WO2015152194A1 - バルーン付きカテーテル - Google Patents
バルーン付きカテーテル Download PDFInfo
- Publication number
- WO2015152194A1 WO2015152194A1 PCT/JP2015/060038 JP2015060038W WO2015152194A1 WO 2015152194 A1 WO2015152194 A1 WO 2015152194A1 JP 2015060038 W JP2015060038 W JP 2015060038W WO 2015152194 A1 WO2015152194 A1 WO 2015152194A1
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- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- diameter
- inner cylinder
- lumen
- shaft
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1006—Balloons formed between concentric tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1068—Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
Definitions
- the present invention relates to a balloon catheter.
- the catheter with balloon is a medical device used in a wide range of fields such as percutaneous angioplasty, percutaneous coronary angioplasty, and ablation.
- this catheter with balloon is used for treatment, in order to facilitate insertion into the body and reduce passage resistance, it is inserted after protecting the balloon catheter with a tubular protective member called a guiding sheath or the like. It is common.
- the balloon of the balloon-equipped catheter is inserted into the protective member in a thinly contracted state.
- the shape of the balloon is deformed from an inflatable shape to a thinly contracted shape by sliding the inner tube shaft and the outer tube shaft.
- an object of the present invention is to provide a catheter with a balloon having a mechanism in which liquid cannot be passed through the balloon if the balloon is in a contracted shape.
- An inner cylindrical shaft having a small-diameter inner cylindrical portion on the distal end side and a large-diameter inner cylindrical portion on the proximal end side, an outer cylindrical shaft in which the inner cylindrical shaft is inserted into a lumen, The distal end is fixed to the distal end of the inner cylindrical shaft, the proximal end is fixed to the distal end of the outer cylindrical shaft, and the outer cylindrical shaft and the inner cylindrical shaft slide relative to each other.
- a catheter with a balloon in which inflow of liquid into the balloon is blocked.
- the housing has a balloon according to any one of (1) to (5), wherein the insertion port has a valve, and a concave portion or a convex portion is provided on a side surface of the large-diameter inner cylinder portion. catheter.
- the balloon when the balloon is extended, it has a mechanism for preventing liquid from passing through the balloon. Therefore, when the balloon is extended, the balloon is not suitable for rupture and treatment by forcibly passing the liquid.
- a balloon catheter capable of preventing treatment can be provided.
- FIG. 4 is a schematic view showing a cross-sectional view along the A-A ′ plane which is a direction perpendicular to the longitudinal direction of the balloon catheter shown in FIG. 3.
- the balloon catheter according to the present invention has an inner cylindrical shaft having a small-diameter inner cylindrical portion on the distal end side and a large-diameter inner cylindrical portion on the proximal end side, and the inner cylindrical shaft inserted into the lumen.
- the outer cylinder shaft, the tip is fixed to the tip of the inner cylinder shaft, and the base end is fixed to the tip of the outer cylinder shaft, and the outer cylinder shaft and the inner cylinder shaft slide relative to each other,
- a balloon whose shape changes between a balloon normal shape and a balloon extension shape, a housing communicating with the lumen of the outer cylinder shaft, and having a small-diameter lumen on the distal end side and a large-diameter lumen on the proximal end side;
- the housing has an insertion port for inserting the inner cylindrical shaft, and a liquid inlet / outlet for flowing liquid into and out of the balloon and the outer cylindrical shaft, and has an inner diameter of the large diameter when the balloon is extended.
- the cylinder is the above-mentioned housing Of by being inserted into the lumen of the small diameter, it is characterized in that the inflow of the liquid into the balloon is cut off.
- FIG. 1 shows a balloon-equipped catheter 1 according to a first embodiment of the present invention.
- FIG. 1 is a longitudinal sectional view of the balloon-equipped catheter 1 when the balloon is in an expanded shape
- FIG. 2 is a longitudinal sectional view of the balloon-equipped catheter 1 when the balloon is expanded.
- the outer cylindrical shaft 2 is a cylindrical shaft, and the opening portion on the proximal end side of the tube is connected to the opening portion on the distal end side of the housing 4, so that the lumen of the outer cylindrical shaft 2 and the lumen of the housing 4 are connected It has a structure that communicates.
- any material can be used for the material of the outer tube shaft 2 as long as it is a material used for a medical catheter shaft.
- a polyamide-based resin such as nylon 11 or nylon 12 or a polyamide elastomer, polypropylene / polyethylene is used.
- flexible polymer materials such as polyolefin such as polyethylene, polyester such as polyethylene terephthalate, polyurethane, and vinyl chloride, and one or more of these can be used in combination.
- the inner cylinder shaft 3 is a cylindrical shaft having a small-diameter inner cylinder portion on the distal end side and a large-diameter inner cylinder portion on the proximal end side.
- a step is formed between the small-diameter inner cylinder part and the large-diameter lumen part, and the small-diameter inner cylinder part and the large-diameter inner cylinder part are coaxially joined to form a cylinder.
- a shaped shaft is formed. Further, the inner tube shaft 3 is inserted into the lumen of the outer tube shaft 2 and the lumen of the housing 4 to be described later, thereby constituting a double tube catheter shaft.
- the “small-diameter inner cylinder portion” is a portion of the inner cylinder shaft that has a small outer diameter in the vertical direction from the longitudinal direction of the cylinder
- the “large-diameter inner cylinder portion” refers to the inner cylinder shaft. This is a portion having a large outer diameter in the vertical direction from the longitudinal direction of the cylinder.
- the material of the small-diameter inner cylinder part that forms the tip side is a flexible polymer material such as polyamide resin, polyamide elastomer, polyolefin, polyester, polyurethane, and vinyl chloride, as with the outer cylinder shaft. It is preferable.
- the material of the large-diameter inner cylinder part forming the proximal end side is preferably a metal, More preferably, stainless steel is used.
- the housing 4 is a cylindrical member having a lumen communicating with the lumen of the outer cylinder shaft 2.
- the lumen on the distal end side in the longitudinal direction forms a small-diameter lumen by reducing the diameter of the lumen
- the lumen on the proximal end side in the longitudinal direction has a diameter of the lumen.
- a large-diameter lumen is formed.
- a step is formed between the small-diameter lumen and the large-diameter lumen, and a lumen communicating with the small-diameter lumen and the large-diameter lumen is formed inside the housing 4.
- the sectional shape of the lumen of the housing 4 is not particularly limited, but the sectional shape is preferably circular from the viewpoint of continuity with the outer cylinder shaft 2.
- a bottom surface is formed at the base end of the cylinder of the housing 4, and an insertion port 6 for inserting the inner cylinder shaft 3 is provided on this bottom surface.
- the inner cylinder shaft 3 is exposed to the outside of the housing 4 through the insertion port 6, and the deformation operation of the balloon 5 as described later can be performed by an operation of sliding the exposed portion in the longitudinal direction. .
- a liquid inflow / outflow port 7 through which liquid flows in and out of the balloon 5 and the outer cylinder shaft 2 is provided on the outer peripheral surface of the cylinder of the housing 4.
- the liquid inlet / outlet 7 is connected to a syringe, a pump, or the like, so that the liquid is first passed through the lumen of the housing 4, and the liquid flows into and out of the balloon 5 and the outer cylindrical shaft 2 through the lumen of the housing 4. can do.
- the material of the housing 4 is a material used for a medical catheter, and any material may be used as long as it has strength suitable for operation.
- the material may be made of metal such as iron or aluminum, polycarbonate, ABS. It may be made of resin.
- the balloon 5 is a member formed in a film shape, and has a structure in which the tip of the balloon 5 is fixed to the tip of the inner cylinder shaft 3 and the base end of the balloon 5 is fixed to the tip of the outer cylinder shaft 2. .
- the internal space of the balloon 5 communicates with the inner cavity of the housing 4 through the space formed between the outer tube shaft 2 and the inner tube shaft 3.
- the balloon 5 can be deformed between a normal balloon shape and a balloon extended shape by sliding the outer cylinder shaft 2 and the inner cylinder shaft 3 concentrically with each other in the longitudinal direction. By passing liquid through the balloon, the balloon normal shape is deformed to the balloon inflated shape.
- the “balloon normal shape” refers to a balloon in which the membrane forming the balloon 5 can be inflated by liquid passage by sliding the inner cylindrical shaft 3 toward the proximal end in the longitudinal direction of the outer cylindrical shaft 2.
- the “balloon extended shape” means that the membrane forming the balloon 5 is pulled when the inner cylindrical shaft 3 slides toward the distal end side in the longitudinal direction of the outer cylindrical shaft 2, and the balloon is attached.
- the shape of the elongated balloon 5 that allows the catheter 1 to be inserted into and passed through a protective member or the like.
- the “balloon inflated shape” refers to a shape in which liquid is passed through the balloon and the balloon is expanded from the normal shape. That is.
- the outer diameter of the balloon 5 in the balloon inflated shape varies depending on the affected part to which the technique is applied. For example, when used for the treatment of arrhythmia, the outer diameter is preferably 20 to 40 mm. . Further, the shape of the balloon 5 when the balloon is inflated is preferably spherical, but may be a conical shape with a conical tip, and is not limited to these shapes.
- any material may be used for the balloon 5 as long as it is a material used for medical catheters. However, in order to improve adhesion to the affected tissue, a rubber such as polyurethane, synthetic rubber or natural rubber is used. It is preferable to use a stretchable material.
- the film thickness of the balloon 5 is preferably 20 to 150 microns, but more preferably 20 to 100 microns in order to improve the adhesion to the affected tissue.
- the liquid filling the balloon 5 is physiological saline, a commonly used urinary tract / angiogram imaging contrast medium for cerebral cistern / spinal cord imaging, or a contrast medium stock solution diluted with physiological saline. Can be used.
- the distal-side lumen in the longitudinal direction of the housing 4 forms a small-diameter lumen
- the proximal-side lumen in the longitudinal direction forms a large-diameter lumen. Therefore, when the inner cylinder shaft 3 slides to the proximal end side in the longitudinal direction of the outer cylinder shaft 2 and the balloon 5 becomes a balloon normal shape, the distal end portion of the large-diameter inner cylinder portion of the inner cylinder shaft 3 Is located in the large-diameter lumen of the housing 4, the liquid can flow into and out of the balloon 5 and the outer cylinder shaft 2 through the lumen of the housing 4.
- the distal end of the large-diameter inner cylinder portion of the inner cylinder shaft 3 is the housing. 4, since the space between the large-diameter lumen of the housing 4 and the small-diameter lumen is narrowed by the large-diameter inner cylinder portion of the inner cylinder shaft 3.
- the liquid flows into and out of the housing 4 from the inlet / outlet port 7, the liquid passing through the space between the large-diameter lumen and the small-diameter lumen is blocked, and the operator sliding the inner cylindrical shaft 3 A state where resistance is felt at hand occurs. As a result, the operator can notice that the balloon 5 is not in a balloon normal shape.
- blocking of liquid refers to an operation of sliding the inner cylindrical shaft 3 by applying a load to the liquid passing through the space between the large-diameter lumen and the small-diameter lumen of the housing 4. It indicates a state where resistance is felt at hand, and specifically indicates a state where the internal pressure of the housing 4 is 0.100 MPa or more.
- the present invention specifically preferably has a shape in which the value calculated by the following formula 1 is 0.11 or less. Moreover, it is more preferable that the value calculated by Formula 1 is 0.06 or less.
- an elastic member may be provided at the tip of the large-diameter inner cylinder portion of the inner cylinder shaft 3 for blocking the liquid.
- the elastic member preferably has a cylindrical shape that covers the distal end of the large-diameter inner cylindrical portion, and the outer diameter of the distal end portion including the elastic member of the inner cylindrical shaft 3 is larger than the small-diameter lumen of the housing 4.
- the elastic member may be a natural material such as sponge or a sponge made of a synthetic resin such as urethane or rubber in order to cut off the liquid flow to the balloon 5, but is not limited thereto.
- FIGS. 3 is a longitudinal sectional view of the balloon-equipped catheter 10 in the balloon inflated shape
- FIG. 4 is an AA ′ plane which is a direction perpendicular to the longitudinal direction of the balloon-equipped catheter 10 shown in FIG. FIG.
- the balloon-equipped catheter 10 shown in FIG. 3 includes a protrusion 11 in the large-diameter inner cylinder of the inner cylinder shaft 3.
- the small-diameter inner cylinder of the housing 4 has a rail part 12 for guiding the sliding of the inner cylinder shaft 3 having the projections 11 in the longitudinal direction.
- the rail portion 12 is a groove carved on the inner peripheral surface of the small-diameter inner cylinder of the housing 4, and is adapted to fit with the protruding portion 11.
- the protrusion 11 is not limited to a circular shape as shown in FIG. 4, and may be an ellipse, a rhombus, a triangle, a quadrangle, other polygons, a trapezoid, or a parallelogram.
- the shape of the rail portion 12 may be a circle (ellipse) shape, a rhombus shape, a triangle shape, a quadrilateral shape, a polygonal shape, a trapezoidal shape, or a parallelogram shape as long as it can accommodate the protruding portion. It is preferable to have a compatible shape.
- the projection 11 is accommodated in the rail 12 to prevent the inner cylinder shaft 3 from rotating inside the housing 4. This shape prevents the inner cylinder shaft 3 from being twisted and prevents damage to the inner cylinder shaft 3 caused by the twist.
- FIG. 5 shows a balloon-equipped catheter 20 according to a third embodiment of the present invention.
- FIG. 5 is a longitudinal sectional view of the balloon-equipped catheter 20 in the balloon inflated shape.
- valve 21 for preventing liquid from leaking from the insertion port 6 on the bottom surface of the housing 4 and preventing inflow of air from the outside of the housing 4.
- the shape of the valve 21 is circular, the shape is not limited to this as long as the shape can prevent leakage of liquid from the insertion port 6 to the outside.
- the valve 21 has a hole, and a circular shape is raised as the shape of the hole. The hole grips the inner cylinder shaft 3 so that the inner cylinder shaft 3 can pass, and the valve 21 and the inner cylinder shaft 3 are in close contact with each other to be out of the lumen of the housing 4. As long as the liquid can be prevented from leaking into the liquid, it is not limited thereto.
- the material of the valve 21 may be any material as long as it has elasticity, such as natural rubber or silicone resin.
- FIG. 6 shows a balloon catheter 30 according to a fourth embodiment of the present invention.
- FIG. 6 is a cross-sectional view in the longitudinal direction of the balloon catheter 30 when the balloon is in an inflated shape.
- a balloon-equipped catheter 30 shown in FIG. 6 includes a valve 21 in the housing 4 and a tube of the inner tube shaft 3 within a range that comes into contact with the valve 21 when the inner tube 3 and the housing 4 are slid.
- a recess 31 is provided on the side surface.
- the concave portion 31 having a smaller diameter than the outer diameter of the inner cylindrical shaft 3 is used, but a convex portion having a larger diameter than the outer diameter of the inner cylindrical shaft 3 may be used.
- the recessed part or the convex part is arrange
- the recesses 31 and the valve 21 come into contact with each other so that resistance can be felt at the operator's hand.
- the operator can recognize the shape of the balloon 5 by feeling resistance even when the balloon 5 is indwelling in the body.
- a scale can be given to the base end of the inner cylindrical shaft 3, and the shape of the balloon 5 can be recognized from the display value of the scale.
- FIG. 7 shows a balloon catheter 40 according to a fourth embodiment of the present invention.
- FIG. 7 is a schematic view of the balloon catheter 40 as viewed from the side when the balloon is in an expanded shape.
- the see-through part 41 may not be transparent as long as the inside can be visually recognized.
- the surface of the housing 4 may be textured on the outer surface for the purpose of suppressing hand slipping, but the lumen may not be visible.
- a see-through portion can be secured by providing a portion on the side surface of the housing 4 that is not subjected to the embossing process. It can also be achieved by cutting out a part of the side surface of the housing 4 and fitting a material that can be seen through.
- the position of the see-through part is preferably provided at a position close to the liquid inflow / outlet.
- the shape of the see-through portion is not limited to a rectangle as shown in FIG. 7, but may be a circle, an ellipse, a rhombus, a triangle, a quadrangle, other polygons, a trapezoid, or a parallelogram.
- Example 1 The balloon catheter according to the embodiment of the present invention shown in FIG. 5 was produced as follows.
- a polyurethane balloon having an outer diameter of 30 mm and a film thickness of 20 ⁇ m having a neck portion having an inner diameter of 3.7 mm, an outer diameter of 4.3 mm, and a length of 3 mm at both ends was prepared by a general blow molding method.
- An outer cylinder shaft made of polyurethane having an outer diameter of 4 mm, an inner diameter of 3 mm, and a length of 905 mm was produced.
- a small inner cylinder portion of an inner cylindrical shaft made of polyamide having an outer diameter of 1.8 mm, an inner diameter of 1.4 mm, and an overall length of 1100 mm is manufactured, and further molded to form a metal inner cylindrical shaft having an outer diameter of 3 mm and a length of 115 mm.
- a large-diameter inner cylinder was produced.
- the surface of the large-diameter inner cylinder portion of the metal inner cylinder shaft was covered with a polyurethane elastic body, and the outer diameter was 3.7 mm.
- the tip of the large-diameter inner cylinder part of the inner cylinder shaft was aligned at a position 10 mm from the rear end of the small-diameter inner cylinder part of the inner cylinder shaft, and the inner cylinder shaft was prepared by injecting an adhesive into the gap and fixing.
- a polycarbonate housing having a total length of 152 mm was prepared.
- a liquid inflow port having an outer diameter of 5.5 mm and an inner diameter of 4.4 mm is provided on the side surface of the housing, and a hemostasis valve made of silicon is provided on the inner cavity side of the housing on the bottom surface serving as the rear end of the housing.
- a 7 mm insertion slot was provided.
- An adhesive was applied to the outer periphery on the front end side of the housing, and the rear end of the outer cylinder shaft was adhered.
- the inner cylinder shaft is inserted into the housing lumen from the rear end of the housing, and the inner cylinder shaft is made to reach the lumen of the outer cylinder shaft, and the tip of the inner cylinder portion with a small diameter of the inner cylinder shaft and the neck on the tip side of the balloon
- the balloon was thermally welded and fixed to the outer periphery of the inner cylinder shaft.
- the base of the rear end side neck portion of the balloon was aligned with the tip of the outer tube shaft, and the balloon was thermally welded and fixed to the outer periphery of the outer tube shaft to produce a catheter with a balloon.
- Example 2 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of Example 1, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 3.58 mm is used, and the surface is covered with an elastic body. A balloon catheter similar to Example 1 (hereinafter, “Example 2”) was prepared except that the treatment was not performed.
- Example 3 As an alternative to the large-diameter inner tube portion of the metal inner tube shaft of Example 2, the large-diameter inner tube portion of the metal inner tube shaft with a total outer diameter of 3.55 mm was used. A balloon catheter (hereinafter referred to as “Example 3”) similar to the above was prepared.
- Example 4 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of the second embodiment, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 3.50 mm is used. A balloon catheter (hereinafter referred to as “Example 4”) similar to the above was prepared.
- Example 5 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of the second embodiment, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 3.45 mm is used. A balloon catheter (hereinafter referred to as “Example 5”) similar to the above was prepared.
- Example 6 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of Example 2, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 3.30 mm was used. A similar balloon catheter (hereinafter, “Example 6”) was produced.
- Example 7 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of Example 2, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 3.30 mm was used. A similar balloon catheter (hereinafter, “Example 7”) was produced.
- Comparative Example 1 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of Example 2, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 2.50 mm was used. A similar balloon catheter (hereinafter referred to as “Comparative Example 1”) was produced.
- Comparative Example 2 As an alternative to the large-diameter inner cylinder portion of the metal inner cylinder shaft of the second embodiment, the large-diameter inner cylinder portion of the metal inner cylinder shaft having an outer diameter of 3.58 mm is used.
- a handle (hereinafter referred to as “Comparative Example 2”) having the same configuration as that of Example 2 except that the distal end of the inner cylinder portion having a diameter was positioned in the large-diameter lumen of the housing was manufactured.
- the present invention can be used as a balloon-equipped catheter that can be easily operated by preventing the balloon from being ruptured by forcibly letting it through when the balloon is in the stretched shape and the treatment in a balloon shape that is not suitable for treatment.
- SYMBOLS 1 ... Catheter with a balloon, 2 ... Outer cylinder shaft, 3 ... Inner cylinder shaft, 4 ... Housing, 5 ... Balloon, 6 ... Insertion port, 7 ... Liquid inflow / outlet DESCRIPTION OF SYMBOLS 10 ... Catheter with balloon, 11 ... Projection part, 12 ... Rail part, 20 ... Catheter with balloon, 21 ... Valve, 30 ... Catheter with balloon, 31 ... Recess 40 ... catheter with balloon, 41 ... fluoroscopic part
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Abstract
Description
(1) 先端側に小径の内筒部を有し、かつ、基端側に大径の内筒部を有する内筒シャフトと、上記内筒シャフトが内腔に挿入された外筒シャフトと、先端が上記内筒シャフトの先端に固定され、かつ、基端が上記外筒シャフトの先端に固定され、上記外筒シャフトと上記内筒シャフトが相互に摺動することにより、バルーン平常形状とバルーン伸張形状の間で形状が変化するバルーンと、上記外筒シャフトの内腔と連通し、先端側に小径の内腔及び基端側に大径の内腔を有するハウジングと、を備え、上記ハウジングは、上記内筒シャフトを挿入する挿入口、並びに、上記バルーン及び上記外筒シャフトに液体を流入出するための液体流入出口を有し、バルーン伸張形状時に上記大径の内筒部が上記ハウジングの上記小径の内腔に挿入されることで、上記バルーンへの液体の流入が遮断される、バルーン付きカテーテル。
(2) 上記小径の内腔及び上記大径の内筒部は、以下の式1を満たす形状である、(1)記載のバルーン付きカテーテル。
(A-B)/2≦0.11 ・・・式1
A: 小径の内腔の内径(mm)
B: 大径の内筒部の外径(mm)
(3) 上記大径の内筒部の先端に弾性部材を有する、(1)又は(2)記載のバルーン付きカテーテル。
(4) 上記大径の筒部は、外周に突起部を有するとともに、上記ハウジングの小径の内腔は、内周に上記突起部と嵌合するレール部を有する、(1)~(3)のいずれか記載のバルーン付きカテーテル。
(5) 上記ハウジングは、上記ハウジングの内部を視認するための透視部を側面に有する、(1)~(4)のいずれか記載のバルーン付きカテーテル。
(6) 上記ハウジングは、上記挿入口に弁を有するとともに、上記大径の内筒部の側面に凹部又は凸部が設けられている、(1)~(5)のいずれか記載のバルーン付きカテーテル。
A: 小径の内腔の内径(mm)
B: 大径の内筒部の外径(mm)
図5に示す本発明の実施形態に係るバルーン付きカテーテルを、以下の通り作製した。
実施例1の金属製の内筒シャフトの大径の内筒部の代替として外径3.58 mmの金属製の内筒シャフトの大径の内筒部を使用し、表面を弾性体で覆う処理を行わない以外は、実施例1と同様としたバルーンカテーテル(以下、「実施例2」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外計3.55 mmの金属製の内筒シャフトの大径の内筒部を使用、その他の条件は実施例2と同様としたバルーンカテーテル(以下、「実施例3」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外径3.50 mmの金属製の内筒シャフトの大径の内筒部を使用、その他の条件は実施例2と同様としたバルーンカテーテル(以下、「実施例4」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外径3.45 mmの金属製の内筒シャフトの大径の内筒部を使用、その他の条件は実施例2と同様としたバルーンカテーテル(以下、「実施例5」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外径3.30mmの金属製の内筒シャフトの大径の内筒部を使用、その他の条件は実施例2と同様としたバルーンカテーテル(以下、「実施例6」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外径3.30mmの金属製の内筒シャフトの大径の内筒部を使用、その他の条件は実施例2と同様としたバルーンカテーテル(以下、「実施例7」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外径2.50mmの金属製の内筒シャフトの大径の内筒部を使用、その他の条件は実施例2と同様としたバルーンカテーテル(以下、「比較例1」)を作製した。
実施例2の金属製の内筒シャフトの大径の内筒部の代替として外径3.58mmの金属製の内筒シャフトの大径の内筒部を使用、金属製の内筒シャフトの大径の内筒部の先端がハウジングの大径の内腔に位置するように固定し、その他の条件は実施例2と同様としたハンドル(以下、「比較例2」)を作製した。
液体注入時の圧力測定においては、作製した各実施例及び比較例のバルーン付きカテーテルのうち、バルーン及び内筒シャフトのうち、小径の内筒部を除いた部分を用いて実験を行った。液体として生理食塩水、造影材を生理食塩水で希釈した希釈造影剤を用意する。希釈造影剤は市販のヨード造影剤のヘキサブリックス320と生理食塩水を1:1の混合比としたものを使用した。MEDRAD社製オートインジェクターMark V ProVis(型番PPD507)に液体を150mL充填した。上記ハンドルの3方活栓に圧力計とオートインジェクターを接続した。液体を15mL/秒で100mL注入したときの最大圧力値を記録した。
Claims (6)
- 先端側に小径の内筒部を有し、かつ、基端側に大径の内筒部を有する内筒シャフトと、
前記内筒シャフトが内腔に挿入された外筒シャフトと、
先端が前記内筒シャフトの先端に固定され、かつ、基端が前記外筒シャフトの先端に固定され、前記外筒シャフトと前記内筒シャフトが相互に摺動することにより、バルーン平常形状とバルーン伸張形状の間で形状が変化するバルーンと、
前記外筒シャフトの内腔と連通し、先端側に小径の内腔及び基端側に大径の内腔を有するハウジングと、を備え、
前記ハウジングは、前記内筒シャフトを挿入する挿入口、並びに、前記バルーン及び前記外筒シャフトに液体を流入出するための液体流入出口を有し、
バルーン伸張形状時に前記大径の内筒部が前記ハウジングの前記小径の内腔に挿入されることで、前記バルーンへの液体の流入が遮断される、バルーン付きカテーテル。 - 前記小径の内腔及び前記大径の内筒部は、以下の式1を満たす形状である、請求項1記載のバルーン付きカテーテル。
(A-B)/2≦0.11 ・・・式1
A: 小径の内腔の内径(mm)
B: 大径の内筒部の外径(mm) - 前記大径の内筒部の先端に弾性部材を有する、請求項1又は2記載のバルーン付きカテーテル。
- 前記大径の筒部は、外周に突起部を有するとともに、前記ハウジングの小径の内腔は、内周に前記突起部と嵌合するレール部を有する、請求項1~3のいずれか一項記載のバルーン付きカテーテル。
- 前記ハウジングは、前記ハウジングの内部を視認するための透視部を側面に有する、請求項1~4のいずれか一項記載のバルーン付きカテーテル。
- 前記ハウジングは、前記挿入口に弁を有するとともに、前記大径の内筒部の側面に凹部又は凸部が設けられている、請求項1~5のいずれか一項記載のバルーン付きカテーテル。
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EP15773663.8A EP3127576B1 (en) | 2014-03-31 | 2015-03-31 | Balloon catheter |
US15/129,002 US10342959B2 (en) | 2014-03-31 | 2015-03-31 | Balloon catheter |
CA2940185A CA2940185C (en) | 2014-03-31 | 2015-03-31 | Balloon catheter |
KR1020167023759A KR101910359B1 (ko) | 2014-03-31 | 2015-03-31 | 벌룬 부착 카테터 |
JP2015516934A JP6439686B2 (ja) | 2014-03-31 | 2015-03-31 | バルーン付きカテーテル |
CN201580018127.9A CN106456943B (zh) | 2014-03-31 | 2015-03-31 | 带球囊的导管 |
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CN106456943A (zh) | 2017-02-22 |
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EP3127576B1 (en) | 2022-01-26 |
TWI633900B (zh) | 2018-09-01 |
CA2940185C (en) | 2018-10-16 |
US10342959B2 (en) | 2019-07-09 |
KR20160113707A (ko) | 2016-09-30 |
EP3127576A4 (en) | 2017-12-06 |
JPWO2015152194A1 (ja) | 2017-04-13 |
US20170128702A1 (en) | 2017-05-11 |
EP3127576A1 (en) | 2017-02-08 |
CN106456943B (zh) | 2019-08-13 |
KR101910359B1 (ko) | 2018-10-22 |
JP6439686B2 (ja) | 2018-12-19 |
CA2940185A1 (en) | 2015-10-08 |
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