheter, a second balloon is divided into multiple circumferential sections to cover the guider section and is independently inflatable. Patent Document 3 discloses a system for noninvasive and / or natural orifice treatment to regulate the enteric nervous system using one or more energy modalities. The system includes a probe insertable into a natural orifice and having an energy converter for applying energy to the enteric nervous system, a power source for supplying power to the probe, and a controller for controlling the application of energy from the probe to the enteric nervous system.

[0003] Japanese Patent Publication No. 2020-54549 Japanese Patent Publication No. 2003-250900 International Publication No. 2013 / 082587

[0004] However, with the configurations disclosed in Patent Documents 1 to 3, the degree of reach to the vicinity of the obstructed area varies depending on the skill of the surgeon, which is highly likely to result in large differences in treatment effectiveness and treatment time. In order to enable easy and reliable access to the obstructed area, it is required that the device be able to move automatically (self-propelled) inside the tubular organ.

[0005] Therefore, an object of the present invention is to provide a medical instrument and a system that can self-propel the medical instrument inside a hollow organ.

[0006] A medical device according to one aspect of the present invention comprises a structure configured to be insertable into a hollow organ having smooth muscle, and a stimulus generating unit configured to apply at least one of heat, vibration, light, and electricity to the hollow organ while the structure is inserted into the hollow organ.

[0007] According to the above aspect, the medical instrument can be self-propelled inside the hollow organ.

[0008] 1 is a diagram illustrating the configuration of a medical device according to a first embodiment; a block diagram of a system according to the first embodiment; a view taken along an arrow III in FIG. 1; a diagram illustrating an example of an electrode arrangement according to the first embodiment; a diagram illustrating another example of an electrode arrangement according to the first embodiment; a diagram illustrating an example of advancing a medical device by electrical stimulation; a diagram illustrating an example of an irregular balloon; a diagram illustrating an example of the relationship between the shape of the device tip, the position of the electrodes, and the conditions inside the intestinal tract (intraluminal air, no saline), and the electrical resistance; a diagram illustrating an example of the relationship between the shape of the device tip, the position of the electrodes, and the conditions inside the intestinal tract (intraluminal air), and the electrical resistance; a diagram illustrating an example of the relationship between the shape of the device tip, the position of the electrodes, and the conditions inside the intestinal tract (intraluminal air, saline ... an electrical stimulation condition (short-axis electrical stimulation); a diagram illustrating an example of an electrical stimulation condition (train pulse); a diagram illustrating an example of a continuous long pulse; a diagram illustrating an example of a long pulse; a diagram illustrating an example of a continuous short pulse; a diagram illustrating an example of the relationship between electrical stimulation conditions and contraction rate; a diagram illustrating an example of the relationship between voltage and contraction rate; a diagram illustrating an example of the relationship between stimulation time and contraction rate; a diagram illustrating an example of a rest period. FIG. 10 is a diagram showing an example of a change in contraction rate in the case of continuous short pulses. FIG. 11 is a diagram showing an example of a change in contraction rate in the case of continuous long pulses. FIG. 12 is a diagram showing an example of a heater arrangement according to a second embodiment. FIG. 13 is a diagram showing an example of a vibrator arrangement according to a third embodiment. FIG. 14 is a diagram showing an example of a light source arrangement according to a fourth embodiment. FIG. 15 is a diagram showing an example of a basket structure according to a fifth embodiment. FIG. 16 is a diagram showing an example of a spiral structure according to a sixth embodiment.

[0009] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the embodiment, a system including a balloon catheter will be described as an example of a system including a medical device configured to be insertable into a hollow organ having smooth muscle.

[0010] <First embodiment> <System> Fig. 1 is a configuration diagram of a medical device 2 according to a first embodiment. Fig. 2 is a block diagram of a system 1 according to the first embodiment. With reference to both Fig. 1 and Fig. 2, the system 1 includes the medical device 2 and a control device 3 that controls the magnitude of the electrical stimulation.

[0011] <Medical Device> The medical device 2 includes a structure 10 configured to be insertable into the interior of a hollow organ having smooth muscle, and a stimulus generating unit 20 configured to be able to apply electrical stimulation to the hollow organ when the structure 10 is inserted into the hollow organ.

[0012] Examples of hollow organs having smooth muscle include the cecum, large intestine, small intestine, urethra, ureter, and bladder. Examples of hollow organs also include blood vessels (arteries and veins). However, the form of hollow organs is not limited to the above.

[0013] <Stimulus generating unit> Fig. 3 is a view taken along arrow III in Fig. 1. Fig. 4 is a diagram showing an example of the arrangement of the electrodes 21 according to the first embodiment. Fig. 5 is a diagram showing another example of the arrangement of the electrodes 21 according to the first embodiment. Referring to Figs. 3 to 5 together, the stimulus generating unit 20 is provided in a part of the structure 10. The stimulus generating unit 20 includes an electrode 21 configured to be able to apply an electrical stimulus to a hollow organ.

[0014] <Structure> The structure 10 includes a balloon 11 that expands when a fluid is supplied. The balloon 11 has a shape with a major axis that follows the hollow organ. For example, the expanded shape of the balloon 11 may be an ellipsoid with a major axis that follows the hollow organ.

[0015] For example, the balloon 11 is made of a resin. Examples of the resin include resins whose main component is polyimide (PI), polyamide (PA), methacrylic resin (PMMA), polypropylene (PP), polyethylene (PE), etc., and synthetic resins containing at least one of these. Note that the material for forming the balloon 11 is not limited to the above and can be changed depending on the design specifications.

[0016] For example, the thickness of the balloon 11 is set to be 0.01 mm or more and 1.0 mm or less. For example, the thickness of the balloon 11 is preferably set to be within a range that satisfies the strength, rigidity, thermal conductivity, etc. required of the balloon 11. The thickness of the balloon 11 is not limited to the above and can be changed according to the design specifications.

[0017] For example, the balloon 11 may be covered with a urethane covering layer (not shown). For example, the manner in which the covering layer is provided can be changed depending on the design specifications.

[0018] The balloon 11 preferably has a rotationally symmetric shape with the long axis as the axis of symmetry, which allows the balloon 11 to be moved more effectively along the luminal organ than when the balloon is not rotationally symmetric with the long axis as the axis of symmetry (an irregular balloon).

[0019] The balloon 11 has a maximum expansion part 12 that expands most in the minor axis direction when inflated, at the center of the major axis direction of the balloon 11. The electrode 21 is disposed offset in the major axis direction from the maximum expansion part 12.

[0020] When the balloon 11 advances due to electrical stimulation by the electrode 21, it is preferable that the relationship 0.1≦G1 / 100≦0.4 be satisfied, where LB is the total length of the balloon 11 in the longitudinal direction, and G1 is the offset amount of the electrode 21 in the longitudinal direction relative to the maximum expansion portion 12.

[0021] 4, the total length LB of the balloon 11 in the longitudinal direction is 40 mm to 50 mm, and the offset G1 is 5 mm to 8 mm. Note that the total length LB of the balloon 11 in the longitudinal direction and / or the offset are not limited to the above and can be changed according to the design specifications.

[0022] On the other hand, when the balloon 11 moves backward due to electrical stimulation by the electrode 21, when the total length LB of the balloon 11 in the longitudinal direction is 100 and the offset amount of the electrode 21 in the longitudinal direction relative to the maximum expansion portion 12 is G2, it is preferable to satisfy 0.6≦G2 / 100≦0.9.

[0023] <Electrodes> A plurality of electrodes 21 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. In the example of Fig. 3, four electrodes 21 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. For example, one or two pairs of electrodes may be arranged. The number of electrodes 21 is not limited to the above and can be changed according to design specifications.

[0024] For example, the electrode 21 is formed of a metal. Examples of the metal include a metal containing copper (Cu), gold (Au), silver (Ag), platinum (Pt), etc. as a main component, or an alloy containing at least one of these. Note that the material for forming the electrode 21 is not limited to the above and can be changed according to design specifications.

[0025] 4, the electrode 21 is formed in a rectangular shape when viewed from the minor axis direction of the balloon 11. When the total length LB of the balloon 11 in the major axis direction is 100 and the maximum length of one side of the electrode 21 is S, it is preferable that the relationship 0.02≦S / 100≦0.1 is satisfied.

[0026] In the example of Fig. 4, the rectangular electrode 21 has a side length of 2 mm to 3 mm. In the case of a circular electrode, the diameter may be 2 mm to 3 mm. The shape and / or size of the electrode (electrode size) are not limited to the above and can be changed according to the design specifications.

[0027] The electrode 21 is disposed on the outer surface of the balloon 11. For example, the electrode 21 may be formed by attaching a metal sheet to a portion of the outer surface of the balloon 11. The method for forming the electrode 21 is not limited to the above, and may be coating using a mask (e.g., screen printing), etching, sputtering, vapor deposition, or other methods.

[0028] For example, it is preferable that the electrode 21 be formed on the outer surface of the balloon 11 when the balloon 11 is fully inflated. This can prevent the electrode 21 from being broken when the balloon 11 is inflated. The method for forming the electrode 21 is not limited to the above and can be changed depending on the design specifications.

[0029] <Wiring> Referring to FIG. 1, the medical device 2 further includes wiring 30 connected to the electrodes 21 and a cylindrical flow path member 40 that allows fluid to flow into the interior of the balloon 11.

[0030] 1 and 3 , the wiring 30 extends along the outer surface of the balloon 11. For example, it is preferable that the wiring 30 extend along the outer surface of the balloon 11 when the balloon 11 is fully inflated. This can prevent the wiring 30 from breaking when the balloon 11 is inflated. Note that the method for forming the wiring 30 is not limited to the above and can be changed according to design specifications.

[0031] The wiring 30 extends along the outer surface of the balloon 11 and then extends through the inside of the flow path member 40. In the example of Fig. 1, the wiring 30 passes through the inside of the flow path member 40 and then is drawn out to the outside through an opening 41 formed in a portion of the flow path member 40 on the base end side. After being drawn out to the outside, the wiring 30 is connected to a connection terminal 50 (e.g., a multi-terminal) of the control device 3.

[0032] In the example of Fig. 4, the wiring 30 connected to the electrode 21 is not shown, but the wiring 30 may extend through the interior of each of the balloon 11 and the flow path member 40. In the example of Fig. 5, the wiring 30 extends in a spiral shape around the balloon 11. Note that the manner in which the wiring 30 extends is not limited to the above and can be changed according to design specifications.

[0033] <Flow Channel Member> The flow channel member 40 is an axial member having a longitudinal axis in one direction. The flow channel member 40 is preferably flexible. The flow channel member 40 may be composed of a single member, or may be composed of a combination of multiple members. In the example of FIG. 4 , the axial length LC from the base end of the flow channel member 40 to the end of the balloon 11 is 2 m or more and 3 m or less. Note that the axial length LC from the base end of the flow channel member 40 to the end of the balloon 11 is not limited to the above and can be changed according to design specifications.

[0034] For example, the flow path member 40 is formed of a resin. Examples of the resin include resins whose main component is polyimide (PI), polyamide (PA), methacrylic resin (PMMA), polypropylene (PP), polyethylene (PE), etc., and synthetic resins containing at least one of these. For example, the flow path member 40 may be formed of the same material as the balloon 11. Note that the material for forming the flow path member 40 is not limited to the above and can be changed according to design specifications.

[0035] Although not shown, the flow path member 40 may be formed with an inlet flow path that allows fluid to flow into the interior of the balloon 11 and an outlet flow path that allows fluid to flow out of the balloon 11. For example, the inlet flow path and the outlet flow path are formed inside the cylindrical flow path member 40. For example, the inlet flow path and the outlet flow path may be separated by a partition wall (not shown) inside the flow path member 40.

[0036] 1 , for example, after the wiring 30 is drawn out from an opening 41 formed in the flow path member 40, a blocking member 42 (e.g., adhesive) is preferably provided to block the gap of the opening 41. This makes it possible to prevent liquid from leaking from the opening 41. Note that the installation mode of the blocking member 42 can be changed depending on the design specifications.

[0037] For example, the flow path member 40 may be covered with a urethane covering layer (not shown). For example, the manner in which the covering layer is provided can be changed depending on the design specifications.

[0038] <Control Device> The control device 3 of this embodiment performs control based on a train pulse, which is an electrical stimulation waveform consisting of multiple rectangular waves spaced apart. In this embodiment, the control device 3 performs control by alternately repeating electrical stimulation and rest with electrical stimulation conditions set to a voltage of 10 volts or more, a stimulation pulse width of 2 milliseconds to 100 milliseconds, and a stimulation pulse interval of 200 milliseconds or less, with a stimulation time of 10 seconds or more and a rest time of 10 seconds or more. For example, data related to the electrical stimulation waveform and / or the electrical stimulation conditions may be stored in a storage unit (not shown) in advance.

[0039] <Device Concept> Next, the concept of the device (including the medical instrument 2 according to this embodiment) will be described with reference to Fig. 6. Fig. 6 is a diagram showing an example of advancing the medical instrument 2 by electrical stimulation. The example in Fig. 6 shows a case where an electrode 21 is provided on a part of the rear of the balloon (a part on the opposite side from the direction of advancement).

[0040] As shown in Figure 6, the medical device 2 may be advanced inside the hollow organ by applying an electrical stimulus to the hollow organ to contract smooth muscles, thereby allowing the medical device 2 to automatically and reliably reach the obstructed area.

[0041] <Shape of the Device Tip> The inventors have investigated the shape of the device tip and the conditions under which the electrode 21 can be optimally brought into contact with the mucosa. Fig. 7 shows an example of an irregular balloon. Fig. 8 shows an example of the relationship between the shape of the device tip, the position of the electrode 21, and the conditions inside the intestinal tract (no air in the lumen, no saline), and the electrical resistance. Fig. 9 shows an example of the relationship between the shape of the device tip, the position of the electrode 21, and the conditions inside the intestinal tract (air in the lumen), and the electrical resistance. Fig. 10 shows an example of the relationship between the shape of the device tip, the position of the electrode 21, and the conditions inside the intestinal tract (air in the lumen, saline), and the electrical resistance.

[0042] The shape of the tip of the device was set to three shapes: a symmetric balloon (the shape of the balloon 11 of this embodiment shown in FIG. 4), an irregular balloon (the shape of the comparative example shown in FIG. 7), and a tube (corresponding to the part without the balloon 11). The position of the electrode 21 was set to three conditions: on the symmetric balloon, on the irregular balloon, and on the tube. The conditions inside the intestinal tract were set to three conditions: "no air or saline in the lumen," "air in the lumen," and "air and saline in the lumen."

[0043] Regarding the contact of the electrode 21 with the mucosa, impedance measurements were performed to determine which would provide the most stable contact with the mucosa. Referring to Figures 8 to 10, it was found that the smaller the electrical resistance, the stronger the adhesion of the electrode 21 to the mucosa. As a result, it was confirmed that the symmetric balloon provided the most stable contact.

[0044] <Electrical Stimulation Conditions> The present inventors used living pigs to study what kind of electrical stimulation to use and at what position the electrode 21 should be when advancing the medical device 2. Fig. 11 is a diagram showing an example of electrical stimulation conditions (short-axis electrical stimulation). Fig. 12 is a diagram showing an example of electrical stimulation conditions (train pulse).

[0045] 11 and 12 , in examining the electrical stimulation conditions, the balloon 11 was inserted into the intestine, and electrical stimulation was applied at various positions from the serous membrane side (for example, the outside in a direction perpendicular to the direction in which the small intestine extends), and the conditions under which the medical device 2 would advance the most were examined. As a result, it was confirmed that the medical device 2 would advance the most when the electrode 21 was placed on the short axis of the intestine and train pulse stimulation was applied.

[0046] The inventors also investigated which electrical stimulation conditions induce the greatest contraction. Fig. 13 is a diagram showing an example of continuous long pulses. Fig. 14 is a diagram showing an example of long pulses. Fig. 15 is a diagram showing an example of continuous short pulses. Fig. 16 is a diagram showing an example of the relationship between electrical stimulation conditions and contraction rate. The contraction rate is expressed by the following formula 1. In formula 1, di ０ is the length of the short axis of the intestine before electrical stimulation, da ０ indicates the length of the short axis of the intestine after electrical stimulation.

[0047]

[0048] 13 to 16, the average contraction rate of the three regions of the small intestine was obtained, and it was confirmed that the continuous long pulse and the continuous short pulse resulted in approximately the same contraction rate, resulting in the greatest contraction rate.

[0049] The inventors also confirmed the relationship between voltage and stimulation time and the contraction rate. Fig. 17 is a diagram showing an example of the relationship between voltage and contraction rate. Fig. 18 is a diagram showing an example of the relationship between stimulation time and contraction rate.

[0050] As shown in Figure 17, the average contraction rates of the three parts of the small intestine were obtained, and it was confirmed that the higher the voltage, the higher the contraction rate. As shown in Figure 18, the average contraction rates of the three parts of the small intestine were obtained, and it was confirmed that the longer the stimulation time, the higher the contraction rate.

[0051] Furthermore, the inventors have investigated the change in contraction rate when continuous electrical stimulation is performed by changing the rest period, with regard to an appropriate rest period. Fig. 19 shows an example of a rest period. Fig. 20 shows an example of a change in contraction rate when continuous short pulses are used. Fig. 21 shows an example of a change in contraction rate when continuous long pulses are used.

[0052] 19 to 21, it was confirmed that the shrinkage rate changes when the rest period is changed under both the continuous short pulse and continuous long pulse conditions. It was also confirmed that the longer the rest period, the more stable the shrinkage rate becomes, regardless of the number of cycles.

[0053] <Action and Effect> As described above, the medical device 2 of this embodiment includes the structure 10 configured to be insertable into a hollow organ having smooth muscle, and the stimulus generator 20 configured to be able to apply an electrical stimulus to the hollow organ while the structure 10 is inserted inside the hollow organ. With this configuration, by applying an electrical stimulus to the hollow organ while the structure 10 is inserted inside the hollow organ, the structure 10 can be moved inside the hollow organ by contraction of the smooth muscle. Therefore, the medical device 2 can be self-propelled inside the hollow organ.

[0054] In this embodiment, the stimulus generator 20 is provided in a part of the structure 10. The stimulus generator 20 includes an electrode 21 configured to be able to apply electrical stimulation to the hollow organ. With this configuration, the medical device 2 can be self-propelled inside the hollow organ by electrical stimulation through the electrode 21. The mechanism of this embodiment is explained below. (1) Local smooth muscle contracts near the stimulation site located at the rear of the structure 10. (2) The lumen narrows. (3) The structure 10 is pushed forward by the contractile force and moves forward. (4) By applying electrical stimulation with an appropriate voltage, time, and rest period, the smooth muscle is stably contracted. By the above (1), (2), (3), and (4), the balloon can be continuously self-propelled using smooth muscle contraction.

[0055] In this embodiment, the structure 10 includes a balloon 11 that expands when a fluid is supplied to the structure 10. With this configuration, the expanded balloon 11 and the contraction action of the smooth muscle work together to allow the medical device 2 to self-propel more smoothly inside the hollow organ.

[0056] In this embodiment, the balloon 11 has a shape with a long axis that is aligned with the hollow organ. This configuration makes it easier to move the balloon 11 along the hollow organ compared to when the balloon 11 has a shape with a short axis that is aligned with the hollow organ.

[0057] In this embodiment, the balloon 11 has a rotationally symmetric shape with respect to the longitudinal axis as the axis of symmetry. This configuration makes it easier to move the balloon 11 along the luminal organ more effectively than when the balloon 11 does not have a rotationally symmetric shape with respect to the longitudinal axis as the axis of symmetry (an irregular balloon).

[0058] In this embodiment, the balloon 11 has a maximum expansion portion 12, which expands most in the minor axis direction when inflated, at the center of the balloon 11 in the longitudinal direction. The electrode 21 is positioned offset in the longitudinal direction from the maximum expansion portion 12. With this configuration, it is easier to move the balloon 11 by contraction of smooth muscle compared to when the electrode 21 is positioned at the maximum expansion portion 12.

[0059] In this embodiment, when the balloon 11 advances due to electrical stimulation from the electrodes 21, the relationship 0.1≦G1 / 100≦0.4 is satisfied, where LB is the total longitudinal length of the balloon 11 and G1 is the offset of the electrodes 21 in the longitudinal direction relative to the maximum expansion portion 12. With this configuration, the balloon 11 can be more effectively advanced by smooth muscle contraction than when G1 / 100 is outside the above range.

[0060] In this embodiment, when the balloon 11 is moved backward by electrical stimulation from the electrode 21, the relationship 0.6≦G2 / 100≦0.9 is satisfied, where LB is the total longitudinal length of the balloon 11 and G2 is the offset of the electrode 21 in the longitudinal direction relative to the maximum expansion portion 12. With this configuration, the balloon 11 can be moved backward more effectively by smooth muscle contraction than when G2 / 100 is outside the above range.

[0061] In this embodiment, multiple electrodes 21 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. This configuration makes it easier to move the balloon 11 more stably and smoothly by electrical stimulation, compared to when only one electrode 21 is arranged or when multiple electrodes 21 are arranged at uneven intervals in the circumferential direction.

[0062] In this embodiment, the electrode 21 is formed in a rectangular shape when viewed in the minor axis direction of the balloon 11. When the total length LB of the balloon 11 in the major axis direction is 100 and the maximum length of one side of the electrode 21 is S, the relationship 0.02≦S / 100≦0.1 is satisfied. With this configuration, the balloon 11 can be moved more effectively by smooth muscle contraction than when S / 100 is outside the above range.

[0063] In this embodiment, the electrode 21 is disposed on the outer surface of the balloon 11. This configuration makes it easier to manufacture the medical device 2 compared to when the electrode 21 is disposed on the inner surface (back surface) of the balloon 11 opposite to the outer surface.

[0064] In this embodiment, the medical device 2 further includes wiring 30 connected to the electrode 21. The wiring 30 extends along the outer surface of the balloon 11. With this configuration, the wiring 30 can be moved in response to the contraction movement of the balloon 11.

[0065] In this embodiment, the medical device 2 further includes a tubular flow path member 40 that allows fluid to flow into the interior of the balloon 11. The wiring 30 extends along the outer surface of the balloon 11 and then extends through the interior of the flow path member 40. This configuration makes it possible to prevent the wiring 30 from coming into contact with a tubular organ, compared to when the wiring 30 extends through the exterior of the flow path member 40.

[0066] The system 1 of this embodiment includes the above-described medical device 2 and a control device 3 that controls the magnitude of the electrical stimulation. With this configuration, the medical device 2 can be self-propelled inside the hollow organ by controlling the magnitude of the electrical stimulation.

[0067] In this embodiment, the control device 3 performs control based on a train pulse, which is an electrical stimulation waveform consisting of a series of rectangular waves spaced apart. This configuration makes it easier to move the balloon 11 more effectively by contracting smooth muscle, compared to control based on a simple long pulse or a series of short pulses.

[0068] In this embodiment, the control device 3 controls the electrical stimulation by alternating stimulation and rest with the following conditions: voltage of 10 volts or more, stimulation pulse width of 2 milliseconds to 100 milliseconds, and stimulation pulse interval of 200 milliseconds or less, with a stimulation time of 10 seconds or more and a rest time of 10 seconds or more. This configuration makes it easier to move the balloon 11 continuously by contracting the smooth muscle.

[0069] <Second embodiment> Fig. 22 is a diagram showing an example of the arrangement of a heater 221 according to a second embodiment. Hereinafter, a medical device according to the second embodiment will be described with reference to Fig. 22. In the configuration shown in Fig. 22, the same components as those in the above-described embodiments are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0070] As shown in Figure 22, the medical device includes an ellipsoid 211 (an example of a structure) configured to be insertable into a tubular organ having smooth muscle, and a heater 221 (an example of a stimulus generating unit) configured to apply a thermal stimulus to the tubular organ when the ellipsoid 211 is inserted into the tubular organ.

[0071] The ellipsoid 211 has a shape with a major axis that is aligned with the tubular organ. The ellipsoid 211 may have a solid structure or a hollow structure. The ellipsoid 211 preferably has a shape that is rotationally symmetrical with the major axis as the axis of symmetry. The ellipsoid 211 has a maximum bulging portion 12 that bulges most in the minor axis direction at the center of the major axis of the ellipsoid 211. The heater 221 is disposed offset in the major axis direction from the maximum bulging portion 12.

[0072] When the ellipsoid 211 advances due to thermal stimulation from the heater 221, it is preferable to satisfy 0.1≦G1 / 100≦0.4, where the total length LB of the ellipsoid 211 in the major axis direction is 100 and the offset amount of the heater 221 in the major axis direction relative to the maximum bulge portion 12 is G1.

[0073] 22, the overall length LB of the ellipsoid 211 in the major axis direction is 40 mm to 50 mm, and the offset amount G1 is 5 mm to 8 mm. Note that the overall length LB of the ellipsoid 211 in the major axis direction and / or the offset amount G1 are not limited to the above and can be changed according to design specifications.

[0074] A plurality of heaters 221 are arranged at equal intervals in the circumferential direction around the major axis of the ellipsoid 211. In the example of Fig. 22, two heaters 221 (the heater 221 on the far side of the page is not shown) are arranged at equal intervals in the circumferential direction around the major axis of the ellipsoid 211. For example, one or two pairs of heaters may be arranged. Note that the number of heaters 221 arranged is not limited to the above and can be changed according to design specifications.

[0075] When viewed from the minor axis direction of the ellipsoid 211, the heater 221 is formed in a rectangular shape. In the example of Fig. 22, one side of the rectangular heater 221 is approximately 5 mm. In the case of a circular heater, the diameter may be approximately 5 mm. Note that the shape and / or size of the heater (heater size) are not limited to those described above and can be changed according to design specifications.

[0076] The medical device of this embodiment includes an ellipsoid 211 configured to be insertable into a hollow organ having smooth muscle, and a heater 221 configured to apply a thermal stimulus to the hollow organ with the ellipsoid 211 inserted inside the hollow organ. With this configuration, by applying a thermal stimulus to the hollow organ with the ellipsoid 211 inserted inside the hollow organ, the ellipsoid 211 can be moved inside the hollow organ by contraction of the smooth muscle. Therefore, the medical device can be self-propelled inside the hollow organ.

[0077] <Third embodiment> Fig. 23 is a diagram showing an example of the arrangement of a vibrator 321 according to a third embodiment. Hereinafter, a medical device according to the third embodiment will be described with reference to Fig. 23. In the configuration shown in Fig. 23, the same components as those in the above-described embodiments are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0078] As shown in Figure 23, the medical device includes a balloon 11 (an example of a structure) that is configured to be able to be inserted into the interior of a hollow organ having smooth muscle, and a vibrator 321 (an example of a stimulus generating unit) that is configured to be able to apply vibrational stimulation to the hollow organ when the balloon 11 is inserted into the hollow organ.

[0079] When the balloon 11 moves forward due to vibration stimulation from the vibrator 321, it is preferable to satisfy 0.1≦G1 / 100≦0.4, where LB is the total length of the balloon 11 in the longitudinal direction, and G1 is the offset of the vibrator 321 in the longitudinal direction relative to the maximum expansion portion 12 (the amount of deviation from the center of the vibrator 321).

[0080] 23, the total length LB of the balloon 11 in the longitudinal direction is 40 mm to 50 mm, and the offset G1 is 5 mm to 8 mm. Note that the total length LB of the balloon 11 in the longitudinal direction and / or the offset G1 are not limited to the above and can be changed according to the design specifications.

[0081] The vibrator 321 is disposed inside the balloon 11. In the example of Fig. 23, one vibrator 321 is disposed inside the balloon 11. Note that the number of vibrators 321 to be disposed is not limited to the above and can be changed according to design specifications.

[0082] For example, the vibrator 321 may be configured to vibrate at a frequency of 10 Hz to 1000 Hz inclusive, with a period of 3 seconds to 10 seconds inclusive. Note that the configuration of the vibrator 321 is not limited to the above and can be changed according to design specifications.

[0083] The medical device of this embodiment includes a balloon 11 configured to be insertable into a hollow organ having smooth muscle, and a vibrator 321 configured to apply a vibration stimulus to the hollow organ while the balloon 11 is inserted inside the hollow organ. With this configuration, applying a vibration stimulus to the hollow organ while the balloon 11 is inserted inside the hollow organ causes the balloon 11 to move inside the hollow organ due to contraction of the smooth muscle. Therefore, the medical device can be self-propelled inside the hollow organ.

[0084] <Fourth embodiment> Fig. 24 is a diagram showing an example of the arrangement of a light source 421 according to a fourth embodiment. Hereinafter, a medical device according to the fourth embodiment will be described with reference to Fig. 24. In the configuration shown in Fig. 24, the same components as those in the above-described embodiments are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0085] As shown in Figure 24, the medical device includes a balloon 11 (an example of a structure) that is configured to be able to be inserted into the interior of a hollow organ having smooth muscle, and a light source 421 (an example of a stimulus generating unit) that is configured to be able to apply optical stimulation to the hollow organ while the balloon 11 is inserted into the hollow organ.

[0086] When the balloon 11 moves forward due to light stimulation from the light source 421, it is preferable that, when the total length LB of the balloon 11 in the longitudinal direction is 100 and the offset amount of the light source 421 in the longitudinal direction relative to the maximum expansion portion 12 (the amount of deviation from the center of the light source 421) is G1, it is preferable that 0.1≦G1 / 100≦0.4 be satisfied.

[0087] 24, the total length LB of the balloon 11 in the longitudinal direction is 40 mm to 50 mm, and the offset G1 is 5 mm to 8 mm. Note that the total length LB of the balloon 11 in the longitudinal direction and / or the offset G1 are not limited to the above and can be changed according to the design specifications.

[0088] A plurality of light sources 421 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. In the example of Fig. 24, four light sources 421 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. The number of light sources 421 arranged is not limited to the above and can be changed according to design specifications.

[0089] For example, the light source 421 may be disposed on the outer surface of the balloon 11. Alternatively, if the balloon 11 is optically transparent, the light source 421 may be disposed inside the balloon 11. For example, the light source 421 may include a near-ultraviolet LED or a purple LED capable of generating ultraviolet light, or may include a blue LED. Note that the configuration of the light source 421 is not limited to the above and can be changed according to design specifications.

[0090] The medical device of this embodiment includes a balloon 11 configured to be insertable into a hollow organ having smooth muscle, and a light source 421 configured to apply a light stimulus to the hollow organ while the balloon 11 is inserted inside the hollow organ. With this configuration, applying a light stimulus to the hollow organ while the balloon 11 is inserted inside the hollow organ causes contraction of the smooth muscle, thereby moving the balloon 11 inside the hollow organ. Therefore, the medical device can be self-propelled inside the hollow organ.

[0091] <Fifth embodiment> Fig. 25 is a diagram showing an example of a basket structure 511 according to a fifth embodiment. Hereinafter, a medical device according to the fifth embodiment will be described with reference to Fig. 25. In the configuration shown in Fig. 25, the same components as those in the above-described embodiments are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0092] As shown in Figure 25, the medical device includes a basket structure 511 (an example of a structure) configured to be insertable into a hollow organ having smooth muscle, and a stimulus generating unit 20 configured to apply a stimulus to the hollow organ using any of heat, vibration, light, and electricity while the basket structure 511 is inserted into the hollow organ.

[0093] The basket structure 511 is configured to include a plurality of linear members that are curved radially outward from the flow path member 40. In other words, the basket structure 511 is formed in a cage shape. In the example of Fig. 25, a stimulus generating unit 20 is provided on a portion of each of the four linear members. Note that the configuration of the basket structure 511 and / or the installation mode of the stimulus generating unit 20 are not limited to those described above and can be changed according to design specifications.

[0094] The medical device of this embodiment includes a basket structure 511 configured to be insertable into a hollow organ having smooth muscle, and a stimulus generator 20 configured to apply a stimulus of heat, vibration, light, or electricity to the hollow organ while the basket structure 511 is inserted inside the hollow organ. With this configuration, by applying a stimulus of heat, vibration, light, or electricity to the hollow organ while the basket structure 511 is inserted inside the hollow organ, the basket structure 511 can be moved inside the hollow organ by contraction of the smooth muscle. Therefore, the medical device can be self-propelled inside the hollow organ.

[0095] <Sixth embodiment> Fig. 26 is a diagram showing an example of a spiral structure 611 according to a sixth embodiment. Hereinafter, a medical device according to the sixth embodiment will be described with reference to Fig. 26. In the configuration shown in Fig. 26, the same components as those in the above-described embodiments are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0096] As shown in Figure 26, the medical device includes a spiral structure 611 (an example of a structure) configured to be insertable into a tubular organ having smooth muscle, and a stimulus generating unit 20 configured to apply a stimulus to the tubular organ using heat, vibration, light, or electricity while the spiral structure 611 is inserted into the tubular organ.

[0097] The spiral structure 611 is configured with a linear member that extends spirally around the flow path member 40. In the example of Fig. 26, two stimulus generators 20 are provided on a portion of one linear member. Note that the configuration of the spiral structure 611 and / or the installation mode of the stimulus generators 20 are not limited to those described above and can be changed according to design specifications.

[0098] The medical device of this embodiment includes a spiral structure 611 configured to be insertable into a hollow organ having smooth muscle, and a stimulus generator 20 configured to apply a stimulus of heat, vibration, light, or electricity to the hollow organ while the spiral structure 611 is inserted inside the hollow organ. With this configuration, applying a stimulus of heat, vibration, light, or electricity to the hollow organ while the spiral structure 611 is inserted inside the hollow organ can move the spiral structure 611 inside the hollow organ by contracting the smooth muscle. Therefore, the medical device can be self-propelled inside the hollow organ.

[0099] <Modifications> In the above-described embodiment (first embodiment), the medical device is described as a balloon catheter, but this is not limited thereto. For example, the medical device may be another device such as a bougie. For example, the medical device may be configured to apply at least one of heat, vibration, light, and electricity to the hollow organ when the structure is inserted inside the hollow organ. For example, the configuration of the medical device may be changed according to design specifications.

[0100] In the above-described embodiment, the stimulus generator is provided in a part of the structure and includes any one of a heater, a vibrator, a light source, and an electrode configured to apply heat, vibration, light, and electrical stimulation to the luminal organ, respectively. However, this is not limited to this. For example, the stimulus generator may include at least one of the heater, vibrator, light source, and electrode. For example, the stimulus generator may be configured by combining at least two of the heater, vibrator, light source, and electrode. The stimulus generator may be configured to apply at least one of heat, vibration, light, and electricity stimulation to the luminal organ. For example, the configuration of the stimulus generator may be changed according to design specifications.

[0101] In the above-described embodiment (first embodiment), the balloon has been described as having a shape with a major axis aligned with the hollow organ, but this is not limiting. For example, the balloon may have a shape with a minor axis aligned with the hollow organ. For example, the shape of the balloon can be changed according to design specifications.

[0102] In the above-described embodiment (first embodiment), the balloon has been described as having a rotationally symmetrical shape with respect to the longitudinal axis as the axis of symmetry, but this is not limiting. For example, the balloon may have a rotationally symmetrical shape with respect to the longitudinal axis as the axis of symmetry (an irregular balloon shape). For example, the shape of the balloon can be changed according to design specifications.

[0103] In the above-described embodiment (first embodiment), the balloon has a maximum expansion portion at the center of the balloon's longitudinal direction, which expands most in the minor axis direction when inflated, and the electrodes are disposed offset in the longitudinal direction from the maximum expansion portion. However, this is not limiting. For example, the electrodes may be disposed at the maximum expansion portion. For example, the electrode arrangement can be changed depending on the design specifications.

[0104] In the above-described embodiment (first embodiment), when the balloon advances due to electrical stimulation from the electrodes, the overall length of the balloon in the longitudinal direction is 100, and the offset of the electrode in the longitudinal direction from the maximum inflation portion is G1, where G1 satisfies 0.1≦G1 / 100≦0.4. However, this is not limiting. For example, G1 / 100 may be set outside the above range. For example, the setting range for G1 / 100 can be changed depending on the design specifications.

[0105] In the above-described embodiment (first embodiment), when the balloon is moved backward by electrical stimulation from the electrodes, an example was described in which, when the total length of the balloon in the longitudinal direction is 100 and the offset of the electrode in the longitudinal direction from the maximum inflation portion is G2, the relationship satisfies 0.6≦G2 / 100≦0.9. However, this is not limited thereto. For example, G2 / 100 may be set outside the above range. For example, the setting range of G2 / 100 can be changed depending on the design specifications.

[0106] In the above-described embodiment (first embodiment), an example was described in which multiple electrodes were arranged at equal intervals in the circumferential direction around the longitudinal axis of the balloon, but this is not limited thereto. For example, only one electrode may be arranged. Alternatively, multiple electrodes may be arranged at uneven intervals in the circumferential direction. For example, the number and / or arrangement of the electrodes may be changed depending on the design specifications.

[0107] In the above-described embodiment (first embodiment), the electrode is formed in a rectangular shape when viewed from the minor axis direction of the balloon, and when the total length of the balloon in the major axis direction is 100 and the maximum length of one side of the electrode is S, the relationship 0.02≦S / 100≦0.1 is satisfied. However, this is not limiting. For example, S / 100 may be set outside the above range. For example, the setting range of S / 100 can be changed depending on the design specifications.

[0108] In the above-described embodiment (first embodiment), the electrodes are disposed on the outer surface of the balloon, but this is not limiting. For example, the electrodes may be disposed on the inner surface (back surface) of the balloon, opposite the outer surface. For example, the electrode arrangement can be changed depending on the design specifications.

[0109] In the above-described embodiment (first embodiment), the medical device further includes wiring connected to the electrodes, and the wiring extends along the outer surface of the balloon. However, this is not limiting. For example, the wiring may extend not along the outer surface of the balloon. For example, the wiring may extend at a position above the outer surface of the balloon. For example, the manner in which the wiring extends can be changed according to design specifications.

[0110] In the above-described embodiment (first embodiment), the medical device further includes a tubular flow path member that allows fluid to flow into the interior of the balloon, and the wiring extends along the outer surface of the balloon and then extends through the interior of the flow path member. However, this is not limiting. For example, the wiring may extend through the exterior of the flow path member. For example, the manner in which the wiring extends can be changed depending on design specifications.

[0111] In the above-described embodiment (first embodiment), an example of a system including the above-described medical device and a control device that controls the magnitude of electrical stimulation has been described, but the present invention is not limited to this. For example, the system may include a control device that controls the magnitude of stimulation other than electrical stimulation (e.g., stimulation by heat, vibration, or light). For example, the system may include a control device that controls the magnitude of at least one of stimulation by heat, vibration, light, and electricity. For example, the configuration of the system can be changed according to design specifications.

[0112] In the above-described embodiment (first embodiment), the control device performs control based on a train pulse in which a plurality of rectangular waves are arranged at intervals as an electrical stimulation waveform. However, this is not limited to this. For example, the control device may perform control based on a simple long pulse or a series of short pulses. For example, the mode of control by the control device can be changed according to design specifications.

[0113] In the above-described embodiment (first embodiment), the control device controls the electrical stimulation by alternating between stimulation and rest, with the electrical stimulation conditions set to a voltage of 10 volts or more, a stimulation pulse width of 2 milliseconds to 100 milliseconds, and a stimulation pulse interval of 200 milliseconds or less, with a stimulation time of 10 seconds or more and a rest time of 10 seconds or more. However, this is not limiting. For example, the control device may control the electrical stimulation under conditions different from the above-described conditions. For example, the conditions of the stimulation applied to the tubular organ can be changed according to design specifications.

[0114] <Computer Configuration> The control device includes a processor, memory, auxiliary storage device (corresponding to a storage unit), etc., which are connected via a bus. The control device functions as a control device that controls the components of the system by executing a program. Examples of the processor include a CPU (Central Processing Unit), a GPU (Graphic Processing Unit), and a microprocessor. The program may be recorded on a computer-readable recording medium. Examples of the computer-readable recording medium include storage devices such as magnetic disks, magneto-optical disks, optical disks, and semiconductor memories. The program may be transmitted via a telecommunications line.

[0115] For example, all or part of the functions of the control device may be implemented using a custom large-scale integrated circuit (LSI) such as an application-specific integrated circuit (ASIC) or a programmable logic device (PLD). Examples of PLDs include programmable array logic (PAL), generic array logic (GAL), complex programmable logic device (CPLD), and field programmable gate array (FPGA). Such integrated circuits are also included in the scope of the processor.

[0116] Although the embodiments of the present invention have been described above, the present invention is not limited to these, and additions, omissions, substitutions, and other modifications to the configuration are possible within the scope of the spirit of the present invention, and the above-described embodiments can also be combined as appropriate.

[0117] (Supplementary Note 1) A medical device comprising: a structure configured to be insertable into a hollow organ having smooth muscle; and a stimulus generating unit configured to apply at least one of heat, vibration, light, and electricity stimulation to the hollow organ while the structure is inserted into the hollow organ.

[0118] (Supplementary Note 2) The medical device according to Supplementary Note 1, wherein the stimulus generating unit is provided in a part of the structure and includes at least one of a heater, a vibrator, a light source, and an electrode configured to be able to apply heat, vibration, light, and electrical stimulation to the tubular organ, respectively.

[0119] (Supplementary Note 3) The medical device according to Supplementary Note 1 or 2, wherein the structure includes a balloon that expands when a fluid is supplied thereto.

[0120] (Supplementary Note 4) The medical device according to Supplementary Note 3, wherein the balloon has a shape with a long axis that follows the tubular organ.

[0121] (Supplementary Note 5) The medical device according to Supplementary Note 4, wherein the balloon has a rotationally symmetric shape with the major axis as an axis of symmetry.

[0122] (Appendix 6) The medical device described in Appendix 5, wherein the balloon has a maximum bulging portion at the center of the balloon's long axis direction that bulges the most in the short axis direction when inflated, the stimulus generating unit includes an electrode configured to be able to apply electrical stimulation to the tubular organ, and the electrode is positioned offset in the long axis direction from the maximum bulging portion.

[0123] (Appendix 7) The medical device according to Appendix 6, wherein, when the balloon advances due to electrical stimulation by the electrode, the relationship 0.1≦G1 / 100≦0.4 is satisfied, where 100 is the total length of the balloon in the longitudinal direction and G1 is the offset amount of the electrode in the longitudinal direction from the maximum expansion portion.

[0124] (Appendix 8) The medical device according to appendix 6 or 7, wherein, when the balloon moves backward due to electrical stimulation by the electrode, the relationship 0.6≦G2 / 100≦0.9 is satisfied, where 100 is the total length of the balloon in the longitudinal direction and G2 is the offset amount of the electrode in the longitudinal direction from the maximum expansion portion.

[0125] (Supplementary Note 9) The medical device described in any one of Supplementary Notes 4 to 8, wherein the stimulation generating unit includes an electrode configured to be able to apply electrical stimulation to the tubular organ, and the electrodes are arranged at equal intervals in a circumferential direction around the longitudinal axis of the balloon.

[0126] (Supplementary Note 10) The medical device according to Supplementary Note 9, wherein the electrode is formed in a rectangular shape when viewed from the minor axis direction of the balloon, and when the total length of the balloon in the major axis direction is 100 and the maximum length of one side of the electrode is S, the relationship 0.02≦S / 100≦0.1 is satisfied.

[0127] (Supplementary Note 11) The medical device according to Supplementary Note 10, wherein the electrode is disposed on an outer surface of the balloon.

[0128] (Supplementary Note 12) The medical device according to Supplementary Note 11, further comprising a wire connected to the electrode, the wire extending along an outer surface of the balloon.

[0129] (Supplementary Note 13) The medical device according to Supplementary Note 12, further comprising a tubular flow path member that allows the fluid to flow into the interior of the balloon, wherein the wiring extends along the outer surface of the balloon and then extends through the interior of the flow path member.

[0130] (Supplementary Note 14) The medical device according to Supplementary Note 1 or 2, wherein the structure includes an ellipsoid, a basket structure, or a spiral structure.

[0131] (Supplementary Note 15) A system comprising: the medical device according to any one of Supplementary Notes 1 to 14; and a control device that controls the magnitude of the stimulation.

[0132] (Supplementary Note 16) The system according to Supplementary Note 15, wherein the stimulation includes electrical stimulation, and the control device performs the control based on a train pulse in which a plurality of rectangular waves are arranged at intervals as an electrical stimulation waveform.

[0133] (Supplementary Note 17) The system according to Supplementary Note 16, wherein the control device controls the electrical stimulation by alternately repeating stimulation and rest with electrical stimulation conditions set to a voltage of 10 volts or more, a stimulation pulse width of 2 milliseconds to 100 milliseconds, and a stimulation pulse interval of 200 milliseconds or less, with a stimulation time of 10 seconds or more and a rest time of 10 seconds or more.

[0134] 1...system, 2...medical device, 3...control device, 10...structure, 11...balloon, 12...maximum expansion portion, 20...stimulus generating portion, 21...electrode, 30...wiring, 40...flow path member, 211...ellipsoid, 221...heater, 321...vibrator, 421...light source, 511...basket structure, 611...spiral structure, LB...total length in the long axis direction of the balloon

Claims

1. A medical device comprising: a structure configured to be insertable into a hollow organ having smooth muscle; and a stimulus generating unit configured to apply at least one of heat, vibration, light, and electricity to the hollow organ while the structure is inserted inside the hollow organ.

2. The medical device according to claim 1, wherein the stimulus generating unit is provided in a part of the structure and includes at least one of a heater, a vibrator, a light source, and an electrode configured to apply heat, vibration, light, and electrical stimulation to the hollow organ, respectively.

3. The medical device according to claim 1 or 2, wherein the structure includes a balloon that expands when a fluid is supplied thereto.

4. The medical device according to claim 3, wherein the balloon has a shape with a long axis that follows the hollow organ.

5. The medical device according to claim 4, wherein the balloon has a rotationally symmetric shape with the major axis as an axis of symmetry.

6. The medical device according to claim 5, wherein the balloon has a maximum bulging portion at the center of the balloon's longitudinal direction that bulges the most in the minor axis direction when inflated, the stimulus generating unit includes an electrode configured to be able to apply electrical stimulation to the tubular organ, and the electrode is positioned offset in the longitudinal direction from the maximum bulging portion.

7. The medical device according to claim 6, wherein, when the balloon advances due to electrical stimulation by the electrode, the relationship 0.1≦G1 / 100≦0.4 is satisfied, where 100 is the total length of the balloon in the longitudinal direction and G1 is the offset of the electrode in the longitudinal direction from the maximum expansion part.

8. The medical device according to claim 6, wherein, when the balloon moves backward due to electrical stimulation by the electrode, the relationship 0.6≦G2 / 100≦0.9 is satisfied, where 100 is the total length of the balloon in the longitudinal direction and G2 is the offset of the electrode in the longitudinal direction from the maximum expansion part.

9. The medical device according to claim 4, wherein the stimulation generating unit includes an electrode configured to be able to apply electrical stimulation to the tubular organ, and the electrodes are arranged at equal intervals in the circumferential direction around the longitudinal axis of the balloon.

10. The medical device according to claim 9, wherein the electrode is formed in a rectangular shape when viewed in the minor axis direction of the balloon, and where the total length of the balloon in the major axis direction is 100 and the maximum length of one side of the electrode is S, the relationship 0.02≦S / 100≦0.1 is satisfied.

11. The medical device according to claim 10, wherein the electrodes are disposed on an outer surface of the balloon.

12. The medical device according to claim 11, further comprising wiring connected to the electrode, the wiring extending along the outer surface of the balloon.

13. The medical device according to claim 12, further comprising a tubular flow path member that allows the fluid to flow into the interior of the balloon, and the wiring extends along the outer surface of the balloon and then extends through the interior of the flow path member.

14. The medical device according to claim 1 or 2, wherein the structure comprises an ellipsoid, a basket structure, or a spiral structure.

15. A system comprising the medical device according to claim 1 or 2 and a control device for controlling the magnitude of the stimulation.

16. The system according to claim 15, wherein the stimulation includes electrical stimulation, and the control device performs the control based on a train pulse in which a plurality of rectangular waves are arranged at intervals as an electrical stimulation waveform.

17. The system described in claim 16, wherein the control device performs the control by alternately repeating the electrical stimulation with a voltage of 10 volts or more, a stimulation pulse width of 2 milliseconds to 100 milliseconds, and a stimulation pulse interval of 200 milliseconds or less, with a stimulation time of 10 seconds or more and a rest time of 10 seconds or more.

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