This disclosure relates to a balloon catheter.
As shown in JP 5913739 B2, in recent years, treatment using a balloon catheter has been performed. Balloon catheters are used to cauterize myocardial tissue with heated liquid in the balloon, for example, in the treatment of arrhythmias.
The catheter system 100 illustrated in
Such an operation of the balloon catheter 110 is very complicated because it is necessary to operate the three-way stopcock 140 and the like while holding the catheter shaft 111 inserted into the body of the patient. Therefore, operation of the balloon catheter 110 requires a plurality of personnel. For example, as indicated by broken lines in
Meanwhile, it is required to improve the operability of the balloon catheter so that the number of personnel required for operating the balloon catheter can be reduced.
It could therefore be helpful to provide a balloon catheter with improved operability.
We thus provide:
A balloon catheter comprises: a housing; a catheter shaft having a proximal end portion disposed in the housing and forming a liquid feeding path communicating with an inside of a balloon attached to a distal end portion of the catheter shaft; a supply-discharge line connection portion which has an internal space communicating with the liquid feeding path, and to which a supply-discharge line that supplies and discharges liquid to and from the liquid feeding path through the internal space can be connected; and a stopcock capable of closing the internal space of the supply-discharge line connection portion, in which a position of the supply-discharge line connection portion with respect to the housing is fixed.
The balloon catheter may further comprise: the supply-discharge line connected to the supply-discharge line connection portion; and a supply-discharge device that is connected to the supply-discharge line to supply and discharge liquid to and from the supply-discharge line, and the supply-discharge line may include a soft tube having a length of 200 mm or more.
The balloon catheter may further comprise a stirring line connection portion which has an internal space communicating with the liquid feeding path, and to which a stirring line that sucks and discharges liquid from and into the liquid feeding path through the internal space of the stirring line connection portion to stir liquid in the balloon can be connected, and a connection portion between the internal space of the stirring line connection portion and the liquid feeding path may be located closer to the distal end portion of the catheter shaft than a connection portion between the internal space of the supply-discharge line connection portion and the liquid feeding path.
The stirring line connection portion may be fixed to the housing.
The catheter shaft may include an inner cylinder shaft to which a distal end of the balloon is fixed and an outer cylinder shaft to which a proximal end of the balloon is fixed, the outer cylinder shaft having a lumen into which the inner cylinder shaft is inserted to form the liquid feeding path between the outer cylinder shaft and the inner cylinder shaft, and the housing may be provided with an operation unit that extends the balloon by moving the inner cylinder shaft relative to the outer cylinder shaft along a first direction in which the proximal end portion of the catheter shaft extends.
The housing may include a narrow portion narrowed in a direction intersecting a first direction in which the proximal end portion of the catheter shaft extends, a first gripping portion connected to the narrow portion from one side in the first direction, and a second gripping portion connected to the narrow portion from the other side in the first direction.
The catheter shaft may include an inner cylinder shaft to which a distal end of the balloon is fixed and an outer cylinder shaft to which a proximal end of the balloon is fixed, the outer cylinder shaft having a lumen into which the inner cylinder shaft is inserted to form the liquid feeding path between the outer cylinder shaft and the inner cylinder shaft, a maximum outer radius of the first gripping portion about an axis extending along the first direction may be larger than a maximum outer radius of the second gripping portion about an axis extending along the first direction, and the first gripping portion may be provided with an operation unit that moves the inner cylinder shaft relative to the outer cylinder shaft along the first direction to extend the balloon.
Alternatively, a balloon catheter comprises: a housing; and a catheter shaft having a proximal end portion disposed in the housing and forming a liquid feeding path communicating with an inside of a balloon attached to a distal end portion, in which the housing includes a narrow portion narrowed in a direction intersecting a first direction in which the proximal end portion of the catheter shaft extends, a first gripping portion connected to the narrow portion from one side in the first direction, and a second gripping portion connected to the narrow portion from the other side in the first direction.
Alternatively, a balloon catheter comprises: a housing;
It is thus possible to provide a balloon catheter with improved operability.
1 catheter system 1, 10 balloon catheter 15 balloon 20 catheter shaft 22 inner cylinder shaft 24 outer cylinder shaft 30 supply-discharge line connection portion 31 internal space of supply-discharge line connection portion 35 stopcock 40 stirring line connection portion 41 internal space of stirring line connection portion 50 operation unit 55 housing 57 narrow portion 58 first gripping portion 59 second gripping portion 60 stirring line 65 stirring device 70 heating electrode 71 lead wire 75 heating device
The catheter system 1 illustrated in
The catheter 10 comprises a catheter shaft 20 having a distal end to which a balloon 15 is attached, a supply-discharge line connection portion 30, a stopcock 35, a stirring line connection portion 40, an operation unit 50 for extending the balloon 15, and a housing 55 that accommodates a proximal end portion of the catheter shaft 20. In the illustrated example, the catheter 10 further comprises a supply-discharge line 36 connected to the supply-discharge line connection portion 30, a supply-discharge device 38 connected to the supply-discharge line 36, and a heating electrode 70 electrically connected to the heating device 75 to heat the liquid in the balloon 15.
The terms “distal ends” and “distal end portions” used with respect to the balloon 15, the catheter shaft 20 (including its inner cylinder shaft 22 and outer cylinder shaft 24 to be described later), the operation unit 50, and the housing 55 (including each portion of the housing 55) respectively mean end portions on the side close to the distal end of the catheter 10 extended in a straight line unless otherwise specified. In addition, the terms “proximal ends” and “proximal end portions” used with respect to the balloon 15, the catheter shaft 20, the operation unit 50, and the housing 55 respectively mean end portions opposite to the distal ends of the balloon 15, the catheter shaft 20, the operation unit 50, and the housing 55 unless otherwise specified.
As illustrated in
The outer cylinder shaft 24 is not movable with respect to the inside of the housing 55. The inner cylinder shaft 22 is movable relative to the outer cylinder shaft 24 along the longitudinal direction of the catheter shaft 20. In the illustrated example, the inner cylinder shaft 22 is movable between two positions (balloon inflatable position illustrated in
The length of the catheter shaft 20 is preferably 0.5 to 2 m from the viewpoint of allowing the balloon 15 to reach the myocardial tissue. Further, the diameter of the catheter shaft 20 is preferably 3 to 5 mm from the viewpoint of insertion into a blood vessel. The material of the catheter shaft 20 is preferably a flexible material having excellent antithrombogenicity, and examples thereof include a fluororesin, a polyamide resin, a polyurethane resin, and a polyimide resin, but are not limited thereto.
The internal space of the balloon 15 communicates with the liquid feeding path 21. In the example illustrated in
The diameter of the balloon 15 is preferably 20 to 40 mm from the viewpoint of being able to closely contact the site where the arrhythmia occurs. Further, the balloon 15 preferably has a spherical shape. Further, the thickness of the balloon 15 is preferably 20 to 100 µm. As the material of the balloon 15, a stretchable material excellent in antithrombogenicity is preferable, and a polyurethane-based polymer material is more preferable. Examples of the polyurethane-based polymer material include thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether polyurethane urea resin, and polyether polyurethane urea amide.
As illustrated in
The engagement between the movement restricting protrusion 53 and the movement restricting recess 56 can be released by the proximal end portion 51 of the operation unit 50 being elastically deformed in the second direction D2. In the illustrated example, since each movement restricting recess 56 is delimited by inclined surfaces of the side wall portions 56b facing one another in the first direction D1, when a force in the first direction D1 is applied to the operation unit 50 in a state where the movement restricting protrusion 53 and the movement restricting recess 56 are engaged, a force in the second direction D2 is applied from the side wall portion 56a to the movement restricting protrusion 53, and the proximal end portion 51 of the operation unit 50 is elastically deformed in the second direction D2. As a result, the movement restricting protrusion 53 moves in the second direction D2, and the engagement between the movement restricting protrusion 53 and the movement restricting recess 56 is released. As a matter of course, the method of releasing the engagement between the movement restricting protrusion 53 and the movement restricting recess 56 is not limited thereto. The engagement between the movement restricting protrusion 53 and the movement restricting recess 56 may be released, for example, by the housing 55 being elastically deformed in the second direction D2.
The supply-discharge line connection portion 30 is formed in a tubular shape and has an internal space 31 communicating with the liquid feeding path 21 (see
As illustrated in
The supply-discharge device 38 supplies and discharges liquid to and from the supply-discharge line 36. In the illustrated example, the supply-discharge device 38 is a syringe, but is not limited thereto. In the example illustrated in
The supply-discharge line 36 and the supply-discharge device 38 may be included in the catheter system 1 and may not be included in the balloon catheter 10.
The stopcock 35 is provided in the supply-discharge line connection portion 30. More specifically, a part of the stopcock 35 is arranged in the internal space 31 of the supply-discharge line connection portion 30, and the internal space 31 of the supply-discharge line connection portion 30 can be closed by rotating the stopcock 35 relative to the supply-discharge line connection portion 30 and arranging the stopcock 35 in a predetermined direction. In the illustrated example, the stopcock 35 is rotatable between a closed position indicated by a solid line in
As described above, the position of the supply-discharge line connection portion 30 with respect to the housing 55 is fixed. This improves the operability of the stopcock 35. Specifically, first, as illustrated in
The stirring line connection portion 40 is formed in a tubular shape and has an internal space 41 communicating with the liquid feeding path 21 (see
The stirring line 60 is connected to the stirring device 65 to suck and discharge the liquid from and into the liquid feeding path 21. The stirring device 65 periodically sucks and discharges the liquid from and into the internal space of the stirring line 60. The stirring device 65 is preferably a device that repeats suction and discharge of liquid 1 to 5 times per 1 second, and preferably includes a pump selected from the group consisting of a roller pump, a diaphragm pump, a bellows pump, a vane pump, a centrifugal pump, and a pump including a combination of a piston and a cylinder.
The stirring line connection portion 40 is connected to the proximal end portion of the outer cylinder shaft 24. In the illustrated example, the stirring line connection portion 40 is fixed to the housing 55. Accordingly, by holding the housing 55, the stirring line connection portion 40 and the stirring line 60 can be held together with the catheter shaft 20.
In the illustrated example, as illustrated in
The stirring line connection portion 40 is not provided with the stopcock 35. In the illustrated example, the stirring line connection portion 40 causes the stirring line 60 and the liquid feeding path 21 to always communicate with each other at least while the stirring line 60 is connected.
As illustrated in
In the illustrated example, the lead wire 71 is inserted into the liquid feeding path 21, but our catheters are not limited thereto.
As illustrated in
In the illustrated example, as illustrated in
Next, an example of a method of operating the catheter system 1 to which the above-described balloon catheter 10 is applied will be described with reference to
First, the distal end of the catheter 10 is inserted into the pulmonary vein. At this time, the inner cylinder shaft 22 is disposed at the balloon extension position illustrated in
After the distal end of the catheter 10 is inserted into the pulmonary vein, as illustrated in
Next, as illustrated in
When the balloon 15 is sufficiently inflated by the supplied liquid, as illustrated in
When it is determined that the balloon 15 has insufficient liquid or the balloon 15 has excessive liquid during cauterization, the liquid is supplied or discharged while the stirring of the liquid in the balloon 15 by the stirring device 65 is continued. Specifically, as illustrated in
When the cauterization is completed, the stirring device 65 and the heating device 75 are stopped. Then, the liquid is discharged from the balloon 15 and the liquid feeding path 21. Specifically, as illustrated in
Next, the balloon 15 is extended while gripping the second gripping portion 59 of the housing 55 with the one hand H1. Specifically, as illustrated in
As described above, the balloon catheter 10 may comprise the housing 55, the catheter shaft 20 having the proximal end portion disposed in the housing 55 and forming the liquid feeding path 21 communicating with the inside of the balloon 15 attached to the distal end portion of the catheter shaft, the supply-discharge line connection portion 30 which has the internal space 31 communicating with the liquid feeding path 21, and to which the supply-discharge line 36 that supplies and discharges the liquid to and from the liquid feeding path 21 through the internal space 31 can be connected, and the stopcock 35 capable of closing the internal space 31 of the supply-discharge line connection portion 30. The position of the supply-discharge line connection portion 30 with respect to the housing 55 is fixed. According to such a balloon catheter 10, the operability of the stopcock 35 is improved.
Further, the balloon catheter 10 may further comprise the supply-discharge line 36 connected to the supply-discharge line connection portion 30 and the supply-discharge device 38 that is connected to the supply-discharge line 36 to supply and discharge the liquid to and from the supply-discharge line 36. The supply-discharge line 36 includes a soft tube having a length of 200 mm or more. According to such a balloon catheter 10, the stopcock 35 can be operated while gripping the supply-discharge device 38 in a state where the supply-discharge device 38 is connected to the catheter shaft 20 via the supply-discharge line 36 and the supply-discharge line connection portion 30.
The balloon catheter 10 may further comprise the stirring line connection portion 40 which has the internal space 41 communicating with the liquid feeding path 21, and to which the stirring line 60 that sucks and discharges the liquid from and into the liquid feeding path 21 through the internal space 41 to stir the liquid in the balloon 15 can be connected. The connection portion between the internal space 41 of the stirring line connection portion 40 and the liquid feeding path 21 is located closer to the distal end portion of the catheter shaft than the connection portion between the internal space 31 of the supply-discharge line connection portion 30 and the liquid feeding path 21. According to such a balloon catheter 10, even during supply of the liquid from the supply-discharge line 36 to the liquid feeding path 21 and discharge of the liquid from the liquid feeding path 21 to the supply-discharge line 36, the liquid can be sucked and discharged from and into the liquid feeding path 21 through the internal space 41 of the stirring line connection portion 40 to stir the liquid in the balloon 15. As a result, even if the liquid is supplied and discharged to and from the liquid feeding path 21 during the cauterization of the diseased part, the surface temperature of the balloon 15 can be uniformly maintained, and the occurrence of uneven cauterization in the diseased part can be prevented. Then, the therapeutic effect can be improved, and the burden on the patient can be reduced.
In addition, in the balloon catheter 10, the stirring line connection portion 40 may be fixed to the housing 55. Accordingly, by holding the housing 55, the stirring line connection portion 40 and the stirring line 60 can be held together with the catheter shaft 20.
In addition, in the balloon catheter 10, the catheter shaft 20 may include the inner cylinder shaft 22 to which the distal end of the balloon 15 is fixed, and the outer cylinder shaft 24 to which the proximal end of the balloon 15 is fixed, the outer cylinder shaft 24 having a lumen into which the inner cylinder shaft 22 is inserted to form the liquid feeding path 21 between the outer cylinder shaft 24 and the inner cylinder shaft 22. The housing 55 is provided with the operation unit 50 that moves the inner cylinder shaft 22 relative to the outer cylinder shaft 24 along the first direction D1 in which the proximal end portion of the catheter shaft 20 extends to extend the balloon 15. According to such a balloon catheter 10, the operation unit 50 can be operated with the same hand H2 as the hand H2 gripping the housing 55.
In addition, in the balloon catheter 10, the housing 55 may include the narrow portion 57 narrowed in the direction intersecting the first direction D1 in which the proximal end portion of the catheter shaft 20 extends, the first gripping portion 58 connected to the narrow portion 57 from one side in the first direction D1, and the second gripping portion 59 connected to the narrow portion 57 from the other side in the first direction D1. According to such a balloon catheter 10, it is possible to prevent the housing 55 from being displaced in the first direction D1 from the hand of a person who grips the housing 55 (person who operates the catheter 10) while the housing 55 is gripped. As a result, it is possible to prevent the catheter shaft 20 and the balloon 15 from unintentionally moving along the longitudinal direction of the catheter shaft 20 while the housing 55 is gripped. As a result, it is possible to prevent the catheter shaft 20 and the balloon 15 from being unintentionally separated from the diseased part during cauterization of the diseased part.
In addition, in the balloon catheter 10, the catheter shaft 20 may include the inner cylinder shaft 22 to which the distal end of the balloon 15 is fixed, and the outer cylinder shaft 24 to which the proximal end of the balloon 15 is fixed, the outer cylinder shaft 24 having a lumen into which the inner cylinder shaft 22 is inserted to form the liquid feeding path 21 between the outer cylinder shaft 24 and the inner cylinder shaft 22. The maximum outer radius R1 of the first gripping portion 58 about the axis X1 extending along the first direction D1 is larger than the maximum outer radius R2 of the second gripping portion 59 about the axis X2 extending along the first direction D1, and the first gripping portion 58 is provided with the operation unit 50 that moves the inner cylinder shaft 22 relative to the outer cylinder shaft 24 along the first direction D1 to stretch the balloon 15. According to such a balloon catheter 10, the operation method of the catheter 10 can be visually transmitted. That is, it is understood that when operating the operation unit 50, the first gripping portion 58 should be firmly gripped to operate the operation unit 50 as illustrated in
Alternatively, the balloon catheter 10 may comprise the housing 55 and the catheter shaft 20 having the proximal end portion disposed in the housing 55 and forming the liquid feeding path 21 communicating with the inside of the balloon 15 attached to the distal end portion of the catheter shaft 20. The housing 55 includes the narrow portion 57 narrowed in the direction intersecting the first direction D1 in which the proximal end portion of the catheter shaft 20 extends, the first gripping portion 58 connected to the narrow portion 57 from one side in the first direction D1, and the second gripping portion 59 connected to the narrow portion 57 from the other side in the first direction D1. According to such a balloon catheter 10, it is possible to prevent the housing 55 from being displaced in the first direction D1 from the hand of a person who grips the housing 55 (person who operates the catheter 10) while the housing 55 is gripped. As a result, it is possible to prevent the catheter shaft 20 and the balloon 15 from unintentionally moving along the longitudinal direction of the catheter shaft 20 while the housing 55 is gripped. As a result, it is possible to prevent the catheter shaft 20 and the balloon 15 from being unintentionally separated from the diseased part during cauterization of the diseased part.
Alternatively, the balloon catheter 10 may comprise the housing 55, the catheter shaft 20 having the proximal end portion disposed in the housing 55 and forming the liquid feeding path 21 communicating with the inside of the balloon 15 attached to the distal end portion of the catheter shaft 20, the supply-discharge line connection portion 30 which has the internal space 31 communicating with the liquid feeding path 21, and to which the supply-discharge line 36 that supplies and discharges the liquid to and from the liquid feeding path 21 through the internal space 31 can be connected, and the stirring line connection portion 40 which has the internal space 41 communicating with the liquid feeding path 21, and to which the stirring line 60 that sucks and discharges the liquid from and into the liquid feeding path 21 through the internal space 41 to stir the liquid in the balloon 15 can be connected. The connection portion between the internal space 41 of the stirring line connection portion 40 and the liquid feeding path 21 is located closer to the distal end portion of the catheter shaft 20 than the connection portion between the internal space 31 of the supply-discharge line connection portion 30 and the liquid feeding path 21. According to such a balloon catheter 10, even during supply of the liquid from the supply-discharge line 36 to the liquid feeding path 21 and discharge of the liquid from the liquid feeding path 21 to the supply-discharge line 36, the liquid can be sucked and discharged from and into the liquid feeding path 21 through the internal space 41 of the stirring line connection portion 40 to stir the liquid in the balloon 15. As a result, even if the liquid is supplied and discharged to and from the liquid feeding path 21 during the cauterization of the diseased part, the surface temperature of the balloon 15 can be uniformly maintained, and the occurrence of uneven cauterization in the diseased part can be prevented. Then, the therapeutic effect can be improved, and the burden on the patient can be reduced.
The above-described example and modifications thereof are included in the scope of this disclosure, and are included in the scope of the appended claims and the equivalents thereof. In addition, as a matter of course, it is also possible to partially appropriately combine the above-described example and modifications thereof within the scope of this disclosure.
Number | Date | Country | Kind |
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2020-064360 | Mar 2020 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2021/013778 | 3/31/2021 | WO |