WO2022034875A1 - 医療デバイス、医療システム、及び処置方法 - Google Patents

医療デバイス、医療システム、及び処置方法 Download PDF

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Publication number
WO2022034875A1
WO2022034875A1 PCT/JP2021/029484 JP2021029484W WO2022034875A1 WO 2022034875 A1 WO2022034875 A1 WO 2022034875A1 JP 2021029484 W JP2021029484 W JP 2021029484W WO 2022034875 A1 WO2022034875 A1 WO 2022034875A1
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WIPO (PCT)
Prior art keywords
esophagus
medical device
stenosis
support structure
support
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PCT/JP2021/029484
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English (en)
French (fr)
Japanese (ja)
Inventor
賢志 澤田
達 末原
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テルモ株式会社
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Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2022542849A priority Critical patent/JPWO2022034875A1/ja
Publication of WO2022034875A1 publication Critical patent/WO2022034875A1/ja

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present invention relates to a medical device, a medical system, and a treatment method used to promote saliva secretion of a subject.
  • a method of controlling the saliva volume of the patient can be considered. If it becomes possible to intentionally control the amount of saliva, it is possible to prevent the patient from having thirst. As a result, it will be feasible to maintain a constant body fluid volume while limiting the amount of drinking water.
  • Patent Document 1 and Patent Document 2 disclose a medical device for nerve stimulation configured to be indwellable in the body of a subject.
  • the medical device disclosed in Patent Document 1 and Patent Document 2 is placed in the patient's esophagus to stimulate the vagus nerve running under the mucosa of the esophagus to control the patient's saliva volume. Is thought to be possible.
  • the recurrent laryngeal nerve and arch aorta are present around the first esophageal stenosis (upper esophageal stenosis). Therefore, stimulating the first stenosis of the esophagus may cause unnecessary reactions other than salivation.
  • the diaphragm and sphincter muscle are present in the vicinity of the third esophageal stenosis (lower esophageal stenosis). Therefore, considering the effect on the patient's body, it is not preferable to positively stimulate the vicinity of the third stenosis of the esophagus.
  • the present invention has been made to solve the above-mentioned problems, and reduces the burden on the subject by stimulating the vagus nerve running under the mucosa of the esophagus at an appropriate position of the esophagus. It is an object of the present invention to provide a medical device, a medical system, and a treatment method capable of promoting saliva secretion.
  • the medical device that achieves the above object includes a stimulating portion capable of imparting a stimulus for promoting salivation to the vagus nerve running under the mucous membrane of the esophagus, a support structure in which the stimulating portion is arranged, and the support. By supporting the structure with respect to the esophagus, it has a support portion for holding the stimulating portion in a fixed position between the second stenosis of the esophagus and the third stenosis of the esophagus.
  • the stimulating portion arranged in the support structure can be held in a fixed position between the second stenosis of the esophagus and the third stenosis of the esophagus.
  • saliva secretion of the subject can be promoted by stimulating the vagus nerve running under the mucosa of the esophagus from the stimulating portion.
  • FIG. 1 It is a figure which shows the medical device and the medical system which concerns on 1st Embodiment simply. It is a perspective view of the medical device which concerns on 1st Embodiment. It is a top view of the medical device seen from the direction of arrow 3A of FIG. It is sectional drawing (vertical sectional view) of the esophagus which shows typically the use example of the medical device which concerns on 1st Embodiment. It is a flowchart which shows the control flow of a medical system. It is sectional drawing of the esophagus which shows typically the use example of the medical device which concerns on modification 1 of 1st Embodiment.
  • FIG. 1 is a diagram illustrating a medical system 10 and a medical device 100 in a simplified manner.
  • 2 and 3 are diagrams showing the configuration of each part of the medical device 100.
  • FIG. 4 is a diagram showing a usage example of the medical device 100, and is a cross-sectional view (vertical cross-sectional view) of the esophagus E of the subject in which the medical device 100 is indwelled.
  • FIG. 5 is a diagram showing a control flow of the medical system 10.
  • FIGS. 1 and 4 schematically show a part of the subject's body.
  • Reference numeral E indicates the esophagus of the subject
  • reference numeral O indicates the oral cavity of the subject
  • reference numeral S indicates the stomach of the subject.
  • reference numeral N1 indicates a first stenosis of the esophagus E (upper esophageal stenosis)
  • reference numeral N2 indicates a second stenosis of the esophagus E (middle esophageal stenosis)
  • reference numeral N3 indicates a third stenosis of the esophagus E (lower esophageal stenosis).
  • the reference numeral L indicates the lumen of the esophagus E
  • the reference numeral Ew indicates the inner wall of the esophagus E.
  • the position of the oral cavity O side (also referred to as "pharyngeal side") of the esophagus E is defined as the "position on the upstream side of the esophagus E"
  • the position of the stomach S side of the esophagus E is defined as the "downstream side of the esophagus E”.
  • the extending direction of the esophagus E shall mean the vertical direction of the esophagus E in FIGS. 1 and 4.
  • the medical system 10 and the medical device 100 are used to promote saliva secretion of a subject.
  • the subject is, for example, a heart failure patient for whom control of body fluid volume including saliva volume is desired.
  • the medical system 10 and the medical device 100 are not particularly limited in terms of the type, pathological condition, symptom, etc. of the disease as long as the purpose is to promote saliva secretion of the subject.
  • the medical device 100 includes a stimulating portion 110 capable of giving a stimulus for promoting salivation to the vagus nerve running under the mucous membrane of the esophagus E, a support structure 120 in which the stimulating portion 110 is arranged, and a support structure.
  • the stimulating portion 110 has a support portion 130 that holds the stimulating portion 110 in a fixed position between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E.
  • the medical device 100 constitutes a medical system 10 together with a monitoring device 200 and a control unit 300, which will be described later.
  • the support structure 120 has a tubular structure in which a lumen 125 extending in the longitudinal direction (left-right direction in FIG. 3) of the support structure 120 is formed.
  • the arrow X attached in the figure indicates the longitudinal direction of the support structure 120, and the arrow Y indicates the width direction orthogonal to the longitudinal direction of the support structure 120.
  • the support structure 120 includes a first opening 121a formed at one end 121 in the longitudinal direction, a second opening 122a formed at the other end 122 in the longitudinal direction, and a lumen 125 extending in the longitudinal direction.
  • the outer diameter of the support structure 120 gradually decreases from both sides of one end portion 121 and the other end portion 122 toward the central portion in the longitudinal direction.
  • the first opening 121a and the second opening 122a communicate with the lumen 125.
  • the one end portion 121 in which the first opening portion 121a is formed is arranged at a position on the upstream side of the esophagus E with respect to the other end portion 122 in which the second opening portion 122a is formed.
  • the lumen 125 does not have to extend continuously along the longitudinal direction of the support structure 120.
  • the support structure 120 is composed of a plurality of members (for example, the first part 120A and the second part 120B) as shown in the embodiment described later, a lumen is provided in each member constituting the support structure 120. It can be formed (see, for example, FIG. 8).
  • the stimulating portion 110 is arranged in the intermediate portion 123 located between the one end portion 121 and the other end portion 122.
  • the stimulating portion 110 is attached to the outer surface of the intermediate portion 123 of the support structure 120.
  • the stimulation portion 110 is arranged so as to come into contact with the inner wall Ew of the esophagus E in a state where the support structure 120 is supported by the esophagus E by the support portion 130. Further, as shown in FIG. 2, the stimulation unit 110 is arranged along the entire circumference of the support structure 120 in the circumferential direction. By arranging the stimulating portion 110 in this way, it becomes possible to apply the stimulus over a wide range in the circumferential direction of the inner wall Ew of the esophagus E. Therefore, the saliva secretion of the subject can be effectively promoted.
  • the stimulation portion 110 is arranged in the longitudinal direction of the support structure 120.
  • the stimulation unit 110 may be arranged at a position close to the one end portion 121 or the other end portion 122, or a plurality of stimulation units 110 may be arranged at different positions in the longitudinal direction of the support structure 120. good.
  • the position where the stimulation portion 110 is arranged in the circumferential direction of the support structure 120 there is no particular limitation on the position where the stimulation portion 110 is arranged in the circumferential direction of the support structure 120.
  • the stimulation unit 110 may be arranged only in a part of the circumferential direction of the support structure 120, or a plurality of stimulation units 110 may be arranged at different positions in the circumferential direction of the support structure 120.
  • the stimulation unit 110 has, for example, an electrode capable of applying electrical stimulation to the vagus nerve running under the mucous membrane of the esophagus E.
  • the stimulator 110 can be made of, for example, a material capable of spreading folds (see FIG. 10) present on the inner wall Ew of the esophagus E.
  • the electrode can be placed on at least a part of the stimulating portion 110 so as to ensure contact with the mucous membrane of the esophagus E when the medical device 100 is placed in the esophagus E.
  • the entire stimulating portion 110 may be made of a conductive metal, and at least a part of the stimulating portion 110 may be arranged so as to be in contact with the mucous membrane of the esophagus E.
  • the stimulator 110 can be made of a material that can be contracted and / or expanded upon delivery to or withdrawal from the site of indwelling target (target site).
  • a material such as stainless steel can be used, but the material is not limited thereto.
  • the start and stop of the application of the stimulus by the stimulus unit 110, the magnitude of the stimulus (the magnitude of the current value), and the like can be controlled by the control unit 300.
  • the stimulating unit 110 is composed of a self-discharge type or a self-charging type that receives a control command from the control unit 300 to generate electricity for stimulation, or receives electricity from an electricity supply unit arranged outside the body. It can be configured with an external power supply type that supplies electricity for stimulation.
  • the type and form of the stimulus given by the stimulating unit 110 is not particularly limited as long as it is possible to give a stimulus for promoting saliva secretion to the vagus nerve running under the mucous membrane of the esophagus E.
  • the stimulating unit 110 has, for example, a structure that generates heat by a magnetic field or an electric field applied from outside the esophagus (for example, inside the esophagus or outside the body) and gives stimulation by heat, or a structure that gives stimulation by ultrasonic waves.
  • the support structure 120 has a network structure that can be deformed according to the movement of the esophagus E (for example, peristaltic movement) while the support structure 120 is held in the esophagus E.
  • the support structure 120 can be composed of, for example, a known esophageal stent-like member having a main skeleton made of woven metal wire or a main skeleton made of a tubular member having gaps formed therein. By being configured in this way, the support structure 120 can be provided with high followability to deformation of the esophagus E in the radial direction, the longitudinal direction (axial direction), and the twisting direction.
  • the constituent material of the support structure 120 is not particularly limited. However, considering that the support structure 120 is placed in the esophagus E, it is possible to use a material having excellent acid resistance, not being corroded by gastric juice, and having high followability to the movement of the esophagus E described above. preferable. As such a material, for example, a superelastic alloy such as a nickel-titanium alloy can be used. Further, it is preferable that an appropriate surface treatment is applied in order to increase the resistance to corrosion.
  • the support structure 120 Although a member having a network structure such as an esophageal stent is exemplified as the support structure 120, the specific structure of the support structure 120 is not particularly limited as long as it can be placed in the esophagus E. Further, even when the support structure 120 is configured with a mesh structure, there are no particular restrictions on the coarseness and density of the mesh, the pattern of the mesh, and the like. Further, a cover for preventing food or the like from leaking from the lumen 125 may be arranged on the inner surface of the support structure 120.
  • the support portion 130 has a first support portion 131 and a first support portion 131 that are in contact with the inner wall of the esophagus E at a position downstream of the second stenosis N2.
  • a second support portion 132 that is in contact with the inner wall Ew of the esophagus E at a position downstream of the esophagus E from the position where the esophagus E is arranged and at a position upstream of the esophagus E from the third stenosis N3.
  • the first support portion 131 is composed of one end portion 121 in the longitudinal direction of the support structure 120.
  • the second support portion 132 is composed of the other end portion 122 in the longitudinal direction of the support structure 120. That is, each of the support portions 131 and 132 is composed of a part of the support structure 120.
  • the first support portion 131 composed of one end portion 121 of the support structure 120 has a second stenosis N2 in the lumen L of the esophagus E. It can be arranged so as to abut from the position on the downstream side of the esophagus E with respect to the protruding portion of the inner wall Ew to be formed. Further, the second support portion 132 composed of the other end portion 122 of the support structure 120 is upstream of the esophagus E with respect to the protruding portion of the inner wall Ew forming the third stenosis N3 in the lumen L of the esophagus E. It can be arranged so as to abut from the side position.
  • the first support portion 131 abuts on the protruding portion of the inner wall Ew forming the second stenosis N2 in the lumen L of the esophagus E, and the lumen of the esophagus E.
  • the second support portion 132 is in contact with the protruding portion of the inner wall Ew forming the third stenosis N3 in L
  • the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E It is held in a fixed position between them.
  • the stimulation portion 110 arranged in the intermediate portion 123 of the support structure 120 is fixedly held between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E, similarly to the support structure 120. Will be done.
  • the support portion 130 has a tapered shape extending in the radial direction away from the central axis C1 side of the support structure 120. That is, the one end portion 121 constituting the first support portion 131 has a shape whose diameter is expanded outward from the central axis C1. Further, the other end portion 122 constituting the second support portion 132 has a shape whose diameter is expanded outward from the central axis C1. Therefore, as shown in FIG. 4, in a state where the medical device 100 is indwelled in the esophagus E, the end portions 121 and 122 protrude from the protruding portion of the inner wall Ew forming the stenosis N2 and N3. Contact with. Therefore, the medical device 100 can be stably held at a desired position of the esophagus E.
  • the support portion 130 (first support portion 131, second support portion 132) does not have to be composed of a part of the support structure 120. That is, a member having a function of holding the support structure 120 at a desired position in the esophagus E may be attached to the support structure 120. Further, the shape, position, number and the like of the support portions 130 are not particularly limited. For example, one of the first support portion 131 and the second support portion 132 may be configured in a shape as described in Modification 1 described later (see FIG. 6).
  • the medical device 100 can be visually recognized so that when the operator or the like indwells the medical device 100, the positional relationship between the support portions 131 and 132 and the stenosis N2 and N3 can be clearly discriminated.
  • the contrastable markers M1 and M2 can be mounted on the support 131, 132, 133 or the support structure 120, respectively.
  • each marker M1 and M2 can be composed of a marker made of Au or Pt having X-ray opacity in a part of or in the vicinity of the first opening 121a and the second opening 122a.
  • markers M3 and M4 that make each end recognizable may be mounted on the proximal end and the distal end of the stimulating portion 110.
  • the material and morphology of each marker M1, M2, M3, M4 may be recognizable by an externally imageable technique, and each marker M1, M2, M3, M4 is periodically spaced and continuous in the circumferential direction. It may be arranged in.
  • the medical system 10 includes a medical device 100, a monitoring device 200, and a control unit 300.
  • the medical system 10 executes control for controlling the body fluid volume of the patient wearing the medical device 100.
  • the stimulation unit 110 of the medical device 100 is operated to stimulate the vagus nerve running under the mucous membrane of the esophagus E. Promotes saliva secretion.
  • the subject wears the monitoring device 200 when performing a procedure for promoting saliva secretion using the medical device 100.
  • the control unit 300 controls the operation of the stimulation unit 110 based on the body fluid index acquired by the monitoring device 200.
  • the control unit 300 controls, for example, the timing of starting and stopping the application of the stimulus by the stimulus unit 110, the intensity of the stimulus, and the like.
  • the monitoring device 200 for example, as shown in FIG. 1, a device having a structure that can be attached to the oral cavity O of the subject can be used.
  • the monitoring device 200 can be configured, for example, with a patch-type structure that can be attached to the oral cavity O.
  • the body fluid index acquired by the monitoring device 200 can include, for example, a parameter related to saliva of the subject and a parameter related to the amount of water in the blood.
  • parameters related to saliva include saliva volume, saliva viscosity, saliva hydrogen ion index (pH value), saliva protein content, and the like.
  • Ht value as parameters related to the amount of water in blood, Ht value, electric resistance value, osmotic pressure, and the like can be mentioned.
  • the body fluid index acquired by the monitoring device 200 includes, for example, the oral humidity, the amount of water on the tongue, the electric resistance value (impedance) which is an alternative parameter of the water state of the tongue, and the biological components related to the body fluid balance (vasopresin and the like.
  • Hormones related to diuresis such as aldosterone, electrolytes such as Na ions related to osmotic pressure, BUN / creatinine ratio as an index related to body fluid filtration) and the like can also be included.
  • the monitoring device 200 is not limited to a device configured to be wearable in the oral cavity O.
  • the monitoring device 200 is, for example, configured to be able to acquire the humidity in the nasal cavity or the paranasal sinuses, to be configured to be able to acquire the blood flow around the place where the stimulating portion 110 is arranged in the vicinity of the esophagus E, or the esophagus E. It may be configured so that the amount of water passing through the inside can be obtained, or the presence or absence of the contents of the stomach can be measured by ultrasonic waves.
  • the monitoring device 200 may be configured to detect the movement of the marker arranged on the support structure 120 or the stimulation unit 110 and calculate the frequency of peristaltic movement from the detection result, for example.
  • the control unit 300 detects the peristaltic movement of the esophagus E accompanying the ingestion of food or the like of the subject by the monitoring device 200, and measures the meal interval from the detection result. be able to.
  • the control unit 300 can memorize the measured meal interval and control the operation of the stimulus unit 110 so as to give a stimulus by shifting the meal interval.
  • the control unit 300 includes a CPU, a storage unit, and a power supply unit.
  • the storage unit includes a ROM for storing various programs and data, a RAM for temporarily storing programs and data as a work area, and a hard disk capable of storing various programs and data.
  • the storage unit included in the control unit 300 can store a series of programs necessary for controlling the stimulation unit 110 based on the monitoring result of the monitoring device 200.
  • the power supply unit supplies a drive current to the stimulation unit 110.
  • the control unit 300 can store information regarding the operation of the stimulus unit 110 and generate a stimulus application pattern for each subject. Further, the control unit 300 applies a stimulus according to the generated pattern, acquires data such as how much saliva secretion is promoted as a result of the application, and feedback-controls the operation of the stimulus unit 110 based on the acquired data. You can also do it.
  • control unit 300 is configured as a device different from the medical device 100 and is arranged outside the body of the subject.
  • the control unit 300 may be mounted on the medical device 100.
  • control unit 300 may be configured by, for example, an existing communication device or the like in which a dedicated program is installed.
  • FIG. 5 shows an example of the control flow of the medical system 10. The control flow will be described with reference to FIG.
  • the monitoring device 200 Upon receiving an instruction from the subject (or medical staff) and the control unit 300 starting a series of programs related to stimulation, the monitoring device 200 starts monitoring changes in the body fluid index of the subject (step S11). ).
  • the monitoring device 200 acquires a body fluid index (step S12).
  • the time interval for acquiring the body fluid index, the period for continuing the acquisition of the body fluid index, and the like can be arbitrarily set.
  • the control unit 300 determines whether or not stimulation should be started based on the body fluid index acquired by the monitoring device 200 (step S13). In the present embodiment, the control unit 300 calculates the degree of oral wetness based on the body fluid index acquired by the monitoring device 200. When the measured oral moistness exceeds the preset “target value of oral moistness” (step S13: YES), the control unit 300 does not perform stimulation and monitors the body fluid index. Continue (step S11).
  • control unit 300 When the oral wetness of the subject does not exceed the "target value of the oral wetness" (step S13: NO), the control unit 300 operates the stimulation unit 110 to apply stimulation (step S14). ..
  • the data regarding the calculation formula of the oral wetness, the target value of the oral wetness, and the like can be stored in advance in the storage unit of the control unit 300.
  • the control unit 300 acquires the body fluid index again via the monitoring device 200. In addition, the control unit 300 recalculates the oral wetness based on the acquired body fluid index, and determines whether or not the oral wetness of the subject has reached the target value (step S15). When the degree of oral wetness does not reach the target value (step S15: NO), the stimulation by the stimulating unit 110 is applied again (step S14). The control unit 300 repeats acquisition of the body fluid index, acquisition of the oral wetness, comparison with the target value of the oral wetness, and application of stimulation until the oral wetness reaches the target value.
  • step S15 When the oral wetness reaches the target value (step S15: YES), the control unit 300 stops applying the stimulus (step S16).
  • the control unit 300 continues monitoring by the monitoring device 200 as necessary after the oral wetness reaches the target value (step S17). Further, when the instruction from the subject (or the medical worker) is received while the monitoring by the monitoring device 200 is being continued, the above-mentioned control flow regarding stimulus application can be executed again.
  • the monitoring target of the monitoring device 200 may be a side effect of the given stimulus. For example, a decrease in heart rate and cardiac output may be considered to stimulate the vagus nerve.
  • Each of the above indicators is monitored, and when an unfavorable reaction occurs, the control unit 300 can stop the stimulation.
  • the items to be monitored may include, but are not limited to, tachycardia, bradycardia, change in cardiac output, and peristaltic movement of the esophagus.
  • the monitoring result of the monitoring device 200 may be used. For example, it can be used as a means for monitoring the applied stimulus and the saliva secretion amount obtained as the effect thereof, and confirming that the stimulus unit 110 is placed at the optimum stimulus application position.
  • the item to be monitored may be a body fluid index or the like, and is not limited to this.
  • a medical worker places the medical device 100 in the esophagus E of the subject when the medical device 100 is used to carry out a procedure for promoting saliva secretion of the subject.
  • the medical device 100 can be delivered and placed in the esophagus E using, for example, a medical device for introduction into the living body (for example, a sheath or the like).
  • the medical staff can also use a balloon device or the like to which the medical device 100 is fitted, if necessary.
  • the medical device 100 may be deformed to a contracted or reduced diameter state as necessary until it is delivered to the indwelling position of the esophagus E.
  • the medical worker can deliver the medical device 100 into the esophagus E, for example, via the oral cavity O.
  • the medical worker arranges the stimulating portion 110 of the medical device 100 between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E.
  • the medical staff supports the support structure 120 with respect to the inner wall Ew of the esophagus E by the support portion 130 (first support portion 131, second support portion 132).
  • the medical staff holds the stimulating portion 110 in a fixed position between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E in a state where the stimulating portion 110 is in contact with the inner wall Ew of the esophagus E. Can be done. In the state where the medical device 100 is placed in the esophagus E in this way, the vagus nerve running under the mucosa of the esophagus E is stimulated from the stimulating portion 110 to surround the first stenosis N1 of the esophagus E.
  • the treatment method (method of promoting saliva secretion) according to the present embodiment is performed from the stimulating portion 110 of the medical device 100 arranged between the first stenosis N1 of the esophagus E and the second stenosis N2 of the esophagus E to the esophagus. It involves stimulating the vagus nerve running under the mucosa of E.
  • the stimulation portion 110 is held in a fixed position between the first stenosis N1 of the esophagus E and the second stenosis N2 of the esophagus E by the support portion 130 of the medical device 100. Includes stimulating from.
  • the above-mentioned treatment method is a position of the first support portion 131 of the support portion 130 arranged at a position downstream of the second stenosis N2 of the esophagus E and a position downstream of the first support portion 131 of the esophagus E.
  • the stimulation portion 110 is fixed between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E by the second support portion 132 arranged at a position upstream of the third stenosis N3. Includes holding the esophagus.
  • control unit 300 starts, stops, and the magnitude of the stimulation by the stimulation unit 110 based on the body fluid index acquired by the monitoring device 200 attached to the subject. Including controlling one.
  • the above-mentioned treatment method can be carried out for the purpose of controlling the body fluid volume of a heart failure patient.
  • the stimulating unit 110 capable of giving a stimulus for promoting saliva secretion to the vagus nerve running under the mucous membrane of the esophagus E and the stimulating unit 110 are arranged.
  • the stimulating portion 110 is held in a fixed position between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E. It has a support portion 130 and a support portion 130.
  • the stimulation portion 110 arranged in the support structure 120 is held in a fixed position between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E. Can be done. With the medical device 100 indwelling in the esophagus E, saliva secretion of the subject can be promoted by stimulating the vagus nerve running under the mucous membrane of the esophagus E from the stimulating portion 110.
  • the medical device 100 it is possible to suppress the application of stimulation to the peripheral portion of the first stenosis N1 of the esophagus E and the peripheral portion of the third stenosis N3 of the esophagus E.
  • the burden can be reduced.
  • the support structure 120 includes a first opening 121a formed at one end 121 in the longitudinal direction, a second opening 122a formed at the other end 122 in the longitudinal direction, and a lumen 125 extending in the longitudinal direction. And has a network structure that can be deformed by following the movement of the esophagus E while being held in the esophagus E.
  • the medical device 100 configured as described above has the inside of the first opening 121a of the support structure 120 even when the subject ingests food or the like while the medical device 100 is indwelled in the esophagus E.
  • Food or the like can be moved from the pharyngeal side to the stomach S side through the lumen 125 and the second opening 122a. Therefore, the subject can ingest food and the like even when the medical device 100 is placed in the esophagus E, and can lead a normal life.
  • the support structure 120 has a network structure that can be deformed according to the movement of the esophagus E, it is possible to prevent the subject from feeling uncomfortable when the medical device 100 is placed in the esophagus E. Further, it is possible to prevent the movement of the esophagus E from being hindered by the support structure 120 having a network structure.
  • the support portion 130 has a first support portion 131 and a second support portion 132 arranged at a position downstream of the esophagus E from the first support portion 131.
  • the medical device 100 configured as described above can support the support structure 120 at at least two positions in the extending direction of the esophagus E. Therefore, the medical device 100 can be held more stably in the esophagus E.
  • the first support portion 131 is arranged so as to abut against the inner wall Ew of the esophagus E at a position downstream of the second stenosis N2 of the esophagus E so that the second support portion 132 abuts on the inner wall Ew of the esophagus E.
  • 3 Arranged so as to abut against the inner wall Ew of the esophagus E at a position upstream of the esophagus E with respect to the stenosis N3.
  • the stimulating portion 110 arranged in the support structure 120 by the first support portion 131 and the second support portion 132 causes the stimulation portion 110 to be the first stenosis N1 of the esophagus E and the first esophagus E. It can be more reliably held between the two stenosis N2.
  • the first support portion 131 is composed of one end portion 121 in the longitudinal direction of the support structure 120
  • the second support portion 132 is composed of the other end portion 122 in the longitudinal direction of the support structure 120.
  • the support portions 131 and 132 are integrally configured with the support structure 120, the device configuration of the medical device 100 can be simplified. Further, since the entire support structure 120 can be held between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E, the support structure 120 can be held in the state where the medical device 100 is placed in the esophagus E. It is possible to prevent contact with the peripheral portion of the second stenosis N2 of the esophagus E and the peripheral portion of the third stenosis N3 of the esophagus E. Thereby, it is possible to prevent unnecessary stimulation from being applied to the peripheral portion of the second stenosis N2 of the esophagus E and the peripheral portion of the third stenosis N3 of the esophagus E.
  • At least a part of the support portion 130 has a tapered shape extending in the radial direction away from the central axis C1 side of the support structure 120.
  • the support portion 130 protruding in the radial direction from the support structure 120 can be brought into contact with the inner wall Ew of the esophagus E. Therefore, the bearing capacity of the supporting structure 120 for the esophagus E can be increased.
  • the support portions 131 and 132 are composed of the end portions 121 and 122 of the support structure 120
  • the tapered first opening 121a allows food and the like that have moved from the pharyngeal side to the stomach S side. Can be smoothly moved to the lumen 125 of the support structure 120, and can be smoothly moved from the lumen 125 of the support structure 120 to the stomach S side through the tapered second opening 122a. be able to.
  • the medical system 10 includes a medical device 100, a monitoring device 200 that acquires a body fluid index of a subject to which the medical device 100 is attached, and a stimulation unit 110 based on the body fluid index acquired by the monitoring device 200. It has a control unit 300 that controls the operation of the above.
  • the medical system 10 configured as described above controls the operation of the stimulating unit 110 after determining the thirst state of the subject based on the body fluid index of the subject acquired by the monitoring device 200. Can be done. Therefore, it is possible to apply the stimulus at an appropriate timing according to the thirst state of the subject.
  • FIG. 6 shows a state in which the medical device 100A according to the first modification is placed in the esophagus E.
  • the medical device 100A according to the first modification is different from the medical device 100 described above in the structure of the support portions (first support portion 131 and second support portion 132).
  • the first support portion 131 and the second support portion 132 have a convex shape curved in the radial direction away from the central axis C1 of the support structure 120.
  • the first support portion 131 has a curved shape that can be arranged along the protruding portion of the inner wall Ew forming the second stenosis N2 of the esophagus E.
  • the second support portion 132 has a curved shape that can be arranged along the protruding portion of the inner wall Ew forming the third stenosis N3 of the esophagus E.
  • the first support portion 131 is composed of one end portion 121 of the support structure 120.
  • the first support portion 131 can be arranged at a position downstream of the second stenosis N2 of the esophagus E.
  • the second support portion 132 is composed of the other end portion 122 of the support structure 120.
  • the second support portion 132 can be arranged at a position upstream of the third stenosis N3 of the esophagus E.
  • the support structure 120 is suitable for the inside of the esophagus E by the first support portion 131 and the second support portion 132 provided on the support structure 120, similarly to the medical device 100 described above. Can be detained in. Further, as shown in FIG. 6, the stimulation portion 110 arranged in the support structure 120 can be held in a fixed position between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E.
  • the support portions 131, 132 are curved so as to be displaceable along the protruding portion of the inner wall Ew forming the second stenosis N2 of the esophagus E and the protruding portion of the inner wall Ew forming the third stenosis N3 of the esophagus E. Since it has a shape, the load on the esophagus E can be reduced as compared with the medical device 100 according to the first embodiment.
  • FIG. 7 shows a state in which the medical device 100B according to the modified example 2 is placed in the esophagus E.
  • the medical device 100B according to the second modification is different from the medical device 100 described above in the structures of the support structure 120 and the support portion.
  • the medical device 100B has a first support portion 131, a second support portion 132, and a third support portion 133.
  • the first support portion 131 is composed of a part of the intermediate portion 123 of the support structure 120.
  • the first support portion 131 can be arranged at a position downstream of the second stenosis N2 of the esophagus E.
  • the first support portion 131 has a curved shape that can be arranged along a protruding portion of the inner wall Ew that forms the second stenosis N2 of the esophagus E.
  • the second support portion 132 is composed of the other end portion 122 of the support structure 120.
  • the second support portion 132 can be arranged at a position upstream of the third stenosis N3 of the esophagus E.
  • the second support portion 132 has a curved shape that can be arranged along the protruding portion of the inner wall Ew that forms the third stenosis N3 of the esophagus E.
  • the third support portion 133 is composed of one end portion 121 of the support structure 120.
  • the third support portion 133 can be arranged at a position upstream of the second stenosis N2 of the esophagus E. Further, the third support portion 133 can be arranged so as to abut against the protruding portion of the inner wall Ew forming the second stenosis N2 of the esophagus E.
  • the third support portion 133 can be formed, for example, in a tapered shape extending in the radial direction away from the central axis C1 side of the support structure 120.
  • the medical device 100B can support the support structure 120 with respect to the esophagus E by the three support portions 131, 132, 133, the medical device 100B can be held more stably in the esophagus E. .. Further, as shown in FIG. 7, in a state where the medical device 100B is placed in the esophagus E, the third support portion 133 forms an inner wall Ew that forms a second stenosis N2 of the esophagus E with the first support portion 131. Insert the protruding part. Therefore, the bearing capacity of the supporting structure 120 in the vicinity of the second stenosis N2 of the esophagus E can be improved. Therefore, the stimulation portion 110 arranged in the support structure 120 can be more reliably held between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E.
  • FIG. 8 shows the medical device 100C according to the second embodiment.
  • FIG. 9 shows a schematic cross-sectional view of a state in which the medical device 100C is placed in the esophagus E.
  • FIG. 11 shows a model partial cross-sectional view (cross-sectional view) of the esophagus E in a state where the medical device 100C is indwelled.
  • the medical device 100C according to the second embodiment is different from the medical device 100 described above in the structures of the support structure 120 and the stimulating portion 110.
  • the support structure 120 has a first site 120A, a second site 120B, and a third site 120C connecting the first site 120A and the second site 120B.
  • the first site 120A is arranged at a position upstream of the esophagus E with respect to the second site 120B.
  • the first support portion 131 is composed of an end portion arranged on the pharyngeal side of the first portion 120A forming one end portion 121 of the support structure 120.
  • the second support portion 132 is composed of an end portion arranged on the stomach S side of the second portion 120B forming the other end portion 122 of the support structure 120.
  • the third part 120C connects an end portion of the first part 120A on the second part 120B side and an end portion of the second part 120B located on the first part 120A side.
  • the connection method for example, a method such as adhesion or welding can be adopted.
  • the third portion 120C is composed of a plurality of stimulation portions 111 arranged so as to be spaced apart from each other along the circumferential direction of the support structure 120.
  • Each of the plurality of stimulating portions 111 is arranged with a gap from each other in the circumferential direction of the support structure 120. Therefore, in the support structure 120 where the third part 120C is arranged, the area on the outer peripheral surface of the support structure 120 is larger than that of the first part 120A and the second part 120B because the gap is formed. small. Therefore, when the medical device 100C is placed in the esophagus E, the area where the third site 120C comes into contact with the inner wall Ew of the esophagus E is smaller than that of the first site 120A and the second site 120B.
  • a network structure constituting the first part 120A and the second part 120B may be arranged in the third part 120C.
  • the number and shape of the stimulating portions 111 and the size of the gap formed between the stimulating portions 111 are not particularly limited. However, it is preferable that the gap formed between the stimulating portions 111 is formed in such a size that food or the like passing through the lumen 125 of the support structure 120 does not excessively flow out to the outside of the support structure 120.
  • the stimulating portion 111 is preferably formed in a vertically long shape along the longitudinal direction of the support structure 120 in order to facilitate entry into the fold-shaped portion of the inner wall Ew of the esophagus E, as will be described later. Further, the cross section of the stimulating portion 111 can be formed in a circular shape, for example.
  • each of the stimulating portions 111 has substantially the same shape. However, the stimulating portions 111 may have different shapes. Each of the stimulating portions 111 can be arranged substantially linearly along the stretching direction of the support structure 120, for example. Each of the stimulating portions 111 can be arranged, for example, substantially in parallel.
  • the stimulation unit 111 can be composed of, for example, a metal electrode capable of applying electrical stimulation. However, the stimulating unit 111 can be selected from any structure and material according to the type of stimulus to be applied.
  • the plurality of stimulating portions 111 constituting the third site 120C are fixed in position between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E. Is retained.
  • FIG. 10 shows a partial cross-sectional view of the esophagus E in a state where food or the like has not passed through.
  • the inner wall Ew of the esophagus E in a state where food or the like has not passed is pleated in an uneven cross section.
  • each of the plurality of stimulating portions 111 arranged with a gap in the circumferential direction of the esophagus E has a fold shape of the inner wall Ew of the esophagus E, as shown in FIG. It is arranged so as to enter the recess of the.
  • the vagus nerve running under the mucous membrane of the esophagus E is stimulated more efficiently. can do. Therefore, by using the medical device 100C according to the modified example 3, it becomes possible to more effectively promote saliva secretion of the subject.
  • FIG. 11 shows the medical device 100D according to the first modification of the second embodiment.
  • each of the plurality of stimulation portions 111 constituting the third portion 120C is arranged so as to be inclined with respect to the longitudinal direction of the support structure 120. Further, each of the plurality of stimulation units 111 is composed of a member having a smaller area than the stimulation unit 111 (see FIG. 8) of the medical device 100C described above. As shown in this modification, the shape, arrangement direction, number, and the like of the stimulating portions 111 constituting the third portion 120C are not particularly limited and can be arbitrarily changed.
  • FIG. 12 shows the medical device 100E according to the second modification of the second embodiment.
  • FIG. 13 shows a schematic cross-sectional view of a state in which the medical device 100E is placed in the esophagus E.
  • the medical device 100E according to the second modification is different from the medical device 100C described above in the structure of the third portion 120C of the support structure 120.
  • the third portion 120C has a plurality of stimulating portions 111 and a linear member 150.
  • the linear member 150 is arranged between the first portion 120A and the plurality of stimulating portions 111. As shown in FIG. 13, in a state where the medical device 100E is placed in the esophagus E, the linear member 150 is arranged at a position upstream of the esophagus E with respect to the plurality of stimulating portions 111.
  • the linear member 150 extends in the extending direction of the support structure 120 while being wound in the circumferential direction of the support structure 120.
  • the linear member 150 can be arranged spirally around the central axis C1 of the support structure 120, for example. There are no particular restrictions on the winding shape, number of windings, cross-sectional shape, etc. of the linear member 150.
  • the linear member 150 can be made of, for example, a flexible material that can be expanded and contracted in the longitudinal direction and the circumferential direction of the support structure 120.
  • a superelastic alloy such as a nickel-titanium alloy can be used.
  • the medical device 100E can be placed, for example, between the first stenosis N1 of the esophagus E and the third stenosis N3 of the esophagus E.
  • the first site 120A is located downstream of the first stenosis N1 of the esophagus E, and can be arranged between the first stenosis N1 of the esophagus E and the second stenosis N2 of the esophagus E.
  • the second site 120B can be arranged at a position downstream of the second stenosis N2 of the esophagus E and at a position upstream of the third stenosis N3 of the esophagus E.
  • the first support portion 131 provided in the first portion 120A can be arranged so as to abut against the protruding portion of the inner wall Ew forming the first stenosis N1 of the esophagus E.
  • the second support portion 132 provided in the second portion 120B can be arranged so as to abut against the protruding portion of the inner wall Ew forming the third stenosis N3 of the esophagus E.
  • the plurality of stimulating portions 111 constituting the third site 120C can be arranged between the second stenosis N2 of the esophagus E and the third stenosis N3 of the esophagus E.
  • the plurality of stimulating portions 111 can be arranged so as to enter the recesses of the fold-shaped portions formed by the inner wall Ew of the esophagus E (see FIG. 10).
  • the linear member 150 constituting the third site 120C can extend from a position upstream of the second stenosis N2 of the esophagus E to a position downstream of the second stenosis N2 of the esophagus E.
  • the portion of the support structure 120 in which the linear member 150 is arranged has a smaller area in contact with the inner wall Ew of the esophagus E than the first portion 120A and the second portion 120B. Therefore, even when the linear member 150 comes into contact with the second stenosis N2 in a state where the medical device 100E is placed in the esophagus E as shown in FIG. 13, the stimulus generated in the peripheral portion of the second stenosis N2 is generated. Can be reduced. Therefore, even when the medical device 100E is placed in the esophagus E with the first site 120A provided with the first support portion 131 arranged at a position upstream of the second stenosis N2 of the esophagus E, the subject is examined. It becomes possible to reduce the load on the person's body.
  • the third portion 120C connecting the first portion 120A and the second portion 120B may be composed of only the linear member 150 described in the modified example 2.
  • the medical device can arbitrarily combine the configurations described in each embodiment and each modification.
  • the structure, material, size, etc. of each part of the medical device can be arbitrarily changed as long as it can stimulate the vagus nerve running under the mucosa of the esophagus to promote saliva secretion. Is.
  • Medical system 100, 100A, 100B, 100C, 100D, 100E Medical device 110 Stimulation unit 111 Multiple stimulation units 120 Support structure 120A First part of support structure 120B Second part of support structure 120C No. 2 of support structure 3 Sites 121 One end of the support structure 121a First opening of the support structure 122 The other end of the support structure 122a Second opening of the support structure 123 Intermediate part of the support structure 125 Lumen of the support structure 130 Support 131 1st support 132 2nd support 133 3rd support 150 Linear member 200 Monitoring device 300 Control unit M1, M2, M3, M4 Marker E Esophageal Ew Lumen of the esophagus L Lumen of the esophagus N1 No. 1 of the esophagus 1 Narrow N2 2nd esophagus N3 3rd esophagus O Oral S Gastric

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PCT/JP2021/029484 2020-08-12 2021-08-10 医療デバイス、医療システム、及び処置方法 WO2022034875A1 (ja)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009512505A (ja) * 2005-10-24 2009-03-26 カーディアック ペースメーカーズ インコーポレイテッド 埋め込み型充電式神経刺激装置
JP2013123484A (ja) * 2011-12-13 2013-06-24 Olympus Corp 神経刺激装置および神経刺激システム
WO2013121725A1 (ja) * 2012-02-14 2013-08-22 テルモ株式会社 治療デバイス及び治療セット
JP2018175044A (ja) * 2017-04-05 2018-11-15 国立大学法人 鹿児島大学 分泌促進装置
US20190201699A1 (en) * 2018-01-02 2019-07-04 Heraeus Deutschland GmbH & Co. KG Electrical contacting device for an implantable medical device, and method for production

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH026057U (enrdf_load_stackoverflow) * 1988-06-28 1990-01-16

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009512505A (ja) * 2005-10-24 2009-03-26 カーディアック ペースメーカーズ インコーポレイテッド 埋め込み型充電式神経刺激装置
JP2013123484A (ja) * 2011-12-13 2013-06-24 Olympus Corp 神経刺激装置および神経刺激システム
WO2013121725A1 (ja) * 2012-02-14 2013-08-22 テルモ株式会社 治療デバイス及び治療セット
JP2018175044A (ja) * 2017-04-05 2018-11-15 国立大学法人 鹿児島大学 分泌促進装置
US20190201699A1 (en) * 2018-01-02 2019-07-04 Heraeus Deutschland GmbH & Co. KG Electrical contacting device for an implantable medical device, and method for production

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