Puncture wire and puncture wire device

Abstract

To correctly and easily cauterize and puncture a puncture target part.SOLUTION: The puncture wire is inserted into at least one of the sheath and the dilator, and is connected to a connector electrically connected to a power generation device, wherein the puncture wire includes a core wire, the core wire includes a distal end portion including a puncture electrode, and a connector connection portion located on a proximal end side of the distal end portion and to which the connector is detachably attached, and the connector attached to the connector connection portion abuts against a proximal end side of at least one of the sheath and the dilator, and defines a protrusion amount of the distal end portion from a distal end side of at least one of the sheath and the dilator.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a puncture wire and the like. [Background technology]

[0002] Conventionally, a puncture device has been proposed, as disclosed in Patent Document 1. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2023-541700 Summary of the Invention [Problem to be solved by the invention]

[0004] However, there is a risk of accidentally operating the control unit and cauterizing or puncturing an unexpected location.

[0005] One example of an object of the present invention is to enable accurate and easy cauterization and puncture of a puncture target site. Other objects of the present invention will become apparent from the description of this specification. [Means for solving the problem]

[0006] One aspect of the present invention is a puncture wire that is inserted into at least one of a sheath and a dilator and is connected to a connector that is electrically connected to a power generating device, the puncture wire comprising a core wire that has a tip portion including a puncture electrode and a connector connection portion that is located proximal to the tip portion and to which the connector is detachably attached, the connector attached to the connector connection portion abutting against the proximal side of at least one of the sheath and the dilator and determining the amount of protrusion of the tip portion from the tip side of at least one of the sheath and the dilator.

[0007] According to the above-described aspects of the present invention, cauterization and puncture of the puncture target area can be performed correctly and easily. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a configuration diagram of an electrosurgical device 1 according to the present embodiment. [Figure 2] FIG. 1 is an explanatory diagram of a puncture wire device in a first state with a short sheath dilator. [Figure 3] FIG. 10 is an explanatory diagram showing a state in which a connector is attached to a first connection portion of a puncture wire in a short sheath dilator in a first state. [Figure 4] FIG. 10 is an explanatory diagram of the puncture wire device in the second state in the short sheath dilator. [Figure 5] FIG. 10 is an explanatory diagram of the puncture wire device in a first state in a medium-length sheath dilator. [Figure 6] FIG. 10 is an explanatory diagram of the puncture wire device in the second state in a medium-length sheath dilator. [Figure 7] FIG. 2 is an explanatory diagram of a puncture wire device in a first state in a long sheath dilator. [Figure 8] FIG. 10 is an explanatory diagram of the puncture wire device in the second state in the long sheath dilator. DETAILED DESCRIPTION OF THE INVENTION

[0009] The electrosurgical device 1 according to this embodiment will be described below with reference to the drawings. The embodiments are not limited to the following. Furthermore, the content described in one embodiment is generally applicable to other embodiments as well. Furthermore, the embodiments and modifications can be combined as appropriate.

[0010] To make the configuration of each part easier to understand, in Figure 1 and other figures, the radial dimensions of the puncture wire 10, dilator 20, and sheath 30 are shown larger than their actual sizes. Furthermore, the proximal end 13 of the puncture wire 10, the connector 50, and the high-frequency generator 80 are shown in three dimensions, while other parts are shown in two dimensions. Here, parts of the puncture wire 10, dilator 20, sheath 30, and connector 50 that cannot be seen from the outside are shown with dotted lines.

[0011] The electrosurgical device 1 is an apparatus for puncturing a target site of a patient, such as the right atrial septum. As shown in Fig. 1, the electrosurgical device 1 includes a puncture wire device 5, a dilator 20, a sheath 30, a high-frequency generator 80, and a return electrode 70. The puncture wire device 5 includes a puncture wire 10 and a connector 50.

[0012] (Puncture Wire 10) The puncture wire 10 has a core wire 10a and an insulating layer 10b that covers a portion of the core wire 10a. For the sake of explanation, the tip (distal) side of the puncture wire 10 that is inserted into the body is defined as the tip portion 11, and the base (proximal) side that is held by a user or the like to insert the tip portion 11 is defined as the base end 13.

[0013] The distal end 11 of the core wire 10a has superelasticity and is made of a conductive material such as a nickel-titanium alloy. A puncturing electrode 11a is provided on the distal side of the distal end 11 of the core wire 10a. The puncturing electrode 11a is configured to deliver energy to a desired puncture site based on high-frequency current from a high-frequency generator 80. A coil 11b is provided on a portion of the distal end 11 of the core wire 10a so as to cover the core wire 10a. An insulating layer 10b is formed on the surface of the distal end 11 of the core wire 10a. However, the puncturing electrode 11a is exposed without the insulating layer 10b formed thereon. The coil 11b is covered by the insulating layer 10b.

[0014] The region of the distal end 11 of the core wire 10a that includes the puncture electrode 11a has shape memory properties and forms a spiral portion 11c. The spiral portion 11c is spiral when no external force is applied. However, when an external force is applied, such as when a part of the spiral portion 11c is inserted into the dilator 20, the spiral shape is deformed and becomes approximately linear.

[0015] The proximal end 13 of the core wire 10a is made of stainless steel (SUS). The distal end 11 of the core wire 10a and the proximal end 13 of the core wire 10a are integrally formed by joining. A connector connection portion 13a is provided at the proximal end 13 of the core wire 10a. The connector connection portion 13a includes a first connection portion 13a1, a second connection portion 13a2, and a third connection portion 13a3. The first connection portion 13a1, the second connection portion 13a2, and the third connection portion 13a3 are provided in this order from the distal end to the proximal end.

[0016] The first connecting portion 13a1 is used to electrically connect the puncture wire 10 and the connector 50 when a short sheath dilator (first dilator 20a, first sheath 30a) is used to perform puncture. The second connecting portion 13a2 is used to electrically connect the puncture wire 10 and the connector 50 when a medium-length sheath dilator (second dilator 20b, second sheath 30b) is used to perform puncture. The third connecting portion 13a3 is used to electrically connect the puncture wire 10 and the connector 50 when a long sheath dilator (third dilator 20c, third sheath 30c) is used to perform puncture. In this embodiment, the term "sheath dilator" refers to the combination of a sheath and a dilator.

[0017] Each of the first to third connection portions 13a1 to 13a3 includes an exposed portion where the core wire 10a is exposed from the insulating layer 10b as a region electrically connected to the connector electrode 51 of the connector 50. As the exposed portion, the first connection portion 13a1 includes a first exposed portion ex1, the second connection portion 13a2 includes a second exposed portion ex2, and the third connection portion 13a3 includes a third exposed portion ex3.

[0018] The first exposed portion ex1 to the third exposed portion ex3 differ from one another in at least one of the size of the exposed area and the number of exposed portions. Specifically, the first exposed portion ex1 has one relatively large exposed portion so as to contact the first contact terminal 51a to the fourth contact terminal 51d of the connector electrode 51. The second exposed portion ex2 has one medium-sized exposed portion so as to contact the second contact terminal 51b and the third contact terminal 51c of the connector electrode 51. The third exposed portion ex3 has two relatively small exposed portions so as to contact the first contact terminal 51a and the fourth contact terminal 51d of the connector electrode 51. That is, in this embodiment, the size of one exposed portion of each exposed portion is first exposed portion ex1 > second exposed portion ex2 > third exposed portion ex3. In this embodiment, only the third exposed portion ex3 has two exposed portions. However, the size of each exposed portion and the number of exposed portions may be changed as appropriate depending on the size and number of the contact terminals of the connector electrode 51 to be connected.

[0019] (Dilator 20) The dilator 20 is used to insert a tapered portion into a hole made in the right atrial septum or the like by a guidewire or the like to expand the hole. In this embodiment, the dilator 20 includes a first dilator 20a, a second dilator 20b, and a third dilator 20c. The first dilator 20a includes a first dilator hub 21a and a first dilator tube 23a. The second dilator 20b includes a second dilator hub 21b and a second dilator tube 23b. The third dilator 20c includes a third dilator hub 21c and a third dilator tube 23c.

[0020] The configurations of the second dilator hub 21b and the third dilator hub 21c are similar to the configuration of the first dilator hub 21a. The second dilator tube 23b is longer than the first dilator tube 23a. The third dilator tube 23c is longer than the second dilator tube 23b.

[0021] (Sheath 30) The sheath 30 is placed in the hole enlarged by the dilator 20 and is used to secure a path for catheter insertion. In this embodiment, the sheath 30 includes a first sheath 30a, a second sheath 30b, and a third sheath 30c. The first sheath 30a includes a first sheath hub 31a, a first sheath tube 33a, a first side tube 35a, and a first three-way stopcock 37a. The second sheath 30b includes a second sheath hub 31b, a second sheath tube 33b, a second side tube 35b, and a second three-way stopcock 37b. The third sheath 30c includes a third sheath hub 31c, a third sheath tube 33c, a third side tube 35c, and a third three-way stopcock 37c.

[0022] The configurations of the second sheath hub 31b and the third sheath hub 31c are similar to the configuration of the first sheath hub 31a. The second sheath tube 33b is longer than the first sheath tube 33a. The third sheath tube 33c is longer than the second sheath tube 33b. The configurations of the second side tube 35b and the third side tube 35c are similar to the configuration of the first side tube 35a. The configurations of the second three-way stopcock 37b and the third three-way stopcock 37c are similar to the configuration of the first three-way stopcock 37a.

[0023] The first dilator 20a and the first sheath 30a are used when the distance between the site where the sheath dilator is inserted into the body, such as the groin, and the site to be punctured is short. For example, the length of the first dilator tube 23a is 63 cm. The second dilator 20b and the second sheath 30b are used when the distance between the site where the sheath dilator is inserted into the body and the site to be punctured is medium. For example, the length of the second dilator tube 23b is 81 cm. The third dilator 20c and the third sheath 30c are used when the distance between the site where the sheath dilator is inserted into the body and the site to be punctured is long. For example, the length of the third dilator tube 23c is 90 cm.

[0024] (Puncture wire 10 when inserted into a short sheath dilator) The puncture wire 10 inserted into the short sheath dilator will be described using Figures 2 to 4. Figure 2 is a diagram illustrating the short sheath dilator (first dilator 20a, first sheath 30a), the puncture wire 10 inserted into the short sheath dilator, and the connector 50 in a first state in which the tip portion 11 protrudes only a small amount from the tip side of the sheath dilator. Figure 3 is a diagram illustrating the short sheath dilator, the puncture wire 10 inserted into the short sheath dilator, and the connector 50 attached to the first connecting portion 13a1 of the puncture wire 10 in the first state in which the tip portion 11 protrudes only a small amount. Figure 4 is a diagram illustrating the short sheath dilator and the puncture wire 10 inserted into the short sheath dilator in a second state in which the tip portion 11 protrudes only a large amount.

[0025] 2 and 3, the first connecting portion 13a1 is formed on the proximal end 13 so that the distance between the puncturing electrode 11a and the first connecting portion 13a1 is a first distance d1 (d1 = 2 to 5 mm) longer than the length of a short sheath dilator. That is, the distance from the puncturing electrode 11a to the distal end of the first connecting portion 13a1 is longer by the first distance d1 than the distance from the distal end of the first dilator 20a to the proximal end of the first dilator 20a. When the puncturing wire 10 is inserted into the first dilator 20a and the distal end 11 is caused to protrude from the distal end of the first dilator 20a by the first distance d1, the first connecting portion 13a1 is exposed from the first dilator 20a. When the puncture wire 10 is inserted into the first dilator 20a and the tip 11 is protruded from the tip side of the first dilator 20a by a second distance d2 (d2 = 25 mm) that is longer than the first distance d1, the first connection portion 13a1 is located inside the first dilator 20a and is not exposed, as shown in Figure 4.

[0026] When the puncture wire 10 is inserted into the first dilator 20a, physical interference between the first dilator 20a and the connector 50 attached to the first connecting portion 13a1 of the connector connecting portion 13a limits the amount of protrusion of the tip portion 11 from the first dilator 20a to a first distance d1 or less. That is, the connector 50 attached to the first connecting portion 13a1 abuts against the base end side of the first dilator 20a, thereby determining the amount of protrusion of the tip portion 11 from the tip side of the first dilator 20a.

[0027] In a first state in which the amount of protrusion of the distal end portion 11 from the first dilator 20a is equal to or less than a first distance d1, the first connection portion 13a1 to the third connection portion 13a3 of the connector connection portion 13a are located outside the first dilator 20a and the first sheath 30a. Therefore, in the first state, the first connection portion 13a1 to the third connection portion 13a3 can be connected to the connector 50. When a short sheath dilator is used, the connector 50 is connected to the first connection portion 13a1.

[0028] In the second state in which the amount of protrusion of the tip portion 11 from the first dilator 20a is greater than the first distance d1, the first connecting portion 13a1 is located inside the first dilator 20a. In the second state, the connector 50 cannot be connected to the first connecting portion 13a1, and therefore, when transitioning from the first state to the second state, the connection between the first connecting portion 13a1 and the connector 50 is released. The release of the connection between the connector 50 and the connector connecting portion 13a is performed manually, but may also be performed mechanically.

[0029] (Puncture wire 10 when inserted into a medium length sheath dilator) The puncture wire 10 inserted into a medium-length sheath dilator will be described using Figures 5 and 6. Figure 5 is a diagram illustrating a medium-length sheath dilator (second dilator 20b, second sheath 30b), the puncture wire 10 inserted into the medium-length sheath dilator, and the connector 50 in a first state in which the distal end portion 11 protrudes a small amount from the distal end side of the sheath dilator. Figure 6 is a diagram illustrating a medium-length sheath dilator and the puncture wire 10 inserted into the medium-length sheath dilator in a second state in which the distal end portion 11 protrudes a large amount.

[0030] 5, the second connecting portion 13a2 is formed on the proximal end 13 so that the distance between the puncturing electrode 11a and the second connecting portion 13a2 is a first distance d1 longer than the length of a medium-length sheath dilator. That is, the distance from the puncturing electrode 11a to the distal end of the second connecting portion 13a2 is a first distance d1 longer than the distance from the distal end of the second dilator 20b to the proximal end of the second dilator 20b. When the puncturing wire 10 is inserted into the second dilator 20b and the distal end 11 of the puncturing wire 10 protrudes from the distal end of the second dilator 20b by the first distance d1, the second connecting portion 13a2 is exposed from the second dilator 20b. When the puncture wire 10 is inserted into the second dilator 20b and the tip 11 of the puncture wire 10 is protruded from the tip side of the second dilator 20b by a second distance d2, the second connection portion 13a2 is located inside the second dilator 20b and is not exposed, as shown in Figure 6.

[0031] When the puncture wire 10 is inserted into the second dilator 20b, physical interference between the connector 50 attached to the second connecting portion 13a2 of the connector connecting portion 13a and the second dilator 20b limits the amount of protrusion of the tip portion 11 from the second dilator 20b to less than or equal to the first distance d1. That is, the connector 50 attached to the second connecting portion 13a2 abuts against the base end side of the second dilator 20b, thereby determining the amount of protrusion of the tip portion 11 from the tip side of the second dilator 20b.

[0032] In a first state in which the amount of protrusion of the distal end portion 11 from the second dilator 20b is equal to or less than a first distance d1, the second connecting portion 13a2 and the third connecting portion 13a3 of the connector connecting portion 13a are located outside the second dilator 20b and the second sheath 30b. Therefore, in the first state, the second connecting portion 13a2 and the third connecting portion 13a3 can be connected to the connector 50. When a medium sheath dilator is used, the connector 50 is connected to the second connecting portion 13a2.

[0033] In the second state in which the amount of protrusion of the tip portion 11 from the second dilator 20b is greater than the first distance d1, the second connecting portion 13a2 is located inside the second dilator 20b. In the second state, the connector 50 cannot be connected to the second connecting portion 13a2, and therefore, when transitioning from the first state to the second state, the connection between the second connecting portion 13a2 and the connector 50 is released.

[0034] (Puncture wire 10 when inserted into a long sheath dilator) The puncture wire 10 inserted into the long sheath dilator will be described using Figures 7 and 8. Figure 7 is a diagram illustrating the long sheath dilator (third dilator 20c, third sheath 30c), the puncture wire 10 inserted into the long sheath dilator, and the connector 50 in a first state in which the tip portion 11 protrudes a small amount from the tip side of the sheath dilator. Figure 8 is a diagram illustrating the long sheath dilator and the puncture wire 10 inserted into the long sheath dilator in a second state in which the tip portion 11 protrudes a large amount.

[0035] 7, the third connecting portion 13a3 is formed on the proximal end 13 so that the distance between the puncturing electrode 11a and the third connecting portion 13a3 is a first distance d1 longer than the length of the long sheath dilator. That is, the distance from the puncturing electrode 11a to the distal end of the third connecting portion 13a3 is longer by the first distance d1 than the distance from the distal end of the third dilator 20c to the proximal end of the third dilator 20c. When the puncturing wire 10 is inserted into the third dilator 20c and the distal end 11 of the puncturing wire 10 protrudes from the distal end of the third dilator 20c by the first distance d1, the third connecting portion 13a3 is exposed from the third dilator 20c. When the puncture wire 10 is inserted into the third dilator 20c and the tip 11 of the puncture wire 10 is protruded from the tip side of the third dilator 20c by the second distance d2, the third connection portion 13a3 is located inside the third dilator 20c and is not exposed, as shown in Figure 8.

[0036] When the puncture wire 10 is inserted into the third dilator 20c, physical interference between the connector 50 attached to the third connecting portion 13a3 of the connector connecting portion 13a and the third dilator 20c limits the amount of protrusion of the tip portion 11 from the third dilator 20c to less than or equal to the first distance d1. That is, the connector 50 attached to the third connecting portion 13a3 abuts against the base end side of the third dilator 20c, thereby determining the amount of protrusion of the tip portion 11 from the tip side of the third dilator 20c.

[0037] In a first state in which the amount of protrusion of the distal end portion 11 from the third dilator 20c is equal to or less than the first distance d1, the third connecting portion 13a3 of the connector connecting portion 13a is located outside the third dilator 20c and the third sheath 30c. Therefore, in the first state, the third connecting portion 13a3 can be connected to the connector 50. When a long sheath dilator is used, the connector 50 is connected to the third connecting portion 13a3.

[0038] In the second state in which the amount of protrusion of the tip portion 11 from the third dilator 20c is greater than the first distance d1, the third connecting portion 13a3 is located inside the third dilator 20c. In the second state, the connector 50 cannot be connected to the third connecting portion 13a3, and therefore, when transitioning from the first state to the second state, the connection between the third connecting portion 13a3 and the connector 50 is released.

[0039] The first dilator tube 23a is longer than the first sheath 30a (the entire length of the first sheath hub 31a and the first sheath tube 33a) by a predetermined length d3 (d3 = approximately 25 mm). Therefore, as shown in Figures 2 to 4, when the first dilator 20a is inserted into the first sheath 30a, the tip of the first dilator tube 23a protrudes from the tip of the first sheath tube 33a by the predetermined length d3.

[0040] The second dilator tube 23b is longer than the second sheath 30b (the entire length of the second sheath hub 31b and the second sheath tube 33b) by a predetermined length d3. Therefore, as shown in Figures 5 and 6, when the second dilator 20b is inserted into the second sheath 30b, the tip of the second dilator tube 23b protrudes from the tip of the second sheath tube 33b by the predetermined length d3.

[0041] The third dilator tube 23c is longer than the third sheath 30c (the entire length of the third sheath hub 31c and the third sheath tube 33c) by a predetermined length d3. Therefore, as shown in Figures 7 and 8, when the third dilator 20c is inserted into the third sheath 30c, the tip of the third dilator tube 23c protrudes from the tip of the third sheath tube 33c by the predetermined length d3.

[0042] (Connector 50) The connector 50 has a connector electrode 51 and a housing 53 that holds the connector electrode 51. The connector electrode 51 is detachably connected to the first connection portion 13a1, the second connection portion 13a2, and the third connection portion 13a3 by clamping. The connector electrode 51 includes four contact terminals (first contact terminal 51a to fourth contact terminal 51d) that are electrically connected to the first connection portion 13a1 to the third connection portion 13a3. The connector electrode 51 has a shape that is line-symmetrical when viewed from a direction perpendicular to the arrangement direction of the first contact terminals 51a to 51d (for example, the radial direction of the puncture wire 10 to which the connector 50 is attached). Specifically, the first contact terminals 51a to 51d are arranged so as to be line-symmetrical when viewed from a direction perpendicular to the arrangement direction of the first contact terminals 51a to 51d. The housing 53 has a clamp shape. At least the portion of the housing 53 that holds the connector electrodes 51 is preferably made of a material that allows the connector electrodes 51 to be seen, such as a transparent resin.

[0043] (Connection between the first connection portion 13a1 and the connector 50) When the connector 50 is properly attached to the first connecting portion 13a1 with the first contact terminal 51a close to the tip of the puncture wire 10, the first contact terminal 51a is located at the tip of the first exposed portion ex1, and the fourth contact terminal 51d is located at the base end of the first exposed portion ex1. Therefore, the first to fourth contact terminals 51a to 51d are connected to the first exposed portion ex1.

[0044] When the connector 50 is properly attached to the first connecting portion 13a1 with the fourth contact terminal 51d close to the tip of the puncture wire 10, the fourth contact terminal 51d is located at the tip side of the first exposed portion ex1, and the first contact terminal 51a is located at the base end side of the first exposed portion ex1. Even in this case, the first contact terminal 51a to the fourth contact terminal 51d are connected to the first exposed portion ex1.

[0045] (Connection between the second connection portion 13a2 and the connector 50) When the connector 50 is properly attached to the second connection portion 13a2 with the first contact terminal 51a close to the tip of the puncture wire 10, the second contact terminal 51b is located at the tip end of the second exposed portion ex2, and the third contact terminal 51c is located at the base end of the second exposed portion ex2. Therefore, the second contact terminal 51b and the third contact terminal 51c are connected to the second exposed portion ex2. However, the first contact terminal 51a is not connected to the second exposed portion ex2 because it contacts the insulating layer 10b between the first exposed portion ex1 and the second exposed portion ex2. The fourth contact terminal 51d is not connected to the second exposed portion ex2 because it contacts the insulating layer 10b between the second exposed portion ex2 and the third exposed portion ex3.

[0046] When the connector 50 is properly attached to the second connection portion 13a2 with the fourth contact terminal 51d close to the tip of the puncture wire 10, the third contact terminal 51c is located at the tip of the second exposed portion ex2, and the second contact terminal 51b is located at the base of the second exposed portion ex2. Even in this case, the second contact terminal 51b and the third contact terminal 51c are connected to the second exposed portion ex2. However, the fourth contact terminal 51d is in contact with the insulating layer 10b between the first exposed portion ex1 and the second exposed portion ex2, and therefore is not connected to the second exposed portion ex2. The first contact terminal 51a is in contact with the insulating layer 10b between the second exposed portion ex2 and the third exposed portion ex3, and therefore is not connected to the second exposed portion ex2.

[0047] (Connection between the third connection portion 13a3 and the connector 50) When the connector 50 is properly attached to the third connection portion 13a3 with the first contact terminal 51a close to the tip of the puncture wire 10, the first contact terminal 51a is located at the exposed portion on the tip side of the third exposed portion ex3, and the fourth contact terminal 51d is located at the exposed portion on the base end side of the third exposed portion ex3. Therefore, the first contact terminal 51a and the fourth contact terminal 51d are connected to the third exposed portion ex3. However, the second contact terminal 51b and the third contact terminal 51c are not connected to the third exposed portion ex3 because they are in contact with the insulating layer 10b located between the two exposed portions of the third exposed portion ex3.

[0048] When the connector 50 is properly attached to the third connection portion 13a3 with the fourth contact terminal 51d close to the tip of the puncture wire 10, the fourth contact terminal 51d is located at the exposed portion on the tip side of the third exposed portion ex3, and the first contact terminal 51a is located at the exposed portion on the base end side of the third exposed portion ex3. Even in this case, the first contact terminal 51a and the fourth contact terminal 51d are connected to the third exposed portion ex3. However, the second contact terminal 51b and the third contact terminal 51c are not connected to the third exposed portion ex3 because they are in contact with the insulating layer 10b located between the two exposed portions of the third exposed portion ex3.

[0049] 1 to 8, for the sake of explanation, a region in the first exposed portion ex1 that comes into contact with the first contact terminal 51a to the fourth contact terminal 51d, a region in the second exposed portion ex2 that comes into contact with the second contact terminal 51b and the third contact terminal 51c, and a region in the third exposed portion ex3 that comes into contact with the first contact terminal 51a and the fourth contact terminal 51d are marked with approximately ring-shaped marks. However, the marks may be omitted, or conductive connecting hardware may be provided.

[0050] (Return electrode 70) The return electrode 70 is a component that serves as a counter electrode for the current generated from the puncture electrode 11a, and is placed at a predetermined position on the patient.

[0051] (High frequency generator 80) High frequency generator 80 is a device equivalent to a power generator, and is connected to connector 50 via a first cable 81 and to return electrode 70 via a second cable 82. High frequency generator 80 generates a high frequency current.

[0052] The high-frequency generator 80 has an operation unit 83 and a selection switch 84. The operation unit 83 is composed of a foot switch or the like, and controls the on / off of the generation of high-frequency current. The user selects one of the first to third usage modes via the selection switch 84. The first usage mode is a usage mode in which high-frequency current flows via the first connection part 13a1. The second usage mode is a usage mode in which high-frequency current flows via the second connection part 13a2. The third usage mode is a usage mode in which high-frequency current flows via the third connection part 13a3.

[0053] When the first usage mode is selected and the first contact terminal 51a to the fourth contact terminal 51d are all conductive, and the operating unit 83 is operated, the connector 50 is electrically connected to the first connection portion 13a1, and the high-frequency generating device 80 generates a high-frequency current.

[0054] When the first use mode is set and at least one of the first contact terminal 51a to the fourth contact terminal 51d is not conducting, and the operation unit 83 is operated, the high-frequency generator 80 determines that the connector 50 is not electrically connected to the first connection portion 13a1, and does not generate a high-frequency current, but instead outputs a warning by voice or the like.

[0055] When the second use mode is selected, the first contact terminal 51a and the fourth contact terminal 51d are not conductive, and the second contact terminal 51b and the third contact terminal 51c are conductive, and the operating unit 83 is operated, the connector 50 is considered to be electrically connected to the second connection portion 13a2, and the high-frequency generating device 80 generates a high-frequency current.

[0056] When the second use mode is selected and the operation unit 83 is operated with at least one of the first contact terminal 51a and the fourth contact terminal 51d in a conductive state, or with at least one of the second contact terminal 51b and the third contact terminal 51c in a non-conductive state, the high-frequency generator 80 determines that the connector 50 is not electrically connected to the second connection portion 13a2, and does not generate a high-frequency current, but instead outputs a warning by voice or the like.

[0057] When the third usage mode is selected, the second contact terminal 51b and the third contact terminal 51c are not electrically connected, and the first contact terminal 51a and the fourth contact terminal 51d are electrically connected, and the operating unit 83 is operated, the high-frequency generating device 80 generates a high-frequency current, assuming that the connector 50 is electrically connected to the third connection portion 13a3.

[0058] When the third use mode is selected and the operation unit 83 is operated with at least one of the second contact terminal 51b and the third contact terminal 51c in a conductive state, or with at least one of the first contact terminal 51a and the fourth contact terminal 51d in a non-conductive state, the high-frequency generator 80 determines that the connector 50 is not electrically connected to the third connection portion 13a3, and does not generate a high-frequency current, but instead outputs a warning by voice or the like.

[0059] (High frequency current flow) High-frequency current from high-frequency generator 80 flows inside the patient's body via first cable 81, connector 50, and puncture wire 10, and returns to high-frequency generator 80 via return electrode 70 and second cable 82. Joule heat is generated in the patient's biological tissue by the high-frequency current flowing between puncture electrode 11a of puncture wire 10 and return electrode 70, causing the site to be punctured near puncture electrode 11a to be cauterized and punctured.

[0060] (First operation procedure) Next, a first operating procedure when using the first dilator 20a and first sheath 30a will be described. The first use mode is selected in advance using the selection switch 84. Furthermore, the first dilator tube 23a is inserted into the first sheath tube 33a via the first sheath hub 31a of the first sheath 30a. At this time, the distal end of the first dilator tube 23a protrudes a predetermined length d3 from the distal end of the first sheath tube 33a.

[0061] The user inserts a vascular access sheath dilator (not shown) into a lower limb vein using the Seldinger technique (vascular access sheath dilator insertion step). The user inserts a general guidewire (not shown) into the dilator of the vascular access sheath dilator and brings the tip of the guidewire into the right atrium (guidewire insertion step). The user removes the dilator of the vascular access sheath dilator (vascular access sheath dilator removal step).

[0062] The user inserts the first dilator 20a and the first sheath 30a into the sheath of the vascular access sheath dilator into the patient's blood vessel, and positions the tip of the first dilator tube 23a and the tip of the first sheath tube 33a near the target puncture site, such as the right atrial septum (sheath insertion process).

[0063] The user inserts the puncture wire 10 into the first dilator 20a via the first dilator hub 21a, causing the puncture electrode 11a of the puncture wire 10 to protrude a first distance d1 from the tip of the first dilator tube 23a (puncture wire protruding step, see FIG. 2). At this time, the spiral portion 11c of the puncture wire 10 is made substantially linear by the first dilator tube 23a and the first sheath tube 33a. At this time, the first connection portion 13a1 to the third connection portion 13a3 are not covered by the first dilator 20a and are exposed. The user clamps the first connection portion 13a1 with the connector 50 (clamping step, see FIG. 3). This electrically connects the connector 50 and the first connection portion 13a1. The user operates the operating unit 83 to cause the high-frequency generator 80 to generate a high-frequency current (high-frequency generating step). The site to be punctured is cauterized and punctured based on the high-frequency current. If the user accidentally pinches a connection part (second connection part 13a2 or third connection part 13a3) of connector 50 that is different from the connection part corresponding to the selected usage mode, high-frequency generator 80 will not generate a high-frequency current and will output a warning even if the user operates operation part 83.

[0064] The user detaches the connector 50 from the first connecting portion 13a1 (detachment step). If the detachment step is not performed, the connector 50 physically interferes with the first dilator hub 21a, preventing the region of the puncture wire 10 including the first connecting portion 13a1 from being inserted into the first dilator 20a, and the process cannot proceed to the next puncture wire re-extension step. The puncture electrode 11a of the puncture wire 10 is protruded a second distance d2 from the tip of the first dilator 20a and positioned within the left atrium (puncture wire re-extension step; see Figure 4). At this time, the first connecting portion 13a1 is hidden inside the first dilator 20a and cannot be electrically connected to the connector 50. If the connector 50 is detached, there is little chance of a high-frequency current flowing even if the operating unit 83 is accidentally operated. At this time, the spiral portion 11c of the puncture wire 10 becomes spiral. Thereafter, while maintaining the spiral shape of the spiral portion 11c, the user brings the distal end of the first dilator 20a and the distal end of the first sheath 30a into the left atrium.

[0065] The user removes the first dilator 20a from the patient's blood vessel (dilator removal step). At this time, the spiral portion 11c of the puncture wire 10 is spiral-shaped and is left in the left atrium when the first dilator 20a is removed. The user inserts a predetermined treatment catheter (not shown) along the puncture wire 10 and performs treatment (treatment step). When using another treatment catheter instead of the treatment catheter in the treatment step, the user removes the treatment catheter, leaving the puncture wire 10, and inserts the other treatment catheter. The user removes the puncture wire 10 from the patient's blood vessel (puncture wire removal step). The user removes the treatment catheter used in the treatment step from the patient's blood vessel (treatment catheter removal step). The user removes the first sheath 30a from the patient's blood vessel (sheath removal step). The user removes the sheath of the vascular access sheath dilator from the patient's blood vessel (a sheath removal step of the vascular access sheath dilator).

[0066] (Second operating procedure) Next, a second operating procedure when using the second dilator 20b and the second sheath 30b will be described (see FIGS. 5 and 6). Each step in the second operating procedure is similar to each step in the first operating procedure. However, the second operating procedure differs from the first operating procedure in that the second use mode is selected instead of the first use mode, that the second dilator 20b and the second sheath 30b are used instead of the first dilator 20a and the first sheath 30a, and that the connector 50 clamps the second connecting portion 13a2 instead of the first connecting portion 13a1.

[0067] (Third operating procedure) Next, a third operating procedure when using the third dilator 20c and the third sheath 30c will be described (see FIGS. 7 and 8). Each step in the third operating procedure is similar to each step in the first operating procedure. However, the third operating procedure differs from the first operating procedure in that the third use mode is selected instead of the first use mode, the third dilator 20c and the third sheath 30c are used instead of the first dilator 20a and the first sheath 30a, and the connector 50 clamps the third connecting portion 13a3 instead of the first connecting portion 13a1.

[0068] (Effect of defining the amount of protrusion of the tip portion 11 by physical interference with the connector 50) When the connector 50 is attached to the first connecting portion 13a1 of the connector connecting section 13a and an attempt is made to move the area including the first connecting portion 13a1 into the first dilator 20a, the connector 50 physically interferes with the first dilator hub 21a of the first dilator 20a, inhibiting movement of the puncture wire 10. Therefore, when the connector 50 is connected to the first connecting portion 13a1 and high-frequency current can flow, the amount of protrusion of the first dilator 20a of the distal end portion 11 from the first dilator tube 23a is inhibited from becoming greater than the first distance d1, reducing the possibility of accidentally cauterizing or puncturing an unexpected location. In other words, cauterizing or puncturing the target puncture location can be performed correctly and easily.

[0069] When the connector 50 is attached to the second connection portion 13a2 of the connector connection part 13a and an attempt is made to move the area including the second connection portion 13a2 into the second dilator 20b, the connector 50 physically interferes with the second dilator hub 21b of the second dilator 20b, preventing the puncture wire 10 from moving. Therefore, when the connector 50 is connected to the second connection portion 13a2 and high-frequency current can flow, the amount of protrusion of the second dilator 20b of the distal end portion 11 from the second dilator tube 23b is prevented from exceeding the first distance d1, reducing the possibility of accidentally cauterizing or puncturing an unexpected location. In other words, cauterizing or puncturing the target location can be performed correctly and easily.

[0070] When the connector 50 is attached to the third connection portion 13a3 of the connector connection portion 13a and an attempt is made to move the area including the third connection portion 13a3 into the third dilator 20c, the connector 50 physically interferes with the third dilator hub 21c of the third dilator 20c, preventing the puncture wire 10 from moving. Therefore, when the connector 50 is connected to the electrode to be connected in the connector connection portion 13a and high-frequency current can flow, the amount of protrusion of the distal end portion 11 from the third dilator tube 23c of the third dilator 20c is prevented from exceeding the first distance d1, reducing the possibility of accidentally cauterizing or puncturing an unexpected location. In other words, cauterizing or puncturing the location to be punctured can be performed correctly and easily.

[0071] (Effect of the connector connection portion 13a including the exposed portion) Since the connector 50 can be directly connected to the core wire 10a, electrical connection between the puncture wire 10 and the connector 50 can be easily achieved.

[0072] (Effect of the connector connection portion 13a having multiple connection portions) A single puncture wire 10 can be used to electrically connect the connectors 50 at multiple locations in correspondence with multiple sheath dilators of different lengths.

[0073] (Effect of making at least one of the size of the exposed area and the number of exposed points of the exposed part different from other exposed parts) Since the user can visually identify the connection part to be connected among the first connection part 13a1 to the third connection part 13a3 of the connector connection part 13a, accurate and easy connection (clamping by the connector 50) is possible. Also, when determining the connection state mechanically, mechanical control can be easily performed such that the high frequency generator 80 passes a high frequency current only when the connector 50 is connected to the connection part to be connected, and the high frequency generator 80 does not pass a high frequency current when the connector 50 is mistakenly connected to a connection part that is not the connection part to be connected.

[0074] (Effect of providing the spiral portion 11c) When the amount of protrusion of tip portion 11 is small, spiral portion 11c is maintained in a substantially straight line, making it easy to direct puncture electrode 11a to the site to be punctured. When the amount of protrusion of tip portion 11 is large, spiral portion 11c is released in a spiral shape, making it easy to place spiral portion 11c in a predetermined location, such as in the left atrium.

[0075] (Effect of limiting the connection of connector 50) In a situation where cauterization or puncture is not required, the connector 50 can be prevented from being mistakenly connected to the connector connection part 13a of the puncture wire 10.

[0076] (Effect of forming the housing part 53 from a visible material) Since the connector electrodes 51 are visible, it is easy to check the connection state between the connector 50 and the connector connection portion 13a.

[0077] (Effect of arranging connector electrodes 51 in line symmetry) The user can easily connect the connector 50 to the connector connection part 13a without being conscious of the direction of the connector 50.

[0078] (Effect of the housing part 53 having a clamp shape) By clamping, the user can easily connect the connector 50 to the connector connecting portion 13a.

[0079] (Example of application of the sheath dilator set) In this embodiment, an example has been described in which the electrosurgical device 1 includes three sets of sheath dilators (first dilator 20a and first sheath 30a, second dilator 20b and second sheath 30b, and third dilator 20c and third sheath 30c). However, the number of sets of sheath dilators included in the electrosurgical device 1 is not limited to three. For example, two sets of sheath dilators may be provided. In this case, the connector connection portion 13a of the puncture wire 10 includes two connection portions corresponding to the two sets of sheath dilators. Furthermore, for example, four or more sets of sheath dilators may be provided. In this case, the connector connection portion 13a of the puncture wire 10 includes four or more connection portions corresponding to the four or more sets of sheath dilators.

[0080] (Application example of the puncture wire 10) In this embodiment, an example has been described in which multiple connection parts (first connection part 13a1 to third connection part 13a3) are provided on one puncture wire 10 to accommodate multiple sheath dilator sets. However, multiple puncture wires 10 may be provided to accommodate multiple sheath dilator sets.

[0081] For example, possible configurations include a first puncture wire 10 including the first connecting portion 13a1 but not the second connecting portion 13a2 and the third connecting portion 13a3, a second puncture wire 10 including the second connecting portion 13a2 but not the first connecting portion 13a1 and the third connecting portion 13a3, and a third puncture wire 10 including the third connecting portion 13a3 but not the first connecting portion 13a1 and the second connecting portion 13a2. The first puncture wire 10 is used when puncturing is performed using a short sheath dilator (first dilator 20a, first sheath 30a). The second puncture wire 10 is used when puncturing is performed using a medium-length sheath dilator (second dilator 20b, second sheath 30b). The third puncture wire 10 is used when puncturing is performed using a long sheath dilator (third dilator 20c, third sheath 30c).

[0082] (Application example of Connector 50) In the present embodiment, an example has been described in which the housing 53 of the connector 50 has a clamp shape and clamps the first connection portion 13a1, etc. However, the connector 50 is not limited to a configuration in which the housing 53 clamps the first connection portion 13a1, etc. For example, the connector 50 may be detachably attached to a region including the first connection portion 13a1 by magnetic force or the like.

[0083] (Application example of selection switch 84) In the present embodiment, an example has been described in which a high-frequency current is generated only when one of the first to third use modes is selected using the selection switch 84 and the connector 50 is connected to one of the first to third connection portions 13a1 to 13a3 that corresponds to the selected use mode. However, the selection switch 84 may be omitted, and a high-frequency current may be generated only when the connector 50 is connected to one of the first to third connection portions 13a1 to 13a3 that is exposed from the sheath dilator. In this case, the first to third exposed portions ex1 to ex3 may have the same size of exposed area or the same number of exposed portions.

[0084] (Example of application of Dilator 20 and Sheath 30) In the present embodiment, an example has been described in which the dilator 20 is inserted into the sheath 30, and the puncture wire 10 is inserted into the dilator 20. However, a configuration may also be adopted in which the member corresponding to the dilator 20 is omitted, and the puncture wire 10 is inserted into a member corresponding to the sheath 30. Also, a configuration in which the member corresponding to the sheath 30 is omitted may also be adopted.

[0085] (Application examples of the distal end 11 and proximal end 13 of the core wire 10a) In the present embodiment, an example has been described in which the distal end 11 of the core wire 10a is made of nickel-titanium alloy and the proximal end 13 of the core wire 10a is made of stainless steel. However, the distal end 11 of the core wire 10a may be made of stainless steel or another conductive material. Furthermore, the proximal end 13 of the core wire 10a may be made of nickel-titanium alloy or another conductive material.

[0086] (Example of application of the number of contact terminals of the connector electrode 51) In this embodiment, the connector electrode 51 has four contact terminals. However, the number of contact terminals of the connector electrode 51 is not limited to four, and may be three or less, or five or more.

[0087] Although several embodiments of the present invention have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their modifications are intended to be included within the scope and spirit of the invention, as well as within the scope of the invention described in the claims and their equivalents.

[0088] According to the present specification, there is provided a puncture wire having the following aspects. (Aspect 1) Aspect 1 is a puncture wire that is inserted into at least one of a sheath and a dilator and is connected to a connector that is electrically connected to a power generating device, the puncture wire comprising a core wire, the core wire having a tip portion including a puncture electrode, and a connector connection portion that is located proximal to the tip portion and to which the connector is detachably attached, the connector attached to the connector connection portion abutting against the proximal side of at least one of the sheath and the dilator and determining the amount of protrusion of the tip portion from the tip side of at least one of the sheath and the dilator.

[0089] According to the above-described embodiment, when an attempt is made to move the area including the connector connection portion into at least one of the sheath and the dilator while the connector is attached to the connector connection portion, the connector physically interferes with at least one of the sheath and the dilator, suppressing movement of the puncture wire. Therefore, when the connector is connected to the puncture wire connector connection portion and high-frequency current can flow, the amount of protrusion of the tip from at least one of the sheath and the dilator is prevented from exceeding a predetermined distance, reducing the possibility of accidentally cauterizing or puncturing an unexpected location. In other words, cauterizing or puncturing the target location can be performed correctly and easily.

[0090] (Aspect 2) In a second aspect, the puncture wire further includes an insulating layer that covers a portion of the core wire, and the connector connection portion includes an exposed portion where the core wire is exposed from the insulating layer.

[0091] According to the above-described embodiment, the connector can be directly connected to the core wire, so that the electrical connection between the puncture wire and the connector can be easily achieved.

[0092] (Aspect 3) In a third aspect, the connector connecting portion has a plurality of connecting portions, and the plurality of connecting portions differ from one another in at least one of the size of the exposed area of ​​the exposed portion and the number of exposed points in the exposed portion.

[0093] According to the above-described embodiment, a single puncture wire can be used to electrically connect the connector at multiple locations corresponding to at least one of multiple sheaths and dilators of different lengths. Since the user can visually identify the connection portion to be connected among the multiple connection portions of the connector connection unit, accurate and easy connection is possible. Furthermore, not only can the user visually determine the connection state, but mechanical control can also be easily performed to determine the connection state.

[0094] (Aspect 4) In a fourth aspect, the needle wire further comprises a spiral portion, the spiral portion comprising a superelastic nickel-titanium alloy having shape memory properties.

[0095] According to the above-described aspect, when the amount of protrusion of the tip portion is small, the spiral portion is maintained in a substantially straight line, which makes it easy to orient the puncture electrode to the site to be punctured.When the amount of protrusion of the tip portion is large, the spiral portion is made spiral, which makes it easy to place the spiral portion at a predetermined location.

[0096] According to the present specification, there is provided a puncture wire device having the following aspects. (Aspect 5) A fifth aspect is a puncture wire device that is inserted into at least one of a sheath and a dilator and electrically connected to a power generating device, the puncture wire device comprising a connector and a puncture wire, the connector having a connector electrode electrically connected to the power generating device and a housing portion that holds the connector electrode, the puncture wire having a core wire that includes a tip portion including a puncture electrode and a connector connection portion that is located proximal to the tip portion and to which the connector is detachably attached, the connector attached to the connector connection portion abutting against the proximal side of at least one of the sheath and dilator and determining the amount of protrusion of the tip portion from the distal side of at least one of the sheath and dilator.

[0097] According to the above-described aspect, when an attempt is made to move the area including the connector connection portion into at least one of the sheath and the dilator while the connector is attached to the connector connection portion, the connector physically interferes with at least one of the sheath and the dilator, thereby suppressing movement of the puncture wire. As a result, when the connector is connected to the connector connection portion and high-frequency current can flow, the amount of protrusion of the tip from at least one of the sheath and the dilator is prevented from exceeding a predetermined distance, thereby reducing the possibility of accidentally cauterizing or puncturing an unexpected location.

[0098] (Aspect 6) In aspect 6, in a first state in which the protrusion amount of the tip portion is equal to or less than a predetermined amount, the connector connection portion is located outside at least one of the sheath and the dilator and is connected to the connector, and in a second state in which the protrusion amount is greater than the predetermined amount, the connector connection portion is located inside at least one of the sheath and the dilator and is disconnected from the connector.

[0099] According to the above-described embodiment, it is possible to prevent the connector from being mistakenly connected to the connector connection portion of the puncture wire in a situation where cauterization or puncture is not required.

[0100] (Aspect 7) In a seventh aspect, at least the portion of the housing that holds the connector electrodes is made of a material that allows the connector electrodes to be seen.

[0101] According to the above-described embodiment, the connector electrodes are visible, making it easy to check the connection state between the connector and the connector connection portion a.

[0102] (Aspect 8) In an eighth aspect, the connector electrode has a shape that is line-symmetric when viewed in a direction perpendicular to the arrangement direction of the plurality of contact terminals of the connector electrode.

[0103] According to the above-described aspect, the user can easily connect the connector to the connector connection portion without being conscious of the orientation of the connector.

[0104] (Aspect 9) In a ninth aspect, the housing portion is clamp-shaped.

[0105] According to the above-described aspect, the user can easily connect the connector to the connector connecting portion by clamping it. [Explanation of symbols]

[0106] 5. Piercing Wire Device 10. Puncture Wire 10a core wire 10b Insulating layer 11 Tip 11a Puncture electrode 11c Spiral 13 Proximal end 13a Connector connection part 13a1 First connection part 13a2 Second connection part 13a3 Third connection part 20 Dilator 30 Sheath 50 connectors 51 Connector electrode 53 Housing 80 High Frequency Generator ex1 1st exposed part ex2 2nd exposed part ex3 3rd exposed part

Claims

1. A puncture wire that is inserted into at least one of a sheath and a dilator and has a connector that is electrically connected to a power generating device, the puncture wire comprises a core wire; The core wire is a tip portion including a puncture electrode; a connector connection portion located closer to the base end than the tip portion and to which the connector is detachably attached, The connector attached to the connector connection portion abuts against the base end side of at least one of the sheath and the dilator, and determines the amount of protrusion of the tip portion from the tip side of at least one of the sheath and the dilator.

2. Further comprising an insulating layer covering a portion of the core wire; the connector connection portion includes an exposed portion where the core wire is exposed from the insulating layer, The puncture wire according to claim 1 .

3. The connector connection portion has a plurality of connection portions, The plurality of connection portions are different from one another in at least one of the size of the exposed area of ​​the exposed portion and the number of exposed points in the exposed portion. The puncture wire according to claim 2 .

4. the puncture wire further has a spiral portion; the spiral portion comprises a superelastic nickel-titanium alloy having shape memory properties; The puncture wire according to claim 1 .

5. A puncture wire device that is inserted into at least one of a sheath and a dilator and is electrically connected to a power generating device, The puncture wire device includes a connector and a puncture wire, The connector comprises: a connector electrode electrically connected to the power generating device; a housing portion that holds the connector electrode, The puncture wire has a core wire, The core wire has a tip portion including a puncture electrode; a connector connection portion located closer to the base end than the tip portion and to which the connector is detachably attached, The connector attached to the connector connection portion abuts against the base end side of at least one of the sheath and the dilator, thereby determining the amount of protrusion of the tip portion from the tip side of at least one of the sheath and the dilator.

6. In a first state in which the protrusion amount of the distal end portion is equal to or less than a predetermined amount, the connector connection portion is located outside at least one of the sheath and the dilator and is connected to the connector; 6. The puncture wire device according to claim 5, wherein in a second state in which the protrusion amount is greater than the predetermined amount, the connector connection portion is located inside at least one of the sheath and the dilator, and the connection with the connector is released.

7. At least a portion of the housing that holds the connector electrodes is formed of a material that allows the connector electrodes to be seen. The puncture wire device according to claim 5 .

8. the connector electrode has a shape that is line-symmetrical when viewed from a direction perpendicular to an arrangement direction of the plurality of contact terminals of the connector electrode; The puncture wire device according to claim 5 .

9. The puncture wire device according to claim 5 , wherein the housing is clamp-shaped.

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