WO2021045132A1

WO2021045132A1 - Movable shaft and medical equipment having movable shaft

Info

Publication number: WO2021045132A1
Application number: PCT/JP2020/033350
Authority: WO
Inventors: 井上　純一
Original assignee: タツタ電線株式会社
Priority date: 2019-09-04
Filing date: 2020-09-03
Publication date: 2021-03-11

Abstract

This movable shaft comprises a pipe member having an outer peripheral surface and an inner peripheral surface. A plurality of through-holes penetrating the pipe member along a direction from the outer peripheral surface to the inner peripheral surface are formed in the pipe member at intervals to form a row along the longitudinal direction of the pipe member. Each of the through-holes is provided with a column part configured to regulate the closing of the through-hole when the pipe member is bent along the longitudinal direction. When the closing of the through-hole is regulated by the column part, the through-hole is still opened along the longitudinal direction.

Description

Movable shaft and medical device with movable shaft

The present invention relates to a movable shaft and a medical device having a movable shaft.

Patent Document 1 (Japanese Unexamined Patent Publication No. 2014-22199) describes a tubular shaft (hereinafter, the tubular shaft described in Patent Document 1 is referred to as a "tubular shaft"). The tubular shaft is formed with a plurality of through holes at intervals so as to form a row along the longitudinal direction of the tubular shaft. The shape of each through hole is the same. The width of the through hole in the longitudinal direction of the tubular shaft is narrower than the width in the circumferential direction of the tubular shaft. The tubular shaft is easy to bend in the portion where the through hole is formed.

Japanese Unexamined Patent Publication No. 2014-22199

In the tubular shaft, the width of the through hole in the longitudinal direction of the tubular shaft is narrower than the width in the circumferential direction of the tubular shaft. Therefore, when the tubular shaft is bent, the vicinity of the opening edge of the through hole becomes a stress concentration point. Become. Such stress concentration may cause cracks in the vicinity of the opening edge of the through hole when the tubular shaft is repeatedly bent.

The present invention has been made in view of the above-mentioned problems of the prior art. More specifically, the present invention provides a movable shaft capable of relaxing stress concentration in the vicinity of the opening edge of the through hole, and a medical device having the movable shaft.

The movable shaft according to one aspect of the present invention includes a pipe member having an outer peripheral surface and an inner peripheral surface. A plurality of through holes penetrating the pipe member along the direction from the outer peripheral surface to the inner peripheral surface are formed in the pipe member at intervals so as to form a row along the longitudinal direction of the pipe member. Each of the through holes is provided with a strut portion configured to regulate the closing of the through hole when the pipe member is bent along the longitudinal direction. The through hole is still open along the longitudinal direction when the strut regulates the closure of the through hole.

The opening width in the longitudinal direction of the through hole when regulated by the strut portion may be different for each through hole.

In the above movable shaft, the shape of the through hole may be an elliptical shape. The elliptical long axis may be along the circumferential direction of the tube member, and the elliptical minor axis may be along the longitudinal direction. In the above movable shaft, the shape of the through hole may be a circular shape or a rectangular shape.

In the above movable shaft, the strut portion may be composed of a first strut and a second strut. The first strut and the second strut may be arranged to face each other at intervals in the longitudinal direction so that the pipe members come into contact with each other when the pipe members are bent along the longitudinal direction.

The movable shaft may further include pull wires arranged along the pipe member while facing a plurality of through holes.

The medical device according to one aspect of the present invention includes the above-mentioned movable shaft. The medical device according to one aspect of the present invention is configured to bend a tube member at a portion where a plurality of through holes are formed by pulling a pull wire.

According to the movable shaft and the medical device according to one aspect of the present invention, it is possible to relax the stress concentration in the vicinity of the opening edge of the through hole.

It is a top view of the movable sheath 100. It is a top view of the movable shaft 10. It is sectional drawing in III-III of FIG. It is an enlarged plan view in the bent part 11c of the 1st pipe member 11. It is a side view of the 1st pipe member 11 seen from the direction V of FIG. It is a side view of the 1st pipe member 11 seen from the direction VI of FIG. It is sectional drawing in VII-VII of FIG. It is a side view of the 1st pipe member 11 which concerns on 1st modification. It is a side view of the 1st pipe member 11 which concerns on 2nd modification. It is a side view of the 1st pipe member 11 which concerns on 3rd modification. It is a side view of the 1st pipe member 11 used for the movable sheath which concerns on a comparative example.

The details of the embodiment will be explained with reference to the drawings. In the following drawings, the same or corresponding parts are designated by the same reference numerals, and duplicate explanations will not be repeated.

(Structure of movable sheath according to the embodiment)
The configuration of the movable sheath (hereinafter referred to as “movable sheath 100”) according to the embodiment will be described below.

<Approximate configuration of movable sheath 100>
FIG. 1 is a plan view of the movable sheath 100. As shown in FIG. 1, the movable sheath 100 includes a movable shaft 10, a hand operation unit 20, a hemostatic valve 30, a tube 40, and a three-way stopcock 50. The movable shaft 10 has a distal end 10a and a proximal end 10b in its longitudinal direction. A hand operation unit 20 is attached to the proximal end 10b side.

<Detailed configuration of movable shaft 10>
FIG. 2 is a plan view of the movable shaft 10. The movable shaft 10 has a bent portion 10c. The movable shaft 10 is configured to bend at the bent portion 10c by operating the hand operating portion 20. In FIG. 1, the movable shaft 10 in a state of being bent by the operation of the hand operation unit 20 is shown by a dotted line.

FIG. 3 is a cross-sectional view taken along the line III-III of FIG. As shown in FIG. 3, the movable shaft 10 has a first pipe member 11, a second pipe member 12, a braid 13, an exodermis 14, a pull wire 15, and a pull wire 16.

The first pipe member 11 is a tubular member. The first tube member 11 is preferably formed of a polyetheretherketone resin (PEEK resin). The first tube member 11 may be made of a liquid crystal polymer, nylon, polycarbonate, polyimide, silicone, polyvinyl chloride (PVC), polyethylene or the like. The material constituting the first pipe member 11 is not limited to this.

The first pipe member 11 has an inner peripheral surface 11a and an outer peripheral surface 11b. A first groove 11ba and a second groove 11bb are formed on the outer peripheral surface 11b. The first groove 11ba and the second groove 11bb extend along the longitudinal direction of the first pipe member 11. In the first groove 11ba and the second groove 11bb, the outer peripheral surface 11b is recessed toward the inner peripheral surface 11a side. The first groove 11ba is located on the opposite side of the second groove 11bb with the central axis of the first pipe member 11 interposed therebetween. The configuration of the other first pipe member 11 will be described later.

The second pipe member 12 is inserted inside the first pipe member 11. The second pipe member 12 is a tubular member. When the movable shaft 10 is applied to the movable sheath, the inside of the second pipe member 12 is hollow. A guide wire, a catheter (for example, a catheter used for ablation treatment of the heart) or the like is inserted into the second tube member 12. The wall thickness of the second pipe member 12 may be thinner than the wall thickness of the first pipe member 11 (the wall thickness of the first pipe member 11 may be thicker than the wall thickness of the second pipe member 12). ..

The second tube member 12 is formed of, for example, a fluorine-based thermoplastic resin such as polytetrafluoroethylene resin (PTFE resin), PEEK resin, polyvinylidene fluoride resin (PVDF resin) and perfluoroalkoxy alkane resin (PFA resin). Has been done. However, the material constituting the second pipe member 12 is not limited to this, and may be made of a resin that satisfies the operational lubricity of a guide wire, a catheter, or the like inserted inside.

Braid 13 has a structure in which metal wires are woven into a net. The braid 13 is arranged so as to cover the outer peripheral surface 11b. The wires constituting the braid 13 are made of, for example, stainless steel. The outer skin 14 is arranged so as to cover the outer peripheral surface 11b and the braid 13. The outer skin 14 is formed of, for example, a fluororesin. The material constituting the exodermis 14 is not limited to this, and any biocompatible material can be applied.

The pull wire 15 is slidably arranged in the groove 11ba along the longitudinal direction of the first pipe member 11. The pull wire 15 is arranged along the longitudinal direction of the first pipe member 11 while facing the row of the first through holes 11d described later. The pull wire 16 is slidably arranged in the groove 11bb along the longitudinal direction of the first pipe member 11. The pull wire 16 is arranged along the longitudinal direction of the first pipe member 11 while facing the row of the second through holes 11e described later. The pull wire 15 and the pull wire 16 are made of, for example, stainless steel. One end of the pull wire 15 and one end of the pull wire 16 are fixed to the distal end 10a.

<Detailed configuration of the first pipe member 11>
FIG. 4 is an enlarged plan view of the bent portion 11c of the first pipe member 11. As shown in FIG. 4, the first pipe member 11 has a bent portion 11c. The bent portion 11c is in a position corresponding to the bent portion 10c. The first pipe member 11 is configured to be bendable along the longitudinal direction of the first pipe member 11 at the bent portion 11c by operating the pull wire 15 and the pull wire 16 (hand operation portion 20).

FIG. 5 is a side view of the first pipe member 11 as viewed from the direction V of FIG. FIG. 6 is a side view of the first pipe member 11 as viewed from the direction VI of FIG. FIG. 7 is a cross-sectional view taken along the line VII-VII of FIG. As shown in FIGS. 4, 5, 6 and 7, a plurality of first through holes 11d and a plurality of second through holes 11e are formed in the bent portion 11c. Each first through hole 11d is provided with a first strut portion 11f, and each second through hole 11e is provided with a second strut portion 11g.

The first through hole 11d penetrates the first pipe member 11 along the direction from the outer peripheral surface 11b to the inner peripheral surface 11a. The first through holes 11d are formed in a row along the longitudinal direction of the first pipe member 11.

The shape and size of each of the first through holes 11d may be the same or different. The shape of the first through hole 11d is, for example, an elliptical shape. The elliptical long axis is along the circumferential direction of the first pipe member 11, and the elliptical short axis is along the longitudinal direction of the first pipe member.

The pitch of the first through hole 11d (the distance between two adjacent first through holes 11d in the longitudinal direction of the first pipe member 11) is, for example, constant. However, the pitch of the first through hole 11d may be different.

The second through hole 11e penetrates the first pipe member 11 along the direction from the outer peripheral surface 11b to the inner peripheral surface 11a. The second through holes 11e are formed in a row along the longitudinal direction of the first pipe member 11. The second through hole 11e is formed on the side opposite to the first through hole 11d with respect to the central axis of the first pipe member 11.

The shape and size of each of the second through holes 11e may be the same or different. The shape of the second through hole 11e is, for example, an elliptical shape. The elliptical long axis is along the circumferential direction of the first pipe member 11, and the elliptical short axis is along the longitudinal direction of the first pipe member.

The pitch of the second through hole 11e (the distance between two adjacent second through holes 11e in the longitudinal direction of the first pipe member 11) is, for example, constant. However, the pitch of the second through hole 11e may be different.

Although not shown, the first through hole 11d and the second through hole 11e are closed by the second pipe member 12 from the inner peripheral surface 11a side.

The first strut portion 11f is composed of, for example, a first strut 11fa and a second strut 11fb. The first support column 11fa and the second support column 11fb are provided on the opening edge of the first through hole 11d. The first support column 11fa and the second support column 11fb are arranged at intervals so as to face each other in the longitudinal direction of the first pipe member 11. The first support column 11fa and the second support column 11fb come into contact with each other when the first pipe member 11 is bent along the longitudinal direction. When the first support column 11fa and the second support column 11fb come into contact with each other, the first pipe member 11 becomes more difficult to bend along the longitudinal direction of the first pipe member 11 by restricting the closing of the first through hole 11d. .. That is, the first support column portion 11f regulates the closing of the first through hole 11d when the first pipe member 11 is bent along the longitudinal direction. When the closing of the first through hole 11d is regulated by the first support column portion 11f, the first through hole 11d is still open along the longitudinal direction of the first pipe member 11. That is, when the closing of the first through hole 11d is regulated by the first support column portion 11f, the opening edge of the first through hole 11d facing along the longitudinal direction of the first pipe member 11 is the first support column. It is still separated except for the portion where the 11fa and the second support column 11fb are provided. The first support column 11fa and the second support column 11fb are preferably formed parallel to the longitudinal direction of the first pipe member 11.

The distance between the first support column 11fa and the second support column 11fb in the longitudinal direction of the first pipe member 11 may be different for each first through hole 11d. That is, the opening width of the first through hole 11d in the longitudinal direction of the first pipe member 11 when the closing is restricted by the first strut portion 11f by bending the first pipe member 11 along the longitudinal direction is It may be different for each first through hole 11d.

The second strut portion 11g is composed of, for example, the first strut 11ga and the second strut 11gb. The first support column 11ga and the second support column 11gb are provided on the opening edge of the second through hole 11e. The first support column 11ga and the second support column 11gb are arranged at intervals so as to face each other in the longitudinal direction of the first pipe member 11. The first support column 11ga and the second support column 11gb come into contact with each other when the first pipe member 11 is bent along the longitudinal direction. That is, the second support column portion 11g regulates the closing of the second through hole 11e when the first pipe member 11 is bent along the longitudinal direction. When the closing of the second through hole 11e is regulated by the second support column portion 11g, the second through hole 11e is still open along the longitudinal direction of the first pipe member 11. The first support column 11ga and the second support column 11gb are preferably formed parallel to the longitudinal direction of the first pipe member 11.

The distance between the first support column 11ga and the second support column 11gb in the longitudinal direction of the first pipe member 11 may be different for each second through hole 11e. That is, the opening width of the second through hole 11e in the longitudinal direction of the first pipe member 11 when the closing is restricted by the second strut portion 11g by being bent along the longitudinal direction of the first pipe member 11. It may be different for each second through hole 11e.

The first support column 11fa, the second support column 11fb, the first support column 11ga, and the second support column 11gb may be integrated with the first pipe member 11 or may be separate from the first pipe member 11.

<First modified example, second modified example, and third modified example of the first pipe member 11>
FIG. 8 is a side view of the first pipe member 11 according to the first modification. As shown in FIG. 8, the first through hole 11d (second through hole 11e) may have, for example, a circular shape. FIG. 9 is a side view of the first pipe member 11 according to the second modification. As shown in FIG. 9, the first through hole 11d (second through hole 11e) may have, for example, a rectangular shape. The long side of the rectangular shape is along the circumferential direction of the first pipe member 11, and the short side of the rectangular shape is along the longitudinal direction of the first pipe member 11. The case where the corners of the first through hole 11d (second through hole 11e) are rounded is also included in the "rectangular shape".

FIG. 10 is a side view of the first pipe member 11 according to the third modification. As shown in FIG. 10, the first strut portion 11f does not have to have the first strut 11fa. That is, the first strut portion 11f does not have to have either the first strut 11fa or the second strut 11fb. When the first strut portion 11f does not have the first strut 11fa (second strut 11fb), the second strut 11fb (first strut 11fa) comes into contact with the opening edge of the first through hole 11d facing the first strut portion 11f. As a result, the closing of the first through hole 11d when the first pipe member 11 is bent along the longitudinal direction is restricted. In short, the first support column portion 11f may be configured so that the closing of the first through hole 11d can be regulated when the first pipe member 11 is bent along the longitudinal direction. Although not shown, the second strut portion 11g may not have either the first strut 11ga or the second strut 11gb, similarly to the first strut portion 11f.

<Detailed configuration of the hand operation unit 20>
As shown in FIG. 1, the hand operation unit 20 has a first end 20a and a second end 20b. The second end 20b is the opposite end of the first end 20a. The movable shaft 10 passes through the inside of the hand operating portion 20, and its proximal end 10b reaches the second end 20b of the hand operating portion 20. The hand operation unit 20 has a grip unit 21 and a drive unit 22.

The grip portion 21 is a portion for the user to grip the movable sheath 100 (hand operation portion 20). The drive unit 22 has, for example, a disk shape. The drive unit 22 can be rotationally driven around the central axis. Although not shown, the other end of the pull wire 15 and the other end of the pull wire 16 are fixed to the outer peripheral surface of the drive unit 22. The position on the outer peripheral surface of the drive unit 22 to which the other end of the pull wire 15 is fixed and the position on the outer peripheral surface of the drive unit 22 to which the other end of the pull wire 16 is fixed are related to the central axis of the drive unit 22. It is point symmetric.

By rotating the drive unit 22 around the central axis, the pull wire 15 is pulled in the direction from the distal end 10a to the proximal end 10b, and the pull wire 16 is drawn from the proximal end 10b to the distal end 10a. Extruded along the direction, the movable shaft 10 bends into the shape shown by the dotted line in FIG. When the drive unit 22 is rotated in the reverse direction around the central axis, the pull wire 15 is pushed out along the direction from the proximal end 10b to the distal end 10a, and the pull wire 16 is pushed from the distal end 10a to the proximal end 10b. It is pulled in along the direction in which the movable shaft 10 returns to its original shape. When the drive unit 22 is further rotated in the reverse direction around the central axis, the movable shaft 10 bends to the side opposite to the shape shown by the dotted line in FIG.

The hand operation unit 20 further has a hemostatic valve 30. The inside of the hemostatic valve 30 is hollow. The hemostatic valve 30 is attached to the second end 20b. As a result, the inside of the hemostatic valve 30 communicates with the inside of the movable shaft 10 (more specifically, the inside of the second pipe member 12). The hemostatic valve 30 is provided with an insertion port. A guide wire, a catheter, or the like is inserted into the movable shaft 10 from this insertion port.

Note that a configuration other than the hand operation unit 20 may be applied in order to bend the movable shaft 10. The movable sheath 100 may be configured so that the bent portion 11c (bent portion 10c) can be bent by pulling the pull wire 15 and the pull wire 16.

<Detailed configuration of tube 40 and three-way stopcock 50>
The tube 40 is connected to the hemostatic valve 30 at one end. The inside of the tube 40 communicates with the inside of the hemostatic valve 30. A three-way stopcock 50 is attached to the other end of the tube 40. By attaching a syringe (not shown) to the three-way stopcock 50, air or blood is removed from the inside of the movable shaft 10 or a chemical solution is supplied to the inside of the movable shaft 10.

(Effect of movable sheath according to the embodiment)
Hereinafter, the effect of the movable sheath 100 will be described in comparison with a comparative example.

The configuration of the movable sheath according to the comparative example is the same as the configuration of the movable sheath 100 except for the detailed configuration of the first pipe member 11. FIG. 11 is a side view of the first pipe member 11 used for the movable sheath according to the comparative example. As shown in FIG. 11, in the movable sheath according to the comparative example, the width of the first through hole 11d (second through hole 11e (not shown)) in the longitudinal direction of the first pipe member 11 is the first penetration. It is different for each hole 11d (second through hole 11e (not shown)).

In the first through hole 11d (second through hole 11e (not shown)) having a narrow width in the longitudinal direction of the first pipe member 11, when the first pipe member 11 is bent, the first pipe member 11 The bending of the movable shaft 10 (first pipe member 11) is restricted by the contact of the opening edges facing each other along the longitudinal direction. As described above, in the movable sheath according to the comparative example, the bending angle of the movable shaft 10 (first pipe member 11) is adjusted for each location on the movable shaft 10 (first pipe member 11).

In the movable sheath according to the comparative example, stress concentration points are likely to occur at the opening edge of the first through hole 11d (second through hole 11e (not shown)) having a narrow width in the longitudinal direction of the first pipe member 11. Therefore, in the movable sheath according to the comparative example, when the movable shaft 10 is repeatedly bent, the opening of the first through hole 11d (second through hole 11e (not shown)) having a narrow width in the longitudinal direction of the first pipe member 11 From the edge, cracks may occur or the generated cracks may grow.

On the other hand, in the movable sheath 100, since each of the first through holes 11d (second through holes 11e) is provided with the first support column portion 11f (second support column portion 11g), the first pipe member 11 The closing of the first through hole 11d (second through hole 11e) when the is bent along the longitudinal direction thereof is regulated by the first strut portion 11f (second strut portion 11g). Therefore, in the movable sheath 100, the bending angle of the movable shaft 10 (first pipe member 11) does not have to be narrowed in the width of the first through hole 11d (second through hole 11e) in the longitudinal direction of the first pipe member 11. Can be adjusted for each location on the movable shaft 10 (first pipe member 11).

In order to make the bending angle of the movable shaft 10 (first pipe member 11) adjustable for each location on the movable shaft 10 (first pipe member 11), the first through hole 11d (in the longitudinal direction of the first pipe member 11) ( Since it is not necessary to narrow the width of the second through hole 11e), in the movable sheath 100, a stress concentration portion is unlikely to occur at the opening edge of the first through hole 11d (second through hole 11e). As a result, according to the movable sheath 100, even if the movable shaft 10 is repeatedly bent, cracks are unlikely to occur from the first through hole 11d (second through hole 11e), and even if a crack is generated, it is unlikely to propagate.

When the shape of the first through hole 11d (second through hole 11e) is elliptical or circular, the opening edges of the first through hole 11d (second through hole 11e) are smoothly connected, so that the stress concentration location. Is even less likely to occur.

When the first pipe member 11 is made of PEEK resin in order to improve the torque property of the movable shaft 10, the flexibility of the first pipe member 11 is reduced, so that the movable shaft 10 (first pipe member 11) is smoothed. It is highly necessary to adjust the bending angle of the movable shaft 10 (first pipe member 11) for each location on the movable shaft 10 (first pipe member 11) in order to bend the movable shaft 10 (first pipe member 11). According to the movable sheath 100, even in such a case, it is possible to suppress the occurrence of stress concentration points at the opening edge of the first through hole 11d (second through hole 11e).

(Other embodiments)
In the above, the movable sheath is exemplified as the medical device having the movable shaft 10, but the medical device having the movable shaft 10 is not limited to this. Other examples of medical devices having a movable shaft 10 include catheters and endoscopes.

Although the embodiment of the present invention has been described above, it is possible to modify the above-described embodiment in various ways. Moreover, the scope of the present invention is not limited to the above-described embodiment. The scope of the present invention is indicated by the claims and is intended to include all modifications within the meaning and scope equivalent to the claims.

This embodiment is particularly advantageously applied to a movable sheath into which a catheter for treating cardiac ablation is inserted.

100 movable sheath, 10 movable shaft, 20 hand operation part, 30 hemostatic valve, 40 tube, 50 three-way stopcock, 10a distal end, 10b proximal end, 10c bending part, 11 first tube member, 11a inner peripheral surface, 11b Outer peripheral surface, 11ba 1st groove, 11bb 2nd groove, 11c bent part, 11d 1st through hole, 11e 2nd through hole, 11f 1st support, 11fa 1st support, 11fb 2nd support, 11g 2nd support , 11ga 1st strut, 11gb 2nd strut, 12 2nd pipe member, 13 braid, 14 exodermis, 15 pull wire, 16 pull wire, 20a 1st end, 20b 2nd end, 21 grip part, 22 drive part.

Claims

A pipe member having an outer peripheral surface and an inner peripheral surface is provided.
A plurality of through holes penetrating the pipe member along the direction from the outer peripheral surface to the inner peripheral surface are spaced apart from each other so as to form a row along the longitudinal direction of the pipe member. Has been formed and
Each of the through holes is provided with a strut portion configured to regulate the closing of the through hole when the pipe member is bent along the longitudinal direction.
A movable shaft in which the through hole is still open along the longitudinal direction when the closure of the through hole is restricted by the strut portion.
The movable shaft according to claim 1, wherein the opening width of the through hole in the longitudinal direction when the closing is restricted by the support column is different for each through hole.
The shape of the through hole is an elliptical shape.
The elliptical long axis is along the circumferential direction of the pipe member.
The movable shaft according to claim 1 or 2, wherein the elliptical short axis is along the longitudinal direction.
The movable shaft according to claim 1 or 2, wherein the shape of the through hole is a circular shape or a rectangular shape.
The strut portion is composed of a first strut and a second strut.
The first strut and the second strut are arranged so as to face each other at intervals in the longitudinal direction so that the pipe members come into contact with each other when the pipe member is bent along the longitudinal direction. Item 2. The movable shaft according to any one of Item 4.
The movable shaft according to any one of claims 1 to 5, further comprising pull wires arranged along the pipe member while facing the plurality of through holes.
The movable shaft according to claim 6 is provided.
A medical device configured to bend the tube member in a portion where a plurality of the through holes are formed by pulling the pull wire.