JP6483941B2 - Balloon, balloon catheter, and balloon manufacturing method - Google Patents

Description

  The present invention relates to a balloon, a balloon catheter, and a balloon manufacturing method.

  A stenosis site in a blood vessel is treated by a noninvasive technique such as PTA (Percutaneous Transluminal Angioplasty) or PTCA (Percutaneous Transluminal Coronary Angioplasty). In these angioplasty procedures, a balloon catheter is usually used.

  Such balloon catheters are not limited to treating arterial stenosis, but are useful for many medical applications including insertion into blood vessels, digestive tracts such as the esophagus and bile ducts, or insertion into various body cavities. Therefore, the balloon and the like in the balloon catheter are required to have a shape and performance suitable for various body cavities.

  For example, in a stenosis that occurs in a blood vessel, a part of the stenosis tends to have a tighter shape and the diameter is often not uniform. In such a case, when a balloon catheter including a balloon having a cylindrical shape (straight tube portion) is mostly treated, the balloon slips from the stenosis site due to the expansion of the balloon, and the balloon is in contact with the stenosis site. It tends to shift. In particular, when the small-diameter portion of the digestive tract is expanded with a balloon, since the inside of the cavity is lubricated, balloon slipping is more likely to occur.

  Therefore, in the balloon catheter disclosed in Patent Document 1, in order to prevent slipping, the balloon is provided with a balloon whose central portion is reduced in diameter from both ends of the balloon, and the constricted portion is caught by the lesioned portion.

  In addition, the balloon catheter disclosed in Patent Document 2 includes an inner balloon and an outer balloon. When the inner balloon is inflated first, slipping is prevented by bringing the entire balloon into close contact with the stenotic site, and then the outer balloon. When the balloon is inflated, the stenotic site is expanded.

JP 2001-009037 A JP 2011-152181 A

  However, the balloon catheter disclosed in Patent Document 1 has a problem that the balloon large-diameter portion excessively expands the blood vessel during high-pressure expansion, leading to blood vessel dissociation.

  In addition, since the balloon catheter disclosed in Patent Document 2 includes an inner balloon and an outer balloon separately, the manufacturing process is complicated, and the process of inserting the inner balloon into the outer balloon is difficult.

  The present invention has been made to solve the above problems. And the purpose is not only to prevent slipping from the stenosis site, but also to prevent blood vessel overdilatation during high-pressure dilation, and more easily manufactured balloon, balloon catheter including the balloon, and manufacture of the balloon It is to provide a method.

  In the balloon attached to the balloon catheter, the balloon includes the first tubular portion, the second tubular portion connected to one of both ends of the first tubular portion, and the other of the both ends of the first tubular portion. And a third cylindrical portion connected to the first cylindrical portion. And in the case of non-therapeutic pressure, a 1st cylindrical part is a 1st cylinder from the 3rd cylindrical part side toward the middle of the full length direction of a 1st cylindrical part from a 2nd cylindrical part side. The taper is tapering toward the middle of the length of the shape part. On the other hand, when the balloon is inflated by applying therapeutic pressure, the expansion rate of the portion of the first cylindrical portion on the tapered side in the case of non-therapeutic pressure is higher than that on the tapered side. ,large.

  Further, in the case of non-therapeutic pressure, the first tubular portion is further tapered in the tapered direction from the middle of the tapered first tubular portion to the tapered portion, the tapered portion. Or including a cylindrical portion.

  In addition, in the first cylindrical portion, when there is a tapering portion, the portion has a constant taper ratio over the entire region, and when there is a taper portion, the portion is constant over the entire region. It is desirable to have a taper rate.

  In addition, the balloon catheter containing the above balloon is also this invention.

  By the way, a balloon tube used as a base of a balloon used for a balloon catheter is placed in a cavity of a plurality of molds and biaxially stretched and blow molded, so that the first cylindrical portion and both ends of the first cylindrical portion are formed. In the balloon manufacturing method for manufacturing a balloon including the second cylindrical portion connected to one of the two and the third cylindrical portion connected to the other of the two ends of the first cylindrical portion, the following two steps are performed. (In the cavity, the part corresponding to the first cylindrical part is the first cavity part, the part corresponding to the second cylindrical part is the second cavity part, and the part corresponding to the third cylindrical part is the second part. 3 cavities).

  In one step, one of the plurality of molds is arranged so that the inner diameter of the first cavity portion on the second cavity portion side, the inner diameter of the first cavity portion on the third cavity portion side, and the first cavity portion The first mold in which the inner diameter is the same inner diameter, or the inner diameter of the portion on the second cavity portion side or the inner diameter of the portion on the third cavity portion among these three inner diameters is the maximum inner diameter. In the first mold, the biaxial stretch blow molding process is performed first.

  In another process, another one of the plurality of molds tapers a portion of the first cavity portion that is tapered from the second cavity portion side or the third cavity portion side toward the middle of the full length direction of the first cavity portion. The second mold includes a process in which biaxial stretch blow molding is performed later in the second mold.

  The first cavity portion of the second mold includes a tapered portion, a tapered portion, or a cylindrical portion so that the taper direction further advances from the middle of the tapered first cavity portion. And desirable.

  Moreover, in the 1st cavity part of a 2nd metal mold | die, when there exists a taper part, the part has a fixed taper rate over the whole area, and when there exists a taper part, the part covers the whole area. It is desirable to have a certain taper rate.

  Further, the first cavity portion of the first mold has a certain taper rate from the second cavity portion side toward the third cavity portion side or from the third cavity portion side toward the second cavity portion side. It is desirable to have a taper shape as a whole or a cylindrical shape as a whole.

  In addition, the balloon manufacturing method including another 1 process different from previous 2 processes may be sufficient. That is, a part of the first cavity part of the mold is partway from the second cavity part side to the middle of the first cavity part in the full length direction, or from the third cavity part side to the middle of the first cavity part in the full length direction. Biaxial stretch blow molding is performed by generating a temperature gradient in which the taper side is a low temperature and the taper side is a high temperature in at least a part of the first cavity portion in the axial direction. A process may be included.

  Moreover, the balloon manufacturing method including another one process as follows may be sufficient. That is, a part of the first cavity part is directed from the second cavity part side to the middle of the first cavity part in the full length direction, or from the third cavity part side to the middle of the first cavity part in the full length direction. A step of performing biaxial stretch blow molding on a balloon tube that is tapered and at least one of at least part of the outer shape and at least part of the lumen is tapered. May be.

  The first cavity portion of the mold includes a tapered portion, a tapered portion, or a cylindrical portion so as to further advance in the tapering direction from the middle of the tapered first cavity portion. desirable.

  Moreover, in the said 1st cavity part of a metal mold | die, when there exists a taper part, the part has a fixed taper rate over the whole area, and when there exists a taper part, the part covers the whole area. It is desirable to have a certain taper rate.

  According to the present invention, the balloon can suppress slipping from the narrowed portion during expansion.

FIG. 4 is a cross-sectional view of the balloon catheter near the balloon, (A) is a cross-sectional view of the balloon under therapeutic pressure, and (B) is a cross-sectional view of the balloon under non-therapeutic pressure. FIG. 3 is a cross-sectional view showing a balloon catheter inserted into a blood vessel. FIG. 3 is a cross-sectional view showing a balloon catheter inserted into a blood vessel. FIG. 3 is a cross-sectional view showing a balloon catheter. These are sectional drawings which show a 1st metal mold | die. These are sectional drawings which show a 2nd metal mold | die. These are sectional drawings which show the tube for balloons. These are sectional drawings which show the tube for balloons. These are sectional drawings which show the tube for balloons. These are sectional drawings which show the tube for balloons. These are sectional drawings which show a 2nd metal mold | die. FIG. 3 is a cross-sectional view of a balloon under non-therapeutic pressure. These are sectional drawings which show a 2nd metal mold | die. FIG. 3 is a cross-sectional view of a balloon under non-therapeutic pressure. These are sectional drawings which show a 1st metal mold | die. FIG. 4 is a cross-sectional view of the balloon catheter near the balloon, (A) is a cross-sectional view of the balloon under therapeutic pressure, and (B) is a cross-sectional view of the balloon under non-therapeutic pressure.

[First Embodiment]
The following describes one embodiment with reference to the drawings. For convenience, hatching, member codes, and the like may be omitted, but in such a case, other drawings are referred to. Conversely, for convenience, hatching may be used even if it is not a sectional view. In addition, the dimensions of various members in the drawings are adjusted for easy viewing.

  FIG. 4 is an overall view of the balloon catheter 29. Hereinafter, in the balloon catheter 29, the side on which the balloon 10 is disposed is the distal side, and the opposite side of the distal side is the proximal side. Moreover, when clearly showing the side in each member, it may be called a proximal side and a distal side. In each member, the proximal end is the proximal end, the vicinity of the proximal end is the proximal end, the distal end is the distal end, and the vicinity of the distal end is the distal end. Sometimes.

  A balloon catheter 29 shown in FIG. 4 includes a shaft tube 21, a balloon 10, a radiopaque marker 25, and a manifold 26.

  The shaft tube 21 includes an outer tube 22 and an inner tube 23. The outer tube 22 is a tube that forms the outer surface of the shaft tube 21, and has a lumen 22 </ b> L for housing the inner tube 23 (note that the lumen 22 </ b> L is a flow path for flowing a fluid for expanding the balloon 10. It is also called inflation lumen 22L).

  The inner tube 23 is a tube that partially fits in the lumen of the outer tube 22 and has a lumen (guide wire lumen) 23L through which a guide wire (not shown) is passed (in addition, the inner tube 23 and the outer tube 22 described above). Is called a coaxial double pipe structure).

  The balloon 10 is a bag-like member that expands (inflates) by storing fluid flowing from the inflation lumen 22L of the shaft tube 21. And this balloon 10 is formed with a cylindrical member.

  More specifically, the distal end portion on the inner surface of the cylindrical balloon 10 is in close contact with the distal end portion on the outer surface of the inner tube 23 exposed from the distal end of the outer tube 22, and the proximal end on the inner surface of the balloon 10 is connected. The end portion is in close contact with and connected to the distal end portion on the outer surface of the outer tube 22. Thereby, the balloon 10 becomes a bag-like member that can store the fluid flowing through the gap between the inner surface of the outer tube 22 and the outer surface of the inner tube 23.

  The radiopaque marker 25 is a member such as a ring formed of a radiopaque material. The radiopaque marker 25 is attached to the outer surface of the inner tube 23 located on the distal side and the proximal side inside the balloon 10 to grasp the size and the like of the balloon 10 under the X-ray. It becomes a landmark. The material of the radiopaque marker 25 is not particularly limited, and may be a metal, a resin, or an inorganic material as long as the material can be confirmed by an operator by not transmitting X-rays. I do not care. Further, the number of radiopaque markers 25 is not particularly limited.

  The manifold 26 has three connection ports, one is connected to the shaft tube 21, one of the remaining two is a passage for a guide wire (not shown), and the other is a fluid for expanding the balloon 10. It becomes a connection port of a syringe (not shown) to be injected.

  There are various joining methods for joining the proximal end of the outer tube 22 to the manifold 26 and joining the outer tube 22 and the inner tube 23 to the balloon 10. For example, bonding using an adhesive may be used. Examples of the adhesive include cyanoacrylate-based, urethane-based, and silicon-based adhesives. Examples of the curing method of the adhesive include a water absorption curing type, a heat curing type, and an ultraviolet curing type.

  Further, for example, if the members to be joined are highly compatible with each other, heat welding may be performed. Conversely, if the members to be joined are a combination of materials that are difficult to adhere, a physical or chemical surface treatment is applied to the joining portion of at least one of the members to be joined to improve the joining property of both. It doesn't matter.

  The balloon catheter 29 as described above is usually used with a guide catheter (not shown) and a guide wire. For example, in angioplasty using a balloon catheter 29, first, a guide catheter is inserted into a patient's blood vessel and placed at a target site.

  Next, the guide wire is passed through the lumen of the guide catheter so that the guide wire is advanced in the vicinity of the target site, more specifically, beyond the stenosis site as the target site. Thereafter, the balloon catheter 29 is advanced toward the stenosis site along the guide wire, and the balloon 10 is disposed at the stenosis site. And the stenosis site | part is expanded by the balloon 10 being expanded. Thereafter, the balloon 10 is deflated and the balloon catheter 29 is removed from the body.

  Here, the balloon 10 for dilating the stenosis site will be described in detail with reference to FIGS. 1A and 1B. 1A and 1B show the vicinity of the balloon 10 at the distal end of the balloon catheter 29. FIG. In particular, FIG. 1A shows a state in which the balloon 10 is expanded in order to expand the stenosis site (in this way, the positive pressure that expands the balloon 10 until the stenosis site is expanded is referred to as treatment pressure). ).

  On the other hand, FIG. 1B shows the balloon 10 in a state in which the stenosis site cannot be expanded, that is, a pressure lower than the treatment pressure, for example, a pressure lower than the recommended use pressure. However, the pressure of the balloon 10 that has expanded only to such an extent that the stenosis site cannot be expanded (in short, the pressure that maintains the state in which the resin constituting the balloon 10 hardly expands from the initial state, such as no pressure or negative pressure). Pressure is also referred to as non-therapeutic pressure}.

  As shown in FIGS. 1A and 1B, in the cylindrical balloon 10 attached to the balloon catheter 29, the first cylindrical portion 11 and a distal end that is one of both ends of the first cylindrical portion 11 are provided. The 2nd cylindrical part 12 which continues, and the 3rd cylindrical part 13 which continues to the proximal end which is the other of the both ends of the 1st cylindrical part 11 are contained.

  The second cylindrical portion 12 and the third cylindrical portion 13 include a partially tapered shape (tapered shape). More specifically, the second cylindrical portion 12 tapers from the joint with the first cylindrical portion 11 (proximal end portion) toward the distal side, and the tapered end portion (distal end portion) of the tapered portion. The inner surface is bonded to the outer surface of the inner tube 23 (Note that the outer diameter (diameter) of the joint between the second cylindrical portion 12 and the first cylindrical portion 11 is D2).

  On the other hand, the third cylindrical portion 13 tapers from the vicinity of the joint with the first cylindrical portion 11 (distal end portion) toward the proximal side, and the tapered end portion (proximal end portion) thereof. The inner surface is bonded to the outer surface of the outer tube 22 (Note that the outer diameter (diameter) of the joint between the third cylindrical portion 13 and the first cylindrical portion 11 is D3).

  And the 1st cylindrical part 11 pinched | interposed into such a 2nd cylindrical part 12 and the 3rd cylindrical part 13 becomes a different shape according to the expansion pressure with respect to the balloon 10. FIG. That is, the first cylindrical portion 11 is different between the case where the expansion pressure for the balloon 10 as shown in FIG. 1A is the therapeutic pressure and the case where the expansion pressure for the balloon 10 as shown in FIG. Shape.

  More specifically, under the treatment pressure, the first cylindrical portion 11 has an outer diameter D3 at the proximal end, an outer diameter D2 at the distal end, and a midway (from the proximal end to the distal end of the first cylindrical portion 11). The outer diameter Dc of a part in the full length direction, for example, the middle part between the proximal end and the distal end, is made the same (the same diameter). In this case, for example, as shown in FIG. 1A, the first cylindrical portion 11 has a cylindrical shape (straight tube) with a constant outer diameter from the proximal side to the distal side over the entire length. Become.

  On the other hand, under the non-therapeutic pressure, the first cylindrical portion 11 increases the outer diameter D2 of the distal end compared to the intermediate outer diameter Dc, and increases the intermediate outer diameter Dc to the outside of the proximal end. The diameter is made larger (expanded) than the diameter D3. In this case, for example, as shown in FIG. 1B, the first tubular portion 11 has a shape that is tapered from the proximal side toward the distal side over the entire length (in other words, the first cylindrical portion 11 The cylindrical portion 11 has a shape that tapers from the distal side toward the proximal end over the entire length). In addition, D2 / D3 at non-therapeutic pressure is desirably 1.02 or more, more desirably 1.05 or more, and desirably 2.50 or less (D2 / D3 is 0.98 < When D2 / D3 <1.02, the outer diameter D2 of the distal end and the outer diameter D3 of the proximal end can be understood to be substantially equivalent).

  Such a balloon 10 has various advantages depending on the usage state of the balloon catheter 29. For example, when the balloon 10 reaches the stenosis site, the balloon 10 under non-therapeutic pressure has a reverse taper shape in which the distal side of the first tubular portion 11 is tapered, so that the surface of the balloon 10 (for example, the first surface) As shown in FIG. 2, the distal portion of the cylindrical portion 11 catches on a stenosis site 52 (portion constricted by the thrombus 53 or the like), and the slipping of the balloon 10 toward the proximal side is prevented.

  On the other hand, since the balloon 10 is used under therapeutic pressure when the balloon 10 dilates the stenotic region 52, as shown in FIG. 1A, the first cylindrical portion 11 has a cylindrical shape. Since the first cylindrical portion 11 does not have a large-diameter portion that causes the blood vessel to over-expand, the balloon 10 does not excessively dilate the blood vessel 51 as shown in FIG. The expanded first tubular portion 11 is designed so as not to overexpand a relatively small diameter blood vessel portion (for example, a peripheral portion of the blood vessel).

  That is, with such a balloon 10, in the initial stage of expansion, the balloon 10 prevents slipping from the stenosis part 52, and further, the stenosis part 52 is sufficiently dilated without causing the blood vessel 51 to overexpand and dissociate. Be made.

  Here, the manufacturing method of such a balloon 10 is explained in full detail using FIGS.

  In this manufacturing method, there are a plurality of molds MD to be used, one is the first mold MD1 as shown in FIG. 5, and the other is the second mold MD2 as shown in FIG. is there. Such a mold MD includes a space (cavity) CY. The cavity CY (CYf · CYs) includes a portion corresponding to the shape of the balloon 10.

  In detail, these portions correspond to the first cylindrical portion CY1 of the balloon 10 as the first cavity portion CY1, the portions corresponding to the second cylindrical portion 12 as the second cavity portion CY2, and the third cylindrical portion 13 respectively. The portion corresponding to is the third cavity portion CY3 (that is, the first cavity portion CY1, the second cavity portion CY2, and the third cavity portion CY3 are arranged in a row to form the cavity CY, The first cavity part CY1 is sandwiched between the second cavity part CY2 and the third cavity part CY3).

  In the first mold MD1, the first cavity part CY1f includes the second cavity part CY2f side, the third cavity part CY3f side, and the middle (in the first cavity part CY1f, The inner diameter of a portion in the entire length direction from the end portion on the cavity portion CY2f side to the end portion on the third cavity portion CY3f side, for example, a portion in the vicinity of the middle portion, is set to the same inner diameter. The second cavity portion CY2f includes a cavity that tapers in a direction opposite to the direction toward the first cavity portion CY1f, and the third cavity portion CY3f tapers in a direction opposite to the direction toward the first cavity portion CY1f. Including cavities.

  In this case, the first cavity part CY1f has a cylindrical shape with a constant inner diameter from the third cavity part CY3f to the second cavity part CY2f, for example, as shown in FIG. (Note that the inner diameter of the first cavity portion CY1f on the second cavity portion CY2f side is Df2, the first cavity portion CY1f is on the third cavity portion CY3f side, and the inner diameter is Df3. The midway inner diameter of the cavity part CY1f is Dfc, and the total length of the first cavity part CY1f is Lf).

  On the other hand, in the second mold MD2, the first cavity part CY1s includes the second cavity part CY2s side, the third cavity part CY3s side, and the middle (in the first cavity part CY1s, In the inner diameter of a part in the full length direction from the end part on the side of the second cavity part CY2s to the end part on the side of the third cavity part CY3s, for example, the part in the vicinity of the middle), the intermediate inner diameter is set to the side of the second cavity part CY2s With a narrower inner diameter, the third cavity portion CY3s side has an inner diameter narrower than the midway inner diameter (in short, the first cavity portion CY1s tapers from the second cavity portion CY2s side toward the middle, The taper also tapers from the middle toward the third cavity portion CY3s).

  In this case, the first cavity part CY1s is tapered from the third cavity part CY3s to the middle, and further from the middle toward the second cavity part CY2s, for example, as shown in FIG. The shape is tapered over the entire length (Note that the inner diameter of the end portion on the second cavity portion CY2s side in the first cavity portion CY1s is Ds2, and the end on the third cavity portion CY3s side in the first cavity portion CY1s is The inner diameter of the first cavity portion CY1s is Dsc, and the total length of the first cavity portion CY1s is Ls). That is, the second mold MD2 includes a first cavity part CY1s different from the first mold MD1.

  The second cavity part CY2s includes a cavity that tapers in a direction opposite to the direction toward the first cavity part CY1s, and the third cavity part CY3s tapers in a direction opposite to the direction toward the first cavity part CY1s. Including cavities.

  In the method for manufacturing the balloon 10 using at least these two types of molds MD (MD1 and MD2), for example, as shown in FIG. 7, the outer diameter (Btp), inner diameter (Bnp), meat, A tube 31P having a constant thickness (Btp−Bnp) (that is, a balloon tube 31 on which the balloon 10 is based) is used. In addition, the manufacturing method of the cylindrical tube 31P which maintained the fixed internal diameter and outer diameter over this full length is not specifically limited, For example, you may form by extrusion molding.

  Next, the manufacturing process of the balloon 10 will be described in detail. First, the tube 31P is disposed in the cavity CYf of the first mold MD1. And biaxial stretching blow molding, that is, by stretching the tube 31P and extending the fluid (such as nitrogen) into the tube 31P, the axial direction and the radial direction (biaxial direction) in the balloon 10 are stretched, The balloon 10 is molded.

  After this biaxial stretch blow molding, the tube 31P is taken out from the first mold MD1, and the tube 31P is disposed in the cavity CYs of the second mold MD2. Then, biaxial stretch blow molding is performed (the stretch amount in each biaxial stretch blow molding may be changed as appropriate).

  As described above, after the first mold MD1, the process in which biaxial stretch blow molding is performed first, and the process in which the biaxial stretch blow molding is performed later in the second mold MD2, are completed. For example, as shown in FIG. 1B, the tube 31P taken out from the second mold MD2 is a balloon 10 having a first tubular portion 11 that is tapered from the proximal side toward the distal side over the entire length. It becomes. That is, the balloon 10 formed in this manner tapers the first tubular portion 11 from the second tubular portion 12 side toward the middle of the first tubular portion 11 in the full length direction under non-therapeutic pressure. Thus, at least a part of the first cylindrical portion 11 is tapered.

  On the other hand, when this balloon 10 is subjected to therapeutic pressure (under therapeutic pressure), as shown in FIG. 1A, the first cylindrical portion 11 extends from the proximal side to the distal side over the entire length. A cylindrical shape with a constant outer diameter. That is, according to the above manufacturing method, when the balloon 10 is inflated by applying therapeutic pressure, the expansion rate of the portion of the first cylindrical portion 11 on the tapered side in the case of non-therapeutic pressure is tapered. It is made larger than the expansion coefficient on the side.

  Therefore, the manufacturing method of such a balloon 10 is a simple process of using two molds MD1 and MD2, and prevents slipping from the stenotic site 52 and overexpands the blood vessel 51 in the initial stage of expansion. The balloon 10 that can sufficiently expand the stenotic region 52 can be manufactured without dissociation.

  In the above description, the tube 31P shown in FIG. 7 is given as an example of the tube 31 disposed in the first mold MD1 and the second mold MD2, but the present invention is not limited to this.

  For example, as shown in FIG. 8, the tube 31Q has a shorter outer diameter (Btqb) at the other end and the same inner diameter (Bnq) than the outer diameter (Btqa) / inner diameter (Bnq) at one end at both ends. The wall thickness may be reduced from one end to the other end (that is, a constant inner diameter (Bnq) over the entire length, but the outer diameter decreases from one end to the other end). Then, the tube 31Q having a tapered outer shape may be used}.

  Further, as shown in FIG. 9, the tube 31R has the same outer diameter (Btr) at the other end as compared with the outer diameter (Btr) and inner diameter (Bnra) at one end at both ends, and the inner diameter (Bnrb) is longer. Then, the wall thickness may be reduced from one end to the other end {that is, a constant outer diameter (Btr) over the entire length, but the inner diameter decreases from one end to the other end. Then, although the outer shape is cylindrical, it may be a tube 31R with a tapered lumen}.

  Further, as shown in FIG. 10, the tube 31S has an outer diameter (Btsb) / inner diameter (Bnsb) at the other end shorter than an outer diameter (Btsa) / inner diameter (Bnsa) at one end at both ends. The wall thickness may be constant from one end to the other end (that is, the tube 31S may have a tapered outer shape and lumen over its entire length).

  That is, as shown in FIGS. 8 to 10, tubes 31Q to 31S in which at least one of the outer shape and the lumen is tapered are used by using the first mold MD1 and the second mold MD2, and the balloons 10, the balloon 10 has the same outer diameter D3 at the proximal end, outer diameter D2 at the distal end, and an outer diameter Dc in the middle of the first tubular portion 11 under the treatment pressure, Under therapeutic pressure, the midway outer diameter Dc of the first cylindrical portion 11 is smaller than the outer diameter D2 of the distal end, and the midway outer diameter Dc is smaller than the outer diameter D3 of the proximal end.

  That is, even in the case of the tubes 31Q to 31S, at least a part of the first cylindrical portion 11 becomes a tapered shape under non-therapeutic pressure, while the first cylindrical portion 11 is pressurized to the therapeutic pressure. The tapered side of the first cylindrical portion 11 swells at a larger expansion rate than the tapered side of the first cylindrical portion 11, and for example, the balloon 10 is formed in which at least a part of the first cylindrical portion 11 is cylindrical.

  In addition, although tube 31Q-31S of FIGS. 8-10 makes the taper shape at least one of all the external shapes and all the internal cavities, it is not limited to this. For example, it may be a tube 31 in which at least one of a part of the outer shape and a part of the lumen is tapered (in short, at least a part of the outer shape and at least a part of the lumen) Or a tube 31 in which at least one of them is tapered.

  By the way, the first mold MD1 shown in FIG. 5 includes an inner diameter Df2 of the first cavity portion CY1f on the second cavity portion CY2f side, an inner diameter Df3 of the first cavity portion CY1f on the third cavity portion CY3f side, In addition, the first cavity portion CY1f includes the first cavity portion CY1f that is entirely cylindrical by setting the midway inner diameter Dfc of the first cavity portion CY1f to the same inner diameter.

  On the other hand, the second mold MD2 shown in FIG. 6 includes a portion tapered from the second cavity portion CY2s side toward the middle of the first cavity portion CY1s in the first cavity portion CY1s, and is tapered. The first cavity portion CY1s includes a first cavity portion CY1s that is entirely tapered by including a tapered portion so as to further advance in the tapering direction from the middle of the first cavity portion CY1s.

However, it is not limited to this. In order to obtain the balloon 10 having a desired shape, the first cavity part CY1f of the first mold MD1 and the first cavity part CY1s of the second mold MD2 may be appropriately changed. For example, FIG. In the second mold MD2 as shown, the first cavity part CY1s is part of the entire length (from the boundary of the second cavity part CY2s in the first cavity part CY1s toward the third cavity part CY3s, and toward the first cavity part CY1s. The part of the first full length of the first cavity portion CY1s extends from the boundary of the third cavity portion CY3s in the first cavity portion CY1s toward the second cavity portion CY2s. The part up to the middle) is cylindrical.

  In other words, the second mold MD2 includes a portion tapered from the second cavity portion CY2s side toward the middle of the first cavity portion CY1s in the first cavity portion CY1s, and further includes a tapering direction thereof. As shown, the cylindrical portion is included (note that the total length of the tapered portion is Lsd and the total length of the cylindrical portion is Lsp in the total length Ls of the first cavity portion CY1s).

  Then, in the first mold MD1 shown in FIG. 5, the tubes 31P to 31S shown in FIG. 7 to FIG. 10 are biaxially stretch blow molded, and further, in the second mold MD2 shown in FIG. When blow molding is performed, the tube 31P taken out from the second mold MD2 becomes the balloon 10 reflecting the cavities CYs of the second mold MD2, as shown in FIG. That is, the balloon 10 formed in this way has a shape in which the first cylindrical portion 11 is tapered from the distal side toward the proximal side over a part of the entire length under non-therapeutic pressure. The remainder is cylindrical.

  More specifically, the first tubular portion 11 is located in the middle of the first tubular portion 11 in the entire length direction from the joint (the second tubular portion 12 side of the first tubular portion 11) to the second tubular portion 12. The taper is tapered and includes a cylindrical portion from the middle of the tapered first cylindrical portion 11 so as to further advance in the tapering direction (in addition, at the total length L1 of the first cylindrical portion 11, The total length of the tapered portion is L1d, and the total length of the cylindrical portion is L1p).

  On the other hand, the balloon 10 has a cylindrical first cylindrical portion 11 having a constant outer diameter from the proximal side to the distal side over the entire length under therapeutic pressure. That is, according to the above manufacturing method, when the balloon 10 is inflated by applying therapeutic pressure, the expansion rate of the portion of the first cylindrical portion 11 on the tapered side in the case of non-therapeutic pressure is tapered. It is made larger than the expansion coefficient on the side.

  Therefore, even in such a balloon 10, as described above, the balloon 10 prevents slipping from the stenotic region 52 in the initial stage of expansion, and further, the stenosis can be performed without overexpanding and dissociating the blood vessel 51. The region 52 is sufficiently expanded.

  Another example is a second mold MD2 as shown in FIG. In the second mold MD2, the first cavity part CY1s has a part in the entire length (from the boundary of the second cavity part CY2s in the first cavity part CY1s toward the third cavity part CY3s and the entire length of the first cavity part CY1s. The middle part) is tapered, and another part (from the boundary of the third cavity part CY3s in the first cavity part CY1s toward the second cavity part CY2s and halfway through the entire length of the first cavity part CY1s) Are also tapered (the total length of one tapered portion is Lsd and the total length of the other tapered portion is Lsp in the total length Ls of the first cavity portion CY1s).

  In other words, the first cavity part CY1s includes a portion tapered from the second cavity part CY2s side toward the middle of the first cavity part CY1s in the first cavity part CY1s, and the taper direction is further reduced. It can be said that it includes a tapered portion, and includes a portion tapered from the third cavity portion CY3s side toward the middle of the first cavity portion CY1s in the first cavity portion CY1s, and the tapering direction thereof. The first cavity portion CY1s can also be said to include a pincushion shape having a constriction by tapering from both ends toward the middle of the first cavity portion CY1s. .

  Then, in the first mold MD1 shown in FIG. 5, the tubes 31P to 31S shown in FIG. 7 to FIG. 10 are biaxially stretch blow molded, and further, in the second mold MD2 shown in FIG. When blow molding is performed, the tube 31P taken out from the second mold MD2 becomes the balloon 10 reflecting the cavities CYs of the second mold MD2, as shown in FIG. That is, the balloon 10 formed in this way has a shape in which the first cylindrical portion 11 is tapered from the distal side toward the proximal side over a part of the entire length under non-therapeutic pressure. The remaining portion is tapered from the distal side toward the proximal side (note that, in the total length L1 of the first cylindrical portion 11, the total length of the tapered portion is L1d, the total length of the tapered portion is L1p, And).

  More specifically, the first tubular portion 11 is located in the middle of the first tubular portion 11 in the entire length direction from the joint (the second tubular portion 12 side of the first tubular portion 11) to the second tubular portion 12. Taper toward the taper and further advance in the tapering direction so that the middle part of the first cylindrical part 11 and the joint with the third cylindrical part 13 (the third cylindrical part of the first cylindrical part 11) 13 side) (including the pincushion shape having a constriction because the first cylindrical portion 11 is tapered from both ends toward the middle of the first cylindrical portion 11). ).

  On the other hand, the balloon 10 has a cylindrical first cylindrical portion 11 having a constant outer diameter from the proximal side to the distal side over the entire length under therapeutic pressure. That is, according to the above manufacturing method, when the balloon 10 is inflated by applying therapeutic pressure, the expansion rate of the portion of the first cylindrical portion 11 on the tapered side in the case of non-therapeutic pressure is tapered. It is made larger than the expansion coefficient on the side.

  Therefore, even in such a balloon 10, as described above, the balloon 10 prevents slipping from the stenotic region 52 in the initial stage of expansion, and further, the stenosis can be performed without overexpanding and dissociating the blood vessel 51. The region 52 is sufficiently expanded.

  Another example is a first mold MD1 as shown in FIG. In the first mold MD1, the first cavity portion CY1f has different inner diameters Df2, inner diameters Df3, and inner diameters Dfc (more specifically, among these three inner diameters, the inner diameter Df3 is equal to the inner diameter Df2 and the inner diameter Df3). In addition to including a portion tapering from the third cavity portion CY3f side toward the middle of the first cavity portion CY1f in the first cavity portion CY1f, the taper is reduced to the maximum inner diameter larger than Dfc. From the middle of the one cavity portion CY1f, the taper shape is formed including the tapered portion so as to further advance in the tapering direction.

  Then, the tubes 31P to 31S shown in FIGS. 7 to 10 are biaxially stretch blow-molded in the first mold MD1 shown in FIG. 15, and further biaxially stretched in the second mold MD2 shown in FIG. When blow-molded, the tube 31P taken out from the second mold MD2 becomes the balloon 10 reflecting the cavities CYs of the second mold MD2, as shown in FIG. 16B. That is, the balloon 10 formed in this way has a shape in which the first cylindrical portion 11 is tapered from the distal side toward the proximal side over the entire length under non-therapeutic pressure.

  More specifically, the first cylindrical part 11 is located in the middle of the first cylindrical part 11 in the entire length direction from the joint with the third cylindrical part 13 (from the third cylindrical part 13 side of the first cylindrical part 11). The taper is tapered, and the taper shape is formed including the tapered portion so as to further advance in the tapering direction.

  On the other hand, when the balloon 10 is under therapeutic pressure, the first tubular portion 11 is connected to the third tubular portion 13 (the third tubular shape of the first tubular portion 11) as shown in FIG. 16A. The first cylindrical portion 11 is tapered toward the middle of the first tubular portion 11 from the side of the portion 13, and further advances in the tapered direction, including the tapered portion, and the whole is tapered. That is, according to the above manufacturing method, when the balloon 10 is inflated by applying therapeutic pressure, the expansion rate of the portion of the first cylindrical portion 11 on the tapered side in the case of non-therapeutic pressure is tapered. It is made larger than the expansion coefficient on the side.

  Therefore, even in such a balloon 10, as described above, the balloon 10 prevents slipping from the stenotic region 52 in the initial stage of expansion, and further, the stenosis can be performed without overexpanding and dissociating the blood vessel 51. The region 52 is sufficiently expanded.

  In the above, in the balloon 10, when there is a tapered portion, the portion has a constant taper ratio over the entire region, and when there is a tapered portion, the portion is constant over the entire region. Although the thing which has a taper rate has been mentioned as an example, it is not limited to this.

[Second Embodiment]
A second embodiment will be described. In addition, about the member which has the same function as the member used in Embodiment 1, the same code | symbol is attached and various description of the member may be simplified. In addition, even when the same effects as the effects described in the first embodiment are achieved, the description may be simplified.

  In the first embodiment, in the manufacture of the balloon 10, an example using a plurality of molds MD (MD1 and MD2) has been described, but the present invention is not limited to this.

  That is, without using the first mold MD1, for example, the second mold MD2 as shown in FIG. 6 will be described in detail. The first cavity part CY1s extends over the entire length from the second cavity part CY2s side to the third cavity. The balloon 10 may be molded using the second mold MD2 having a tapered inner diameter toward the part CY3s.

  For example, as shown in FIGS. 8 to 10, tubes 31 </ b> Q to 31 </ b> S in which at least one of the entire outer diameter and the entire lumen is tapered are arranged in the cavity CYs of the second mold MD <b> 2. Then, biaxial stretch blow molding is performed. And in such shaping | molding, the gradient of the draw ratio of the circumferential direction in the tubes 31Q-31S generate | occur | produces along an axial direction.

  As a result, for example, as shown in FIGS. 1A and 1B, the outer diameter D2 of the first cylindrical portion 11 on the second cylindrical portion 12 side and the third cylindrical portion 13 side of the first cylindrical portion 11 In the case of non-therapeutic pressure, the outer diameter D3 is larger than the outer diameter D3, which is the outer diameter of one part, and the outer diameter D3, which is the outer diameter of the other part. Compared with the expansion coefficient of the outer diameter D2 of the first cylindrical part 11 on the second cylindrical part 12 side, the expansion coefficient of the outer diameter D3 of the first cylindrical part 11 on the third cylindrical part 13 side is greater. A large balloon 10 is formed.

[Embodiment 3]
A third embodiment will be described. In addition, about the member which has the same function as the member used in Embodiment 1 * 2, the same code | symbol is attached, and various description of the member may be simplified. In addition, when the same effects as the effects described in the first and second embodiments are achieved, the description may be simplified.

  In the first embodiment, as shown in FIG. 7, a cylindrical tube 31P that maintains a constant inner diameter and outer diameter over its entire length is formed into a balloon by molding using a plurality of molds MD (MD1 and MD2). The production of 10 has been described. However, even with such a tube 31P, the balloon 10 as described in the first and second embodiments is obtained just by using the second mold MD2 as in the second embodiment.

  Specifically, without using the first mold MD1, for example, the second mold MD2 as shown in FIG. 6, that is, the first cavity part CY1s extends over the entire length from the second cavity part CY2s side to the third cavity. Biaxial stretching while generating a temperature gradient in at least part of the axial direction of the first cavity part CY1s after the second mold MD2 having a tapered inner diameter is arranged in the cavity CYs toward the part CY3s side Blow molded. In such molding, the crystallinity of the resin or the resin density in the balloon 10 depends on the thermal history in the biaxial stretch blow molding. Therefore, in the first tubular portion 11 of the balloon 10, a gradient of resin crystallinity or resin density occurs in the axial direction.

  As a result, for example, as shown in FIGS. 1A and 1B, the outer diameter D2 of the first cylindrical portion 11 on the second cylindrical portion 12 side and the third cylindrical portion 13 side of the first cylindrical portion 11 In the case of non-therapeutic pressure, the outer diameter D3 is larger than the outer diameter D3, which is the outer diameter of one part, and the outer diameter D3, which is the outer diameter of the other part. Compared with the expansion coefficient of the outer diameter D2 of the first cylindrical part 11 on the second cylindrical part 12 side, the expansion coefficient of the outer diameter D3 of the first cylindrical part 11 on the third cylindrical part 13 side is greater. A large balloon 10 is formed.

[Other embodiments]
The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

  For example, the material used for the tube 31 (and thus the balloon 10) is a polyolefin such as polyethylene, polypropylene, or an ethylene-propylene copolymer, a polyester such as polyethylene terephthalate, or a polyester elastomer, polyurethane, polyurethane elastomer, or polyphenylene sulfide. , Polyamide, polyamide elastomer, fluororesin, silicone rubber, latex rubber and the like.

  Moreover, the manufacturing method of the tube 31 is not specifically limited, For example, extrusion molding or injection molding is mentioned. In addition, the cylindrical tube 31 maintaining a constant inner diameter and outer diameter over the entire length is post-processed, so that at least one of at least a part of the outer shape and at least a part of the lumen is tapered. The tube 31 made into the shape may be manufactured.

  Further, the temperature of the mold MD in the biaxial stretch blow molding is arbitrarily set depending on the resin of the tube 31 or the shape of the tube 31. For example, in the case of the tube 31 including a tapered portion, it is desirable that the biaxial stretch blow molding is performed at a temperature equal to or higher than the glass transition point of the resin forming the tube.

  Biaxial stretch blow molding may be performed singly or multiple times. Further, the stretching in the axial direction may be performed simultaneously with or before and after the stretching in the radial direction. Further, in order to stabilize the shape and size of the balloon 10, the balloon 10 may be annealed.

  In the present embodiment, the outer diameter of the first cylindrical portion 11 on the second cylindrical portion 12 side is larger than the outer diameter of the third cylindrical portion 13 side under non-therapeutic pressure, or the first cylinder. Although the balloon 10 having the same outer diameter on the second cylindrical portion 12 side of the cylindrical portion 11 and the outer diameter on the third cylindrical portion 13 side has been described, the third cylindrical portion 13 side of the first cylindrical portion 11 is described. The outer diameter may be larger than the outer diameter on the second cylindrical portion 12 side.

  FIG. 4 shows an over-the-wire type balloon catheter 29 in which a guide wire lumen 23L is arranged over the entire region of the shaft tube 21, but only a part of the distal side of the shaft tube 21 is guided. It may be a rapid exchange type balloon catheter in which a wire lumen is arranged (in any type, the effective system length is preferably 200 mm or more and 1800 mm or less).

  Here, the concrete Example regarding the above balloon 10 and the result of experiment are shown. However, the balloon 10 is not limited to the results of these examples and experiments. In any of the examples, five balloons 10 were produced.

[Example 1]
First, the inner diameter and outer diameter [inner diameter (Bnp): 0.50 mm, outer diameter (Btp): 1.00 mm] are made full length by extrusion molding using polyamide (trade name “RILSAN-AESN”; manufactured by ARKEMA). A balloon tube (Parison) 31P made constant over the entire length is produced (see FIG. 7).

  Next, this tube 31P is placed in the cavity CYf of the first mold MD1 (Df2 = Df3: 3.00 mm, Lf: 20 mm) shown in FIG. 5, and the first stage biaxial stretch blow molding is performed at 100 ° C. Done. Further, the tube 31P taken out from the first mold MD1 is disposed in the cavity CYs of the second mold MD2 (Ds2: 3.00 mm, Ds3: 2.70 mm, Ls: 20 mm) shown in FIG. The biaxial stretch blow molding method of the 2nd step is performed at ° C. As a result of this molding, the balloon 10 is completed.

[Example 2]
First, an inner diameter and an outer diameter [inner diameter (Bnp): 1.00 mm, outer diameter (Btp): 2.00 mm] are made full length by extrusion molding using a polyamide elastomer (trade name “PEBAX 7233SA01”; manufactured by ARKEMA). A balloon tube 31P that is constant over the entire length is produced (see FIG. 7).

  Next, this tube 31P is placed in the cavity CYf of the first mold MD1 (Df2 = Df3: 5.00 mm, Lf: 40 mm) shown in FIG. 5, and the first stage biaxial stretch blow molding is performed at 100 ° C. Done. Furthermore, the tube 31P taken out from the first mold MD1 is disposed in the cavity CYs of the second mold MD2 (Ds2: 5.50 mm, Ds3: 5.00 mm, Ls: 40 mm) shown in FIG. The biaxial stretch blow molding method of the 2nd step is performed at ° C. As a result of this molding, the balloon 10 is completed.

[Example 3]
First, the inner diameter and outer diameter [inner diameter (Bnp): 0.50 mm, outer diameter (Btp): 1.00 mm] are made full length by extrusion molding using a polyamide elastomer (trade name “PEBAX 7233SA01”; manufactured by ARKEMA). A balloon tube 31P that is constant over the entire length is produced (see FIG. 7).

  Next, this tube 31S is disposed in the cavity CYf of the first mold MD1 (Df2: 3.00 mm, Df3: 3.50 mm, Lf: 15 mm) shown in FIG. Stretch blow molding is performed. Further, the tube 31P taken out from the first mold MD1 is arranged in the cavity CYs of the second mold MD2 (Ds2: 3.00 mm, Ds3: 2.50 mm, Ls: 15 mm) shown in FIG. The biaxial stretch blow molding of the 2nd step is performed at ° C. As a result of this molding, the balloon 10 is completed.

[Example 4]
First, an inner diameter and an outer diameter [inner diameter (Bnp): 0.25 mm, outer diameter (Btp): 0.50 mm] by extrusion molding using a polyester elastomer (trade name “Perprene S-6001”; manufactured by Toyobo Co., Ltd.) Is produced over the entire length of the balloon tube 31P (see FIG. 7).

  Next, the tube 31P is disposed in the cavity CYs of the second mold MD2 (Ds2: 1.50 mm, Ds3: 1.00 mm, Ls: 8 mm) shown in FIG. 6, and the temperature near the second cavity part CY2s is set. Biaxial stretch blow molding is performed at 100 ° C. and a temperature in the vicinity of the third cavity portion CY3s of 80 ° C. As a result of this molding, the balloon 10 is completed.

[Example 5]
First, the outer diameter (Btr) is constant at 2.50 mm over the entire length by extrusion molding using a polyamide elastomer (trade name “PEBAX 7233SA01”; manufactured by ARKEMA), but the inner diameter (Bnra) at one end is 1 A balloon tube 31R having a diameter of .50 mm and an inner diameter (Bnrb) of the other end of 1.90 mm is produced (see FIG. 9).

  Next, this tube 31P is disposed in the cavity CYs of the second mold MD2 (Ds2: 12.0 mm, Ds3: 9.00 mm, Ls: 300 mm) shown in FIG. 6, and biaxial stretch blow molding is performed at 100 ° C. Done. The tube 31R has one end having a small inner diameter directed to the second cavity part CY2s of the second mold MD2, and the other end having a large inner diameter is set to the third cavity part CY3s of the second mold MD2. Toward the cavity CYs. As a result of this molding, the balloon 10 is completed.

[Example 6]
First, the same tube as in Example 2, that is, a polyamide elastomer, for a balloon having an inner diameter and an outer diameter [inner diameter (Bnp): 1.00 mm, outer diameter (Btp): 2.00 mm] constant over the entire length. A tube 31P is produced (see FIG. 7).

  Next, this tube 31P is placed in the cavity CYf of the first mold MD1 (Df2 = Df3: 5.00 mm, Lf: 40 mm) shown in FIG. 5, and the first stage biaxial stretch blow molding is performed at 100 ° C. Done. Further, the tube 31P taken out from the first mold MD1 is arranged in the cavity CY2s of the second mold MD2 (Ds2: 5.00 mm, Ds3: 4.50 mm, Lsd = Lsp: 20 mm) shown in FIG. The biaxial stretch blow molding method of the 2nd step is performed at 80 degreeC. As a result of this molding, the balloon 10 is completed.

[Example 7]
First, the same tube as in Example 2, that is, a polyamide elastomer, for a balloon having an inner diameter and an outer diameter [inner diameter (Bnp): 1.00 mm, outer diameter (Btp): 2.00 mm] constant over the entire length. A tube 31P is produced (see FIG. 7).

  Next, this tube 31P is disposed in the cavity CYf of the first mold MD1 (Df2 = Df3: 5.00 mmLf: 40 mm) shown in FIG. 13, and the first-stage biaxial stretch blow molding is performed at 100 ° C. . Further, the tube 31P taken out from the first mold MD1 is arranged in the cavity CYs of the second mold MD2 (Ds2 = Ds3: 5.00 mm, Dsc: 4.50 mm, Ls: 40 mm) shown in FIG. The biaxial stretch blow molding method of the 2nd step is performed at 80 degreeC. As a result of this molding, the balloon 10 is completed.

[■ Experiment]
A balloon catheter 29 using the balloon 10 of Examples 1 to 7 was produced and the performance was examined.

＜ ● Production of balloon catheter ＞
The balloon catheter 29 is an over-the-wire type as shown in FIG. 4, and the inner tube 23 and the outer tube 22 have a coaxial double tube structure.

  The inner tube 23 has an inner diameter and an outer diameter [inner diameter: 0.40 mm, outer diameter: 0.60 mm] by extrusion molding using high-density polyethylene (trade name “HY540”; manufactured by Mitsubishi Chemical Corporation). Over the entire range. The outer tube 22 has an inner diameter and an outer diameter [inner diameter 0.80 mm, outer diameter 1.00 mm] constant over the entire length by extrusion molding using polyamide (trade name “RILSAN-AESN”; manufactured by ARKEMA). It is a thing. The manifold 26 was molded by injection molding using a styrene-butadiene copolymer (trade name “K-resin KR03”; manufactured by Philips Petroleum Corporation).

  The balloons of Examples 1 to 7 were attached to the shaft tube 21 using a two-component curable urethane-based adhesive (trade name “UR0531”; manufactured by HB Fuller). The balloon catheter 29 is completed by being attached to the shaft tube 21. Such a balloon catheter 29 is sterilized with ethylene oxide gas after wrapping the balloon 10 and used for experiments.

<● Measurement>
An expansion solution was injected into the balloon 10 in the balloon catheter 29 (Samples 1 to 7) including Examples 1 to 7, and the outer diameter of the balloon 10 was measured. The expansion solution is a mixture of a contrast medium (trade name “Iomelon 350”; manufactured by Eisai Co., Ltd.) and physiological saline at a volume ratio of 50:50.

  A state in which the balloon 10 is expanded at 1 atm, which is a non-therapeutic pressure, and a state after the balloon 10 is expanded at 10 atm, which is a therapeutic pressure, for 30 seconds are a laser outer diameter measuring instrument (LS-7500 manufactured by KEYENCE). ).

  In addition, the balloon 10 in the samples 1 to 5 becomes a first cylindrical portion 11 having a tapered shape from the proximal side toward the distal side over the entire length, for example, as shown in FIG. 1B under non-therapeutic pressure. It was. Further, under the treatment pressure, in the samples 1, 2, and 4, for example, as shown in FIG. 1A, a cylindrical first cylindrical portion 11 having a constant outer diameter from the proximal side to the distal side over the entire length. It became. Further, under the treatment pressure, the samples 3 and 5 became the first tubular portion 11 having a tapered shape from the proximal side toward the distal side over the entire length as shown in FIG. 16A, for example.

  On the other hand, in the balloon 10 in the sample 6, under non-therapeutic pressure, for example, as shown in FIG. 12, the first cylindrical portion 11 has a cylindrical shape from the joint with the third cylindrical portion 13 toward the distal side. Thus, from the midway part of the entire length to the second cylindrical part 12, a tapered shape was obtained. Further, under the treatment pressure, for example, as shown in FIG. 1A, a cylindrical first cylindrical portion 11 having a constant outer diameter from the proximal side to the distal side over the entire length was obtained.

  Further, in the balloon 10 in the sample 7, under non-therapeutic pressure, for example, as shown in FIG. 14, the first cylindrical portion 11 has a tapered shape from the joint with the third cylindrical portion 13 toward the distal side. From the midway part of the entire length to the second cylindrical part 12, it became a tapered shape. Further, under the treatment pressure, for example, as shown in FIG. 1A, a cylindrical first cylindrical portion 11 having a constant outer diameter from the proximal side to the distal side over the entire length was obtained.

  The results of samples 1 to 7 (S1 to S7) are summarized as follows (see FIGS. 1, 12, 14, and 16). In addition, a numerical value is an average value of 5 in each sample 1-7.

◇ Long axis length ◇ Non-treatment pressure ◇ Treatment pressure
L1 (mm) D2 (mm) & D3 (mm) D2 (mm) & D3 (mm)
S1: 19.9 2.86 & 2.67 3.01 & 2.97
S2: 40.3 5.18 & 4.87 5.31 & 5.23
S3: 14.6 2.70 & 2.41 3.07 & 3.48
S4: 8.0 1.32 & 0.97 1.47 & 1.45
S5: 303.2 10.71 & 8.97 12.50 & 13.01
◇ Long axis length ◇ Non-treatment pressure ◇ Treatment pressure
L1d (mm) & L1p (mm) D2 (mm) & D3 (mm) D2 (mm) & D3 (mm)
S6: 20.1 & 19.7 4.76 & 4.23 5.19 & 5.18
◇ Long axis length ◇ Non-treatment pressure ◇ Treatment pressure
L1d (mm) & L1p (mm) D2 (mm) & Dc (mm) & D3 (mm) D2 (mm) & Dc (mm) & D3 (mm)
S7: 20.0 & 19.7 4.72 & 4.36 & 4.74 5.10 & 5.06 & 5.12
As is apparent from the above measurement results, the balloons 10 in the samples 1 to 6 have the outer diameter D2> the outer diameter D3 under non-therapeutic pressure (1 atm), and the outer diameter D2 and the outer diameter D3 under the therapeutic pressure (10 atm). It became substantially equivalent or the outer diameter D2 <the outer diameter D3. That is, in any of the balloons 10 of the samples 1 to 6, in the case of non-therapeutic pressure, the entire length or a part of the first tubular portion 11 is from the second tubular portion 12 side to the first tubular portion 11. The expansion rate of the portion of the first cylindrical portion 11 on the tapered side in the case of non-therapeutic pressure is reduced by the taper toward the middle, and the expansion rate on the tapered side. It was bigger than

  In the balloon 10 in the sample 7, the outer diameter D2 and the outer diameter D3 were substantially equal at 1 atm, and the outer diameter Dc was smaller than the outer diameter D2 and the outer diameter D3. On the other hand, at 10 atm, the outer diameter D2, the outer diameter Dc, and the outer diameter D3 were substantially equivalent. That is, in the balloon 10 of the sample 7, in the case of non-therapeutic pressure, a part of the first cylindrical part 11 tapers from the second cylindrical part 12 side toward the middle of the first cylindrical part 11. The first cylindrical portion 11 is tapered from the third cylindrical portion 13 side toward the middle of the first cylindrical portion 11 and is tapered in the case of non-therapeutic pressure by applying therapeutic pressure. The expansion coefficient of the intermediate part of the cylindrical part 11 is larger than the expansion coefficient of the first cylindrical part 11 on the second cylindrical part 12 side and the first cylindrical part 11 on the third cylindrical part 13 side. It was big.

DESCRIPTION OF SYMBOLS 10 Balloon 11 1st cylindrical part 12 2nd cylindrical part 13 3rd cylindrical part D2 The outer diameter of the 2nd cylindrical part side in the 1st cylindrical part D3 The 3rd cylindrical part side in the 1st cylindrical part Outer diameter Dc Outer diameter of the middle part of the first cylindrical part L1 Total length of the first cylindrical part 21 Shaft tube 22 Outer tube 23 Inner tube 23L Guide wire lumen 29 Balloon catheter 31 Tube [Tube on which the balloon is based]
31P tube [tube on which balloon is based]
31Q Tube [Tube on which the balloon is based]
31R tube [balloon base tube]
31S Tube [Tube on which the balloon is based]
MD mold CY cavity MD1 first mold CYf first mold cavity CY1f first cavity part in the first mold cavity CY2f second cavity part in the first mold cavity CY3f first cavity in the first mold cavity 3 cavity part Df2 In the 1st cavity part in the cavity of the 1st metallic mold,
The inner diameter of the end portion on the tee portion side Df3 In the first cavity portion in the cavity of the first mold, the third cavity
The inner diameter of the end on the side of the tee part Dfc The middle of the first cavity part in the full length direction in the cavity of the first mold
Diameter Lf Total length of the first cavity portion in the cavity of the first mold MD2 Second mold CYs Second cavity CY1s First cavity portion in the second mold cavity CY2s Second cavity in the second mold cavity Part CY3s Third cavity part in the cavity of the second mold Ds2 In the first cavity part in the cavity of the second mold, the second cavity
The inner diameter of the end portion on the side of the tee portion Ds3 In the first cavity portion in the cavity of the second mold, the third cavity
The inner diameter of the end on the side of the tee part Dsc In the middle of the first cavity part in the cavity of the second mold
Diameter Ls Total length of the first cavity portion in the cavity of the second mold

Claims (8)

A balloon attached to a balloon catheter,
The balloon includes a first cylindrical part, a second cylindrical part connected to a distal side which is one of both ends of the first cylindrical part, and the other of the both ends of the first cylindrical part. A third cylindrical portion connected to a certain proximal side ,
In the case of non-treatment pressure, the first tubular section may thinning ahead towards the middle of the entire length direction of the first cylindrical portion from said second cylindrical portion,
When the balloon is inflated by applying therapeutic pressure, the expansion rate of the portion of the first cylindrical portion on the tapered side in the case of non-therapeutic pressure is larger than the expansion rate on the tapered side. Is getting bigger,
The first cylindrical portion, the second cylindrical portion, and the third cylindrical portion are configured using the same resin,
Under the non-therapeutic pressure, the outer diameter on the distal side which is the one of the two ends of the first tubular portion is larger than the midway outer diameter of the first tubular portion, and the midway The outer diameter of the first cylindrical portion is larger than the other outer diameter of the first cylindrical portion on the other side ,
The balloon which expands so that the said 1st cylindrical part may become a cylindrical shape which made the outer diameter constant over the full length, or it becomes a taper shape over the full length. In the case of non-therapeutic pressure,
It said first cylindrical portion, from the halfway of the first tubular portion being tapered, so as to further advances the direction indicated by the tapering, including tapered portion, a balloon according to claim 1. In the first tubular portion,
If tapered part there, the part over the entire region, we have a constant taper rate,
The balloon according to claim 2.   The balloon catheter containing the balloon of any one of Claims 1-3. A balloon tube used as a base of a balloon used for a balloon catheter is placed in a cavity of a plurality of molds and biaxially stretched and blow molded, so that the first cylindrical portion and both ends of the first cylindrical portion are Manufacturing a balloon including a second cylindrical portion connected to the distal side which is one of the first cylindrical portions, and a third cylindrical portion connected to the proximal side which is the other of both ends of the first cylindrical portion. In the way,
The first cylindrical portion, the second cylindrical portion, and the third cylindrical portion are configured using the same resin,
In the cavity, a portion corresponding to the first tubular portion is a first cavity portion, a portion corresponding to the second tubular portion is a second cavity portion, and a portion corresponding to the third tubular portion is a third cavity. Part,
One of the plurality of molds is a first mold in which the inner diameter of the first cavity portion is a constant inner diameter over the entire length, or the first cavity portion is tapered over the entire length. In one mold, the above biaxial stretch blow molding is performed first,
Another one of the plurality of the mold includes the middle portion is tapered toward the full-length direction of the second cavity portion or al the first cavity portion in the first cavity portion, said first cavity The inner diameter of the distal side which is one of the two ends of the part is larger than the inner diameter of the first cavity part in the full length direction, and the intermediate inner diameter is the other of the two ends of the first cavity part. A second mold larger than an inner diameter of a certain proximal side , and the step of performing the biaxial stretch blow molding later in the second mold;
A balloon manufacturing method comprising: The said first cavity of the second mold from the middle of the first cavity portion which is the tapered, so as to further advances the direction indicated by the tapering comprises tapered portions, according to claim 5 Balloon manufacturing method. In the first cavity portion of the second mold,
If tapered part there, the part over the entire region, we have a constant taper rate,
The balloon manufacturing method according to claim 6. The first cavity part of the first mold is
By having a certain taper rate from the second cavity part side toward the third cavity part side or from the third cavity part side toward the second cavity part side, a taper shape is formed as a whole. become,
Or
It becomes a cylindrical shape as a whole.
The balloon manufacturing method of any one of Claims 5-7.