Energy treatment tool
The energy treatment device addresses the risk of accidental energy release in ultrasonic surgical instruments by requiring a specific two-step movement of the operating unit to release therapeutic energy, thereby enhancing procedural safety.
Patent Information
- Application Number
- JP2023171230
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-10-02
- Publication Date
- 2025-04-14
AI Technical Summary
Existing ultrasonic surgical instruments risk tissue damage due to accidental release of therapeutic energy from the treatment section, particularly during procedures where higher energy levels are used for treatment rather than diagnosis.
The energy treatment device features a controller with a housing and an operating unit that moves in both the longitudinal and radial directions. The operating unit must be moved from the second position to the first position and then radially inward to release therapeutic energy, thereby preventing erroneous energy release to tissues other than the lesion.
This design ensures that therapeutic energy is only released when the user intentionally positions the operating unit correctly, significantly reducing the risk of tissue damage from accidental energy release during procedures.
Smart Images

Figure 2025062280000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an energy treatment device for performing treatment, such as cauterization or defibrillation, on internal body tissue such as a lesion using therapeutic energy. [Background technology]
[0002] In the treatment of arrhythmias such as atrial fibrillation, a catheter with an electrode may be used as a treatment tool. For example, during treatment, an ablation procedure is performed in which a high-frequency current is applied from the catheter electrode to the myocardium causing the arrhythmia, cauterizing the source of the arrhythmia and electrically isolating it from the heart, or a defibrillation procedure is performed in which an electrical signal is applied to the heart from the catheter electrode when atrial fibrillation occurs.
[0003] A controller is connected to the proximal side of such a catheter, and a user can operate the controller to pass a high-frequency current to the electrode or apply a voltage. In another embodiment, there is a device that can turn the power on and off using a foot switch connected to the electrode of the catheter. A controller that can be operated by a user may also be connected to the proximal side of the catheter for treatments other than cauterization performed on internal tissue, such as energy treatment devices for defibrillation, light irradiation, or ultrasound irradiation.
[0004] For example, Patent Document 1 describes an ultrasonic surgical instrument having a handpiece, an ultrasonically activated blade disposed distal to the handpiece, and a controller operable to select the level of ultrasonic energy of the blade and formed integrally with the handpiece. Patent Document 1 also describes that the ultrasonic surgical instrument includes a sliding activation and control button, and that the energy level is based on the slide position, and that the configuration of the instrument can be incorporated into a radio frequency (RF) surgical device, a laser, or any other surgical device that uses portable energy. Furthermore, in the surgical instrument of Patent Document 1, different energy levels of ultrasound can be activated by pressing one of two buttons on a rocker switch or by moving the button assembly along a rail. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] Special Publication No. 2012-501805 Summary of the Invention [Problem to be solved by the invention]
[0006] In the ultrasonic surgical instrument described in Patent Document 1, if the user erroneously operates the controller during the procedure, energy may be released from the treatment section, causing damage to tissues other than the lesion. In particular, since a higher level of energy is used for treatment than for diagnosis, there is a high risk of damaging tissues other than the lesion due to erroneous operation of the controller during treatment. The present invention has been made in view of the above circumstances, and its purpose is to provide an energy treatment instrument that can prevent erroneous operation of the controller during treatment. [Means for solving the problem]
[0007] The energy treatment device according to the embodiment of the present invention that can solve the above problems is as follows. [1] A shaft having a longitudinal direction and a radial direction; A treatment section disposed at a distal portion of the shaft and emitting therapeutic energy; a controller connected to a proximal portion of the shaft, the controller having a housing and an operation unit movable in the longitudinal axis direction and the radial direction relative to the housing; the operation unit moves from a first position to a second position in the longitudinal axis direction relative to the housing, When the operation unit is moved inward in the radial direction with respect to the housing while the operation unit is located at the first position, energy for treatment is released from the treatment unit, The energy treatment device in which, when the operation section is located at the second position, no therapeutic energy is released from the treatment section.
[0008] According to the above energy treatment device, when a user wants to release energy from the treatment section during treatment, the user must move the operation unit from the second position to the first position and then move the operation unit radially inward relative to the housing. This makes it possible to prevent the energy for treatment from being released to tissues other than the lesion due to erroneous operation of the controller. This makes it possible to obtain a highly safe energy treatment device that can prevent damage to tissues other than the lesion.
[0009] Further, the energy treatment device according to the embodiment is preferably any one of the following [2] to
[10] . [2] The energy treatment device according to [1], wherein the first position is located at the most proximal side of a movable range of the operation unit relative to the housing in the longitudinal axis direction. [3] The energy treatment device described in [1] or [2], wherein the second position is located at the most distal side of the movable range of the operation unit relative to the housing in the longitudinal axis direction. [4] The energy treatment device according to any one of [1] to [3], wherein even if the operating section is moved radially inward relative to the housing while being positioned at the second position, therapeutic energy is not released from the treatment section. [5] The energy treatment device according to any one of [1] to [3], wherein the operation section does not move radially inward relative to the housing when the operation section is located at the second position. [6] The energy treatment device described in any one of [1] to [5], wherein the housing has a recess recessed in the radial direction, the operation unit has a protrusion protruding inward in the radial direction, and when the operation unit is moved inward in the radial direction relative to the housing, the protrusion is inserted into the recess. [7] The energy treatment device according to any one of [1] to [6], wherein when the operation unit is moved radially inward relative to the housing while being positioned at the first position, a portion of the operation unit is bent. [8] The energy treatment device according to any one of [1] to [7], wherein the operation unit has a first contact portion on the radially inward side, and the controller has a second contact portion at a position facing the first contact portion within the housing, and when the operation unit is moved radially inward with respect to the housing with the operation unit positioned at the first position, the first contact portion and the second contact portion come into contact with each other, and when the operation unit is moved radially inward with respect to the housing with the operation unit positioned at the second position, the first contact portion does not come into contact with the second contact portion. [9] An energy treatment device described in any one of [1] to [8], wherein the controller has a spring member housed within the housing and biases the operating unit distally, and the operating unit moves from the second position to the first position when the spring member is pushed proximally by the operating unit.
[10] The energy treatment device described in any one of [1] to [9], wherein the housing has a finger hook portion on which a user's fingers are hooked, and the operation portion is located on the opposite side of the finger hook portion in the radial direction. Effect of the Invention
[0010] According to the above energy treatment device, when a user wants to release energy from the treatment section during treatment, the user must move the operation unit from the second position to the first position and then move the operation unit radially inward relative to the housing. This makes it possible to prevent the energy for treatment from being released to tissues other than the lesion due to erroneous operation of the controller. This makes it possible to obtain a highly safe energy treatment device that can prevent damage to tissues other than the lesion. [Brief description of the drawings]
[0011] [Figure 1] FIG. 2 is a side view of the energy treatment device according to the embodiment of the present invention. [Diagram 2] 2 is an explanatory diagram of the controller shown in FIG. 1 in a state where the cover of the housing is open and the operation unit is not moved. [Diagram 3] 2 is an explanatory diagram of the controller shown in FIG. 1 in a state where the cover of the housing is open and the operation unit is moved in the longitudinal axial direction but not in the radial direction. FIG. [Figure 4] 2 is an explanatory diagram of the controller shown in FIG. 1 in a state where the cover of the housing is opened and the operation unit is moved in the longitudinal axial direction and in the radial direction. FIG. [Diagram 5] FIG. 2 is a plan view of the controller shown in FIG. [Figure 6] FIG. 2 is a front view of the controller shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0012] The present invention will be described in more detail below based on the following embodiments, but the present invention is not limited to the following embodiments, and can be modified as long as it meets the purpose described above and below, and all of these modifications are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, the specification and other drawings should be referred to. In addition, the dimensions of various components in the drawings may differ from the actual dimensions because priority is given to helping understand the features of the present invention.
[0013] With reference to Figs. 1 to 6, an energy treatment device according to an embodiment of the present invention will be described. Fig. 1 is a side view of an energy treatment device according to an embodiment of the present invention. Fig. 2 is an explanatory diagram of the controller shown in Fig. 1 in a state where the cover of the housing is opened and the operation unit is not moved. Fig. 3 is an explanatory diagram of the controller shown in Fig. 1 in a state where the cover of the housing is opened and the operation unit is moved in the longitudinal axis direction and not moved in the radial direction. Fig. 4 is an explanatory diagram of the controller shown in Fig. 1 in a state where the cover of the housing is opened and the operation unit is moved in the longitudinal axis direction and in the radial direction. Fig. 5 is a plan view of the controller shown in Fig. 1. Fig. 6 is a front view of the controller shown in Fig. 1. The energy treatment device 1 has a shaft 2, a treatment unit 10, and a controller 18. The controller 18 has a housing 20 and an operation unit 30.
[0014] The energy treatment device 1 is inserted into the body at least at its distal part, and is for applying therapeutic energy to the internal tissue of the patient, such as a lesion, to perform various treatments such as cauterization, defibrillation, light irradiation, and ultrasonic irradiation. Examples of therapeutic energy include electric energy such as high frequency energy and microwave energy, light energy such as laser light, and ultrasonic energy. Examples of the energy treatment device 1 include devices that emit electromagnetic waves toward the internal tissue, such as an electrode catheter and an electric knife that use radio waves such as high frequency and microwaves, and a light irradiation device that uses light irradiation by laser light. The energy treatment device 1 may also be an ultrasonic irradiation device that emits ultrasonic energy. In the following, an example will be described in which the energy treatment device 1 is an electrode catheter. The electrode catheter is passed from its distal side through the patient's blood vessels to reach the heart, and an electric current is passed through the electrode as the treatment unit 10, so that it can be used, for example, for treating arrhythmia in the heart, defibrillation, and the like.
[0015] In FIG. 1, the shaft 2 has a longitudinal direction x and a radial direction y. The radial direction y is a direction perpendicular to the longitudinal direction x. In FIG. 1, the shaft 2 has a circumferential direction z, which is a direction along its outer circumference. The energy treatment device 1 preferably has a longitudinal direction x, a radial direction y, and a circumferential direction z, similar to the shaft 2. The energy treatment device 1 preferably has a distal end and a proximal end in the longitudinal direction x. In this specification, the direction toward the user's hand in the longitudinal direction x is referred to as the proximal side, and the opposite side to the proximal side, i.e., the direction toward the treatment subject, is referred to as the distal side. The longitudinal direction x can also be referred to as the far-near direction or the extension direction of the shaft 2. The radial direction y refers to the radial direction of the shaft 2, and in the radial direction y of the shaft 2, the inward direction refers to the direction toward the longitudinal axis center of the shaft 2, and in the radial direction y, the outward direction refers to the direction extending radially from the longitudinal axis center opposite to the inward direction. In FIG. 1 to FIG. 5, the right side of the figure is the proximal side, and the left side of the figure is the distal side.
[0016] Each member or portion constituting the energy treatment device 1 may have a longitudinal axis direction x, a radial direction y, and a circumferential direction z, which may be the same as or different from the longitudinal axis direction x, radial direction y, and circumferential direction z of the shaft 2.
[0017] The energy treatment device 1 may be capable of bending the distal portion of the shaft 2, or may not be capable of bending. In the latter case, the shape of the distal portion of the shaft 2 may not be changed from a curved state to an unbent state or vice versa even if the shaft 2 is operated. Here, the bending operation refers to an operation that the user intentionally performs to bend the shaft 2, and does not include a case where the shape of the shaft 2 changes to be curved following the shape of the body cavity when the energy treatment device 1 is inserted into the body cavity of the patient. As can be seen from Figs. 1 and 2, an example of the energy treatment device 1 capable of bending the shaft 2 is one in which a pull wire 13 for bending operation is connected to the distal tip 12. The distal portion of the shaft 2 may be bent. In other words, the shaft 2 may be curved in a natural state in which no external force is applied to the shaft 2.
[0018] Although not shown, the shaft 2 may have an inner cavity extending in the longitudinal axis direction x. The shaft 2 may have a single lumen structure having one inner cavity, or a multi-lumen structure having multiple inner cavities. If the shaft 2 has one inner cavity, there is no partition or the like that divides the inner cavity inside the shaft 2, so that the flexibility of the shaft 2 can be increased and the insertability of the energy treatment device 1 can be improved. If the shaft 2 has multiple inner cavities, the members such as the conductor wire, pull wire, and core material arranged in the inner cavity can be arranged in separate cavities to prevent them from contacting each other and prevent damage to these members. It is preferable that the multiple inner cavities of the shaft 2 each extend in the longitudinal axis direction x of the shaft 2.
[0019] The shaft 2 may have a distal opening and a proximal opening communicating with the inner cavity. The distal opening is preferably an opening whose opening surface has a normal vector facing the distal side. The proximal opening is preferably an opening whose opening surface has a normal vector facing the proximal side. The distal opening may have a tip 12 disposed therein. The proximal opening may have a controller 18 connected thereto. The configurations of the tip 12 and the controller 18 will be described later.
[0020] Examples of the material for the shaft 2 include synthetic resins such as polyolefin resins, such as polyethylene and polypropylene, polyamide resins, such as nylon, polyester resins, such as PET, polyimide resins, aromatic polyether ketones, such as PEEK, polyether polyamide resins, polyurethane resins, fluorine resins, such as PTFE, PFA, ETFE, vinyl chloride resins, and silicone resins, as well as natural rubber. These may be used alone or in combination of two or more.
[0021] 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, the shaft 2 may have a structure in which a metal braid such as stainless steel, carbon steel, or nickel-titanium alloy is used as an intermediate layer of a resin tube constituting the shaft 2. The material constituting the shaft 2 is preferably a polyamide resin, and more preferably a polyamide elastomer. When the material constituting the shaft 2 is a polyamide elastomer, the outer surface of the shaft 2 has good slipperiness, and the shaft 2 has appropriate rigidity, so that the energy treatment device 1 can be easily inserted into a blood vessel.
[0022] The length of the shaft 2 in the longitudinal direction x can be selected to be an appropriate length for treatment. For example, the length of the shaft 2 in the longitudinal direction x can be 400 mm or more and 2000 mm or less. The length of the shaft 2 in the longitudinal direction x is preferably relatively long when the tip of the energy treatment device 1 is inserted from a lower limb vein and delivered to the heart, and may be relatively short when the tip of the energy treatment device 1 is inserted from a subclavian vein or a jugular vein and delivered to the heart.
[0023] The outer diameter of the shaft 2 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1.0 mm or more. By setting the lower limit of the outer diameter of the shaft 2 within the above range, it is possible to impart appropriate rigidity to the shaft 2 and improve the insertability into blood vessels. The outer diameter of the shaft 2 is preferably 3.0 mm or less, more preferably 2.8 mm or less, and even more preferably 2.5 mm or less. By setting the upper limit of the outer diameter of the shaft 2 within the above range, it is possible to prevent the outer diameter of the energy treatment device 1 from becoming too large, and to improve minimal invasiveness.
[0024] The thickness of the shaft 2, i.e., 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 of the thickness of the shaft 2 within the above range, it is possible to increase the rigidity of the shaft 2 and to provide an energy treatment device 1 with good insertability into blood vessels. Moreover, 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 of the thickness of the shaft 2 within the above range, the inner cavity of the shaft 2 can be widened, and the electrodes of the energy treatment device 1 can be multipolarized.
[0025] It is preferable that a side hole is provided in the peripheral wall (side wall) of the shaft 2, which communicates the inner cavity with the outside of the shaft 2. The side hole is provided so as to penetrate the peripheral wall of the shaft 2. The shaft 2 may have a plurality of side holes arranged at intervals in the longitudinal axis direction x. The side hole is provided to draw members such as a lead wire, which is preferably connected to the treatment portion 10, into the inner cavity of the shaft 2.
[0026] The method for forming the side hole in the shaft 2 is not particularly limited, but examples 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 an awl, or a method of irradiating the peripheral wall with laser light.
[0027] The shape of the side hole when the shaft 2 is viewed from the outside in the radial direction y is not particularly limited, and may be, for example, a circle, an oval, a polygon, or a combination of these, or may be an irregular shape. The oval shape includes an ellipse, an egg, and a rounded rectangle. The same applies in the following description.
[0028] As shown in Fig. 1, the energy treatment device 1 has a treatment section 10 disposed at the distal portion of a shaft 2. Energy for treatment is emitted from the treatment section 10. The treatment section 10 may be disposed at a portion including the distal end of the shaft 2, or may be disposed proximal to the distal end.
[0029] Examples of the treatment unit 10 include an electrode, an ultrasound generating unit, and a light emitting unit. In FIG. 1, the treatment unit 10 is shown as an example of an electrode 11. Target tissue can be cauterized by passing a high-frequency current or a microwave current through the electrode to heat it. The electrode may function as a measurement electrode or a reference electrode when measuring the electric potential, or as an electrode that provides an electrical signal.
[0030] The treatment section 10 may be a light-emitting section that emits light toward the outside of the shaft 2. For example, an LED element or an optical fiber core can be used as the light-emitting section. It is preferable that the light-emitting section emits light in the distal direction or outward in the radial direction y.
[0031] When an LED element is used as the light-emitting section, a power supply device that supplies electricity can be connected to the LED element via a conductor, so that electricity is supplied from the power supply device via the conductor to the LED element, which is the light-emitting section, causing the LED element to emit light.
[0032] When the core of an optical fiber is used as the light-emitting section, it is preferable that the optical fiber has a first end and a second end in its longitudinal direction, and the first end side of the optical fiber is connected to the LED light source device. This allows a configuration in which light emitted from the LED light source device enters the first end side of the optical fiber connected to the LED light source device, and the entered light passes through the core of the optical fiber and is emitted from the second end side of the optical fiber.
[0033] The treatment unit 10 may be an ultrasonic generator that emits ultrasonic waves toward the outside of the shaft 2. The oscillation frequency and ultrasonic output of the ultrasonic waves generated by the ultrasonic generator can be appropriately set according to the type of treatment, etc. Methods for generating ultrasonic waves include a piezoelectric method and an electrostatic method. It is preferable that the ultrasonic generator emits ultrasonic waves in the distal direction or outward in the radial direction y.
[0034] The ultrasonic generating unit may include an ultrasonic probe. The ultrasonic probe converts an electric signal into ultrasonic waves and transmits and receives ultrasonic waves. The ultrasonic probe may be a single transducer type probe, or may be a dual transducer type probe having a transmitting transducer and a receiving transducer. The transducer may have, for example, two electrodes and a piezoelectric material sandwiched between the two electrodes. The piezoelectric material is a crystalline material that exhibits piezoelectricity, and generates a voltage when mechanical strain is applied, or conversely, generates mechanical strain when a voltage is applied. Examples of the piezoelectric material that can be used include barium titanate (BaTiO3), lead zirconate titanate (PZT), polyvinylidene fluoride (PVDF), and 1-3 composite piezoelectric material.
[0035] Returning to FIG. 1, an example in which the treatment unit 10 is an electrode 11 will be described. The treatment unit 10 may be a bipolar electrode or a monopolar electrode. As shown in FIG. 1, the treatment unit 10 may have two or more electrodes 11. For example, the treatment unit 10 may have a first electrode and a second electrode located proximal to the first electrode. Tissue may be cauterized by passing a current from the first electrode to the second electrode or in the opposite direction. The treatment unit 10 can function as a bipolar electrode. The electrode as the treatment unit 10 is connected to a body surface electrode (counter electrode) attached to the body surface of the patient, and internal tissue can be cauterized by passing a current from the treatment unit 10 to the body surface electrode. In this case, the treatment unit 10 can function as a monopolar electrode.
[0036] The electrode as the treatment section 10 may be in the shape of a ring, a ring with a notch in cross section that is C-shaped, a coil shape with a wound wire, or the like. With such a shape, the electrode can be arranged on the outer surface of the shaft 2 by crimping the electrode to the shaft 2. The electrode may be a plate electrode formed independently in an island shape when viewed from the outside of the shaft 2. The shape of the plate electrode may be any shape, such as a polygonal shape such as a rectangle or a square, or a circle. It is preferable that at least one of the inner surface and the outer surface of such a plate electrode is curved so as to easily fit the curved surface of the surface of the shaft 2.
[0037] The electrodes only need to be conductive, and can be made of a metal or a mixture containing a metal and a resin. Among them, metals such as platinum, platinum-iridium alloy, stainless steel, and tungsten, or conductive resins are preferably used as the material for the electrodes. When the electrodes are made of conductive resin, it is preferable to mix a contrast agent such as barium sulfate or bismuth oxide into the electrodes so that they can be seen under X-ray fluoroscopy.
[0038] The number of electrodes in the treatment section 10 is not limited, and may be, for example, 1 or more, 2 or more, 3 or more, 5 or more, 8 or more, 10 or more, 15 or more, 50 or less, 40 or less, 30 or less, 25 or less, 20 or less, etc. Depending on the purpose of use of the energy treatment device 1, the energy treatment device 1 may have a plurality of electrode groups including a plurality of electrodes. In this case, the plurality of electrode groups may be arranged on the shaft 2 at a distance from each other in the longitudinal axis direction x.
[0039] When the energy treatment device 1 has a plurality of electrodes, the electrodes may be the same or different in size. The different sizes of the electrodes refer to, for example, that the lengths of the electrodes in the longitudinal axis direction x are different.
[0040] As shown in FIG. 1, the energy treatment device 1 may have a tip 12. Examples of the tip 12 include a hollow tube member, a hemispherical member, a lid-shaped member, and the like connected to the distal end of the shaft 2. The tip 12 may have a through hole through which a guide wire can be inserted. By having the tip 12 in the energy treatment device 1, it is possible to prevent unexpected foreign matter such as blood from entering the inner cavity of the shaft 2 in which the conductor wires and the like are arranged when the energy treatment device 1 is used. In addition, by forming the tip 12 from a highly flexible material, it is possible to prevent the tip of the energy treatment device 1 from damaging the wall of the body cavity, such as the inner wall of the heart or blood vessel, and to improve the insertability of the energy treatment device 1 in the body cavity.
[0041] It is preferable that the tip chip 12 is disposed at the distal end of the shaft 2, and it is more preferable that the tip chip 12 is disposed at the distal opening of the shaft 2. It is preferable that the tip chip 12 is disposed so as to block the distal opening. When the distal opening is blocked by the tip chip 12, it is also possible to prevent unexpected foreign matter such as blood from entering the lumen of the shaft 2 when the energy treatment device 1 is used.
[0042] As the material constituting the distal tip 12, for example, the material constituting the shaft 2 described above can be referred to. Alternatively, the distal tip 12 can be made to function as a distal electrode by constituting the distal tip 12 with a material constituting an electrode as the treatment section 10. The distal tip 12 may function as at least one of an electrode for emitting energy for treatment, an electrode for measurement during potential measurement, a reference electrode, and an electrode for providing an electrical signal. When the distal tip 12 emits energy for treatment, the distal tip 12 can also function as the treatment section 10.
[0043] The energy treatment device 1 may have one or more conductors connected to the treatment section 10. The conductors connected to the treatment section 10 preferably extend into the inner cavity of the shaft 2 through the side holes. The conductors have a longitudinal axis direction x, and have a distal end and a proximal end in the longitudinal axis direction x. The distal end of the conductor may be connected to the inner surface of the treatment section 10. For example, when a plurality of electrodes are provided on the shaft 2 as the treatment section 10, each of the plurality of conductors may be connected to one electrode and extend into the inner cavity of the shaft 2. The proximal end of the conductor connected to the treatment section 10 is preferably connected to a terminal preferably provided on the controller.
[0044] The conductive wire may be any wire that is conductive, and may be, for example, a copper wire, an iron wire, a stainless steel wire, a piano wire, a tungsten wire, a nickel-titanium alloy wire, or the like.
[0045] In order to prevent short circuits with adjacent members, the conductor is preferably covered with a coating made of an insulating material. Examples of the coating material include 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.
[0046] The conductor and the treatment section 10 can be connected by a method such as soldering, laser welding, resistance welding, adhesion with an adhesive, etc. The conductor and the treatment section 10 may be directly connected, or may be indirectly connected via a conductive member.
[0047] Although not shown, the energy treatment device 1 may have a radiopaque marker. The radiopaque marker may be disposed on the shaft 2 or in the shaft 2 at least on the distal side or the proximal side of the treatment portion 10. 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, and tantalum.
[0048] 1, in the energy treatment device 1, a controller 18 is connected to a proximal portion of the shaft 2. The controller 18 is a portion that is held or gripped by the user of the energy treatment device 1 with the fingers.
[0049] The controller 18 has a housing 20 and an operation unit 30. The housing 20 is hollow, and a part of the operation unit 30 is housed inside the housing 20. The other part of the operation unit 30 is disposed so as to protrude outside the housing 20. In addition, a switch 40 for switching ON and OFF of the emission of energy from the treatment unit 10 is preferably disposed inside the housing 20.
[0050] As can be seen from Figs. 5 and 6, the housing 20 may have a first case body 21 and a second case body 22 that covers the first case body 21. The first case body 21 and the second case body 22 may be configured to be able to accommodate various members inside the housing 20. In Figs. 2 to 4, the first case body 21 is a member having a bottom surface 211 and a side wall 212 that extends in a direction perpendicular to the surface direction of the bottom surface 211 (a direction horizontal to the paper surface in Figs. 2 to 4). The second case body 22 may be a lid-like member and may have a bottom surface and a side wall like the first case body 21. Note that Figs. 2 to 4 show a state in which the second case body 22 is removed in order to make it easier to understand the movement of the operation unit 30. For the same reason, the shaft 2 and the tube 14 are omitted in Fig. 2, and only the housing 20, the operation unit 30, and the switch 40 of the controller 18 are shown in Figs. 3 and 4.
[0051] In order to fix the positions of various members housed in the housing 20, the housing 20 may have one or more partitions 213. In Fig. 2, the first case body 21 has a plurality of partitions 213, and the partitions 213 extend in a direction perpendicular to the surface direction of the bottom surface 211 from the bottom surface 211, similar to the side walls 212. The height of the partitions 213 can be set appropriately according to the types of members housed in the housing 20, and may be the same height as the side walls 212, or may be lower than the side walls 212.
[0052] As shown in FIG. 2, a first opening 281 connected to the shaft 2 may be provided in the distal portion of the housing 20. A second opening 282 connected to the tube 14 shown in FIG. 1 may be provided in the proximal portion of the housing 20. The tube 14 is a tube for connecting to a fluid supplier, a connector, or the like. Other members may be connected in place of the tube 14. A third opening 283 for extending members such as the lead wire 16 from inside the housing 20 to the outside of the controller 18 may be provided in the proximal portion of the housing 20. The third opening 283 may be provided so that a normal vector to the opening surface is inclined with respect to the longitudinal axis direction x.
[0053] The operation unit 30 moves in the longitudinal direction x and the radial direction y with respect to the housing 20. The operation unit 30 moves from a first position P1 to a second position P2 in the longitudinal direction x with respect to the housing 20. The operation unit 30 can move not only from the first position P1 to the second position P2, but also from the second position P2 to the first position P1. A range in which the operation unit 30 can move in the longitudinal direction x is called a movable range R of the operation unit 30. In FIG. 2, the operation unit 30 is located at the second position P2, and in FIGS. 3 to 4, the operation unit 30 is located at the first position P1. Note that in FIGS. 2 to 4, the first position P1 and the second position P2 are determined based on the position of the proximal end 301 of the operation unit 30, but they may be determined based on the position of the distal end 302 or other positions.
[0054] In the energy treatment device 1, moving the operation unit 30 from the first position P1 to the second position P2, or from the second position P2 to the first position P1, means moving at least a part of the operation unit 30 in the longitudinal axis direction x with respect to the housing 20. In this case, although only a part of the operation unit 30 may be moved in the longitudinal axis direction x with respect to the housing 20, it is preferable to move the entire operation unit 30 in the longitudinal axis direction x with respect to the housing 20 as shown in Figs. 2 to 4.
[0055] In the energy treatment device 1, moving the operation unit 30 inward in the radial direction y with respect to the housing 20 while the operation unit 30 is located at the first position P1 means moving at least a part of the operation unit 30 inward in the radial direction y with respect to the housing 20. In this case, only a part of the operation unit 30 may be moved inward in the radial direction y with respect to the housing 20, or the entire operation unit 30 may be moved inward in the radial direction y with respect to the housing 20. When only a part of the operation unit 30 is moved inward in the radial direction y, it is preferable that the position of the other part of the operation unit 30 with respect to the housing 20 is fixed.
[0056] In the energy treatment device 1, when the operating unit 30 is located at the second position P2 as shown in FIG. 2, the energy for treatment is not discharged from the treatment unit 10. As shown in FIG. 3, the operating unit 30 is moved proximally with respect to the housing 20, that is, in the direction indicated by the arrow A, from the second position P2 to the first position P1, and then, when the operating unit 30 is moved inward in the radial direction y with respect to the housing 20, that is, in the direction indicated by the arrow B, with the operating unit 30 located at the first position P1 as shown in FIG. 4, the energy for treatment is discharged from the treatment unit 10. In this way, in the energy treatment device 1, when the user wants to discharge energy from the treatment unit 10 during treatment, the user must move the operating unit 30 from the second position P2 to the first position P1 and then move the operating unit 30 inward in the radial direction y. By intentionally making the operation complicated so that energy can be discharged only after the operating unit 30 is operated in two stages, it is possible to prevent the energy for treatment from being discharged to tissue other than the lesion due to an erroneous operation of the controller 18. Therefore, it is possible to obtain a highly safe energy treatment device 1 that can prevent damage to tissue other than the affected area.
[0057] 2 to 5, the housing 20 may have a fourth opening 284 on the outside in the radial direction y. A part of the operation unit 30 is housed in the housing 20, and the other part of the operation unit 30 is exposed to the outside from the fourth opening 284 of the housing 20. The operation unit 30 can be moved in the longitudinal axis direction x or the radial direction y by a user touching the part of the operation unit 30 that is exposed to the outside of the housing 20. The shape of the operation unit 30 is not particularly limited, and may have a longitudinal direction along the longitudinal axis direction x of the shaft 2, for example.
[0058] The configuration for discharging energy from the treatment unit 10 by operating the operation unit 30 can be exemplified as follows. The operation unit 30 has a first contact portion, for example, a first protrusion 31, on the inside in the radial direction y, and the controller 18 has a second contact portion, for example, an actuator 41, which contacts the first contact portion at a position facing the first contact portion in the housing 20. When the operation unit 30 is moved inward in the radial direction y with respect to the housing 20 while the operation unit 30 is located at the first position P1, the first contact portion and the second contact portion come into contact with each other, and when the operation unit 30 is moved inward in the radial direction y with respect to the housing 20 while the operation unit 30 is located at the second position P2, it is preferable that the first contact portion does not come into contact with the second contact portion. In this way, energy can be discharged from the treatment unit 10 by contacting the first contact portion of the operation unit 30 with the second contact portion in the housing 20. A more detailed explanation will be given with reference to Figs. 2 to 4.
[0059] In FIG. 2, the switch 40 is accommodated in the housing 20. The switch 40 is disposed inward in the radial direction y from the operation unit 30. The switch 40 has an actuator 41 (second contact portion) on the side facing the operation unit 30. The switch 40 has a first terminal 401, a second terminal 402, and a third terminal 403 as connection terminals. The first terminal 401 is connected to a conductor 15 connected to the treatment unit 10. The second terminal 402 and the third terminal 403 are preferably connected to an external device such as a power supply device via conductors 161 and 162, respectively. When the switch 40 is in an OFF state, the first terminal 401 and the second terminal 402 are connected so as to be conductive inside the switch 40, and when the switch 40 is in an ON state, the first terminal 401 and the third terminal 403 are connected so as to be conductive. The operation unit 30 has a first protrusion 31 (first contact portion) at a position facing the actuator 41 on the inner side in the radial direction y. When the operation unit 30 is moved inward in the radial direction y with respect to the housing 20 while it is positioned at the first position P1, the first convex portion 31 comes into contact with the actuator 41 and pushes the actuator 41 inward in the radial direction y, thereby turning on the switch 40 and controlling to release energy from the treatment unit 10. In contrast, when the operation unit 30 is positioned at the second position P2 as shown in Fig. 2, the first convex portion 31 (first contact portion) and the actuator 41 (second contact portion) do not come into contact with each other, and the actuator 41 cannot be pushed in, so the switch 40 remains OFF and energy is not released from the treatment unit 10.
[0060] The operation unit 30 may have a protrusion 35 at a distal portion in the longitudinal direction that is in contact with the user's finger. By providing the protrusion 35 on the operation unit 30, the user can operate the operation unit 30 by the sensation of the fingertips without checking the hand. The protrusion 35 is preferably arranged on a portion exposed from the housing 20, and more preferably arranged on a portion protruding outward in the radial direction y from the housing 20. In FIG. 2, the protrusion 35 is formed in a hemispherical shape, but the shape is not particularly limited and may be linear. In the radial direction y, the outer end of the protrusion 35 is preferably located at the outermost position of the controller 18. This makes it easier for the protrusion 35 to come into contact with the user's finger, making it easier to operate the operation unit 30 by the sensation of the fingertips alone.
[0061] With the operating unit 30 located at the first position P1, the first convex portion 31 may be disposed proximal to the distal end 302 of the operating unit 30. In addition, the first convex portion 31 may be disposed proximal to the outer end of the projection 35, or may be disposed proximal to the proximal end of the projection 35.
[0062] As can be seen from FIG. 2 to FIG. 4, the housing 20 has a recess 25 recessed in the radial direction y, the operation unit 30 has a protrusion (second protrusion 32) protruding inward in the radial direction y, and it is preferable that the protrusion (second protrusion 32) is inserted into the recess 25 when the operation unit 30 is moved inward in the radial direction y with respect to the housing 20. The recess 25 is disposed at the distal portion of the controller 18. The second protrusion 32 is disposed at the distal end portion of the operation unit 30. By providing the recess 25 and the second protrusion 32 in this manner, when the operation unit 30 is moved inward in the radial direction y with the operation unit 30 positioned at the first position P1 with respect to the housing 20, the second protrusion 32 hits the recess 25, so that the switch 40 can be turned on while preventing the operation unit 30 from being pushed inward excessively in the radial direction y. Note that FIG. 2 shows an example in which the recess 25 is formed in the housing 20 by the case of the switch 40 and the partition 213. The second convex portion 32 is preferably disposed at the most distal portion of the operating portion 30. In addition, the second convex portion 32 is preferably disposed distal to the outer end of the projection 35, and more preferably disposed distal to the distal end of the projection 35.
[0063] 2 to 4, the housing 20 has a groove 26 extending in the longitudinal direction, and the operation unit 30 has a proximal extension portion 36 that is located at the proximal end in the longitudinal direction and extends toward the proximal side. The proximal extension portion 36 is inserted into the groove 26. Since the proximal extension portion 36 remains inserted into the groove 26 within the movable range R of the operation unit 30, it is possible to prevent the operation unit 30 from falling outward in the radial direction y from the housing 20 during use.
[0064] 2 to 4, the operation unit 30 has a recess 37 on the outer surface of the proximal extension 36 in the radial direction y. The housing 20 has a protrusion 27 on the inner surface of the side wall 212 at a position facing the operation unit 30. The protrusion 27 protrudes inward in the radial direction y. The protrusion 27 is disposed on the side wall 212 that defines the groove 26. The proximal extension 36 is provided with the recess 37, so that the third protrusion 33 protrudes outward in the radial direction y from the recess 37 on the proximal side. For this reason, in order to move the operation unit 30 from the first position P1 to the second position P2, it is necessary to push the operation unit 30 in the proximal direction so that the third protrusion 33 overcomes the protrusion 27. In this way, the third protrusion 33 and the protrusion 27 have a non-slip function, so that the operation unit 30 is less likely to slide relative to the housing 20, and it is possible to prevent the operation unit 30 from easily moving from the second position P2 to the first position P1.
[0065] As shown in Figs. 2 to 4, the controller 18 is preferably housed in the housing 20 and has a spring member 45 for biasing the operation unit 30 to the distal side. Also, as shown in Figs. 3 to 4, it is preferable that the operation unit 30 moves from the second position P2 to the first position P1 by pushing the spring member 45 to the proximal side by the operation unit 30. On the other hand, in a state where the user is not operating the operation unit 30, for example, in a state where the operation unit 30 is not touched or is not moved, it is preferable that the operation unit 30 is biased to the distal side by the spring member 45 and is located at the second position P2. This allows the user to prevent energy from being released from the treatment unit 10 by a simple operation of releasing the finger from the operation unit 30. This makes it easier to prevent the energy for treatment from being released to tissue other than the lesion due to an erroneous operation of the controller 18.
[0066] The type of the spring member 45 is not particularly limited, but may be, for example, a coil spring, particularly a compression coil spring. The direction of expansion and contraction of the spring member 45 is preferably along the longitudinal axis direction x, but may be inclined with respect to the longitudinal axis direction x. The spring member 45 has a first end and a second end in the expansion and contraction direction, and it is preferable that the first end contacts the operating unit 30 and the second end contacts the housing 20. The proximal end of the spring member 45 may contact the partition 213.
[0067] The operation section 30 may have a fourth convex portion 34 that protrudes inward in the radial direction y and is in contact with the distal end of the spring member 45. The fourth convex portion 34 is preferably disposed between the first convex portion 31 and the proximal extension portion 36 in the longitudinal direction. The inner end of the fourth convex portion 34 is preferably disposed at the innermost position of the operation section 30 in the radial direction y. In order to make it easier to push in the spring member 45 by the fourth convex portion 34, the length of the fourth convex portion 34 in the radial direction y is preferably longer than the diameter of the spring member 45.
[0068] 2 to 4, the spring member 45 is preferably disposed radially inward of the proximal extension portion 36 in the y direction. By disposing the spring member 45 in this manner, the proximal extension portion 36 can cover the spring member 45, and therefore, the spring member 45 can be prevented from falling out of the housing 20 even when the operating unit 30 is moved.
[0069] In the longitudinal axis direction x, the operation unit 30 is preferably arranged in the order of the second convex portion 32, the first convex portion 31, the fourth convex portion 34, and the third convex portion 33 from the distal side to the proximal side. By setting the positions of the convex portions in this manner, it becomes easier to move the operation unit 30 while preventing the operation unit 30 from falling off the housing 20.
[0070] In the radial direction y, the inner end of the second convex portion 32 of the operating part 30 is preferably located further inward than the inner end of the first convex portion 31 of the operating part 30. By setting the positional relationship of the convex portions in this manner, it becomes easier to turn on the switch 40 to release energy while preventing the operating part 30 from being pushed excessively inward in the radial direction y.
[0071] The materials of the housing 20 and the operation unit 30 are not particularly limited, but are preferably made of synthetic resin because precision machining is easy. When the housing 20 has a first case body 21 and a second case body 22, at least one of the first case body 21 and the second case body 22 may be made of a transparent or semi-transparent material. This makes it easier for the user to move the operation unit 30 while visually checking it.
[0072] The type of switch 40 in the controller 18 is not particularly limited, but a microswitch, for example, may be used. The type of actuator of the microswitch is also not limited, and may be a push button type as shown in Figures 2 to 4, a hinge lever type, or other types.
[0073] 3 and 4, the first position P1 is preferably located on the proximal side of the movable range R of the operation unit 30 relative to the housing 20 in the longitudinal axis direction x. By setting the first position P1 in this manner, the user can perform the first step of releasing energy from the treatment unit 10 by intuitively moving the operation unit 30 to the proximal side.
[0074] 2, the second position P2 is preferably located on the distal end side of the movable range R of the operation unit 30 relative to the housing 20 in the longitudinal axis direction x. By setting the second position P2 in this manner, the user can prevent energy from being released from the treatment unit 10 by a simple operation of moving the operation unit 30 to the distal end side. Therefore, the user can easily move the operation unit 30 to the second position P2 without checking his / her hand.
[0075] It is preferable that the operation unit 30 does not move proximally beyond the first position P1 in the longitudinal axis direction x, and does not move distally beyond the second position P2. When the user is not operating the operation unit 30, it is preferable that the operation unit 30 stops at the second position P2.
[0076] 2, it is preferable that therapeutic energy is not released from the treatment unit 10 even if the operating unit 30 is moved inward in the radial direction y with respect to the housing 20 while the operating unit 30 is located at the second position P2. This makes it possible to prevent therapeutic energy from being released to tissues other than the lesion due to erroneous operation of the controller 18. An example of such a configuration is one in which, when the operating unit 30 is at the second position P2, the first convex portion 31 of the operating unit 30 is located at a position that does not overlap with the actuator 41 of the switch 40, and the actuator 41 cannot be pressed by the first convex portion 31 even if the operating unit 30 is moved inward in the radial direction y.
[0077] As can be seen from Fig. 2, it is preferable that the operation unit 30 does not move inward in the radial direction y with respect to the housing 20 when the operation unit 30 is located at the second position P2. When the operation unit 30 does not move inward in the radial direction y, the operation unit 30 cannot press the switch 40, and therefore it is possible to prevent energy from being released from the treatment unit 10 when the operation unit 30 is located at the second position P2. An example of such a configuration is one in which the second convex portion 32 abuts against a partition 213 as shown in Fig. 2, so that the operation unit 30 cannot be moved inward in the radial direction y.
[0078] It is preferable that the treatment energy is released from the treatment unit 10 only when the operation unit 30 is positioned at the first position P1. In other words, it is preferable that the treatment energy is not released from the treatment unit 10 when the operation unit 30 is positioned at any position other than the first position P1. For example, it is preferable that the treatment energy is not released from the treatment unit 10 when the operation unit 30 is positioned at any third position between the first position P1 and the second position P2 in the longitudinal axis direction x. By making it possible to release energy only when the operation unit 30 is at the second position P2 in this way, it is possible to further improve safety. Specifically, it is preferable that the treatment energy is not released from the treatment unit 10 even if the operation unit 30 is moved inward in the radial direction y with respect to the housing 20 when the operation unit 30 is positioned at any position other than the first position P1. It is also preferable that the operation unit 30 is not moved inward in the radial direction y with respect to the housing 20 when the operation unit 30 is positioned at any position other than the first position P1.
[0079] As shown in FIG. 4, when the operation unit 30 is moved inward in the radial direction y with respect to the housing 20 while the operation unit 30 is located at the first position P1, it is preferable that a part of the operation unit 30 bends. By configuring the operation unit 30 in this manner, the operation unit 30 can be moved inward in the radial direction y with the other parts of the operation unit 30 fixed in the housing 20, so that it is possible to prevent the operation unit 30 from falling off from the housing 20. A first end of the operation unit 30 in the longitudinal axis direction x may be fixed to the housing 20, and a second end may be elastically deformed with the first end side as a fulcrum. For example, in FIG. 4, the proximal extension part 36 of the operation unit 30 is inserted into the groove 26, so that the distal side of the operation unit 30 is elastically deformed with the proximal extension part 36 side as a fulcrum.
[0080] As shown in Fig. 1, the housing 20 has a finger hook 24 on which the user's fingers can be hooked, and the operation unit 30 is preferably located on the opposite side of the finger hook 24 in the radial direction y. Such a shape of the housing 20 makes it easier for the user to grip the controller 18, and therefore easier to operate the operation unit 30. For example, the controller 18 can be gripped so that the thumb touches the operation unit 30 and the index finger touches the finger hook 24. The outer surface of the finger hook 24 may be provided with projections and recesses to prevent slipping. The projections and recesses may be linear or dot-like. [Explanation of symbols]
[0081] 1: Energy treatment device 2: Shaft 10: Treatment department 18: Controller 20: Cabinet 24: Finger rest part 25: Recess 30:Operation unit 31: First convex part 32: Second convex part 40: Switch 41: Actuator 45: Spring material x: Longitudinal direction y: radial direction P1: 1st position P2: 2nd position
Claims
1. a shaft having a longitudinal direction and a radial direction; A treatment section disposed at a distal portion of the shaft and emitting therapeutic energy; a controller connected to a proximal portion of the shaft, the controller having a housing and an operation unit movable in the longitudinal axis direction and the radial direction relative to the housing; the operation unit is movable from a first position to a second position in the longitudinal axis direction relative to the housing, When the operation unit is moved inward in the radial direction with respect to the housing while the operation unit is located at the first position, energy for treatment is released from the treatment unit, The energy treatment device in which, when the operation section is located at the second position, therapeutic energy is not emitted from the treatment section.
2. The energy treatment device according to claim 1 , wherein the first position is located on a proximal side of a movable range of the operation unit relative to the housing in the longitudinal axis direction.
3. The energy treatment device according to claim 1 or 2, wherein the second position is located on the most distal side of a movable range of the operation unit relative to the housing in the longitudinal axis direction.
4. The energy treatment device according to claim 1 or 2, wherein even if the operating section is moved radially inward relative to the housing while the operating section is positioned at the second position, therapeutic energy is not released from the treatment section.
5. The energy treatment device according to claim 1 or 2, wherein the operation section does not move radially inward relative to the housing when the operation section is located at the second position.
6. 3. The energy treatment device according to claim 1, wherein the housing has a recess recessed in the radial direction, the operation unit has a protrusion protruding inward in the radial direction, and when the operation unit is moved inward in the radial direction relative to the housing, the protrusion is inserted into the recess.
7. The energy treatment device according to claim 1 or 2, wherein when the operation section is moved radially inward with respect to the housing while the operation section is positioned at the first position, a portion of the operation section bends.
8. The operation portion has a first contact portion on the inner side in the radial direction, the controller has a second contact portion at a position facing the first contact portion inside the housing, When the operation unit is moved radially inward with respect to the housing while the operation unit is positioned at the first position, the first contact portion and the second contact portion come into contact with each other, 3. The energy treatment device according to claim 1, wherein even when the operating portion is moved radially inward relative to the housing while being positioned at the second position, the first contact portion does not come into contact with the second contact portion.
9. The controller includes a spring member that is housed in the housing and biases the operation unit toward a distal side, The energy treatment device according to claim 1 or 2, wherein the operation portion moves from the second position to the first position by pushing the spring member proximally with the operation portion.
10. The housing has a finger hook portion on which a user's fingers can be hooked, The energy treatment device according to claim 1 or 2, wherein the operation portion is located on an opposite side to the finger grip portion in the radial direction.
Citation Information
Patent Citations
Ultrasound device that can be operated with your fingertips
JP2012501805A