JP2016019627A - Lead take-out device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a lead take-out device capable of holding a lead stably.SOLUTION: A lead take-out device 10 comprises: a tubular outer shaft 11 inserted into a lead 51; an inner shaft 12 inserted into a tube hole of the outer shaft 11; and operation parts connected to the base end sides of both shafts 11, 12 respectively. By forming spiral notches 21-23 on a peripheral wall part of the outer shaft 11 along an axial direction, coil parts 24-26, in which the peripheral wall part is formed in a coil shape, are provided in a part of the outer shaft 11 in the axial direction. The operation parts are operated so as to generate twist around an axis line in the coil parts 24-26 by relatively rotating the distal end side of the outer shaft 11, which is connected through the inner shaft 12, around the axis line with respect to the base end side of the outer shaft 11. The coil parts 24-26 press and hold the lead 51 from the inner peripheral side by being enlarged in diameter according to the twist operation by the operation parts.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a lead extraction device.

  Conventionally, pacemakers have been used for the purpose of treating cardiac arrhythmia diseases. The pacemaker has a lead (conductor) for transmitting electrical stimulation to the heart. The lead is formed of a coiled wire having conductivity, and is placed in an embedded state inside the heart.

  When a defect such as a disconnection occurs in the lead or a pocket infection occurs in the surgical site, it may be necessary to remove the lead from the body. In that case, there is a method of removing the lead from the body by open heart surgery, but this method is very invasive and places a heavy burden on the patient. Therefore, in recent years, an attempt has been made to extract and remove the lead from the body without relying on open-heart surgery. In this method, a dedicated lead take-out device is used for taking the lead out of the body.

  As such a lead extraction device, Patent Document 1 discloses a device having the configuration shown in FIG. Hereinafter, the configuration of the lead take-out device will be described with reference to FIG. As shown in FIG. 7, the lead take-out device 60 of Patent Document 1 includes a tubular outer shaft 61 that is inserted into a lumen 65 a (see FIG. 8) of a lead 65, an inner end of the outer shaft 61, and a distal end. The inner shaft 62 is connected to the distal end portion of the outer shaft 61, and the operation portion 63 is provided on the proximal end side of each shaft 61, 62. On the distal end side of the outer shaft 61, a plurality of notches 64 are formed in the peripheral wall portion 61a. These notches 64 are concave notches opened in a predetermined direction orthogonal to the axial direction of the outer shaft 61, and have a long shape extending in the axial direction. The plurality of notches 64 are arranged at equal intervals in the axial direction of the outer shaft 61, and the notches 64 adjacent to each other in the same direction are opened toward the opposite side in the predetermined direction. A portion of the peripheral wall portion 61 a of the outer shaft 61 that remains without being cut out by the cutouts 64 is a deformed portion 66. The deformation portion 66 can project and be deformed outward in the radial direction based on the operation of the operation portion 63.

  Next, the operation of the lead extraction device 60 will be described with reference to FIGS. 8 (a) and 8 (b). When the lead 65 is taken out from the body using the lead take-out device 60, first, the outer shaft 61 of the device 60 is inserted into the lumen 65a of the lead 65, as shown in FIG. Thereafter, as shown in FIG. 8B, the inner shaft 62 is pulled toward the proximal end by the operation of the operation portion 63. Thereby, the front-end | tip part of the outer shaft 61 connected with the inner shaft 62 is pulled to the base end side, and each deformation | transformation part 66 of the outer shaft 61 protrudes and deform | transforms to the outer side of radial direction in connection with it. Then, the projecting deformed deforming portions 66 press the lead 65 from the inner peripheral side and hold the lead 65. Thereafter, the lead take-out device 60 is pulled out from the body while the lead 65 is held. As a result, the lead 65 is pulled out (taken out) from the body together with the lead take-out device 60.

US Pat. No. 6,358,256

  By the way, the lead take-out device 60 described in Patent Document 1 has a configuration in which a part of the outer shaft 61 in the circumferential direction (deformation part 66) protrudes outward so that the lead 65 is pressed and held by the part. Yes. Therefore, it is considered that the lead take-out device 60 is difficult to hold the lead 65 in a stable state.

  The present invention has been made in view of the above circumstances, and has as its main object to provide a lead take-out device that can hold a lead in a stable state.

  In order to solve the above-mentioned problems, a lead takeout device according to a first aspect of the present invention is a lead takeout device for taking out a tubular lead embedded in the body from the body, and is a tubular outer shaft inserted into the lead. And an inner shaft that is inserted into a tube hole of the outer shaft, and an operation portion that is provided to be connected to the proximal end sides of the both shafts, and a part of the outer shaft in the axial direction includes a peripheral wall thereof A spiral cut is formed in the axial direction in the part to provide a coil part in which the peripheral wall part is coiled, and the inner shaft is connected to the distal end side of the outer shaft The operation portion rotates the distal end side of the outer shaft connected via the inner shaft relative to the proximal end side of the outer shaft about an axis. By operating the coil portion, the coil portion is operated to cause twisting around an axis, and the coil portion is expanded in diameter based on the twisting operation by the operation portion, so that the lead is moved from the inner peripheral side. The lead is held by pressing.

  According to the present invention, a spiral cut is formed in the peripheral wall portion of the outer shaft that is inserted into the lead, thereby providing the coil portion in which the peripheral wall portion is coiled. When the distal end side of the outer shaft is rotated relative to the base end side of the outer shaft via the inner shaft by the operation of the operating portion, the coil portion is twisted around the axial line to expand its diameter. The lead is pressed and held from the inner peripheral side. In such a configuration, since the entire circumferential area of the coil portion is displaced radially outward to hold the lead, the lead can be held in a stable state.

  In the lead takeout device according to a second aspect of the present invention, in the first aspect, the coil portion is formed in a predetermined range from the vicinity of the distal end portion or the distal end portion toward the proximal end side in the outer shaft. It is characterized by.

  According to the present invention, since the coil portion is formed in the outer shaft near the distal end portion or in a predetermined range from the distal end portion toward the proximal end side, the vicinity of the distal end portion of the lead can be held by the coil portion. Since the tip of the lead is a site that is strongly adhered to the living tissue in the body, the lead can be suitably removed from the body by holding the vicinity of the tip with the coil part.

  Here, in the lead take-out device of Patent Document 1 described above, the deformed portion is protruded and deformed by pulling the distal end portion of the outer shaft to the base end side via the inner shaft, and the lead is held by the protruded and deformed protruded portion. It is the composition to do. In such a configuration, it is considered that it is difficult to hold the vicinity of the distal end portion of the lead by the deforming portion because the deforming portion is displaced to the proximal end side in the process of moving the deforming portion to the holding state. In this regard, in the present invention, the proximal end side and the distal end side of the outer shaft are rotated relative to each other around the axis line to cause the coil portion to be twisted to expand its diameter, and the lead is pressed and held by the expanded coil portion. Therefore, the coil part is not displaced to the proximal end side in the process of shifting the coil part to the holding state (in other words, the expanded diameter state). Therefore, the vicinity of the tip of the lead can be reliably held by the coil portion, and as a result, the above-described effect of suitably taking out the lead from the body can be reliably obtained.

  According to a third aspect of the present invention, in the first or second aspect of the present invention, the coil section is provided with a plurality of coil portions at predetermined intervals in the axial direction of the outer shaft, and the inner shaft includes the coil sections. It is connected with the said outer shaft in the front end side rather than.

  According to the present invention, a plurality of coil portions are provided at predetermined intervals along the axial direction of the outer shaft. In this case, when there are a plurality of adhesion sites that strongly adhere to the living tissue in the lead embedded in the body, the coil portion can be arranged corresponding to each adhesion site. Therefore, each of these adhesion sites can be held by the coil portion, and as a result, the lead can be more suitably taken out from the body.

  Also, by forming one coil portion long in the axial direction of the outer shaft, it is possible to hold a plurality of adhesion sites that strongly adhere to living tissue in the lead by the (one) coil portion. However, in that case, in order to increase the diameter of the entire coil portion, the amount of twist applied to the outer shaft by the operation of the operation portion becomes large, and this operation may become difficult. In this respect, according to the present invention, the above-described effects can be obtained without the difficulty of such operation.

  In a lead takeout device according to a fourth aspect of the present invention, in any one of the first to third aspects of the invention, the operation portion restricts the rotation of the base end side of the outer shaft around the axis line, It is operated to apply a rotational force around an axis to the tip side via the inner shaft.

  By the way, as a method of causing the coil portion to twist around the axis, for example, a method of applying a rotational force around the axis to the base end side of the outer shaft while restricting the distal end side of the outer shaft from rotating around the axis. Conceivable. In this method, the applied rotational force is transmitted from the proximal end side to the distal end side of the outer shaft, and the coil portion is twisted by the transmitted rotational force. However, the coil portion is considered to be disposed on the distal end side of the outer shaft so as to hold the distal end side of the lead. In this case, a long range from the proximal end side to the coil portion on the distal end side of the outer shaft extends around the axis. Need to rotate. If it does so, there exists a possibility that a big sliding resistance may generate | occur | produce between the outer peripheral surface of an outer shaft and the inner peripheral surface of a lead with rotation, and we are anxious about the fall of the operativity at the time of rotating operation.

  Accordingly, in the present invention, in view of such a point, contrary to the above-described method, while the rotation of the proximal end side of the outer shaft around the axis is restricted, the axis line is connected to the distal end side of the outer shaft via the inner shaft. The surrounding rotational force is applied. In this case, the applied rotational force is transmitted from the distal end side to the proximal end side of the outer shaft, and the coil portion is twisted by the transmitted rotational force. Therefore, it is not necessary to rotate the base end side (larger) than the coil portion of the outer shaft in order to cause the coil portion to be twisted. As a result, the outer peripheral surface of the outer shaft and the inner peripheral surface of the lead are accompanied by such rotation. The sliding resistance generated between the two can be reduced. Thereby, the effect of the first invention can be obtained while suppressing a decrease in operability.

  According to a fifth aspect of the present invention, in the fourth invention, the portion of the coil portion that presses and holds the lead when the diameter of the coil portion is expanded is a pressing holding portion, and the coil portion having the pressing holding portion is A plurality of or only one outer shaft is provided at predetermined intervals in the axial direction of the outer shaft, and the pressing holding portion is formed among the notches forming the plurality or one of the coil portions in the outer shaft. The predetermined cut portion is generally characterized in that the circumferential pitch around the axis decreases as it goes from the distal end side to the proximal end side.

  By the way, in the configuration of the fourth invention in which the rotational force is applied to the distal end side of the outer shaft through the inner shaft by the operation of the operation portion, the rotational force is transmitted from the distal end side to the proximal end side of the outer shaft. Will be. In such a configuration, for example, when the distal end side of the coil portion first expands in diameter and shifts to a holding state in which the lead is pressed and held, thereafter, the distal end side rotates even if a rotational force is applied to the distal end side. It is assumed that it will disappear. In that case, it is difficult to transmit the rotational force to the proximal end side than the distal end side in the coil portion, and as a result, it is difficult to increase the diameter of the proximal end side than the distal end side in the coil portion and shift to the holding state. There is a risk.

  Therefore, in the present invention, in view of this point, in the press holding portion that presses and holds the lead when the diameter of the coil portion is expanded, the circumferential pitch of the cut portion is reduced from the distal end side toward the proximal end side. In this case, since the proximal end side is easier to expand than the distal end side in the press holding portion, the diameter on the proximal end side is expanded to the inner peripheral portion of the lead earlier than the distal end side when expanding the diameter. Then, the lead shifts to a holding state where the lead is pressed and held. As a result, it is possible to avoid the above-described inconvenience that the distal end side is held first and the rotational force cannot be transmitted to the proximal end side, so that the entire pressing holding portion is surely shifted to the holding state. be able to. Therefore, the lead holding function by the coil part (press holding part) can be surely exhibited.

  In a lead take-out device according to a sixth aspect of the present invention, in the fourth aspect of the invention, a plurality of the coil portions are provided at predetermined intervals in the axial direction of the outer shaft, and the inner shaft is more distal than the coil portions. Each notch forming each coil part has a minimum pitch part in which the circumferential pitch around the axis is minimum and constant in the notch, and is connected to the outer shaft on the side, The minimum pitch portion of the cut in the coil portion is characterized in that the circulation pitch becomes smaller from the distal end side toward the proximal end side.

  The portion formed by the minimum pitch portion of the cut in the coil portion is the portion where the diameter is most easily expanded in the coil portion, and thus the portion that functions as a press holding portion that presses and holds the lead from the inner peripheral side in the coil portion. It is thought that. Here, in a configuration in which a plurality of coil portions are provided at predetermined intervals in the axial direction of the outer shaft, when a rotational force is applied to the distal end side of the outer shaft by operation of the operation portion, the rotational force is applied to the outer shaft. In this case, the signal is sequentially transmitted from the coil portion on the distal end side to the coil portion on the proximal end side. In this case, for example, when the tip coil portion (press holding portion) first expands in diameter and shifts to a holding state in which the lead is pressed and held, thereafter, a rotational force is applied to the tip coil portion. Also, it is assumed that the coil portion does not rotate. If it does so, it will become difficult to transmit a rotational force to the base end side rather than the said coil part, and there exists a possibility that it may become difficult to expand the diameter of the coil part of the base end side rather than the said coil part, and to transfer to a holding state.

  Therefore, in the present invention, in view of this point, in the minimum pitch portion of the cut in each coil portion, the circumferential pitch is made smaller from the distal end side toward the proximal end side. In this case, since the diameter of the proximal end side is easier to expand than the distal end side of the press holding portion of each coil portion, the proximal end side of the lead end side leads to the inner peripheral portion of the lead earlier when expanding the diameter. The diameter of the lead is increased and the lead is pressed and held. Accordingly, in the configuration in which the outer shaft is provided with a plurality of coil portions, each of the coil portions (press holding portions) can be surely shifted to the holding state, so that the holding function of the lead by each coil portion Can be exhibited reliably.

  The lead extraction device according to a seventh aspect of the present invention is the lead extraction device according to any one of the first to sixth aspects, wherein the outer shaft is a non-coil portion other than the coil portion where the cut is not formed in the peripheral wall portion. The notch forming the coil portion is provided between a constant pitch portion having a constant circumferential pitch around the axis, and between the constant pitch portion and the non-coil portion, and the circular pitch is the constant pitch portion. And a pitch changing portion that gradually increases from the circulation pitch of the constant pitch portion toward the non-coil portion.

  According to the present invention, the notch forming the coil portion has a constant pitch portion and a pitch change portion provided between the constant pitch portion and the non-coil portion. The circumferential pitch gradually increases from the circumferential pitch of the constant pitch portion as it goes from the constant pitch portion to the non-coiled portion. In this case, since it is possible to suppress a local change in rigidity at the boundary portion between the coil portion and the non-coil portion in the outer shaft, the outer shaft from the distal end side to the proximal end side (or from the proximal end side to the distal end side). When the rotational force is transmitted, the rotational force can be successfully transmitted from the non-coil portion to the coil portion (or from the coil portion to the non-coil portion). As a result, the rotational force cannot be transmitted well between the coil part and the non-coil part, and the coil part is less likely to be deformed or damaged at the boundary with the non-coil part. Can do.

  Further, it is desirable that the pitch changing portion is provided on each of the base end side and the tip end side of the constant pitch portion. If it does so, it can make it difficult to produce said malfunction in the both ends of the axial direction in a coil part, respectively.

  According to an eighth aspect of the present invention, there is provided the lead take-out device according to any one of the first to seventh aspects, wherein the distal end side of the outer shaft is rotated around the axis with respect to the proximal end side of the outer shaft by the operation of the operation portion. The coil portion is configured such that the distal end side of the outer shaft is one side in the axial direction relative to the proximal end side of the outer shaft by the operation of the operation portion. The diameter is increased when rotated relative to the other side, and the diameter is decreased when rotated relative to the other side.

  According to the present invention, the diameter of the coil portion can be increased and decreased by operating the operation portion. In this case, the holding state can be released by reducing the diameter of the coil portion after the coil portion is expanded to hold the lead. As a result, if any trouble occurs while taking out the lead, the lead holding state can be released and only the lead take-out device can be taken out from the body, so it is safe to take out the lead. Can increase the sex.

The side view which shows the whole structure of a lead extraction apparatus. The side view which shows an outer shaft and an inner shaft. The longitudinal cross-sectional view which shows the structure of the operation part periphery. Explanatory drawing for demonstrating the effect | action of a lead extraction apparatus. Explanatory drawing for demonstrating a mode at the time of shifting to the holding state in which each coil part hold | maintains a lead. Explanatory drawing for demonstrating the mode at the time of taking out the lead embedded in the heart from the inside of the heart. The side view which shows the whole structure of the lead extraction apparatus of patent document 1. FIG. Explanatory drawing for demonstrating the effect | action of the lead extraction apparatus of patent document 1. FIG.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the present embodiment, a lead extracting device that takes out a lead of a pacemaker embedded in the body from the body is embodied. FIG. 1 is a side view showing the overall configuration of the lead extraction device. FIG. 2 is a side view showing an outer shaft and an inner shaft of the lead extraction device.

  As shown in FIG. 1, the lead take-out device 10 includes an outer shaft 11 inserted into the lead, an inner shaft 12 inserted inside the outer shaft 11, and proximal ends of the shafts 11 and 12. And an operation unit 13 provided. The lead extraction device 10 has a length of, for example, about 600 mm to 700 mm as a whole.

  As shown in FIG. 2, the outer shaft 11 is formed in a circular tube shape from a metal material, and is specifically formed from stainless steel. The outer shaft 11 has a tube hole 11a therein. The tube hole 11 a extends continuously over the entire axial direction (longitudinal direction) of the outer shaft 11. Moreover, the outer shaft 11 has the same inner diameter and outer diameter throughout the entire axial direction.

  The inner shaft 12 is formed in a linear shape from a metal material, and specifically is formed from stainless steel. The inner shaft 12 has a circular cross section (cross section perpendicular to the axial direction), and the outer diameter of the inner shaft 12 is the same over the entire axial direction. The outer diameter of the inner shaft 12 is smaller than the inner diameter of the outer shaft 11. The inner shaft 12 is inserted through the tube hole 11 a of the outer shaft 11, and a gap exists between the outer peripheral surface of the inner shaft 12 and the inner peripheral surface of the outer shaft 11 in the inserted state.

  The inner shaft 12 has its tip end aligned with the tip end of the outer shaft 11 at the same position in the axial direction. In the aligned state, the tip of the inner shaft 12 is joined (connected) to the tip of the outer shaft 11 by welding (for example, YAG welding). In this case, a weld bead 15 generated by welding is formed across the tip portions of the shafts 11 and 12, and the tip portions of the shafts 11 and 12 are coupled to each other via the weld beads 15. . The weld bead 15 constitutes the distal end portion of the lead extraction device 10 and has a hemispherical shape that is convex toward the distal end side. This prevents the lead from being damaged by the weld bead 15 when the lead take-out device 10 is inserted into the lead.

  In a state where the tip portions of the shafts 11 and 12 are joined, the shafts 11 and 12 are arranged with their axis lines (center axis lines) positioned on the same straight line. Further, in a state where the shafts 11 and 12 are joined, a part of the inner shaft 12 extends to the base end side from the base end portion of the outer shaft 11 and becomes an extension portion 18.

  The outer shaft 11 and the inner shaft 12 are not necessarily formed of stainless steel, and may be formed of other metal materials such as nickel titanium. Further, the outer shaft 11 and the inner shaft 12 may be formed of a resin material such as polyether ether ketone (PEEK). In that case, what is necessary is just to join the front-end | tip part of each shaft 11 and 12 by welding, adhesion | attachment, etc. FIG.

  Next, the configuration of the outer shaft 11 will be described in detail.

  In the outer shaft 11, spiral cuts 21 to 23 are formed in the peripheral wall portion 17 surrounding the tube hole 11a. A plurality of (specifically, three) cuts 21 to 23 are formed at predetermined intervals in the axial direction in the outer shaft 11. Each of the cuts 21 to 23 penetrates the peripheral wall portion 17 in the thickness direction, and continuously extends in a spiral shape along the axial direction of the outer shaft 11. In the following description, the notches 21 to 23 are referred to as a first notch 21, a second notch 22, and a third notch 23 in order from the distal end side toward the proximal end side.

  Each of the notches 21 to 23 has the same spiral direction. That is, each of the cuts 21 to 23 is formed so as to circulate around the axis line in the same direction (specifically, counterclockwise) as it goes from the distal end side to the proximal end side. Each of the cuts 21 to 23 has the same width (slit width), and the width is the same over the entire length direction of the cuts 21 to 23.

  In the outer shaft 11, portions where the peripheral wall portion 17 is coiled (in other words, spiral) by the notches 21 to 23 are coil portions 24 to 26. The coil portions 24 to 26 have spiral portions that are spirally wound around the axis, and the spiral portions extend spirally along the cuts 21 to 23. A plurality (specifically three) of coil portions 24 to 26 are provided at predetermined intervals in the axial direction corresponding to the notches 21 to 23. These coil portions 24 to 26 are all provided on the distal end side of the outer shaft 11.

  In the following, the coil portions 24 to 26 are referred to as a first coil portion 24, a second coil portion 25, and a third coil portion 26 in order from the distal end side toward the proximal end side. Further, a portion other than the coil portions 24 to 26 where the notches 21 to 23 are not formed in the outer shaft 11 is referred to as a non-coil portion 27. In the outer shaft 11, the coil parts 24 to 26 and the non-coil part 27 are arranged alternately in the axial direction.

  The first coil portion 24 (in other words, the first cut 21) is formed in a predetermined range from the vicinity of the distal end portion of the outer shaft 11 toward the proximal end side. That is, the first coil portion 24 extends slightly from the position on the base end side toward the base end side with respect to the tip end portion of the outer shaft 11, and more specifically, only 0.5 to 2.0 mm from the tip end portion of the outer shaft 11. It extends from the position on the base end side to the base end side. In this case, a non-coil portion 27 having an extremely short axial length exists on the outer shaft 11 on the tip side of the first coil portion 24, and the non-coil portion 27 is welded to the tip portion of the inner shaft 12. (Via the weld bead 15).

  The second coil part 25 is arranged at a position on the proximal side by a predetermined dimension from the first coil part 24, and the third coil part 26 is arranged at a position on the proximal side by a predetermined dimension from the second coil part 25. Yes. Specifically, when the outer shaft 11 is inserted into a lead embedded in the body, the second coil part 25 and the third coil part 26 are arranged at an adhesion site where the lead is strongly adhered to a living body tissue. (The details will be described later.)

  Then, the structure of each coil part 24-26 (each notch 21-23) is demonstrated in detail. In addition, since each coil part 24-26 has the same structure fundamentally, description of each coil part 24-26 is collectively carried out below.

  The notches 21 to 23 forming the coil portions 24 to 26 are, respectively, pitch constant portions 21a to 23a formed in the intermediate portion in the axial direction, and tip sides formed continuously to the tip sides of the pitch constant portions 21a to 23a. Pitch changing portions 21b to 23b and base end side pitch changing portions 21c to 23c formed continuously on the base end side of the constant pitch portions 21a to 23a are provided. The distal end side pitch changing portions 21b to 23b include the distal end portions of the notches 21 to 23, and the proximal end side pitch changing portions 21c to 23c include the proximal end portions of the notches 21 to 23. Each of these pitch changing portions 21 b to 23 b and 21 c to 23 c is adjacent to the non-coil portion 27. Each of these pitch changing portions 21b to 23b and 21c to 23c corresponds to a pitch changing portion.

  In the constant pitch portions 21a to 23a, the circumferential pitches of the cuts 21 to 23 are the same over the entire axial direction. Here, the circumferential pitch of the incisions 21 to 23 refers to a length that is displaced in the axial direction as the incisions 21 to 23 go around (turn around) the axis, in other words, between the notches 21 to 23 adjacent in the axial direction. Distance (distance in the axial direction). In the constant pitch portions 21a to 23a, the circulation pitch is smaller than the rotation pitches of the pitch change portions 21b to 23b and 21c to 23c. In other words, in the constant pitch portions 21a to 23a, the circulation pitch is the smallest at the cuts 21 to 23. Therefore, the constant pitch portions 21a to 23a correspond to the minimum pitch portion.

  In the front end side pitch changing portions 21b to 23b, gradually from the peripheral pitch of the constant pitch portions 21a to 23a (more specifically, 1 of the cuts 21 to 23) as the peripheral pitch moves away from the constant pitch portions 21a to 23a toward the front end side. It increases with each lap. Further, in the base end side pitch changing portions 21c to 23c, the circumference pitch gradually increases from the circumference pitch of the constant pitch portions 21a to 23a as it moves away from the constant pitch portions 21a to 23a toward the base end side. That is, in each of the pitch changing portions 21b to 23b and 21c to 23c, the circulation pitch gradually increases as the pitch changes from the constant pitch portions 21a to 23a toward the non-coil portion 27.

  The pitch constant portions 21a to 23a of the notches 21 to 23 are different from each other in the circulation pitch. Specifically, the pitch constant portion 22 a of the second cut 22 has a smaller circumferential pitch than the pitch constant portion 21 a of the first cut 21, and the pitch of the third cut 23 is smaller than the pitch constant portion 22 a of the second cut 22. The constant portion 23a has a smaller circulation pitch. That is, the circumferential pitch of each of the fixed pitch portions 21a to 23a decreases in order from the distal end side toward the proximal end side.

  The portions formed by the constant pitch portions 21a to 23a in the coil portions 24 to 26 are intermediate coil portions 24a to 26a. In the intermediate coil portions 24a to 26a, the width of the spiral portion is constant throughout the coil portions 24a to 26a. In the coil portions 24 to 26, the distal end sides of the intermediate coil portions 24a to 26a are distal end side coil portions 24b to 26b, and the proximal end sides of the intermediate coil portions 24a to 26a are proximal end side coil portions 24c to 26c. Yes. The distal end side coil portions 24b to 26b are formed by the distal end side pitch changing portions 21b to 23b, and the proximal end side coil portions 24c to 26c are formed by the proximal end side pitch changing portions 21c to 23c.

  The outer peripheral surfaces of the coil portions 24 to 26 are each subjected to surface processing for increasing the surface roughness over the entire region. This surface processing is performed by sandblasting, for example. By performing this surface processing, the outer peripheral surface of each of the coil portions 24 to 26 is a high friction surface 29 having a higher frictional resistance than the outer peripheral surface of the non-coil portion 27. In FIG. 2, the high friction surface 29 is shown with a dot hatch. In the present embodiment, the high friction surface 29 slightly protrudes from the outer peripheral surfaces of the coil portions 24 to 26 to both sides in the axial direction and straddles the non-coil portion 27.

  In addition to the sandblasting, other processes such as laser texturing may be performed as the surface processing for increasing the surface roughness. Such surface processing is not necessarily applied to all the coil portions 24 to 26, and may be performed only to any one of the coil portions 24 to 26. Moreover, you may make it not perform such surface processing to all the coil parts 24-26.

  Next, the operation unit 13 will be described with reference to FIG. FIG. 3 is a longitudinal sectional view showing a configuration around the operation unit 13.

  As shown in FIG. 3, the operation unit 13 includes an outer operation unit 31 connected to the base end side of the outer shaft 11 and an inner operation unit 32 connected to the base end side of the inner shaft 12. The outer operation part 31 is formed in a cylindrical shape from a metal material, and is specifically formed from stainless steel. A cylindrical hole 33 extending in the axial direction is formed inside the outer operation portion 31. The outer shaft 11 is inserted through the cylindrical hole 33. The outer shaft 11 is joined (connected) to the outer operation portion 31 by welding in the inserted state.

  The inner operation part 32 is provided on the proximal end side of the outer operation part 31. The inner operation portion 32 is formed in a cylindrical shape from a metal material, and specifically is formed from stainless steel. A cylindrical hole 34 extending in the axial direction is formed inside the inner operation portion 32. The extending portion 18 of the inner shaft 12 is inserted into the cylindrical hole 34. A columnar joint 35 is fixed by welding to the base end portion of the extending portion 18. The cylindrical hole 34 is enlarged in diameter at the base end side to form an enlarged diameter portion 34 a, and a joint 35 is inserted into the enlarged diameter portion 34 a and is welded and fixed to the inner operation portion 32.

  The cylindrical hole 34 has a diameter-expanded portion 34b with the diameter of the tip thereof being increased. The base end portion 31a of the outer operation portion 31 is inserted into the enlarged diameter portion 34b. In the inserted state of the base end portion 31a, the inner operation portion 32 is connected to the base end portion 31a so as to be rotatable around the axis. Thereby, the inner operation part 32 can be rotated around the axis with respect to the outer operation part 31.

  Here, when the inner operation portion 32 is rotated around the axis with respect to the outer operation portion 31, the rotational force is applied to the distal end portion of the outer shaft 11 via the inner shaft 12. And the front end side of the outer shaft 11 rotates around an axis line with respect to the base end side by the applied rotational force. As a result, the outer shaft 11 is twisted around the axis, and as a result, the coils 24 to 26 are twisted around the axis. When the inner operation unit 32 is rotated about the axis with respect to the outer operation unit 31, the outer end of the outer shaft 11 is rotated about the axis by holding (gripping) the outer operation unit 31. regulate.

  The operation unit 13 is provided with a holding structure 37 that holds the rotational position of the inner operation unit 32 with respect to the outer operation unit 31. The holding structure 37 is configured by using a ratchet mechanism. The holding structure 37 includes a plurality of ratchet teeth 38 provided on the outer peripheral surface of the base end portion 31 a of the outer operation portion 31, and the ratchet teeth 38 provided on the inner operation portion 32. It has the latching claw 39 which can be stopped. In the holding structure 37, rotation to the one side in the direction around the axis of the inner operation unit 32 with respect to the outer operation unit 31 (hereinafter also referred to as rotation in the positive direction) is allowed, whereas rotation to the other side ( Hereinafter, the rotation in the reverse direction is also regulated by the locking claw 39 engaging the ratchet teeth 38. And the rotation position of the inner operation part 32 with respect to the outer operation part 31 is hold | maintained by this rotation control to the other side.

  The locking claw 39 is in a locked state that can be locked to the ratchet teeth 38 by the operation of the switching operation unit 41 provided on the outer peripheral surface of the inner operation unit 32, and the locking that is released from the locking on the ratchet teeth 38. Switching to the release state is possible. When the locking claw 39 is in the unlocked state, the inner operation part 32 can rotate on both sides in the direction around the axis with respect to the outer operation part 31.

  The holding structure 37 does not necessarily have to be configured using a ratchet mechanism, and other configurations may be adopted.

  Next, the operation of the lead extraction device 10 will be described with reference to FIG. Here, the action when the lead of the pacemaker implanted in the body is taken out from the body using the lead extraction device 10 will be described. FIG. 4 is an explanatory diagram for explaining the operation of the lead take-out device 10.

  As shown in FIG. 4 (a), the lead 51 of the pacemaker is formed in a coil shape by a conductive metal wire, and has a lumen 51a extending in the axial direction inside thereof. When taking out the lead 51 from the body using the lead take-out device 10, first, the outer shaft 11 of the device 10 is inserted into the inner cavity 51 a of the lead 51.

  Next, with the outer shaft 11 inserted, the inner operation portion 32 is rotated in the positive direction around the axis with respect to the outer operation portion 31. Thus, the rotational force is applied to the distal end portion of the outer shaft 11 via the inner shaft 12, and the applied positive rotational force is applied to each coil portion 24 from the distal end portion of the outer shaft 11 toward the proximal end side. To 26. And the twist about the axis arises in each coil part 24-26 by the transmitted rotational force of the positive direction.

  Here, the rotational force in the positive direction is a rotational force that rotates the outer shaft 11 leftward (counterclockwise) when the outer shaft 11 is viewed from the base end side (FIG. 4B). ) See arrow). That is, the rotational force in the positive direction is the rotational force in the same direction as the direction in which the coil portions 24 to 26 (cuts 21 to 23) circulate around the axis from the distal end side toward the proximal end side. Therefore, when the rotational force in the positive direction is transmitted to each of the coil parts 24 to 26, the coil parts 24 to 26 are twisted in the direction of rewinding the coil parts 24 to 26 (winding thereof). And the winding of each coil part 24-26 loosens by the twist, and each coil part 24-26 expands to a radial direction outer side (namely, diameter expansion).

  FIG. 4B shows a state where the diameters of the coil portions 24 to 26 are expanded. As shown in FIG. 4B, when the diameters of the coil portions 24 to 26 are increased, the expanded diameter coil portions 24 to 26 press the lead 51 from the inner peripheral side and hold the lead 51 (hold). It becomes a state to do. Here, among the cuts 21 to 23 that form the coil portions 24 to 26, in the constant pitch portions 21a to 23a that form the intermediate coil portions 24a to 26a, the distal end side coil portions 24b to 26b and the proximal end side coil portions 24c to 26c. The circumferential pitch is smaller than the pitch change portions 21b to 23b and 21c to 23c forming the. For this reason, the intermediate coil portions 24a to 26a are easier to expand in diameter than the distal end side coil portions 24b to 26b and the proximal end side coil portions 24c to 26c. The coil portions 24a to 26a have a larger diameter than the distal end side coil portions 24b to 26b and the proximal end side coil portions 24c to 26c, and press and hold the lead 51 from the inner peripheral side. That is, in the holding state of the lead 51 by the coil portions 24 to 26, only the intermediate coil portions 24a to 26a press and hold the lead 51, and the intermediate coil portions 24a to 26a correspond to the press holding portion. Yes.

  Next, in a state where the leads 51 are held by the coil portions 24 to 26, the lead take-out device 10 (outer shaft 11) is pulled out from the body. As a result, the lead 51 is pulled out (taken out) from the body together with the lead extracting device 10.

  In this case, the operation of the operation unit 13 causes the coil units 24 to 26 to be twisted about the axis, thereby increasing the diameter of the coil units 24 to 26, and the expanded coil portions 24 to 26 allow the leads 51 to be connected to the inner circumference. Since the pressure is held from the side, the leads 51 can be held in the entire circumferential direction of the coil portions 24 to 26. Therefore, the lead 51 can be held in a stable state.

  Incidentally, when the inner operation part 32 is operated to rotate in the reverse direction around the axis with respect to the outer operation part 31 in the holding state of the lead 51 by the coil parts 24 to 26 (the state shown in FIG. 4B), A rotational force is applied to the distal end portion of the outer shaft 11 via the inner shaft 12. Thereby, the rotational force of the reverse direction is transmitted from the front-end | tip part of the outer shaft 11 to a base end side, and the twist of each coil parts 24-26 is eliminated with the transmitted reverse direction rotational force. And by eliminating the twist of each coil part 24-26, each coil part 24-26 is diameter-reduced, respectively, and the holding | maintenance state of the lead 51 by the coil parts 24-26 is cancelled | released (FIG. 4 (a)). Will be in the state shown). Therefore, if any trouble occurs when the lead 51 is taken out from the body, the holding state of the lead 51 can be released and only the lead take-out device 10 can be taken out from the body. Safety can be increased.

  Further, the amount of diameter expansion of each of the coil portions 24 to 26 can be adjusted in size by adjusting the amount of rotation (operation amount) of the inner operation portion 32 with respect to the outer operation portion 31. Therefore, by adjusting the diameter expansion amount of the coil parts 24 to 26, the pressing force of the coil parts 24 to 26 against the lead 51 can be adjusted, and as a result, the holding force of the leads 51 by the coil parts 24 to 26 can be adjusted. As a result, the holding force of the lead 51 can be appropriately adjusted according to the strength of the adhesion of the lead 51 to the living tissue in the body, and the lead 51 is preferably taken out from the body regardless of the strength of the adhesion of the lead 51. It becomes possible.

  Subsequently, a state in which each of the coil portions 24 to 26 is expanded to shift to a holding state in which the lead 51 is held will be described in detail. FIG. 5 is an explanatory diagram for explaining a state when each of the coil portions 24 to 26 shifts to the holding state.

  As described above, when the inner operation portion 32 is rotated in the forward direction with respect to the outer operation portion 31, the rotational force is applied to the distal end portion of the outer shaft 11 via the inner shaft 12. Then, the applied rotational force is transmitted to each of the coil portions 24 to 26 of the outer shaft 11, and each of the coil portions 24 to 26 is twisted around the axis to expand the diameter by the transmitted rotational force.

  Here, in each coil part 24-26, since the notch part (pitch constant part 21a-23a) which forms the intermediate coil part 24a-26a mutually differs in a circumference pitch, expansion of each intermediate coil part 24a-26a is carried out. Ease of diameter is different. Specifically, since the circumferential pitch of each pitch constant portion 21a to 23a is smaller from the tip side toward the base end, each intermediate coil portion 24a to 26a is smaller than the tip side. The diameter on the proximal side is easier to expand. Therefore, when each coil part 24-26 expands in diameter, the intermediate coil parts 24a-26a of each coil part 24-26 are diameter-expanded in order toward the thing of the front end side from the thing of a base end side. .

  That is, when each of the coil portions 24 to 26 is expanded in diameter, first, as shown in FIG. 5A, the intermediate coil portion 26 a of the third coil portion 26 is expanded in diameter so that the lead 51 is pressed and held. After that, as shown in FIG. 5 (b), the intermediate coil portion 25a of the second coil portion 25 expands in diameter and shifts to a holding state in which the lead 51 is pressed and held, and then as shown in FIG. 5 (c). Then, the intermediate coil portion 24a of the first coil portion 24 expands in diameter and shifts to a holding state in which the lead 51 is pressed and held.

  When the intermediate coil portions 24a to 26a shift to the holding state in this order, the rotational force applied to the distal end portion of the outer shaft 11 by the rotation operation of the inner operation portion 32 is applied to the intermediate coil portions 24a to 26a. It can be suitably transmitted. That is, when each of the intermediate coil portions 24a to 26a sequentially shifts to the holding state from the distal end side toward the proximal end side, after the distal end side intermediate coil portion 24a shifts to the holding state, Thereafter, it is assumed that the first coil portion 24 does not rotate even when a rotational force is applied to the coil portion 24a (and thus the first coil portion 24). In this case, it is difficult to transmit the rotational force to the base end side with respect to the first coil portion 24. As a result, the second coil portion 25 and the third coil portion 26 on the base end side with respect to the first coil portion 24 are expanded. There is a possibility that it may be difficult to shift the diameter to the holding state.

  In this regard, if the intermediate coil portions 24a to 26a are shifted to the holding state in this order, that is, from the proximal end side toward the distal end side, the distal end side first coil portion 24 is moved forward. Therefore, it is possible to avoid the above-described inconvenience that the rotational force cannot be transmitted to the coil portions 25 and 26 on the proximal end side than the coil portions 25 and 26. Therefore, the coil portions 24 to 26 (intermediate coil portions 24a to 24a 26a) can transmit the rotational force, and as a result, each of the coil portions 24 to 26 can be reliably shifted to the holding state. Thereby, in the configuration in which the outer shaft 11 is provided with the plurality of coil portions 24 to 26, the function of holding the lead 51 by each of the coil portions 24 to 26 can be surely exhibited.

  Next, a description will be given of a case where the pacemaker lead 51 embedded in the heart is taken out from the body using the lead take-out device 10. FIG. 6 is an explanatory diagram for explaining such a situation.

  As shown in FIG. 6, a pacemaker lead 51 is implanted inside the patient's heart. The lead 51 is introduced into the right ventricle 55 via the superior vena cava 53 and the tricuspid valve 54, and the distal end portion (electrode portion) is attached to the inner wall of the right ventricle 55. In the introduced state, at least a part of the lead 51 is adhered to the living body tissue of the heart. Specifically, the distal end portion of the lead 51 attached to the right ventricle 55, the portion disposed in the tricuspid valve 54, and the portion disposed in the superior vena cava 53 are particularly strongly adhered to living tissue. It has become.

  When the lead 51 is taken out from the body using the lead take-out device 10, the outer shaft 11 is inserted into the inner cavity 51 a of the lead 51. At this time, the outer shaft 11 is inserted into the lead 51 until the tip of the outer shaft 11 reaches the tip of the lead 51 or the vicinity thereof. Accordingly, the first coil portion 24 of the outer shaft 11 is disposed in the vicinity of the distal end portion attached to the right ventricle 55 in the lead 51, and the second coil portion 25 is disposed in a portion of the lead 51 passing through the tricuspid valve 54. The third coil portion 26 is disposed at a portion of the lead 51 that passes through the superior vena cava 53. In other words, in this case, the coil portions 24 to 26 are arranged at the adhesion sites where the leads 51 are strongly adhered to the living tissue in the heart.

  Next, by rotating the inner operation part 32, each coil part 24 to 26 is expanded in diameter, and is shifted to a holding state in which the lead 51 is held. Thereby, each said adhesion part strongly adhered to the biological tissue in the lead | read | reed 51 is each hold | maintained by each coil parts 24-26. Then, the lead take-out device 10 is pulled toward the proximal end while the lead 51 is held, and is pulled out from the heart. As a result, the lead 51 is pulled out (taken out) from the heart together with the lead extraction device 10.

  In this case, since the lead 51 can be taken out from the heart in a state where the respective adhesion sites strongly adhered to the living tissue in the lead 51 are held by the coil portions 24 to 26, the lead 51 is suitably taken out from the heart. be able to. In addition, by forming one coil portion long in the axial direction of the outer shaft 11, it is possible to hold each adhesion site that strongly adheres to the living tissue in the lead 51 by the (one) coil portion. In that case, in order to increase the diameter of the entire coil portion, the amount of twist applied to the outer shaft 11 is increased by the operation of the inner operation portion 32, and this operation may become difficult. In this regard, according to the above-described configuration in which the outer shaft 11 is provided with the plurality of coil portions 24 to 26, the above-described effects can be obtained without the difficulty of the operation.

  As mentioned above, according to the structure of this embodiment explained in full detail, the following outstanding effects are acquired.

  Since the first coil portion 24 is formed in a predetermined range from the vicinity of the distal end portion toward the proximal end side in the outer shaft 11, the vicinity of the distal end portion of the lead 51 can be held by the first coil portion 24. Since the distal end portion of the lead 51 is a site that is strongly adhered to living tissue in the body, the lead 51 can be suitably removed from the body by holding the vicinity of the distal end portion with the first coil portion 24.

  Further, by rotating the distal end side of the outer shaft 11 around the axis with respect to the proximal end side, the first coil portion 24 is twisted to expand the diameter of the coil portion 24, and the expanded first coil Since the lead 51 is pressed and held by the portion 24, unlike the lead take-out device of Patent Document 1, the first coil portion 24 is in the process of shifting the first coil portion 24 to the holding state (in other words, the expanded diameter state). Does not displace to the base end side. Therefore, the first coil portion 24 can reliably hold the vicinity of the tip of the lead 51, and as a result, the above-described effect of suitably taking out the lead 51 from the body can be reliably obtained.

  While the outer operation portion 31 is held, the inner operation portion 32 is rotated around the axis with respect to the outer operation portion 31, thereby controlling the rotation of the outer shaft 11 around the axis while restricting the rotation of the outer end of the outer shaft 11. A rotational force around the axis is applied to the tip of the shaft 11 via the inner shaft 12. In this case, the rotational force applied to the distal end portion of the outer shaft 11 is transmitted from the distal end portion of the outer shaft 11 to the proximal end side, and the coil portions 24 to 26 are twisted by the transmitted rotational force. Become. Therefore, in order to cause the coil portions 24 to 26 to be twisted, it is not necessary to rotate (largely) a long range of the outer shaft 11 on the proximal end side relative to the coil portions 24 to 26, and as a result, the outer shaft 11 rotates. Accordingly, the sliding resistance generated between the outer peripheral surface of the shaft 11 and the inner peripheral surface of the lead 51 can be reduced. Thereby, when performing operation which causes twist to coil parts 24-26, the fall of the operativity can be controlled.

  In the notches 21 to 23 forming the coil portions 24 to 26, the pitch constant portions 21a to 23a whose circulation pitch is made constant, and as the circulation pitch goes from the pitch constant portions 21a to 23a toward the non-coil portion 27, the pitch becomes constant. Pitch changing portions 21b to 23b and 21c to 23c that gradually increase from the circumferential pitch of the portions 21a to 23a are provided. In this case, since it is possible to suppress a local change in rigidity at the boundary between the coil portions 24 to 26 and the non-coil portion 27 in the outer shaft 11, a rotational force is generated from the distal end side to the proximal end side in the outer shaft 11. When transmitted, the rotational force can be successfully transmitted from the non-coil portion 27 to the coil portions 24-26 (or from the coil portions 24-26 to the non-coil portion 27). As a result, the rotational force cannot be successfully transmitted between the coil parts 24 to 26 and the non-coil part 27, and the coil parts 24 to 26 are deformed or damaged at the boundary with the non-coil part 27. It is possible to make it difficult to cause problems.

  In addition, since the pitch changing portions 21b to 23b and 21c to 23c are provided on the proximal end side and the distal end side of the constant pitch portions 21a to 23a, respectively, the above-described problems are caused at both end portions in the axial direction of the coil portions 24 to 26. Can be difficult.

  Since the outer peripheral surface of each of the coil portions 24 to 26 is a high friction surface 29 having a higher frictional resistance than the outer peripheral surface of the non-coil portion 27, the lead 51 is displaced in the axial direction when the lead 51 is held by each of the coil portions 24 to 26. Can be suppressed. Thereby, the lead 51 can be held in a more stable state.

  The present invention is not limited to the above embodiment, and may be implemented as follows, for example.

  (1) In the above embodiment, the pitch changing portions 21b to 23b and 21c to 23c are provided on the leading end side and the base end side of the constant pitch portions 21a to 23a in the cuts 21 to 23, respectively. You may provide a pitch change part only in any one of the front end side and base end side. Moreover, you may make it not provide a pitch change part in both the front end side and base end side of pitch constant part 21a-23a.

  (2) In the above-described embodiment, in the pitch constant portions 21a to 23a of the notches 21 to 23, the circumferential pitch is reduced from the tip side toward the base end side. The circulation pitch of the constant pitch portions 21a to 23a may be the same.

  (3) In the above embodiment, the intermediate coil portions 24a to 26a of the coil portions 24 to 26 are formed by the constant pitch portions 21a to 23a, but this may be changed. For example, the intermediate coil portions 24a to 26a may be formed by a pitch gradually changing portion in which the circumferential pitch gradually decreases from the distal end side toward the proximal end side. In such a configuration, the circumferential pitch of the cut portion (pitch gradually changing portion) forming the intermediate coil portion (corresponding to the press holding portion) gradually decreases from the distal end side toward the proximal end side. The diameter on the base end side is easier to expand than the front end side. For this reason, when the diameter of the intermediate coil portion is increased, the proximal end side is expanded to the inner peripheral portion of the lead 51 before the distal end side, and the lead 51 is pressed and held. As a result, it is possible to avoid the inconvenience that the distal end side of the intermediate coil portion is first held and the rotational force cannot be transmitted to the proximal end side more than that, so that the entire intermediate coil portion can be more securely held. As a result, the holding function of the lead 51 by the intermediate coil portion can be more reliably exhibited.

  (4) The aspect of the circumferential pitch of the notches 21 to 23 is not necessarily limited to that of the above embodiment. For example, the circumferential pitch may be constant over the entire area in the axial direction of the notches 21 to 23, or the circumferential pitch may be gradually decreased from the distal end side toward the proximal end side in the entire axial direction area of the notches 21 to 23. .

  (5) In the above embodiment, the three coil portions 24 to 26 are provided on the outer shaft 11, but this may be changed to provide two or four or more coil portions. Further, only one coil portion may be provided on the outer shaft 11.

  (6) In the above embodiment, the first coil portion 24 (in other words, the first notch 21) is formed from the vicinity of the distal end portion of the outer shaft 11 toward the proximal end side. 24 (first notch 21) may be formed from the distal end portion of the outer shaft 11 toward the proximal end side. In that case, the first cut 21 is opened at the tip of the outer shaft 11.

(7) In the above-described embodiment, rotation of the outer shaft 11 around the axis via the inner shaft 12 on the distal end side of the outer shaft 11 while restricting rotation of the proximal end of the outer shaft 11 around the axis by operation of the operation unit 13. The force is applied, but this is changed, and the operation portion 13 is operated to restrict the distal end side of the outer shaft 11 from rotating around the axis line, and the proximal end side of the outer shaft 11 is moved around the axis line. A rotational force may be applied. Even in such a case, the coil portions 24 to 26 are twisted by the applied rotational force, so that each coil portion 24 to 26 can be expanded to a holding state in which the lead 51 is held. .
(8) In the above embodiment, the inner shaft 12 is connected to the distal end side of the coil portions 24 to 26 (specifically, the first coil portion 24) in the outer shaft 11, but this is changed to change the inner shaft 12 to the outer shaft 12. You may connect with the front-end | tip part of the 1st coil part 24 in the shaft 11. FIG. Even in this case, when the rotational force around the axis is applied to the distal end portion (the distal end side of the outer shaft 11) of the first coil portion 24 through the inner shaft 12 by the operation of the operation portion 13, each coil is caused by the rotational force. Since the portions 24 to 26 can be twisted around the axis, the coil portions 24 to 26 can be expanded in diameter based on the twisting operation to shift to a holding state in which the leads 51 are held.

  (9) At least one of the outer shaft 11 and the inner shaft 12 may be formed of a metal material having radiopacity. Then, since the visibility of the outer shaft 11 (or the inner shaft 12) can be improved under X-ray projection, the operation of inserting the outer shaft 11 into the vicinity of the tip portion in the lead 51 is facilitated. Can do.

  (10) When the lead 51 is taken out from the body using the lead take-out device 10, an excimer laser sheath may be used in combination. In this case, an excimer laser sheath is arranged on the outer peripheral side of the lead 51, and the lead 51 is taken out while peeling the adhesion tissue adhering to the lead 51 by the laser light irradiated from the tip of the sheath. Thereby, the lead 51 can be more reliably taken out from the body.

  (11) In the above-described embodiment, the case where the lead of the pacemaker is taken out from the body by the lead take-out device 10 has been described. However, the lead take-out device 10 may be used when taking the lead of another medical device from the body. Further, the lead taken out by the lead take-out device 10 does not necessarily have a coil shape, and may have a tube shape.

  DESCRIPTION OF SYMBOLS 10 ... Lead taking out device, 11 ... Outer shaft, 12 ... Inner shaft, 13 ... Operation part, 21-23 ... Incision, 21a-23a ... Predetermined incision part and minimum pitch part as a minimum pitch part, 21b-23b ... Pitch Tip side pitch change part as change part, 21c to 23c ... Base end side pitch change part as pitch change part, 24 to 26 ... Coil part, 24a to 26a ... Intermediate coil part as press holding part, 27 ... Non-coil Part, 51 ... lead.

Claims (8)

A lead extraction device for removing a tubular lead embedded in the body from the body,
A tubular outer shaft inserted into the lead;
An inner shaft that is inserted through a tube hole of the outer shaft;
An operation part provided to be connected to the proximal end side of both shafts,
A part of the outer shaft in the axial direction is provided with a coil portion in which the peripheral wall portion is coiled by forming a spiral cut in the peripheral wall portion along the axial direction.
The inner shaft is connected to the tip side of the outer shaft,
The operation unit rotates the distal end side of the outer shaft connected via the inner shaft relative to the proximal end side of the outer shaft around the axis, thereby twisting the coil portion around the axis. Is operated to generate
The coil take-out device according to claim 1, wherein the coil portion is expanded on the basis of the twisting operation by the operation portion, thereby pressing the lead from the inner peripheral side and holding the lead.   2. The lead extraction device according to claim 1, wherein the coil portion is formed in a predetermined range from the vicinity of the distal end portion or the distal end portion toward the proximal end side of the outer shaft. A plurality of the coil portions are provided at predetermined intervals in the axial direction of the outer shaft,
3. The lead extraction device according to claim 1, wherein the inner shaft is connected to the outer shaft at a distal end side with respect to the coil portions. 4.   The operation portion is operated to apply a rotational force around the axis line to the distal end side of the outer shaft via the inner shaft while restricting rotation of the base end side of the outer shaft around the axis line. The lead extraction device according to any one of claims 1 to 3, wherein the lead extraction device is a device. The part that presses and holds the lead when the diameter of the coil portion is expanded is a pressing holding portion,
A plurality of the coil portions having the pressing holding portion are provided at a predetermined interval in the axial direction of the outer shaft, or only one is provided,
Among the notches forming the plurality of or one coil portion in the outer shaft, the predetermined notch portion forming the pressing holding portion generally has a circumferential pitch around the axis line from the distal end side to the proximal end side. The lead extraction device according to claim 4, wherein the lead extraction device becomes smaller as it goes. A plurality of the coil portions are provided at predetermined intervals in the axial direction of the outer shaft,
The inner shaft is connected to the outer shaft on the tip side of the coil portions,
Each notch forming each coil part has a minimum pitch part in which the circumferential pitch around the axis is the smallest and constant in the notch,
5. The lead extraction device according to claim 4, wherein the minimum pitch portion of the notches in each coil portion has a smaller circumferential pitch from the distal end side toward the proximal end side. In the outer shaft, the portion other than the coil portion where the cut is not formed in the peripheral wall portion is a non-coil portion,
The notch forming the coil portion is
A constant pitch portion in which the circumferential pitch around the axis is constant;
A pitch changing portion provided between the constant pitch portion and the non-coil portion, and gradually increasing from the peripheral pitch of the constant pitch portion as the peripheral pitch moves from the constant pitch portion toward the non-coil portion; The lead take-out device according to claim 1, wherein the lead take-out device is provided. By the operation by the operation portion, the distal end side of the outer shaft can be relatively rotated on both sides in the axial direction with respect to the proximal end side of the outer shaft,
The coil portion increases in diameter when the distal end side of the outer shaft is relatively rotated to one side in the direction around the axis with respect to the proximal end side of the outer shaft by the operation of the operation portion, and is relatively rotated to the other side. The lead extraction device according to any one of claims 1 to 7, wherein the lead extraction device has a configuration in which the diameter is reduced.

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