WO2018062116A1 - Cathéter à ballonnet - Google Patents

Cathéter à ballonnet Download PDF

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Publication number
WO2018062116A1
WO2018062116A1 PCT/JP2017/034594 JP2017034594W WO2018062116A1 WO 2018062116 A1 WO2018062116 A1 WO 2018062116A1 JP 2017034594 W JP2017034594 W JP 2017034594W WO 2018062116 A1 WO2018062116 A1 WO 2018062116A1
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WO
WIPO (PCT)
Prior art keywords
balloon
diameter
balloon catheter
shaft
central
Prior art date
Application number
PCT/JP2017/034594
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English (en)
Japanese (ja)
Inventor
一洋 永田
武史 飯塚
Original Assignee
オリンパス株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by オリンパス株式会社 filed Critical オリンパス株式会社
Publication of WO2018062116A1 publication Critical patent/WO2018062116A1/fr

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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

Definitions

  • the present invention relates to a balloon catheter.
  • Priority is claimed on Japanese Patent Application No. 2016-190533, filed September 29, 2016, the content of which is incorporated herein by reference.
  • a balloon catheter is known as a treatment tool used with a medical endoscope or the like.
  • a balloon catheter is used for the purpose of, for example, expanding a stenosis such as a digestive tract and securing a lumen, and includes an expandable balloon.
  • pressure resistance against pressure applied during expansion and positional deviation prevention performance during expansion are required.
  • Patent Document 1 describes a balloon for expanding a constriction part (balloon catheter) that can prevent positional deviation from a constriction part at the time of balloon expansion by the dog-bone shape of the expanded state of the naturally expanded state.
  • Patent Document 2 describes a balloon catheter provided with a balloon that becomes substantially cylindrical at the time of expansion by reducing the thickness of both end portions in the longitudinal direction as compared with the thickness of the central portion.
  • the conventional balloon catheter as described above has the following problems.
  • the balloon since the balloon has a dog bone-shaped three-dimensional shape, when folded, the outer diameter after folding is not due to the overlapping of the balloon near the dog bone without being flat feathered. It gets bigger. Therefore, the outer diameter of the balloon at the time of folding becomes large, and the variation in the outer diameter in the longitudinal direction becomes large.
  • the present invention has been made in view of the above problems, and provides a balloon catheter capable of suppressing axial displacement during attachment to a lumen without reducing the pressure resistance and insertion / extraction performance of the balloon.
  • the purpose is to
  • the balloon catheter according to the aspect of the present invention is fixed to a shaft that circulates the expansion fluid through the distal end opening, and to the distal end side of the outer periphery of the shaft than the distal end opening.
  • a balloon having an enlarged diameter portion expanded by the expansion fluid supplied from the distal end side opening portion, the enlarged diameter portion moving from the first fixed portion toward the second fixed portion.
  • the first end, the central portion, and the second end are adjacent to each other in this order, and 100% modulus of the material of the first end and the second end is the material of the central portion. Less than 100% modulus.
  • the length in the longitudinal direction of the shaft of the first end and the second end is 15% or more and 25% or less of the length in the longitudinal direction of the shaft of the enlarged diameter portion It is also good.
  • the breaking strength of the material of the first end and the second end may be 80% or more of the breaking strength of the material of the central part.
  • the maximum outer diameter of the first end portion, the central portion, and the second end portion may be equal to one another.
  • the first end portion and the second end portion are directed to the central portion, respectively.
  • the balloon catheter of this invention is effective in the ability to suppress the position shift of the axial direction at the time of mounting
  • FIG. 1 is a schematic partial cross-sectional view showing an example of the configuration of the balloon catheter according to the embodiment of the present invention in a naturally-deployed state.
  • FIG. 2 is a schematic graph showing an example of the change in the wall thickness of the balloon of the balloon catheter according to the embodiment of the present invention.
  • the balloon catheter 10 of the present embodiment is an elongated member extending along the central axis O from the proximal end on the right side to the distal end on the left side.
  • the balloon catheter 10 is used by being inserted from the tip into the lumen of a patient.
  • the balloon catheter 10 comprises a shaft 1 and a balloon 2.
  • the balloon 2 can be expanded and contracted.
  • FIG. 1 shows the expanded state of the balloon 2 in a natural unfolded state.
  • the naturally deployed state of the balloon 2 is defined as the maximum state in which the balloon 2 is expanded without generating tension (stress) in a state in which the balloon 2 is fixed to the shaft 1.
  • the state in which the balloon 2 is expanded more than the naturally expanded state is referred to as the “expanded state”.
  • the balloon 2 is contracted in the initial state before the balloon catheter 10 is inserted into the lumen, and the outer periphery of the shaft 1 is folded in a plurality of thin wings. It is wrapped around the department.
  • the balloon 2 has a fold or crease (hereinafter, referred to as a fold or the like) by a known folding process or the like in advance so that the initial state is restored when the balloon 2 contracts after expanding.
  • the balloon catheter 10 in the initial state is an elongated member having generally the same outer diameter.
  • the type of lumen into which the balloon catheter 10 is inserted is not limited.
  • the balloon catheter 10 may be inserted into the digestive tract, esophagus, bile duct, urethra, blood vessels and the like.
  • the outer diameter in the initial state of the balloon catheter 10 the maximum outer diameter in the natural deployed state of the balloon 2 and the outer diameter in the expanded state of the balloon 2 correspond to the inner diameter of the lumen to be inserted.
  • a direction along the axis is an axial direction and a circumferential direction is a circumferential direction
  • a direction along a line intersecting the axis in a plane orthogonal to the axis is referred to as a radial direction.
  • the shaft 1 is an elongated member extending along the central axis O from the proximal end to the distal end of the balloon catheter 10.
  • the longitudinal direction of the shaft 1 coincides with the axial direction along the central axis O.
  • the shaft 1 is formed of a flexible resin material.
  • the shaft 1 may be formed by a single tube or may be formed by a plurality of tubes.
  • the shaft 1 in the present embodiment includes, as an example, an inner tube 1B and an outer tube 1A.
  • a multi-lumen tube or the like may be used.
  • the inner tube 1 B is a tubular member extending over the entire length of the shaft 1.
  • the outer shape of the inner tube 1B is not limited.
  • the outer peripheral surface 1 e of the inner tube 1 B is circular with the central axis O as a center in a cross section orthogonal to the central axis O.
  • a through hole axially penetrating along the central axis O is formed. This through hole may be used, for example, for the purpose of inserting a guide wire or flowing a drug to be supplied to a lumen.
  • the inner diameter of the inner circumferential surface 1f of the through hole is set to an appropriate size according to the application.
  • the through hole inside the inner tube 1B does not penetrate the outer peripheral surface 1e.
  • the outer diameter of the outer peripheral surface 1e is set to a size that allows an inner tube 1B to be inserted by opening a gap inside an outer tube 1A described later.
  • the outer tube 1A is a pipe member through which the inner tube 1B is inserted.
  • the length of the outer tube 1A is shorter than the length of the inner tube 1B.
  • the inner tube 1B inserted into the outer tube 1A extends to the tip side more than the tip of the outer tube 1A.
  • FIG. 1 although the proximal end of the outer tube 1A and the proximal end of the inner tube 1B are drawn to be in line, this is an example.
  • the inner tube 1B may extend to the proximal end side of the outer tube 1A, or the outer tube 1A and the inner tube 1B may branch to each other on the proximal end side.
  • the outer shape of the outer tube 1A is not limited.
  • the outer peripheral surface 1a of the outer tube 1A has a circular shape centered on the central axis O in a cross section orthogonal to the central axis O.
  • a through hole penetrating in the axial direction is formed in the inside of the outer tube 1A.
  • An internal flow path P having an annular cross section surrounding the outer peripheral surface 1 e is formed between the inner peripheral surface 1 b of the through hole and the outer peripheral surface 1 e of the inner tube 1 B inserted into the inside.
  • the outer diameter of the outer peripheral surface 1a of the outer tube 1A is smaller than the inner diameter of the lumen into which the shaft 1 is to be inserted.
  • an expansion fluid (not shown) for expanding the balloon 2 described later can flow.
  • the expanding fluid may be liquid or gas.
  • the internal flow path P communicates with the outside through the proximal end opening 1d on the proximal end side of the outer tube 1A and the inner tube 1B and the distal end opening 1c on the distal end side of the outer tube 1A.
  • the proximal end opening 1 d is connectable to an expansion fluid supply unit (not shown).
  • the distal end side opening 1 c communicates with the inside of a balloon 2 described later.
  • Examples of the material of the shaft 1 include nylon, polyamide, PTFE (polytetrafluoroethylene) and the like.
  • the balloon 2 is a member which is formed of a thin film and becomes tubular in an expanded state.
  • the tip of the shaft 1 is inserted into the balloon 2.
  • the balloon 2 includes a first fixing portion 2A, an enlarged diameter portion 2B, and a second fixing portion 2C from the distal end side to the proximal end side.
  • the first fixing portion 2A is a cylindrical portion fixed in close contact with the outer peripheral surface 1e of the inner tube 1B at the end of the inner tube 1B which is closer to the end than the end opening 1c.
  • fixed part 2A and the outer peripheral surface 1e can be a suitable fixing method which can seal the fluid for expansion.
  • the first fixing portion 2A may be welded to the outer peripheral surface 1e.
  • the length of the first fixing portion 2A in the axial direction is represented by L 2A .
  • the length L 2A is set to an appropriate length such that the fixing strength required for the first fixing portion 2A can be obtained.
  • the enlarged diameter portion 2B has a cylindrical shape larger in diameter than the outer peripheral surface 1e which can be deformed between the state of being separated and expanded from the outer peripheral surface 1e of the inner tube 1B and the contracted state contacting or close to the outer peripheral surface 1e. It is a department. Below, the shape of the enlarged diameter part 2B in a natural expansion
  • the enlarged diameter portion 2B includes a first end 2D, a central portion 2E, and a second end 2F from the distal end side to the proximal end side.
  • the first end 2D, the center 2E, and the second end 2F are adjacent in this order.
  • the length of the enlarged diameter portion 2B in the axial direction is represented by L 2B .
  • the first end 2D includes a diameter transition portion 2a and a constant diameter portion 2b from the distal end side to the proximal end side.
  • the lengths of the diameter transition portion 2a and the constant diameter portion 2b in the axial direction are represented by L 2a and L 2b , respectively.
  • the first end 2D may be configured of only the diameter transition portion 2a.
  • L 2 b of the constant diameter portion 2 b is 0 or more so that the case where the constant diameter portion 2 b is not included can be included.
  • L 2 b 0 corresponds to the case where the constant diameter portion 2 b is not provided.
  • the constant diameter portion 2b in the following description may be read as the base end of the diameter transition portion 2a.
  • the diameter transition portion 2a is a cylindrical portion whose outer diameter gradually increases from the base end of the first fixed portion 2A toward the base end.
  • the outer shape of the diameter transition portion 2a may be a strict conical surface in which the rate of change of the outer diameter in the axial direction is constant, or the rate of change of the outer diameter changes the outer side of the conical surface. Or it may be variously curved inward.
  • the diameter transition portion 2a may have, for example, a bowl shape, a shell shape, a bell shape, a funnel shape, a trumpet shape or the like.
  • the cross-sectional shape in the radial direction of the diameter transition portion 2a may be a rounded C-shape at the tip or a V-shape with a tapered tip.
  • the rate of change of the outer diameter is monotonous from the positive maximum value to the zero or more minimum value.
  • the outer shape of the diameter transition portion 2a shown in FIG. 1 is a convex curved surface which bulges outside the conical surface connecting the tip and the proximal end, and has a shape close to a partial spherical surface.
  • the constant diameter portion 2 b is a cylindrical portion of a length L 2 b whose outer diameter matches the diameter of the proximal end of the diameter transition portion 2 a.
  • the fixed diameter portion 2b is connected to the base end of the diameter transition portion 2a without any level difference (however, for example, minute irregularities generated in manufacturing such as parting line etc. are excluded).
  • the outer diameter of the constant diameter portion 2b is represented by D 0 in the natural deployed state.
  • the tip end of the fixed diameter portion 2b is smoothly connected to the base end of the diameter transition portion 2a in the axial direction when the rate of change of the outer diameter at the base end of the diameter transition portion 2a is zero.
  • the tip of the fixed diameter portion 2b is connected to form a bent portion with the base end of the diameter transition portion 2a when the rate of change of the outer diameter at the base end of the diameter transition portion 2a is a positive value.
  • FIG. 1 as an example, the case where the rate of change of the outer diameter at the base end of the diameter transition portion 2a is 0 and the diameter transition portion 2a and the constant diameter portion 2b are connected smoothly is illustrated.
  • the diameter transition portion 2a and the constant diameter portion 2b of the first end portion 2D are all formed of the same material.
  • the material of the first end 2D may be different from the material of the first fixing portion 2A, but in the present embodiment, as an example, the first end 2D and the first fixing portion 2A are formed of similar materials. It is done.
  • the material of the first end 2D has a breaking strength not to be broken even by the internal pressure applied to the expanded balloon 2 and has a 100% modulus lower than the 100% modulus of the material of the central portion 2E described later A resin material is used.
  • the breaking strength of the material of the first end 2D is more preferably 80% or more of the breaking strength of the material of the central portion 2E described later.
  • thermoplastic polyamide system elastomer polyethylene (PE), a thermoplastic polyurethane elastomer (PTU) etc. are mentioned, for example.
  • the central portion 2E is a cylindrical portion connected to the base end of the first end portion 2D without any level difference (however, for example, minute irregularities generated in manufacturing such as parting lines are excluded).
  • the outer shape of the naturally developed state of the central portion 2E is the same as the outer diameter D of the proximal end of the first end 2D, corresponding to the first end 2D having a circular cross section. It is a cylindrical surface of 0 .
  • the length of the central portion 2E in the axial direction is represented by L 2E .
  • FIG. 1 is a schematic view, the first end 2D and the central portion 2E are drawn as being joined via a joint 2e along a plane orthogonal to the central axis O.
  • the joint portion 2e between the first end portion 2D and the central portion 2E may be deviated from a plane orthogonal to the central axis O or may be corrugated for manufacturing reasons to be described later. Furthermore, at the joint 2e between the first end 2D and the central portion 2E, the material of the first end 2D and the material of the central portion 2E are mixed for a manufacturing reason to be described later, and a clear boundary is It does not have to appear. In these cases, the position of the joint 2e related to the length of the first end 2D and the central portion 2E in the axial direction is defined as the position of a plane orthogonal to the central axis O so as to average these material distributions. Ru.
  • the material of the central portion 2E has a breaking strength not to be broken even by the internal pressure applied to the expanded balloon 2 at the time of use, and 100% modulus of the material of the first end 2D and the second end 2F described later Materials having a higher 100% modulus are used.
  • the resin material used for the central portion 2E all the materials conventionally used for the balloon of the balloon catheter can be used, as well as the materials usable for the first end 2D, as long as the above-mentioned conditions are satisfied.
  • the second end portion 2F includes a constant diameter portion 2c and a diameter transition portion 2d from the distal end side to the proximal end side.
  • the lengths of the constant diameter portion 2c and the diameter transition portion 2d in the axial direction are respectively represented by L 2c and L 2d .
  • the 2nd end 2F may be constituted only by diameter transition part 2d.
  • L 2 c 0 corresponds to the case where the constant diameter portion 2 c is not provided. In this case, unless otherwise specified, the constant diameter portion 2c in the following description is read as the tip of the diameter transition portion 2d.
  • the distal end of the second end 2F is connected to the proximal end of the central portion 2E without any step (except, for example, minute irregularities generated in manufacturing such as a parting line).
  • a joint 2f between the second end 2F and the central part 2E is schematically drawn in the same manner as the joint 2e.
  • the joint 2 f can have the same shape as the joint 2 e.
  • the position of the joint 2f related to the length of the second end 2F and the central part 2E in the axial direction is the same as the joint 2e, and the material distribution of the material of the second end 2F and the material of the central part 2E is averaged. Is defined as the position of a plane orthogonal to the central axis O.
  • the constant diameter portion 2c and the diameter transition portion 2d in the second end portion 2F have the same shape as the constant diameter portion 2b and the diameter transition portion 2a in the first end portion 2D, respectively.
  • the diameter transition part 2d is a cylindrical part whose outer diameter gradually reduces as it goes from the base end of the central part 2E to the base end side.
  • the constant diameter portion 2c and the diameter transition portion 2d of the second end portion 2F may have the same shape as the constant diameter portion 2b and the diameter transition portion 2a at the first end portion 2D, respectively, except for the direction.
  • the length in the axial direction or the rate of change of the outer diameter at the diameter transition portion 2d is the diameter of the constant diameter portion 2b of the first end portion 2D. It may be different from the transition part 2a.
  • the constant diameter portion 2c and the diameter transition portion 2d of the second end portion 2F are formed of the same material.
  • the material of the second end 2F may be different from or the same as the material of the first end 2D. Similar to the first end 2D, the material of the second end 2F has a breaking strength not to be broken even by the internal pressure applied to the expanded balloon 2, and 100% modulus of the material of the central portion 2E described later Materials with lower 100% modulus are used.
  • the breaking strength of the material of the second end 2F is, like the material of the first end 2D, more preferably 80% or more of the breaking strength of the material of the central portion 2E.
  • As the resin material used for the second end 2F all materials conventionally used for the balloon of the balloon catheter can be used, as well as the materials usable for the first end 2D, provided that the above conditions are satisfied. is there.
  • the second fixing portion 2C is connected to the proximal end of the second end 2F, and is fixed in close contact with the outer peripheral surface 1a of the outer tube 1A at the distal end of the outer tube 1A which is proximal to the distal end side opening 1c. It is a cylindrical part that has been As a method of fixing the second fixing portion 2C and the outer peripheral surface 1a, an appropriate fixing method capable of sealing the expansion fluid is possible.
  • the second fixing portion 2C may be welded to the outer peripheral surface 1a.
  • the length of the second fixed portion 2C in the axial direction is represented by L 2C .
  • the length L 2 C is set to an appropriate length such that the fixing strength required for the second fixing portion 2 C can be obtained.
  • the length L 2B of the enlarged diameter portion 2B in the axial direction is the length of the first end 2D, the central portion 2E, and the second end 2F in the axial direction (L 2a + L 2b + L 2E + L 2c + L 2d ).
  • the length L2B is set to an appropriate length that can expand the narrowing of the lumen into which the balloon 2 is inserted.
  • the lengths of the first end 2D and the second end 2F in the axial direction (longitudinal direction of the shaft 1) may be 15% or more and 25% or less of the length of the enlarged diameter portion 2B in the axial direction. .
  • the lengths of the first end 2D and the second end 2F in the axial direction may be equal to the maximum outer diameters of the first end 2D and the second end 2F in the expanded state.
  • the balloon 2 is closely fixed to the outer peripheral surfaces 1e and 1a, which are the outer peripheral portions of the distal end portion of the shaft 1, by the first fixing portion 2A and the second fixing portion 2C.
  • the enlarged diameter portion 2B around the outer peripheral surface 1e on the tip side with respect to the tip side opening 1c, an internal space S through which the expansion fluid flows in and out through the tip side opening 1c is formed.
  • the expansion fluid flows into the internal space S through the distal end opening 1c
  • the enlarged diameter portion 2B expands.
  • the internal pressure of the internal space S rises.
  • the enlarged diameter portion 2B contracts. Since the enlarged diameter portion 2B is creased or the like as described above, the folded shape in the initial state is restored as it is contracted.
  • the balloon 2 may be manufactured, for example, by blow molding using a mold that transfers the shape in a naturally developed state.
  • a parison tube in which a forming material of the first fixing portion 2A and the first end 2D, a forming material of the central portion 2E, and a forming material of the second end 2F and the second fixing portion 2C are joined in this order
  • the parison tube is manufactured and placed in the interior of the mold described above to effect blow molding. That is, when the parison tube is expanded toward the inner surface of the mold and brought into close contact with the molding surface of the mold and cured, the shape of the molding surface is transferred as the outer shape of the expanded parison tube. Thereby, the balloon 2 is manufactured.
  • the expanded parison tube is thinned according to the diameter expansion rate.
  • the thickness at the time of expansion may also vary.
  • Manufacturing variations of the balloon 2 may also occur in the axial direction.
  • the dissimilar material joint in the parison tube before expansion may not necessarily be formed along a plane orthogonal to the axial direction.
  • the blow molding since there is a possibility that the deformation in the axial direction may also vary during expansion, the axial position of the joint portion of the different material may change during the expansion.
  • the shapes of the joints 2e and 2f deviate from the shape along the plane orthogonal to the central axis O as schematically shown in FIG. There is also.
  • FIG. 2 schematically shows an example of the thickness distribution in the axial direction of a balloon 2 manufactured from a constant thickness parison tube.
  • the horizontal axis represents the position of the balloon 2 in the axial direction
  • the vertical axis represents the thickness.
  • the origin 0 on the horizontal axis corresponds to the position of the tip of the balloon 2 (the tip of the first fixing portion 2A).
  • the point a indicates the position of the tip of the enlarged diameter portion 2B (the tip of the diameter transition portion 2a).
  • the point b indicates the position of the boundary between the diameter transition portion 2a and the constant diameter portion 2b.
  • a point c (d) indicates the position of the joint 2e (2f).
  • a point e indicates the position of the boundary between the constant diameter portion 2c and the diameter transition portion 2d.
  • Points b and e correspond to the positions of the parting line of the mold.
  • the point f indicates the position of the proximal end of the enlarged diameter portion 2B (the proximal end of the diameter transition portion 2d).
  • the point g indicates the position of the proximal end of the balloon 2 (the proximal end of the second fixed portion 2C).
  • the wall thickness of the balloon 2 is substantially the same thickness t 3 and the thickness of the parison tube at the proximal end of the tip and the second fixing portion 2C of the first fixing portion 2A.
  • the proximal end of the first fixed portion 2A (the tip of the second fixed portion 2C) is stretched toward the center at the time of expansion, and thus decreases to a thickness t 2 (where t 2 ⁇ t 3 ). Since the diameter transition portion 2a (diameter transition portion 2d) gradually expands in diameter from the tip (base end) toward the central portion 2E, the thickness of the diameter transition portion 2a (diameter transition portion 2d) is gradually decreases from the thickness t 2 from the end) toward the central portion 2E.
  • the inner tube 1B is inserted into the outer tube 1A, and the first fixed portion 2A is on the outer peripheral surface 1e and the second fixed portion 2C is on the outer peripheral surface 1a. It is fixed to each by heat fusion etc.
  • the balloon 2 fixed to the shaft 1 is folded so as to make a fold or the like by a known folding process or the like, and is wound around the inner tube 1B.
  • the balloon catheter 10 is manufactured.
  • the balloon 2 is folded so as to have an outer diameter substantially equal to the outer diameter of the shaft 1.
  • FIG. 3 is a schematic partial cross-sectional view showing an example of the configuration of the balloon catheter according to the embodiment of the present invention in the expanded diameter state.
  • the balloon catheter 10 is, for example, a proximal end of a guide wire (not shown, the same applies hereinafter) inserted in advance to the placement position of the balloon 2 in the patient's body from the distal end side of the shaft 1 to the inner circumferential surface 1f of the inner tube 1B.
  • a guide wire By following the guide wire, it is inserted into the patient's body.
  • the balloon catheter 10 is inserted, as necessary, through an insertion tube member inserted into the body, such as an endoscope (not shown).
  • an endoscope not shown.
  • the distal end portion of the balloon catheter 10 has a diameter as small as the outer diameter of the shaft 1 and, like the shaft 1, can be smoothly inserted into the patient's body.
  • the operator connects a fluid supply device (not shown, hereinafter the same) to the proximal opening 1 d of the shaft 1.
  • the operator operates the fluid supply device to introduce the expansion fluid into the internal flow path P.
  • the expanding fluid introduced into the internal flow path P flows into the internal space S of the balloon 2 from the distal end opening 1c at the distal end of the outer tube 1A.
  • the balloon 2 expands.
  • the diameter-increased portion 2B is expanded in diameter, and the inner surface of the lumen in contact with the diameter-increased portion 2B is pushed apart.
  • the operator stops the supply and pressurization of the expansion fluid.
  • the balloon 2 is expanded to a certain expanded state, and the lumen is expanded to a predetermined shape.
  • the treatment of the expansion of the lumen by balloon catheter 10 is completed.
  • the shape of the diameter-expanded state of the balloon 2 will be described using an example in which the balloon 2 is expanded in free space.
  • the balloon 2 expands into the naturally deployed state as shown in FIG. 1 when the expansion fluid corresponding to the volume in the naturally deployed state is introduced.
  • Tension (stress) is not generated in the balloon 2 in the natural expanded state, the balloon 2 will generally cylindrical shape of the outer diameter D 0.
  • the expansion fluid is further supplied into the internal space S, the internal pressure of the balloon 2 rises, and the balloon 2 is expanded.
  • the balloon 2 differs in material depending on the part, so the expansion rate differs depending on the elongation property and thickness of the material of each part.
  • the elongation properties of the material of each part can be represented by the magnitude of 100% modulus.
  • the thinner the portion the greater the stress and thus the easier it is to stretch. That is, in the balloon 2, the expansion rate becomes relatively large at the portion of the first end 2D close to the joint 2e and the portion of the second end 2F close to the joint 2f. As a result, as shown in FIG. 3, the portion of the first end 2D near the joint 2e and the portion of the second end 2F near the joint 2f have outer diameters D 2B and D 2D respectively (where D 2B > D 0 , D 2D > D 0 ).
  • the outer diameter of the portion excluding both ends of the central portion 2E is D 2E smaller than the outer diameters D 2B and D 2D (where D 0 ⁇ D 2E ⁇ D 2B , D 0 ⁇ D 2E ⁇ Stay in D 2 D).
  • D 2B D 2D .
  • the tip 2g (base end 2i) of the central portion 2E receives tensile stress including a component directed radially outward from the first end 2D (second end 2F) via the joint 2e (2f). , D 2E and D 2B (D 2D ) expand to an outer diameter.
  • the distal end side of the central portion 2E closer to the joint portion 2e than the distal end portion 2g and the proximal end side of the central end 2e near the joint portion 2f are formed.
  • Bulging portions 2j, 2k outer diameter D 2B, D 2D can be appropriately sized to positional deviation in the axial direction of the balloon 2 at the time of insertion into the lumen can be suppressed. For example, it may be 103% or more and 120% or less of the outer diameter D 2E of the intermediate portion 2 h.
  • the positional deviation of the balloon 2 may be suppressed to such an extent that the balloon 2 does not come out of the narrowed portion of the lumen at the time of diameter expansion.
  • the balloon is not formed with bulges at both ends, and the central part of the central part has a maximum outer diameter and the diameter is reduced toward both ends so that the central part is thickened and expanded.
  • the constriction portion abuts on the top of the convex surface at the center of the central portion, an unstable contact state is formed.
  • the narrowed portion is in a stable contact state. Try to move relative to the end of the direction.
  • the balloon having no bulging portion at both ends may be pushed out in the axial direction during diameter expansion.
  • the diameter of the intermediate portion is smaller than that of the bulges 2j and 2k. Since the length of the portion 2h becomes short, the contact amount between the lumen and the central portion 2E becomes too small, so that the effect of suppressing the axial movement by the bulging portions 2j and 2k may be reduced.
  • FIG. 4 is a schematic front view of the balloon catheter of the comparative example in a naturally deployed state.
  • FIG. 5 is a schematic front view of the balloon catheter of the comparative example in the expanded state.
  • the shape of the natural expansion state is the first fixing portion 2A of this embodiment and the enlarged diameter portion from the distal end side to the proximal end side.
  • a diameter transition portion 200a having the same outer shape as the diameter transition portion 2a of the present embodiment, a constant diameter portion 2b, a central portion 2E, and a constant diameter portion 2c from the distal end side to the proximal end side.
  • a diameter transition portion 200c having an outer shape similar to that of the diameter transition portion 2d.
  • the constant diameter portion 2b of the present embodiment, the central portion 2E, and like the constant diameter portion 2c, the outer diameter of the central portion 200b in the natural development state is D 0.
  • the balloon 200 is formed of one type of material, the 100% modulus of the material of the enlarged diameter portion 200B is constant regardless of the part.
  • the balloon 200 is manufactured, for example, by blow molding a parison tube made of a single material using a mold for molding the balloon 2 of the present embodiment.
  • the thickness distribution of the balloon 200 is similar to the thickness distribution of the balloon 2.
  • the balloon 200 in the expanded state is expanded in a substantially cylindrical shape having a constant outer diameter D 200B (where D 200B > D 0 ) over substantially the entire length of the central portion 200b.
  • D 200B constant outer diameter
  • Such a substantially uniform diameter expansion condition occurs when the lumen does not have a constriction.
  • the amount of biting into the lumen of the balloon 200 becomes substantially constant over the entire length, sliding movement of the balloon 200 in the axial direction is likely to occur.
  • the balloon 200 of the comparative example which is inflated as shown in FIG. 5 in free space, is a portion where the balloon located at the non-narrowed portion is the narrow portion when inflated in the lumen having the narrowed portion and the non-narrowed portion. There is less expansion resistance than the part of the balloon located at. For this reason, in a lumen having a constricted part and a non-constricted part, inflation starts from a balloon located in the non-constricted part. For this reason, inflation is started from either the front or back end of the balloon unless the stenosis is accurately located at the center of the balloon, so the balloon tends to move due to the reaction force from the stenosis at the balloon being inflated. is there.
  • the balloon may be subjected to a drag to move.
  • the balloon 200 of the comparative example since the balloon 200 of the comparative example is easily moved due to the resistance of the constriction part during the uneven expansion, it may be separated from the constriction part in the expansion process. Even if the shaft is not completely removed, the balloon may be locked by the uneven bulging portions at both ends, so that the shaft may be easily removed from the narrowed portion only by lightly pushing and pulling the shaft.
  • the wall thickness of both ends of the central portion 200b or the diameter transition portions 200a and 200c is compared to the middle portion of the central portion 200b. It is also conceivable to make it thinner. However, in this case, since the breaking strength is reduced at the portion where the thickness is thin, the pressure resistance of the balloon is reduced.
  • the shape of the balloon in a naturally deployed state into a dog bone shape since the shape of the balloon in a naturally-expanded state becomes a complicated three-dimensional shape, when the balloon is contracted, it can not be folded into a plurality of flat wings. Thereby, even if it winds around a shaft in the state which folded the balloon, a part will rise and an uneven part will arise.
  • the balloon 2 of the present embodiment since the balloon 2 of the present embodiment is substantially cylindrical in a naturally deployed state, it can be folded into a plurality of flat plates if the folding position is appropriately set when the balloon 2 is contracted. It is.
  • the outer diameter when wound around the shaft 1 is substantially uniform. Therefore, the balloon can be smoothly inserted into and removed from the lumen. Similarly, insertion and removal to a tube member such as an endoscope which is inserted to guide the balloon 2 can be smoothly performed.
  • the operator After the expansion of the balloon 2 is completed, the operator performs the removal operation of the balloon catheter 10.
  • the operator operates the fluid supply device to decompress the expansion fluid and aspirate the expansion fluid from the proximal opening 1d.
  • the expansion fluid in the internal space S is gradually discharged into the internal flow path P from the distal end opening 1 c.
  • the balloon 2 is contracted according to the discharge amount of the expansion fluid.
  • the balloon 2 is in the same state as being wound around the shaft 1 as in the initial state.
  • the operator retracts the balloon catheter 10 along the guide wire or with the guide wire, and withdraws from the lumen. At this time, since the outer diameter of the reduced balloon 2 is substantially the same as the outer diameter of the shaft 1, smooth removal is possible.
  • the balloon catheter 10 provided with the balloon 2 of the present embodiment, it is possible to suppress axial positional deviation at the time of attachment to the lumen without reducing the pressure resistance and the insertion / extraction performance of the balloon 2. . For this reason, at the time of diameter expansion, the balloon 2 is disposed at the narrowing portion without being separated from the narrowing portion of the lumen.
  • the shaft has an internal flow passage used for the circulation of the expansion fluid, and a through hole used for other applications such as insertion of a guide wire and circulation of a chemical solution, for example. I explained in the example.
  • the shaft may be formed with only the internal flow path.
  • the inner tube 1B may be replaced by a tube whose tip is sealed or a solid rod-like member.
  • the shaft may be configured such that the distal end side opening is provided on the side surface of the single-lumen tube whose distal end is sealed.
  • Examples 1 to 8 of the balloon catheter 10 of the above embodiment will be described together with Comparative Examples 1 to 4.
  • the structures of the balloons in Examples 1 to 8 and Comparative Examples 1 to 4 and the evaluation results are shown in the following Table 1.
  • [Table 1] the material of the balloon and the length ratio (%) of each part of the balloon are shown among the configurations of the balloon.
  • the ratio of the axial length of each part to the axial length of the enlarged diameter part is displayed as a percentage of the length ratio of the balloon.
  • Specific material names of the materials in the following [Table 1] are shown in the following [Table 2].
  • the resin A, the resin B, the resin C, the resin D, the resin E, and the resin F the value of 100% modulus increases in this order.
  • Example 1 As shown in Table 1, in the balloon 2 in Example 1, the resin C was used for the first end 2D and the second end 2F, and the resin F was used for the central portion 2E.
  • Resin C is PEBAX (registered trademark) 6333 (trade name; manufactured by Arkema). The 100% modulus and tensile strength at break of resin C are 17 MPa and 55 MPa, respectively.
  • Resin F is Grilamid (registered trademark) L25 (trade name; manufactured by Emskemy). The 100% modulus and tensile strength at break of the resin F are 28 MPa and 71 MPa, respectively.
  • the tensile breaking strengths of the first end 2D and the second end 2F are 77% of the tensile breaking strength of the central portion 2E.
  • the axial lengths of the enlarged diameter portion 2B, the first end 2D, the central portion 2E, and the second end 2F are 100 mm, 25 mm (length ratio 25%), 50 mm, respectively. (Length ratio 50%), 25 mm (Length ratio 25%).
  • the outer diameter D 0 of the balloon 2 in the natural deployed state in this example was 16.5 mm.
  • the thickness of each of the central portion 2E and the constant diameter portions 2b and 2c was 0.04 mm. The thickness was determined as half of the thickness of two sheets measured by bending the balloon 2.
  • the balloon 2 of Example 1 was made by blow molding, forming a parison tube from the above-mentioned materials.
  • the balloon 2 of Example 1 was fixed by welding to a shaft 1 having an outer diameter of the inner tube 1B of 1.6 mm and an outer diameter of the outer tube 1A of 2.0 mm.
  • the outer diameter of the balloon 2 was substantially uniform in the axial direction, and was about 2.7 mm.
  • the balloon catheter 10 of Example 1 was formed.
  • Example 2 As shown in [Table 1], in the configuration of the balloon 2 in Example 2, the length ratio of the first end 2D, the center 2E, and the second end 2F is 15%, 70%, and 15%, respectively. The same as in Example 1 except for the above.
  • Examples 3 and 4 As shown in Table 1, the configuration of the balloon 2 in Example 3 was the same as Example 1 except that resin E was used as the material of the central portion 2E.
  • the balloon 2 in Example 4 was the same as Example 2 except that resin E was used as the material of the central portion 2E.
  • resin E is PEBAX (registered trademark) 7233 (trade name; manufactured by Arkema).
  • the 100% modulus and tensile strength at break of resin E are 22 MPa and 67 MPa, respectively. For this reason, the tensile breaking strength of the first end 2D and the second end 2F is 82% of the tensile breaking strength of the central portion 2E.
  • Examples 5, 6 As shown in [Table 1], the configuration of the balloon 2 in Example 5 was the same as Example 3 except that resin D was used as the material of the first end 2D and the second end 2F. .
  • the configuration of the balloon 2 in Example 6 was the same as that of Example 4 except that the resin D was used as the material of the first end 2D and the second end 2F.
  • resin D is PEBAX (registered trademark) 7033 (trade name; manufactured by Arkema).
  • the 100% modulus and tensile strength at break of resin D are 21 MPa and 59 MPa, respectively. Therefore, the tensile breaking strength of the first end 2D and the second end 2F is 88% of the tensile breaking strength of the central portion 2E.
  • Example 7 As shown in [Table 1], in the configuration of the balloon 2 in Example 7, the resin B was used as the material of the first end 2D and the second end 2F, the first end 2D, and the central part Except for the fact that the length ratio of 2E and the second end 2F was set to 20%, 60%, and 20%, respectively, it was assumed that it was the same as Example 1.
  • the resin B is PEBAX (registered trademark) 5533 (trade name; manufactured by Arkema).
  • the 100% modulus and tensile strength at break of the resin B are 16 MPa and 44 MPa, respectively. Therefore, the tensile breaking strength of the first end 2D and the second end 2F is 62% of the tensile breaking strength of the central portion 2E.
  • Example 8 As shown in [Table 1], the configuration of the balloon 2 in Example 8 is the same as Example 7 except that resin A was used as the material of the first end 2D and the second end 2F. .
  • Resin A is PEBAX (registered trademark) 4033 (trade name; manufactured by Arkema).
  • the 100% modulus and tensile strength at break of the resin A are 13 MPa and 36 MPa, respectively. Therefore, the tensile breaking strength of the first end 2D and the second end 2F is 51% of the tensile breaking strength of the central portion 2E.
  • Comparative Example 1 As shown in [Table 1], in the configuration of the balloon in Comparative Example 1, resin C was used as the material of the central portion, and resin F was used as the material of the first end and the second end. , The same as Example 7. Therefore, the 100% modulus at the first end and the second end is 11 MPa larger than the 100% modulus at the central portion. The tensile breaking strength of the first end and the second end was 129% of the tensile breaking strength of the central portion.
  • Comparative Example 2 As shown in Table 1, the configuration of the balloon in Comparative Example 2 was the same as Comparative Example 1 except that resin D was used as the material of the central portion. Therefore, the 100% modulus at the first end and the second end was 7 MPa larger than the 100% modulus at the central portion. The tensile breaking strength of the first end and the second end was 120% of the tensile breaking strength of the central part.
  • FIG. 6 is a schematic cross-sectional view showing the shape of a narrowed portion used for evaluation of positional deviation.
  • the positional deviation was evaluated using an evaluation jig 100 as shown in FIG.
  • the evaluation jig 100 was formed in a shape that simulates a narrow portion of a lumen whose internal diameter of the non-constriction portion is 20 mm.
  • the evaluation jig 100 is provided with a through hole 101 in which a taper portion 101a, a circular hole portion 101b, and a taper portion 101c are coaxially formed in this order in a block material made of silicone.
  • the circular hole portion 101 b is a shape portion that simulates a narrowed portion.
  • the circular hole portion 101 b had a diameter ⁇ of 5 mm and a length ⁇ of 10 mm.
  • the tapered portion 101a (101c) is expanded in diameter from the distal end (proximal end) of the circular hole portion 101b toward the distal end (proximal end) to the inner diameter of the non-constricted portion of the lumen.
  • the taper angle ⁇ of the tapered portions 101a and 101c was 25 °.
  • the balloon of the balloon catheter of each example and each comparative example was inserted into the circular hole portion 101b of the evaluation jig 100, and the expansion fluid consisting of warm water was introduced into the internal space of the balloon.
  • the balloon was thus expanded.
  • the pressure of the expansion fluid was set to a pressure at which the outer diameter of the central portion of the enlarged diameter portion in the free space became 18 mm.
  • the pressure varies depending on the material of the central portion of the enlarged diameter portion, but was 2026.5 hPa to 4053.0 hPa in Examples 1 to 8 and 2026.5 hPa to 4053.0 hPa in Comparative Examples 1 to 4. Thereby, each balloon was able to expand the hole portion 101 b.
  • the evaluation of the releasability was performed by measuring the amount of force when the balloon catheter in a deflated state was inserted into and removed from the evaluation jig 100.
  • the insertion capacity is 7N or less and the extraction capacity is 20N or less, "Good” (described as “o” in [Table 1])
  • the insertion capacity exceeds 7N, or the extraction capacity is When it exceeded 20 N, it was evaluated as “defect” (denoted as "good” and described as "x” in [Table 1]).
  • Comparative Example 3 the reason why the “displacement” becomes defective in Comparative Example 3 is that the diameter-increased portion of Comparative Example 3 is formed of a single material. That is, when the balloon starts to inflate from the non-constriction part, the expansion of both ends becomes uneven, and as a result of being expanded in one direction by the drag of the constriction part, it is dislodged when it is pushed and pulled to one side. Is considered to be The reason why the “removability” is “defective (x)” in Comparative Examples 1 to 3 is considered to be that the material at both ends is formed of the resins E and F having a relatively large modulus of 100%.
  • Comparative Example 4 was evaluated as “good (o)” for "pressure resistance strength” and "removability” but because "displacement” was “defect (x)", “poor” as a comprehensive evaluation. It was evaluated as (no good, described as "x” in [Table 1]). In Comparative Example 4, the reason why the “displacement” is “defect (x)” is considered to be the same reason as in Comparative Example 3. The reason why the “removability” was “good ( ⁇ )” in Comparative Example 4 is considered to be that the 100% modulus of the material at both ends of the Comparative Example is made of the resin C smaller than the resins E and F. .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
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  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un cathéter à ballonnet (10) comprend : une tige (1) qui distribue un fluide d'expansion à travers une ouverture côté extrémité avant (1c); et un ballonnet (2) qui a une première partie de fixation (2A) qui est fixée sur une surface périphérique externe (1e) de la tige (1) à un emplacement plus proche du côté extrémité avant que l'ouverture côté extrémité avant (1c), une seconde partie de fixation (2C) qui est fixée sur la surface périphérique externe (1e) de la tige (1) à un emplacement plus proche du côté d'extrémité de base que l'ouverture côté extrémité avant (1c), et une partie à diamètre dilatable (2B) qui est formée entre la première partie de fixation (2A) et la seconde partie de fixation (2C), et qui se dilate en diamètre par le fluide d'expansion, la partie à diamètre dilatable (2B) étant configurée pour avoir une première partie d'extrémité (2D), une partie centrale (2E), et une seconde partie d'extrémité (2F) disposées adjacentes l'une à l'autre dans cette séquence, et le matériau pour la première partie d'extrémité (2D) et la seconde partie d'extrémité (2F) a un module de 100 % inférieur à celui du matériau pour la partie centrale (2E).
PCT/JP2017/034594 2016-09-29 2017-09-25 Cathéter à ballonnet WO2018062116A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005323714A (ja) * 2004-05-13 2005-11-24 Kaneka Corp 医療用カテーテルバルーン
JP2008000553A (ja) * 2006-06-26 2008-01-10 Asahi Intecc Co Ltd バルーンカテーテルの製造方法及びバルーンカテーテル
US20080171977A1 (en) * 2006-10-20 2008-07-17 Boston Scientific Scimed, Inc. Reinforced rewrappable balloon

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005323714A (ja) * 2004-05-13 2005-11-24 Kaneka Corp 医療用カテーテルバルーン
JP2008000553A (ja) * 2006-06-26 2008-01-10 Asahi Intecc Co Ltd バルーンカテーテルの製造方法及びバルーンカテーテル
US20080171977A1 (en) * 2006-10-20 2008-07-17 Boston Scientific Scimed, Inc. Reinforced rewrappable balloon

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