WO2025164763A1 - Medical instrument and system - Google Patents

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

The present invention relates to medical devices and systems.
The present invention claims priority based on Japanese Patent Application No. 2024-015136, filed on February 2, 2024, the contents of which are incorporated herein by reference.

Nasal ileus tubes have been known as a conservative treatment for intestinal obstruction. For example, ileus tubes are designed to provide 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 midpoint in the longitudinal direction, into which a guide device can be inserted, and also has a lubricant lumen that can spray lubricating water 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 provided on the catheter body behind the guider section. In this medical catheter, a second balloon is divided into multiple sections in the circumferential direction so as to cover the guider section and is provided so as to be independently inflatable.
Patent Literature 3 discloses a system for non-invasive and/or natural orifice treatment for regulating the enteric nervous system using one or more energy modalities, which includes a probe having an energy converter for applying energy to the enteric nervous system and insertable into a natural orifice, 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.

Japanese Patent Application Publication No. 2020-54549 Japanese Patent Application Publication No. 2003-250900 International Publication No. 2013/082587

However, with the configurations disclosed in Patent Documents 1 to 3, the degree of reach to the area near the obstruction varies depending on the skill of the surgeon, which is likely to result in significant differences in treatment effectiveness and treatment time. To enable easy and reliable access to the obstruction, it is necessary for the device to move automatically (self-propelled) inside the hollow organ.

The present invention therefore aims to provide a medical device and system that can self-propel the medical device inside a hollow organ.

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 generator 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.

According to the above aspect, the medical device can be self-propelled inside the hollow organ.

FIG. 1 is a configuration diagram of a medical device according to a first embodiment. FIG. 1 is a block diagram of a system according to a first embodiment. FIG. 3 is a view taken along arrow III in FIG. FIG. 2 is a diagram showing an example of an electrode arrangement according to the first embodiment. FIG. 4 is a diagram showing another example of the arrangement of electrodes according to the first embodiment. FIG. 10 shows an example of advancing a medical device using electrical stimulation. FIG. 10 is a diagram showing an example of an irregular balloon. FIG. 10 is a diagram showing 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 electrical resistance. FIG. 10 is a diagram showing an example of the relationship between the shape of the tip of the device, the position of the electrodes, and the conditions inside the intestinal tract (with air in the lumen), and the electrical resistance. FIG. 10 is a diagram showing an example of the relationship between the shape of the device tip, the position of the electrodes, and the conditions inside the intestinal tract (air in the lumen, presence of saline), and the electrical resistance. FIG. 10 is a diagram showing an example of electrical stimulation conditions (short-axis electrical stimulation). FIG. 10 is a diagram showing an example of electrical stimulation conditions (train pulses). FIG. 10 is a diagram showing an example of continuous long pulses. FIG. 10 is a diagram showing an example of a long pulse. FIG. 10 is a diagram showing an example of continuous short pulses. FIG. 10 is a diagram showing an example of the relationship between electrical stimulation conditions and contraction rates. FIG. 10 is a diagram showing an example of the relationship between voltage and shrinkage rate. FIG. 10 is a diagram showing an example of the relationship between stimulation time and contraction rate. FIG. 10 is a diagram showing 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. 10 is a diagram showing an example of a change in contraction rate in the case of a continuous long pulse. FIG. 10 is a diagram showing an example of heater arrangement according to the second embodiment. FIG. 11 is a diagram showing an example of an arrangement of transducers according to the third embodiment. FIG. 10 is a diagram showing an example of an arrangement of light sources according to a fourth embodiment. FIG. 13 is a diagram showing an example of a basket structure according to a fifth embodiment. FIG. 13 is a diagram showing an example of a spiral structure according to a sixth embodiment.

Embodiments of the present invention will be described below with reference to the drawings. In the embodiments, an example of 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.

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

<Medical equipment>
The medical device 2 comprises a structure 10 configured to be insertable into the interior of a hollow organ having smooth muscle, and a stimulation 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.

Examples of hollow organs with smooth muscle include the appendix, large intestine, small intestine, urethra, ureter, and bladder. Examples of hollow organs also include blood vessels (arteries and veins). Note that the forms of hollow organs are not limited to those listed above.

<Stimulus generation unit>
Fig. 3 is a view taken along the 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.
3 to 5 , 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 the hollow organ.

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

For example, the balloon 11 is formed from a resin. Examples of resins include resins whose main components are polyimide (PI), polyamide (PA), methacrylic resin (PMMA), polypropylene (PP), polyethylene (PE), etc., or synthetic resins containing at least one of these. Note that the material from which the balloon 11 is formed is not limited to the above and can be changed depending on the design specifications.

For example, the thickness of the balloon 11 is set to a value between 0.01 mm and 1.0 mm. For example, it is preferable that the thickness of the balloon 11 be set within a range that satisfies the strength, rigidity, thermal conductivity, etc. required of the balloon 11. Note that the thickness of the balloon 11 is not limited to the above and can be changed according to the design specifications.

For example, the balloon 11 may be covered with a urethane coating layer (not shown). For example, the installation manner of the coating layer can be changed depending on the design specifications.

It is preferable that the balloon 11 has a rotationally symmetrical shape with the long axis as the axis of symmetry. This makes it easier to move the balloon 11 more effectively along the tubular organ compared to a balloon that is not rotationally symmetrical with the long axis as the axis of symmetry (an irregular balloon).

The balloon 11 has a maximum expansion portion 12 at the center of the balloon 11's longitudinal direction, which expands most in the minor axis direction when inflated. The electrode 21 is positioned offset in the longitudinal direction from the maximum expansion portion 12.

When the balloon 11 moves forward due to electrical stimulation from 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 of the electrode 21 in the longitudinal direction relative to the maximum expansion portion 12.

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

On the other hand, when the balloon 11 moves backward due to electrical stimulation from the electrode 21, it is preferable that the relationship 0.6≦G2/100≦0.9 be satisfied, where LB is the total length of the balloon 11 in the longitudinal direction, and G2 is the offset of the electrode 21 in the longitudinal direction relative to the maximum expansion portion 12.

<Electrode>
The electrodes 21 are arranged at equal intervals in the circumferential direction around the longitudinal 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 longitudinal 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.

For example, the electrode 21 is formed from a metal. Examples of metals include metals whose main components are copper (Cu), gold (Au), silver (Ag), platinum (Pt), etc., or alloys containing at least one of these. Note that the material from which the electrode 21 is formed is not limited to the above and can be changed depending on the design specifications.

In the example of Figure 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 be satisfied.

In the example of Figure 4, the rectangular electrode 21 has a side size of 2 mm or more and 3 mm or less. Furthermore, in the case of a circular electrode, its diameter may be 2 mm or more and 3 mm or less. The shape and/or size of the electrode (electrode size) is not limited to the above and can be changed according to the design specifications.

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 part of the outer surface of the balloon 11. Note that the method for forming the electrode 21 is not limited to the above, and may also be coating using a mask (e.g., screen printing), etching, sputtering, vapor deposition, or other methods.

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 prevents the electrode 21 from breaking when the balloon 11 is inflated. Note that the method for forming the electrode 21 is not limited to the above and can be changed depending on the design specifications.

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

Referring to Figures 1 and 3 together, 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 makes it possible to prevent the wiring 30 from breaking when the balloon 11 is inflated. Note that the method of forming the wiring 30 is not limited to the above and can be changed according to design specifications.

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

In the example of Figure 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 Figure 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.

<Flow path member>
The flow path member 40 is an axial member having a longitudinal axis in one direction. The flow path member 40 is preferably flexible. The flow path 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 path 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 path member 40 to the end of the balloon 11 is not limited to the above and can be changed according to design specifications.

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

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 may be 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.

Referring to FIG. 1, for example, after the wiring 30 is drawn to the outside through the opening 41 formed in the flow path member 40, it is preferable to provide a blocking member 42 (e.g., adhesive, etc.) to block the gap in the opening 41. This makes it possible to prevent liquid leakage from the opening 41. Note that the installation mode of the blocking member 42 can be changed depending on the design specifications.

For example, the flow path member 40 may be covered with a urethane coating layer (not shown). For example, the installation manner of the coating layer can be changed depending on the design specifications.

<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 controls 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. For example, data regarding the electrical stimulation waveform and/or the electrical stimulation conditions may be stored in a storage unit (not shown) in advance.

<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).

As shown in Figure 6, applying electrical stimulation to the hollow organ may cause smooth muscle contraction, thereby advancing the medical device 2 inside the hollow organ. This allows the medical device 2 to automatically and reliably reach the obstructed area.

<Device tip shape>
The present inventors have investigated the shape of the tip of the device to determine what shape would allow the electrode 21 to make suitable contact with the mucous membrane under what conditions.
Fig. 7 is a diagram showing an example of an irregular balloon. Fig. 8 is a diagram showing 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 (intraluminal air, no saline), and the electrical resistance. Fig. 9 is a diagram showing 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 (intraluminal air), and the electrical resistance. Fig. 10 is a diagram showing 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 (intraluminal air, saline), and the electrical resistance.

The shape of the device tip was determined to be one of three shapes: a symmetric balloon (the shape of the balloon 11 of this embodiment shown in Figure 4), an irregular balloon (the shape of the comparative example shown in Figure 7), and a tube (corresponding to the part without the balloon 11). The electrode 21 was positioned under three conditions: on the symmetric balloon, on the irregular balloon, and on the tube. The conditions inside the intestinal tract were determined to be three conditions: "no intraluminal air or saline," "intraluminal air present," and "intraluminal air and saline present."

In regards to 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 also to Figures 8 to 10, it is clear that the lower the electrical resistance, the greater the adhesion of the electrode 21 to the mucosa. As a result, it was confirmed that the symmetrical balloon was the most stable.

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

Referring to Figures 11 and 12 together, an investigation into electrical stimulation conditions involved inserting a balloon 11 into the intestine and applying electrical stimulation 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 examining the conditions under which the medical device 2 would advance the most. 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.

The inventors also investigated which electrical stimulation conditions would result in the greatest contraction.
Fig. 13 is a diagram showing an example of a continuous long pulse. Fig. 14 is a diagram showing an example of a long pulse. Fig. 15 is a diagram showing an example of a continuous short pulse. 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 equation 1. In equation 1, di ₀ represents the length of the short axis of the intestinal tract before electrical stimulation, and da ₀ represents the length of the short axis of the intestinal tract after electrical stimulation.

Referring to Figures 13 to 16, the average contraction rate was calculated for three areas of the small intestine, and it was confirmed that the continuous long pulse and continuous short pulse produced roughly the same contraction rate, resulting in the greatest contraction rate.

The inventors also confirmed the relationship between voltage, stimulation time and contraction rate.
17 is a diagram showing an example of the relationship between voltage and contraction rate, and FIG. 18 is a diagram showing an example of the relationship between stimulation time and contraction rate.

As shown in FIG. 17, the average contraction rate of the three parts of the small intestine was obtained, and it was confirmed that the higher the voltage, the higher the contraction rate tends to be.
As shown in FIG. 18, the average contraction rate of the three regions of the small intestine was obtained, and it was confirmed that the contraction rate tended to increase as the stimulation time increased.

Furthermore, the inventors have investigated the appropriate rest period by varying the rest period to see how the contraction rate changes when electrical stimulation is performed continuously.
Fig. 19 is a diagram showing an example of a rest period, Fig. 20 is a diagram showing an example of a change in the contraction rate in the case of continuous short pulses, and Fig. 21 is a diagram showing an example of a change in the contraction rate in the case of continuous long pulses.

Referring to Figures 19 to 21 together, it was confirmed that the shrinkage rate changes when the rest period is changed, regardless of whether the pulse is a continuous short pulse or a continuous long pulse. It was also confirmed that the longer the rest period, the more stable the shrinkage rate becomes, regardless of the number of cycles.

<Action and effect>
As described above, the medical device 2 of this embodiment comprises 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.
With this configuration, when the structure 10 is inserted into the hollow organ, electrical stimulation of the hollow organ can be applied to cause smooth muscle contraction, thereby moving the structure 10 inside the hollow organ. Thus, the medical device 2 can be self-propelled inside the hollow organ.

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 an electrical stimulus to the hollow organ. With this configuration, the medical device 2 can be self-propelled inside the hollow organ by the electrical stimulus applied through the electrode 21.
The mechanism of this embodiment will be explained below.
(1) Local smooth muscle contracts near the stimulation point located at the rear of the structure 10.
(2) The lumen narrows.
(3) The structure 10 is pushed forward by the contraction force and moves forward.
(4) Electrical stimulation is applied with appropriate voltage, time and rest period to induce stable contraction of smooth muscle.
The above (1), (2), (3), and (4) enable the balloon to be continuously self-propelled using smooth muscle contraction.

In this embodiment, the structure 10 includes a balloon 11 that is inflated by the supply of fluid.
According to this configuration, the expanded balloon 11 and the contraction action of the smooth muscle work together to allow the medical device 2 to move more smoothly and independently inside the hollow organ.

In this embodiment, the balloon 11 has a shape with a long axis that follows the hollow organ.
With this configuration, it is easier to move the balloon 11 along the hollow organ compared to when the balloon 11 has a shape with a minor axis that follows the hollow organ.

In this embodiment, the balloon 11 has a rotationally symmetric shape with the long axis as the axis of symmetry.
This configuration makes it easier to move the balloon 11 more effectively along the tubular organ compared to when the balloon 11 is not rotationally symmetrical about the long axis (in the case of an irregular balloon).

In this embodiment, the balloon 11 has a maximum expansion portion 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 portion 12.
With this configuration, it is easier to move the balloon 11 by contraction of smooth muscles compared to when the electrode 21 is placed at the maximum expansion portion 12.

In this embodiment, when the balloon 11 advances due to electrical stimulation by the electrode 21, the total length LB of the balloon 11 in the longitudinal direction is set to 100, and the offset amount of the electrode 21 in the longitudinal direction relative to the maximum expansion portion 12 is set to G1, and the relationship 0.1≦G1/100≦0.4 is satisfied.
With this configuration, the balloon 11 can be more effectively advanced by contraction of smooth muscles compared to when G1/100 is outside the above range.

In this embodiment, 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, the relationship 0.6≦G2/100≦0.9 is satisfied.
With this configuration, the balloon 11 can be more effectively moved backward by contraction of smooth muscles compared to when G2/100 is outside the above range.

In this embodiment, a plurality of electrodes 21 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11 .
With this configuration, it is 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 around the circumference.

In this embodiment, 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, the relationship 0.02≦S/100≦0.1 is satisfied.
This configuration makes it easier to move the balloon 11 more effectively by contracting the smooth muscles, compared to when S/100 is outside the above range.

In this embodiment, the electrodes 21 are 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.

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

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.
According to this configuration, the wiring 30 can be prevented from coming into contact with the hollow organ, compared to when the wiring 30 extends outside the flow path member 40 .

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.
According to this configuration, the medical device 2 can be self-propelled inside the hollow organ by controlling the magnitude of the electrical stimulation.

In this embodiment, the control device 3 performs control based on a train pulse in which a plurality of rectangular waves are arranged at intervals as an electrical stimulation waveform.
This configuration makes it easier to move the balloon 11 more effectively by contracting the smooth muscles, compared to when control is performed based on a simple long pulse or a series of short pulses.

In this embodiment, the control device 3 controls the electrical stimulation by alternately repeating 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 for a longer period of time due to the contraction of smooth muscles.

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

As shown in Figure 22, the medical device comprises an ellipsoid 211 (an example of a structure) configured to be insertable into a hollow organ having smooth muscle, and a heater 221 (an example of a stimulus generator) configured to apply a thermal stimulus to the hollow organ when the ellipsoid 211 is inserted into the hollow organ.

The ellipsoid 211 has a shape with a long axis that aligns 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 long 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 long axis direction of the ellipsoid 211. The heater 221 is positioned offset in the long axis direction from the maximum bulging portion 12.

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

In the example of Figure 22, the overall length LB of the ellipsoid 211 in the major axis direction is 40 mm or more and 50 mm or less, and the offset amount G1 is 5 mm or more and 8 mm or less. 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 the design specifications.

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 Figure 22, two heaters 221 (the heater 221 at the back 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 heater pairs 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.

When viewed from the minor axis direction of the ellipsoid 211, the heater 221 is formed in a rectangular shape. In the example of Figure 22, each 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) is not limited to the above and can be changed according to design specifications.

The medical device of this embodiment comprises an ellipsoid 211 configured to be insertable into the interior of a tubular organ having smooth muscle, and a heater 221 configured to be able to apply thermal stimulation to the tubular organ when the ellipsoid 211 is inserted into the interior of the tubular organ.
With this configuration, when the ellipsoid 211 is inserted into the hollow organ, applying a thermal stimulus to the hollow organ causes smooth muscle contraction, thereby moving the ellipsoid 211 inside the hollow organ. Therefore, the medical device can be self-propelled inside the hollow organ.

Third Embodiment
FIG. 23 is a diagram showing an example of the arrangement of the vibrators 321 according to the third embodiment.
A medical device according to the third embodiment will be described below 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.

As shown in Figure 23, the medical device includes a balloon 11 (an example of a structure) that can be inserted into a hollow organ having smooth muscle, and a vibrator 321 (an example of a stimulus generator) that can apply vibrational stimuli to the hollow organ while the balloon 11 is inserted inside the hollow organ.

When the balloon 11 moves forward due to vibration stimulation from the vibrator 321, 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 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).

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

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

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 the design specifications.

The medical device of this embodiment comprises a balloon 11 configured to be insertable into the interior of a hollow organ having smooth muscle, and a vibrator 321 configured to be able to apply vibrational stimulation to the hollow organ while the balloon 11 is inserted into the hollow organ.
With this configuration, when the balloon 11 is inserted inside a hollow organ, vibration stimulation is applied to the hollow organ, causing smooth muscle contraction to move the balloon 11 inside the hollow organ, thereby allowing the medical device to self-propel inside the hollow organ.

Fourth Embodiment
FIG. 24 is a diagram showing an example of the arrangement of the light source 421 according to the fourth embodiment.
A medical device according to a fourth embodiment will be described below 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.

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 a hollow organ having smooth muscle, and a light source 421 (an example of a stimulus generator) that is configured to be able to apply optical stimuli to the hollow organ while the balloon 11 is inserted inside the hollow organ.

When the balloon 11 moves forward in response to light stimulation from the light source 421, 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 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).

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

Multiple light sources 421 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. In the example of Figure 24, four light sources 421 are arranged at equal intervals in the circumferential direction around the long axis of the balloon 11. Note that the number of light sources 421 arranged is not limited to the above and can be changed according to design specifications.

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.

The medical device of this embodiment comprises a balloon 11 configured to be insertable into the interior of a hollow organ having smooth muscle, and a light source 421 configured to be able to apply optical stimulation to the hollow organ while the balloon 11 is inserted inside the hollow organ.
With this configuration, when the balloon 11 is inserted inside a hollow organ, applying a light stimulus to the hollow organ causes smooth muscle contraction, thereby moving the balloon 11 inside the hollow organ, thereby allowing the medical device to self-propel inside the hollow organ.

Fifth Embodiment
FIG. 25 is a diagram showing an example of a basket structure 511 according to the fifth embodiment.
A medical device according to a fifth embodiment will be described below 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.

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

The basket structure 511 is composed of multiple linear members that curve 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 Figure 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 of the stimulus generating unit 20 are not limited to the above and can be changed according to design specifications.

The medical device of this embodiment comprises a basket structure 511 configured to be insertable into the interior of a tubular organ having smooth muscle, and a stimulus generating unit 20 configured to be able to apply a stimulus to the tubular organ using any of heat, vibration, light, and electricity while the basket structure 511 is inserted into the tubular organ.
With this configuration, when the basket structure 511 is inserted into the hollow organ, applying a stimulus of heat, vibration, light, or electricity to the hollow organ causes smooth muscle contraction, thereby moving the basket structure 511 inside the hollow organ. Therefore, the medical instrument can be self-propelled inside the hollow organ.

Sixth Embodiment
FIG. 26 is a diagram showing an example of a spiral structure 611 according to the sixth embodiment.
A medical device according to the sixth embodiment will be described below 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.

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

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

The medical device of this embodiment comprises a spiral structure 611 configured to be insertable into the interior of a tubular organ having smooth muscle, and a stimulus generating unit 20 configured to be able to apply a stimulus to the tubular organ using any of heat, vibration, light, and electricity when the spiral structure 611 is inserted into the tubular organ.
With this configuration, when the spiral structure 611 is inserted into the hollow organ, applying a stimulus of heat, vibration, light, or electricity to the hollow organ causes smooth muscle contraction, thereby moving the spiral structure 611 inside the hollow organ. Thus, the medical device can be self-propelled inside the hollow organ.

<Modification>
In the above-described embodiment (first embodiment), the medical device is described as a balloon catheter, but the present invention 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 into the hollow organ. For example, the configuration of the medical device may be changed according to design specifications.

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, or electrical stimulation to the hollow organ, but 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 hollow organ. For example, the configuration of the stimulus generator can be changed according to design specifications.

In the above-described embodiment (first embodiment), an example was given in which the balloon has a shape with a long axis that aligns with the tubular organ, but this is not limited to this. For example, the balloon may have a shape with a short axis that aligns with the tubular organ. For example, the shape of the balloon can be changed according to design specifications.

In the above-described embodiment (first embodiment), an example was given in which the balloon has a rotationally symmetric shape with the long axis as the axis of symmetry, but this is not limited to this. For example, the balloon may have a rotationally symmetric shape with the long axis as the axis of symmetry (an irregular balloon shape). For example, the shape of the balloon can be changed according to the design specifications.

In the above-described embodiment (first embodiment), an example was described in which the balloon has a maximum bulging portion at the center of the balloon's longitudinal direction that bulges most in the minor axis direction when inflated, and the electrodes are positioned offset in the longitudinal direction from the maximum bulging portion, but this is not limited to this. For example, the electrodes may be positioned at the maximum bulging portion. For example, the electrode placement can be changed depending on the design specifications.

In the above-described embodiment (first embodiment), when the balloon advances due to electrical stimulation from the electrodes, an example was given 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 expansion portion is G1, the relationship 0.1≦G1/100≦0.4 is satisfied, but this is not limited to this. 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.

In the above-described embodiment (first embodiment), when the balloon moves backward due to electrical stimulation from the electrodes, an example was given 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 expansion part is G2, the relationship 0.6≦G2/100≦0.9 is satisfied, but this is not limited to this. For example, G2/100 may be set outside the above range. For example, the setting range for G2/100 can be changed depending on the design specifications.

In the above-described embodiment (first embodiment), an example was given in which multiple electrodes were arranged at equal intervals in the circumferential direction around the long axis of the balloon, but this is not limited to this. 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 electrodes can be changed depending on the design specifications.

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, an example is given in which 0.02≦S/100≦0.1 is satisfied, but this is not limited to this. For example, S/100 may be set outside the above range. For example, the setting range for S/100 can be changed depending on the design specifications.

In the above-described embodiment (first embodiment), an example was given in which the electrodes were arranged on the outer surface of the balloon, but this is not limited to this. For example, the electrodes may be arranged on the inner surface (back surface) of the balloon, opposite the outer surface. For example, the arrangement of the electrodes can be changed depending on the design specifications.

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, but this is not limiting. For example, the wiring may extend without extending 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.

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 through the interior of the flow path member. However, this is not limited to this. 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 the design specifications.

In the above-described embodiment (first embodiment), an example was given in which the system includes the above-described medical device and a control device that controls the magnitude of the electrical stimulation, but this is not limited to this. For example, the system may also 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 stimulation by at least one of heat, vibration, light, and electricity. For example, the configuration of the system can be changed according to design specifications.

In the above-described embodiment (first embodiment), an example was given in which the control device performs control based on a train pulse in which multiple rectangular waves are spaced apart as an electrical stimulation waveform, but 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.

In the above-described embodiment (first embodiment), an example was given in which the control device controls electrical stimulation by alternating between 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, but this is not limited to this. For example, the control device may control under conditions different from the above electrical stimulation conditions. For example, the conditions for stimulation applied to the tubular organ can be changed according to design specifications.

<Computer Configuration>
The control device includes a processor, memory, auxiliary storage device (corresponding to a storage unit), etc., all 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.

For example, all or part of the functions of the control device may be realized using custom LSIs (Large Scale Integrated Circuits) such as ASICs (Application Specific Integrated Circuits) and PLDs (Programmable Logic Devices). Examples of PLDs include PALs (Programmable Array Logic), GALs (Generic Array Logic), CPLDs (Complex Programmable Logic Devices), and FPGAs (Field Programmable Gate Arrays). Such integrated circuits are also examples of processors.

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 without departing from the spirit of the present invention, and the above-described embodiments can also be combined as appropriate.

(Appendix 1)
a structure configured to be insertable into a hollow organ having smooth muscle;
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.

(Appendix 2)
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 a stimulus of heat, vibration, light, or electricity to the hollow organ, respectively;
2. The medical device of claim 1.

(Appendix 3)
The structure includes a balloon that is inflated by the supply of a fluid.
3. The medical device of claim 1 or 2.

(Appendix 4)
The balloon has a shape having a long axis along the hollow organ.
4. The medical device of claim 3.

(Appendix 5)
The balloon has a rotationally symmetric shape with the long axis as an axis of symmetry.
5. The medical device of claim 4.

(Appendix 6)
The balloon has a maximum expansion portion at the center of the long axis direction of the balloon, the maximum expansion portion expanding in the short axis direction when inflated,
the stimulus generator includes an electrode configured to be able to apply an electrical stimulus to the hollow organ,
the electrode is disposed offset in the long axis direction with respect to the maximum bulge portion;
6. The medical device of claim 5.

(Appendix 7)
When the balloon advances due to electrical stimulation by the electrodes, the total length of the balloon in the longitudinal direction is 100, and the offset amount of the electrode in the longitudinal direction from the maximum inflation portion is G1.
0.1≦G1/100≦0.4 is satisfied,
7. The medical device of claim 6.

(Appendix 8)
When the balloon moves backward due to electrical stimulation by the electrode, the total length of the balloon in the longitudinal direction is 100, and the offset amount of the electrode in the longitudinal direction with respect to the maximum bulging portion is G2.
0.6≦G2/100≦0.9 is satisfied,
8. The medical device of claim 6 or 7.

(Appendix 9)
the stimulus generator includes an electrode configured to be able to apply an electrical stimulus to the hollow organ,
The electrodes are arranged at equal intervals in the circumferential direction around the longitudinal axis of the balloon.
9. The medical device of any one of claims 4 to 8.

(Appendix 10)
When viewed from the minor axis direction of the balloon, the electrode is formed in a rectangular shape,
When the total length of the balloon in the longitudinal direction is 100 and the maximum length of one side of the electrode is S,
0.02≦S/100≦0.1 is satisfied,
10. The medical device of claim 9.

(Appendix 11)
The electrodes are disposed on the outer surface of the balloon.
11. The medical device of claim 10.

(Appendix 12)
Further, wiring connected to the electrode is provided,
The wiring extends along the outer surface of the balloon.
12. The medical device of claim 11.

(Appendix 13)
The balloon further includes a cylindrical flow path member for allowing the fluid to flow into the balloon,
The wiring extends along the outer surface of the balloon and then extends through the inside of the flow path member.
13. The medical device of claim 12.

(Appendix 14)
The structure comprises an ellipsoid, a basket structure, or a spiral structure.
3. The medical device of claim 1 or 2.

(Appendix 15)
A medical device according to any one of appendices 1 to 14;
A control device for controlling the magnitude of the stimulus.
system.

(Appendix 16)
the stimulation includes electrical stimulation;
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.
16. The system of claim 15.

(Appendix 17)
The control device controls the electrical stimulation by alternately repeating 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.
17. The system of claim 16.

1...System, 2...Medical device, 3...Control device, 10...Structure, 11...Balloon, 12...Maximum expansion portion, 20...Stimulus generator, 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 of balloon in the longitudinal direction

Claims (17)

a structure configured to be insertable into a hollow organ having smooth muscle;
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;
Medical equipment. 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 a stimulus of heat, vibration, light, or electricity to the hollow organ, respectively;
The medical device of claim 1 . The structure includes a balloon that is inflated by the supply of a fluid.
The medical device according to claim 1 or 2. The balloon has a shape having a long axis along the hollow organ.
The medical device of claim 3 . The balloon has a rotationally symmetric shape with the long axis as an axis of symmetry.
The medical device of claim 4. The balloon has a maximum expansion portion at the center of the long axis direction of the balloon, the maximum expansion portion expanding in the short axis direction when inflated,
the stimulus generator includes an electrode configured to be able to apply an electrical stimulus to the hollow organ,
the electrode is disposed offset in the long axis direction with respect to the maximum bulge portion;
The medical device according to claim 5. When the balloon advances due to electrical stimulation by the electrodes, the total length of the balloon in the longitudinal direction is 100, and the offset amount of the electrode in the longitudinal direction from the maximum inflation portion is G1.
0.1≦G1/100≦0.4 is satisfied,
The medical device of claim 6. When the balloon moves backward due to electrical stimulation by the electrode, the total length of the balloon in the longitudinal direction is 100, and the offset amount of the electrode in the longitudinal direction with respect to the maximum bulging portion is G2.
0.6≦G2/100≦0.9 is satisfied,
The medical device of claim 6. the stimulus generator includes an electrode configured to be able to apply an electrical stimulus to the hollow organ,
The electrodes are arranged at equal intervals in the circumferential direction around the longitudinal axis of the balloon.
The medical device of claim 4. When viewed from the minor axis direction of the balloon, the electrode is formed in a rectangular shape,
When the total length of the balloon in the longitudinal direction is 100 and the maximum length of one side of the electrode is S,
0.02≦S/100≦0.1 is satisfied,
The medical device of claim 9. The electrodes are disposed on the outer surface of the balloon.
The medical device of claim 10. Further, wiring connected to the electrode is provided,
The wiring extends along the outer surface of the balloon.
The medical device of claim 11. The balloon further includes a cylindrical flow path member for allowing the fluid to flow into the balloon,
The wiring extends along the outer surface of the balloon and then extends through the inside of the flow path member.
The medical device of claim 12. The structure comprises an ellipsoid, a basket structure, or a spiral structure.
The medical device according to claim 1 or 2. The medical device according to claim 1 or 2;
A control device for controlling the magnitude of the stimulus.
system. the stimulation includes electrical stimulation;
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.
The system of claim 15. The control device controls the electrical stimulation by alternately repeating 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.
17. The system of claim 16.