JP2013059411A - Measuring apparatus, measuring system, and member for medical treatment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a measuring apparatus and a measuring system capable of acquiring information related to the shape, length and diameter of a constricted part formed in the tubular organ of a living body without performing fluoroscopy, and a member for medical treatment suitably used in measurement.SOLUTION: The measuring apparatus 10 includes: an introduction part 20 which has a plurality of flow paths 21a-21f extending in an axial direction and observation parts 23a-23f each provided at a different position in the axial direction for each flow path and opened to the side of the flow path, and is to be introduced into the living body; a suction part 50 which draws fluid from the observation parts to the respective flow paths by sucking the inside of the respective flow paths; and a detection part 60 which detects the change of a physical quantity of the fluid flowing through the flow paths for each flow path.

Description

  The present invention relates to a measurement device, a measurement system, and a medical member that can be used suitably for measurement that can acquire information on the shape, length, and diameter of a stenosis formed in a tubular organ of a living body.

  There are many tubular organs such as thoracic cavity, abdominal cavity and nasal cavity in the living body, and digestive organs, luminal tracts and other tubular organs, and oxygen and various nutrients are delivered to each part of the living body through these tubular organs. . When the circulation of oxygen, nutrients, and the like is hindered by a narrowed portion generated in a body cavity or a lumen, each function of the living body is remarkably lowered, and various diseases are caused. Examples of this type of disease include sinusitis caused by the formation of a stenosis in the natural mouth leading to the nasal cavity, and urethral stricture caused by the formation of a stenosis in the urethra.

  For the treatment of these diseases, an endoscope for diagnosing the stenosis, and a treatment tool such as a balloon catheter or a stent for expanding the stenosis are used. By acquiring in advance information on the lumen shape of the tubular organ and the shape, length, and diameter of the stenosis at the time of treatment, a treatment policy can be easily established and effective treatment can be performed.

  For example, by grasping the whole image of the blood vessel and the position of the ultrasonic probe with a fluoroscopic image, and observing the ultrasonic tomographic image of the blood vessel at the position of the ultrasonic probe, the stenotic site and the degree of the blood vessel are qualitatively determined. It becomes possible to grasp.

JP-A-5-64638

  However, diagnostic devices using X-rays have a problem with the amount of exposure to patients and medical workers due to X-rays, and acquire information on stenosis that has occurred in the body lumen without performing X-ray fluoroscopy. There is a need for a way to do that. Furthermore, there is a problem that the ultrasonic diagnostic apparatus can be applied only to a site filled with a liquid such as a blood vessel and cannot be applied to a site having a cavity such as a nasal cavity or a digestive tract.

  The present invention has been made to solve the above-described problem, and can acquire information on the shape, length, and diameter of a stenosis formed in a tubular organ of a living body without performing fluoroscopy. An object of the present invention is to provide a measurement device, a measurement system, and a medical member that is suitably used for measurement.

  The above object of the present invention can be achieved by any of the following means.

  (1) A plurality of flow paths extending in the axial direction, and an introduction unit that is provided in the living body with an observation unit that is provided at a different position in the axial direction for each flow path and that opens to the side of the flow path. A suction section that draws fluid from the observation section into each of the flow paths by sucking the inside of the flow path, and a detection section that detects a change in the physical quantity of the fluid flowing through the flow path for each of the flow paths. A measuring device.

  (2) The measurement according to (1), wherein the detection unit includes at least one of a flow velocity sensor that detects a flow velocity change of the fluid flowing through the flow path of the introduction portion and a pressure sensor that detects a pressure change of the fluid. apparatus.

  (3) The measurement device according to (1) or (2), wherein the observation units provided in each of the flow paths are arranged at a certain interval from each other.

  (4) The measurement device according to any one of (1) to (3), wherein the observation unit provided in each of the flow paths is disposed at a different position around the axis of the introduction unit. .

  (5) The measuring device according to any one of (1) to (4), wherein the introduction unit includes a plurality of long members each including the flow path and the observation unit.

  (6) The measuring device according to (5), wherein the introduction portion has a stranded wire structure in which the plurality of long members are spirally wound around the axis of the introduction portion.

  (7) The introduction portion is configured by assembling the plurality of long members so that a gap extending in the axial direction is formed in an axial center of the introduction portion. Measuring device.

  (8) The measuring device according to any one of (1) to (4), wherein the introduction unit includes a long member including a lumen in which the plurality of flow paths are partitioned.

  (9) The measurement device according to any one of (1) to (8), wherein the observation unit is formed by a through hole that is formed on a side surface of the flow channel and penetrates the inside and outside of the flow channel.

(10) The flow path includes a front end opening that is arranged to face the side of the flow path from the front end of the flow path.
The said observation part is a measuring apparatus as described in any one of said (1)-(8) comprised by the said front-end | tip opening.

  (11) The measuring device according to any one of (1) to (10), wherein the introduction portion has a tapered tip shape whose outer shape tapers toward the tip.

(12) It further has a cover member that covers the introduction part,
The said cover member is a measuring apparatus as described in any one of said (1)-(11) which has a some communication hole each piled up on the said observation part.

  (13) A fluid supply unit that supplies a fluid into the living body via the flow channel and the observation unit, and a fluid-tight connection between the fluid supply unit and the flow channel that is provided on the proximal side of the observation unit. The measuring apparatus according to any one of (1) to (12), further including a connection unit.

  (14) A measurement system comprising: the measurement device according to any one of (1) to (13) above; and a control unit that performs operation control of the measurement device. A measurement system that draws fluid into the flow path by causing the suction section to perform a suction operation in a state where the observation section provided in the section is introduced into the living body.

(15) A medical member used as the introduction section according to any one of (1) to (14) above,
A medical member in which the detection unit and the suction unit are detachable on the proximal side of the observation unit.

  According to the measurement apparatus of the present invention, an introduction portion having a plurality of flow paths is introduced into a living body, and a fluid is drawn into the flow path via each observation section provided for each flow path. By detecting the change in the physical quantity of the fluid flowing through the inside, the lumen shape of the tubular organ of the living body can be grasped. Further, from this result, it is possible to acquire information on the shape, length, and diameter of the stenosis portion formed in the tubular organ of the living body without performing X-ray fluoroscopy.

1 is a schematic diagram illustrating an overall configuration of a measurement system according to an embodiment of the present invention. 2A and 2B are diagrams for explaining the introduction portion, FIG. 2A is an enlarged view of the introduction portion, and FIG. 2B is a cross-sectional view taken along line 2B-2B in FIG. 2A. FIG. FIG. 3 is a partial cross-sectional view for explaining the detection unit, and FIG. 3A is a diagram conceptually showing a state before a change in the physical quantity of the fluid flowing in the flow path occurs, and FIG. These are figures which show notionally the state after a change has arisen in the physical quantity of the fluid which flows through the inside of a flow path from the state shown to FIG. 3 (A). It is the elements on larger scale with which it uses for description of the connection part provided in the introduction part. It is a figure for explanation of a measuring method by a measuring device, and is a figure showing typically a paranasal sinus periphery of a living body. FIG. 6 is a diagram for explaining the operation of the measurement device, and FIG. 6A is a diagram illustrating a state before introducing the introduction portion into the tubular organ of the living body in which the narrowed portion is formed, together with the measurement result. FIG. 6B is a diagram showing a state in which the introduction part is introduced into the living tubular organ by moving the introduction part in the distal direction from the state of FIG. FIG. 7 is a diagram for explaining the operation of the measuring device, and FIG. 7A is a diagram illustrating a state in which the introduction unit is moved in the distal direction from the state illustrated in FIG. FIG. 7B is a diagram illustrating a state in which the introduction unit is further moved in the distal direction from the state illustrated in FIG. FIGS. 8A and 8B are partially enlarged views for explaining modified examples (1) and (2) of the introduction unit according to the embodiment, respectively. FIGS. 9A to 9C are partial enlarged views for explaining modified examples (3) to (5) of the introduction unit according to the embodiment. FIGS. 10A and 10B are partially enlarged views for explaining modified examples (6) and (7) of the introduction unit according to the embodiment, respectively. FIGS. 11A to 11C are partial enlarged views for explaining modified examples (8) to (10) of the introduction unit according to the embodiment. FIGS. 12A and 12B are a partially enlarged view and a cross-sectional view for explaining modified examples (11) and (12) of the introduction unit according to the embodiment, respectively.

  Hereinafter, the present invention will be described based on embodiments with reference to the drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. The dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

  FIG. 1 shows a measurement apparatus 10 according to an embodiment of the present invention and a measurement system 1 in which the measurement apparatus 10 is incorporated. The measuring device 10 is used for grasping the lumen shape of a tubular organ of a living body and the shape, diameter, and length of a stenosis portion formed in the tubular organ. The tubular organ to be applied is not particularly limited, and examples thereof include body cavities such as a thoracic cavity, abdominal cavity and nasal cavity, and a lumen such as a digestive organ and a ureter.

  With reference to FIG. 1 and FIG. 2, the measuring device 10 is provided with a plurality of flow paths 21 a to 21 f extending in the axial direction and one flow path 21 a to 21 f. The observation sections 23a to 23f opening to the side of 21f are provided, and the introduction section 20 introduced into the living body and the respective flow paths 21a to 21f from the observation sections 23a to 23f by sucking the inside of the respective flow paths 21a to 21f. A suction unit 50 that draws fluid into 21f, and a detection unit 60 (see also FIG. 3) that detects a change in the physical quantity of the fluid flowing through the flow channels 21a to 21f for each of the flow channels 21a to 21f.

  First, each configuration of the measuring device will be described.

  Referring to FIG. 2, introduction portion 20 has an outer shape that is entirely extended in the axial direction (the left-right direction in FIG. 2A). The end side that is introduced into the living body in the introduction unit 20 is referred to as the distal end side (left side in the figure), and the side that is located on the opposite side of the distal end side and that is operated by the user is the proximal end side (right side in the figure). ). In FIG. 2 (A), the site | part located in the front end side rather than the binding member 70 comprises the introducing | transducing part 20. FIG. The binding member 70 and its peripheral part constitute a hand operating part.

  Each dimension of the introducing | transducing part 20 is not specifically limited, It can be changed according to each organ of the biological body to which the measuring device 10 is applied. For example, when used for a body cavity such as the sinuses, the introduction part 20 is formed with an outer diameter of 2 mm and a length of 120 mm. When applied to a respiratory organ such as the bronchus, the introduction portion 20 is formed with an outer diameter of about 1 to 20 mm and a length of about 800 to 2000 mm, preferably an outer diameter of about 1.5 mm and a length of about 1000 mm. When applied to a thin tube such as a lacrimal duct, the introduction part 20 has an outer diameter of about 0.8 to 2 mm and a length of about 80 to 200 mm, preferably an outer diameter of about 1.0 to 1.2 mm and a length of about 100 mm. It is formed. When applied to the ureter, the introduction part 20 is formed with an outer diameter of about 4 to 7 mm and a length of about 400 to 1000 mm, preferably an outer diameter of about 5 mm and a length of about 500 mm. When applied to a digestive organ such as a bile duct, the introduction part 20 is formed with an outer diameter of about 5 to 10 mm, a length of about 1500 to 3000 mm, preferably an outer diameter of about 6 to 8 mm, and a length of about 2200 mm.

  The introduction part 20 includes a plurality of long members 30a to 30f constituting the introduction part 20 (see FIG. 1). Further, a cover member 40 that covers the entire introduction portion 20 is attached to the introduction portion 20.

  Each of the long members 30a to 30f includes flow paths 21a to 21f through which a fluid can flow and observation units 23a to 23f communicating with the inside and the outside of the flow paths 21a to 21f, respectively, and the longest ends of the long members 30a to 30f. Are respectively sealed. In the embodiment, the six long members 30a to 30f are assembled. For this reason, the introduction unit 20 includes six observation units 23a to 23f. The insides of the flow channels 21a to 21f of the respective long members 30a to 30f are communicated with the stenosis portion formed in the biological tubular organ or the tubular organ located outside the flow channel via the observation units 23a to 23f ( (See FIGS. 6 and 7).

  In the introduction part 20 constituted by a plurality of long members 30a to 30f, relative movement of the long members 30a to 30f is allowed by a slight gap formed between the long members 30a to 30f. . Since the flexibility of the introduction part 20 as a whole and the flexibility of bending are increased, the operability in a narrow biological organ and the operability in a curved biological organ are improved.

  The shapes and dimensions of the long members 30 a to 30 f are determined according to each organ of the living body to be applied in the same manner as the introduction unit 20. For example, when the introduction part 20 is formed with an outer diameter of 2 mm and a length of 120 mm, each of the long members 30a to 30f is formed with an outer diameter of 0.6 mm and a length of about 1000 mm. Further, the inner diameters of the long members 30a to 30f only need to be formed with dimensions that do not hinder the flow of the fluid drawn into the flow path. For example, the long members 30a to 30f have an inner diameter of about 0.4 mm.

  Each of the long members 30a to 30f is preferably formed of a material having a certain degree of flexibility in consideration of operability in the living body. Examples of such a material include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, soft polyvinyl chloride resin, Polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, thermoplastic resin such as fluororesin, silicone rubber, latex rubber and the like can be used.

  As shown in FIG. 2A, since the introduction part 20 is configured by assembling a plurality of long members 30a to 30f, the flexibility of the introduction part 20 and the degree of freedom of bending are increased, and the introduction part 20 Plastic deformation is prevented. Moreover, when the long members 30a to 30f are provided with a stranded wire structure in which the long members 30a to 30f are spirally wound around the axis of the introduction portion 20, the torque transmission performance of the entire introduction portion 20 is improved. Furthermore, the rigidity of the entire introducing portion 20 is improved while maintaining the elastic restoring force included in each of the long members 30a to 30f.

  The introduction part 20 is configured by assembling a plurality of long members 30 a to 30 f so that a gap 25 extending in the axial direction is formed in the axial center of the introduction part 20. The gap 25 formed in the shaft core allows a guide tool such as a guide wire 90 to guide the movement of the introduction part 20 to be inserted when the introduction part 20 is introduced or guided to each part in the living body. (See FIG. 5). Further, the gap 25 allows the long members 30a to 30f to move inward in the radial direction. When the introduction part 20 is moved to a narrow site in the living body, the entire introduction part 20 is deformed in a reduced diameter according to the inner surface shape of the living body organ. For this reason, smooth operation of the introduction part 20 in the living body is ensured.

  Each observation part 23a-23f is comprised by the through-hole formed in the side surface of the flow paths 21a-21f. The through hole is provided to communicate the inside and outside of the flow paths 21a to 21f.

  The fluid drawn into the flow paths 21a to 21f through the observation units 23a to 23f is a gas or a liquid existing in a tubular organ in the living body. Although the target fluid is not limited, for example, the gas is oxygen, nitrogen, carbon dioxide, or the like circulating in the living body. In addition, for example, the liquid is saliva, urine, various secretions, bile, pus that stays at the affected site, and the like.

  The shape and dimensions of the through hole are not particularly limited as long as the function of drawing the fluid into each flow path by communicating inside and outside the flow paths 21a to 21f is exhibited. In the illustrated form, the through hole has a diameter of about 0.25 mm and is formed in a circular shape when viewed from the front. The shape of the hole is not limited to a circle but may be an ellipse or a rectangle.

  The through holes may be provided in the long members 30a to 30f in advance in a state before the plurality of long members 30a to 30f are assembled, and are opened after the long members 30a to 30f are assembled. Also good. Moreover, although the method of opening is not specifically limited, For example, laser processing etc. are employable.

  The observation units 23a to 23f provided in the respective flow paths 21a to 21f are arranged with a certain distance d from each other. As will be described later, the shape of the tubular organ of the living body and the shape of the constriction are determined based on the change in the physical quantity of the fluid drawn into the flow paths 21a to 21f from the respective observation units 23a to 23f. For this reason, the dimension of the space | interval d is defined according to the biological organ to which it applies. For example, when used for a body cavity such as the sinuses, an interval of about d = 2 to 4 mm is provided.

  Each observation part 23a-23f provided in each flow path 21a-21f is each arrange | positioned in the different position around the axis | shaft of the introduction part 20. As shown in FIG.

  As shown in FIG. 2A, for example, when the introduction unit 20 includes six observation units 23a to 23f, the observation units 23a to 23f are equally spaced around the entire circumference (360 ° direction) of the introduction unit 20. Arranged to be empty. The observation units 23a to 23f are provided one for each of the flow paths 21a to 21f. However, when the observation units 23a to 23f are arranged linearly along the axial direction, the introduction unit 20 is formed on a straight line extension. The rigidity of the steel will be partially reduced. In such a case, if an excessive pressing force is applied from the distal end side of the introduction part 20, the introduction part 20 may be kinked in a direction intersecting the axial direction or the introduction part 20 may be broken. . Therefore, by arranging the observation units 23a to 23f at equal intervals around the entire circumference of the introduction unit 20, a reduction in rigidity of the introduction unit 20 that may be caused by providing the observation units 23a to 23f is suppressed.

  The cover member 40 can prevent the plurality of long members 30a to 30f constituting the introduction portion 20 from being dispersed after the long members 30a to 30f are assembled without bonding or welding. To do. Although it does not prevent that the elongate members 30a-30f are joined by adhesion | attachment or welding and comprise the introducing | transducing part 20, the rigidity of the introducing | transducing part 20 is improved by covering the introducing | transducing part 20 with the cover member 40, and The torque transmission performance can be improved. Needless to say, the surface characteristics of the cover member can be appropriately selected depending on the constituent material of the cover member 40 described later.

  The cover member 40 includes a plurality of communication holes 43 that are respectively arranged so as to overlap the observation portions 23a to 23f of the long members 30a to 30f. This communication hole 43 is provided in order to maintain the communication inside and outside the flow paths 21a to 21f of the long members 30a to 30f even when the cover member 40 is attached to the long members 30a to 30f. . Therefore, the communication hole 43 is formed in a size and shape that allows at least a part of each of the observation portions 23a to 23f to be exposed from the cover member 40 when the cover member 40 is attached. In the illustrated form, the communication hole 43 has a diameter of about 0.3 mm and is formed in a circular shape when viewed from the front.

  Examples of the constituent material of the cover member 40 include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, and silicone resin. Note that a metal wire, coil, blade wire, or the like may be embedded in the cover member 40 as a reinforcing member.

  As shown in FIG. 2B, a bundling member 70 that bundles the long members 30a to 30f is provided at the proximal end of the introduction portion 20. The bundling member 70 is disposed in communication with the insertion hole 71 through which the portion exposed from the cover member 40 is inserted in each of the long members 30a to 30f and the gap 25 formed in the axial center of the introduction portion 20. A hole 72 is provided.

  The plurality of long members 30 a to 30 f are separated from each other by being inserted into the insertion hole 71, and their base ends are connected to the suction part 50. By using the bundling member 70, variations and displacements of the long members 30a to 30f on the base end side are prevented, so that operability at hand is improved. The center hole 72 is provided so that a guide tool such as the guide wire 90 can be inserted. Although not shown in the drawings, a guide tool such as a guide wire 90 may be introduced by inserting a hole extending from the center hole 72 to the side wall of the binding member 70, or may be inserted from the proximal end side of the binding member 70 of the center hole 72. May be introduced.

  Referring to FIG. 1, suction section 50 is used for sucking the inside of flow paths 21 a to 21 f of each of the long members 30 a to 30 f and drawing the fluid into the flow paths 21 a to 21 f. For the suction part 50, for example, a known fluid pump whose suction force is adjustable can be used. Note that the function of the suction unit 50 is not limited to suction but may be a function of discharge or the like in preparation for a case where clogging or the like is caused at the tip portion and suction becomes difficult.

  The suction part 50 includes a port 51 in which the base ends of the long members 30a to 30f can be connected and separated. For connection between the long members 30a to 30f and the port 51, for example, a mechanical connection structure such as a fitting type or a screwing type is adopted.

  With reference to FIG. 3, a flow rate sensor 61 capable of detecting a change in the flow rate of the fluid flowing in the flow paths 21 a to 21 f of the long members 30 a to 30 f is used for the detection unit 60.

  The flow rate sensor 61 includes a detection end 62 that detects a change in flow rate, and a signal line 63 for transmitting an electric signal output according to the detection result to the control unit 7. One flow rate sensor 61 is arranged in each of the flow paths 21a to 21f in order to be able to detect a change in flow speed in each of the flow paths 21a to 21f of the long members 30a to 30f.

  The flow rate sensor detects the flow rate of the fluid flowing in each of the flow paths 21 a to 21 f, and the detection result is transmitted to the control unit 7 and displayed on the display unit 8. For example, from the state where the flow velocity V1 shown in FIG. 3A is detected, the state where the flow velocity V2 shown in FIG.

  As the flow rate sensor, for example, a known flow rate sensor such as a differential pressure measurement type, an ultrasonic measurement type, a thermal measurement type, or a non-contact type laser measurement type is used. In addition, it is not limited to the form which detects the change of the physical quantity of a fluid only with a flow velocity sensor. For example, a pressure sensor that captures and outputs a change in fluid pressure as a change in physical quantity can be used together with a flow rate sensor. By using the pressure sensor together with the flow rate sensor, it becomes possible to detect a smaller change in the physical quantity of the fluid. It is also possible to use a pressure sensor instead of the flow rate sensor. For example, a known pressure sensor such as a strain gauge type or a diaphragm type can be used as the pressure sensor.

  As for each elongate member 30a-30f, the detection part 60 is attached to the base end side rather than observation part 23a-23f so that attachment or detachment is possible. For the attachment, for example, a form embedded in a hole formed in a side wall of the long members 30a to 30f or a form to be fitted can be adopted. Furthermore, it is also possible to improve the operability in the axial direction of rotation by taking out the output of the detection unit 60 attached to the long members 30a to 30f with a known configuration that does not affect the rotation of the introduction unit 20. It is.

  Referring to FIG. 4, the measuring device 10 includes a fluid supply unit 65 that supplies fluid into the living body via the flow paths 21 a to 21 f and the observation units 23 a to 23 f of the long members 30 a to 30 f.

  The fluid supply unit 65 includes a main body 66 that holds and pumps fluid, and a supply line 67 that connects the main body 66 and the long members 30a to 30f. For the main body 66, for example, a known pump used for pumping fluid such as a syringe pump can be used.

  Each elongate member 30a-30f which comprises the introducing | transducing part 20 is provided with the connection part 27 which is provided in the base end side rather than observation part 23a-23f, and the supply line 67 is each connected liquid-tightly. The connection part 27 can be comprised by the non-return valve etc. which can connect the supply line 67 and each elongate member 30a-30f, for example.

  For example, when body fluid having relatively high viscosity is clogged in the flow paths 21a to 21f, the clogging in the flow paths 21a to 21f is eliminated by pumping various fluids from the fluid supply unit 65. In addition, it is possible to supply a cleaning liquid from the fluid supply unit 65 to clean each part of the living body, or to inject a chemical solution to each part of the living body using the fluid supply unit 65. In the illustrated form, the main body 66 and each of the flow paths 21a to 21f are connected to one main body 66 via a plurality of supply lines 67, so that the supply of fluid into each of the flow paths 21a to 21f is performed. Can be performed simultaneously by one pumping operation by the main body 66, and it becomes possible to uniformly supply the cleaning liquid and the chemical liquid to the target site.

  In the long members 30a to 30f constituting the introduction unit 20, the detection unit 60 and the suction unit 50 are detachably connected to the base end side of the observation units 23a to 23f. Therefore, after the measurement, it is possible to remove the detection unit 60 and the suction unit 50 from the used introduction unit 20 and use the detection unit 60 and the suction unit 50 for other introduction units. Since the detection unit 60 and the suction unit 50 can be used repeatedly, the cost can be reduced. In addition, by preparing a plurality of types of introduction parts 20 having different outer shapes, outer dimensions, etc. as medical members at the time of measurement, the introduction part 20 having an optimum form selected according to the patient and each living organ can be obtained. The used measurement can be performed.

  The measurement system 1 includes a control unit 7 that controls the operation of each unit of the measurement apparatus 10 and a display unit 8 that displays the detection result of the detection unit 60.

  The control unit 7 comprehensively controls the operation of the entire measurement apparatus 10. The control unit 7 transmits an operation signal via the electrically connected signal lines 9, 63, and the like. For example, the detection unit 60 performs detection of the flow velocity change, the suction unit 50 performs the suction operation, and the suction force. The control of each operation related to measurement, such as adjustment of display and display of detection results by the display unit 8, is performed.

  Although the configuration form of the measurement system 1 is not particularly limited, in the embodiment, a PC (personal computer) including a CPU as the control unit 7 and a display as the display unit 8 is used in the measurement system 1. For example, it is possible to store a measurement processing program in a ROM of a PC in advance and execute this program to perform a series of operations such as suction, detection, and display on a display unit. Further, for example, it is possible to adopt a measurement system that performs transmission / reception of detection results, transmission / reception of each operation signal, and the like by a wireless communication method without using the signal lines 9 and 63.

  Next, with reference to FIGS. 5-7, the measuring method by the measuring device 10 is demonstrated. In the following description, a usage example in which the measurement device 10 is applied to acquisition of information on the shape, length, and diameter of the stenosis S that causes sinusitis will be described. 6 and 7 are diagrams schematically showing a process of introducing the introduction part 20 into the sinus A, and the fluid drawn into the flow paths 21a to 21f from the observation parts 23a to 23f. It is a figure which shows the change of the flow velocity V of. The flow velocity V indicated by P1 to P6 is the flow velocity of the fluid drawn from the observation units 23a to 23f, respectively.

  Referring to FIG. 5, the paranasal sinus A is an intraosseous cavity adjacent to the nasal cavity N and communicates with the nasal cavity N through a small hole called a natural mouth E. The secretions and bacteria in the sinus A are excreted in the nasal cavity N through the natural mouth E, but the mucous membrane in the nasal cavity N is swollen by rhinitis or allergic rhinitis due to a cold, nasal septal curvature, hypertrophic rhinitis, etc. When the inside of the nasal cavity N becomes narrow due to the above, the natural mouth E is narrowed, and chronic inflammation occurs in the sinus A. This is sinusitis.

  For the treatment of sinusitis, a technique for expanding the stenosis S formed in the natural mouth E and a technique for removing the stenosis S are performed. For example, in order to spread the stenosis S, an expansion method using a balloon using a balloon catheter or an expansion method using a stent or the like is employed. These medical instruments have predetermined product specifications such as an effective expansion diameter and an effective expansion length (the length of a portion pressed against the constriction S during expansion). In order to perform effective treatment, it is desirable to select a medical device having an appropriate effective expansion diameter and effective expansion length corresponding to the shape, length, and diameter of the constriction S formed in the natural mouth E. . Prior to the selection of the medical instrument, the practitioner needs information on the shape, length, and diameter of the stenosis S that is a guide for selection. The measuring device 10 is used for acquiring information related to the shape of the stenosis, which is a guide for selecting a medical instrument and determining a treatment policy, for example.

  Referring to FIG. 5, prior to measurement, a guide wire 90 is introduced from the outer nose into the nasal cavity N located in front of the natural mouth E. Next, the introduction unit 20 is introduced into the living body over the guide wire 90. At this time, the guide wire 90 is inserted into the gap 25 that functions as a working lumen formed in the axial center of the introduction portion 20.

  As shown in FIG. 6A, the control unit 7 operates the suction unit 50 to draw the fluid into the respective flow paths 21a to 21f. Since each observation part 23a-23f is located in the nasal cavity N, the flow velocity of the fluid which flows through each flow path 21a-21f is substantially constant. The suction operation by the suction unit 50 can be performed before the introduction unit 20 is introduced into the living body, or can be performed after the introduction unit 20 is introduced into the living body.

  As illustrated in FIG. 6B, the introduction unit 20 is advanced toward the natural mouth E while performing the suction operation by the suction unit 50. When the observation part 23a located at the foremost end is introduced into the natural mouth E, the flow velocity of the fluid in the flow path 21a leading to the observation part 23a decreases. By detecting the decrease in the flow velocity, it can be confirmed that the distal end side of the introduction portion 20 has moved from the nasal cavity N into the natural mouth E where the constriction S is formed. The physical quantity of various fluids circulating in the living body is changed by performing the suctioning operation by the sucking unit 50 in a state where at least one of the observation units 23a to 23f provided in the introducing unit 20 is introduced into the tubular organ of the living body. Can be detected and observed.

  As shown in FIG. 7A, the introduction unit 20 is further advanced. When a decrease in the flow velocity of the fluid flowing through the flow path 21c leading to the third observation unit 23c located from the front end side is detected, at least the observation unit 23c located third from the front end side is in the natural mouth E. You can confirm that you have reached it. Moreover, it can confirm that the constriction part S is extended at least by the length more than the distance to observation part 23a-23c. Furthermore, since a decrease in the flow velocity of the fluid flowing through the flow paths 21a to 21c communicating with the observation units 23a to 23c arranged at different positions around the axis of the introduction unit 20 is detected, the respective observation units 23a to 23c face each other. It can be confirmed that the stenosis S exists at the position. And since the reduction | decrease in the flow velocity of the fluid which flows through the flow paths 21a-21c leading to each observation part 23a-23c was detected, the diameter of the natural port E in the site | part in which the constriction part S was formed is the outer diameter of the introduction part 20. It can also be confirmed that it is the same level.

  As shown in FIG. 7B, when the observation part 23a located at the most distal end is introduced into the paranasal sinus A, the flow velocity of the fluid in the flow path 21a leading to the observation part 23a increases. By detecting an increase in the flow velocity, it can be confirmed that the distal end side of the introduction portion 20 has moved from the natural mouth E into the sinus A. In addition, the approximate position of the entrance and exit of the natural mouth E, the length of the natural mouth E, and the like can be determined from the amount of movement of the introduction unit 20 in the living body and the movement speed of the introduction unit 20.

  When the introduction unit 20 is further advanced, and an increase in the flow velocity of the fluid flowing in the flow paths 21b and 21c communicating with the observation units 23b and 23c is detected, the sinus A extends to a predetermined site on the distal end side of the introduction unit 20. We can confirm that we reached in. On the other hand, the flow velocity of the fluid flowing in the flow paths 21d to 21f communicating with the observation sections 23d to 23f located on the proximal end side of the introduction section 20 is slower than the flow velocity of the fluid flowing through the flow path 21a leading to the observation section 23a. Therefore, it can confirm that the site | part in which the observation parts 23d-23f were provided in the introduction part 20 is the state located in the natural mouth E. FIG. At this time, it can be confirmed that the constriction S is present at the positions where the observation units 23d to 23f face.

  After confirming the entrance and exit of the natural mouth E, the introduction unit 20 is led out of the living body. At the time of measurement, in order to obtain more detailed information regarding the shape, length, and diameter of the stenosis portion S, the introduction portion 20 may be moved while being rotated, or an operation of repeating forward and backward movements may be performed. Furthermore, when the diameter of the stenosis S is small and the introduction part 20 cannot be inserted into the stenosis, it is preferable to remove the introduction part 20 once and select the introduction part 20 having a smaller outer diameter. Thus, by gradually reducing the outer diameter of the introduction portion, it is possible to obtain highly accurate information regarding the diameter of the constriction S.

  The measurement is thus completed. From the measurement result, it can be confirmed that the narrowed portion S is continuously formed along the length direction in the natural mouth E. Further, the approximate length and inner diameter of the constriction S can be grasped.

  Thereafter, based on the measurement result, a balloon catheter including an expansion balloon having an effective expansion diameter and an effective expansion length suitable for expansion of the stenosis S is selected, and a procedure for expanding the stenosis S with the balloon is performed.

  As described above, according to the present embodiment, the introduction unit 20 including the plurality of flow paths 21a to 21f is introduced into the living body, and the observation units 23a to 23f provided for the respective flow paths 21a to 21f are used. By drawing the fluid into the flow paths 21a to 21f and detecting the change in the physical quantity of the fluid flowing through the flow paths 21a to 21f, it is possible to grasp the lumen shape of the biological tubular organ. Further, from this result, it is possible to acquire information on the shape, length, and diameter of the stenosis portion formed in the tubular organ of the living body without performing X-ray fluoroscopy.

  Moreover, since at least one of the flow rate sensor which detects the flow velocity change of the fluid which flows through the flow paths 21a-21f of the introducing | transducing part 20 and the pressure sensor which detects the pressure change of the fluid is utilized as the detection part 60, the flow paths 21a-. The change in the physical quantity of the fluid flowing through 21f can be detected with high accuracy.

  Moreover, since the observation parts 23a-23f provided in each flow path 21a-21f of the introducing | transducing part 20 are arrange | positioned at predetermined intervals d, the relative position of each observation part 23a-23f in the living body. From the relationship, it is possible to easily obtain information on the length of the tubular organ of the living body and the shape and diameter of the stenosis.

  In addition, since the observation parts 23a to 23f provided in the flow paths 21a to 21f of the introduction part 20 are respectively arranged at different positions around the axis of the introduction part 20, the inside of the tubular organ into which the introduction part 20 is inserted. Information on the cavity shape and the shape, length, and diameter of the stenosis can be suitably obtained.

  Moreover, since the introducing | transducing part 20 is comprised by the some elongate member 30a-30f provided with the flow paths 21a-21f and the observation parts 23a-23f, respectively, the softness | flexibility of the whole introducing | transducing part 20 and the freedom degree of bending are raised. It is possible to prevent plastic deformation from occurring.

  Moreover, since the introducing | transducing part 20 has the strand wire structure where the some elongate member 30a-30f was helically wound around the axis | shaft of the introducing | transducing part 20, the torque transmission property of the introducing | transducing part 20 whole is improved. Furthermore, the rigidity of the introducing portion 20 is improved while maintaining the elastic restoring force included in each of the long members 30a to 30f.

  The introduction unit 20 is configured by assembling a plurality of long members 30 a to 30 f so that a gap 25 extending in the axial direction is formed in the axial center of the introduction unit 20. The gap 25 can be used as a working lumen through which the guide wire 90 or the like is inserted. In addition, since the long members 30a to 30f are allowed to move inward in the radial direction by the gap 25, the introduction unit 20 can be smoothly operated in the living body.

  Moreover, each observation part 23a-23f is comprised by the through-hole which is formed in the side surface of each flow path 21a-21f and penetrates the inside and outside of the flow paths 21a-21f. A change in the physical quantity of the fluid can be detected by drawing the fluid into the flow paths 21a to 21f from the through holes 23a to 23f.

  In addition, by providing the cover member 40 that covers the introduction portion 20, it is possible to prevent variation after the long members 30a to 30f are assembled. Furthermore, the rigidity of the introduction part 20 and the torque transmission are improved. In addition, since the cover member 40 includes a plurality of communication holes 43 that are respectively disposed so as to overlap the observation portions 23a to 23f of the long members 30a to 30f, even when the cover member 40 is mounted, the long member 30a. Communication between the inside and outside of the flow paths 21a to 21f of ~ 30f can be maintained.

  In addition, the measuring device 10 fluid-tightly connects the fluid supply unit 65 that supplies fluid into the living body via the flow paths 21a to 21f and the observation units 23a to 23f, and the fluid supply unit 65 and the flow paths 21a to 21f. Since the connecting portion 27 is provided, various fluids can be pumped from the fluid supply portion 65 to eliminate clogging in the flow paths 21a to 21f or to uniformly inject the cleaning liquid or the chemical solution into each part of the living body. .

  It is possible to perform measurement by the measurement system 1 configured by the measurement device 10 and the control unit 7. Measurement can be easily performed through measurement automation. Furthermore, since it becomes possible to evaluate a measurement result quantitatively, a more reliable measurement result can be obtained.

  In addition, since the long members 30a to 30f constituting the introduction unit 20 are detachably connected to the detection unit 60 and the suction unit 50 on the proximal end side with respect to the observation units 23a to 23f, only the introduction unit 20 is provided alone. It can be handled as a medical member, and the cost can be reduced.

  The present embodiment is not limited to the above-described embodiment, and can be changed as appropriate.

  Although the embodiment has been described in which the measurement is performed by detecting at least one of the fluid flow velocity change and the pressure change, the physical quantity change captured by the detection unit 60 is not limited thereto. For example, it is possible to adopt a configuration in which a detection unit capable of capturing changes in physical quantities such as fluid viscosity, temperature, and pigment is used, and information on the constriction S is acquired based on changes in these physical quantities. .

  Moreover, the introduction part 20 is not limited to the form provided with the six observation parts 23a-23f and the six flow paths 21a-21f demonstrated in embodiment. In order to be used in the measurement apparatus 10, the introduction unit 20 may include at least two observation units provided at different positions in the axial direction and at least two flow paths respectively connected to the observation units. Similarly, the arrangement position of the observation unit around the axis, the number of long members constituting the introduction unit, and the connection form thereof are not limited to those described in the embodiment.

  In the description of the embodiment, the present invention has been described through the measurement system 1 in which the measurement device 10 is incorporated. However, the object of the present invention can be achieved only by the measurement device 10.

<Introduction example modification>
Next, modified examples (1) to (12) of the introduction unit will be described with reference to FIGS.

  In the modified example (1) shown in FIG. 8A, the introduction portion 20 is not formed in a stranded wire structure in which a plurality of long members 30a to 30f are wound in a spiral shape, and the shafts of the long members 30a to 30f are They are different from the above-described embodiment in that they are arranged in parallel. According to such an introduction part 20, although the improvement in torque transmission as when the stranded wire structure is adopted cannot be achieved, the work of winding the long members 30a to 30f in a spiral shape can be omitted. The introduction part 20 can be manufactured in a simplified manner. In addition, since the plurality of long members 30a to 30f are assembled and configured, the effect of increasing the flexibility and flexibility of the introduction part 20 and the effect of preventing plastic deformation of the introduction part 20 are exhibited. .

  In the modified example (2) shown in FIG. 8B, the observation units 23a to 23f are not arranged along the entire circumference around the axis of the introduction unit 20, but are arranged in a line on a straight line along the axial direction. However, it differs from the above-described embodiment. In this case, compared with the arrangement along the entire circumference around the axis, there is a concern about a decrease in rigidity. However, since the observation units 23a to 23f are arranged on a straight line, the introduction unit 20 is inserted after being inserted into the constriction. By rotating in the axial direction, the shape change in the circumferential direction of the narrowed portion can be measured more clearly. In addition, even if it is the introduction part 20 of such a form, since the effect which raises the softness | flexibility of the introduction part 20 and the freedom degree of a bending is exhibited, it can be used suitably for the introduction to the constriction part S etc. .

  In modification examples (3) to (5) shown in FIGS. 9A to 9C, the cover member 40 that covers the introduction portion 20 is not provided in order to reduce the number of members. By omitting the mounting of the cover member 40, the manufacturing cost of the introduction unit 20 can be reduced. Each long member 30a-30f which comprises the introducing | transducing part 20 can be joined by heat sealing | fusion or an adhesive agent, for example. In addition, from the viewpoint of simplifying the manufacturing operation, the introduction portion 20 is not formed with a gap 25 that functions as a working lumen.

  Although detailed description is omitted, in the modified example (3) shown in FIG. 9A, a stranded wire structure in which a plurality of long members 30a to 30f are spirally wound is not adopted, and each of the long members 30a to 30a is used. It has a configuration in which the axial direction of 30f is arranged in parallel. The modification (4) shown in FIG. 9B employs a stranded wire structure in which a plurality of long members 30 a to 30 f are spirally wound, and the observation units 23 a to 23 f are all around the axis of the introduction unit 20. It is provided with the form arranged along. In the modified example (5) shown in FIG. 9C, a stranded wire structure in which a plurality of long members 30a to 30f are spirally wound is adopted, and the observation units 23a to 23f are arranged in a line on a straight line along the axial direction. It has an arranged form.

  In modified examples (6) and (7) shown in FIGS. 10A and 10B, the introduction part 20 has a tapered tip shape whose outer shape tapers toward the tip. Since the outer shape of the introduction portion 20 becomes smaller toward the tip, the insertion property into the narrowed portion is improved. Further, the followability of each organ in the living body is improved by increasing the flexibility on the distal end side. In addition, as shown in FIG. 10A, the long members 30a to 30f are not spirally wound. As shown in FIG. 10 (B), in any case where the long members 30a to 30f are spirally wound, it is possible to provide a tapered tip shape. Moreover, in the form to show in figure, although mounting | wearing of the cover member 40 and formation of the clearance gap 25 which functions as a working lumen are abbreviate | omitted, it can also be set as the form which added these.

  In this modified example, since the leading end shape of the introducing portion 20 has a taper shape that tapers toward the leading end, the introducing portion 20 is inserted into the narrowed portion S and advanced, and the flow velocity when the leading portion 20 stops moving further is obtained. If the observation part leading to the decreasing flow path is specified, the outer diameter of the part where the observation part is arranged is the diameter of the opening of the constriction S, and the diameter of the opening is measured. be able to. Furthermore, when using an introduction part smaller than the diameter of the stenosis part, it is possible to specify the length of the stenosis part by tilting the tip or performing an operation of repeating forward / reverse.

  In modified examples (8) to (10) shown in FIGS. 11 (A) to (C), the introduction part 120 is provided at the tip of the flow paths 121a to 121f and is arranged to face the flow paths 121a to 121f. Tip openings 123a to 123f are provided. The observation part communicating between the inside and outside of the flow paths 121a to 121f is different from the above-described embodiment in which the observation part is configured by a through hole formed in the flow path in that the observation parts are configured by the tip openings 123a to 123f.

  The distal ends of the long members 130a to 130f constituting the introducing portion 120 are shaped so that the distal end openings 123a to 123f face the sides of the flow paths 121a to 121f. For example, as in Modification Example (8) shown in FIG. 11A, it is possible to adopt a form in which the tip openings 123a to 123f of the flow paths 121a to 121f are arranged to face in different directions. . Also, as in Modification Example (9) shown in FIG. 11B, a configuration in which the tip openings 123a to 123f are arranged in two rows along two axes shifted in the direction orthogonal to the paper surface is adopted. Is possible. Moreover, it is possible to employ | adopt the form by which the front-end | tip opening 123a-123f is arrange | positioned in 1 row so that one axial direction may be followed like the modification (10) shown to FIG. 11 (C).

  Although not shown in the figure, the cover member 140 that covers the introduction part 120 is provided with a communication hole 143 that is arranged in accordance with the tip openings 123a to 123f. In addition, as the material used for each of the long members 130a to 130f, the same material as that of the long member having no tip opening described in the above-described embodiment can be used.

  Even in the case of using the introduction part 120 shown in the modified examples (8) to (10), it is possible to draw fluid into the flow paths 121a to 121f from the respective tip openings 123a to 123f, and observations formed by through holes As in the case of using the introduction part including the part, it is possible to suitably acquire information on the shape, length, and diameter of the stenosis part formed in the tubular organ.

  In modified examples (11) and (12) shown in FIGS. 12 (A) and 12 (B), the introduction part 220 is provided by a long member 230 having a lumen 235 in which a plurality of flow paths 221a to 221f are defined. Composed. The introduction part 220 is different from the above-described embodiment in which the introduction part is constituted by a plurality of long members in that the introduction part 220 is constituted by a single long member 230. In each drawing, a sectional view of the introducing portion 220 is shown together with an enlarged view of the leading end portion of the introducing portion 220.

  The long member 230 constituting the introduction part 220 includes a plurality of flow paths 221a to 221f that are not opened at the tip and are provided with through holes 223a to 223f as observation parts one by one on the side surface. According to the introduction part 220 having such a configuration, it is not necessary to perform an operation of connecting a plurality of long members, and thus the manufacturing operation can be simplified. Moreover, since it is not necessary to use a cover member, the number of parts of the material can be reduced. In addition, as shown to FIG. 12 (A), it is possible to comprise in the form in which the working lumen | penetration which a guide wire is penetrated to the introducing | transducing part 220 is not formed, and as shown to FIG. 12 (B), A configuration in which a working lumen 225 is formed in the introduction part 220 is also possible.

  As a material constituting the long member 230, for example, a material similar to the material constituting the plurality of long members 30a to 30f described in the above-described embodiment can be used.

  Even when the introduction unit 220 shown in the modification examples (11) and (12) is used, it is possible to draw a fluid from the observation units 223a to 223f into the flow paths 221a to 221f and detect a change in the physical quantity of the fluid. is there.

  In addition, also in each introduction part 20,120,220 which concerns on modification (1)-(12), the structure to which the detection part 60 and the suction part 50 are connected so that attachment or detachment is possible is employable. Therefore, after the measurement, it is possible to remove the detection unit 60 and the suction unit 50 from the introduction unit and use the detection unit 60 and the suction unit 50 for other introduction units.

1 measuring system,
10 Measuring device,
20 Introduction part (medical member),
21a-21f flow path,
23a-23f Observation part (through hole),
25 gap,
27 connections,
30a-30f long member,
40 cover member,
43 communication hole,
50 suction part,
60 detector,
65 fluid supply section,
70 binding members,
90 guide wire,
120 Introduction,
121a-121f flow path,
123a-123f tip opening (observation part),
130a-130f long member,
220 Introduction,
221a to 221f flow paths,
223a to 223f observation section,
225 Working lumen,
230 long member,
235 lumen,
N nasal cavity,
E Natural mouth,
A sinuses,
S Stenosis.

Claims (15)

A plurality of flow paths extending in the axial direction, and an observation section that is provided one by one at different positions in the axial direction for each flow path and that opens to the side of the flow path, and is introduced into the living body,
A suction section that draws fluid from the observation section into each of the flow paths by sucking the inside of the flow paths;
And a detection unit that detects a change in the physical quantity of the fluid flowing through the flow path for each flow path.   The measurement device according to claim 1, wherein the detection unit includes at least one of a flow rate sensor that detects a flow rate change of the fluid flowing through the flow path of the introduction unit and a pressure sensor that detects a pressure change of the fluid.   The measuring device according to claim 1, wherein the observation units provided in the respective flow paths are arranged at a predetermined interval from each other.   The measurement device according to claim 1, wherein the observation units provided in the respective flow paths are respectively arranged at different positions around the axis of the introduction unit.   The measuring device according to claim 1, wherein the introduction unit includes a plurality of long members each having the flow path and the observation unit.   The measuring device according to claim 5, wherein the introduction unit has a stranded wire structure in which the plurality of long members are spirally wound around an axis of the introduction unit.   The measuring device according to claim 5, wherein the introduction portion is configured by assembling the plurality of long members so that a gap extending in an axial direction is formed in an axial center of the introduction portion.   The measuring device according to any one of claims 1 to 4, wherein the introduction unit includes a long member including a lumen in which the plurality of flow paths are partitioned.   The measuring device according to claim 1, wherein the observation unit is formed by a through hole that is formed on a side surface of the flow channel and penetrates the inside and outside of the flow channel. The flow path is provided with a front end opening arranged facing the side of the flow path from the front end of the flow path,
The measurement device according to claim 1, wherein the observation unit is configured by the tip opening.   The measuring device according to claim 1, wherein the introduction portion has a tapered tip shape whose outer shape tapers toward the tip. A cover member covering the introduction part;
The measuring device according to claim 1, wherein the cover member has a plurality of communication holes that are respectively arranged to overlap the observation unit.   A fluid supply unit that supplies fluid into the living body via the flow channel and the observation unit; and a connection unit that is provided on a proximal end side with respect to the observation unit and that fluidly connects the fluid supply unit and the flow channel. Furthermore, the measuring device of any one of Claims 1-12 which has. The measuring device according to any one of claims 1 to 13,
A control system that performs operation control of the measurement device,
The control unit is configured to draw a fluid into the flow path by causing the suction unit to perform a suction operation in a state where the observation unit provided in the introduction unit is introduced into a living body. It is a medical member used as an introducing | transducing part of any one of Claims 1-14,
A medical member in which the detection unit and the suction unit are detachable on the proximal side of the observation unit.

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