Medical device
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-01-28
- Publication Date
- 2026-08-13
Smart Images
Figure JP2026002849_13082026_PF_FP_ABST
Abstract
Description
Medical device
[0001] The present invention relates to a medical device for puncturing and cutting a biological membrane.
[0002] When an injury (entry) occurs in the inner membrane of the aorta, blood may flow between the inner membrane and the middle membrane or between the middle membrane and the outer membrane from the injury, and aortic dissection may occur in which a false lumen different from the true lumen is formed. For the treatment of aortic dissection, a technique of cutting the biological membrane, which is the blood vessel wall separating the true lumen and the false lumen, to make the lumen into one and implanting a stent graft is known. Patent Document 1 discloses a device for cutting the biological membrane of the aorta.
[0003] The device described in Patent Document 1 has a hook-shaped conductive wire. The conductive wire has a conduction part inside the hook. When cutting the biological membrane that has undergone aortic dissection with this device, the device is passed from the true lumen side to the false lumen side, the hook-shaped conductive wire is hooked on the biological membrane, an electric current is passed through from the conduction part to cauterize the biological membrane, and the biological membrane is cut from the central side to the peripheral side.
[0004] U.S. Patent No. 9,387,039
[0005] When cutting the biological membrane caused by arterial dissection with the device described in Patent Document 1, it is necessary to puncture the biological membrane with another device in order to pass the device from the true lumen side to the false lumen side. Therefore, the procedure takes time and the burden on the patient is large.
[0006] The present invention has been made to solve the above-described problems, and an object thereof is to provide a medical device capable of performing puncturing and cutting of a biological membrane with one device.
[0007] The above objective is achieved by the invention described in (1) below. (1) The medical device according to the present invention is a long medical device comprising a long shaft and an electrode portion, wherein the shaft has a long shaft body including a proximal end and a distal end, and an extending portion that protrudes laterally from the distal end of the shaft body and extends toward the proximal end of the shaft body, the extending portion has a first end connected to the distal end of the shaft body, a second end located on the opposite side of the first end in the extending direction of the extending portion, and a long axis extending from the first end to the second end, the electrode portion has a puncture portion located at the distal end of the medical device that can cauterize and puncture a biological membrane by applying an electric current, and a cutting portion that contacts the biological membrane proximal to the puncture portion when the medical device is pulled toward the proximal side and can cauterize and cut the biological membrane by applying an electric current, and at least a part of the cutting portion is arranged on the surface of the extending portion between the first end and the second end, on the side of the central axis of the shaft body relative to the long axis of the extending portion.
[0008] The medical device described in (1) above can puncture biological membranes by cauterizing them with a puncture site located at its distal end, and can also cut biological membranes by cauterizing them with a cutting site when the medical device is pulled proximal. Therefore, the medical device can perform both puncture and cutting of biological membranes with a single device.
[0009] (2) In the medical device described in (1) above, the electrode portion may have a first electrode and a second electrode, wherein the first electrode is the puncture portion and the second electrode is the cutting portion. In this way, the medical device can puncture by cauterizing the biological membrane with the first electrode and cut by cauterizing the biological membrane with the second electrode.
[0010] (3) In the medical device described in (1) or (2) above, the puncture portion and the cutting portion may be a single electrode. This makes it easier to create the shaft.
[0011] (4) In the medical device described in any one of (1) to (3) above, the first end may be located at the distal end of the shaft body. This makes it easier to manufacture the shaft as the extended portion and the shaft body form a single continuous elongated member. In addition, the length required to insert the entire extended portion into the punctured hole in the biological membrane can be shortened, making the procedure easier.
[0012] (5) In the medical device described in any one of (1) to (4) above, the medical device has a sheath having a lumen capable of housing the shaft, the sheath has a side hole from which the lumen opens laterally, and the cutting portion located on the extended portion may be able to protrude laterally from the sheath through the side hole. This allows the medical device to house the cutting portion in the sheath when performing a puncture and to protrude the cutting portion from the side hole of the sheath when performing a cut. As a result, the cutting portion is less exposed to blood during puncture, and the formation of thrombi at the cutting portion can be suppressed. Furthermore, since the medical device can house the extended portion extending from the shaft body in the sheath, the movement of the shaft within the blood vessel is facilitated.
[0013] (6) In the medical device described in (5) above, the sheath has a distal opening at its distal end through which the lumen opens, and when the puncture portion located at the distal end of the shaft protrudes distal to the sheath through the distal opening, the cutting portion is stored in the sheath, and when the cutting portion located at the extension portion protrudes laterally to the sheath through the side hole, the puncture portion may be stored in the sheath. This allows the medical device to protrude the puncture portion from the distal opening and store the cutting portion in the sheath when performing a puncture, and to protrude the cutting portion from the side hole of the sheath and store the puncture portion in the sheath when performing a cut. As a result, the cutting portion is less exposed to blood during puncture, and the formation of thrombi at the cutting portion can be suppressed.
[0014] (7) In the medical device described in (5) or (6) above, at least a portion of the extension on the second end side may be bent in a direction away from the central axis of the shaft body. This makes it easier for the extension to enter the side hole from the second end side.
[0015] (8) In the medical device described in any one of (5) to (7) above, the electrode portion comprises a first electrode which is the puncture portion and a second electrode which is the cutting portion, and the first electrode may be positioned at the distal end of the sheath. This allows the medical device to puncture the biological membrane by cauterizing it by moving the sheath distally and bringing the first electrode at the distal end into contact with the biological membrane.
[0016] (9) In the medical device described in (8) above, the shaft body may be provided with a conductive portion at its distal end that can conduct electricity with the first electrode. This allows the medical device to easily conduct electricity with the first electrode located at the distal end of the sheath by moving the shaft body distally within the lumen of the sheath.
[0017] (10) In the medical device described in (9) above, the shaft body is slidable relative to the sheath in a direction along the central axis when housed in the sheath, and when the first electrode and the conductive portion come into contact, the conductive portion energizes the first electrode, the second electrode is housed in the sheath, and when the second electrode, which is positioned on the extended portion, protrudes laterally from the sheath through the side hole of the sheath, the first electrode and the conductive portion may be separated. As a result, when the first electrode is used to puncture a biological membrane, the second electrode is housed in the sheath, and when the second electrode is used to cut a biological membrane, the first electrode is not energized. Therefore, the formation of blood clots caused by the electrode not used for puncturing or cutting the biological membrane energizing the blood can be suppressed.
[0018] (11) In the medical device described in (1) or (2) above, the shaft has a shaft lumen, the electrode portion has a first electrode which is the puncture portion and a second electrode which is the cutting portion, the first electrode is positioned at the distal end of the shaft body, the medical device has a long energizing shaft having an energizing portion which is slidable within the shaft lumen and is energizable to the first electrode and the second electrode, the energizing portion of the energizing shaft is energizable to the first electrode or the second electrode at different positions in the sliding direction of the shaft lumen, and as the energizing portion moves from a position where it is energized with the first electrode to a position where it is energized with the second electrode, the shaft may be deformed by a force from the energizing shaft and the second end may be displaced in a direction away from the surface of the shaft body. This makes it possible to energize only the electrode used for puncturing or cutting a biological membrane without introducing blood into the shaft lumen. Therefore, it is possible to suppress the formation of thrombi due to electrical current flow in the shaft lumen by allowing blood to flow into the shaft lumen, and also to suppress the formation of thrombi due to electrical current flowing through the blood by the electrode that is not used for puncturing or cutting biological membranes.
[0019] (12) In the medical device described in any one of (1) to (11) above, the second end of the extension portion may be displaceable in a direction toward or toward the central axis of the shaft body. This allows the second end of the extension portion to be brought toward the central axis of the shaft body when puncturing a biological membrane with the puncture portion, thereby suppressing the extension portion from affecting the puncture, and when cutting a biological membrane with the cutting portion, the second end of the extension portion to be moved toward the central axis of the shaft body, thereby ensuring that the cutting portion makes reliable contact with the biological membrane.
[0020] (13) In the medical device described in any one of (1) to (12) above, the biomembrane may be a biomembrane that separates the true lumen and false lumen of the aortic dissection. This allows the medical device to puncture and cut the biomembrane separating the true lumen and false lumen with a single device, thereby combining the true lumen and false lumen of the aortic dissection into a single lumen.
[0021] This is a plan view showing a medical system including a medical device according to the first embodiment. This is a cross-sectional view showing the distal part of the medical device according to the first embodiment, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a schematic diagram showing a state in which the medical system including the medical device is being used. This is a cross-sectional view showing the first modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the second modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the third modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the distal part of the medical device according to the second embodiment, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the fifth modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the sixth modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the seventh modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the eighth modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the ninth modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the distal part of the medical device according to the third embodiment, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut. This is a cross-sectional view showing the tenth modified example, where (A) shows a state in which it can be punctured and (B) shows a state in which it can be cut.
[0022] Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensions in the drawings may be exaggerated for illustrative purposes and may differ from the actual dimensions. Furthermore, in this specification and the drawings, components having substantially the same function are denoted by the same reference numerals to avoid redundant explanations. In this specification, the side inserted into the lumen of a medical device will be referred to as the distal side, and the side operated will be referred to as the proximal side.
[0023] <First Embodiment> The medical device 10 according to the first embodiment of the present invention is a medical device that has both the function of puncturing a biological membrane 200 that is the target of treatment and the function of cutting the biological membrane 200 through a puncture hole formed in the biological membrane 200. The medical device 10 is suitably usable for puncturing and cutting the biological membrane 200 that separates the true lumen 201 and the false lumen 202 in the treatment of aortic dissection. The biological membrane 200 that separates the true lumen 201 and the false lumen 202 in aortic dissection is the intima and media of the aortic vessel wall. Note that the biological membrane 200 is not limited to the intima and media that separate the true lumen 201 and the false lumen 202 of the aorta, but may be, for example, cerebral artery dissection, visceral artery dissection, etc.
[0024] As shown in Figures 1-2, the medical device 10 according to the first embodiment includes a long sheath 20 with a proximal end 31 and a distal end 32, a shaft 30 that allows the lumen 21 of the sheath 20 to move in the longitudinal direction relative to the sheath 20, an electrode portion 40 for puncturing or cutting a biological membrane 200, and an operating portion 50. The medical device 10 is used together with a guiding catheter 60 having a lumen into which the medical device 10 can be inserted, and a current supply device 70 that supplies current to the electrode portion 40 of the medical device 10, in order to deliver the medical device 10 to the desired location. The guiding catheter 60 is, for example, a steerable sheath whose distal end direction can be manipulated, but is not limited thereto. The guiding catheter 60 is used to hold the medical device 10 in the appropriate position near the biomembrane 200 to be punctured and cut. Its length is shorter than that of the medical device 10, and when the medical device 10 is inserted into the lumen of the guiding catheter 60, the operating section 50 is positioned proximal to the proximal end of the guiding catheter 60, and the tip of the medical device 10 protrudes beyond the tip of the guiding catheter 60. The medical device 10, the guiding catheter 60, and the current supply device 70 form a single medical system 1.
[0025] The electrode section 40 has a first electrode 41, which is a puncture section located at the distal end of the medical device 10 and burns and punctures the biological membrane 200 by applying an electric current, and a second electrode 42, which is a cutting section that burns and cuts the biological membrane 200 by applying an electric current, and each is a monopolar electrode. In this embodiment, the first electrode 41 (puncture section) is positioned at the distal end of the sheath 20, thereby being positioned at the distal end of the medical device 10. The first electrode 41 (puncture section) may also be positioned on the shaft 30, as in other embodiments and modifications described later. The first electrode 41 is formed to reach from the outer surface to the inner surface of the distal end of the sheath 20.
[0026] The shaft 30 has a long shaft body 33 including a proximal end 31 and a distal end 32, and an extended portion 34 extending from the distal portion of the shaft body 33. The shaft body 33 is formed to be long and has a central axis 39 extending from the proximal end 31 to the distal end 32.
[0027] The proximal portion of the shaft body 33 is located inside the operating section 50. The shaft body 33 is formed by covering a conductor, such as copper, stainless steel, or nickel-titanium alloy, with an insulator. The shaft body 33 has a conductive portion 35 at its distal end where the insulator is removed and the conductor is exposed. The shaft body 33 can conduct current supplied to the conductor inside the operating section 50 to the conductive portion 35 at its distal end. The conductive portion 35 can contact and conduct electricity with the first electrode 41 located at the distal end of the lumen 21 of the sheath 20.
[0028] The extended portion 34 extends from the distal end of the shaft body 33, protruding laterally toward the proximal end 31 of the shaft body 33. In this embodiment, the extended portion 34 is formed by bending a single, integral wire from the distal end of the shaft body 33. This simplifies manufacturing. The extended portion 34 is formed from a conductor and an insulator that are continuous with the shaft body 33. The extended portion 34 is formed to be elongated, having a first end 36 connected to the distal end of the shaft body 33, a second end 37 located on the opposite side of the first end 36 in the direction of extension of the extended portion 34, and a long axis 38 extending from the first end 36 to the second end 37. The long axis 38 extends so as to pass through the axial center of the elongated extended portion 34. Between the first end 36 and the second end 37 of the extended portion 34, a second electrode 42 (cut portion) is positioned where the insulator is removed and the conductor is exposed. The second electrode 42 (cut portion) may be formed such that there is no step between it and the insulator, with an additional conductor wound around the conductor that is exposed after the insulator has been removed. At least a portion of the second electrode 42 is positioned on the surface of the extended portion 34 on the side of the central axis 39 of the shaft body 33 that is closer to the long axis 38 of the extended portion 34. That is, the second electrode 42 is positioned on the surface of the extended portion 34 on the side facing the shaft body 33. The second electrode 42 may be positioned on the opposite side of the surface of the extended portion 34 from the side facing the shaft body 33, but it is preferable that it is not positioned there.
[0029] Furthermore, since the conductive portion 35 and the second electrode 42 are formed by removing the insulating layer covering the conductor of the shaft 30, a common current is supplied to them. However, the conductive portion 35 and the second electrode 42 may be formed by other structures. For example, the conductive conductive portion 35 and the second electrode 42 may be arranged on an insulating, elongated shaft 30, and an electric wire extending along the shaft 30 from the proximal side of the shaft 30 may be connected to them.
[0030] The sheath 20 has a lumen 21 capable of housing the shaft 30 and a side hole 22 through which the lumen 21 is open to the outside. The proximal end of the sheath 20 is connected to the operating section 50. The lumen 21 is formed distally from the proximal end of the sheath 20. The distal end of the sheath 20 is closed, with the first electrode 41 positioned there, and the lumen 21 does not open. The side hole 22 is a portion of the lumen 21 that opens laterally at a predetermined length from the distal end of the sheath 20 toward the proximal side. The predetermined length is preferably 10 mm to 50 mm, and more preferably 20 mm to 30 mm. It is preferable that the side hole 22 is formed so as to extend from the inner surface of the lumen 21 of the sheath 20 toward the outer surface while moving proximal. That is, the side hole 22 opens proximal while being inclined with respect to the axis of the sheath 20. The side hole 22 has a curved surface that gradually increases in inclination angle from the tip side to the proximal end side so that the extended portion 34 can smoothly adhere to it. As a result, the side hole 22 adheres closely to the outer surface of the extended portion 34 that is housed within it, suppressing the inflow of blood and other fluids from the outside into the lumen 21. When the shaft 30 is in the most distal position in the lumen 21 of the sheath 20 (when the conductive portion 35 is in contact with the first electrode 41), it is preferable that a part of the extended portion 34 is positioned in the side hole 22. This prevents the extended portion 34 from falling out of the side hole 22 and makes it easy to move the extended portion 34 along the side hole 22. In addition, since the side hole 22 is always sealed by the extended portion 34, the inflow of blood into the lumen 21 can be effectively suppressed. The shape of the side hole 22 is not particularly limited and may, for example, be formed to penetrate perpendicularly through the inner and outer surfaces of the sheath 20. The sheath 20 is preferably made of a resin material that has a certain degree of flexibility. The sheath 20 may have coils, braided tubes, or the like embedded as reinforcing elements.
[0031] The operating unit 50 includes a casing 51 connected to the base end of the sheath 20, a shaft operating unit 52 connected to the base end of the shaft body 33 and movable relative to the casing 51, and a cable 53 led out from the casing 51 and connectable to the current supply device 70. The shaft operating unit 52 is slidable relative to the casing 51 along the central axis 39 of the shaft body 33. The wires of the cable 53 are electrically connected to the conductor at the proximal end of the shaft body 33. The current supply device 70 is capable of supplying high-frequency current to conduct electricity between the first electrode 41 or the second electrode 42 and a counter electrode plate (not shown) provided outside the body.
[0032] Next, a method for using the medical device 10 according to the first embodiment will be described.
[0033] As shown in Figure 3, the surgeon inserts the guiding catheter 60 percutaneously into the blood vessel, bringing the tip of the guiding catheter 60 close to the blood vessel where the aortic dissection occurred. Next, as shown in Figures 2(A) and 3, the surgeon inserts the medical device 10, with the extended portion 34 of the shaft 30 housed in the sheath 20, into the guiding catheter 60, allowing the distal portion of the medical device 10 to protrude from the tip of the guiding catheter 60 and position it within the true lumen 201 of the blood vessel where the aortic dissection occurred. At this time, the conductive portion 35 of the shaft 30 is electrically connected to the first electrode 41 located in the sheath 20. Next, the surgeon brings the first electrode 41, located at the distal end of the sheath 20, into contact with the planned puncture site of the biomembrane 200 separating the true lumen 201 and the false lumen 202.
[0034] Next, the surgeon pushes the first electrode 41 in while supplying high-frequency current from the current supply device 70 to the first electrode 41 via the conductor and conductive part 35 of the shaft 30. The first electrode 41, which is the puncture site, cauterizes the biological membrane 200 by current flowing between it and the counter electrode plate, thereby puncturing the biological membrane 200. The second electrode 42 is housed in the sheath 20 and therefore does not conduct electricity to the blood vessel wall or blood. This prevents the blood in contact with the second electrode 42 from being heated and forming a thrombus. After a puncture hole is formed in the biological membrane 200 by the first electrode 41, the surgeon stops supplying current from the current supply device 70 to the first electrode 41. The surgeon pushes the distal part of the medical device 10 inward until the side hole 22 passes through the puncture hole formed by the puncture and reaches the false lumen 202. Here, the sheath 20 may have an X-ray contrast marker at the position of the side hole 22 so that its position can be confirmed under an X-ray image.
[0035] Next, with the side hole 22 positioned towards the false lumen 202, the operator operates the shaft operating section 52 of the operating section 50 to move the shaft 30 proximal to the sheath 20. As a result, as shown in Figure 2(B), the conductive portion 35 of the shaft 30 separates from the first electrode 41, and the extended portion 34 protrudes from the side hole 22. This exposes the second electrode 42, which is the cut portion located on the extended portion 34, to the outside of the sheath 20 through the side hole 22.
[0036] Next, the operator pulls the medical device 10 proximal to the guiding catheter 60. At this time, the proximal end of the medical device 10 beyond the side hole 22 is located in the true lumen 201, and the distal end of the medical device 10 beyond the side hole 22 and the extended portion 34 are located in the false lumen 202. As a result, the biomembrane 200 on the proximal end of the puncture hole is sandwiched between the extended portion 34 and the sheath 20, and the second electrode 42 comes into contact with the puncture hole formed in the biomembrane 200. Next, the operator pulls the medical device 10 while supplying current from the current supply device 70 to the second electrode 42 via the conductor of the shaft 30. The second electrode 42, which is the cutting portion, cauterizes the biomembrane 200 by current flow between it and the counter electrode plate, thereby cutting the biomembrane 200. Since the extended portion 34 protrudes laterally from the side hole 22 of the sheath 20 and extends proximally, when the operator pulls the medical device 10 proximally, the biological membrane 200 is held on the side of the extended portion 34 closer to the first end 36 than to the second end 37. Therefore, even when the cutting of the biological membrane 200 is ongoing, the second electrode 42 can be maintained in contact with the biological membrane 200, allowing the cutting of the biological membrane 200 to continue. The first electrode 41 does not conduct electricity because it is away from the conductive portion 35. Therefore, even if the first electrode 41 comes into contact with the blood vessel wall, the blood vessel wall will not be cauterized. In addition, the formation of a thrombus by blood in contact with the first electrode 41 can be suppressed. The second electrode 42 is positioned between the first end 36 and the second end 37 of the extended portion 34, on the surface of the extended portion 34 on the side of the central axis 39 of the shaft body 33 relative to the long axis 38 of the extended portion 34, but not on the surface of the extended portion 34 on the opposite side of the long axis 38 relative to the central axis 39 of the shaft body 33. Therefore, the area in which the second electrode 42 is exposed to blood is limited, and the formation of a thrombus by the blood in contact with the second electrode 42 can be suppressed.
[0037] After the surgeon cuts the biological membrane 200 with the second electrode 42, the surgeon stops the supply of current from the current supply device 70 to the second electrode 42. Next, the surgeon operates the shaft operating unit 52 of the operating unit 50 to move the shaft 30 distal to the sheath 20. As a result, the second electrode 42, which is positioned on the extended portion 34 of the shaft 30, is housed in the sheath 20, as shown in Figure 2(A). The conductive portion 35 of the shaft 30 may or may not be in contact with the first electrode 41. After this, the surgeon places the medical device 10 into the guiding catheter 60 and removes it from the body.
[0038] Next, a modified example of the first embodiment will be described.
[0039] In the first modified example shown in Figure 4, the extended portion 34 of the shaft 30 extends from a position proximal to the distal end of the shaft body 33. As a result, the shaft 30 is formed without being bent at the distal end. Therefore, it is possible to prevent the shaft 30 from becoming too thick at the distal end, and thus prevent the outer diameter of the medical device 10 from becoming too thick.
[0040] In the second modified example shown in Figure 5, the conductive portion 35 and the second electrode 42, which are arranged on the shaft 30, are integrally formed. That is, the conductor is exposed from the distal end of the shaft body 33 to a position between the first end 36 and the second end 37 of the extended portion 34. Therefore, the first electrode 41, which is the puncture portion that conducts to the conductive portion 35, is formed by the second electrode 42. In other words, the puncture portion and the cutting portion are a single electrode formed by the second electrode 42. This eliminates the need to form the conductive portion 35 and the second electrode 42 separately, making it easier to manufacture the shaft 30.
[0041] In the third modified example shown in Figure 6, a wire 23 extending from the operating section 50 to the first electrode 41 is arranged in the sheath 20. The shaft 30 has a second electrode 42, but does not have a conductive portion that connects to the first electrode 41. The first electrode 41 and the second electrode 42 can each be supplied with current independently from the current supply device 70. When performing a puncture using the medical device 10 according to the third modified example, as shown in Figure 6(A), the operator energizes the first electrode 41 via the wire 23 in the sheath 20 with the extended portion 34 of the shaft 30 housed in the sheath 20. This allows the operator to cauterize and puncture the biological membrane 200 with the first electrode 41. When cutting the biological membrane 200, as shown in Figure 6(B), the operator operates the shaft operating section 52 of the operating section 50 with the side hole 22 positioned towards the false lumen 202, moving the shaft 30 proximal to the sheath 20. As a result, the extended portion 34 protrudes from the side hole 22, and the second electrode 42 positioned on the extended portion 34 is exposed to the outside of the sheath 20 through the side hole 22. This allows the surgeon to supply current from the current supply device 70 to the second electrode 42 via the conductor of the shaft 30, and to cauterize and cut the biological membrane 200 with the second electrode 42, which is the cutting portion.
[0042] The fourth modified example shown in Figure 7 differs from the third modified example only in that the extended portion 34 of the shaft 30 extends from a position proximal to the distal end of the shaft body 33. As a result, the shaft 30 is formed without being bent at the distal end. Therefore, it is possible to prevent the shaft 30 from becoming too thick at the distal end, and thus prevent the outer diameter of the medical device 10 from becoming too thick.
[0043] As described above, the medical device 10 according to the first embodiment is a long medical device 10 including a long shaft 30 and an electrode unit 40. The shaft 30 has a long shaft body 33 including a proximal end portion 31 and a distal end portion 32, and an extending portion 34 that protrudes from the distal portion of the shaft body 33 to the side of the shaft body 33 and extends toward the proximal end portion 31 side of the shaft body 33. The extending portion 34 has a first end portion 36 connected to the distal portion of the shaft body 33, a second end portion 37 located on the opposite side of the first end portion 36 in the extending direction of the extending portion 34, and a long axis 38 extending from the first end portion 36 toward the second end portion 37. The electrode unit 40 has a puncturing portion located at the distal end of the medical device 10 and capable of puncturing the biological membrane 200 by energization, and a cutting portion that contacts the biological membrane 200 on the proximal side of the puncturing portion when the medical device 10 is pulled proximally and is capable of cutting the biological membrane 200 by energization. At least a part of the cutting portion is disposed on the surface of the extending portion 34 on the central axis 39 side of the shaft body 33 rather than the long axis 38 of the extending portion 34 between the first end portion 36 and the second end portion 37. Thereby, the medical device 10 can puncture the biological membrane 200 by burning it with the puncturing portion located at the distal end, and can cut the biological membrane 200 by burning it with the cutting portion by pulling the medical device 10 proximally. For this reason, the medical device 10 can puncture and cut the biological membrane 200 with one device.
[0044] Further, the electrode unit 40 has a first electrode 41 and a second electrode 42. The first electrode 41 is the puncturing portion, and the second electrode 42 is the cutting portion. Thereby, the medical device 10 can puncture the biological membrane 200 by burning it with the first electrode 41, and can cut the biological membrane 200 by burning it with the second electrode 42.
[0045] Also, as in the second modification, the puncturing portion and the cutting portion may be a single electrode. This facilitates the creation of the shaft 30.
[0046] Further, the first end portion 36 is disposed at the distal end of the shaft body 33. Thereby, since the extending portion 34 and the shaft body 33 form a single continuous elongated member, it becomes easy to create the shaft 30. Also, the length for inserting the entire extending portion 34 into the hole punctured in the biological membrane 200 can be shortened, making the procedure easier.
[0047] Further, the medical device 10 has a sheath 20 having a lumen 21 capable of storing the shaft 30. The sheath 20 has a side hole 22 through which the lumen 21 opens to the side, and a cutting portion disposed on the extending portion 34 may be able to protrude to the side of the sheath 20 through the side hole 22. Thereby, the medical device 10 can store the cutting portion in the sheath 20 when performing puncture and protrude the cutting portion from the side hole 22 of the sheath 20 when performing cutting. For this reason, since the cutting portion is less likely to be exposed to blood during puncture, the generation of thrombus in the cutting portion can be suppressed. Also, since the medical device 10 can accommodate the extending portion 34 extending from the shaft body 33 in the sheath 20, the movement of the shaft 30 within the blood vessel becomes easy.
[0048] Further, the electrode portion 40 has a first electrode 41 which is a puncturing portion and a second electrode 42 which is a cutting portion. The first electrode 41 is disposed at the distal end of the sheath 20. Thereby, the medical device 10 can cauterize and puncture the biological membrane 200 by moving the sheath 20 distally and bringing the first electrode 41 at the distal end into contact with the biological membrane 200.
[0049] Further, the shaft body 33 is provided with a conducting portion | 35 at the distal end that can be electrically connected to the first electrode 41. Thereby, the medical device 10 can easily electrically connect the conducting portion 35 at the distal end of the shaft body 33 to the first electrode 41 disposed at the distal end of the sheath 20 by moving the shaft body 33 distally within the lumen 21 of the sheath 20.
[0050] Furthermore, when the shaft body 33 is housed in the sheath 20, it is slidable relative to the sheath 20 in a direction along the central axis 39. When the first electrode 41 and the conductive portion 35 come into contact, the conductive portion 35 energizes the first electrode 41, and the second electrode 42 is housed in the sheath 20. When the second electrode 42, which is positioned on the extended portion 34, protrudes laterally from the sheath 20 through the side hole 22 of the sheath 20, the first electrode 41 and the conductive portion 35 may be separated. As a result, when the first electrode 41 is used to puncture the biological membrane 200, the second electrode 42 is housed in the sheath 20, and when the second electrode 42 is used to cut the biological membrane 200, the first electrode 41 is not energized. Therefore, the formation of thrombi caused by the electrode not used for puncturing or cutting the biological membrane 200 energizing the blood can be suppressed.
[0051] Furthermore, the second end 37 of the extension portion 34 is displaceable in a direction toward or toward the central axis 39 of the shaft body 33. This allows the second end 37 of the extension portion 34 to be brought toward the central axis 39 of the shaft body 33 when puncturing the biological membrane 200 with the puncture portion, thereby suppressing the extension portion 34 from affecting the puncture. Conversely, when cutting the biological membrane 200 with the cutting portion, the second end 37 of the extension portion 34 can be moved toward the central axis 39 of the shaft body 33, ensuring that the cutting portion makes reliable contact with the biological membrane 200.
[0052] Furthermore, the biomembrane 200 is the biomembrane that separates the true lumen 201 and the false lumen 202 of the aortic dissection. As a result, the medical device 10 can puncture and cut the biomembrane 200 that separates the true lumen 201 and the false lumen 202 with a single device, thereby combining the true lumen 201 and the false lumen 202 of the aortic dissection into a single lumen.
[0053] <Second Embodiment> The medical device 80 according to the second embodiment differs from the first embodiment in that, as shown in Figure 8, the distal end of the sheath 20 is open and the first electrode 41 is located on the shaft 30 instead of the sheath 20.
[0054] The sheath 20 has a distal opening 24 at its distal end, through which the lumen 21 opens. The distal opening 24 allows the distal portion of the shaft 30, located in the lumen 21 of the sheath 20, to protrude distally.
[0055] The first electrode 41 is positioned at the distal end of the shaft body 33 and is formed by a portion where the insulator is removed and the conductor is exposed. The second end 37 of the extension portion 34 is separated from the surface of the shaft body 33. Preferably, a portion of the extension portion 34 on the second end 37 side is bent away from the central axis 39 of the shaft body 33, but it does not have to be bent. The first electrode 41, which is the puncture portion, is located at the distal end of the medical device 80 when the distal portion of the shaft 30 protrudes distally from the distal opening 24 of the sheath 20.
[0056] Next, a method for using the medical device 80 according to the second embodiment will be described.
[0057] As shown in Figure 8(A), the operator extends the first electrode 41, located at the distal end of the shaft 30, distally through the distal opening 24 of the sheath 20, and retracts the second end 37 of the extended portion 34 of the shaft 30 into the sheath 20, bringing the first electrode 41 into contact with the biological membrane 200. In this state, the shaft operating portion 52 of the operating unit 50 is slid to its furthest position, and the shaft 30 is structured in such a way that it cannot move any further toward the tip relative to the sheath 20. Next, the operator supplies current from the current supply device 70 to the first electrode 41 via the conductor of the shaft 30. This allows the operator to cauterize and puncture the biological membrane 200 with the first electrode 41, which is the puncture site. Next, as shown in Figure 8(B), with the side hole 22 positioned toward the false lumen 202, the operator operates the shaft operating portion 52 of the operating unit 50 to move the shaft 30 proximal to the sheath 20. As a result, the first electrode 41 is housed in the lumen 21 of the sheath 20, the extended portion 34 protrudes from the side hole 22, and the second electrode 42, which is the cutting portion positioned on the extended portion 34, is exposed to the outside of the sheath 20 through the side hole 22. The second end 37 of the shaft 30 is separated from the central axis 39 of the shaft body 33, and at least a portion of the second end 37 side is bent in the direction away from the central axis 39 of the shaft body 33, so the extended portion 34 can easily enter the side hole 22 from the second end 37. Next, the operator supplies current from the current supply device 70 to the second electrode 42 via the conductor of the shaft 30, and the medical device 10 can be cut by pulling it proximal to the second electrode 42, which is the cutting portion, while cauterizing the biological membrane 200.
[0058] After cutting with the second electrode 42, the operator operates the shaft operating section 52 of the operating section 50 to move the shaft 30 distal to the sheath 20, as shown in Figure 8(A). As a result, the first electrode 41 of the shaft 30 protrudes distally from the distal opening 24, and the extended portion 34 is retracted into the sheath 20 through the side hole 22. Note that the first electrode 41 of the shaft 30 does not necessarily have to protrude distally from the distal opening 24. The operator can then place the medical device 80 into the guiding catheter 60 and remove it from the body.
[0059] Next, a modified example of the second embodiment will be described.
[0060] In the fifth modified example shown in Figure 9, the extended portion 34 of the shaft 30 extends from a position proximal to the distal end of the shaft body 33 where the first electrode 41 is located. As a result, the shaft 30 is formed without being bent at the distal end. Therefore, it is possible to prevent the shaft 30 from becoming too thick at the distal end and to prevent the outer diameter of the medical device 80 from becoming too thick.
[0061] In the sixth modified example shown in Figure 10, no side holes are formed in the sheath 20. Therefore, the sheath 20 may be a general-purpose product. In the sixth modified example, it is preferable that the second end 37 of the extended portion 34 is located at a distance greater than the thickness of the tip of the sheath 20 from the surface of the shaft body 33, so that when it is protruding distally from the distal opening 24 of the sheath 20, it can move proximally to protrude laterally from the sheath 20. However, since the second end 37 of the extended portion 34 must also be able to be retracted into the sheath 20 from the distal opening 24 when it is protruding distally from the distal opening 24 of the sheath 20, it is preferable that the maximum distance between the second end and the surface of the shaft body 33 is shorter than the diameter of the lumen of the sheath 20.
[0062] In the sixth modification, as shown in Figure 10(A), puncture with the first electrode 41 can be performed in the same manner as in the second embodiment shown in Figure 8. When cutting the biological membrane 200 with the second electrode 42, the operator operates the shaft operating part 52 of the operating part 50 to make the entire extended portion 34 of the shaft 30 protrude from the distal opening 24. Then, as shown in Figure 10(B), the operator hooks the second end 37 of the extended portion 34 onto the edge of the distal opening 24, preventing it from returning to the lumen 21 of the sheath 20, and makes it protrude laterally from the sheath 20. As a result, the shaft 30 deforms so that the second end 37 of the extended portion 34 separates from the surface of the shaft body 33, and the second electrode 42 is exposed to the outside of the sheath 20 so as to contact the distal opening 24 of the sheath 20. This allows the surgeon to supply current from the current supply device 70 to the second electrode 42 via the conductor of the shaft 30, and to cauterize and cut the biological membrane 200 with the second electrode 42, which is the cutting part.
[0063] After cutting with the second electrode 42, the operator operates the shaft operating section 52 of the operating section 50 to move the extended portion 34 of the shaft 30 distal to the sheath 20. As a result, the shaft 30, due to its own elastic force, restores to its original shape so that the second end 37 of the extended portion 34 approaches the surface of the shaft body 33. This allows the operator to store the entire extended portion 34, on which the second electrode 42 is located, into the sheath 20 from the second end 37 side. Furthermore, the operator can store the first electrode 41, located at the distal end of the shaft body 33, into the sheath 20.
[0064] The seventh modification shown in Figure 11 is the same as the sixth modification, except that the extended portion 34 of the shaft 30 extends from a position proximal to the distal end of the shaft body 33 where the first electrode 41 is located. The method of using the seventh modification is substantially the same as that of the sixth modification. In the seventh modification, the shaft 30 is formed without being bent at the distal end. This prevents the shaft 30 from becoming too thick at the distal end, and prevents the outer diameter of the medical device 80 from becoming too thick.
[0065] The eighth modified example shown in Figure 12 is the same as the sixth modified example, except that the first electrode 41 and the second electrode 42, which are arranged on the shaft 30, are formed integrally. This eliminates the need to form the first electrode 41 and the second electrode 42 separately, making it easier to manufacture the shaft 30.
[0066] The ninth modified example shown in Figure 13 is the same as the second embodiment shown in Figure 8, except that the first electrode 41 and the second electrode 42, which are arranged on the shaft 30, are formed integrally. This eliminates the need to form the first electrode 41 and the second electrode 42 separately, making it easier to manufacture the shaft 30.
[0067] As described above, in the medical device 80 according to the second embodiment, the sheath 20 has a distal opening 24 at its distal end through which a lumen 21 opens. When the puncture portion located at the distal end of the shaft 30 protrudes distal to the sheath 20 through the distal opening 24, the cutting portion is stored inside the sheath 20. When the cutting portion located at the extension portion 34 protrudes laterally from the sheath 20 through the side hole 22, the puncture portion may be stored inside the sheath 20. This allows the medical device 80 to protrude the puncture portion from the distal opening 24 and store the cutting portion inside the sheath 20 when performing a puncture, and to protrude the cutting portion from the side hole 22 of the sheath 20 and store the puncture portion inside the sheath 20 when performing a cut. Therefore, the cutting portion is less exposed to blood during puncture, thus suppressing the formation of thrombi at the cutting portion.
[0068] Furthermore, at least a portion of the extension portion 34 on the second end 37 side may be bent in a direction away from the central axis 39 of the shaft body 33. This allows the extension portion 34 to easily enter the side hole 22 from the second end 37 side.
[0069] <Third Embodiment> The medical device 90 according to the third embodiment differs from the first and second embodiments in that a first electrode 41 and a second electrode 42 are arranged on a cylindrical shaft 100, and a long current-carrying shaft 110 is arranged inside the shaft 100.
[0070] The shaft 100 has a shaft lumen 101 formed distal to the proximal end 31. The shaft 100 has a bent portion 102 that bends back towards the proximal end at the distal end. That is, the shaft 100 bends at the bent portion 102 located at the distal end of the elongated shaft body 103, and an extended portion 104 is formed beyond that point that extends proximal. The extended portion 104 is positioned so as to be in contact with or close to the surface of the shaft body 103. The shaft lumen 101 is formed in communication from the shaft body 103 to the extended portion 104. The shaft 100 does not have an opening at the distal end through which the shaft lumen 101 opens. Therefore, blood does not flow into the shaft lumen 101 from the distal end.
[0071] The first electrode 41 is positioned at the distal end of the shaft body 103, i.e., outside the bent portion 102 of the shaft 100, and the second electrode 42 is positioned inside the bent portion 102 of the shaft 100. The shaft 100 is elastically deformable so that the second end 37 moves closer to and further away from the surface of the shaft body 103.
[0072] The current-carrying shaft 110 is arranged so as to be slidable within the shaft lumen 101 in the extending direction of the shaft 100. The current-carrying shaft 110 has a first conductive portion 111 that can conduct to the first electrode 41 and a second conductive portion 112 that can conduct to the second electrode 42. The first conductive portion 111 is located near the distal end of the current-carrying shaft 110, and the second conductive portion 112 is located proximal to the first conductive portion 111. The current-carrying shaft 110 is a long member formed by covering a conductor such as copper, stainless steel, or nickel-titanium alloy with an insulator. The first conductive portion 111 and the second conductive portion 112 are the parts where the insulator is removed and the conductor is exposed. The current-carrying shaft 110 can conduct the current supplied to the conductor inside the operating portion 50 to the first conductive portion 111 and the second conductive portion 112. The first conductive portion 111 and the second conductive portion 112 may be formed integrally.
[0073] Next, a method for using the medical device 90 according to the third embodiment will be described.
[0074] As shown in Figure 14(A), the surgeon brings the first electrode 41, located at the distal end of the shaft 100, into contact with the biological membrane 200 with the first conductive portion 111 connected to the first electrode 41. Note that when the first conductive portion 111 is connected to the first electrode 41, the bent portion 102 of the shaft 100 is bent and the energizing shaft 110 is not inserted through it. Next, the surgeon supplies current from the current supply device 70 to the first electrode 41 via the conductor of the energizing shaft 110 and the first conductive portion 111. This allows the surgeon to cauterize and puncture the biological membrane 200 with the first electrode 41, which is the puncture site. At this time, the second electrode 42 does not apply current because the second conductive portion 112 is not energized.
[0075] Next, when cutting the biological membrane 200, the operator, with the entire extended portion 104 positioned on the false lumen 202 side from the puncture hole as shown in Figure 14(B), operates the shaft operating portion 52 of the operating portion 50 to move the energizing shaft 110 distal to the sheath 20. As a result, the energizing shaft 110 moves distally to the shaft lumen 101, the first conductive portion 111 separates from the first electrode 41, and the second conductive portion 112 makes contact with the second electrode 42. The bent portion 102 deforms as the energizing shaft 110 is inserted into the shaft lumen 101 inside it. As a result, the bend in the bent portion 102 deforms to become closer to a straight line, and the extended portion 104 extends toward the proximal end 31 of the shaft body 103 while protruding laterally from the distal end of the shaft body 103. As a result, the operator supplies current from the current supply device 70 to the second electrode 42 via the conductor of the shaft 100 and the second conductive part 112, and the biological membrane 200 can be cauterized and cut by the second electrode 42, which is the cutting part. At this time, the first electrode 41 is not energized at the first conductive part 111, so the first electrode 41 does not apply current.
[0076] After cutting with the second electrode 42, the operator operates the shaft operating section 52 of the operating section 50 to move the energized shaft 110 proximal to the sheath 20. As a result, the energized shaft 110, which was inserted into the shaft lumen 101 inside the bent section 102, moves proximal, and the bent section 102 returns to its original shape by its own elastic force, as shown in Figure 14(A). That is, the second end 37 of the extended section 104 approaches the surface of the shaft body 103, and the extended section 104 of the shaft 100 takes on a shape that conforms to the shaft body 103. This allows the operator to house the medical device 90 in the guiding catheter 60 and remove it from the body.
[0077] Next, a modified example of the third embodiment will be described.
[0078] In the third embodiment described above, as the energizing shaft 110 moves distally, the bent portion 102 receives force from the energizing shaft 110 and deforms to become closer to a straight line. However, as shown in the tenth modified example in Figure 15, the bent portion 102 may deform to become closer to a straight line as the energizing shaft 110 moves proximal. For this purpose, for example, as shown in Figure 15(A), the energizing shaft 110 is inserted into the shaft lumen 101 inside the bent portion 102 while the first conductive portion 111 of the energizing shaft 110 is in contact with the first electrode 41 placed on the shaft 100. In this state, the energizing shaft 110 and the shaft 100 are shaped to bend. Therefore, in this state, the operator can cauterize and puncture the biological membrane 200 with the first electrode 41, which is the puncture site. At this time, the second electrode 42 is not energized in the second conductive portion 112, so the second electrode 42 does not apply current.
[0079] As the energized shaft 110 moves proximal to the shaft lumen 101 from this state, as shown in Figure 15(B), the first conductive portion 111 separates from the first electrode 41 and the second conductive portion 112 becomes conductive to the second electrode 42. As the shaped portion of the energized shaft 110 moves proximal to the shaped bent portion 102 of the shaft 100, the bend of the bent portion 102 deforms to approach a straight line, and the extended portion 104 extends toward the proximal end 31 of the shaft body 103, protruding laterally from the distal portion of the shaft body 103. As a result, the operator can supply current from the current supply device 70 to the second electrode 42 via the conductor and second conductive portion of the shaft 100, and the biological membrane 200 can be cauterized and cut by the second electrode 42, which is the cutting portion. At this time, the first electrode 41 is not energized in the first conductive portion 111, so the first electrode 41 does not apply current.
[0080] As described above, in the medical device 90 according to the third embodiment, the shaft 100 has a shaft lumen 101, the electrode portion 40 has a first electrode 41 which is a puncture portion and a second electrode 42 which is a cutting portion, the first electrode 41 is positioned at the distal end of the shaft body 103, the medical device 90 has a long energizing shaft 110 that is slidable within the shaft lumen 101 and has an energizing portion 35 that can conduct to the first electrode 41 and the second electrode 42, the energizing portion 35 of the energizing shaft 110 can conduct to the first electrode 41 or the second electrode 42 at different positions in the sliding direction of the shaft lumen 101, and as the energizing portion 35 moves from a position where it conducts with the first electrode 41 to a position where it conducts with the second electrode 42, the shaft 100 is deformed by a force from the energizing shaft 110, and the second end portion 37 may be displaced in a direction away from the surface of the shaft body 103. This allows current to be applied only to the electrode used for puncturing or cutting the biological membrane 200, without introducing blood into the shaft lumen 101. Therefore, the formation of thrombi due to current flow in the shaft lumen 101 caused by blood inflow can be suppressed, as can the formation of thrombi due to current flow in the blood through the electrode not used for puncturing or cutting the biological membrane 200.
[0081] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. Therefore, for example, the configurations included in each of the embodiments and modifications described above can be combined as appropriate.
[0082] This application is based on Japanese Patent Application No. 2025-016736, filed on February 4, 2025, and its disclosures are referenced and incorporated as a whole.
[0083] 1 Medical System 10, 80, 90 Medical Device 20 Sheath 21 Lumen 22 Side Hole 24 Distal Opening 30, 100 Shaft 31 Proximal End 32 Distal End 33, 103 Shaft Body 34, 104 Extended Section 35 Conductive Section 36 First End 37 Second End 38 Long Axis 39 Central Axis 40 Electrode Section 41 First Electrode 42 Second Electrode 60 Guiding Catheter 70 Current Supply Device 101 Shaft Lumen 102 Bent Section 110 Conductive Shaft 111 First Conductive Section (Conductive Section) 112 Second Conductive Section (Conductive Section) 200 Biomembrane 201 True Lumen 202 False Lumen
Claims
1. A long medical device comprising a long shaft and an electrode portion, wherein the shaft has a long shaft body including a proximal end and a distal end, and an extending portion that protrudes laterally from the distal end of the shaft body and extends toward the proximal end of the shaft body, the extending portion has a first end connected to the distal end of the shaft body, a second end located on the opposite side of the first end in the extending direction of the extending portion, and a long axis extending from the first end to the second end, the electrode portion has a puncture portion located at the distal end of the medical device that can cauterize and puncture a biological membrane by applying an electric current, and a cutting portion that contacts the biological membrane proximal to the puncture portion when the medical device is pulled proximal, and can cauterize and cut the biological membrane by applying an electric current, and at least a part of the cutting portion is arranged on the surface of the extending portion between the first end and the second end, on the side of the central axis of the shaft body relative to the long axis of the extending portion.
2. The medical device according to claim 1, wherein the electrode portion comprises a first electrode and a second electrode, the first electrode being the puncture portion and the second electrode being the cutting portion.
3. The medical device according to claim 1, characterized in that the puncture portion and the cutting portion are a single electrode.
4. The medical device according to any one of claims 1 to 3, characterized in that the first end is located at the distal end of the shaft body.
5. The medical device according to any one of claims 1 to 3, wherein the medical device has a sheath having a lumen capable of housing the shaft, the sheath has a side hole from which the lumen opens laterally, and the cutting portion disposed on the extended portion is capable of protruding laterally from the sheath through the side hole.
6. The medical device according to claim 5, wherein the sheath has a distal opening at its distal end through which the lumen opens, and when the puncture portion located at the distal end of the shaft protrudes distal to the sheath through the distal opening, the cutting portion is housed within the sheath, and when the cutting portion located at the extension portion protrudes laterally from the sheath through the side hole, the puncture portion is housed within the sheath.
7. The medical device according to claim 5, characterized in that at least a portion of the extension portion on the second end side is curved in a direction away from the central axis of the shaft body.
8. The medical device according to claim 5, wherein the electrode portion comprises a first electrode which is the puncture portion and a second electrode which is the cutting portion, and the first electrode is positioned at the distal end of the sheath.
9. The medical device according to claim 8, characterized in that the shaft body has a conductive portion at its distal end that can conduct electricity with the first electrode.
10. The medical device according to claim 9, characterized in that the shaft body is slidable relative to the sheath in a direction along the central axis when housed in the sheath, the conductive portion energizes the first electrode when the first electrode and the conductive portion come into contact, the second electrode is housed in the sheath, and the first electrode and the conductive portion are separated when the second electrode, which is positioned on the extended portion through the side hole of the sheath, protrudes laterally from the sheath.
11. The medical device according to claim 1, wherein the shaft has a shaft lumen, the electrode portion has a first electrode which is the puncture portion and a second electrode which is the cutting portion, the first electrode is positioned at the distal end of the shaft body, the medical device has a long energizing shaft that is slidable within the shaft lumen and has an energizing portion that is energized to the first electrode and the second electrode, the energizing portion of the energizing shaft is energized to the first electrode or the second electrode at different positions in the sliding direction of the shaft lumen, and as the energizing portion moves from a position where it is energized to the first electrode to a position where it is energized to the second electrode, the shaft is deformed by a force from the energizing shaft and the second end is displaced in a direction away from the surface of the shaft body.
12. The medical device according to any one of claims 1 to 3, characterized in that the second end of the extended portion is displaceable in a direction toward or toward the central axis of the shaft body.
13. The medical device according to any one of claims 1 to 3, characterized in that the biological membrane is a biological membrane that separates the true lumen and false lumen of an aortic dissection.