WO2012060328A1

WO2012060328A1 - Medical device

Info

Publication number: WO2012060328A1
Application number: PCT/JP2011/075075
Authority: WO
Inventors: 小林　裕昌; 悟菊池; 池田　浩; 雅之小林
Original assignee: オリンパス株式会社
Priority date: 2010-11-01
Filing date: 2011-10-31
Publication date: 2012-05-10
Also published as: JP2012095812A

Abstract

This medical device enables even a dilator or other device having a flat distal end surface to pass through a lumen wall while the position of the distal end is precisely controlled. The medical device provided comprises a guide wire (2) inserted into a body, and a cylindrical dilator (3) which has a distal end part (3a) formed so as to gradually taper toward the distal end surface thereof, in which the guide wire (2) is inserted so as to be able to move in the longitudinal direction and the peripheral direction, and the guide wire (2) has a retractable opening in the distal end surface thereof. The guide wire (2) is provided with an externally threaded part (2b), and the dilator (3) is provided with an internally threaded part (3b) that is in communication with the opening and that is threaded onto the externally threaded part (2b).

Description

Medical device

The present invention relates to a medical device.

Conventionally, a method of perforating the pericardium and inserting an electrode into the pericardial cavity is known (for example, see Patent Document 1). In Patent Document 1, a guide wire is passed through the pericardium and inserted into the pericardial cavity, and then a dilator or cannula (hereinafter referred to as a dilator or the like) is advanced along the guide wire so that the guide wire penetrates. The dilator or the like is introduced into the pericardial cavity by allowing the dilator or the like to penetrate the pericardium while expanding the perforation of the pericardium.

US Pat. No. 5,071,428

However, a dilator or the like has a flat tip surface unlike a thin guide wire. Therefore, in the case of Patent Document 1, the operator presses the dilator or the like and pushes and stretches the soft and elastic pericardium inward by the tip surface thereof, thereby penetrating the dilator or the like through the pericardium. At this time, the resistance force from the pericardium, which had been acting on the dilator until then, disappears suddenly, so the operator must adjust the pressing force applied to the dilator etc. to adjust the position of the tip of the dilator etc. There is a problem that it is difficult to control accurately.

The present invention has been made in view of the above-described circumstances, and even for a device having a flat tip surface such as a dilator, the medical device can penetrate the cavity wall while accurately controlling the tip position. The purpose is to provide a device.

In order to achieve the above object, the present invention provides the following means.
The present invention has a guide wire to be inserted into the body and a distal end portion that is gradually tapered toward the distal end surface, and the guide wire is inserted movably in the longitudinal direction and in the circumferential direction. A cylindrical dilator having an opening through which the guide wire can protrude and retract on the distal end surface, the guide wire having a male screw portion, and the dilator being fastened to the male screw portion and communicating with the opening Provided is a medical device including a unit.

According to the present invention, a guide wire is inserted into a body cavity through a cavity wall perforation formed by a puncture needle, a dilator is run along the guide wire, and a cavity wall through which the guide wire passes is drilled. By allowing the tip of the dilator to pass through, the dilator can be introduced into the body cavity while gradually expanding the perforation.
In this case, the dilator is rotated in the circumferential direction so that the female screw portion is guided forward along the male screw portion of the guide wire after the distal end surface of the dilator reaches at least the vicinity of the cavity wall. Move forward.

Thus, the position of the tip surface of the dilator is controlled not by the pressing force from the base end side but by the rotation angle of the dilator. That is, the dilator can be penetrated through the cavity wall while accurately controlling the position of the tip surface without being influenced by the position control of the dilator by the resistance force from the cavity wall. Also, by attaching another device to the dilator, even if the other device has a flat tip surface, it can be introduced into the cavity wall while accurately controlling the position together with the dilator.

In the above-described invention, the dilator may be configured to include a cylindrical sheath that protrudes from the opening of the distal end surface of the dilator and is movably accommodated on the proximal end side.
In this way, after the distal end portion of the dilator penetrates the cavity wall, the dilator is further advanced to introduce a part of the distal end side of the sheath into the body cavity, and then the dilator is moved toward the proximal end side. By moving to the outside of the body, a path from the outside of the body to the inside of the body cavity can be secured in the sheath.

In the above configuration, the sheath may be formed to be gradually tapered toward the tip.
By doing so, when the sheath is penetrated into the perforation of the cavity wall, the perforation can be easily penetrated while gradually expanding.
Moreover, in the said invention, the said external thread part may have a polygonal cross-sectional shape.
By doing in this way, the unevenness | corrugation of the outer surface of an external thread part can be made comparatively small.

Moreover, in the said invention, the said external thread part may be comprised with the wire wound helically.
By doing in this way, the unevenness | corrugation of the outer surface of an external thread part can be made comparatively small.
In the above configuration, the male screw portion may be formed by winding a plurality of the wire members in parallel.
By doing so, the moving distance (pitch) in the longitudinal direction per rotation when the dilator is rotated in the circumferential direction can be increased, and the dilator can be advanced and retracted efficiently.

Moreover, in the said invention, you may provide the holding | maintenance part which hold | maintains the base end side of the said guide wire inserted in the said body in a predetermined position.
This prevents the guide wire, not the dilator, from moving backward or forward when the dilator is rotated and resisting the forward or backward movement of the dilator. The dilator can be moved reliably.

Moreover, in the said invention, you may provide the supporting member which supports the side surface of the said guide wire in the said dilator.
By doing so, it is possible to prevent the guide wire from being bent in the dilator when a compressive force in the longitudinal direction is applied to the guide wire. In particular, in the case of the configuration including the above-described holding portion, a relatively large compressive force is applied to the guide wire, and thus it is preferable to include a support member.

In the above invention, an operation unit that allows an operator to perform a predetermined motion, and a motion transmission mechanism that converts the predetermined motion of the operation unit into rotation in the circumferential direction of the dilator and transmits the rotation to the dilator. You may have.
By doing so, the operator can easily rotate the dilator by a predetermined operation of the operation unit without directly rotating the dilator inserted into the body.

According to the present invention, there is an effect that even a device having a flat tip surface such as a dilator can be penetrated into the cavity wall while accurately controlling the position of the tip.

1 is an overall configuration diagram of a medical device according to an embodiment of the present invention. It is a perspective view of the external thread part cut | disconnected by the horizontal direction in the middle position. It is the longitudinal cross-sectional view which expanded the front-end | tip part of the medical device of FIG. FIG. 4 is a sectional view taken along the line III-III in FIG. 3. It is a figure which shows the structure of a motion transmission mechanism. It is a figure which shows the modification of an external thread part and an internal thread part. It is a figure which shows another modification of an external thread part and an internal thread part. It is a figure which shows another modification of an external thread part and an internal thread part. It is a figure which shows the modification of a handle | steering-wheel and a motion transmission mechanism. It is a figure which shows the modification of arrangement | positioning of an external thread part and an internal thread part.

Below, medical device 1 concerning one embodiment of the present invention is explained with reference to drawings.
As shown in FIG. 1, the medical device 1 according to this embodiment includes a guide wire 2, a dilator 3 through which the guide wire 2 is inserted, and a sheath 4 attached to the outside of the dilator 3. A holding portion 5 that holds the guide wire 2 inserted into the body, a handle (operation portion) 6 that is rotated by an operator, and a motion transmission mechanism 7 that rotates the sheath 4 by the rotational movement of the handle 6. I have.

The guide wire 2 has a flexibility capable of bending along the tissue shape in the living body, and has a rigidity capable of transmitting an operation on the proximal end side by the operator to the distal end side. The guide wire 2 has a diameter that can be inserted into the body through a hole that is perforated by a puncture needle (not shown) having a sharp tip that can perforate the pericardium (cavity wall). The guide wire 2 has a male screw portion 2b at least at a part on the distal end side. As shown in FIG. 2, the male screw portion 2 b has a polygonal (regular octagonal in the illustrated example) cross-sectional shape, and the cross-sectional shape is uniform along the longitudinal direction of the guide wire 2 around the center. It has a spiral outer surface shape that rotates in the direction.

The guide wire 2 is inserted into a tube (support member) 8 having lower flexibility than the guide wire 2 in the dilator 3, and the side surface is supported by the side wall of the tube 8. As a result, the guide wire 2 is corrected to a sufficiently stretched shape by the tube 8 and is prevented from being excessively curved in the dilator 3 even when an external force in the direction of compression is applied from both ends.

The dilator 3 has a cylindrical shape with both ends opened. The tip portion 3a of the dilator 3 is gradually tapered toward the tip surface. Thereby, even if it is a comparatively small piercing | piercing formed with the guide wire 2, the dilator 3 can be penetrated to a piercing | piercing, expanding a piercing | piercing gradually by the front-end | tip part 3a.

As shown in FIG. 3, a female screw portion 3b communicating with an opening formed in the tip surface is formed in the tip portion 3a along the longitudinal direction. The female screw portion 3b has an inner surface shape that can be fastened to the male screw portion 2b. By rotating the dilator 3 in the circumferential direction with the male screw portion 2b fitted in the female screw portion 3b, the dilator 3 advances and retracts along the guide wire 2 in a screw manner according to the spiral shape of the male screw portion 2b. It is like that. At this time, the dilator 3 is advanced or retracted by a predetermined distance per rotation according to the length (pitch) between positions where the cross-sectional shape of the male screw portion 2b differs by 360 °.

The sheath 4 has a cylindrical shape with both ends opened. At least the distal end portion of the sheath 4 is gradually tapered toward the distal end surface. The sheath 4 accommodates the dilator 3 by projecting the distal end portion 3a of the dilator 3 from the opening of the distal end surface thereof.

As shown in FIG. 3, a convex portion 3 c that is abutted against the inner surface of the distal end surface of the sheath 4 is provided at an intermediate position of the dilator 3. As a result, when the operator advances the dilator 3, the sheath 4 is also advanced together, and when the dilator 3 is retracted, only the dilator 3 can be retracted while the sheath 4 is left in place. Further, as shown in FIG. 4, a concave portion 4 a into which the convex portion 3 c is fitted is formed on the inner surface of the distal end surface of the sheath 4. Thereby, the operator can also rotate the dilator 3 by rotating the sheath 4 in the circumferential direction with the convex portion 3c fitted in the concave portion 4a.

The holding unit 5 includes a base plate 5a placed on the patient's body surface and an arm 5b that extends from the base plate 5a and grips the proximal end portion of the guide wire 2. The base plate 5 a has a hole (not shown) having a diameter larger than the outer diameter of the sheath 4. The base plate 2 is placed on the body surface so that the guide wire 2 is disposed at substantially the center of the hole, and the base end of the guide wire 2 is held by the arm 5b. Thereby, the position of the guide wire 2 is kept substantially constant.

As shown in FIG. 5, the motion transmission mechanism 7 includes a driving roller 7 b that is disposed in contact with the outer peripheral surface of the proximal end side of the sheath 4 and that has a rotating shaft 7 a common to the handle 6. . The operator can rotate the sheath 4 in the opposite direction to the driving roller 7b by rotating the handle 6 to rotate the driving roller 7b. At this time, at least one (two in the illustrated example) driven rollers 7c are provided on the outer circumferential surface of the sheath 4 so that the rotational motion is uniformly transmitted at each position in the circumferential direction of the sheath 4. Are arranged in contact with the outer surface of the sheath 4. It is preferable that the driving roller 7b and the driven roller 7c have a rotating shaft held at an arbitrary position and ensure a state in which a rotational force can be stably transmitted with respect to the rotating operation of the handle 6.

In the base end portion of the sheath 4, when the outer dimensions vary depending on the position in the longitudinal direction, the

rollers

7 b and 7 c are sheathed so that the outer peripheral surface of each

roller

7 b and 7 c and the outer surface of the sheath 4 are always maintained. 4 is provided with an urging member for urging inward in the radial direction, for example, an annular rubber 7d stretched around three

rollers

7b and 7c. At this time, the annular rubber 7d urges the rotation shaft 7a arranged at the rotation center of the roller 7b and the rotation shaft (not shown) arranged at the rotation center of the driven roller 7c inward in the radial direction of the sheath 4. It may be arranged as follows.

Next, the operation of the medical device 1 according to this embodiment configured as described above will be described.
In order to introduce the sheath 4 into the pericardial cavity using the medical device 1 according to this embodiment, for example, a puncture needle (not shown) inserted into the body from below the xiphoid process is run to the outside of the pericardium. The pericardium is pierced by the tip of the puncture needle, and the guide wire 2 is penetrated through the perforation, whereby the tip of the guide wire 2 is inserted to an arbitrary position in the pericardial cavity. Next, the dilator 3 with the sheath 4 attached to the outside is inserted into the body along the guide wire 2.

After the distal end surface of the dilator 3 reaches the base end of the male screw portion 2b, the male screw portion 2b is fitted into the female screw portion 3b and the handle 6 is rotated, so that the dilator 3 is formed in the outer surface shape of the male screw portion 2b. According to the screw type. The dilator 3 penetrates the perforation through the perforation through which the guide wire 2 penetrates while gradually expanding the perforation through the tip 3a. When the dilator 3 is further advanced, the sheath 4 penetrates the perforation and is introduced into the pericardial cavity. After the distal end of the sheath 4 is inserted to a desired position in the pericardial cavity, the guide wire 2 and the dilator 3 are pulled out, so that a path from the outside of the body to the pericardial cavity can be secured in the sheath 4.

In this case, according to the present embodiment, the dilator 3 and the sheath 4 having a flat distal end surface are in a state where the pericardium is stretched inward before being penetrated by the perforation, and the dilator 3 or the sheath 4 has a heart. Resistance from the film is added. Here, in the case of a method in which the dilator or the sheath is advanced by a pressing operation by a conventional operator, it is necessary to press the dilator or the sheath with a force exceeding the resistance force from the pericardium. Therefore, immediately after the dilator or sheath penetrates the perforation, the pressing force applied to the dilator or sheath must be adjusted as the resistance force from the pericardium disappears instantaneously. It is difficult to adjust the pressing force, and there is a problem that the dilator or the sheath is inserted too far forward from a desired position.

On the other hand, according to the present embodiment, the position operation of the dilator 3 and the sheath 4 is controlled not by the pressing force from the base end side by the operator but by the rotation angle thereof. Therefore, even if the resistance force received from the pericardium on the distal surface of the dilator 3 or the sheath 4 changes suddenly, the operator can stably position the dilator 3 or the sheath 4 without being affected by the change in the resistance force. There is an advantage that it can be accurately controlled.

Further, when a resistance force is applied to the dilator 3 and the sheath 4 when the dilator 3 and the sheath 4 are rotated and advanced, the guide wire 2 passes through the female screw portion 3b without the dilator 3 and the sheath 4 moving forward. There is a possibility of retreating. Thus, there is an advantage that the dilator 3 and the sheath 4 can be reliably advanced along the guide wire 2 by holding the proximal end side of the guide wire 2 by the holding portion 5 and restricting the movement of the guide wire 2. is there.

In the present embodiment, the male screw portion 2b has a polygonal cross-sectional shape, but this shape is merely an example, and the shape of the male screw portion 2b is not limited thereto.
Other examples of the spiral shape of the male screw portion 2b are shown in FIGS.

The male screw portion 2b shown in FIG. 6 is configured by winding a strip-shaped wire 2d spirally around the outer peripheral surface of a core material 2c made of a thin metal wire or the like. In this case, the female screw portion 3b has a protrusion 3d having a shape complementary to the shape of the groove formed between the adjacent wire rods 2d on the inner peripheral surface, and the protrusion 3d moves spirally along the groove. As a result, the dilator 3 moves forward and backward. When using the wire rod 3d having a small diameter, as shown in FIG. 7, the wire rod 3d may be wound in a state of being bundled in parallel. By doing so, the pitch can be easily increased.

The male screw portion 2b shown in FIG. 8 is configured by forming a helical peak 2e on the outer surface of the core member 2c. In this case, the female screw portion 3b has a groove having a shape complementary to the outer shape of the peak portion 2e formed on the inner surface.
As described above, even if the male screw portion 2b has another shape, the dilator 3 and the sheath 4 are advanced along the guide wire 2 in a screw manner, so that the position operation of these 3, 4 can be resisted from the pericardium. The dilator 3 and the sheath 4 can be penetrated into the pericardium while accurately controlling the position.

In the present embodiment, the drive roller 7b is rotated by rotating the handle 6 that is rotated by the operator. However, the configuration of the operation unit and the motion transmission mechanism 7 is not limited to this. The movement of the operation unit by the operator may be transmitted to the sheath 4 as a rotational movement.

For example, as shown in FIG. 9, the motion transmission mechanism 7 may include a rack 7e, a pinion 7f meshed with the rack 7e, and a gear 7g meshed with the pinion 7f and connected to the rotation shaft 7a. Good. In this case, when the operator pushes and pulls the handle 6 to linearly move the rack 7e, the linear motion is converted into a rotational motion by the pinion 7f and transmitted to the gear 7g, and the drive roller 7b is rotated. Even in this way, the operator can rotate the sheath 4 and the dilator 3 inserted into the body by a simple operation.

In the present embodiment, the case where the sheath 4 is introduced into the pericardial cavity using the medical device 1 has been described as an example, but the medical device 1 can be used for other purposes.
For example, since the cavity wall such as the stomach has elasticity like the pericardium, when the dilator or sheath penetrates the cavity wall, the cavity wall is pressed by the distal end surface, and the dilator or sheath penetrates the cavity wall. Position control immediately after is difficult. Therefore, by using the medical device 1 according to the present embodiment, these 3, 4 can be penetrated through the cavity wall while accurately controlling the positions of the dilator 3 and the sheath 4.

In addition, the perforation formed by the guide wire 2 is expanded by passing only the dilator 3 through the cavity wall without attaching the sheath 4, and the expansion of the perforation is repeated while gradually increasing the outer diameter of the dilator 3 to be used. Thus, for example, the perforation can be expanded to such a size that an endoscope or the like can be inserted.

In the present embodiment, the male screw portion 2b and the female screw portion 3b are provided at the distal ends of the guide wire 2 and the dilator 3, respectively, but the arrangement of the male screw portion 2b and the female screw portion 3b is as follows. It is not limited to this. For example, as shown in FIG. 10, a male screw portion 2 b and a female screw portion 3 b may be provided on the proximal end sides of the guide wire 2 and the dilator 3, respectively. By doing so, it is not necessary to provide an uneven shape on the outer surface of the distal end portion of the guide wire 2, so that the diameter of the distal end portion of the guide wire 2 is reduced and the guide wire 2 is inserted into the body in a less invasive manner. be able to.

DESCRIPTION OF SYMBOLS 1 Medical device 2 Guide wire 2b Male thread part 2c Core material

2d Wire material

2e Mountain part 3 Dilator 3a Tip part 3b Female thread part 3c Convex part 3d Protrusion 4 Sheath 4a Concave part 5 Holding part 5a Base board 5b Arm 6 Handle (Operation part) )
7 motion rotation mechanism 7a rotation axis (motion rotation mechanism)
7b Drive roller (motion rotation mechanism)
7c driven roller 7d rubber 7e rack (motion rotation mechanism)
7f Pinion (motor rotation mechanism)
7g gear (motion rotation mechanism)
8 Tube (support member)

Claims

A guide wire inserted into the body,
The distal end portion has a distal end portion that is gradually tapered toward the distal end surface, the guide wire is inserted so as to be movable in a longitudinal direction and a circumferential direction, and an opening through which the guide wire can protrude and retract is formed in the distal end surface. A cylindrical dilator,
The guide wire includes a male screw part,
A medical device, wherein the dilator includes a female screw portion fastened to the male screw portion and communicated with the opening.
The medical device according to claim 1, further comprising a cylindrical sheath that houses the dilator so that the distal end portion of the dilator protrudes from the opening of the distal end surface and is movable to the proximal end side.
The medical device according to claim 2, wherein the sheath is formed to be gradually tapered toward the tip.
The medical device according to claim 1, wherein the male screw portion has a polygonal cross-sectional shape.
The medical device according to claim 1, wherein the male screw portion is formed of a wire wound in a spiral shape.
The medical device according to claim 5, wherein the male screw portion has a plurality of the wire rods wound in parallel.
The medical device according to claim 1, further comprising a holding portion that holds a proximal end side of the guide wire inserted into the body in a predetermined position.
The medical device according to claim 1 or 7, further comprising a support member that supports a side surface of the guide wire in the dilator.
An operation unit that allows the operator to perform a predetermined movement;
The medical device according to claim 1, further comprising: a motion transmission mechanism that converts the predetermined motion of the operation unit into rotation in the circumferential direction of the dilator and transmits the rotation to the dilator.