JP2016146919A - Manufacturing apparatus and manufacturing method of ballon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a manufacturing apparatus and a manufacturing method capable of heightening efficiency of a production process for covering a sheath on a ballon wound part of a balloon catheter body having many varieties.SOLUTION: A manufacturing apparatus of a balloon catheter includes handling means 1 for taking out one sheath 94 from among a plurality of sheaths 94, cutting means 2 for cutting the sheath 94 at a prescribed position in the axial direction so as to be set at a proper length, support means 3 for supporting the cut sheath 94 in the opened state without blocking one end opening part 94a into which at least a balloon catheter body is inserted, and positioning means 4 for positioning the sheath 94 supported by the support means 3.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a balloon catheter manufacturing apparatus and manufacturing method, and more particularly, to a balloon catheter manufacturing apparatus and manufacturing method that can improve the efficiency of a production process of covering a balloon winding portion of a balloon catheter body with a sheath.

  In manufacturing the balloon catheter, as shown in FIGS. 7A and 7B, the balloon 91 produced at the tip of the balloon catheter body 90 is folded, and the folded balloon 91 is wound around the catheter tube 92. Further, the balloon winding part 93 is covered with a sheath 94 to hold the wound state. For example, the balloon is wound small under reduced pressure and covered with a sheath to maintain this state, or a sheath made of a heat-shrinkable tube is covered over the balloon winding part before pressure reduction, and the sheath is heated and contracted with pressure reduction. (See Patent Documents 1 and 2). The sheath that covers the balloon winding part also functions as a protective tube for protecting the balloon until the balloon catheter is actually used by covering the sheath as it is.

  Such a sheath needs to be covered with a size suitable for the outer diameter (depressurized / not decompressed) and the length of the balloon winding portion, but there are various sizes of catheter tubes and balloons. In order to cope with this, a sheath with an appropriate diameter must be prepared separately for the difference in outer diameter. However, for the difference in length, a large number of long sheaths are prepared in advance and covered with a balloon winding. By cutting and using the dimensions corresponding to the length of the turning part, it is possible to cope with a wide variety of products and to improve production efficiency.

  However, since the operation of attaching the sheath to the balloon winding portion needs to be performed carefully so as not to damage or buckle the balloon, it has been conventionally performed manually. Specifically, each sheath is taken out from a container in which a large number of long sheaths are stored, and is cut by hand to a length suitable for the length of the balloon winding portion to be attached, and the balloon after folding. Lubricate the surface of the winding part by hand, hold the sheath and balloon catheter body in both hands, and carefully rotate the balloon winding part in the sheath, for example, relative rotation so that the wound balloon does not break. The work of inserting while doing is performed.

  As described above, since the process of attaching the sheath to the balloon winding part requires skilled and careful work, it is conventionally considered difficult to automate, and as described above, it is produced by manual work requiring time and labor. It was. However, when the sheath is manually attached to the balloon winding part, the balloon at the tip of the catheter is very small, so it takes time to perform the work in any process of picking up the sheath, cutting, and attaching to the winding part. There is a problem that it takes. In addition, there is a problem that production loss due to misidentification or the like is likely to occur. Also, when the work is mechanized and a sheath corresponding to the balloon winding part to be covered with the sheath is prepared in advance, it is necessary to switch the sheath each time the production type is changed, which is complicated and causes loss of the sheath. It's easy to do.

JP 2005-211142 A JP 2006-271678 A

  Therefore, in view of the above-described situation, the present invention intends to provide a manufacturing apparatus and a manufacturing method capable of improving the efficiency of a production process for covering a balloon winding portion of a variety of balloon catheter main bodies with a sheath. .

  In order to solve the above-mentioned problems, the present invention provides a balloon catheter manufacturing apparatus for covering a balloon winding portion of a balloon catheter body with a sheath having a length suitable for the length of the winding portion. Handling means for taking out one of the sheaths, cutting means for cutting the sheath at a predetermined position in the axial direction and setting the sheath to a suitable length, and the sheath to be cut at least by the balloon catheter body. Supporting means that can be supported in an open state without closing the one end opening to be inserted, and inserting the balloon catheter body into the sheath cut by the cutting means and supported by the supporting means. Provided is a balloon catheter manufacturing apparatus that allows the sheath to be attached to the balloon winding section.

  Here, the handling means recognizes the attitude of the sheath, the attitude recognition means, the holding means for holding a predetermined portion of the sheath based on the attitude of the sheath recognized by the attitude recognition means, and the holding means It is preferable to include a transporting unit that transports the sheath while being held in place.

  Further, the supporting means includes a gripping means for gripping a predetermined part of the sheath conveyed by the handling means, and a part held by the holding means is a part excluding the predetermined part gripped by the gripping means It is preferable that the handling means directly transfers the sheath to the support means.

  In particular, it is preferable that the grasping means includes a grasping portion that grasps the outer peripheral surface of the sheath.

  Further, it is preferable to provide positioning means for positioning the sheath supported by the supporting means.

  Here, it is preferable that the positioning means includes an abutting means for abutting and positioning on an end portion of the sheath when supported by the supporting means.

  In particular, it is preferable that the positioning means is provided with a lubricant supply means for supplying a lubricant into the inside from the abutted sheath end.

  Furthermore, it is preferable that the lubricant supply means is inserted into the inside from the opening of the abutted sheath end portion and has a nozzle portion for discharging the lubricant.

  Further, it is preferable that the support means support the sheath so as to be rotatable about the axis of the sheath.

  In particular, the support means includes a rotating frame that rotates about the axis, a driving means that rotates the rotating frame, and a predetermined portion of the sheath that is provided on the rotating frame and is conveyed on the central axis of the rotating frame. And a gripping means that rotates integrally with the rotary frame.

  Further, it is preferable that the cutting means cuts a predetermined axial position of the sheath in a state of being supported by the support means.

  The present invention also relates to a balloon catheter manufacturing method for covering a balloon winding portion of a balloon catheter body with a sheath having a length suitable for the length of the winding portion, and one of the plurality of sheaths. Removing the sheath, cutting the sheath at a predetermined position in the axial direction, setting the suitable length, supporting the sheath before or after the cutting step, and the suitable length. And a step of inserting the balloon catheter main body and attaching the sheath to the balloon winding portion with respect to the sheath that is set in a state where the opening is opened at one end. A method is also provided.

  Here, the step of taking out the one sheath includes a step of recognizing the posture of the sheath, a step of holding a predetermined portion of the sheath based on the recognized posture of the sheath, And a step of conveying.

  Moreover, it is preferable that the step of supporting the sheath includes a step of positioning the sheath to be supported.

  In particular, it is preferable that the positioning step positions the end portion of the sheath in contact with the contact means when the sheath is supported in the step of supporting the sheath.

  Furthermore, it is preferable that the positioning step includes a step of supplying a lubricant from a sheath end portion in contact with the contact means.

  In the step of attaching the sheath, the sheath supported with the one end opening opened is rotated about the axis of the sheath, and the balloon is rotated with respect to the rotating sheath. It is preferable that the catheter body is inserted and the sheath is attached to the balloon winding part.

  According to the balloon catheter manufacturing apparatus and manufacturing method according to the present invention as described above, the sheath can be automatically cut and supported one by one into a suitable length. Compared to the conventional production process where the sheath is manually picked up, cut, and attached to the winding part, the efficiency can be remarkably improved. It can adapt without waste. In the present invention, since the length setting process by the cutting means can be performed on demand one by one in the sheath, if the sheath is prepared by cutting in advance and picked up and attached, When the type of the balloon catheter main body is switched, a large amount of the sheath is cut and is wasted. However, such a mechanism that can avoid such inefficiency and can quickly switch the type is realized.

  The handling means includes a posture recognition means for recognizing the posture of the sheath, a holding means for holding a predetermined portion of the sheath based on the posture of the sheath recognized by the posture recognition means, and the holding means. Since the holding means for transferring the sheath while being held is provided, even if the sheath is placed in a stacked state, it can be held and transferred in a correct posture by the posture recognition means. Therefore, it is not necessary to align the sheath in advance with a parts feeder or the like, and the degree of freedom in equipment design is maintained.

  Further, the support means includes a gripping means for gripping a predetermined part of the sheath conveyed by the handling means, and a part held by the holding means is a part excluding the predetermined part gripped by the gripping means And since the sheath is directly transferred to the support means by the handling means, there is no need for a step in which the handling means is once placed in another place before passing to the support means, and the efficiency is improved. When the sheath is supported by the support means, the sheath can be held in a stable posture by the handling means, and a more accurate position can be supported.

  In addition, since positioning means for positioning the sheath supported by the support means is provided, a predetermined position of the sheath can be grasped, and in particular, when cutting after supporting, cutting by the cutting means The position shift can be prevented more reliably.

  Further, since the positioning means is provided with contact means for positioning by contacting the end portion of the sheath when supported by the support means, the determined position of the sheath is reliably supported by the contact. can do.

  Further, since the positioning means is provided with a lubricant supply means for supplying the lubricant from the sheath end portion in contact therewith, the lubricant is separately supplied by moving the nozzle to the sheath end portion in the same manner. Compared with the supply of the lubricant supply means for supplying, the efficiency of equipment and processes (operation tact) can be greatly improved.

  Further, since the support means supports the sheath so as to be rotatable about the axis of the sheath, when the balloon winding portion is inserted into the sheath, the resistance between the balloon winding portion and the sheath is reduced. The occurrence of defects that cause the balloon to buckle can be reduced.

  In addition, the support means includes a rotating frame that rotates about the axis, driving means that rotates the rotating frame, and a predetermined portion of the sheath that is provided on the rotating frame and is conveyed on the center axis of the rotating frame. And the gripping means that rotates integrally with the rotating frame, the sheath gripped by the gripping means by the rotation of the rotating frame can be rotated in a stable posture around the axis.

  In addition, since the cutting means cuts a predetermined position in the axial direction of the sheath supported by the support means, the sheath can be reliably cut in a stable posture.

(A) is explanatory drawing which shows the balloon catheter manufacturing apparatus which concerns on typical embodiment of this invention, (b) is explanatory drawing which looked at this from the axial direction of the support means. Explanatory drawing which shows a mode that a balloon catheter main body is similarly inserted in a sheath in a balloon catheter manufacturing apparatus. (A), (b) is explanatory drawing which shows a mode that a sheath is similarly hold | gripped by the holding part of a support means. Explanatory drawing which similarly shows the manufacture procedure by a balloon catheter manufacturing apparatus. Explanatory drawing which similarly shows the modification of the holding part of a support means. Explanatory drawing which similarly shows the modification of a support means. Explanatory drawing which shows the conventional sheath mounting | wearing operation | work.

  Next, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

  In the present invention, as shown in FIG. 2, the balloon winding portion 93 of the balloon catheter main body 90 (the winding portion where the balloon is folded and wound around the catheter tube) has a length suitable for the length of the winding portion 93. The present invention relates to an apparatus for improving the efficiency of a manufacturing process of a balloon catheter for covering a sheath 94.

  As shown in FIG. 1, the balloon catheter manufacturing apparatus S of the present embodiment is suitable for handling the handling means 1 for taking out one of the plurality of sheaths 94 and cutting the sheath 94 at a predetermined position in the axial direction. A cutting means 2 set to a length, a supporting means 3 for supporting the cut sheath 94 in an open state without closing at least one end opening 94a into which the balloon catheter body is inserted, and a supporting means 3 Positioning means 4 for positioning the sheath 94 to be supported and control means (not shown) for controlling these operations are provided.

  Then, by inserting the balloon catheter main body 90 into the sheath 94 cut by the cutting means 2 and supported by the support means 3, the sheath 94 is attached to the balloon winding portion 93 as shown in FIG. . In this way, each of the sheaths can be cut to a suitable length and supported by an automatic machine, and after that, only the balloon winding part 93 is inserted, and the conventional process that has been manually cut and mounted is performed. Compared to the above, it is possible to improve the efficiency, and it is possible to adapt to a variety of small-quantity production without waste and to produce efficiently.

  The sheath 94 of this example is attached to maintain the balloon winding state and protect the balloon in the balloon folding process. After the attachment, the sheath 94 is covered even during the distribution process until the catheter is actually used. In other words, it functions as a protective tube for protecting the balloon. However, the present invention also includes a case where a sheath is temporarily placed on the balloon winding part for folding brazing.

  That is, a sheath for maintaining such a temporary winding state, such as a sheath that is removed in a subsequent manufacturing process, or a sheath that can be replaced with another protective tube, also relates to the present invention. Included in the sheath. In this example, the opening 94a at the end of the sheath that receives the balloon catheter main body 90 is a plastic tube having a tapered receptacle shape. However, the present invention is not limited to such a configuration, and is conventionally attached to a balloon winding portion. A well-known sheath can be widely applied. Reference numeral 95 is a core material for ensuring the rigidity of the catheter body 90 when the winding portion 93 is inserted into the sheath 94 and preventing deformation and buckling of the balloon and the catheter tube. The material is a metal such as stainless steel. Or it is a hard plastic. The core material 95 is a member that is not used during use, like the sheath 94. However, such a core material 95 can be omitted.

  The handling unit 1 includes a posture recognition unit 10 that recognizes the posture of the sheath 94, a holding unit 11 that holds a predetermined portion of the sheath 94 based on the posture of the sheath 94 recognized by the posture recognition unit 10, and a holding unit. 11 and transporting means 12 for transporting the sheath 94 while being held at 11. By having the posture recognition means 10 in this way, even if the sheath 94 is placed in a stacked state, it can be picked up and transported in the correct posture. Therefore, it is not necessary to align the sheath 94 in advance with a parts feeder or the like, and the degree of freedom in equipment design is maintained. Of course, if the sheaths are arranged and supplied, such posture recognition means 10 can be omitted.

  The posture recognizing means 10 is a means for enabling the holding means 11 to pick up each sheath 94 placed in a bulk state in the same posture. For example, a camera that outputs an image of each sheath 94, a force sensor (such as a strain gauge type tactile sensor) attached to the holding means 11, and the position and posture of the sheath 94 are recognized based on image data and sensor data of these cameras. It is configured by processing of a control means (processing by a program realized using a CPU or a memory).

  The holding means 11 is preferably a robot hand equipped with a force sensor as described above. Even if the holding means 11 cannot hold the predetermined portion of the sheath 94 by one operation, the holding means 11 can be configured so that the sheath 94 is once placed or supported in another portion and is replaced with the correct predetermined portion. .

  The part of the sheath 94 held by the holding unit 11 is a part excluding a predetermined part gripped by the support unit 3 at the transport destination. Accordingly, the sheath 94 is directly transferred to the support means 3 by the handling means 1, and when the sheath 94 is supported by the support means 3, the sheath 94 can be held in a stable posture by the handling means 1. It is configured to support a more accurate position.

  However, when the sheath 94 is not required to be held by the handling means 1 when the sheath 94 is supported by the support means 3, for example, when the sheath 94 is supported at a stable position near the center of the sheath, the holding means 11 is used. The portion of the sheath 94 that is held by may overlap the portion that is supported by the support means 3. In addition to holding the outer peripheral surface of the sheath 94, the inner peripheral surface and the outer peripheral surface of the sheath end can be pinched and held.

  The transport unit 12 is preferably, for example, a robot arm (an arm, a joint, an actuator such as a motor, a sensor, or a process of a control unit that operates the actuator) having a robot hand as the holding unit 11 at the tip. Known robot systems can be used. Of course, other than such a robot arm, a conveying means can be widely employed.

  The cutting means 2 includes a cutting blade 20 that cuts a predetermined position in the axial direction of the sheath 94 supported by the support means 3, a moving mechanism 21 that moves the sheath 94 so as to be able to advance and retreat, and an adjustment (not shown) that can adjust the cutting position. It comprises a mechanism and control means for controlling the operation of the moving mechanism and the adjusting mechanism. In the present embodiment, since the sheath 94 is supported by the support means 3 at a specific position by the positioning means 4 described later, the cutting means 2 has a predetermined size suitable for the balloon size of the sheath 94 protruding from the support means 3. What is necessary is just to cut a position.

  However, even if there is no such positioning means 4, the cutting means is provided with specifying means for specifying the cutting position of the sheath, for example, means for specifying the position from the end of the sheath, so that the predetermined position of the sheath 94 can be determined. It is possible to cut. If the portion of the sheath 94 held by the handling means 1 is a portion other than the position where the cutting means 2 cuts, the holding means of the handling means 1 together with the support means 3 when the sheath 94 is cut by the cutting means 2. 11, the sheath 94 can be kept held, and the sheath 94 can be stably cut by the cutting means 2. The cutting means 2 is preferably attached to the frame or the like of the support means 3.

  Further, in this example, the sheath 94 is cut by the cutting means 2 while being supported by the support means 3, but may be cut while being held only by the handling means 1 before being supported by the support means 3. preferable. In this case, for example, it is preferable to attach the cutting means 2 to the holding means 11. Further, it is possible to cut the predetermined position by the cutting means 2 in a state where the sheath 94 is temporarily placed or supported in another place during the transport of the sheath 94 by the handling means 1.

  In this embodiment, when the length of the balloon to be attached is changed and the length of the sheath 94 is changed, the part held by the holding means 11 of the handling means 1 and the part supported by the support means 3 are not changed. And the cutting position by the cutting means 2 is changed and adjusted. However, the length of the sheath 94 after cutting is changed without changing or adjusting the position of the cutting means 2 by changing the portion supported by the support means 3 by changing the set position of the positioning means 4 described later. It is also possible to do. In this case, for example, the sheath 94 is preferably cut using the end portion of the support means 3 (the position at which the supported sheath protrudes from the support means 3) as a cutting position.

  If necessary, it is also preferable to provide a sensor for checking whether the length of the sheath 94 after being cut by the cutting means 2 is within the standard range. In the present invention, when the length of the sheath 94 is set by the cutting means 2 on demand one by one, the sheath 94 is prepared in advance so that the sheath is prepared and picked up and mounted. A mechanism that avoids the inefficiency that the sheath is cut excessively when the type of the balloon catheter body is switched and is wasted and the type can be switched quickly is realized.

  The support means 3 includes a gripping portion 32 </ b> A that grips the outer peripheral surface of the sheath as the gripping means 32 that grips a predetermined portion of the sheath 94 conveyed by the handling means 1. More specifically, a rotating frame 30 that rotates about the axis, driving means 31 that rotates the rotating frame 30, and a sheath provided on the rotating frame 30 and conveyed on the center axis of the rotating frame 30. The gripping portion 32 </ b> A is configured as a gripping means 32 that grips 94 predetermined portions and rotates integrally with the rotating frame 30.

  Thus, by supporting the sheath 94 rotatably around the axis by the support means 3, when inserting the balloon winding portion 93, the balloon 94 is rotated by rotating the sheath 94 in the same direction as the balloon winding direction. 93 and the resistance of the sheath 94 are reduced, and it is possible to reduce the occurrence of defects that cause the balloon to buckle.

  The rotating frame 30 has a structure in which a pair of ring-shaped frames 50, 50 are connected by a plurality of straight frames 51, and each ring-shaped frame 50 is configured as a large gear having teeth formed on the outer peripheral surface. Further, the driving means 31 is arranged around each ring-shaped frame 50 and is composed of a plurality of small gears 52 that mesh with the ring-shaped frame 50, and is driven by a driving mechanism such as a motor (not shown) that rotationally drives the small gears 52. The frame 50 is rotated. The rotating frame 30 is rotatably supported by the plurality of small gears 52.

  The gripping means 32 includes a base portion 32B fixed to the central axis side of the rotating frame of the straight frame 51 and a chuck device as a gripping portion 32A supported by the base portion 32B. The sheath 94 is held coaxially with the central axis of the rotating frame by the gripping portion 32 </ b> A, and rotates about the axis by the rotation of the rotating frame 30. As shown in FIGS. 3A and 3B, the chuck device as the gripping portion 32A is sandwiched by the fixed wings 53 from two directions that are orthogonal to the axis of the sheath 94 that is the gripping object and that are opposed to each other by 180 °. It is a mechanical chuck.

  Each fixed wing 53 includes a substantially V-shaped contact surface 54 that contacts the outer peripheral surface of the sheath 94 from two directions of obliquely upward and obliquely downward, and a plurality of the fixed wings 53 intersect each other in a zigzag manner from the two left and right directions. In this example, two are provided on the left and right. Thus, the sheath 94 can be gripped in a stable posture without being displaced, and the gripped shaft position is always kept constant even when the outer diameter of the sheath 94 is changed.

  In this example, two left and right sheets are provided, but if there are a plurality of sheets on one side, the other can be held in a staggered manner by arranging at least one sheet in a staggered position. Further, in this example, the angles of the two upper and lower oblique surfaces that contact the actual sheath 94 of the contact surface 54 of each fixed wing 53 are the angles formed at an inclination angle of 45 degrees obliquely upward and 45 degrees obliquely downward, respectively. Is set to 90 degrees. As a result, the sheath 94 is held in a stable posture at the four angular positions that are equidistant in cross-section by the left and right fixed wings 53.

  Of course, mechanical chucks other than this example can also be widely employed. For example, as shown in FIG. 5, a chuck device including a plurality of diaphragm blades 55 is also preferable. In addition to a mechanical chuck, a vacuum chuck using a negative pressure may be employed. In addition, for example, a structure in which the outer peripheral surface of the sheath is sandwiched between three rollers 56 that are rotationally driven as shown in FIG. 6 is also preferable. If supported in this way, the rotating frame can be omitted, and the sheath can be cut more accurately and reliably by the cutting means 2 while rotating. In addition, it is also preferable to provide gripping portions of the support means 3 at a plurality of locations in the sheath axial direction, and attach the cutting means 2 to one of them.

  As shown in FIGS. 1 and 4, the positioning means 4 includes a contact member 40 having a contact surface 40a that contacts the sheath end, a moving mechanism 41 that moves the contact member 40 so as to be able to advance and retract, A lubricant supply means 42 that is provided in the member 40 and supplies lubricant from the contacted sheath end portion to the inside, and a control means that controls the operation of the moving mechanism 41 and the lubricant supply means 42. The lubricant supply means 42 protrudes from the contact surface of the contact member 40 and is inserted into the inside of the opening 94a at the sheath end that contacts the contact surface to discharge the lubricant. It is comprised from the lubricant supply part 61 which supplies a lubricant to the nozzle part 60. FIG.

  The positioning means 4 is not limited to the structure in which the sheath end is brought into contact with the positioning as in the present embodiment, and a contact or non-contact sensor may be provided. The positioning means 4 is preferably attached to a frame or the like constituting the support means 3. Further, by providing the handling means 1 with a sensor for recognizing a specific position of the support means 3, the sheath 94 can be set at a specific position of the support means 3. In this case, the positioning means 4 is omitted. You can also

  In the present embodiment, the nozzle portion 60 of the lubricant supplying means 6 protrudes from the abutting surface 40a of the abutting member 40 of the positioning means 4, and the nozzle portion 60 is simultaneously inserted into the sheath at the time of positioning to supply the lubricant. Since it is configured so that it can also serve as a discharge, separately from the provision of the lubricant supply means 6 that can supply the lubricant by moving the nozzle to the end of the sheath in the same way, the equipment, process (operation) Tact) is greatly improved.

  However, the lubricant supply means 6 to which the lubricant is automatically applied may be omitted. In particular, in the present embodiment in which the support means 3 can be rotated to rotate the sheath 94 about the axis, the lubricant supply means can be omitted, and the lubricant can be efficiently applied to the sheath 94 manually. . Further, the lubricant may be applied to the balloon winding portion 93 side together with the application of the lubricant to the sheath 94 or instead of the application of the lubricant to the sheath 94. As the lubricant, silicone oil or glycerin can be used.

  Hereinafter, based on FIG.1 and FIG.4, the manufacturing procedure by the manufacturing apparatus S of this embodiment is demonstrated.

  First, as shown in FIGS. 1 and 4 (a), the posture recognition unit 10 of the handling unit 1 recognizes the posture of the sheath placed in a stacked state, and based on the result of this recognition, a predetermined sheath is determined. The part is held by the holding unit 11 and is directly transferred to the position of the support unit 3 by the transfer unit 12. As shown in FIG. 4A, the contact member 40 as the positioning means 4 is set at a position where the end portion (opening 94a) of the sheath 94 held by the support means 3 is to be located.

  Then, as shown in FIG. 4B, the end portion (opening 94a) of the sheath 94 to be conveyed comes into contact with the contact surface 40a. Recognize that the position is correct and stop the transfer operation. Simultaneously with this contact, the nozzle portion 60 of the lubricant supply means 42 protruding from the contact surface 40a of the contact member 40 is inserted into the inside from the sheath opening 94a.

  Next, as shown in FIG. 4C, the grip portion 32 </ b> A constituting the support means 3 grips the sheath outer peripheral surface, and the sheath 94 is fixed to the support means 3. Thus, since positioning is performed by the positioning means 4 when supporting the sheath, the sheath 94 can be supported at an accurate position. During this time, the holding means 11 of the handling means 1 maintains the state of holding the sheath 94, and the contact member 40 also maintains the same position.

  When the sheath 94 is fixed to the support unit 3 in a stable state, the lubricant is discharged into the sheath through the nozzle portion 60 by the lubricant supply unit 42. The step of positioning and supporting the sheath in this way includes a step of supplying a lubricant.

  4D, the sheath 94 is cut at a predetermined position in the axial direction by the cutting means 2 while the sheath is held by the holding means 11, and set to a suitable length. When the sheath is cut in this way and the discharge of the lubricant is finished, the contact member 40 is retracted from the position on the sheath axis as shown in FIG. 4 (e) and supported as shown in FIG. 4 (f). The means 3 rotates around the axis while the sheath 94 is fixed. By rotating the support means 3, the sheath 94 is also rotated around the axis, and the balloon catheter main body 90 is inserted into the rotating sheath 94 to attach the sheath 94 to the balloon winding portion 93. Is done. The rotation direction of the sheath 94 may be the same direction as the balloon winding direction, but it is also preferable that the sheath 94 be configured so as to be able to perform operations such as changing or stopping the rotation speed as appropriate.

  The balloon catheter main body 90 may be inserted by automatic control by providing a balloon catheter main body feed mechanism or the like, or may be manually performed. Further, in this example, the sheath 94 is configured to be rotatable about the axis, but in addition to the rotation of the sheath 94, or instead of a mechanism for rotating the sheath 94 (without rotating the sheath 94), A mechanism for rotating the balloon catheter body may be provided. Of course, the sheath 94 may not be rotated, and the balloon catheter body may be manually inserted while rotating. Further, in this example, the sheath 94 is cut after the sheath 94 is supported by the support means 3, but the sheath 94 can be cut before being supported.

  The embodiment of the present invention has been described above, but the present invention is not limited to such an example. For example, the holding means 11 of the handling means 1 is configured to also serve as the support means 3 (gripping means 32). Of course, the present invention can be implemented in various forms without departing from the scope of the present invention.

DESCRIPTION OF SYMBOLS S Manufacturing apparatus 1 Handling means 2 Cutting means 3 Support means 4 Positioning means 10 Posture recognition means 11 Holding means 12 Conveying means 20 Cutting blade 21 Moving mechanism 30 Rotating frame 31 Driving means 32 Holding means 32A Holding part 32B Base part 40 Contact Member 40a Contact surface 41 Moving mechanism 42 Lubricant supply means 50 Frame 51 Frame 52 Small gear 53 Fixed blade 54 Contact surface 55 Diaphragm blade 56 Roller 60 Nozzle portion 61 Lubricant supply portion 90 Balloon catheter body 91 Balloon 92 Catheter tube 93 Balloon winding part 94 Sheath 94a Opening part 95 Core material

Claims (17)

A balloon catheter manufacturing apparatus for covering a balloon winding portion of a balloon catheter body with a sheath having a length suitable for the length of the winding portion,
Handling means for taking out one of the plurality of sheaths;
Cutting means for cutting the sheath at a predetermined position in the axial direction and setting the appropriate length;
Support means capable of supporting the sheath to be cut in an open state without closing at least one end opening into which the balloon catheter body is inserted;
An apparatus for manufacturing a balloon catheter in which the sheath can be attached to the balloon winding part by inserting the balloon catheter body into the sheath cut by the cutting means and supported by the support means. The handling means is
Posture recognition means for recognizing the posture of the sheath;
Holding means for holding a predetermined part of the sheath based on the posture of the sheath recognized by the posture recognition means;
The balloon catheter manufacturing apparatus according to claim 1, further comprising a conveying unit configured to convey the sheath while being held by the holding unit. The support means includes a gripping means for gripping a predetermined portion of the sheath conveyed by the handling means;
The part held by the holding means is a part excluding the predetermined part gripped by the gripping means,
The balloon catheter manufacturing apparatus according to claim 2, wherein the sheath is directly delivered to the support means by the handling means. The gripping means is
The balloon catheter manufacturing apparatus according to claim 3, further comprising a grasping portion that grasps an outer peripheral surface of the sheath.   The balloon catheter manufacturing apparatus according to any one of claims 1 to 4, further comprising positioning means for positioning a sheath supported by the supporting means.   The balloon catheter manufacturing apparatus according to claim 5, wherein the positioning unit includes a contact unit that contacts and positions the end of the sheath when supported by the support unit.   The balloon catheter manufacturing apparatus according to claim 6, wherein the positioning means is provided with a lubricant supply means for supplying a lubricant into the inside from the abutted sheath end.   The balloon catheter manufacturing apparatus according to claim 7, wherein the lubricant supply means is inserted into the inside from the opening of the abutted sheath end and projects a nozzle portion for discharging the lubricant.   The balloon catheter manufacturing apparatus according to any one of claims 1 to 8, wherein the support means supports the sheath so as to be rotatable about an axis of the sheath. The support means comprises
A rotating frame that rotates about its axis;
Drive means for rotationally driving the rotary frame;
The balloon according to claim 9, further comprising: gripping means that is provided on the rotating frame and grips a predetermined portion of the sheath conveyed on the central axis of the rotating frame and rotates integrally with the rotating frame. An apparatus for manufacturing a catheter.   The balloon catheter manufacturing apparatus according to any one of claims 1 to 10, wherein the cutting means cuts a predetermined axial position of the sheath in a state of being supported by the support means. A balloon catheter manufacturing method for covering a balloon winding portion of a balloon catheter body with a sheath having a length suitable for the length of the winding portion,
Removing one of the plurality of sheaths;
Cutting the sheath at a predetermined position in the axial direction, and setting the suitable length;
Supporting the sheath before or after the cutting step;
A step of inserting the balloon catheter body and attaching the sheath to the balloon winding portion with respect to the sheath which is set to the appropriate length and is supported in a state where the one end opening is opened;
A method for manufacturing a balloon catheter. The step of taking out the one sheath comprises:
Recognizing the posture of the sheath;
Holding a predetermined portion of the sheath based on the recognized posture of the sheath;
The method of manufacturing a balloon catheter according to claim 12, further comprising a step of conveying the sheath while holding the sheath.   The method for manufacturing a balloon catheter according to claim 12 or 13, wherein the step of supporting the sheath includes a step of positioning the sheath to be supported.   The method of manufacturing a balloon catheter according to claim 14, wherein the positioning step includes positioning an end of the sheath in contact with a contact means when the sheath is supported in the step of supporting the sheath.   The balloon catheter manufacturing method according to claim 15, wherein the positioning step includes a step of supplying a lubricant from a sheath end portion in contact with the contact means.   The step of attaching the sheath rotates the sheath supported with the opening of the one end opened around the axis of the sheath, and the balloon catheter body with respect to the rotating sheath The method for manufacturing a balloon catheter according to any one of claims 12 to 16, which is a step of inserting a sheath into the balloon winding portion.

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