JP6547541B2 - Diameter reduction device - Google Patents

Description

  The present invention relates to a diameter reducing device for reducing the outer diameter of a medical device such as a stent.

  For example, Patent Document 1 shown below is known as a diameter reducing device for reducing the outer diameter of a medical device such as a stent. In the conventional diameter reducing device, by rotating the ring, the plurality of tops rotate around the respective fulcrum support portions, and the tips of the plurality of tops move in cooperation in the radial direction to open the opening It is configured to change the inner diameter of.

  In the conventional diameter reducing device, the diameter of a circle connecting the centers of a plurality of supporting points is PCD, and the distance from the center of the supporting point to the tip of the top held by the supporting point is L0. In the case, L0 / PCD is designed to be exactly 0.5. By designing in this manner, for example, when the PCD is 62 mm, the inner diameter of the opening can be reduced from 12 mm to 0 mm.

  However, in the conventional diameter reducing device, in the process of narrowing the inner diameter of the opening, a gap (gap) of about 0.1 mm at the maximum is formed between the tip portions of adjacent cotters. Therefore, if the wire diameter of the wire constituting the stent is smaller than 0.1 mm, there is a possibility that the wire may enter the gap between the tip of the cotter body and damage the stent as a product.

  In recent years, a stent having a small wire diameter has been developed, and in a diameter reducing device used to reduce the outer diameter of such a stent, a technique for reducing the gap between the cotters is required.

US2004 / 0128818

  The present invention has been made in view of such a situation, and an object thereof is a diameter reducing apparatus capable of favorably changing the outer diameter of a diameter reducing object without a part of the diameter reducing object being bitten. To provide.

  As a result of intensive studies on reducing the gap between the top bodies, the inventors set the diameter of a circle connecting the centers of a plurality of supporting points to PCD, and hold the supporting point from the center of the supporting point to the supporting point In the case where the distance to the tip portion of the top piece is L0, it is found that the gap between the top pieces can be reduced by making L0 / PCD larger than 0.5, and the present invention is completed. It came to

That is, the diameter reducing device according to the present invention is
With multiple frames,
A diameter reducing device comprising: a ring on which a plurality of fulcrum support portions for rotatably holding the base end portions of the plurality of cotters are mounted along a circumferential direction;
The tips of the plurality of cotters are combined to form an opening,
By rotating the ring, the plurality of tops rotate around the respective fulcrum support portions, and the tips of the plurality of tops move in a radial direction in cooperation with each other, and the inner diameter of the opening Is configured to change the
Assuming that the diameter of a circle connecting the centers of the plurality of fulcrum supports is PCD, and the distance from the center of the fulcrum support to the tip of the top held by the fulcrum support is L0, L0 / It is characterized in that PCD is larger than 0.5.

  In the diameter reducing device of the present invention, the gap between the top members can be reduced only by setting L0 / PCD to be larger than 0.5. As a result, using the diameter reducing device of the present invention, for example, the outer diameter of an object having a reduced diameter such as a stent can be obtained without any part of the object having a reduced diameter being caught in the gap between the tops of the diameter reducing device. It is possible to reduce the diameter well. Thus, a product such as a reduced diameter stent can be inserted into a protective tube or the like and transported without being damaged.

  The lower limit of L0 / PCD is preferably greater than 0.5005, more preferably greater than or equal to 0.5008, and still more preferably greater than 0.5010. The upper limit of L0 / PCD is preferably less than 0.504, more preferably less than 0.503, and still more preferably 0.5020 or less.

  By configuring the diameter reducing device so as to have such a relationship, the gap between the tops is preferably at most 0.08 mm or less, more preferably 0.07 mm or less, particularly preferably 0.05 mm or less. It can be made smaller.

FIG. 1 is a partially transparent perspective view of a diameter reducing device according to an embodiment of the present invention. FIG. 2 is a partial sectional plan view of the diameter reducing device shown in FIG. 3 (A) is a plan view of the drive ring shown in FIGS. 1 and 2, and FIG. 3 (B) is a side view of the drive ring shown in FIG. 3 (A). 4 (A) is a plan view of the auxiliary ring shown in FIG. 1, and FIG. 4 (B) is a side view of the auxiliary ring shown in FIG. 4 (A). 5 (A) is a front view of the frame shown in FIG. 1, FIG. 5 (B) is a plan view of the frame shown in FIG. 5 (A), and FIG. 5 (C) is a frame shown in FIG. Bottom view of FIG. FIG. 6 is a plan side perspective view of the lid shown in FIG. 7 (A) is a plan view of the lid shown in FIG. 6, and FIG. 7 (B) is a side view of the lid shown in FIG. 7 (A). FIG. 8 is a plan view showing the relationship between PCD and L0 of the diameter reducing device from which one lid shown in FIG. 1 is removed. FIG. 9A is a partially broken perspective view of one of the lids shown in FIG. 1 and the diameter reducing device seen from another angle. FIG. 9B is a partially broken perspective view of the diameter reducing device shown in FIG. 9A with the drive ring and the auxiliary ring removed. FIG. 10A is a perspective view of an essential part when the diameter reducing device is viewed from another angle with one lid and the case shown in FIG. 1 removed. FIG. 10B is a perspective view of an essential part showing a state in which the opening of the diameter reducing device shown in FIG. 10A is moved to be narrowed. FIG. 10C is a perspective view of an essential part showing a state in which the opening of the diameter reducing device shown in FIG. 10B is moved to be further narrowed. 11A is a plan view showing a partial cross section of the diameter reducing device from which one lid shown in FIG. 1 is removed. 11B is a plan view of a group of tops showing a state in which the drive ring is moved in the direction to narrow the opening from the state shown in FIG. 11A. FIG. 11C is a plan view of a group of tops showing a state in which the drive ring has been moved in the direction to further narrow the opening from the state shown in FIG. 11B. FIG. 11D is a plan view of a group of tops showing a state in which the drive ring has been moved in the direction to narrow the opening further from the state shown in FIG. 11C. FIG. 12 is a graph showing the relationship between the diameter reduction diameter of the opening of the diameter reducing device according to the embodiment of the present invention and the comparative example and the gap between the tops.

Hereinafter, the present invention will be described based on embodiments shown in the drawings.
As shown in FIG. 1, the diameter reducing device 2 according to an embodiment of the present invention is a device used to reduce the outer diameter of a stent (not shown) of a medical device, for example. And a drive ring 6a and auxiliary rings 6b and 6c. The plurality of tops 4 and the drive ring 6a and the auxiliary rings 6b and 6c are mounted inside the cylindrical case 10, and lids 12a and 12b are mounted on both ends of the case 10 in the Z-axis direction. is there.

  The tip end portion of the fixing lever 20 is fixed to the outer periphery of the body of the case 10. The rotating lever 22 is attached to the fixed lever 20 via the link lever 24. In FIG. 1, the case 10 and the lids 12 a and 12 b are indicated by two-dot chain lines, and are illustrated so that the inside can be seen. Similarly, the fixed lever 20, the pivot lever 22 and the link lever 24 are indicated by a two-dot chain line. In the drawings, the central axis of the case 10 is parallel to the Z axis, the longitudinal direction of the fixed lever 20 is parallel to the X axis, and the Y axis is an axis perpendicular to the X axis and the Z axis.

  As shown in FIG. 2 in which the illustrations of the lids 12a and 12b are omitted, a hollow portion 21 is formed inside the distal end portion of the fixing lever 20 fixed to the body outer peripheral portion of the case 10. Inside the hollow portion 21, the link piece 28 is rotatably mounted in the arrow A2 direction (or the opposite direction) with the rotary shaft 30 as a rotation fulcrum. The pivot shaft 30 is attached to the fixed lever 20 inside the hollow portion 21 of the fixed lever 20.

  The distal end portion of the control lever 22 is attached to the pivotal end portion of the link piece 28 via the pivotal shaft 31, and the control lever 22 is an arrow with respect to the fixed lever 20 with the pivotal shaft 31 as a pivot point. It is rotatable in the A1 direction (or the opposite direction). The driving pin 32 is fixed to the rotating tip of the link piece 28 at a position different from the rotating shaft 31. The drive pin 32 engages with the drive elongated hole 36 of the drive convex portion 34 integrally formed on the outer peripheral portion of the drive ring 6 a shown in FIG. 1. The pivots 30, 31 and the axis of the drive pin are parallel to the Z axis.

  As shown in FIG. 2, when the turning lever 22 is turned in the direction of arrow A1 with respect to the fixed lever 20, the link lever 24 turns the link piece 28 in the direction of arrow A2 with the turning shaft 30 as a fulcrum. It will make you move. As a result, the drive pin 32 of the link piece 28 moves in the longitudinal direction in the long drive hole 36 and applies a rotational drive force in the direction of arrow A3 to the drive convex portion 34.

  Since the drive convex portion 34 is integrated with the drive ring 6a shown in FIG. 1, when the rotational drive force in the direction of arrow A3 is applied to the drive convex portion 34, the drive ring 6a is in the direction of arrow A3. It is rotationally driven. Next, the relationship between the drive ring 6a and the auxiliary rings 6b and 6c and the top 4 will be described.

  As shown to FIG. 3 (A) and FIG. 3 (B), the drive ring 6a has the disk-shaped ring main body 33a which the inner peripheral part 37a becomes a circular opening. In the ring main body 33a, a plurality of through holes 38a penetrating the front and back surfaces are formed at substantially equal intervals along the circumferential direction. The fulcrum support pin 8 shown in FIG. 1 and FIG. 2 is passed through each through hole 38a.

  The drive convex portion 34 is integrally formed on a part of the outer peripheral portion of the ring main body 33 a so as to project in the radial direction. In the driving convex portion 34, a driving long hole 36 is formed. The driving elongated hole 36 is formed to be elongated in the radial direction of the ring main body 33a, and the width (circumferential length) of the driving elongated hole 36 is such a width that the drive pin 32 shown in FIG.

  As shown in FIG. 3B, the drive convex portions 34 are formed in a pair in the axial direction of the drive ring 6 a via the notches 35. The link pieces 28 shown in FIG. 2 are inserted in the notches 35, and the drive pins 32 respectively projecting on the front and back surfaces of the link pieces 28 enter the inside of the drive elongated holes 36 of the respective drive convex portions 34 and engage with each other. Match.

  As shown in FIGS. 4A and 4B, the auxiliary rings 6b and 6c have disk-shaped ring bodies 33b and 33c whose inner peripheral portions 37b and 37c are circular openings. In the ring bodies 33b and 33c, a plurality of through holes 38b and 38c penetrating the front and back surfaces are formed at substantially equal intervals along the circumferential direction. The fulcrum support pin 8 shown in FIGS. 1 and 2 is passed through the through holes 38 b and 38 c. The longitudinal direction of the fulcrum support pin 8 is parallel to the Z axis.

  As shown in FIGS. 5 (A), 5 (B) and 5 (C), each top body 4 has an elongated plate main plate 4d along the longitudinal direction of the fulcrum support pin 8 as a whole. The tip 4a at one end in the short direction of the plate body 4d has a sharp edge shape. As shown in FIG. 2, a set of tip portions 4 a of the tops 4 becomes openings 4 b extending in the Z-axis direction. The inner diameter of the opening 4b changes in accordance with the movement of the tip 4a as described later.

  A drive ring mounting groove 42 is formed at the central portion in the longitudinal direction of the proximal end 4c which is the other end in the lateral direction of the plate body 4d, and at both ends in the longitudinal direction of the proximal end 4c, An auxiliary ring mounting groove 44 is formed. Moreover, the through-hole 4e penetrated to a longitudinal direction is formed in the base end part 4c, and the fulcrum support pin 8 is penetrated to the through-hole 4e.

  As shown in FIG. 1, the drive ring 6a is inserted into the drive ring attachment groove 42 shown in FIG. 5A, and a fulcrum is formed in the through hole 38a formed in the circumferential direction of the drive ring 6a shown in FIG. The support pin 8 is adapted to be threaded. Further, as shown in FIG. 1, the auxiliary rings 6b and 6c are inserted into the auxiliary ring attachment groove 44 shown in FIG. 5A, and formed in the circumferential direction of the auxiliary rings 6b and 6c shown in FIG. The fulcrum support pin 8 is passed through certain through holes 38b and 38c. Both ends of the fulcrum support pin 8 may be configured to protrude from the auxiliary rings 6 b and 6 c as shown in FIG. 9A. FIG. 9B shows a state in which the drive ring 6a and the auxiliary ring 6c shown in FIG. 9A are removed.

  Pin holes 4f are formed at both ends in the longitudinal direction of the plate body 4d at a position drawn a predetermined distance in the short direction from the tip 4a of the plate body 4d shown in FIG. 5A. Guide pins 40 are fitted in the pin holes 4f, and the guide pins 40 project from both ends in the longitudinal direction of the plate body 4d.

  As shown in FIGS. 6 and 7 (A) and 7 (B), the lids 12a and 12b have a disc-shaped lid main body 13, and a circular entrance 14 is formed at the center of the lid main body 13. Yes. The inside diameter of the inlet / outlet 14 is set larger than the maximum outside diameter of the opening 4 b shown in FIG.

  On the inner surface of the lid main body 13 (the surface facing the end surface in the Z-axis direction of the top 4 shown in FIG. 1), elongated groove guide grooves elongated in the radial direction at substantially equal intervals in the circumferential direction along the outer periphery of the entrance 14 A plurality of 18 are formed. The number of the guide grooves 18 is equal to the number of the top 4 arranged as shown in FIG. 1 and also corresponds to the number of the guide pins 40 shown in FIG. In each of the guide grooves 18, as shown in FIGS. 11B to 11D, a guide pin 40 is movably engaged in the radial direction.

  As shown in FIGS. 6 and 7 (A) and 7 (B), the inner surface of the lid body 13 is formed with a guide convex portion 16 extending along the circumferential direction on the outer peripheral portion thereof. good. The guide convex portion 16 enters the inside of the case 10 shown in FIG. 1, for example, and can guide the rotational movement of the both ends of the fulcrum support pin 8 in the circumferential direction inside the guide convex portion 16.

  As shown in FIG. 8, in the present embodiment, the diameter of a circle connecting the centers of the plurality of supporting point support pins 8 is PCD, and the tip end of the top 4 held by the supporting point support pins from the center of the supporting point support pin L0 / PCD is larger than 0.5, when distance to L0 is set to L0. Preferably, the lower limit of L0 / PCD is preferably greater than 0.5005, more preferably greater than or equal to 0.5008, and still more preferably greater than 0.5010. The upper limit of L0 / PCD is preferably less than 0.504, more preferably less than 0.503, and still more preferably 0.5020 or less.

  Next, the movement of the diameter reducing device 2 according to the present embodiment will be described. For example, after inserting a diameter reducing object such as a medical stent into the inside of the opening 4b shown in FIGS. 1 and 2, from the state shown in FIG. When the link lever 24 is turned, the link piece 28 is turned in the direction of the arrow A2 about the turning shaft 30 by the action of the link lever 24. As a result, the drive pin 32 of the link piece 28 moves in the longitudinal direction in the long drive hole 36 and applies a rotational drive force in the direction of arrow A3 to the drive convex portion 34.

  As shown in FIGS. 10A and 11B, when a rotational driving force in the direction of arrow A3 is applied to the drive convex portion 34, the drive ring 6a also rotates (pivots) in the direction of arrow A3. Since the drive ring 6a and the auxiliary rings 6b and 6c are connected via the fulcrum support pin 8 as shown in FIG. 9A, when the drive ring 6a rotates, the auxiliary rings 6b and 6c move in the same manner. .

  Each fulcrum support pin 8 is rotatably inserted into the through hole 4 e of the top 4 as shown in FIG. 5A. Therefore, when the drive ring 6 a is rotated, the through hole 4 e of the top 4 is rotated. The fulcrum supporting pins 8 rotatably inserted are also moved in the direction of the arrow A3 as shown in FIGS. 11B to 11C. Each fulcrum support pin 8 may be fixed to the through hole 4e of the top 4, and in this case, each fulcrum support pin 8 is fixed to the through holes 38a to 38c of the rings 6a to 6c. It is held rotatably.

  Since the case 10 and the lids 12a and 12b shown in FIG. 1 are fixed, the guide pin 40 shown in FIG. 11B has a radius along the guide groove 18 (see FIG. 6) formed on the inner surface of the lids 12a and 12b. Guided inside the direction. Therefore, when the drive ring 6a pivots in the arrow A3 direction, the plurality of tops 4 pivot around the respective fulcrum support pins 8 in the arrow A4 direction, and the tip portions 4a of the tops 4 from FIG. 11C As shown in FIG. 11D, they move together in the radial direction to change the inner diameter of the opening 4b in the direction to reduce the diameter.

  For example, since a diameter reducing object such as a stent is inserted into the opening 4b, the outer diameter of the stent is also reduced along with the diameter reduction of the opening 4b. By rotating the rotation lever 22 in the direction opposite to the arrow A1 with respect to the fixed lever 20 shown in FIGS. 1 and 2, an operation opposite to the above-described operation is performed, and the opening 4b can be opened. The diameter-reduced stent or the like can be taken out from the opened opening 4b.

  In the diameter reducing device 2 of the present embodiment, as shown in FIG. 8, it is possible to reduce the gap between the top bodies 4 only by making L0 / PCD larger than 0.5. In particular, the gap between the tip portions 4a of the adjacent cotters 4 can be reduced. As a result, using the diameter reducing device 2, for example, the outer diameter of a diameter reducing object such as a stent can be prevented without a part of the diameter reducing object getting caught in the gap between the tops 4 of the diameter reducing device 2. It is possible to reduce the diameter well. Thus, a product such as a reduced diameter stent can be inserted into a protective tube or the like and transported without being damaged.

  The present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention.

  For example, the specific shape and the number of arrangement of the top body 4 are not limited to the illustrated embodiment and can be variously modified. Further, the shapes of the fixed lever 20 and the pivot lever 22 or the structure of the link connecting these levers 20 and 22 can be variously modified.

  Hereinafter, the present invention will be described based on more detailed examples and comparative examples, but the present invention is not limited to these examples.

Example 1
Adjust the positions of the through holes 38a to 38c formed in the drive ring 6a and the auxiliary rings 6b and 6b so that the length L0 of the top 4 shown in FIG. 8 is 31.0 mm and the PCD is 61.75 mm. The diameter reducing device shown in FIGS. 1 to 11D was assembled. The total number of the tops 4 was 12.

  At the tip 4a of the top 4, the gap (gap) between adjacent tops 4 was measured by an image size measurement device “IM-6020” (manufactured by Keyence Corporation). The result of having investigated the gap between coma bodies with respect to the change of the internal diameter (diameter reduction diameter) of the opening part 4b is shown in FIG. Further, Table 1 shows the maximum gap between the tops, the maximum diameter reduction diameter and the minimum diameter diameter of the opening 4b.

Example 2
The diameter reduction is performed in the same manner as in Example 1 except that the length L0 of the top 4 shown in FIG. 8 is 31.0 mm and the positions of the through holes 38a to 38c are adjusted so that the PCD is 61.8 mm. The device was assembled.

  The result of having investigated the gap between coma bodies with respect to the change of the internal diameter (diameter reduction diameter) of the opening part 4b is shown in FIG. Further, Table 1 shows the maximum gap between the tops, the maximum diameter reduction diameter and the minimum diameter diameter of the opening 4b.

Example 3
The diameter is reduced in the same manner as in Example 1 except that the positions L of the cotters 4 shown in FIG. 8 are 31.0 mm and the positions of the through holes 38a to 38c are adjusted so that the PCD is 61.9 mm. The device was assembled.

  The result of having investigated the gap between coma bodies with respect to the change of the internal diameter (diameter reduction diameter) of the opening part 4b is shown in FIG. Further, Table 1 shows the maximum gap between the tops, the maximum diameter reduction diameter and the minimum diameter diameter of the opening 4b.

Comparative Example 1
The diameter reduction is performed in the same manner as in Example 1, except that the length L0 of the top 4 shown in FIG. 8 is 31.0 mm and the positions of the through holes 38a to 38c are adjusted so that the PCD is 62.0 mm. The device was assembled.

  The result of having investigated the gap between coma bodies with respect to the change of the internal diameter (diameter reduction diameter) of the opening part 4b is shown in FIG. Further, Table 1 shows the maximum gap between the tops, the maximum diameter reduction diameter and the minimum diameter diameter of the opening 4b.

Comparative example 2
The diameter is reduced in the same manner as in Example 1 except that the length L0 of the top 4 shown in FIG. 8 is 31.0 mm and the positions of the through holes 38a to 38c are adjusted so that the PCD is 62.1 mm. The device was assembled.

  The result of having investigated the gap between coma bodies with respect to the change of the internal diameter (diameter reduction diameter) of the opening part 4b is shown in FIG. Further, Table 1 shows the maximum gap between the tops, the maximum diameter reduction diameter and the minimum diameter diameter of the opening 4b.

As shown in Evaluation Table 1, it was confirmed that the gap between the top bodies 4 can be reduced by only making L0 / PCD larger than 0.5000. In particular, the lower limit of L0 / PCD is preferably larger than 0.5005, more preferably larger than 0.5008, and still more preferably larger than 0.5010 to maximize the space between the tops, preferably It has been confirmed that the size can be reduced to 0.08 mm or less, more preferably 0.07 mm or less, and particularly preferably 0.05 mm or less.

  Further, as shown in Table 1 and FIG. 12, when L0 / PCD is increased, the minimum diameter reduction diameter is increased, so the upper limit of L0 / PCD is preferably smaller than 0.504, more preferably 0.503. It has been confirmed that the size is small, more preferably 0.5020 or less.

2 ... Diameter reduction device 4 ... Top body 4a ... Tip 4b ... Opening 4c ... Base end 4d ... Board body 4e ... Through hole 4f ... Pin hole 6a ... Drive ring 6b, 6c ... Auxiliary ring 8 ... Support point pin ( Support point)
DESCRIPTION OF SYMBOLS 10 ... Case 12a, 12b ... Lid 13 ... Lid main body 14 ... Entrance 16 ... Guidance convex part 18 ... Guidance groove 20 ... Fixed lever 21 ... Hollow part 22 ... Rotation lever 24 ... Link lever 28 ... Link piece 30 and 31 ... Times Drive shaft 33 ... Drive pin 33a-33c ... Ring body 34 ... Drive convex part 35 ... Notch 36 ... Drive long hole 37a-37c ... Inner peripheral part 38a-38c ... Through hole 40 ... Guide pin 42 ... Drive ring attachment groove 44 ... Auxiliary ring mounting groove

Claims (2)

With multiple frames,
A diameter reducing device comprising: a ring on which a plurality of fulcrum support portions for rotatably holding the base end portions of the plurality of cotters are mounted along a circumferential direction;
The tips of the plurality of cotters are combined to form an opening,
By rotating the ring, the plurality of tops rotate around the respective fulcrum support portions, and the tips of the plurality of tops move in a radial direction in cooperation with each other, and the inner diameter of the opening Is configured to change the
Assuming that the diameter of a circle connecting the centers of the plurality of fulcrum supports is PCD, and the distance from the center of the fulcrum support to the tip of the top held by the fulcrum support is L0, L0 / Diameter reducing device characterized by PCD being larger than 0.5 005 and smaller than 0.504 . The diameter reducing device according to claim 1, wherein the L0 / PCD is 0.5008 or more and 0.5020 or less .

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