CATHETER ASSEMBLY
20200155813 ยท 2020-05-21
Assignee
Inventors
Cpc classification
A61M25/0009
HUMAN NECESSITIES
A61M25/0052
HUMAN NECESSITIES
A61M25/1025
HUMAN NECESSITIES
A61M2025/0006
HUMAN NECESSITIES
A61M2025/1079
HUMAN NECESSITIES
A61M2025/1061
HUMAN NECESSITIES
A61M25/005
HUMAN NECESSITIES
A61M25/0053
HUMAN NECESSITIES
International classification
Abstract
Disclosed herein is a catheter comprising an outer shaft; and an inner shaft that is disposed inside the outer shaft, wherein the inner shaft includes: a first shaft part that is made of a first resin, a second shaft part that is made of a second resin, harder than the first resin, and provided on a proximal end of the first shaft part, and a large diameter portion that is provided between the first shaft part and the second shaft part so that a proximal end portion of the first shaft part and a distal end portion of the second shaft part overlap and has an outer diameter larger than an outer diameter of the first shaft part and an outer diameter of the second shaft part, and the large diameter portion includes a joint part joining the outer shaft and the inner shaft to each other.
Claims
1. A catheter, comprising: an outer shaft; and an inner shaft that is disposed inside the outer shaft, wherein the inner shaft includes: a first shaft part that is made of a first resin, a second shaft part that is made of a second resin, harder than the first resin, and provided on a proximal end of the first shaft part, and a large diameter portion that is provided between the first shaft part and the second shaft part so that a proximal end portion of the first shaft part and a distal end portion of the second shaft part overlap and has an outer diameter larger than an outer diameter of the first shaft part and an outer diameter of the second shaft part, and the large diameter portion includes a joint part joining the outer shaft and the inner shaft to each other.
2. The catheter according to claim 1, wherein the large diameter portion is formed so that the proximal end portion of the first shaft part covers the distal end portion of the second shaft part, the outer shaft is joined to the proximal end portion of the first shaft part at the large diameter portion.
3. The catheter according to claim 1, wherein the large diameter portion is formed so that the distal end portion of the second shaft part covers the proximal end portion of the first shaft part, the outer shaft is joined to the distal end portion of the second shaft part at the large diameter portion.
4. The catheter according to claim 1, wherein the inner shaft further includes a reinforcing layer that extends from the first shaft part through the large diameter portion to the second shaft part and is wound by strands having a gap between the adjacent strands.
5. The catheter according to claim 4, wherein in the large diameter portion, the proximal end portion of the first shaft part is joined to the distal end portion of the second shaft part in a state of entering the gap between the strands.
6. The catheter according to claim 1, wherein the large diameter portion is formed by irradiation with laser light from outside of the outer shaft.
7. The catheter according to claim 1, wherein the joint part is formed by joining the outer shaft and the inner shaft to each other using an adhesive.
8. A balloon catheter, comprising: a balloon; an outer shaft that is joined to a proximal end of the balloon; and an inner shaft that is disposed inside the outer shaft and joined to a distal end of the balloon, wherein the inner shaft includes: a first shaft part that is made of a first resin, a second shaft part that is made of a second resin, harder than the first resin, and provided on a proximal end of the first shaft part, and a large diameter portion that is provided between the first shaft part and the second shaft part so that a proximal end portion of the first shaft part and a distal end portion of the second shaft part overlap and has an outer diameter larger than an outer diameter of the first shaft part and an outer diameter of the second shaft part, and the large diameter portion includes a joint part joining the outer shaft and the inner shaft to each other.
9. The balloon catheter according to claim 8, wherein the large diameter portion is formed so that the proximal end portion of the first shaft part covers the distal end portion of the second shaft part, the outer shaft is joined to the proximal end portion of the first shaft part at the large diameter portion.
10. The balloon catheter according to claim 8, wherein the large diameter portion is formed so that the distal end portion of the second shaft part covers the proximal end portion of the first shaft part, the outer shaft is joined to the distal end portion of the second shaft part at the large diameter portion.
11. The balloon catheter according to claim 8, wherein the inner shaft further includes a reinforcing layer that extends from the first shaft part through the large diameter portion to the second shaft part and is wound by strands having a gap between the adjacent strands.
12. The balloon catheter according to claim 11, wherein in the large diameter portion, the proximal end portion of the first shaft part is joined to the distal end portion of the second shaft part in a state of entering the gap between the strands.
13. The balloon catheter according to claim 8, wherein the large diameter portion is formed by irradiation with laser light from outside of the outer shaft.
14. The balloon catheter according to claim 8, wherein the joint part is formed by joining the outer shaft and the inner shaft to each other using an adhesive.
15. A balloon catheter, comprising: a balloon; an outer shaft that is joined to a proximal end of the balloon; and an inner shaft that is disposed inside the outer shaft and joined to a distal end of the balloon, wherein an expansion lumen is formed between an outer surface of the inner shaft and an inner surface of the outer shaft; a core wire disposed in the expansion lumen; and wherein the inner shaft includes: a first shaft part that is made of a first resin, a second shaft part that is made of a second resin, harder than the first resin, and provided on a proximal end of the first shaft part, and a large diameter portion that is provided between the first shaft part and the second shaft part so that a proximal end portion of the first shaft part and a distal end portion of the second shaft part overlap and has an outer diameter larger than an outer diameter of the first shaft part and an outer diameter of the second shaft part, and the large diameter portion includes a joint part joining the outer shaft and the inner shaft to each other.
16. The balloon catheter of claim 15, wherein a distal end of the core wire has a bulging portion formed to transmit a pushing force from the core wire to the distal end of the inner shaft through the large diameter portion.
17. The balloon catheter according to claim 15, wherein the large diameter portion is formed so that the proximal end portion of the first shaft part covers the distal end portion of the second shaft part, the outer shaft is joined to the proximal end portion of the first shaft part at the large diameter portion.
18. The balloon catheter according to claim 15, wherein the large diameter portion is formed so that the distal end portion of the second shaft part covers the proximal end portion of the first shaft part, the outer shaft is joined to the distal end portion of the second shaft part at the large diameter portion.
19. The balloon catheter according to claim 15, wherein the inner shaft further includes a reinforcing layer that extends from the first shaft part through the large diameter portion to the second shaft part and is wound by strands having a gap between the adjacent strands.
20. The balloon catheter according to claim 19, wherein in the large diameter portion, the proximal end portion of the first shaft part is joined to the distal end portion of the second shaft part in a state of entering the gap between the strands.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0008]
[0009]
[0010]
[0011]
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
DETAILED DESCRIPTION
[0025] Embodiments of the present disclosure aim at providing a catheter capable of preventing a guide wire from being caught at the joint part between the outer shaft and the inner shaft.
[0026] A catheter according to one aspect of the present disclosure for solving the above-described problem may include an outer shaft, and an inner shaft that is disposed inside the outer shaft, in which the inner shaft includes a first shaft part that is made of a first resin, a second shaft part that is made of a second resin, harder than the first resin and provided on a proximal end of the first shaft part, and a large diameter portion that is provided between the first shaft part and the second shaft part so that a proximal end portion of the first shaft part and a distal end portion of the second shaft part overlap and the large diameter portion has an outer diameter larger than an outer diameter of the first shaft part and an outer diameter of the second shaft part, and the large diameter portion includes a joint part joining the outer shaft and the inner shaft to each other.
[0027] Although the detailed description below refers primarily to a balloon catheter, those skilled in the art will recognize that the embodiments described herein may be used for other types of catheters.
[0028] Embodiments of the present disclosure will now be described in detail with reference to
[0029]
[0030] The balloon catheter 1 may be used for expanding and treating a constricted part formed in a blood vessel or a digestive organ, for example. As illustrated in
[0031] The balloon 10 may be made of a resin member formed with materials such as a polyether block amide copolymer (nylon-based elastomer resin) and polyurethane resin, and may include a distal end attachment portion 12 on the distal end and a proximal end attachment portion 13 on the proximal end. The distal end attachment portion 12 may be joined to the distal end of the inner shaft 30 through the distal tip 40, and the proximal end attachment portion 13 may be joined to the distal end of the outer shaft 20. In
[0032] The outer shaft 20 may be a tubular member that forms an expansion lumen 36 for supplying liquid such as a contrast medium or physiological saline in order to expand the balloon 10. The outer shaft 20 may include a distal end outer shaft portion 21, a guide wire port portion 22, an intermediate outer shaft portion 23, and a proximal end outer shaft portion 24 in this order from the distal end. The distal outer shaft portion 21 and the intermediate outer shaft portion 23 may be tubes made of resin such as polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer. The guide wire port portion 22 may be a portion where the proximal end of the distal end outer shaft portion 21, the distal end of the intermediate outer shaft portion 23, and the proximal end of the inner shaft 30 are joined.
[0033] The inner shaft 30 may be inserted into the distal outer shaft portion 21, and the above-described expansion lumen 36 may be formed between the distal end outer shaft portion 21 and the inner shaft 30.
[0034] The proximal end outer shaft portion 24 may be a metallic tubular member referred to as a so-called hypotube. The distal end of the proximal end outer shaft portion 24 may be inserted and joined to the proximal end of the intermediate outer shaft portion 23. The connector 55 may be attached to the proximal end of the proximal end outer shaft portion 24. When liquid such as a contrast medium or physiological saline for expanding the balloon 10 is supplied from an indeflator (not illustrated) attachable to the connector 55, the liquid may pass through the expansion lumen 36 and expand the balloon 10. The material of the proximal end outer shaft portion 24 is not particularly limited, and stainless steel (SUS304) or superelastic alloys such as NiTi alloy may be used.
[0035] The inner shaft 30 may form a guide wire lumen 31 for inserting a guide wire to the inside. Further, the proximal end of the inner shaft 30 may be joined to the guide wire port portion 22 of the outer shaft 20 to form a proximal end guide wire port 32.
[0036] The distal tip 40 may be joined to the distal end of the inner shaft 30. The distal tip 40 may be made of a soft resin. The material is not particularly limited, and polyurethane, polyurethane elastomer, or the like may be used. The distal tip 40 may have a distal end guide wire port 42 at the distal end.
[0037] One or more markers 15 having radiopacity may be attached to the inner shaft 30 in the balloon 10 so that the position of the balloon 10 may be observed under irradiation. The number and position of the markers 15 may be appropriately changed depending on the length of the balloon 10.
[0038] A core wire 50 may be attached to the inner peripheral surface of the distal end of the proximal end outer shaft portion 24. The core wire 50 may be a tapered metal wire rod having a circular cross section and having a diameter reduced toward the distal end. The material of the core wire 50 is not particularly limited, and stainless steel (SUS304) or superelastic alloys such as NiTi alloy may be used. The core wire 50 may pass through the intermediate outer shaft portion 23 and the guide wire port portion 22, and may extend to the distal end outer shaft portion 21.
[0039] The inner shaft 30 may include a first shaft part 60 formed of a flexible first resin, and a second shaft part 70 formed of a second resin harder than the first resin on the proximal end of the first shaft part 60. In an embodiment, a polyether block amide copolymer (nylon elastomer resin) may be used for the first shaft part 60, while polyamide resin may be used for the second shaft part 70. The embodiment is not limited thereto, and may be such that the first shaft part 60 and the second shaft part 70 are formed of the same resin, and the Shore hardness of the first shaft part 60 on the distal end can be lower than the Shore hardness of the second shaft part 70 on the proximal end.
[0040]
[0041]
[0042] Thus, in the balloon catheter 1, the outer shaft 20 and the inner shaft 30 are joined to each other at the large diameter portion 80 having the large outer diameter D3. This may reduce the possibility that the inner shaft 30 is curved appreciably to the outer shaft 20 side (paper surface upper side in
[0043] Further, with the large diameter portion 80 including the joint part 90 joining the outer shaft 20 and the inner shaft 30, it is possible to reduce the possibility that the second shaft portion 70 is pulled out from the first shaft part 60 when the balloon catheter 1 is pulled toward the proximal end. Further, in the large diameter portion 80, the proximal end portion of the first shaft part 60 and the distal end portion of the second shaft part 70 are overlapped, and thereby the thickness of the large diameter portion 80 is increased (see
[0044] In the balloon catheter 1, the second shaft part 70 on the proximal end may be formed of a hard resin, and the first shaft part 60 on the distal end may be formed of a flexible resin. Thus, when the operator pushes the balloon catheter 1 into the distal end, the pushing force of the operator can be easily transmitted to the distal end, thereby allowing the balloon 10 to be easily inserted into a constricted part.
[0045] In an embodiment, the joint part 90 may be formed by irradiation with laser light from the outside of the outer shaft 20 in a state where the large diameter portion 80 is drawn toward the outer shaft 20 side (paper surface upper side in
[0046]
[0047]
[0048] Also with this configuration, it is possible to exert the same actions and effects as with the balloon catheter 1 according to some embodiments. In addition, in the balloon catheter 2, with the hard second shaft part 70a existing on the inner side of the flexible first shaft 60a at the joint part 90a between the outer shaft 20 and the inner shaft 30a, the circularity of the guide wire lumen 31 at the joint part 90a is further secured (in other words, the crushing of the inner shaft 30a at the joint part 90a can be further reduced), which consequently reduces the possibility that the guide wire is caught at the joint part 90a.
[0049]
[0050] The material of the strand 101 forming the reinforcement layer 100 is not particularly limited, and stainless steel (SUS304), superelastic alloys such as NiTi alloy, or PEEK (polyether ether ketone) resin may be used. In an embodiment, polytetrafluoroethylene (PTFE) may be used as the inner layer 33. However, the material used for the inner layer 33 is not particularly limited.
[0051] As illustrated in
[0052]
[0053] Also with this configuration, it may be possible to exert the same actions and effects as the balloon catheter 1 and the balloon catheter 2. In addition, in the balloon catheter 3, with the reinforcing layer 100 existing inside the second shaft part 70b at the joint part 90b between the outer shaft 20 and the inner shaft 30b, the circularity of the guide wire lumen 31 at the joint part 90b is further secured (in other words, the crushing of the inner shaft 30b at the joint part 90b can be further reduced), which consequently reduces the possibility that the guide wire is caught at the joint part 90b.
[0054]
[0055] The large diameter portion 80c may include a joint part 90c where the proximal end portion 62 of the first shaft part 60c is joined to the distal end portion 72 of the second shaft part 70c in a state where the proximal end portion 62 of the first shaft part 60c enters the gap 102 between the strands 101. Therefore, with the anchor effect between the proximal end portion 62 of the first shaft part 60c and the distal end portion 72 of the second shaft part 70c, and the anchor effect between the proximal end portion 62 of the first shaft part 60c and the strand 101 of the reinforcing layer 100, it may be possible to further reduce the possibility that the second shaft part 70c is pulled out from the first shaft part 60c when the balloon catheter 4 is pulled toward the proximal end.
[0056] In an embodiment, the joint part 90c may be provided by being irradiated with laser light from the outside of the outer shaft 20 in a state where the large diameter portion 80c is drawn toward the outer shaft 20 side (paper surface upper side in
[0057]
[0058]
[0059] The first shaft parts 60a, 60b, 60c described in the above-described embodiments may be formed of the same resin material as that of the first shaft part 60 described in the embodiments illustrated in
[0060] Further, the bulging portion 52 described in the embodiments illustrated in
[0061] Further, in the balloon catheters 1, 2, 3, 4, 5, the position of the joint parts 90, 90a, 90b, and 90c is not particularly limited. It may be formed, for example, slightly on the proximal end from the proximal end attachment portion 13 of the balloon 10, or slightly on the distal end from the guide wire port portion 22.