Balloon catheter
The balloon catheter's design with a longer distal sleeve prevents unintended dislodgment and ensures easy sizing, addressing fitting challenges in existing catheters, thereby improving treatment efficiency.
Patent Information
- Application Number
- JP2024003246
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-01-12
- Publication Date
- 2025-07-25
AI Technical Summary
Existing balloon catheters face issues with the balloon group unintentionally dislodging from the valve and requiring multiple adjustments to fit the valve size, leading to prolonged treatment times.
A balloon catheter design featuring a distal sleeve longer than the proximal sleeve, ensuring the distal portion catches on the valve and allowing easy sizing to fit the valve, with a balloon group comprising parallel balloon parts, a distal and proximal shaft, and sleeve connections.
Prevents unintended dislodgment and facilitates quick, precise fitting of the balloon group within the valve, enhancing treatment efficiency.
Smart Images

Figure 2025109389000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a balloon catheter.
Background Art
[0002] When a stenotic portion hardened by calcification or the like is formed in the blood vessel wall, diseases such as angina pectoris and myocardial infarction are caused. As one of these treatment methods, there is angioplasty in which the stenotic portion is expanded by a balloon catheter. Angioplasty is a minimally invasive treatment method that does not require thoracotomy such as bypass surgery and is a widely performed treatment method.
[0003] There is a disease called aortic valve stenosis in which the aortic valve becomes hard due to calcification or the like, making it difficult for the aortic valve to open and obstructing blood flow. As treatment methods for aortic valve stenosis, there are aortic valve replacement surgery involving thoracotomy and transcatheter aortic valve replacement in which a bioprosthesis (artificial valve) is placed by a catheter and the hardened aortic valve is replaced with a bioprosthesis.
[0004] Patent Document 1 discloses a balloon catheter used for expanding a hardened stenotic portion or placing a bioprosthesis, in which a plurality of outer balloon members are arranged so as to surround the outer surface of an inner balloon member.
Prior Art Documents
Patent Documents
[0005]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0006] However, the part composed of the outer balloon member and the inner balloon member provided in the balloon catheter described in Patent Document 1 was likely to come out of the valve at an unintended timing. Further, when the outer diameter of the part composed of the outer balloon member and the inner balloon member did not match the valve, it was necessary to once remove the balloon catheter and then arrange a new balloon catheter, which sometimes took a long time for the treatment.
[0007] The present invention has been made in view of the above circumstances, and an object thereof is to provide a balloon catheter that can easily suppress the balloon group from coming out of the valve at an unintended timing and can easily arrange a part of the balloon group that matches the size of the valve in the valve.
Means for Solving the Problems
[0008] One embodiment of the balloon catheter of the present invention that has solved the above problems is as follows. [1] A balloon group including a plurality of parallel balloon parts, A distal shaft part located on the distal side of the balloon part, A proximal shaft part located on the proximal side of the balloon part, A distal sleeve part connecting the balloon part and the distal shaft part, A proximal sleeve part connecting the balloon part and the proximal shaft part, and having a balloon catheter in which the length of the distal sleeve part is longer than the length of the proximal sleeve part.
[0009] Since the length of the distal sleeve portion is longer than the length of the proximal sleeve portion, the maximum length of the circumscribed circle radius at the distal portion of the balloon group becomes larger than the maximum length of the circumscribed circle radius at the proximal portion of the balloon group. Therefore, when the balloon group is arranged in the valve and inflated, the distal portion of the balloon group is likely to catch on the valve, so it is easy to suppress the balloon group from coming off the valve at an unintended timing. Also, since the length of the distal sleeve portion is longer than the length of the proximal sleeve portion, the circumscribed circle radius of the balloon group when the balloon group is inflated has different lengths in the longitudinal direction of the proximal shaft portion. For this reason, it is possible to easily arrange the portion of the balloon group that fits the size of the valve in the valve.
[0010] The balloon catheter according to an embodiment of the present invention is preferably any one of the following [2] to
[11] . [2] The balloon group includes an inner balloon portion in which a guide wire tube into which a guide wire is inserted is arranged inside, and an outer balloon portion located radially outward of the inner balloon portion, the balloon catheter according to [1]. [3] The length of the distal sleeve portion connecting the outer balloon portion and the distal shaft portion is longer than the length of the proximal sleeve portion connecting the outer balloon portion and the proximal shaft portion, the balloon catheter according to [2]. [4] The proximal end of the inner balloon portion is located more distally than the proximal end of the outer balloon portion, the balloon catheter according to [2] or [3]. [5] The maximum outer diameter at the distal portion of the inner balloon portion is larger than the maximum outer diameter at the proximal portion of the inner balloon portion, the balloon catheter according to any one of [2] to [4]. [6] The maximum outer diameter at the distal portion of the outer balloon portion is larger than the maximum outer diameter at the proximal portion of the outer balloon portion, the balloon catheter according to any one of [2] to [5]. [7] The proximal sleeve portion has a flow path through which fluid can pass, the balloon catheter according to any one of [1] to [6]. [8] The distal sleeve portion has a flow path through which fluid can pass, and the balloon catheter according to any one of [1] to [7]. [9] The distal sleeve portion does not have a flow path through which fluid can pass, and the balloon catheter according to any one of [1] to [7].
[10] The balloon portion has a straight tube portion, a distal tapered portion located on the distal side of the straight tube portion and having a smaller outer diameter toward the distal side, and a proximal tapered portion located on the proximal side of the straight tube portion and having a smaller outer diameter toward the proximal side, and the balloon catheter according to any one of [1] to [9].
[11] The length of the proximal sleeve portion in the longitudinal direction of the proximal shaft portion is equal to or less than the length of the proximal tapered portion in the longitudinal direction of the proximal shaft portion, and the balloon catheter according to
[10] . [Advantages of the Invention]
[0011] The balloon catheter according to the embodiment of the present invention can easily suppress the balloon group from coming out of the valve at an unintended timing, and can easily arrange the portion of the balloon group that fits the size of the valve in the valve. [Brief Description of the Drawings]
[0012]
Figure 1
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Figure 15
DETAILED DESCRIPTION OF THE INVENTION
[0013] Hereinafter, the present invention will be specifically described with reference to the drawings. However, the present invention is not limited to the illustrated examples, and it is also possible to appropriately modify and implement the invention within the scope that can conform to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each figure, for convenience, hatching, reference signs, etc. may be omitted, but in such cases, reference should be made to the specification and other figures. Also, the dimensions of various components in the drawings may differ from the actual dimensions because priority is given to facilitating understanding of the features of the present invention.
[0014] One embodiment of the balloon catheter of the present invention includes a balloon portion group including a plurality of parallel balloon portions, a distal shaft portion located distally of the balloon portion, a proximal shaft portion located proximally of the balloon portion, a distal sleeve portion connecting the balloon portion and the distal shaft portion, and a proximal sleeve portion connecting the balloon portion and the proximal shaft portion, and the gist lies in that the length of the distal sleeve portion is longer than the length of the proximal sleeve portion.
[0015] With reference to FIGS. 1 to 15, the overall configuration of the balloon catheter according to the embodiment of the present invention will be described. In this drawing, a balloon catheter 100 including a balloon portion group 1, a distal shaft portion 2, a proximal shaft portion 3, a distal sleeve portion 4, and a proximal sleeve portion 5 is shown. In this drawing, the longitudinal direction of the balloon catheter 100 is indicated by x, the radial direction by y, and the circumferential direction by c.
[0016] The members and parts included in the balloon catheter 100 also have a longitudinal direction, a radial direction, and a circumferential direction, respectively. The longitudinal direction, the radial direction, and the circumferential direction of the members and parts included in the balloon catheter 100 may coincide with the longitudinal direction x, the radial direction y, and the circumferential direction c of the balloon catheter 100, or may be different from each other. In this specification, for ease of understanding, an aspect is shown in which the longitudinal direction, the radial direction, and the circumferential direction of all members and parts other than the balloon portion 10, the distal sleeve portion 4, and the proximal sleeve portion 5 coincide with the longitudinal direction x, the radial direction y, and the circumferential direction c of the balloon catheter 100, respectively.
[0017] In this specification, the proximal side refers to the direction towards the user's hand with respect to the longitudinal direction x of the balloon catheter 100, and the distal side refers to the opposite side of the proximal side, that is, the direction towards the treatment target side. Also, when each member or each part is bisected in the longitudinal direction x of the balloon catheter 100, the part located on the distal side of each member or each part is referred to as the distal part of each member or each part, and the part located on the proximal side of each member or each part is referred to as the proximal part of each member or each part. The distal end of each member or each part is the end located on the most distal side of each member or each part. The proximal end of each member or each part is the end located on the most proximal side of each member or each part. The end portion includes the peripheral portion of the end. That is, the distal end portion refers to the distal end and the peripheral portion of the distal end, and the proximal end portion refers to the proximal end and the peripheral portion of the proximal end.
[0018] Figure 1 shows a side view of a balloon catheter according to an embodiment of the present invention. More specifically, in Figure 1, a state where the balloon portion provided in the balloon catheter is expanded is shown. Figure 2 shows an enlarged side view of the balloon portion group provided in the balloon catheter shown in Figure 1. Figure 3 shows a cross-sectional view of the cut end surface along line III-III shown in Figure 2. Figure 4 shows a cross-sectional view of the cut end surface along line IV-IV shown in Figure 2. Figures 5 and 6 show cross-sectional views of the cut end surface showing a modified example of the balloon catheter shown in Figure 4. Figure 7 shows a side view showing a modified example of the balloon portion group shown in Figure 2. Figure 8 shows a side view showing a modified example of the inner balloon portion provided in the balloon catheter shown in Figure 1. Figure 9 shows a side view showing a modified example of the outer balloon portion provided in the balloon catheter shown in Figure 1. Figure 10 shows an enlarged cross-sectional view of the balloon portion, the distal side sleeve portion, and the proximal side sleeve portion provided in the balloon catheter shown in Figure 1. Figure 11 shows a cross-sectional view showing a modified example of the balloon portion, the distal side sleeve portion, and the proximal side sleeve portion shown in Figure 10. More specifically, Figures 10 and 11 are cross-sectional views in a cross-section passing through the central axis of the balloon portion and parallel to the longitudinal direction of the balloon catheter. Figure 12 shows a cross-sectional view of the cut end surface along line XII-XII shown in Figure 2. Figures 13 to 15 show cross-sectional views of the cut end surface showing modified examples of the balloon catheter shown in Figure 12.
[0019] As shown in FIGS. 1 and 2, the balloon catheter 100 has a balloon section group 1, a distal shaft section 2, a proximal shaft section 3, a distal sleeve section 4, and a proximal sleeve section 5.
[0020] As shown in FIGS. 1 to 3 and FIG. 7, the balloon section group 1 includes a plurality of balloon sections 10 arranged in parallel. The plurality of balloon sections 10 are preferably arranged in a direction perpendicular to the longitudinal direction x of the balloon catheter 100.
[0021] The balloon section 10 is a portion that expands when fluid is supplied therein and contracts when fluid is discharged therefrom. FIG. 3 shows the cut end face of the balloon section 10 in a direction perpendicular to the longitudinal direction x of the balloon catheter 100. FIGS. 10 and 11 show the cross section of the balloon section 10 in a direction parallel to the longitudinal direction x of the balloon catheter 100. In order to control the expansion and contraction of the balloon section 10, a configuration can be adopted in which fluid is introduced or discharged using an inflator (balloon pressurizer). As the fluid, for example, a gas such as nitrogen or air, or a liquid such as physiological saline or a mixture of a contrast agent and physiological saline can be used. The fluid may be a pressurized fluid pressurized by a pump or the like.
[0022] As shown in FIG. 1, the distal shaft section 2 is a portion located more distally than the balloon section 10 and is a portion to which the distal sleeve section 4 described later is connected.
[0023] As shown in FIG. 1, the proximal shaft section 3 is a portion located more proximally than the balloon section 10 and is a portion to which the proximal sleeve section 5 described later is connected.
[0024] As shown in FIGS. 1, 2, and 7, the distal sleeve portion 4 is a portion connecting the balloon portion 10 and the distal shaft portion 2. It is preferable that one distal sleeve portion 4 is connected to one balloon portion 10, and it is more preferable that the proximal end portion of one distal sleeve portion 4 is connected to the distal end portion of one balloon portion 10. And it is preferable that one distal shaft portion 2 is connected to a plurality of distal sleeve portions 4, and it is more preferable that the proximal end portion of one distal shaft portion 2 is connected to the distal end portions of the plurality of distal sleeve portions 4.
[0025] As shown in FIGS. 1, 2, and 7, the proximal sleeve portion 5 is a portion connecting the balloon portion 10 and the proximal shaft portion 3. It is preferable that one proximal sleeve portion 5 is connected to one balloon portion 10, and it is more preferable that the distal end portion of one proximal sleeve portion 5 is connected to the proximal end portion of one balloon portion 10. And it is preferable that one proximal shaft portion 3 is connected to a plurality of proximal sleeve portions 5, and it is more preferable that the distal end portion of one proximal shaft portion 3 is connected to the proximal end portions of the plurality of proximal sleeve portions 5.
[0026] As shown in FIGS. 1, 2, and 7, in the balloon catheter 100, the length of the distal sleeve portion 4 is configured to be longer than the length of the proximal sleeve portion 5. The length of the distal sleeve portion 4 is the length of the distal sleeve portion 4 in the extending direction of the distal sleeve portion 4. The length of the proximal sleeve portion 5 is the length of the proximal sleeve portion 5 in the extending direction of the proximal sleeve portion 5. The length of the distal sleeve portion 4 connected to one balloon portion 10 may be longer than the length of the proximal sleeve portion 5 connected to the one balloon portion 10. Only the distal sleeve portion 4 and the proximal sleeve portion 5 connected to some of the balloon portions 10 may satisfy the relationship that the length of the distal sleeve portion 4 connected to one balloon portion 10 is longer than the length of the proximal sleeve portion 5 connected to the one balloon portion 10. The distal sleeve portion 4 and the proximal sleeve portion 5 connected to all the balloon portions 10 may satisfy the relationship that the length of the distal sleeve portion 4 connected to one balloon portion 10 is longer than the length of the proximal sleeve portion 5 connected to the one balloon portion 10.
[0027] Since the length of the distal sleeve portion 4 is longer than the length of the proximal sleeve portion 5, as shown in FIGS. 2 and 7, the maximum length of the circumradius at the distal portion of the balloon portion group 1 is larger than the maximum length of the circumradius at the proximal portion of the balloon portion group 1. For this reason, when the balloon portion group 1 is arranged in the valve and inflated, the distal portion of the balloon portion group 1 is likely to be caught by the valve, so it is possible to easily suppress the balloon portion group 1 from coming out of the valve at an unintended timing. Further, since the length of the distal sleeve portion 4 is longer than the length of the proximal sleeve portion 5, as shown in FIGS. 2 and 7, the circumradius of the balloon portion group 1 when the balloon portion group 1 is inflated has different lengths in the longitudinal direction of the proximal shaft portion 3. For this reason, it is possible to easily arrange the portion of the balloon portion group 1 that fits the size of the valve in the valve.
[0028] In a state where the balloon section group 1 is inflated, the length of the distal sleeve section 4 in the longitudinal direction of the proximal shaft section 3 may be configured to be longer than the length of the proximal sleeve section 5 in the longitudinal direction of the proximal shaft section 3. The length of the distal sleeve section 4 connected to one balloon section 10 in the longitudinal direction of the proximal shaft section 3 may be longer than the length of the proximal sleeve section 5 connected to the one balloon section 10 in the longitudinal direction of the proximal shaft section 3. Only the distal sleeve section 4 and the proximal sleeve section 5 connected to some of the balloon sections 10 may satisfy the relationship that the length of the distal sleeve section 4 connected to one balloon section 10 in the longitudinal direction of the proximal shaft section 3 is longer than the length of the proximal sleeve section 5 connected to the one balloon section 10 in the longitudinal direction of the proximal shaft section 3. The distal sleeve section 4 and the proximal sleeve section 5 connected to all of the balloon sections 10 may satisfy the relationship that the length of the distal sleeve section 4 connected to one balloon section 10 in the longitudinal direction of the proximal shaft section 3 is longer than the length of the proximal sleeve section 5 connected to the one balloon section 10 in the longitudinal direction of the proximal shaft section 3. By adopting the above configuration, the circumradius is likely to increase at the distal portion of the balloon section group 1. Therefore, when the balloon section group 1 is arranged in the valve and inflated, the distal portion of the balloon section group 1 is likely to be caught by the valve, so that it is easy to suppress the balloon section group 1 from coming off the valve at an unintended timing. Further, the circumradius of the balloon section group 1 when inflated is likely to have different lengths in the longitudinal direction of the proximal shaft section 3. Therefore, it is easy to arrange the portion of the balloon section group 1 that fits the size of the valve in the valve.
[0029] The balloon catheter 100 according to an embodiment of the present invention is preferably used for dilating the aortic valve, deforming a biological valve implanted in the heart, or destroying a biological valve. Specifically, for the purpose of dilating an aortic valve hardened by calcification or the like, or deforming or destroying an artificial valve ring or the like of a biological valve for replacing a biological valve implanted in the heart and deteriorated over time, the balloon catheter 100 according to an embodiment of the present invention is preferably used.
[0030] The balloon catheter 100 has a distal end and a proximal end in its longitudinal direction x.
[0031] The number of balloon portions 10 included in the balloon portion group 1 can be, for example, 2 or more, 3 or more, 4 or more, etc. The number of balloon portions 10 included in the balloon portion group 1 can be, for example, 15 or less, 13 or less, 10 or less, etc. FIGS. 1 to 3 and FIG. 7 show an aspect in which 7 balloon portions 10 are included in the balloon portion group 1.
[0032] As shown in FIGS. 2, 7, 10, and 11, the balloon portion 10 has a distal end 10d and a proximal end 10p in the longitudinal direction x of the balloon catheter 100. Note that the distal end of the balloon portion group 1 coincides with the most distal distal end 10d among the distal ends 10d that each of the plurality of balloon portions 10 has. The proximal end of the balloon portion group 1 coincides with the most proximal proximal end 10p among the proximal ends 10p that each of the plurality of balloon portions 10 has.
[0033] Examples of the material constituting the balloon portion 10 include polyamide resins such as nylon 11 and nylon 12, polyester resins such as polyethylene terephthalate and polybutylene terephthalate, polyurethane resins, thermoplastic elastomers such as polyether block amide copolymers, or combinations thereof.
[0034] As shown in FIG. 2, the balloon portion 10 may include a straight tube portion 10a, a distal tapered portion 10b that is located on the distal side of the straight tube portion 10a and has a smaller outer diameter toward the distal side, and a proximal tapered portion 10c that is located on the proximal side of the straight tube portion 10a and has a smaller outer diameter toward the proximal side. Only a part of the plurality of balloon portions 10 provided in the balloon catheter 100 may include the straight tube portion 10a, the distal tapered portion 10b, and the proximal tapered portion 10c. All of the plurality of balloon portions 10 provided in the balloon catheter 100 may include the straight tube portion 10a, the distal tapered portion 10b, and the proximal tapered portion 10c.
[0035] The straight tube portion 10a may be a hollow cylindrical shape having approximately the same diameter in the longitudinal direction x of the balloon catheter 100, or may have different diameters in the longitudinal direction x of the balloon catheter 100.
[0036] The distal tapered portion 10b and the proximal tapered portion 10c are preferably formed in a hollow conical shape or a hollow frustum shape that tapers as they move away from the straight tube portion 10a.
[0037] As shown in FIGS. 2, 3, and 7, the balloon portion group 1 may include an inner balloon portion 11 and an outer balloon portion 12 located radially outward of the inner balloon portion 11. The inner balloon portion 11 refers to a balloon portion 10 among the plurality of balloon portions 10 in which a guide wire tube 13 into which a guide wire is inserted is disposed inside. The outer balloon portion 12 refers to a balloon portion 10 among the plurality of balloon portions 10 in which a guide wire tube 13 into which a guide wire is inserted is not disposed and that is located radially outward of the inner balloon portion 11.
[0038] As shown in FIGS. 7 and 8, one inner balloon portion 11 has a distal end 11d and a proximal end 11p.
[0039] As shown in FIGS. 7 and 9, one outer balloon portion 12 has a distal end 12d and a proximal end 12p.
[0040] The number of the inner balloon parts 11 can be, for example, 1 or more, 2 or more, 3 or more, etc. The number of the inner balloon parts 11 can be, for example, 6 or less, 5 or less, 4 or less, etc. FIGS. 2, 3, and 7 show an embodiment in which only 1 inner balloon part 11 is provided.
[0041] The number of the outer balloon parts 12 can be, for example, 1 or more, 2 or more, 3 or more, etc. The number of the outer balloon parts 12 can be, for example, 14 or less, 12 or less, 10 or less, etc. FIGS. 2, 3, and 7 show an embodiment in which 6 outer balloon parts 12 are provided.
[0042] When a plurality of outer balloon parts 12 are provided, it is preferable that all the outer balloon parts 12 are in contact with the inner balloon part 11. Note that an embodiment in which a part of the plurality of outer balloon parts 12 is in contact with the inner balloon part 11 and the remaining outer balloon parts 12 are not in contact with the inner balloon part 11 is also allowed.
[0043] The material constituting the inner balloon part 11 and the material constituting the outer balloon part 12 may be the same or different.
[0044] A plurality of outer balloon parts 12 may be arranged around the inner balloon part 11. The inner balloon part 11 may exist at a position through which the central axis of the balloon part group 1 passes. The plurality of outer balloon parts 12 may be arranged in the circumferential direction c of the balloon catheter 100.
[0045] The guide wire tube 13 is for inserting a guide wire. The guide wire tube 13 has a lumen into which a guide wire is inserted. The lumen of the guide wire tube 13 preferably extends in the longitudinal direction x of the balloon catheter 100.
[0046] As the material constituting the guide wire tube 13, those exemplified as the material constituting the proximal shaft portion 3 described later can be used.
[0047] The shape of the guide wire tube 13 can be a hollow cylindrical shape, a hollow polygonal columnar shape, or the like.
[0048] An X-ray opaque marker may be disposed on the outer surface of the guide wire tube 13 at a position where the inner balloon portion 11 exists in the longitudinal direction x of the balloon catheter 100. The X-ray opaque marker is preferably disposed on the outer surface of the guide wire tube 13 at a position where the distal end of the straight tube portion of the inner balloon portion 11 and the proximal end of the straight tube portion of the inner balloon portion 11 exist in the longitudinal direction x of the balloon catheter 100. Further, an X-ray opaque marker may be disposed at a position where the center of the straight tube portion of the inner balloon portion 11 is located in the longitudinal direction x of the balloon catheter 100.
[0049] As described above, in the balloon catheter 100, it is only necessary that the length of the distal sleeve portion 4 is configured to be longer than the length of the proximal sleeve portion 5. Among these, it is preferable that the length of the distal sleeve portion 4 connecting the outer balloon portion 12 and the distal shaft portion 2 is longer than the length of the proximal sleeve portion 5 connecting the outer balloon portion 12 and the proximal shaft portion 3. The length of the distal sleeve portion 4 connected to one outer balloon portion 12 may be longer than the length of the proximal sleeve portion 5 connected to the one outer balloon portion 12. Only the distal sleeve portion 4 and the proximal sleeve portion 5 connected to some of the outer balloon portions 12 may satisfy the relationship that the length of the distal sleeve portion 4 connected to one outer balloon portion 12 is longer than the length of the proximal sleeve portion 5 connected to the one outer balloon portion 12. The distal sleeve portion 4 and the proximal sleeve portion 5 connected to all of the outer balloon portions 12 may satisfy the relationship that the length of the distal sleeve portion 4 connected to one outer balloon portion 12 is longer than the length of the proximal sleeve portion 5 connected to the one outer balloon portion 12. Further, the length of the distal sleeve portion 4 connecting the outer balloon portion 12 and the distal shaft portion 2 in the longitudinal direction of the proximal shaft portion 3 may be configured to be longer than the length of the proximal sleeve portion 5 connecting the outer balloon portion 12 and the proximal shaft portion 3 in the longitudinal direction of the proximal shaft portion 3. The length of the distal sleeve portion 4 connected to one outer balloon portion 12 in the longitudinal direction of the proximal shaft portion 3 may be longer than the length of the proximal sleeve portion 5 connected to the one outer balloon portion 12 in the longitudinal direction of the proximal shaft portion 3. Only the distal sleeve portion 4 and the proximal sleeve portion 5 connected to some of the outer balloon portions 12 may satisfy the relationship that the length of the distal sleeve portion 4 connected to one outer balloon portion 12 in the longitudinal direction of the proximal shaft portion 3 is longer than the length of the proximal sleeve portion 5 connected to the one outer balloon portion 12 in the longitudinal direction of the proximal shaft portion 3.The distal sleeve portion 4 and the proximal sleeve portion 5 connected to all the outer balloon portions 12 may satisfy the relationship that the length in the longitudinal direction of the proximal shaft portion 3 of the distal sleeve portion 4 connected to one outer balloon portion 12 is longer than the length in the longitudinal direction of the proximal shaft portion 3 of the proximal sleeve portion 5 connected to the one outer balloon portion 12. With the above configuration, at the distal portion of the balloon portion group 1, the circumradius is likely to increase. Therefore, when the balloon portion group 1 is arranged in the valve and inflated, the distal portion of the balloon portion group 1 is likely to catch on the valve, so it is easy to suppress the balloon portion group 1 from coming out of the valve at an unintended timing. Further, the circumradius of the balloon portion group 1 when inflated is likely to have different lengths in the longitudinal direction of the proximal shaft portion 3. Therefore, it is easy to arrange the portion of the balloon portion group 1 that fits the size of the valve in the valve.
[0050] Note that the length of the distal sleeve portion 4 connecting the inner balloon portion 11 and the distal shaft portion 2 may be configured to be longer than the length of the proximal sleeve portion 5 connecting the inner balloon portion 11 and the proximal shaft portion 3. The length of the distal sleeve portion 4 connecting the inner balloon portion 11 and the distal shaft portion 2 may be configured to be the same as the length of the proximal sleeve portion 5 connecting the inner balloon portion 11 and the proximal shaft portion 3. The length of the distal sleeve portion 4 connecting the inner balloon portion 11 and the distal shaft portion 2 may be configured to be shorter than the length of the proximal sleeve portion 5 connecting the inner balloon portion 11 and the proximal shaft portion 3.
[0051] As shown in Fig. 7, it is preferable that the proximal end 11p of the inner balloon portion 11 is located more distally than the proximal end 12p of the outer balloon portion 12. Thereby, the maximum length of the circumradius at the distal portion of the balloon portion group 1 is likely to be larger than the maximum length of the circumradius at the proximal portion of the balloon portion group 1. For this reason, when the balloon portion group 1 is arranged in the valve and inflated, the distal portion of the balloon portion group 1 is likely to catch on the valve, so it is easy to suppress the balloon portion group 1 from coming out of the valve at an unintended timing. In addition, it is possible to easily arrange the portion of the balloon portion group 1 that fits the size of the valve in the valve.
[0052] As shown in Fig. 2, in the longitudinal direction x of the balloon catheter 100, the proximal end 11p of the inner balloon portion 11 may be located at the same position as the proximal end 12p of the outer balloon portion 12. Although not shown, an aspect in which the proximal end 11p of the inner balloon portion 11 is located more proximally than the proximal end 12p of the outer balloon portion 12 is also acceptable.
[0053] As shown in Figs. 2 and 7, in the longitudinal direction x of the balloon catheter 100, the distal end 11d of the inner balloon portion 11 may be located at the same position as the distal end 12d of the outer balloon portion 12. Although not shown, an aspect in which the distal end 11d of the inner balloon portion 11 is located more proximally than the distal end 12d of the outer balloon portion 12 may also be acceptable. An aspect in which the distal end 11d of the inner balloon portion 11 is located more distally than the distal end 12d of the outer balloon portion 12 may also be acceptable.
[0054] As shown in Fig. 8, it is preferable that the maximum outer diameter at the distal portion of the inner balloon portion 11 is larger than the maximum outer diameter at the proximal portion of the inner balloon portion 11. In the case where a plurality of inner balloon portions 11 are provided, only a part of the plurality of inner balloon portions 11 may satisfy the above configuration, but it is preferable that all the inner balloon portions 11 satisfy the above configuration. Thereby, the maximum length of the circumradius at the distal portion of the balloon portion group 1 is likely to be larger than the maximum length of the circumradius at the proximal portion of the balloon portion group 1. For this reason, when the balloon portion group 1 is disposed in the valve and inflated, the distal portion of the balloon portion group 1 is likely to be caught by the valve, so that it is easy to suppress the balloon portion group 1 from coming out of the valve at an unintended timing. Also, it is possible to easily dispose the portion of the balloon portion group 1 that fits the size of the valve in the valve.
[0055] As shown in Fig. 9, it is preferable that the maximum outer diameter at the distal portion of the outer balloon portion 12 is larger than the maximum outer diameter at the proximal portion of the outer balloon portion 12. In the case where a plurality of outer balloon portions 12 are provided, only a part of the plurality of outer balloon portions 12 may satisfy the above configuration, but it is preferable that all the outer balloon portions 12 satisfy the above configuration. Thereby, the maximum length of the circumradius at the distal portion of the balloon portion group 1 is likely to be larger than the maximum length of the circumradius at the proximal portion of the balloon portion group 1. For this reason, when the balloon portion group 1 is disposed in the valve and inflated, the distal portion of the balloon portion group 1 is likely to be caught by the valve, so that it is easy to suppress the balloon portion group 1 from coming out of the valve at an unintended timing. Also, it is possible to easily dispose the portion of the balloon portion group 1 that fits the size of the valve in the valve.
[0056] As shown in FIG. 2, it is preferable that the length 5L of the proximal sleeve portion 5 in the longitudinal direction of the proximal shaft portion 3 is equal to or less than the length 10cL of the proximal tapered portion 10c in the longitudinal direction of the proximal shaft portion 3. The length 5L of the proximal sleeve portion 5 connected to one balloon portion 10 in the longitudinal direction of the proximal shaft portion 3 may be equal to or less than the length 10cL of the proximal tapered portion 10c that the one balloon portion 10 has in the longitudinal direction of the proximal shaft portion 3. Also, the length 5L of the proximal sleeve portion 5 in the longitudinal direction of the proximal shaft portion 3 may be shorter than the length 10cL of the proximal tapered portion 10c in the longitudinal direction of the proximal shaft portion 3. The length 5L of the proximal sleeve portion 5 connected to one balloon portion 10 in the longitudinal direction of the proximal shaft portion 3 may be shorter than the length 10cL of the proximal tapered portion 10c that the one balloon portion 10 has in the longitudinal direction of the proximal shaft portion 3. Thereby, the maximum length of the circumscribed circle radius at the distal portion of the balloon portion group 1 is likely to be larger than the maximum length of the circumscribed circle radius at the proximal portion of the balloon portion group 1. For this reason, when the balloon portion group 1 is arranged in the valve and inflated, the distal portion of the balloon portion group 1 is likely to catch on the valve, so it is easy to suppress the balloon portion group 1 from coming off the valve at an unintended timing. Also, the circumscribed circle radius of the balloon portion group 1 when the balloon portion group 1 is inflated is likely to have different lengths in the longitudinal direction of the proximal shaft portion 3. For this reason, it is possible to easily arrange the portion of the balloon portion group 1 that fits the size of the valve in the valve. In addition, by adopting the above configuration, the arrangement positions of the respective balloon portions 10 are less likely to shift in the proximal portion of the balloon portion group 1. Since the same effects as described above can be obtained, the length of the proximal sleeve portion 5 in the longitudinal direction of the balloon portion group 1 may be equal to or less than the length of the proximal tapered portion 10c in the longitudinal direction of the balloon portion group 1. The length of the proximal sleeve portion 5 connected to one balloon portion 10 in the longitudinal direction of the balloon portion group 1 may be equal to or less than the length of the proximal tapered portion 10c that the one balloon portion 10 has in the longitudinal direction of the balloon portion group 1. The length of the proximal sleeve portion 5 in the longitudinal direction of the balloon portion group 1 may be shorter than the length of the proximal tapered portion 10c in the longitudinal direction of the balloon portion group 1.The length of the proximal sleeve portion 5 connected to one balloon portion 10 in the longitudinal direction of the balloon portion group 1 may be shorter than the length of the proximal tapered portion 10c that the one balloon portion 10 has in the longitudinal direction of the balloon portion group 1.
[0057] The proximal shaft portion 3 preferably extends in the longitudinal direction x of the balloon catheter 100. The proximal shaft portion 3 preferably has a lumen through which the fluid supplied to the balloon portion 10 can pass. The lumen through which the fluid supplied to the balloon portion 10 can pass preferably extends in the longitudinal direction x of the balloon catheter 100.
[0058] The shape of the proximal shaft portion 3 can be a hollow cylindrical shape, a hollow polygonal cylindrical shape, or the like.
[0059] Examples of the proximal shaft portion 3 include a hollow body formed by arranging one or a plurality of wire rods in a predetermined pattern; a coated resin on at least one of the inner surface or the outer surface of the hollow body; a resin tube; or a combination thereof, for example, those connected in the longitudinal axis direction. Examples of the hollow body in which the wire rods are arranged in a predetermined pattern include a cylindrical body having a mesh structure formed by intersecting or knitting the wire rods, and a coil around which the wire rods are wound. The wire rod may be one or a plurality of single wires, or one or a plurality of stranded wires. The resin tube can be manufactured, for example, by extrusion molding. When the proximal shaft portion 3 is a resin tube, the proximal shaft portion 3 can be composed of a single layer or a plurality of layers. A part of the proximal shaft portion 3 in the longitudinal direction x or the circumferential direction c of the balloon catheter 100 may be composed of a single layer, and the other part may be composed of a plurality of layers.
[0060] The proximal shaft portion 3 can be made of, for example, synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, fluorine resins (e.g., PTFE, PFA, ETFE), etc., or metals such as stainless steel, carbon steel, nickel-titanium alloys, etc. These may be used alone, or two or more of them may be used in combination.
[0061] The proximal shaft portion 3 may be composed of only one cylindrical member, or may be composed of a plurality of cylindrical members.
[0062] As shown in FIGS. 4 to 6, the proximal shaft portion 3 can be configured to have a guide wire lumen 30 into which a guide wire is inserted, a first lumen 31 through which fluid supplied to the inner balloon portion 11 can pass, and a second lumen 32 through which fluid supplied to the outer balloon portion 12 can pass. In a cross-section perpendicular to the longitudinal direction x of the balloon catheter 100, it is preferable that the guide wire lumen 30, the first lumen 31, and the second lumen 32 are formed in different regions. The guide wire lumen 30, the first lumen 31, and the second lumen 32 preferably extend in the longitudinal direction x of the balloon catheter 100.
[0063] The guide wire lumen 30 preferably communicates with the inner cavity of the guide wire tube 13 disposed inside the inner balloon portion 11.
[0064] The first lumen 31 preferably communicates with the inside of the inner balloon portion 11. It is preferable that the inner balloon portion 11 expands by the fluid supplied through the first lumen 31. It is preferable that the inner balloon portion 11 contracts by discharging the fluid through the first lumen 31.
[0065] A plurality of first lumens 31 may be provided, but preferably only one is provided. The number of first lumens 31 is preferably the same as the number of inner balloon portions 11.
[0066] The second lumen 32 preferably communicates with the inside of the outer balloon portion 12. It is preferable that the outer balloon portion 12 is expanded by the fluid supplied through the second lumen 32. It is preferable that the outer balloon portion 12 is contracted by discharging the fluid through the second lumen 32.
[0067] Only one second lumen 32 may be provided, but preferably a plurality of second lumens 32 are provided. The number of second lumens 32 is preferably the same as the number of outer balloon portions 12.
[0068] In a cross-section perpendicular to the longitudinal direction of the proximal shaft portion 3, the second lumen 32 is preferably located radially outward of the proximal shaft portion 3 with respect to the first lumen 31.
[0069] The outer shape of the guide wire lumen 30, the outer shape of the first lumen 31, and the outer shape of the second lumen 32 in a cross-section perpendicular to the longitudinal direction of the proximal shaft portion 3 may each be a circular shape, a polygonal shape including a triangular shape or a square shape, a semi-circular shape, a fan shape, a wedge shape, a convex character shape, a crescent shape, or a combination thereof.
[0070] As shown in FIGS. 2, 4, and 6, the proximal shaft portion 3 may have an outer tube 33 having a lumen 331 extending in the longitudinal direction x of the balloon catheter 100, a first tube 34 disposed in the lumen 331 of the outer tube 33, and a second tube 35 disposed in the lumen 331 of the outer tube 33. The second tube 35 is preferably located radially outward of the first tube 34. In a cross-section perpendicular to the longitudinal direction of the proximal shaft portion 3, the second tube 35 is preferably located radially outward of the proximal shaft portion 3 with respect to the first tube 34.
[0071] The material constituting the outer tube 33, the material constituting the first tube 34, and the material constituting the second tube 35 may be the same or different.
[0072] It is preferable that a guide wire lumen 30 and a first lumen 31 are formed in the first tube 34, and a second lumen 32 is formed in the second tube 35.
[0073] A plurality of first tubes 34 may be provided, but it is preferable that there is only one. It is preferable that the number of first tubes 34 is the same as the number of inner balloon portions 11. And, it is preferable that the distal end portion of the first tube 34 is connected to the proximal end portion of the proximal sleeve portion 5 connected to the inner balloon portion 11. Thereby, fluid can be supplied to the inside of the inner balloon portion 11 via the first lumen 31 of the first tube 34 and the flow path 6 of the proximal sleeve portion 5 described later.
[0074] Only one second tube 35 may be provided, but it is preferable that a plurality of second tubes 35 are provided. It is preferable that the number of second tubes 35 is the same as the number of outer balloon portions 12. And, it is preferable that the distal end portion of the second tube 35 is connected to the proximal end portion of the proximal sleeve portion 5 connected to the outer balloon portion 12. Thereby, fluid can be supplied to the inside of the outer balloon portion 12 via the second lumen 32 of the second tube 35 and the flow path 6 of the proximal sleeve portion 5.
[0075] As shown in FIG. 6, a filler 36 may be disposed in the space surrounded by the inner surface of the outer tube 33, the outer surface of the first tube 34, and the outer surface of the second tube 35.
[0076] As the filler 36, those exemplified as the material constituting the balloon portion 10 or the material constituting the proximal shaft portion 3 can be used.
[0077] As shown in FIG. 5, the proximal shaft portion 3 may be constituted by a cylindrical member 37 having a guide wire lumen 30 into which a guide wire is inserted, a first lumen 31 through which fluid supplied to the inner balloon portion 11 can pass, and a second lumen 32 through which fluid supplied to the outer balloon portion 12 can pass. In this case, it is preferable that the proximal end portion of the proximal sleeve portion 5 connected to the inner balloon portion 11 and the distal end portion of the proximal shaft portion 3 are connected so that the flow path 6 of the proximal sleeve portion 5 connected to the inner balloon portion 11 communicates with the first lumen 31. And it is preferable that the proximal end portion of the proximal sleeve portion 5 connected to the outer balloon portion 12 and the distal end portion of the proximal shaft portion 3 are connected so that the flow path 6 of the proximal sleeve portion 5 connected to the outer balloon portion 12 communicates with the second lumen 32. With the above configuration, fluid can be supplied to the inside of the inner balloon portion 11 via the first lumen 31 and the flow path 6 of the proximal sleeve portion 5. Also, fluid can be supplied to the inside of the outer balloon portion 12 via the second lumen 32 and the flow path 6 of the proximal sleeve portion 5.
[0078] The distal shaft portion 2 preferably extends in the longitudinal direction x of the balloon catheter 100. The distal shaft portion 2 may or may not have a lumen through which fluid after being supplied to the balloon portion 10 can pass.
[0079] The shape of the distal shaft portion 2 can be a hollow cylindrical shape, a hollow polygonal cylindrical shape, a conical shape, a frustum shape, a tapered shape, or the like.
[0080] As shown in FIG. 1, in the longitudinal direction x of the balloon catheter 100, it is preferable that the length of the distal shaft portion 2 is shorter than the length of the proximal shaft portion 3.
[0081] As the material constituting the distal shaft portion 2, those exemplified as the material constituting the proximal shaft portion 3 can be used.
[0082] As shown in FIGS. 12 to 15, the distal shaft portion 2 can be configured to have a guide wire lumen 20 into which a guide wire is inserted. As shown in FIGS. 12 to 14, the distal shaft portion 2 may be configured to have a guide wire lumen 20 into which a guide wire is inserted, a first lumen 21 through which fluid can pass after being supplied to the inner balloon portion 11, and a second lumen 22 through which fluid can pass after being supplied to the outer balloon portion 12. In this case, in a cross-section perpendicular to the longitudinal direction x of the balloon catheter 100, it is preferable that the guide wire lumen 20, the first lumen 21, and the second lumen 22 are formed in different regions. From the viewpoint of ease of reducing the diameter, as shown in FIG. 15, it is preferable that the distal shaft portion 2 is configured to have only the guide wire lumen 20 into which a guide wire is inserted. The guide wire lumen 20, the first lumen 21, and the second lumen 22 preferably extend in the longitudinal direction x of the balloon catheter 100.
[0083] The guide wire lumen 20 preferably communicates with the inner cavity of the guide wire tube 13 disposed inside the inner balloon portion 11.
[0084] The first lumen 21 may communicate with the inside of the inner balloon portion 11.
[0085] A plurality of first lumens 21 may be provided, or only one may be provided. The number of first lumens 21 may be the same as the number of inner balloon portions 11.
[0086] The second lumen 22 may communicate with the inside of the outer balloon portion 12.
[0087] Only one second lumen 22 may be provided, or a plurality may be provided. The number of second lumens 22 may be the same as the number of outer balloon portions 12.
[0088] In a cross-section perpendicular to the longitudinal direction of the proximal shaft portion 3, it is preferable that the second lumen 22 is located radially outward of the proximal shaft portion 3 than the first lumen 21.
[0089] The outer shape of the guide wire lumen 20, the outer shape of the first lumen 21, and the outer shape of the second lumen 22 in a cross-section perpendicular to the longitudinal direction of the proximal shaft portion 3 may each be a circular shape, a polygonal shape including a triangular shape or a quadrangular shape, a semi-circular shape, a fan shape, a wedge shape, a convex character shape, a crescent shape, or a combination thereof, etc.
[0090] As shown in FIGS. 2, 12, and 14, the distal shaft portion 2 may have an outer tube 23 having a lumen 231 extending in the longitudinal direction x of the balloon catheter 100, a first tube 24 disposed in the lumen 231 of the outer tube 23, and a second tube 25 disposed in the lumen 231 of the outer tube 23. In a cross-section perpendicular to the longitudinal direction of the proximal shaft portion 3, it is preferable that the second tube 25 is located radially outward of the proximal shaft portion 3 than the first tube 24.
[0091] The material constituting the outer tube 23, the material constituting the first tube 24, and the material constituting the second tube 25 may be the same or different.
[0092] The guide wire lumen 20 and the first lumen 21 may be formed in the first tube 24, and the second lumen 22 may be formed in the second tube 25.
[0093] A plurality of first tubes 24 may be provided, or only one first tube 24 may be provided. The number of first tubes 24 may be the same as the number of inner balloon portions 11. And the proximal end portion of the first tube 24 may be connected to the distal end portion of the distal sleeve portion 4 connected to the inner balloon portion 11. Thereby, fluid is supplied from the inner balloon portion 11 to the first lumen 21 of the first tube 24 through the flow path 6 of the distal sleeve portion 4 described later.
[0094] Only one second tube 25 may be provided, or a plurality of second tubes 25 may be provided. The number of second tubes 25 may be the same as the number of outer balloon parts 12. And the proximal end part of the second tube 25 may be connected to the distal end part of the distal sleeve part 4 connected to the outer balloon part 12. Thereby, fluid is supplied from the outer balloon part 12 to the second lumen 22 of the second tube 25 through the flow path 6 of the distal sleeve part 4.
[0095] As shown in FIG. 14, a filler 26 may be disposed in the space surrounded by the inner surface of the outer tube 23, the outer surface of the first tube 24, and the outer surface of the second tube 25.
[0096] As the filler 26, those exemplified as the material constituting the balloon part 10 or the material constituting the proximal shaft part 3 can be used.
[0097] As shown in FIG. 13, the distal shaft part 2 may be constituted by a cylindrical member 27 having a guide wire lumen 20 into which a guide wire is inserted, a first lumen 21 through which fluid can pass after being supplied to the inner balloon part 11, and a second lumen 22 through which fluid can pass after being supplied to the outer balloon part 12. In this case, the distal end part of the distal sleeve part 4 connected to the inner balloon part 11 and the proximal end part of the distal shaft part 2 may be connected so that the flow path 6 of the distal sleeve part 4 connected to the inner balloon part 11 and the first lumen 21 communicate with each other. And it is preferable that the distal end part of the distal sleeve part 4 connected to the outer balloon part 12 and the proximal end part of the distal shaft part 2 are connected so that the flow path 6 of the distal sleeve part 4 connected to the outer balloon part 12 and the second lumen 22 communicate with each other. With the above configuration, the fluid after being supplied to the inner balloon part 11 is supplied to the first lumen 21 through the flow path 6 of the distal sleeve part 4. Also, the fluid after being supplied to the outer balloon part 12 is supplied to the second lumen 22 through the flow path 6 of the distal sleeve part 4.
[0098] The guide wire lumen 20 preferably penetrates in the longitudinal direction x of the balloon catheter 100.
[0099] The first lumen 21 and the second lumen 22 preferably have an open proximal end and a closed distal end. That is, it is preferable that no fluid is supplied to the distal side of the distal shaft portion 2. As a result, fluid is likely to accumulate inside the balloon portion 10, and the balloon portion 10 is likely to expand.
[0100] The distal sleeve portion 4 may be connected to a plurality of balloon portions 10, but is preferably connected to only one balloon portion 10.
[0101] The distal sleeve portion 4 is preferably connected to a plurality of distal shaft portions 2.
[0102] As shown in FIG. 10, the distal sleeve portion 4 may have a flow path 6 through which fluid can pass. Although not shown in detail, the flow path 6 may communicate from the distal end to the proximal end of the distal sleeve portion 4. The flow path 6 may exist only in a part of the distal end to the proximal end of the distal sleeve portion 4.
[0103] As shown in FIG. 11, the distal sleeve portion 4 may not have a flow path 6 through which fluid can pass. This makes it possible to easily reduce the diameter of the distal sleeve portion 4.
[0104] The shape of the distal sleeve portion 4 can be cylindrical, polygonal columnar, hollow cylindrical, hollow polygonal columnar, etc.
[0105] As the material constituting the distal sleeve portion 4, those exemplified as the material constituting the balloon portion 10 or the proximal shaft portion 3 can be used.
[0106] The proximal sleeve portion 5 may be connected to a plurality of balloon portions 10, but is preferably connected to only one balloon portion 10.
[0107] The proximal sleeve portion 5 is preferably connected to a plurality of the proximal shaft portions 3.
[0108] As shown in FIGS. 10 and 11, the proximal sleeve portion 5 preferably has a flow path 6 through which fluid can pass. Although not shown in detail, the flow path 6 preferably communicates from the distal end to the proximal end of the proximal sleeve portion 5. Thereby, fluid can be supplied into the balloon portion 10 through the flow path 6 of the proximal sleeve portion 5.
[0109] The shape of the proximal sleeve portion 5 can be a hollow cylindrical shape, a hollow polygonal columnar shape, or the like.
[0110] As the material constituting the proximal sleeve portion 5, those exemplified as the material constituting the balloon portion 10 or the material constituting the proximal shaft portion 3 can be used.
[0111] As shown in FIG. 1, a hub 7 may be connected to the proximal portion of the proximal shaft portion 3. Although not shown, the hub 7 may have a bifurcated structure. Further, the hub 7 may be provided with a fluid injection portion 8 capable of injecting fluid supplied into the balloon portion 10. The fluid injection portion 8 is preferably connected to the above-described inflator.
[0112] The proximal shaft portion 3 and the hub 7 may be fixed. For example, the proximal shaft portion 3 and the hub 7 can be fixed by adhesion with an adhesive, welding, screws, or the like. Among these, the proximal shaft portion 3 and the hub 7 are preferably fixed by adhesion. When the proximal shaft portion 3 and the hub 7 are fixed by adhesion, for example, when the proximal shaft portion 3 is made of a highly flexible material and the hub 7 is made of a highly rigid material, and the materials constituting the proximal shaft portion 3 and the hub 7 are different, the connection strength between the proximal shaft portion 3 and the hub 7 can be increased, so that the durability of the balloon catheter 100 can be easily improved.
[0113] FIG. 1 discloses an embodiment in which a guide wire port 9 is formed midway from the distal end to the proximal end of the proximal shaft portion 3. The guide wire port 9 communicates with the guide wire lumen 30 of the proximal shaft portion 3. FIG. 1 shows a so-called rapid exchange type balloon catheter 100. The proximal shaft portion 3 may have a first proximal shaft portion 3a and a second proximal shaft portion 3b located more distally than the first proximal shaft portion 3a. The first proximal shaft portion 3a and the second proximal shaft portion 3b may be separate members, and the distal end portion of the member constituting the first proximal shaft portion 3a may be connected to the proximal end portion of the member constituting the second proximal shaft portion 3b. Alternatively, the first proximal shaft portion 3a and the second proximal shaft portion 3b may be constituted by one member.
[0114] As shown in FIG. 2, the proximal end portion of the guide wire tube 13 is preferably connected to the distal end portion of the proximal shaft portion 3. The proximal end portion of the guide wire tube 13 and the distal end portion of the proximal shaft portion 3 may be directly connected without an intervening member, or may be indirectly connected via an intervening member. When the proximal shaft portion 3 has a configuration having a first proximal shaft portion 3a and a second proximal shaft portion 3b, the proximal end portion of the guide wire tube 13 is preferably connected to the distal end portion of the second proximal shaft portion 3b.
[0115] As shown in FIG. 2, the distal end portion of the guide wire tube 13 is preferably connected to the proximal end portion of the distal shaft portion 2. The distal end portion of the guide wire tube 13 and the proximal end portion of the distal shaft portion 2 may be directly connected without an intervening member, or may be indirectly connected via an intervening member.
[0116] Although not shown, the balloon catheter 100 can also be of a so-called over-the-wire type in which a guide wire lumen 30 is formed from the distal end to the proximal end of the proximal shaft portion 3. When the balloon catheter 100 is of the over-the-wire type, it is preferable that the guide wire lumen 30 of the proximal shaft portion 3 extends to the position where the hub 7 is present in the longitudinal direction x of the balloon catheter 100. The first lumen 31 and the second lumen 32 of the proximal shaft portion 3 preferably extend to midway from the distal end to the proximal end of the proximal shaft portion 3. The proximal ends of the first lumen 31 and the second lumen 32 of the proximal shaft portion 3 are preferably located more distally than the distal end of the hub 7. Note that the first lumen 31 and the second lumen 32 of the proximal shaft portion 3 may extend to the position where the hub 7 is present in the longitudinal direction x of the balloon catheter 100.
[0117] The outer surface of the proximal shaft portion 3 or the outer surface of the distal shaft portion 2 may be coated. As shown in FIG. 1, when the balloon catheter 100 is of the rapid exchange type, the outer surface of at least one of the first proximal shaft portion 3a and the second proximal shaft portion 3b may be coated, and the outer surfaces of both the first proximal shaft portion 3a and the second proximal shaft portion 3b may be coated. When the balloon catheter 100 is of the over-the-wire type, only a part or the whole of the outer surface of the proximal shaft portion 3 may be coated. Only a part or the whole of the outer surface of the distal shaft portion 2 may be coated.
[0118] The coating applied to the outer surface of the proximal shaft portion 3 or the outer surface of the distal shaft portion 2 can be a hydrophilic coating or a hydrophobic coating according to the purpose. The proximal shaft portion 3 and the distal shaft portion 2 can be immersed in a hydrophilic coating agent or a hydrophobic coating agent, or a hydrophilic coating agent or a hydrophobic coating agent can be applied to the outer surface of the proximal shaft portion 3 or the outer surface of the distal shaft portion 2, or the outer surface of the proximal shaft portion 3 or the outer surface of the distal shaft portion 2 can be coated with a hydrophilic coating agent or a hydrophobic coating agent to apply the coating. A drug or an additive may be added to the coating agent.
[0119] Examples of the hydrophilic coating agent include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinyl pyrrolidone, and methyl vinyl ether maleic anhydride copolymer, or hydrophilic coating agents composed of combinations thereof.
[0120] Examples of the hydrophobic coating agent include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy alkane (PFA), silicone oil, hydrophobic urethane resin, carbon coat, diamond coat, diamond-like carbon (DLC) coat, ceramic coat, and substances with low surface free energy terminated with an alkyl group or a perfluoroalkyl group.
Explanation of Signs
[0121] 1: Balloon portion group 10: Balloon portion 10a: Straight tube portion 10b: Distal tapered portion 10c: Proximal tapered portion 10cL: Length of the proximal tapered portion in the longitudinal direction of the proximal shaft portion 10d: Distal end 10p: Proximal end 11: Inner balloon portion 11d: Distal end 11p: Proximal end 12 Outer balloon portion 12d: Distal end 12p: Proximal end 13: Guide wire tube 2: Distal shaft portion 20: Guide wire lumen 21: First lumen 22: Second lumen 23: Outer tube 231: Inner cavity 24: First tube 25: Second tube 26: Filling material 27: Cylindrical member 3: Proximal shaft portion 3a: First proximal shaft portion 3b: Second proximal shaft portion 30: Guide wire lumen 31: First lumen 32: Second lumen 33: Outer tube 331: Inner cavity 34: First tube 35: Second tube 36: Filling material 37: Cylindrical member 4: Distal sleeve portion 5: Proximal sleeve portion 5L: Length of the proximal sleeve portion in the longitudinal direction of the proximal shaft portion 6: Flow path 7: Hub 8: Fluid injection portion 9: Guide wire port 100: Balloon catheter x: Longitudinal direction of the balloon catheter y: Radial direction of the balloon catheter c: Circumferential direction of the balloon catheter
Claims
1. A balloon portion group including a plurality of juxtaposed balloon portions, A distal shaft portion located on the distal side of the balloon portion, A proximal shaft portion located on the proximal side of the balloon portion, A distal sleeve portion connecting the balloon portion and the distal shaft portion, A proximal sleeve portion connecting the balloon portion and the proximal shaft portion, and having A balloon catheter in which the length of the distal sleeve portion is longer than the length of the proximal sleeve portion.
2. The balloon portion group includes an inner balloon portion in which a guide wire tube into which a guide wire is inserted is disposed inside, and an outer balloon portion located radially outside the inner balloon portion. The balloon catheter according to claim 1.
3. The length of the distal sleeve portion connecting the outer balloon portion and the distal shaft portion is longer than the length of the proximal sleeve portion connecting the outer balloon portion and the proximal shaft portion. The balloon catheter according to claim 2.
4. The proximal end of the inner balloon portion is located on the distal side of the proximal end of the outer balloon portion. The balloon catheter according to claim 2.
5. The maximum outer diameter at the distal portion of the inner balloon portion is larger than the maximum outer diameter at the proximal portion of the inner balloon portion. The balloon catheter according to claim 2.
6. The maximum outer diameter at the distal portion of the outer balloon portion is larger than the maximum outer diameter at the proximal portion of the outer balloon portion. The balloon catheter according to claim 2.
7. The proximal sleeve portion has a flow path through which fluid can pass. The balloon catheter according to any one of claims 1 to 6.
8. The distal sleeve portion has a flow path through which fluid can pass. The balloon catheter according to any one of claims 1 to 6.
9. The distal sleeve portion does not have a flow path through which fluid can pass. The balloon catheter according to any one of claims 1 to 6.
10. The balloon portion has a straight tube portion, a distal tapered portion located on the distal side of the straight tube portion and having an outer diameter decreasing toward the distal side, and a proximal tapered portion located on the proximal side of the straight tube portion and having an outer diameter decreasing toward the proximal side. The balloon catheter according to any one of claims 1 to 6.
11. The balloon catheter according to claim 10, wherein a length of the proximal sleeve portion in a longitudinal direction of the proximal shaft portion is equal to or less than a length of the proximal tapered portion in the longitudinal direction of the proximal shaft portion.
Citation Information
Patent Citations
Stability device for use with percutaneous delivery systems
US20120209375A1