Catheter and catheter system

Abstract

To provide a catheter and a catheter system that can obtain accurate intracardiac potential data even if using wireless communication.SOLUTION: A catheter 1 has: a shaft 2 having a longitudinal axis direction, and having lumen; a first electrode 11 and a second electrode 12 arranged in a distal part of the shaft 2, and for measuring intracardiac potential; a first lead wire 21 connected to the first electrode 11, and extending in the lumen of the shaft 2; a second lead wire 22 connected to the second electrode 12, and extending in the lumen of the shaft 2; a handle 30 arranged in a proximal part of the shaft 2, and held by a user with a hand; a control part 31 connected to the first lead wire 21 and the second lead wire 22, and for calculating a potential difference in the intracardiac potential of the first electrode 11 and the second electrode 12; and a wireless communication device 32 connected to the control part 31, and for wirelessly transmitting data processed by the control part 31 to an external device 40.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention relates to a catheter that is inserted into internal organs, mainly into the heart cavity, for performing potential measurement, defibrillation, transfer of images obtained by an endoscope, and the like.

Background Art

[0002] In the treatment of arrhythmias such as atrial fibrillation, a catheter having electrodes may be used as a treatment tool. For example, during treatment, a high-frequency current is passed from the electrodes of the catheter to the myocardium that causes the arrhythmia, and ablation surgery is performed to electrically isolate the source of the arrhythmia by cauterizing it, or defibrillation treatment is performed to apply an electrical signal from the electrodes of the catheter to the heart when atrial fibrillation occurs.

[0003] A handle is connected to the proximal side of such a catheter via a cable, and an external device such as an electrocardiograph or a defibrillator is connected to the proximal side of the handle via another cable. By the user operating the handle, a high-frequency current can be passed through the electrodes, a voltage can be applied, or the intracardiac potential can be measured using the electrodes. Therefore, when the user grips the handle, it is necessary to perform the operation while being concerned about the length and handling of the cable.

[0004] Patent Document 1 describes an intravascular blood pump system including a blood pump having functions of electrocardiogram (EKG) monitoring, defibrillation, and pacing. This system includes an intravascular blood pump including a catheter having a proximal end and a distal end, a pump housing connected to the distal end of the catheter, etc.; and electrodes connected to the intravascular blood pump and configured to sense an electrocardiogram (EKG) signal of a patient's heart. Patent Document 1 also describes that this system has a controller communicably connected to the intravascular blood pump and the electrodes, and that the electrodes 212 can be connected to a wireless transmitter and can be designed to function on the blood pump system 200 without a wire 219 directly connecting the electrodes 212 to the controller 238.

[0005] Patent Document 2 describes a system and method for determining electrode-tissue contact for tissue resection. The electrode contact detection system includes an electrode housed in a distal portion of a catheter shaft, and at least one electromechanical sensor that is operatively coupled to the electrode and is configured to generate an electrical signal in response to a mechanical load on the sensor caused by contact between the electrode and the tissue, and an output device electrically connected to the at least one sensor, the output device being configured to receive the electrical signal and present a contact indicator between the electrode and the tissue to a user of the system. Patent Document 2 also describes that in the system, electrode 10 is connected to electrical wiring 28 via piezoelectric sensor - 20, and an electrical signal is sent from the piezoelectric sensor to a data collection device / processing device / output device (such as an ECG device), or alternatively, a transmitter is provided within the catheter and a receiver is provided in relation to the data collection device etc. to achieve a wireless connection.

[0006] Patent Document 3 describes a system including a catheter including an optical circuit, a pulsed field ablation energy source coupled to the catheter, and a processing device. Patent Document 3 also describes that wireless communication may occur between a catheter 100 including an electrode and wiring and other elements of the ablation system (such as ablation energy source 102 etc.).

[0007] Patent Document 4 describes a medical system 100 for mapping and ablating the heart with a catheter 110 including an electrode 130. Patent Document 4 also describes that the catheter has a transceiver and the transceiver communicates wirelessly with a console 120.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Summary of the Invention

Problems to be Solved by the Invention

[0009] As described in Patent Documents 1 to 4, if the cable extending proximally from the handle is made wireless, the user can operate without worrying about the length or handling of the cable when gripping the handle. By the way, when measuring the intracardiac potential, the potential difference measured by two electrodes may be monitored. When trying to wirelessly transmit this intracardiac potential data, it is considered that accurate potential difference data cannot be obtained due to the phase delay of the two electrocardiogram waveforms with a time lag when converting to a high-frequency electrical signal. The present invention has been made in view of the above circumstances, and an object thereof is to provide a catheter and a catheter system capable of acquiring accurate intracardiac potential data even using wireless communication.

Means for Solving the Problems

[0010] The catheter according to an embodiment of the present invention that has solved the above problems is as follows. [1] A shaft having a longitudinal axis and having a lumen, A first electrode disposed at the distal portion of the shaft for measuring intracardiac potential, A second electrode disposed at the distal portion of the shaft and proximal to the first electrode for measuring intracardiac potential, A first wire connected to the first electrode and extending into the lumen of the shaft, A second wire connected to the second electrode and extending into the lumen of the shaft, A handle disposed at the proximal portion of the shaft and held by the user's hand, A control unit that is connected to the first conductor and the second conductor and calculates the potential difference between the intracardiac potentials of the first electrode and the second electrode; A catheter having a wireless communicator that is connected to the control unit and wirelessly transmits the data processed by the control unit to an external device.

[0011] The catheter according to a further embodiment is preferably any one of the following [2] to [6]. [2] The catheter according to [1], wherein the wireless communicator is disposed on the shaft or the handle. [3] The catheter according to [1] or [2], wherein the control unit is disposed on the shaft or the handle. [4] The catheter according to any one of [1] to [3], wherein the first electrode and the second electrode are respectively attached to the outer surface of the shaft. [5] The catheter according to any one of [1] to [4], wherein all the electrodes are disposed at the distal portion of the shaft. [6] The catheter according to any one of [1] to [5], wherein the data processed by the control unit is not wired-transmitted to the external device.

[0012] The catheter system according to the first embodiment of the present invention that has solved the above problems is as follows. [7] A shaft having a longitudinal axis direction and having a lumen, A first electrode disposed at the distal portion of the shaft for measuring an intracardiac potential, A second electrode disposed at the distal portion of the shaft and proximal to the first electrode for measuring an intracardiac potential, A first conductor connected to the first electrode and extending into the lumen of the shaft, A second conductor connected to the second electrode and extending into the lumen of the shaft, A handle disposed at the proximal portion of the shaft and held by a user by hand, A control unit that is connected to the first conductor and the second conductor and calculates the potential difference between the intracardiac potentials of the first electrode and the second electrode; A catheter having a wireless communicator connected to the control unit and wirelessly transmitting the data processed by the control unit to an external device; An electrocardiograph having a receiving unit that wirelessly receives the data processed by the control unit from the wireless communicator; A catheter system having.

[0013] Furthermore, the catheter system according to the first embodiment is preferably any one of the following [8] to [9].

[0014] [8] Furthermore, an external lead connected to the control unit and a defibrillator connected to the external lead and applying a voltage to the first electrode and the second electrode. The catheter system according to [7]. [9] The catheter system according to [8], wherein the external lead is located outside the catheter.

[0015] The catheter system according to the second embodiment of the present invention that has solved the above problems is as follows.

[10] A shaft having a longitudinal axis and having a lumen, A first electrode arranged at the distal portion of the shaft for measuring an intracardiac potential, A second electrode arranged at the distal portion of the shaft and proximal to the first electrode for measuring an intracardiac potential, A first conductor connected to the first electrode and extending into the lumen of the shaft, A second conductor connected to the second electrode and extending into the lumen of the shaft, A handle arranged at the proximal portion of the shaft and held by the user by hand, A control unit connected to the first conductor and the second conductor for calculating the potential difference between the intracardiac potentials of the first electrode and the second electrode, A catheter having a wireless communicator connected to the control unit and wirelessly transmitting the data processed by the control unit to an external device; A defibrillator having a receiving unit that receives the data processed by the control unit from the wireless communicator; A catheter system having.

[0016] Furthermore, the catheter system according to the second embodiment is preferably as follows.

[11] The catheter system according to

[10] , which has an external wire connected to the defibrillator and the control unit, and the external wire is located outside the catheter.

[0017] Furthermore, the catheter system according to the first embodiment and the second embodiment is preferably as follows.

[12] The catheter system according to any one of [8], [9], and

[11] , wherein the external wire does not transmit the data processed by the control unit.

[13] The catheter system according to any one of [7] to

[12] , wherein all the wires for transmitting the data of the intracardiac potential are located inside the catheter and not outside the catheter. [Advantages of the Invention]

[0018] According to the above catheter and catheter system, the intracardiac potential measured by the first electrode and the second electrode is wirelessly transmitted from the wireless communicator to an external device after the potential difference between the intracardiac potentials of the first electrode and the second electrode is calculated by the control unit. Therefore, compared with the case where the potential difference is calculated after wirelessly transmitting the data of the intracardiac potential measured by the two electrodes to an external device, the influence due to the phase delay etc. of the two electrocardiogram waveforms can be reduced. As a result, accurate potential difference data can be obtained, and due to the possibility of wireless communication, the user can operate without worrying about the length and handling of the wires related to the measurement of the intracardiac potential. [Brief Description of the Drawings]

[0019]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Embodiments for Carrying Out the Invention

[0020] Hereinafter, the present invention will be described more specifically based on the following embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to appropriately modify and implement it within the range that can conform to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, hatching, reference numerals of members, etc. may be omitted, but in such a case, reference shall be made to the specification and other drawings. Also, the dimensions of various members in the drawings may differ from the actual dimensions because priority is given to facilitating the understanding of the features of the present invention.

[0021] With reference to FIGS. 1 to 5, a catheter and a catheter system according to an embodiment of the present invention will be described. FIG. 1 is a side view of a catheter in an embodiment of the present invention. FIG. 2 is a cross-sectional view (partial side view) along the longitudinal direction of the distal portion of the catheter shown in FIG. 1. FIG. 3 is a block diagram of the catheter system in the first embodiment of the present invention. FIG. 4 is a block diagram showing a modified example of the catheter system shown in FIG. 3. FIG. 5 is a block diagram of the catheter system in the second embodiment of the present invention. The catheter 1 has a shaft 2, a first electrode 11, a second electrode 12, a first wire 21, a second wire 22, a handle 30, a control unit 31, and a wireless communicator 32. The catheter system 100 according to the first embodiment has the above catheter 1 and an electrocardiograph 41. The catheter system 100 according to the second embodiment has the above catheter 1 and a defibrillator 50.

[0022] The catheter can reach the heart through the patient's blood vessel from its distal side, for example, and detect weak electrical signals generated when the heart beats with the first electrode and the second electrode. By connecting the catheter to an electrocardiograph, the intracardiac potential can be measured using the first electrode and the second electrode. Further, the catheter is connected to a defibrillator, and defibrillation can be performed by passing high energy of, for example, several tens to several hundreds of J between the first electrode and the second electrode from the defibrillator. Note that the catheter described in this specification has a distal portion with electrodes inserted into the body, but the handle on the user's hand side is a part that the user holds and operates by hand and is not inserted into the body, so the entire device is distinguished from an implantable defibrillator that is indwelled in the heart.

[0023] As shown in FIG. 1, the shaft 2 has a longitudinal axis direction x. The shaft 2 further preferably has a radial direction which is a direction perpendicular to the longitudinal axis direction x, a circumferential direction which is a direction along the outer periphery of the shaft 2, a distal end and a proximal end in the longitudinal axis direction x. In this specification, the direction on the user's hand side in the longitudinal axis direction x is referred to as the proximal side, and the side opposite to the proximal side, that is, the direction of the treatment target person is referred to as the distal side. Further, the extending direction of the shaft 2 is referred to as the longitudinal axis direction x. The longitudinal axis direction x can also be referred to as the far - near direction. The radial direction refers to the radial direction of the shaft 2. In the radial direction of the shaft 2, the inner side refers to the direction toward the longitudinal axis center side of the shaft 2, and the outer side in the radial direction refers to the direction radially extending from the longitudinal axis center on the opposite side to the inner side. Note that in FIGS. 1 - 2, the right side of the figure is the proximal side and the left side of the figure is the distal side.

[0024] The catheter 1 and each member and each part constituting the catheter 1 preferably have the longitudinal axis direction x, the radial direction, and the circumferential direction respectively, and they may be the same as or different from the longitudinal axis direction x, the radial direction, and the circumferential direction of the catheter 1. As shown in FIG. 1, the catheter 1 has the longitudinal axis direction x.

[0025] The shaft 2 has a lumen 5. Members such as conducting wires are arranged in the lumen 5. The shaft may have a single lumen structure with one lumen, or a multi-lumen structure with a plurality of lumens. If the shaft has only one lumen, there is no partition wall or the like inside the shaft to divide the lumen, so the flexibility of the shaft can be increased, and the insertability of the catheter 1 can be improved. If the shaft has a plurality of lumens, by arranging the plurality of conducting wires arranged in the lumens in separate lumens, it is possible to prevent them from contacting each other and prevent damage to the conducting wires. Note that the lumen of the shaft preferably extends in the longitudinal axis direction x of the shaft, and each of the plurality of lumens of the shaft preferably extends in the longitudinal axis direction x of the shaft.

[0026] The shaft 2 is made of, for example, polyolefin resins such as polyethylene and polypropylene; polyamide resins such as nylon; polyester resins such as PET; polyimide resins; aromatic polyether ketone systems such as PEEK; polyether polyamide resins; polyurethane resins; fluorine-based resins such as PTFE, PFA, and ETFE; vinyl chloride resins; synthetic resins such as silicone resins, and natural rubbers. These may be used alone or in combination of two or more.

[0027] The shaft 2 may have a single-layer structure or a multi-layer structure. When the shaft 2 has a multi-layer structure, for example, a structure using a metal braid such as stainless steel, carbon steel, or nickel-titanium alloy can be used as the intermediate layer of the resin tube constituting the shaft 2. The material constituting the shaft 2 is preferably a polyamide resin, and more preferably a polyamide elastomer. Since the material constituting the shaft 2 is a polyamide elastomer, the slidability of the outer surface of the shaft 2 is good, and since the shaft 2 has appropriate rigidity, the catheter 1 can have good insertability into blood vessels.

[0028] The thickness of the shaft 2, that is, the thickness of the peripheral wall, is preferably 50 μm or more, more preferably 100 μm or more, and even more preferably 150 μm or more. By setting the lower limit value of the thickness of the shaft 2 within the above range, the rigidity of the shaft 2 can be increased, and the catheter 1 with good insertability into blood vessels can be obtained. Further, the thickness of the shaft 2 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. By setting the upper limit value of the thickness of the shaft 2 within the above range, the lumen 5 of the shaft 2 can be widened, and the electrodes of the catheter 1 can be multi-polarized.

[0029] The shaft 2 preferably has a distal opening 3 and a proximal opening (not shown) that communicate with the lumen 5 in the longitudinal axis direction x. The distal opening 3 preferably has a tip chip 17 described later disposed therein. The proximal opening preferably has a handle 30 connected thereto.

[0030] As shown in FIG. 1, a handle 30 that can be held by a user's hand is disposed at the proximal portion of the shaft 2. By the user gripping the handle 30, the catheter 1 can be easily operated. The handle 30 preferably has a shape adapted to the shape of the user's hand.

[0031] The handle 30 can be composed of one or a plurality of members. The handle 30 preferably has a housing, and the housing preferably incorporates a control unit 31, a wireless communicator 32, etc. described later.

[0032] The handle 30 is preferably composed of an insulating material. The handle 30 can be composed of, for example, synthetic resins such as polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, fluorine resins such as PTFE, PFA, and ETFE, and polyvinyl chloride resins.

[0033] As shown in FIGS. 1 and 2, a first electrode 11 for measuring intracardiac potential is disposed at the distal portion of the shaft 2. Further, a second electrode 12 for measuring intracardiac potential is disposed at the distal portion of the shaft 2 and proximal to the first electrode 11. The first electrode 11 and the second electrode 12 can also function as electrodes for applying a voltage during defibrillation.

[0034] In addition to the first electrode 11 and the second electrode 12, one or more electrodes for measuring intracardiac potential may be disposed at the distal portion of the shaft 2. For example, as shown in FIGS. 1 and 2, in addition to the first electrode 11 and the second electrode 12, the shaft 2 may have a third electrode 13 disposed proximal to the second electrode 12 and a fourth electrode 14 disposed proximal to the third electrode 13.

[0035] As shown in FIGS. 1 and 2, the first electrode 11 and the second electrode 12 are preferably attached to the outer surface of the shaft 2, respectively. Further, in the catheter 1, it is preferable that all the electrodes are disposed at the distal portion of the shaft 2. Thereby, when the catheter 1 is inserted into the heart, the intracardiac potential can be measured by the first electrode 11 and the second electrode 12. The distal portion of the shaft 2 is a portion located on the distal side when the length of the shaft 2 is bisected in the longitudinal axis direction x.

[0036] Preferably, a plurality of side holes through which the inner cavity 5 communicates with the outside of the shaft 2 are disposed in the peripheral wall (side wall) of the shaft 2. The side holes are provided so as to penetrate the peripheral wall of the shaft 2. The plurality of side holes are spaced apart in the longitudinal axis direction x. In FIG. 2, the shaft 2 has a first side hole 6, a second side hole 7, a third side hole 8, and a fourth side hole 9.

[0037] The method of forming the side holes in the shaft 2 is not particularly limited, and examples thereof include a method of piercing the peripheral wall of the shaft 2 with a rod-shaped member having a sharp tip such as a needle or a drill, and a method of irradiating laser light.

[0038] When the shaft 2 is viewed from the outside in the radial direction, the shape of the side holes is not particularly limited, and for example, it may be circular, oval, polygonal, or a combination of these shapes, or an irregular shape. Oval shapes include elliptical, egg-shaped, and rounded rectangular shapes. The same applies to the following descriptions.

[0039] It is preferable that electrodes are arranged outside the side holes of the shaft 2. In FIG. 2, the first side hole 6 is provided with the first electrode 11, the second side hole 7 is provided with the second electrode 12, the third side hole 8 is provided with the third electrode 13, and the fourth side hole 9 is provided with the fourth electrode 14. Hereinafter, the electrodes arranged in the side holes of the shaft 2 may be referred to as side electrodes 10. It is preferable that one side electrode 10 is arranged for one side hole, but one side electrode 10 may be arranged for a plurality of side holes. The side electrode 10 is preferably arranged on the outer surface of the shaft 2.

[0040] As can be understood from FIGS. 1 to 2, the side electrode 10 may be a ring-shaped electrode, or may have a shape such as a C-shaped cross-section with a cut in the ring, or a coil shape formed by winding a wire. When the side electrode 10 has such a shape, the side electrode 10 can be arranged on the outer surface of the shaft 2 by caulking the side electrode 10 to the shaft 2. When the side electrode 10 has a shape with a diameter such as a ring shape, a C shape, or a coil shape, the inner diameter of the side electrode 10 is preferably smaller than the maximum outer diameter of the shaft 2. Thereby, the end portion of the side electrode 10 is less likely to be caught by other objects, and the insertability can be improved and the body cavity wall such as the inner wall of the heart or blood vessel can be hardly damaged.

[0041] The side electrode 10 may be a flat plate electrode formed independently in an island shape when viewed from the outside of the shaft 2. The shape of the flat plate electrode may be any shape such as a polygonal shape such as a rectangle or a square, or a circular shape. It is preferable that at least one of the inner surface and the outer surface of such a flat plate electrode has a curved surface so as to easily follow the curved surface of the surface of the shaft 2.

[0042] A recess for arranging the side electrode 10 may be formed on the radially outer side of the side hole of the shaft 2. Since the side electrode 10 can be arranged in the recess, it is possible to prevent the side electrode 10 from protruding outward in the radial direction, and prevent the side electrode 10 from getting caught on the wall of a body cavity such as a blood vessel or the inner wall of the heart, resulting in a decrease in insertability or damage to the body cavity wall. Examples of the method for forming a recess in the peripheral wall of the shaft 2 include cutting with a drill or the like, pressing with a rod-shaped object, hot working by pressing a heated rod-shaped object, and irradiation with laser light.

[0043] The side electrode 10 only needs to have conductivity and can be composed of a metal or a mixture containing a metal and a resin. Among them, as the material of the side electrode 10, it is preferable to use a metal such as platinum, a platinum-iridium alloy, stainless steel, tungsten, or a conductive resin. When the side electrode 10 is composed of a conductive resin, it is preferable to mix a contrast agent such as barium sulfate or bismuth oxide in order to be visible under fluoroscopy.

[0044] The number of the side electrodes 10 arranged on the catheter 1 is not limited. For example, it can be 2 or more, 3 or more, 5 or more, 8 or more, 10 or more, 15 or more, and also 50 or less, 40 or less, 30 or less, 25 or less, 20 or less, etc. Depending on the purpose of using the catheter 1, the catheter 1 may have a plurality of side electrode groups each including a plurality of side electrodes 10. In that case, the plurality of side electrode groups may be arranged at intervals in the longitudinal axis direction x.

[0045] When the catheter 1 has a plurality of side electrodes 10, the sizes of the respective side electrodes 10 may be the same or different. The fact that the sizes of the respective electrodes are different means, for example, that the lengths of the respective side electrodes 10 in the longitudinal axis direction x are different.

[0046] As shown in FIGS. 1 to 2, the catheter 1 may have a tip chip 17. Examples of the tip chip 17 include a hollow tube member, a hemispherical member, and a lid-shaped member connected to the distal end of the shaft 2. The hemispherical member and the lid-shaped member may be formed with through holes through which a guide wire can be inserted. By having the tip chip 17 on the catheter 1, it is possible to prevent foreign substances such as blood from entering the lumen 5 of the shaft 2 where the conducting wire is arranged during the use of the catheter 1. Further, by configuring the tip chip 17 with a highly flexible material, it is possible to prevent the tip of the catheter 1 from damaging the body cavity wall such as the inner wall of the heart or blood vessels, or to improve the insertability of the catheter 1 within the body cavity.

[0047] As the material constituting the tip chip 17, for example, the material constituting the aforementioned shaft 2 can be referred to. Alternatively, by configuring the tip chip 17 with the material constituting the side electrode 10, the tip chip 17 can also function as a tip electrode.

[0048] As shown in FIG. 2, the first conducting wire 21 is connected to the first electrode 11 and extends into the lumen 5 of the shaft 2. Specifically, the first conducting wire 21 has a longitudinal axis direction x, and has a distal end portion and a proximal end portion in the longitudinal axis direction x. The distal end portion of the first conducting wire 21 is preferably connected to the inner surface of the first electrode 11. The proximal end portion of the first conducting wire 21 is connected to the control unit 31.

[0049] As shown in FIG. 2, the second conducting wire 22 is connected to the second electrode 12 and extends into the lumen 5 of the shaft 2. Specifically, the second conducting wire 22 has a longitudinal axis direction x, and has a distal end portion and a proximal end portion in the longitudinal axis direction x. The distal end portion of the second conducting wire 22 is preferably connected to the inner surface of the second electrode 12. The proximal end portion of the second conducting wire 22 is connected to the control unit 31.

[0050] The catheter 1 preferably has a plurality of conductors including a first conductor 21 and a second conductor 22. The plurality of conductors including the first conductor 21 and the second conductor 22 electrically and wired-connect the electrodes and the control unit 31 respectively. In FIG. 2, the catheter 1 has four conductors, namely a first conductor 21, a second conductor 22, a third conductor 23, and a fourth conductor 24. The first conductor 21 is connected to the first electrode 11, the second conductor 22 is connected to the second electrode 12, the third conductor 23 is connected to the third electrode 13, and the fourth conductor 24 is connected to the fourth electrode 14. Each of the plurality of conductors is preferably connected to one side electrode 10 and extends into the inner cavity 5 of the shaft 2. The plurality of conductors are preferably connected to the inner side surface of the side electrode 10 respectively. Also, the proximal ends of the plurality of conductors are preferably connected to the control unit 31 respectively. Each of the plurality of conductors including the first conductor 21 and the second conductor 22 may be simply referred to as a conductor hereinafter.

[0051] The conductor only needs to have conductivity. For example, copper wire, iron wire, stainless steel wire, piano wire, tungsten wire, nickel-titanium alloy wire, etc. can be used. Among them, stainless steel wire is particularly preferable in that it has straightness and rigidity, so it is easy to pass the conductor through the side holes of the shaft 2, and it is difficult for the connection part between the conductor and the side electrode 10 to break.

[0052] One conductor may be a single wire or a stranded wire. The shape of the cross section perpendicular to the longitudinal axis direction x of one conductor can be, for example, circular, oval, polygonal, or a combination of these shapes. The major diameter of the conductor is not particularly limited. For example, it is preferably 0.05 mm or more, more preferably 0.08 mm or more, still more preferably 0.1 mm or more, and preferably 0.3 mm or less, more preferably 0.2 mm or less, still more preferably 0.15 mm or less. The major diameter of the conductor means the diameter of the circumscribed circle of one conductor in the cross section perpendicular to the longitudinal axis direction x, regardless of whether one conductor is a single wire or a stranded wire, and regardless of the cross-sectional shape.

[0053] It is preferable that the conductive wire is provided with a coating material. More preferably, the coating material is provided on a portion of the conductive wire other than the end portion connected to the side electrode 10. This can prevent a short circuit with an adjacent member. The coating material is disposed on the outer periphery of the conductive wire.

[0054] The coating material of the conductive wire only needs to be composed of an insulating material. For example, polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, fluorine resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins can be mentioned.

[0055] The conductive wire and the side electrode 10 can be connected by methods such as soldering, laser welding, resistance welding, and adhesion with an adhesive. The conductive wire and the side electrode 10 may be directly connected, or the conductive wire and the side electrode 10 may be indirectly connected via a conductive member.

[0056] When the catheter 1 has the tip 17, as shown in FIG. 2, a linear member 27 may be connected to the tip 17. The linear member 27 preferably extends into the lumen 5 of the shaft 2. The linear member 27 may be a solid member such as a wire, or a hollow member having a lumen 5, such as a coil or a tube. In order to easily maintain the overall shape of the catheter 1, the linear member 27 is preferably a solid member. Further, when the linear member 27 is used as a pull wire for bending the distal side of the shaft 2, the linear member 27 is preferably a coil. The linear member 27 may be an insulating member or a conductive member. When the linear member 27 is a conductive member and the tip 17 is made of a conductive material, the tip 17 can also be used as an electrode.

[0057] Although not shown, the catheter 1 may have a radiopaque marker. Thereby, the position of the catheter 1 in the body cavity can be specified under fluoroscopy. The radiopaque marker may be arranged, for example, at least either at the distal portion of the shaft 2 or at the distal portion of the linear member. The radiopaque marker may contain a radiopaque substance. Examples of the radiopaque substance include lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, tantalum, and the like.

[0058] As shown in FIGS. 3 to 5, the catheter 1 is connected to a first conductor 21 and a second conductor 22, and has a control unit 31 that calculates the potential difference between the intracardiac potentials of the first electrode 11 and the second electrode 12. After calculating the potential difference of the intracardiac potential in the control unit 31, the data of the potential difference may be transmitted to the wireless communicator 32 without any other processing, that is, in the form of raw data. Further, in the control unit 31, various processes may be performed on the data of the potential difference and then transmitted to the wireless communicator 32. For example, the control unit 31 may have a potential amplifier. The weak electrical signal detected by the first electrode 11 and the second electrode 12 can be amplified and output by the potential amplifier. Further, the control unit 31 may have a differential amplifier. The potential difference between the intracardiac potential measured by the first electrode 11 and the intracardiac potential measured by the second electrode 12 can be calculated and amplified and output by the differential amplifier.

[0059] The control unit 31 is preferably arranged on the shaft 2 or the handle 30. FIGS. 3 to 4 show an example in which the control unit 31 is arranged on the handle 30. The control unit 31 is preferably built in the shaft 2 or the handle 30, and more preferably built in the handle 30.

[0060] Since the applied voltage during defibrillation is as high as about 1200V to 2000V, for example, it is in an environment where large current switching noise is likely to occur. By the way, since noise generally easily enters cables, it is better that the number of conductors in the catheter and the catheter system is as small as possible, and it is preferable to configure a wireless type catheter by making all cables wireless. On the other hand, in order to realize a wireless defibrillation catheter, it is necessary to incorporate a battery power source inside the handle of the catheter, etc. However, since the applied voltage for defibrillation is high, there is a concern about the increase in the diameter and size of the handle, etc. For this reason, it is preferable to use an AC power source as the defibrillation power source, and it is inevitable that a power cable is connected to the catheter. In view of the above situation, in order to minimize noise generation in the entire catheter and catheter system, it is preferable that the transmission of intracardiac potential data is performed by wireless communication, and the transmission of electrical signals related to defibrillation is performed by wired communication. Therefore, it is preferable that the data processed by the control unit 31 is not wired-transmitted to the external device 40.

[0061] The data processed by the control unit 31 includes data on the potential difference of the intracardiac potential calculated by the control unit 31, data obtained by performing various processes on the potential difference data, for example, data from which abnormal values have been removed from the potential difference data, data with the amplitude of the potential difference data amplified, and the like.

[0062] As shown in FIGS. 3 to 5, the catheter 1 is connected to the control unit 31 and has a wireless communicator 32 that wirelessly transmits the data processed by the control unit 31 to the external device 40. According to the catheter 1, the intracardiac potential measured by the first electrode 11 and the second electrode 12 is wirelessly transmitted from the wireless communicator 32 to the external device after the control unit 31 calculates the potential difference between the intracardiac potentials of the first electrode 11 and the second electrode 12. For this reason, compared with the case where the potential difference is calculated after wirelessly transmitting the data of the intracardiac potential measured by the two electrodes to the external device, the influence due to the phase delay of the two electrocardiogram waveforms can be reduced. As a result, accurate potential difference data can be obtained, and due to the possibility of wireless communication, the user can operate without worrying about the length and handling of the conductors related to the measurement of the intracardiac potential.

[0063] It is preferable for the wireless communicator 32 to perform radio wave communication. The wireless communicator 32 may include an antenna that radiates radio waves toward the external device 40, and a transmission circuit that is connected to the control unit 31 and the antenna, modulates and encodes the intracardiac potential data received from the control unit 31, and outputs the data to the antenna. The transmission circuit may include a modulation circuit, an oscillator, an amplifier, various filters, and the like. The wireless communicator 32 only needs to have a wireless communication function and may be a wireless communication module. Examples of the communication standard used in the wireless communicator 32 include Bluetooth, Wi-Fi, LTE-M, and the like.

[0064] It is preferable for the wireless communicator 32 to wirelessly receive data from the external device 40. Thereby, for example, when defibrillation is performed using the first electrode 11 and the second electrode 12, it is possible to wirelessly receive the data of the applied voltage set by the defibrillator 50 as the external device 40 for controlling the first electrode 11 and the second electrode 12. For example, in addition to the antenna and the transmission circuit, the wireless communicator 32 may include a reception circuit that is connected to the control unit 31 and the antenna, demodulates and decodes the data received by the antenna, and transmits the data to the control unit 31. The reception circuit may include a demodulation circuit, an oscillator, an amplifier, various filters, and the like. Note that the data of the applied voltage set by the defibrillator 50 is preferably transmitted to the control unit 31 via the wireless communicator 32.

[0065] The wireless communicator 32 is preferably arranged on the shaft 2 or the handle 30. FIGS. 3 to 5 show an example in which the wireless communicator 32 is arranged on the handle 30. Specifically, the handle 30 may have a housing, and the wireless communicator 32 may be built in the housing.

[0066] As shown in FIGS. 1 to 3, the catheter system 100 according to the first embodiment has a shaft 2 having a longitudinal axis direction x and a lumen 5, a first electrode 11 arranged at the distal portion of the shaft 2 for measuring an intracardiac potential, a second electrode 12 arranged at the distal portion of the shaft 2 and proximal to the first electrode 11 for measuring an intracardiac potential, a first wire 21 connected to the first electrode 11 and extending into the lumen 5 of the shaft 2, a second wire 22 connected to the second electrode 12 and extending into the lumen 5 of the shaft 2, a handle 30 arranged at the proximal portion of the shaft 2 and held by a user by hand, a control unit 31 connected to the first wire 21 and the second wire 22 for calculating the potential difference of the intracardiac potentials of the first electrode 11 and the second electrode 12, and a wireless communicator 32 connected to the control unit 31 for wirelessly transmitting the data processed by the control unit 31 to an external device 40. The catheter 1 has a configuration that can be referred to the above description.

[0067] The electrocardiograph 41 is a device for measuring an intracardiac potential through various electrodes. As shown in FIG. 3, the electrocardiograph 41 has a receiving unit 42 for wirelessly receiving the data processed by the control unit 31 from the wireless communicator 32. The receiving unit 42 may have a second antenna for receiving radio waves radiated from the wireless communicator 32 of the catheter 1 and a second receiving circuit connected to the second antenna for demodulating the data received by the receiving unit 42 and transmitting it to at least one of a processing unit 43, a recording unit 44, and a display unit 45. The second receiving circuit may have a demodulation circuit, an oscillator, an amplifier, various filters, etc.

[0068] As shown in FIG. 3, the electrocardiograph 41 may be connected to the receiving unit 42 and have a processing unit 43 for performing various processes such as noise removal and R-wave peak detection on the data (electrocardiogram waveform) received by the receiving unit 42 and subjected to conversion processing.

[0069] As shown in FIG. 3, the electrocardiograph 41 may be connected to a receiving unit 42 and a processing unit 43, and may have a recording unit 44 for recording data that has been subjected to conversion processing after being received by the receiving unit 42 and data that has been processed by the processing unit 43. As the recording unit 44, a storage device such as a RAM (Random Access Memory), a flash memory, or a hard disk can be used.

[0070] As shown in FIG. 3, the electrocardiograph 41 may have a display unit 45 for displaying data that has been subjected to conversion processing after being received by the receiving unit 42 and data that has been processed by the processing unit 43. The display unit 45 is preferably connected to the receiving unit 42 and the processing unit 43, and more preferably connected to the recording unit 44. Examples of the display unit 45 include a display and a touch panel.

[0071] The catheter system 100 may have a plurality of external devices 40 other than the catheter 1. As shown in FIG. 4, the catheter system 100 according to the first embodiment preferably further includes an external lead wire 57 connected to the control unit 31 and a defibrillator 50 connected to the external lead wire 57 and applying a voltage to the first electrode 11 and the second electrode 12. Thereby, the transmission of the intracardiac potential data can be performed by wireless communication, and the transmission of the electrical signal related to defibrillation can be performed by wired communication.

[0072] The external lead wire 57 electrically and wiredly connects the control unit 31 of the catheter 1 and the defibrillator 50. The external lead wire 57 is different from the first lead wire 21 connected to the first electrode 11 and the second lead wire 22 connected to the second electrode 12. The configuration of the external lead wire 57 can refer to the configuration of the first lead wire 21 and the second lead wire 22.

[0073] As can be understood from FIG. 4, the external lead wire 57 is preferably located outside the catheter 1. For example, preferably, 90% or more and 100% or less of the length of the external lead wire 57 in the longitudinal axis direction x is arranged outside the catheter 1.

[0074] The external lead 57 is preferably a lead dedicated to voltage application. Also, it is preferable that the external lead 57 does not transmit the data processed by the control unit 31. In the external lead 57, it is preferable that electrical signals related to voltage measurement are not transmitted or received, and only electrical signals related to voltage application are transmitted or received. By providing the external lead 57 as a lead dedicated to voltage application in this way, the transmission and reception of electrical signals related to voltage application can be performed by wired communication.

[0075] As can be understood from FIG. 4, it is preferable that all the leads for transmitting the data of the intracardiac potential are located inside the catheter 1 and not outside the catheter 1. That is, the first lead 21 and the second lead 22 are preferably located inside the catheter 1. Thereby, since the physical transmission of the data of the intracardiac potential to an external device cannot be performed by wired communication, the generated noise can be minimized. In addition, since the number of leads extending proximally from the handle 30 of the catheter 1 can be minimized, the user can concentrate on the operation without worrying more than necessary about the length and handling of the leads when using the catheter 1.

[0076] As shown in FIG. 4, the catheter 1 is preferably connected to the control unit 31 and has a connection connector 35 exposed outside the catheter 1. It is preferable that the external lead 57 is connected to the connection connector 35. By providing the connection connector 35 in this way, it becomes easier to arrange the external lead 57 outside the catheter 1.

[0077] The defibrillator 50 is an instrument for performing a defibrillation treatment that applies an electrical signal to the heart from the first electrode 11 and the second electrode 12 of the catheter 1 when atrial fibrillation occurs.

[0078] As shown in FIG. 4, the defibrillator 50 preferably has a capacitor for charging the applied voltage and a power supply unit 52 for applying a voltage to the first electrode 11 and the second electrode 12. It can be controlled so that charging of the capacitor is started by operating an operation unit 55 described later.

[0079] The power supply unit 52 preferably includes at least one of a power supply, a booster circuit for boosting a DC voltage, a charging circuit, and a waveform generation circuit for generating a pulse voltage. Note that at least a part of these may be provided outside the power supply unit 52. The arrangement of the power supply unit 52 is not particularly limited, and it may be provided outside the arithmetic processing unit 54 described later, or may be provided inside the arithmetic processing unit 54. When the power supply unit 52 is provided outside the arithmetic processing unit 54, the power supply unit 52 is preferably connected to the arithmetic processing unit 54.

[0080] As shown in FIG. 4, the defibrillator 50 preferably has a permission signal generation unit 53 that is connected to the power supply unit 52 and generates a permission signal for permitting the application of a voltage for defibrillation. The permission signal generated by the permission signal generation unit 53 is not particularly limited as long as it is a signal related to the application of a voltage for defibrillation. Examples include a charging permission signal for the power supply unit 52, a permission signal for generating a pulse voltage, a permission signal for voltage application, and a switch-on permission signal for the switching unit 56 described later. On the other hand, by operating the operation unit 55 or the like, a part of these permission signals may be generated. Note that the permission signal generation unit 53 is not limited to the arithmetic processing unit 54 and may be provided in the power supply unit 52.

[0081] Although not shown in FIG. 4, as shown in FIG. 5 described later, the defibrillator 50 may have a receiving unit 51 that receives data processed by the control unit 31 from the wireless communicator 32. Also, although not shown, the defibrillator 50 may be connected to the electrocardiograph 41, and the defibrillator 50 may be able to receive the electrocardiogram waveform data received by the receiving unit 42 of the electrocardiograph 41.

[0082] As shown in FIG. 4, the defibrillator 50 may be connected to the power supply unit 52 and may have an arithmetic processing unit 54 that performs various processes such as noise removal and R-wave peak detection on the electrocardiogram waveform data.

[0083] As shown in FIG. 4, it is preferable that the defibrillator 50 has an operation unit 55 connected to a power supply unit 52. Since an input signal from the operation unit 55 is transmitted to the power supply unit 52 by the operation unit 55, an operation of charging the capacitor can be performed. As the operation unit 55, known input means such as buttons, switches, and levers can be used. Some of the above permission signals may be generated by operating the operation unit 55. The operation unit 55 may be connected to the arithmetic processing unit 54. Thereby, an input signal from the operation unit 55 is transmitted to the power supply unit 52 via the arithmetic processing unit 54.

[0084] As shown in FIG. 4, the defibrillator 50 may be connected to the arithmetic processing unit 54 and may have a switching unit 56 that switches between a first mode in which a voltage is applied to the first electrode 11 and the second electrode 12 and a second mode in which no voltage is applied. The switching unit 56 can be composed of, for example, one or a plurality of switches. The switching unit 56 may be connected to the power supply unit 52. As the switch, for example, a semiconductor switch can be used. Examples of the semiconductor switch element include elements using IGBT, MOSFET, thyristor, SiC semiconductor, and GaN semiconductor.

[0085] As shown in FIG. 5, a catheter system 100 according to a second embodiment of the present invention has a shaft 2 having a longitudinal axis direction x and having a lumen 5, a first electrode 11 arranged at a distal portion of the shaft 2 for measuring an intracardiac potential, a second electrode 12 arranged at a distal portion of the shaft 2 and proximal to the first electrode 11 for measuring an intracardiac potential, a first lead wire 21 connected to the first electrode 11 and extending into the lumen 5 of the shaft 2, a second lead wire 22 connected to the second electrode 12 and extending into the lumen 5 of the shaft 2, a handle 30 arranged at a proximal portion of the shaft 2 and held by a user, a control unit 31 connected to the first lead wire 21 and the second lead wire 22 for calculating a potential difference between the intracardiac potentials of the first electrode 11 and the second electrode 12, and a wireless communicator 32 connected to the control unit 31 for wirelessly transmitting data processed by the control unit 31 to an external device 40. A defibrillator 50 having a receiving unit 51 for receiving data processed by the control unit 31 from the wireless communicator 32 may also be included. The catheter system 100 according to the second embodiment differs from the catheter system 100 according to the first embodiment in that the defibrillator 50 has a receiving unit 51 for receiving data wirelessly transmitted from the wireless communicator 32 of the catheter 1.

[0086] The receiving unit 51 of the defibrillator 50 may have a third antenna for receiving radio waves radiated from the wireless communicator 32 of the catheter 1, and a third receiving circuit connected to the third antenna for demodulating the data received by the receiving unit 51 and transmitting it to at least one of a permission signal generation unit 54 and an arithmetic processing unit 54. The third receiving circuit may have a demodulation circuit, an oscillator, an amplifier, various filters, and the like.

[0087] The catheter system 100 according to the second embodiment has an external lead wire 57 connected to the defibrillator 50 and the control unit 31, and it is preferable that the external lead wire 57 is located outside the catheter 1. For the same reason as the catheter system 100 according to the first embodiment, in the catheter system 100 according to the second embodiment, it is also preferable that the external lead wire 57 does not transmit the data processed by the control unit 31, and it is preferable that all the wires for transmitting the data of the intracardiac potential are located inside the catheter 1 and not outside the catheter 1.

[0088] Regarding the configuration of the catheter 1, the defibrillator 50, the external lead wire 57, etc., which the catheter system 100 according to the second embodiment essentially or preferably has, reference can be made to the description of the catheter system 100 according to the first embodiment. Note that the catheter system 100 according to the second embodiment may not have an electrocardiograph.

[0089] At least any one of the functions included in the catheter systems 100 according to the first and second embodiments, for example, the functions of the control unit 31 included in the catheter 1, the receiving unit 42, the processing unit 43 included in the electrocardiograph 41, the receiving unit 51, the power supply unit 52, the permission signal generation unit 53, the arithmetic processing unit 54, the switching unit 56, etc. included in the defibrillator 50 may be realized by hardware or may be realized by software. Examples of hardware include logic circuits formed in integrated circuits such as LSI (Large Scale Integration) and ASIC (Application Specific Integrated Circuit).

[0090] The catheter system 100 according to the first and second embodiments may include a computer that executes program instructions of software for realizing functions such as the control unit 31 of the catheter 1, the receiving unit 42 of the electrocardiograph 41, the processing unit 43, the receiving unit 51 of the defibrillator 50, the power supply unit 52, the permission signal generation unit 53, the arithmetic processing unit 54, and the switching unit 56. The computer preferably includes a processor and a computer-readable recording medium storing the above program. By the processor executing the program stored in the computer-readable recording medium, the above functions are realized. As the processor, a CPU (Central Processing Unit) can be used. As the recording medium, a ROM (Read Only Memory) or the like can be used. Further, the recording medium can also include a RAM (Random Access Memory). The above program may be supplied to the above computer via any transmission medium capable of transmitting this program. Examples of the transmission medium include a communication network and a communication line.

[0091] In this specification, examples in which the catheter and the catheter system are used for transmitting intracardiac potential data and defibrillation have been described, but the present invention is not limited thereto, and it is also applicable to transferring images (including both still images and moving images) acquired by an endoscope to an external device or the like.

Explanation of Reference Numerals

[0092] 1: Catheter 2: Shaft 5: Lumen 11: First Electrode 12: Second Electrode 21: First Conductor 22: Second Conductor 30: Handle 31: Control Unit 32: Wireless Communicator 40: External Device 41: Electrocardiograph 42: Receiving Unit 50: Defibrillator 51: Receiving Unit 57: External lead 100: Catheter system x: Longitudinal axis direction

Claims

1. A shaft having a longitudinal axis and a lumen, A first electrode disposed at the distal portion of the shaft for measuring an intracardiac potential, A second electrode disposed at the distal portion of the shaft proximal to the first electrode for measuring an intracardiac potential, A first wire connected to the first electrode and extending into the lumen of the shaft, A second wire connected to the second electrode and extending into the lumen of the shaft, A handle disposed at the proximal portion of the shaft for the user to hold by hand, A control unit connected to the first wire and the second wire for calculating the potential difference between the intracardiac potentials of the first electrode and the second electrode, A catheter having a wireless communicator connected to the control unit for wirelessly transmitting the data processed by the control unit to an external device.

2. The catheter according to claim 1, wherein the wireless communicator is disposed on the shaft or the handle.

3. The catheter according to claim 1 or 2, wherein the control unit is disposed on the shaft or the handle.

4. The catheter according to claim 1 or 2, wherein the first electrode and the second electrode are respectively attached to the outer surface of the shaft.

5. The catheter according to claim 1 or 2, wherein all the electrodes are disposed at the distal portion of the shaft.

6. The catheter according to claim 1 or 2, wherein the data processed by the control unit is not wired-transmitted to the external device.

7. A shaft having a longitudinal axis and a lumen, A first electrode disposed at the distal portion of the shaft for measuring an intracardiac potential, A second electrode disposed at the distal portion of the shaft proximal to the first electrode for measuring an intracardiac potential, A first wire connected to the first electrode and extending into the lumen of the shaft, A second wire connected to the second electrode and extending into the lumen of the shaft, A handle disposed at the proximal portion of the shaft for the user to hold by hand, A control unit connected to the first wire and the second wire for calculating the potential difference between the intracardiac potentials of the first electrode and the second electrode, A catheter having a wireless communicator connected to the control unit for wirelessly transmitting the data processed by the control unit to an external device; and An electrocardiograph having a receiving unit for wirelessly receiving the data processed by the control unit from the wireless communicator. A catheter system.

8. Furthermore, an external wire connected to the control unit, The catheter system according to claim 7, further comprising a defibrillator connected to the external wire and applying a voltage to the first electrode and the second electrode.

9. The catheter system according to claim 8, wherein the external wire is located outside the catheter.

10. A catheter having a shaft with a longitudinal axis and a lumen, A first electrode disposed at the distal portion of the shaft for measuring an intracardiac potential, A second electrode disposed at the distal portion of the shaft and proximal to the first electrode for measuring an intracardiac potential, A first wire connected to the first electrode and extending into the lumen of the shaft, A second wire connected to the second electrode and extending into the lumen of the shaft, A handle disposed at the proximal portion of the shaft and held by a user, A control unit connected to the first wire and the second wire for calculating a potential difference between the intracardiac potentials of the first electrode and the second electrode, A catheter having a wireless communicator connected to the control unit and wirelessly transmitting the data processed by the control unit to an external device; A catheter system having a defibrillator with a receiving unit for receiving the data processed by the control unit from the wireless communicator.

11. The catheter system according to claim 10, further comprising an external wire connected to the defibrillator and the control unit, wherein the external wire is located outside the catheter.

12. The catheter system according to claim 8 or 11, wherein the external wire does not transmit the data processed by the control unit.

13. The catheter system according to claim 7 or 10, wherein all the wires for transmitting intracardiac potential data are located within the catheter and not outside the catheter.

Images