JP2013202068A - Valve body for medical device, medical device and manufacturing method of valve body for medical device - Google Patents

Valve body for medical device, medical device and manufacturing method of valve body for medical device Download PDF

Info

Publication number
JP2013202068A
JP2013202068A JP2012070787A JP2012070787A JP2013202068A JP 2013202068 A JP2013202068 A JP 2013202068A JP 2012070787 A JP2012070787 A JP 2012070787A JP 2012070787 A JP2012070787 A JP 2012070787A JP 2013202068 A JP2013202068 A JP 2013202068A
Authority
JP
Japan
Prior art keywords
valve body
portion
medical device
insert
formed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP2012070787A
Other languages
Japanese (ja)
Other versions
JP5928064B2 (en
Inventor
Yuta Narumi
雄太 鳴海
Atsushi Ogawa
篤志 小川
Original Assignee
Kaneka Corp
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaneka Corp, 株式会社カネカ filed Critical Kaneka Corp
Priority to JP2012070787A priority Critical patent/JP5928064B2/en
Publication of JP2013202068A publication Critical patent/JP2013202068A/en
Application granted granted Critical
Publication of JP5928064B2 publication Critical patent/JP5928064B2/en
Application status is Active legal-status Critical
Anticipated expiration legal-status Critical

Links

Images

Abstract

PROBLEM TO BE SOLVED: To provide a valve body for a medical device, which has a liquidtight property to a fluid such as a contrast medium, saline or blood at all times, and is capable of improving the liquidtight property and setting sliding resistance with an insert such as guide wire small, and to provide the medical device and a manufacturing method of the valve body for the medical device.SOLUTION: In a valve body 30 disposed in a body lumen part in a Y connector, at an insertion part 34 of the valve body to which an insert is to be inserted, a cut part 35 having a width extending from the insertion center of the insert to the outer side of a radial direction over the entire length extending from a distal end side to a proximal end side is formed. For at least a partial surface of the inner surface of the cut part 35, the minimum angle θ at which a plane in contact with the partial surface and the axial direction CL of the insertion center cross is set to be 0°<θ<90°.

Description

  The present invention relates to a medical device valve body incorporated in a medical device such as a Y adapter, a catheter, and a sheath introducer, a medical device, and a method for manufacturing the medical device valve body.

  Currently, a method using a catheter or the like is known as a diagnosis / treatment method with less invasiveness to an intravascular lesion. In order to prevent blood from being lost outside the body, a valve body for preventing blood backflow is incorporated in the Y connector, catheter, sheath introducer and the like used in this endovascular treatment method.

  A Y connector is known as one of the medical devices having the valve body. For example, as described in Patent Document 1, a Y-shaped cylindrical main body member, a catheter connection part, a syringe, or a three-way stopcock connection part A cap member provided on the base end side (proximal side) of the cylindrical main body member and a valve body assembled in the cylindrical main body member have been proposed.

  A slit for allowing a long member such as a guide wire to be inserted and removed in a liquid-tight manner is formed in the central portion of the valve body, and an injection solution from a syringe connected to a Y connector, Y It is configured such that a contrast medium, physiological saline, blood or the like in the connector does not flow out of the Y connector from the gap between the valve body and the guide wire.

  As the slit, there has been proposed a slit formed so that a cross section orthogonal to the center line of the valve body is a single letter, a crossed letter, or a Y shape and extends linearly along the center line of the valve body (for example, Patent Documents). 2). Further, Patent Document 1 has a width extending in the radial direction from the center line of the valve body, an arc-shaped first slit extending from one surface side of the valve body to the inside of the valve body, and the center line of the valve body And a second arcuate slit extending from the other surface side of the valve body to the inside of the valve body, the center line of the valve body so that both slits intersect in the valve body A valve body has been proposed in which both slits are arranged at an angle with respect to the circumferential direction.

  On the other hand, as the cylindrical main body member, an annular stepped portion having a tapered surface whose diameter is reduced toward the distal side is formed in the middle portion, and a small diameter portion is disposed further to the distal side than the stepped portion, and the proximal side. The valve body is formed with a tapered portion at the distal side and the proximal side, and a through hole having a diameter larger than the outer diameter of the guide wire is formed at the central portion. A Y-connector made of is put to practical use. In this Y connector, the cap member is screwed onto the cylindrical main body member, and by tightening the cap member, the valve body is pressed against the stepped portion at the tip of the cap member, and the valve body is elastically reduced in the diameter reducing direction. By deforming, closing the through hole of the valve body, and loosening the cap member, the valve body is elastically returned in the diameter increasing direction so that the through hole of the valve body can be opened.

  However, in this Y connector, when the valve body is not elastically deformed in the direction of diameter reduction by the cap member, a fluid such as a contrast medium, physiological saline, or blood flows out of the Y connector from the outer peripheral portion of the valve body. was there. For example, when the Y connector is applied to a single lumen balloon catheter, the following problems occur. That is, in a single lumen balloon catheter, a long member such as a guide wire is inserted into the lumen of the catheter, the tip is sealed, and then the balloon is expanded by injecting a balloon expansion solution mixed with a contrast agent. At the same time, it is configured so that visibility under X-rays can also be obtained. However, when the Y connector is applied to this single lumen balloon catheter, blood flows into the catheter lumen by blood pressure when the seal of the balloon catheter tip is released while the valve body of the Y connector is opened. If the tip of the balloon catheter is sealed again and the balloon is expanded, the blood that has flowed into the catheter lumen flows into the balloon, and the visibility of the balloon decreases due to the blood flowing in, so there is a high risk of damaging the blood vessel. Problem arises.

International Publication No. 2009/091018 Pamphlet JP 2005-87574 A

  By the way, in the valve body of the said patent documents 1 and 2, in the state which has not inserted inserts, such as a guide wire, in the slit, the inner surface of a slit closely_contact | adheres without a gap, and a valve body hold | maintains liquid-tight. In addition, in the state where the insert is inserted into the slit, the valve body is held in a liquid-tight state by closely contacting the inner surface of the slit with the outer surface of the insert, so that regardless of whether a guide wire is inserted or not. This has the advantage that the valve body can be kept liquid-tight at all times.

  However, since the present inventor forms the slit along the axial direction of the insertion center of the insert even in the valve body described in Patent Documents 1 and 2, the tubular body is formed on the distal side of the valve body. In the direction of separating the inner surface of the slit from the insert at the outlet side end of the insert from the slit of the valve body by the fluid pressure of the contrast medium, physiological saline or blood filled in the main body member It was found that the liquid tightness between the inner surface of the slit and the insert was lowered due to the above-mentioned force. In order to prevent liquid leakage due to this decrease in liquid tightness, the slit length is inevitably long, and the sliding resistance of the valve body with respect to the insert such as a guide wire is increased, and the operability of the insert is reduced. I found that there is a problem.

  It is an object of the present invention to always have liquid tightness to a fluid such as a contrast medium, physiological saline or blood, and to improve the liquid tightness and to set a sliding resistance with an insert such as a guide wire. A medical device valve body, a medical device, and a method for manufacturing a medical device valve body are provided.

The medical device valve body according to the present invention is a medical device valve body disposed in a fluid passage in a medical device, and the valve body includes an insertion portion into which an insert is inserted. A notch having a width extending radially outward from the insertion center of the insert over the entire length of the insert extending from the distal side to the proximal side. At least a part of the inner surface satisfies the following conditional expression (1).
0 ° <θ <90 ° (1)
However, θ: At least a part of the inner surface has an angle toward the proximal side when viewed from the distal side of the shaft into which the insert is inserted, and is a plane in contact with the part of the surface And the minimum angle that intersects the axial direction of the insertion center. In addition, in this specification, an insert means the thing which can be inserted in a notch part, Needless to say long members, such as a guide wire, shall also include short members, such as an injection needle.

  In this valve body, when an insert such as a guide wire is not inserted into the notch, the inner surface of the notch is brought into close contact with the gap so that the valve is held in a liquid-tight state. Is inserted into the notch, the inner surface of the notch closely contacts the outer surface of the insert without any gaps, so that the valve body is held in a liquid-tight state. It can be kept liquid-tight at all times. Moreover, since at least a part of the inner surface of the cut portion is arranged to intersect at an angle θ of 0 ° to 90 ° with respect to the axial direction of the insertion center, the fluid passage on the distal side of the valve body The distal portion of the notch in the valve body is pushed in the direction in which it is pressed against the insert by the fluid pressure inside, and the axial direction of the insertion center, that is, the incision having an angle θ of 0 ° is simply formed. Compared with this valve body, the liquid tightness between the insert and the valve body is enhanced. In addition, since the liquid tightness is improved in this way, the length of the insertion portion in the valve body can be set short, the sliding resistance of the valve body with respect to the insert can be reduced, and the operability of the insert can be improved.

  Here, it is preferable that the shape of the cut portion in the cross section with respect to the axial direction of the insertion center is changed at a plurality of locations in the axial direction, and the change is a plurality of locations in the axial direction. In a preferred embodiment, the shape of the notch is to rotate around the axial direction or to change the deviation distance from the axial direction. Note that the cut portion having a cross-sectional shape that rotates about the axial direction has, for example, a width extending radially outward from the insertion center of the insert, and spirally along the center line of the insertion center. It means a belt-shaped cut section that circulates. And when such a cut portion is formed, the section of the insert portion formed by the cut portion expands and contracts along the outer shape of the insert, so the gap between the insert and the inner surface of the cut portion is reduced. The liquid tightness can be further improved.

  Further, it is preferable that the cut portion changes at least a part of the entire length in a non-linear manner, and the non-linear shape means that the insertion portion is moved from the proximal side to the distal side in the full length of the insertion portion. It means that the approach angle of the cut portion with respect to the insertion portion is partially different in the entire length of the cut portion.

  Further, the cut portion extends in a curved shape or a straight shape from the insertion center of the insert toward the outside, and the cut portion is centered on the insertion center of the insert. It is a preferred embodiment that a plurality of slits are formed at intervals in the circumferential direction, and a plurality of types of slits having different widths as the slits are formed.

  Furthermore, the fluid passage of the medical device has an annular stepped portion formed in the middle thereof, a small diameter portion formed distal to the stepped portion, and a large step formed proximal to the stepped portion. And a taper that forms a cylindrical portion fitted into the large-diameter portion on the proximal side of the valve body, and decreases in diameter toward the distal side of the valve body. Forming a cut-out portion at the distal portion of the taper portion with the center line of the taper portion as the insertion center, and disposing an annular seal portion that can be pressed against the step portion on the outer peripheral portion of the taper portion It is preferable to form in a protruding shape toward the side. In this case, the sealing portion of the valve body is brought into pressure contact with the step portion of the fluid passage, so that the seal portion and the step portion can be reliably sealed in a liquid-tight manner, and the valve body is elastic in the reduced diameter direction. The cut portion can be reliably sealed in a liquid-tight manner by being deformed.

  Here, it is a preferred embodiment that the inner peripheral surface of the seal portion is configured with a tapered surface that increases in diameter toward the distal side. In this case, it is possible to effectively prevent the valve body from moving over the stepped portion and moving toward the small diameter portion by being pressed against the stepped portion and deformed inward.

  The medical device according to the present invention is formed by fitting the valve body for medical device into a fluid passage and closing the fluid passage. In this medical device, the fluid passage can always be closed in a liquid-tight manner by the valve body, and the liquid-tightness at the incision is increased, so that the length of the incision is shortened while ensuring the liquid-tightness. The sliding resistance of the insert can be reduced, and the operability of the insert can be improved.

  A method for manufacturing a valve body for a medical device according to the present invention is a method for manufacturing a valve body for a medical device that is disposed in a fluid passage of the medical device, and an insert of the valve body formed of an elastic material is provided. The insertion portion to be inserted includes a cutting step for forming a cutting portion using a processing tool, and in the cutting step, the processing tool has a width extending radially outward from the rotation center axis. , Using a processing tool provided with a strip-shaped cutting blade that spirally circulates along the central axis of rotation, and feeding the rotary tool while rotating the processing tool, the insertion portion of the valve body over its entire length To form. In this manufacturing method, as the cut portion, a band-shaped cut portion having a width extending radially outward from the insertion center of the insert and spirally wound along the insertion center may be formed. it can.

  According to the valve body for a medical device according to the present invention, in a state where an insert such as a guide wire is not inserted into the cut portion, the inner surface of the cut portion is in close contact with the gap portion, so that the valve body is liquid tight. In the state where the insert is inserted into the cut portion, the valve body is held in a liquid-tight state by closely contacting the inner surface of the cut portion with the outer surface of the insert without any gap. Regardless of the presence or absence of the valve, the valve body can be kept liquid-tight at all times. Moreover, since at least a part of the inner surface of the cut portion is arranged to intersect at an angle θ of 0 ° to 90 ° with respect to the axial direction of the insertion center, the fluid passage on the distal side of the valve body The distal portion of the notch in the valve body is pushed in the direction in which it is pressed against the insert by the fluid pressure inside, and the axial direction of the insertion center, that is, the incision having an angle θ of 0 ° is simply formed. Compared with this valve body, the liquid tightness between the insert and the valve body is enhanced. In addition, since the liquid tightness is improved in this way, the length of the insertion portion in the valve body can be set short, the sliding resistance of the valve body with respect to the insert can be reduced, and the operability of the insert can be improved.

FIG. 1 is a longitudinal sectional view of a Y connector of the valve body of the present invention. FIG. 2 is a perspective view of the valve body of the present invention. 3A is a left side view of the valve body of the present invention, FIG. 3B is a left side view of the valve body of the present invention, and FIG. 3C is a right side view of the valve body of the present invention. is there. FIG. 4 is a longitudinal sectional view of the valve body of the present invention. 5A is a cross-sectional view taken along the line aa in FIG. 4, FIG. 5B is a cross-sectional view taken along the line bb in FIG. 4, and FIG. 5C is a cross-sectional view taken along the line cc in FIG. Fig.6 (a) is a front view of the notch part of the valve body of this invention, FIG.6 (b) is a top view of the notch part of the valve body of this invention. Fig.7 (a) is a front view of the processing tool for processing the notch part of the valve body of this invention, FIG.7 (b) is a top view of the processing tool. FIG. 8 is a perspective view of a slit of a valve body having another configuration of the present invention. FIG. 9A is a perspective view of a slit of a valve body having another configuration of the present invention, and FIG. 9B is a plan view of the slit. FIG. 10A is a perspective view of a slit of a valve body having another configuration of the present invention, and FIG. 10B is a plan view of the slit.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
FIG. 1 is a cross-sectional view of a Y connector 1 incorporating a valve body 30 according to the present invention. In the present embodiment, the Y connector 1 shown in FIG. 1 is used as a reference, and the left side in FIG. 1 is defined as “distal side” and the right side is defined as “proximal side”.

  As shown in FIG. 1, the Y connector 1 is used by connecting a hub or the like of the catheter 2 and the catheter connecting portion 4, for example. As a result, an insert 3 made of a long member such as a guide wire can be inserted into the catheter 2 through the Y connector 1.

  The Y connector 1 includes a Y-shaped cylindrical main body member 10, a catheter connecting portion 4 provided at the distal end (distal side) of the cylindrical main body member 10, and a proximal end side (proximal) of the cylindrical main body member 10. And a valve body 30 incorporated in the cylindrical main body member 10. Hereinafter, the structure of each part is demonstrated.

  As shown in FIG. 1, a Y-shaped cylindrical main body member 10 includes a tubular main body portion 11 that penetrates from the distal end to the proximal end, and a tubular branch portion 12 that branches obliquely from a middle portion of the main body portion 11. A connecting portion 13 for connecting a syringe or a three-way stopcock is formed at the outer end portion of the branching portion 12, and a male portion for attaching the cap member 20 to the outer peripheral portion of the base end portion of the main body portion 11. A screw 14 is formed.

  A main body lumen portion 15 is formed in the main body portion 11, and a branch lumen portion 16 communicating with the main body lumen portion 15 is formed in the branch portion 12, and supplied to the branch lumen portion 16 by a syringe or a three-way cock. The contrast medium and physiological saline thus prepared are configured to be injected into the catheter 2 connected to the Y connector 1 through the branch lumen 16 and the main body lumen 15 on the distal side of the valve body 30. The Y connector 1 corresponds to a medical device, and the main body lumen 15 corresponds to a fluid passage of the medical device.

  The main body cavity portion 15 includes an annular step portion 15a formed in a middle portion on the proximal side of the communication portion of the branch lumen portion 16 and having a tapered surface with a diameter reduced toward the distal end side, and a step portion 15a. Also has a small-diameter portion 15b formed on the distal end side (distal side) and a large-diameter portion 15c formed on the proximal end side (proximal side) with respect to the stepped portion 15a.

  The cap member 20 includes a cap main body 22 in which a female screw 21 that is screwed into the male screw 14 of the main body portion 11 is formed, and a cylindrical operation cylinder portion 23 that protrudes from the center portion of the cap main body 22 toward the distal end side. The operation cylinder portion 23 is fitted into the large diameter portion 15 c of the main body lumen portion 15, and the female screw 21 is screwed into the male screw 14 of the cylindrical main body member 10, thereby being assembled to the cylindrical main body member 10. ing.

  The valve body 30 is liquid-tightly fitted into the large-diameter portion 15 c of the main body lumen portion 15 on the distal end side of the operation cylinder portion 23, and the screwing amount of the female screw 21 of the cap member 20 with respect to the male screw 14 of the main body portion 11. Accordingly, it is configured such that the distal end portion of the operation cylinder portion 23 is pushed to the distal end side of the large diameter portion 15c. Further, the movement of the valve body 30 toward the distal end side is restricted by the step portion 15a, so that the valve body 30 is not pushed out into the small diameter portion 15b. Furthermore, when the valve body 30 is pressed against the step portion 15a, the outer peripheral portion of the valve body 30 and the main body lumen 15 are held in a liquid-tight state, and the valve body 30 is held by the tapered surface of the step portion 15a. It is comprised so that it may compress-deform in a diameter reducing direction.

  An insert 3 such as a guide wire is inserted into the through hole 24 of the operation tube portion 23 and introduced into the Y connector 1, and passes through the cut portion 35 of the valve body 30 and the small diameter portion 15 b of the body lumen portion 15. And inserted into the catheter 2 connected to the Y connector 1. And the state which inserted the insert 3 in the valve body 30 also in the state which loosened the screwing of the cap member 20 by always inserting the insert 3 in the notch part 35 of the valve body 30 in the liquid-tight state. Thus, the distal end side and the proximal end side of the main body lumen portion 15 are always partitioned in a liquid-tight manner via the valve body 30. However, when the cap member 20 is tightened, the outer peripheral portion of the valve body 30 is pressed against the stepped portion 15a, and the valve body 30 is compressed and deformed in the direction of diameter reduction, so that the inner surface of the valve body 30 is pressed strongly against the insert 3. Therefore, the movement of the insert 3 is restricted, and even when a large fluid pressure acts on the distal end side of the main body lumen portion 15, the space between the outer peripheral portion of the valve body 30 and the rear portion 15 in the main body is liquid-tight. While being held, the space between the insert 3 and the valve body 30 is held in a liquid-tight manner. The fluid pressure acting on the distal end side of the main body lumen 15 includes blood pressure received from the distal end side of the Y connector 1 and fluid injection pressure from a syringe connected to the Y connector 1.

  In addition, as a raw material of the cylindrical main body member 10 and the cap member 20, various synthetic resins such as polyvinyl chloride, polyethylene, polypropylene, polycarbonate, acrylic resin, and polyamide can be suitably used, but the material is not limited thereto. Absent.

Next, a specific configuration of the valve body 30 will be described.
As shown in FIGS. 1 to 6, the valve body 30 is connected to a cylindrical tube portion 31 that fits in a liquid-tight manner in the large-diameter portion 15 c of the main body lumen portion 15, and a distal end portion of the tube portion 31. A tapered portion 32 that decreases in diameter as it goes to the distal end of the valve body 30 that protrudes toward the distal end of the main body lumen 15, a guide wire that is formed inside the cylindrical portion 31 and the tapered portion 32, etc. The guide hole 33 having a diameter larger than that of the insert 3, the notch 35 formed in the insertion portion 34 at the tip of the tapered portion 32 into which the insert 3 is inserted, and the outer periphery of the taper 32 toward the distal side And an annular seal portion 36 formed in a protruding shape. However, the configuration of the valve body 30 can be changed as appropriate according to the configuration of the Y connector 1 to be applied. For example, a disc-shaped valve body can be adopted.

  As a material constituting the valve body 30, various rigid rubbers such as silicone rubber, urethane rubber, fluorine rubber, and acrylic rubber, natural rubber, or elastic materials such as various thermoplastic elastomers such as polyamide and polyester can be adopted. .

  The outer diameter of the valve body 30 is formed to be larger than the large diameter portion 15c of the main body lumen portion 15, and the valve body 30 is fitted into the large diameter portion 15c while compressing the valve body 30 in the diameter reducing direction. The liquid-tightness between the large-diameter portion 15c is obtained.

  A first tapered surface 32a is formed on the distal end side of the tapered portion 32, and a second tapered surface 32b having a larger angle with the center line than the first tapered surface 32a is formed on the proximal end side of the tapered portion 32. Yes. The insertion portion 34 at the distal end portion of the tapered portion 32 is formed with a cut portion 35 through which the insert 3 can be inserted, and the valve element is caused by the fluid pressure acting on the distal end side of the body lumen portion 15 by the first tapered surface 32a. 30 is pushed in the center direction. The cut portion 35 provided in the valve body 30 is also closed by these pressures, and the liquid tightness of the Y connector 1 is maintained.

  The second taper surface 32b formed on the proximal end side of the valve body 30 is formed so that the angle with respect to the center line is the same as the taper surface of the step portion 15a of the body lumen portion 15, and the cap member 20 is tightened. At this time, the valve body 30 is configured to be prevented from being pushed out toward the distal end side of the main body lumen portion 15.

  The inner peripheral surface of the seal portion 36 is formed with a taper surface that increases in diameter as it goes to the distal end side, whereby the seal portion 36 is subjected to the fluid pressure acting on the distal end side of the main body lumen portion 15 and the inner surface of the large diameter portion 15c. Therefore, the fluid such as the contrast medium or the physiological saline from the outer peripheral surface of the valve body 30 can be prevented from flowing out.

  As shown in FIGS. 4 to 6, the insertion portion 34 at the distal end portion of the valve body 30 extends in the radial direction from the insertion center of the insert 3 over the entire length from the distal end side to the proximal end side of the insertion portion 34. A notch 35 having a width W extending outward is formed, and at least a part of the inner surface of the notch 35 has a plane in contact with the part and a direction of the center line CL of the insertion center (valve element). The minimum angle θ intersecting with the direction of the center line of 30 is configured to satisfy 0 ° <θ <90 °.

  Specifically, as shown in FIG. 6, a band-shaped 2 having a width W extending radially outward from the insertion center of the insert 3 and spirally wrapping around the center line CL of the insertion center. The notches 35 can be provided on both sides in the radial direction with the insertion center interposed therebetween. FIG. 5 is a cross-sectional view taken along the lines aa, bb, and cc of FIG. 6, and the inner surface of the cut portion 35 is always closed in a natural state, and the cross section is formed in a single character. Has been.

  The dimension of the width W of the notch 35 is not particularly limited, but is preferably set according to the outer diameter of the insert 3, for example, a guide used for introducing a guide wire into the Y connector 1 as the insert 3. When the wire inserter is used, if the maximum outer diameter is 0.9 mm, damage to the cut portion 35 due to the insert 3 can be suppressed by setting the width W to 0.45 mm or more. Note that as the width W is set larger, the slidability is improved.

  The cut portion 35 having a shape as shown in FIG. 6 can be processed using, for example, a drill-like processing tool 40. Specifically, as shown in FIG. 7, as the processing tool 40, two strip-shaped cuts having a width extending radially outward from the rotation center RC and spirally wound along the rotation center RC. The thing provided with the blade 41 is used. The machining tool 40 and the valve body 30 are arranged on the same axis, and the feeding operation is performed while rotating the machining tool 40 to form the cut portion 35 over the entire length of the insertion portion 34 of the valve body 30, and then the machining tool 40 is reversed. The cutting part 35 is formed by pulling out the processing tool 40 from the insertion part 34 of the valve body 30 while rotating. You may form similarly by rotating a valve body instead of a processing tool. More specifically, by inserting the processing tool 40 into the insertion portion 34, the valve body 30 formed of an elastic material is stretched along with the insertion of the processing tool 40. Then, when the processing tool 40 is gradually advanced, the valve body 30 is torn while being in close contact with the shape of the processing tool 40, thereby forming the cut portion 35. Further, since the cut portion 35 formed in the stretched state contracts in the center direction of the valve body 30 by elasticity when the processing tool 40 is pulled back, the cut portion which is closed in the natural state as shown in FIG. A portion 35 is formed.

  Note that a silicone layer may be formed on the inner surface of the cut portion 35 by adding silicone oil when the cut portion 35 of the valve body 30 is processed. In this case, the slidability of the insert 3 with respect to the cut portion 35 is improved by forming a silicone layer having a small friction coefficient on the inner surface of the cut portion 35. Moreover, since the clearance gap between the inner surfaces of the notch part 35 becomes dense with a silicone layer, the liquid-tightness in the notch part 35 can be improved. Further, it is also preferable that a sharpened portion is formed in a protruding shape at the distal end portion of the processing tool 40 and the insertion portion 34 made of an elastic material is compressed and deformed to make a cut. Further, the shape in which the four cut portions 35 as shown in FIG. 8 are arranged in a cross shape, the shape in which the three cut portions 35 are arranged in a Y shape, etc. It can process similarly to the above using the processing tool which has a cutting blade of a size.

  In addition, since the slidability varies depending on the material, outer diameter, and hardness of the long member inserted into the medical device in which the valve body 30 is incorporated, the outer diameter of the processing tool 40 and the axial direction of the insertion center of the cut portion 35 are different. By adjusting the length, the same actions and effects as in the embodiment can be obtained.

  Note that the shape of the cut portion 35 in a cross section orthogonal to the center line CL of the insertion center can be formed not only in a straight line but also in a non-linear shape such as a curved line. Further, the number of the cut portions 35 can be arbitrarily set, and can be formed only one, or three or more can be provided at intervals in the circumferential direction around the center line CL of the insertion center. it can. For example, as shown in FIG. 8, four notches 35 are formed at intervals of 90 ° in the circumferential direction, and the shape of the notches 35 in a cross section perpendicular to the center line of the insertion center is a cross shape. Can be formed. Furthermore, in the case of forming a plurality of cut portions 35, the width W of the cut portions 35 can be set to be the same, but the cut portions 35 having different widths are provided, and the separation distance from the center line CL is increased. It can also be configured to change. Furthermore, the minimum angle θ at which at least a part of the inner surface of the cut portion 35 intersects the plane in contact with the part and the direction of the center line CL of the insertion center is 0 ° <θ <90. It is possible to form a cut portion having an arbitrary shape as long as the cut portion 35 is formed at the position where the cut portion 35 is formed in the insertion portion 34 of the valve body 30. Instead, for example, a triangular wave-shaped cut portion 35A or a sine wave-shaped cut portion 35B as shown in FIGS. 9 and 10 can be formed. In addition, in the cut portions 35A and 35B, the divergence distance EL from the center line CL changes, and the approach angle with respect to the center line CL changes. In addition, as shown in FIG. 9B and FIG. 10B, “the deviation distance EL changes” means that the shapes of the cut portions 35A and 35B in the cross section with respect to the center line CL of the insertion center are as follows. This means that the deviation distance EL from the center line CL is changed at a plurality of locations in the direction of the center line CL. In addition, as shown in FIGS. 9 and 10, “the entry angle changes” means that the notches 35A and 35B have an entry angle without being along the direction of the center line CL (not 0 °). It means that the approach angle is changed at a plurality of locations in the direction of the center line CL in the cut portions 35A and 35B. For example, the approach angle is alternately changed like the cut portion 35A shown in FIG. 9, or the approach angle is continuously changed like the cut portion 35B shown in FIG.

  In the valve body 30 in which the cut portion 35 having such a configuration is formed, the inner surface of the cut portion 35 is always closed in a natural state, and the shape of the cut portion 35 is complicated. Or, fluid such as blood is less likely to flow out of the Y connector 1 through the notch 35. Further, with the insert 3 inserted into the notch 35, the inner surface of the notch 35 is pressed against the outer surface of the insert 3 by the elasticity of the material constituting the valve 30. Liquid tightness between the inserts 3 is maintained. Moreover, since the minimum angle θ is set to 0 ° <θ <90 °, the tip side portion of the notch 35 in the valve body 30 is caused by the fluid pressure in the body lumen 15 on the tip side of the valve body 30. Is pushed in the direction pressed against the insert 3, and the insert 3 and the valve body 30 are simply compared with the conventional valve body 30 in which an axial direction of the insertion center, that is, a cut having a minimum angle θ of 0 ° is formed. The liquid tightness between the two will be improved. In addition, since the liquid tightness is improved in this way, the length of the cut portion 35 in the center line direction can be set short to reduce the sliding resistance of the valve body 30 with respect to the insert 3, and the operation of the insert 3 can be reduced. Can be improved. In addition, as in the case of the notch portion 35 shown in FIG. 6, when it is formed so as to spiral around the center line CL of the insertion center, the section of the insert portion 34 formed by the notch portion 35 becomes the notch. Since it expands / contracts along the outer shape of the insert 3 inserted into the portion 35, the gap between the inner surface of the insert 3 and the cut portion 35 can be reduced to further improve the liquid tightness.

  In the present embodiment, the case where the valve body 30 of the present invention is applied to the Y connector 1 has been described. However, the present invention is not limited to this, and medical devices such as sheath introducers, microcatheters, balloon catheters, and other catheters. The valve body 30 of the present invention can also be applied to the above. For example, when incorporated in a single lumen balloon catheter in which a lumen through which a balloon-expanding fluid containing a guide wire lumen and a contrast medium passes is used in combination, the valve body 30 causes blood from the living body to flow into the catheter lumen. Since it is suppressed, the visibility fall of the balloon under X-ray | X_line is suppressed.

  In addition to the long member such as a guide wire, a short object such as an injection needle or a fluid such as a drug solution can be inserted as the insert 3 depending on the medical device to be applied.

  Next, an evaluation test performed for confirming the effect of the valve body 30 will be described.

<Evaluation test 1>
An evaluation test on the axial length of the insertion center of the cut portion was performed as follows.

1. Valve body Three types of valve bodies having axial lengths of 0.5 mm, 1.0 mm, and 1.5 mm in the insertion center of the cut portion were made of silicone rubber. And the notch part was processed into the front-end | tip part of the valve body with the processing tool 40 with an outer diameter of 0.9 mm.

2. Valve performance evaluation The three types of produced valve bodies were assembled in the Y connector 1 and the Y connector 1 was filled with water, and then an internal pressure of 200 mmH 2 O was applied. While confirming the outflow of water from the Y connector 1 under water pressure, the presence or absence of water leakage when a guide wire having an outer diameter of 0.25 mm was inserted was confirmed. The results are shown in Table 1. However, a valve element that did not cause water leakage was indicated by “◯”, and a valve element that caused water leakage was indicated by “x”.

3. Evaluation of sliding property Three kinds of manufactured valve bodies are arranged in the Y connector 1 and a guide wire (polytetrafluoroethylene coating) having an outer diameter of 0.25 mm is inserted into the Y connector 1 so that the sliding property is tactile. And evaluated. The results are shown in Table 1. However, a valve element having a large sliding resistance is indicated by “x”, and a valve element having a small sliding resistance is indicated by “◯”.

<Evaluation Test Example 2>
An evaluation test on the machining diameter of the cut portion was performed as follows.

1. Valve body As the valve body, two kinds of valve bodies in which the cut portion 35 is formed using two kinds of machining tools having an outer diameter of 0.9 mm and 1.1 mm, and a machining tool having an outer diameter of 1.1 mm are used. Then, a total of three types of valve bodies, which were provided with silicone oil and formed a cut portion, were made of silicone rubber.

2. Valve performance evaluation The produced three types of valve bodies were arranged in the Y connector 1, and after filling the Y connector 1 with water, an internal pressure of 200 mmH 2 O was applied. While confirming the outflow of water from the Y connector 1 under water pressure, the presence or absence of water leakage when a guide wire having an outer diameter of 0.25 mm was inserted was confirmed. The results are shown in Table 2. However, the valve body where no water leak occurred is indicated by “◯”.

3. Sliding performance evaluation The Y connector 1 in which the prepared two types of valve bodies are arranged is filled with a mixed solution of physiological saline and contrast medium (volume ratio 1: 1), and a guide wire having an outer diameter of 0.35 mm is inserted. The sliding load was measured with a force gauge (manufactured by Nidec Symposium). The guide wire was slid 5 reciprocations at a speed of 10 mm / sec and a stroke of 20 mm, and the average value of each peak load at the time of pushing and pulling was measured. The results are shown in Table 2.

  From Table 1 and Table 2, it is confirmed that both the valve performance and slidability can be achieved by setting the axial length of the insertion center of the incision and the processing method according to the outer diameter of the catheter inserted into the Y connector 1 did.

DESCRIPTION OF SYMBOLS 1 Y connector 2 Catheter 3 Insert 4 Catheter connection part 10 Tubular main body member 11 Main body part 12 Branch part 13 Connection part 14 Male screw 15 Body cavity part 15a Step part 15b Small diameter part 15c Large diameter part 16 Branch lumen part 20 Cap member 21 Female screw 22 Cap body 23 Operation cylinder portion 24 Through hole 30 Valve body 31 Tube portion 32 Taper portion 32a First taper surface 32b Second taper surface 33 Guide hole 34 Insertion portion 35 Cut portion 36 Seal portion 35A Cut Part 35B Cutting part 40 Processing tool 41 Cutting blade

Claims (12)

  1. In the valve body for a medical device arranged in a fluid passage in the medical device,
    The valve body includes an insertion portion into which an insert is inserted,
    The insert includes a notch having a width extending radially outward from the insertion center of the insert over its entire length extending from the distal side to the proximal side,
    In the said notch part, the valve body for medical devices in which at least one surface of the inner surface of the notch part satisfy | fills the following conditional expression (1).
    0 ° <θ <90 ° (1)
    However,
    θ: At least a part of the inner surface has an angle toward the proximal side when viewed from the distal side in the axis in which the insert is inserted, and a plane in contact with the part of the surface; This is the minimum angle that intersects the axial direction of the insertion center.
  2.   The medical device valve body according to claim 1, wherein a shape of the cut portion in a cross section with respect to the axial direction of the insertion center changes at a plurality of locations in the axial direction.
  3.   3. The change is that the shape of the cut portion at a plurality of locations in the axial direction rotates around the axial direction or changes a deviation distance from the axial direction. The valve body for medical equipment as described.
  4.   The said cutting part is a valve body for medical devices of any one of Claims 1-3 which change at least one part in a full length non-linearly.
  5.   The non-linear shape means that the approach angle of the cut portion with respect to the insert portion is partially different in the full length of the cut portion from the proximal side to the distal side in the full length of the insert portion. The medical device valve body according to claim 4.
  6.   The said notch part is a valve body for medical devices of any one of Claims 1-5 extended in the said curved shape or linear shape toward the outer side from the insertion center of the said insert.
  7.   The valve body for a medical device according to any one of claims 1 to 6, wherein a plurality of the cut portions are formed at intervals in the circumferential direction around the insertion center of the insert.
  8.   The valve body for medical devices according to claim 7, wherein a plurality of types of cut portions having different widths as the cut portion are formed.
  9.   An annular stepped portion formed in the middle of the fluid passage of the medical device, a small-diameter portion formed distal to the stepped portion, and a large-diameter portion formed proximal to the stepped portion. A cylindrical portion fitted into the large-diameter portion is formed on the proximal side of the valve body, and a tapered portion that is reduced in diameter toward the distal side is formed on the distal side of the valve body. The cut portion is formed at the distal portion of the tapered portion with the center line of the tapered portion as the insertion center, and an annular seal portion capable of being pressed against the stepped portion on the outer peripheral portion of the tapered portion is directed to the distal side. The valve body for medical devices of any one of Claims 1-8 formed in the protruding shape.
  10.   The medical device valve body according to claim 9, wherein the valve body for a medical device is configured with a tapered surface whose diameter increases toward the distal side on an inner peripheral surface of the seal portion.
  11.   A medical device formed by fitting the valve body for medical device according to any one of claims 1 to 10 into a fluid passage and closing the fluid passage.
  12. A method for manufacturing a valve body for a medical device disposed in a fluid passage of the medical device,
    The insertion part into which the insert of the valve body formed of an elastic material is inserted includes a cutting process for forming a cutting part using a processing tool,
    In the cutting step, as the processing tool, using a processing tool having a band-shaped cutting blade having a width extending radially outward from the rotation center axis and spirally wound along the rotation center axis, A feed operation is performed while rotating the processing tool, and a cut portion is formed over the entire length of the insertion portion of the valve body.
    The manufacturing method of the valve body for medical devices characterized by the above-mentioned.
JP2012070787A 2012-03-27 2012-03-27 Medical device valve, medical device, and method for manufacturing medical device valve Active JP5928064B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2012070787A JP5928064B2 (en) 2012-03-27 2012-03-27 Medical device valve, medical device, and method for manufacturing medical device valve

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2012070787A JP5928064B2 (en) 2012-03-27 2012-03-27 Medical device valve, medical device, and method for manufacturing medical device valve

Publications (2)

Publication Number Publication Date
JP2013202068A true JP2013202068A (en) 2013-10-07
JP5928064B2 JP5928064B2 (en) 2016-06-01

Family

ID=49521833

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2012070787A Active JP5928064B2 (en) 2012-03-27 2012-03-27 Medical device valve, medical device, and method for manufacturing medical device valve

Country Status (1)

Country Link
JP (1) JP5928064B2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016056376A1 (en) * 2014-10-08 2016-04-14 日本ライフライン株式会社 Chemical ablation device and chemical ablation system

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59133877A (en) * 1983-01-18 1984-08-01 Terumo Corp Valve element
JPH01139077A (en) * 1987-09-21 1989-05-31 Cordis Corp Valve for medical apparatus
JPH03114475A (en) * 1989-09-29 1991-05-15 Terumo Corp Medical valve disc, preparation thereof and catheter fitted with valve disc
JPH0528351U (en) * 1991-06-04 1993-04-16 株式会社トツプ The valve body
US5273546A (en) * 1991-08-01 1993-12-28 Medtronic, Inc. Hemostasis valve
US5409464A (en) * 1994-05-13 1995-04-25 Cordis Corporation Intravascular catheter having barrier valve
US5520655A (en) * 1994-07-15 1996-05-28 Cordis Corporation Catheter hemostasis valve
EP0771574A1 (en) * 1995-11-01 1997-05-07 Cordis Corporation Gasket for catheter hemostasis valve
JP2001149487A (en) * 1999-11-18 2001-06-05 Joline Gmbh & Co Kg Device for inserting objective in blood vessel of patient
JP2005503838A (en) * 2000-12-19 2005-02-10 キンバリー クラーク ワールドワイド インコーポレイテッド Improved sealing valve assembly for medical supplies
EP1920700A1 (en) * 2006-11-13 2008-05-14 Pentax Europe GmbH Seal element
US20100312190A1 (en) * 2009-06-09 2010-12-09 Oscor Inc. Low insertion force hemostasis valve for vascular introducer
JP2011510686A (en) * 2007-06-22 2011-04-07 メディカル コンポーネンツ,インコーポレイテッド Peelable sheath assembly with hemostatic valve

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59133877A (en) * 1983-01-18 1984-08-01 Terumo Corp Valve element
JPH01139077A (en) * 1987-09-21 1989-05-31 Cordis Corp Valve for medical apparatus
JPH03114475A (en) * 1989-09-29 1991-05-15 Terumo Corp Medical valve disc, preparation thereof and catheter fitted with valve disc
JPH0528351U (en) * 1991-06-04 1993-04-16 株式会社トツプ The valve body
US5273546A (en) * 1991-08-01 1993-12-28 Medtronic, Inc. Hemostasis valve
US5409464A (en) * 1994-05-13 1995-04-25 Cordis Corporation Intravascular catheter having barrier valve
US5520655A (en) * 1994-07-15 1996-05-28 Cordis Corporation Catheter hemostasis valve
EP0771574A1 (en) * 1995-11-01 1997-05-07 Cordis Corporation Gasket for catheter hemostasis valve
JP2001149487A (en) * 1999-11-18 2001-06-05 Joline Gmbh & Co Kg Device for inserting objective in blood vessel of patient
JP2005503838A (en) * 2000-12-19 2005-02-10 キンバリー クラーク ワールドワイド インコーポレイテッド Improved sealing valve assembly for medical supplies
EP1920700A1 (en) * 2006-11-13 2008-05-14 Pentax Europe GmbH Seal element
JP2011510686A (en) * 2007-06-22 2011-04-07 メディカル コンポーネンツ,インコーポレイテッド Peelable sheath assembly with hemostatic valve
US20100312190A1 (en) * 2009-06-09 2010-12-09 Oscor Inc. Low insertion force hemostasis valve for vascular introducer

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016056376A1 (en) * 2014-10-08 2016-04-14 日本ライフライン株式会社 Chemical ablation device and chemical ablation system
JP2016073523A (en) * 2014-10-08 2016-05-12 日本ライフライン株式会社 Chemical ablation device and chemical ablation system

Also Published As

Publication number Publication date
JP5928064B2 (en) 2016-06-01

Similar Documents

Publication Publication Date Title
US4449693A (en) Catheter check valve
US10183157B2 (en) Assemblies for identifying a power injectable access port
US5928203A (en) Medical fluid infusion and aspiration
US4726374A (en) Leakproof hemostasis valve
US7985232B2 (en) Detachable hemostasis valve and splittable sheath assembly
US5853394A (en) Catheter
US5599327A (en) Connector
JP5335976B2 (en) Surgical fluid transfer device
JP6401906B2 (en) System and method for providing a catheter assembly
EP2324873A2 (en) One piece low drag septum
EP2015821B1 (en) Removable valves and methods for making them
US4591355A (en) Close clearance seal for rotatable therapeutic catheters
US8096525B2 (en) Swabbable needle-free injection port valve system with zero fluid displacement
US9114241B2 (en) Systems and methods for providing a flushable catheter assembly
EP0484092A1 (en) Catheter with selfclosing valve
CA2983535C (en) Systems and methods for providing a flushable catheter assembly
JP3864925B2 (en) Indwelling catheter set
EP2616127B1 (en) A catheter assembly
EP2670468B1 (en) Intravenous catheter and insertion device with reduced blood spatter
JP2008529672A (en) Medical instruments
JP2007143813A (en) Medical stopcock
JP4940526B2 (en) Hemostatic valve
JP2008043445A (en) Catheter, hollow needle and dwelling needle assembly
US4626245A (en) Hemostatis valve comprising an elastomeric partition having opposed intersecting slits
EP0993839A1 (en) Self-retaining needle assembly and valve element for use therein

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20150121

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20151020

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20151023

A521 Written amendment

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20151218

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20160329

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20160411

R150 Certificate of patent or registration of utility model

Ref document number: 5928064

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250