BALLOON CATHETER
20230191091 · 2023-06-22
Assignee
Inventors
Cpc classification
A61M25/008
HUMAN NECESSITIES
A61M2025/1052
HUMAN NECESSITIES
A61M2025/1075
HUMAN NECESSITIES
A61M25/1036
HUMAN NECESSITIES
A61M25/007
HUMAN NECESSITIES
International classification
Abstract
A balloon catheter includes a shaft having a first shaft portion and a second shaft portion located on a proximal side of the first shaft portion, and a balloon covering and joined to the second shaft portion. The first shaft portion is more flexible than the second shaft portion and has a length in an axial direction of 1.5 cm or more.
Claims
1. A balloon catheter comprising: a shaft including a first shaft portion and a second shaft portion located on a proximal side of the first shaft portion; and a balloon covering and joined to the second shaft portion, wherein the first shaft portion is more flexible than the second shaft portion and has a length in an axial direction of 1.5 cm or more.
2. The balloon catheter according to claim 1, wherein: an outer layer of the first shaft portion and an outer layer of the second shaft portion are each formed of a resin; and a resin material of the outer layer of the first shaft portion has a Shore hardness of D47 or less.
3. The balloon catheter according to claim 1, wherein: an outer layer of the first shaft portion and an outer layer of the second shaft portion are each formed of a resin; and a resin material of the outer layer of the first shaft portion has a Shore hardness of D40 or less.
4. The balloon catheter according to claim 1, wherein: a first lumen penetrating from a proximal side of the second shaft portion to a distal end of the first shaft portion is formed in the shaft; and a side hole communicating with the first lumen is formed in an outer peripheral surface of the first shaft portion on a proximal side.
5. The balloon catheter according to claim 1, wherein a hydrophilic coating is formed on at least a distal side of an outer peripheral surface of the first shaft portion.
6. The balloon catheter according to claim 5, wherein: the hydrophilic coating is formed on the outer peripheral surface of a distal portion of the first shaft portion; and a coefficient of friction of the outer peripheral surface of the first shaft portion at a position proximal of the hydrophilic coating is higher than a coefficient of friction of the hydrophilic coating.
7. The balloon catheter according to claim 1, wherein: the first shaft portion and the second shaft portion are integrally formed; a first lumen and a second lumen are formed in the shaft, the first lumen penetrating from a proximal side of the second shaft portion to a distal end of the first shaft portion, the second lumen extending from the proximal side of the second shaft portion to an inside of the balloon and communicating with the balloon; and an outer diameter of the first shaft portion is smaller than an outer diameter of the second shaft portion.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
DETAILED DESCRIPTION OF EMBODIMENTS
A-1. Basic Configuration of Balloon Catheter 100:
[0024]
[0025] In
[0026] The balloon catheter 100 is a medical device which is inserted into the blood vessel, for example, in order to block a blood flow by inflating the balloon 30 so as to be in close contact with the blood vessel wall on a front side of a lesion (a stenosis or occluded part) in the blood vessel. As shown in
[0027] The shaft 10 is a tubular (e.g., cylindrical) member with distal and proximal ends opened. Note that, in the present specification, the term “tubular (cylindrical)” is not limited to a complete tubular shape (cylindrical shape) and may include a substantially tubular shape (substantially cylindrical shape, e.g., a slightly conical shape, a shape with some unevenness, and the like) as a whole. As shown in
[0028] Specifically, the shaft 10 includes the distal shaft portion 14 and the proximal shaft portion 16. The distal shaft portion 14 is an example of a first shaft portion in the scope of claims, and the proximal shaft portion 16 is an example of a second shaft portion in the scope of claims.
[0029] The distal shaft portion 14 is a portion that includes the distal end of the shaft 10. The distal shaft portion 14 has a single lumen structure in which only the main lumen Si is formed. The main lumen S1 penetrates the entire length of the distal shaft portion 14 in the axial direction. As shown in
[0030] Note that the distal tip 12 is disposed at the distal end of the distal shaft portion 14. The distal tip 12 is a tubular member with front and rear ends opened. The distal tip 12 may have an outer shape with the same outer diameter over the entire length or may have a tapered outer shape in which the outer diameter gradually decreases toward the distal end. A device inserted into the main lumen S1 is led out from the distal end of the distal tip 12 to the outside. The distal tip 12 has flexibility equal to or more than that of the proximal side of the distal shaft portion 14.
[0031] The proximal shaft portion 16 is a portion that includes the proximal end of the shaft 10. The distal shaft portion 14 and the proximal shaft portion 16 are adjacent to each other in the axial direction. The proximal shaft portion 16 has a double lumen structure in which the expansion lumen S2 is formed in addition to the main lumen S1. The main lumen S1 penetrates the entire length of the proximal shaft portion 16 in the axial direction. The expansion lumen S2 extends from the proximal end of the proximal shaft portion 16 toward the distal side and opens to the outer peripheral surface of the distal portion of the proximal shaft portion 16. Specifically, as shown in
[0032] The diameter of the main lumen S1 formed in the distal shaft portion 14 and the diameter of the main lumen S1 formed in the proximal shaft portion 16 are substantially the same. Note that, in the present specification, the phrase “A and B being substantially the same” means that the error between A and B is 5% or less of A or B. That is, the main lumen S1 having substantially the same diameter is formed so as to penetrate the entire length of the shaft 10. When viewed from the axial direction, a thickness D2 of the proximal shaft portion 16 on the side opposite the expansion lumen S2 is substantially the same as the thickness D1 of the distal shaft portion 14. A thickness D3 of the proximal shaft portion 16 on the side where the expansion lumen S2 is formed is larger than the thickness D2 on the side opposite to the expansion lumen S2. In this manner, the distal shaft portion 14 has a thinner part as compared with the proximal shaft portion 16, and the outer diameter of the distal shaft portion 14 is smaller than the outer diameter of the proximal shaft portion 16. This makes the distal shaft portion 14 more flexible than the proximal shaft portion 16. For example, the Shore hardness of an outer layer resin material of the distal shaft portion 14 is D47 or less. The Shore hardness of the outer layer resin material of the distal shaft portion 14 may be D40 or less. Note that the connector 40 is attached to the proximal end of the proximal shaft portion 16 for introducing a device, a fluid, and the like into the lumens S1 and S2.
[0033] In the present embodiment, the shaft 10 is integrally formed of the same material in the entire shaft. The shaft 10 is preferably formed of a material that can be heat-sealed and has a certain degree of flexibility. Examples of the material for forming the shaft 10 include a thermoplastic resin, more specifically a polyolefin such as polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more kinds thereof, a polyvinyl chloride resin, polyamide, nylon, a polyamide elastomer, polyester, a polyester elastomer, thermoplastic polyurethane, and the like.
[0034] As shown in
[0035] The balloon 30 is an inflation portion that can be inflated and deflated with supply and exhaustion of a fluid. The balloon 30 covers the outer periphery of the distal portion of the proximal shaft portion 16. A distal portion 32 and a rear portion 34 of the balloon 30 are each joined to the outer peripheral surface of the distal portion of the proximal shaft portion 16 by, for example, welding. Note that, in the present embodiment, the distal portion 32 of the balloon 30 is joined to the outer peripheral surface of the distal end of the proximal shaft portion 16, and the joint part between the distal portion 32 and the proximal shaft portion 16 is adjacent to the distal shaft portion 14 in the axial direction. The expansion lumen S2 described above communicates with an internal space S3 (refer to
[0036] The balloon 30 is preferably formed of a material having a certain degree of flexibility, and more preferably formed of a material that is thinner than the shaft 10 and has flexibility. Examples of the material for forming the balloon 30 include a thermoplastic resin such as a polyolefin such as polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more kinds thereof, a soft polyvinyl chloride resin, polyamide, a polyamide elastomer, polyester, a polyester elastomer, polyurethane, or a fluororesin, silicone rubber, latex rubber, and the like.
A-2. Usage Example of Balloon Catheter 100:
[0037] Next, a usage example of the balloon catheter 100 in the first embodiment will be described.
[0038] Specifically, the balloon catheter 100 with the deflated balloon 30 is inserted into the blood vessel and pushed through the common carotid artery B into, for example, the cervical part of internal carotid artery B2. A petrous P, which is a bent blood vessel, exists in the cervical part of internal carotid artery B2. Here, the proximal shaft portion 16 of the shaft 10 has relatively low flexibility (high rigidity), and in particular, the joint part between the balloon 30 and the proximal shaft portion 16 has low flexibility. This makes it difficult to insert the proximal shaft portion 16 into the petrous P.
[0039] On the other hand, the distal shaft portion 14 of the shaft 10 has relatively high flexibility, and the length of the distal shaft portion 14 in the axial direction is 1.5 cm or more. Thus, as shown in
A-3. Advantageous Effects of Present Embodiment:
[0040] As described above, in the balloon catheter 100 of the present embodiment, the distal shaft portion 14 having relatively high flexibility is disposed on the distal side of the balloon 30 (refer to
[0041] Further, as shown in
[0042] In particular, the hydrophilic coating 18 having the relatively low coefficient of friction is formed in the distal portion of the distal shaft portion 14. This allows the distal side of the distal shaft portion 14 to be smoothly inserted into the petrous P. Further, the hydrophilic coating 18 is not formed on the proximal side of the distal shaft portion 14, providing the relatively high coefficient of friction. As a result, the proximal side of the distal shaft portion 14 is brought into contact with the inner wall surface of the petrous P, while the distal shaft portion 14 is bent, allowing the position of the distal shaft portion 14 in the blood vessel to be more firmly fixed. This can further improve the support force of the balloon catheter 100.
B-1. Basic Configuration of Balloon Catheter 100a:
[0043]
[0044] The shaft 10a included in the balloon catheter 100a is a tubular (e.g., cylindrical) member with distal and proximal ends opened. As shown in
[0045] Specifically, the shaft 10a includes the distal shaft portion 14a and the proximal shaft portion 16a. The distal shaft portion 14a is an example of the first shaft portion in the scope of claims, and the proximal shaft portion 16a is an example of the second shaft portion in the scope of claims.
[0046] Like the distal shaft portion 14 of the above-mentioned first embodiment, the distal shaft portion 14a has a single lumen structure in which only the main lumen S1 is formed (refer to
[0047] The proximal shaft portion 16a has a coaxial structure in which the expansion lumen S2a is formed in addition to the main lumen S1. The expansion lumen S2a extends from the proximal end of the proximal shaft portion 16a toward the distal side and opens to the outer peripheral surface of the distal portion of the proximal shaft portion 16a. Specifically, as shown in
[0048] As shown in
B-2. Usage Example of Balloon Catheter 100a:
[0049] Next, a usage example of the balloon catheter 100a in the second embodiment will be described.
[0050]
C. Modifications:
[0051] The technology disclosed in the present specification is not limited to the above-described embodiments and can be modified in various forms without departing from the scope of the disclosed embodiments. For example, the following modifications are possible.
[0052] The configurations of the balloon catheters 100 and 100a in the above-mentioned embodiments are merely examples, and various modifications are possible. For example, the length of the distal shaft portions 14 and 14a in the axial direction in each of the above-mentioned embodiments may be any length of 1.5 cm or more. Specifically, in the above-mentioned first embodiment, the length of the distal shaft portion 14 in the axial direction may be 1.5 cm or more and less than 2 cm, or longer than 2 cm. In the above-mentioned second embodiment, the length of the distal shaft portion 14a in the axial direction may be 1.5 cm or more and less than 20 cm, or longer than 20 cm. In each of the above-mentioned embodiments, the distal shaft portions 14 and 14a may be configured without the distal tip 12.
[0053] In each of the above-mentioned embodiments, the configuration may be made such that the main lumen S1 and the expansion lumens S2 and S2a do not extend to the proximal ends of the proximal shaft portions 16 and 16a (shafts 10 and 10a) but bend halfway and open to the outer peripheral surface of the shaft 10. Further, the expansion lumens S2 and S2a may be configured to extend to the distal shaft portions 14 and 14a. In the above-mentioned embodiments, the number of the lumens formed in the distal shaft portions 14 and 14a may be 2 or more, and the number of the lumens formed in the proximal shaft portions 16 and 16a may be 3 or more. In essence, in the configuration in which the first shaft portion and the second shaft portion are formed of the same material, the first shaft portion is formed in a shape having a cross section more flexible (i.e., less rigid in bending) than that of the second shaft portion, so that it becomes possible to achieve the shaft in the scope of claims. For example, in the above-mentioned embodiments, the configuration is made such that the number of the lumens formed in the first shaft portion is less than the number of the lumens formed in the second shaft portion, and the outer diameter of the first shaft portion is smaller than the outer diameter of the second shaft portion. Further, the shaft may be configured such that the first shaft portion is formed of a material having hardness lower than that of the material forming the second shaft portion.
[0054] In the above-mentioned embodiments, the distal portion 32 of the balloon 30 may be configured to join to the slightly further proximal side than the distal portions of the proximal shaft portions 16 and 16a. That is, the balloon 30 may be configured to join to the distal side of the proximal shaft portions 16 and 16a. In essence, the balloon catheter in the scope of claims only needs to have a configuration in which the first shaft portion having relatively high flexibility is disposed on the further distal side than the second shaft portion to which the balloon is joined.
[0055] In the above-mentioned embodiments, the balloon catheters 100 and 100a may be configured without the hydrophilic coatings 18 and 18a. Further, in the above-described first embodiment, the configuration may be made such that a side hole is formed in the outer peripheral surface of the distal shaft portion 14. In the above-described second embodiment, the configuration may be made such that no side hole is formed in the outer peripheral surface of the distal shaft portion 14a.
[0056] In the above-mentioned embodiments, the configuration may be made such that the outer diameter of the shafts 10 and 10a are substantially the same over the entire length. Further, the shape of the cross section of the shafts 10 and 10a is not limited to a circular shape and may be a polygonal shape or the like. Further, the entire shafts 10 and 10a, the distal shaft portions 14 and 14a, or the proximal shaft portions 16 and 16a are not limited to a single-layer structure, and they may be configured to include a plurality of resin layers (e.g., an inner layer resin and an outer layer resin) or have a structure in which a reinforcing body (blade), a coil body, or the like is further embedded. In the above-mentioned embodiments, when the shafts 10 and 10a include a plurality of the resin layers and the reinforcing body, the configuration may be made such that, for each of the plurality of the resin layers and the reinforcing body, the distal shaft portions 14 and 14a and the proximal shaft portions 16 and 16a are integrally formed using the same material.
[0057] Further, the material of each member in the above-mentioned embodiments is merely an example, and various modifications are possible.
[0058] In the above-mentioned embodiments, the balloon catheters 100 and 100a to be inserted into the blood vessel are exemplified as the balloon catheter. However, the balloon catheter may be the one to be inserted into a body lumen other than the blood vessel (e.g., the esophagus, etc.).
DESCRIPTION OF REFERENCE NUMERALS
10, 10a: Shaft
12: Distal tip
[0059] 14, 14a: Distal shaft portion
16, 16a: Proximal shaft portion
18, 18a: Hydrophilic coating
20: Side hole
30: Balloon
[0060] 32: Distal portion
34: Rear portion
40: Connector
[0061] 100, 100a: Balloon catheter
B1: External carotid artery
B2: Cervical part of internal carotid artery
B3: Petrous part of internal carotid artery
B4: Ophthalmic artery
B5: Anterior cerebral artery
B6: Middle cerebral artery
B: Common carotid artery
C: Thrombus piece
P: Petrous
[0062] S1: Main lumen
S2, S2a: Expansion lumen
S3: Internal space