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WO2025204640A1 - Ballonnet médical et cathéter - Google Patents

Ballonnet médical et cathéter

Info

Publication number
WO2025204640A1
WO2025204640A1 PCT/JP2025/008016 JP2025008016W WO2025204640A1 WO 2025204640 A1 WO2025204640 A1 WO 2025204640A1 JP 2025008016 W JP2025008016 W JP 2025008016W WO 2025204640 A1 WO2025204640 A1 WO 2025204640A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
layer
cross
longitudinal direction
outer layer
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/JP2025/008016
Other languages
English (en)
Japanese (ja)
Inventor
一歩 飯塚
真太郎 大角
和明 生駒
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kaneka Corp
Original Assignee
Kaneka Corp
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 Kaneka Corp filed Critical Kaneka Corp
Publication of WO2025204640A1 publication Critical patent/WO2025204640A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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 medical balloon and a catheter equipped with this balloon.
  • angioplasty which uses a medical balloon and a catheter equipped with this to expand the narrowed area.
  • various balloon catheters have also been proposed for the purpose of expanding narrowed areas in body cavities such as the trachea and digestive tract. Treatment using balloon catheters is widely used because it is a minimally invasive therapy that does not require open chest surgery like bypass surgery.
  • Patent documents 1 to 5 disclose balloons with multi-layered balloon membranes designed to achieve desired performance.
  • a medical balloon having a longitudinal direction, a radial direction, and a circumferential direction, an outer layer made of a first polymeric material; an inner layer disposed inside the outer layer and made of a second polymer material; A medical balloon, wherein the birefringence of the inner layer in a cross section perpendicular to the longitudinal direction is higher than the birefringence of the outer layer in a cross section perpendicular to the longitudinal direction.
  • the birefringence of the inner layer in a cross section perpendicular to the longitudinal direction is an absolute value of a difference between a refractive index in the circumferential direction of the inner portion of the inner layer and a refractive index in the radial direction of the inner portion of the inner layer when the inner layer is divided into two equal parts, an inner portion and an outer portion, in the radial direction
  • the birefringence of the outer layer in a cross section perpendicular to the longitudinal direction is the absolute value of the difference between the circumferential refractive index of the inner part of the outer layer and the radial refractive index of the inner part of the outer layer when the outer layer is divided into two equal parts in the radial direction: an inner part and an outer part.
  • the medical balloon according to the embodiment is preferably any one of the following [2] to [8].
  • [2] The medical balloon according to [1], wherein the birefringence of the inner layer in a cross section perpendicular to the longitudinal direction is higher by 0.001 or more than the birefringence of the outer layer in a cross section perpendicular to the longitudinal direction.
  • the first polymer material is a polyamide;
  • the medical balloon according to [1] or [2], wherein the second polymer material is a polyamide elastomer.
  • [4] The medical balloon according to any one of [1] to [3], wherein the compliance of the medical balloon is higher than the compliance of a hypothetical single-layer balloon having the same outer diameter and thickness as the medical balloon.
  • a catheter according to an embodiment of the present invention that can solve the above problems is as follows. [9] A catheter comprising the medical balloon according to any one of [1] to [8].
  • the above-mentioned medical balloon and catheter equipped with it have both high pressure resistance and compliance, allowing them to be used for a variety of treatments, eliminating the need to use different balloons and catheters depending on the type of lesion or body part.
  • FIG. 2 is a schematic diagram of a catheter equipped with the balloon shown in FIG. 1.
  • 1 is an optical microscope photograph showing the cutting position of a sample from a balloon in Example 1.
  • 1 is an optical microscope photograph showing the cutting position of a sample from a balloon in Example 2.
  • 1 is an optical microscope photograph showing the cutting position of a sample from a balloon in Example 3.
  • FIG. 2 is an explanatory diagram showing the positions at which retardation is measured in the examples.
  • 1 is an optical microscope photograph showing the retardation measurement positions in the cross section of the sample of Example 1.
  • 10 is an optical microscope photograph showing the retardation measurement positions in the cross section of the sample of Example 2.
  • 10 is an optical microscope photograph showing the retardation measurement positions in the cross section of the sample of Example 3.
  • a medical balloon according to one embodiment of the present invention is a medical balloon having longitudinal, radial, and circumferential directions, and includes an outer layer made of a first polymer material and an inner layer made of a second polymer material disposed inside the outer layer, wherein the birefringence of the inner layer in a cross section perpendicular to the longitudinal direction is higher than the birefringence of the outer layer in a cross section perpendicular to the longitudinal direction.
  • the birefringence of the inner layer in the cross section perpendicular to the longitudinal direction is the absolute value of the difference between the circumferential refractive index of the inner portion of the inner layer and the radial refractive index of the inner portion of the inner layer when the inner layer is divided into two equal parts in the radial direction.
  • the birefringence of the outer layer in the cross section perpendicular to the longitudinal direction is the absolute value of the difference between the circumferential refractive index of the inner portion of the outer layer and the radial refractive index of the inner portion of the outer layer when the outer layer is divided into two equal parts in the radial direction.
  • the radial direction y of balloon 1 refers to the radial direction of balloon 1, and inward in the radial direction y of balloon 1 refers to the direction toward the center of the longitudinal axis of balloon 1, and outward in the radial direction y refers to the direction extending radially from the center of the longitudinal axis opposite to inward.
  • the circumferential direction p of balloon 1 refers to the direction around the longitudinal axis.
  • Balloon 1 preferably has an outer surface 6A and an inner surface 6B.
  • the balloon 1 has an outer layer 2 made of a first polymer material and an inner layer 3 made of a second polymer material, which is disposed inside the outer layer 2.
  • the inner layer 3 is disposed inside the outer layer 2 in the radial direction y.
  • the outer layer 2 may be disposed outermost in the radial direction y.
  • the inner layer 3 may be disposed innermost in the radial direction y.
  • the outer layer 2 and the inner layer 3 may abut in the radial direction y.
  • One or more layers may be disposed between the outer layer 2 and the inner layer 3 in the radial direction y.
  • an intermediate layer 4 is disposed between the outer layer 2 and the inner layer 3.
  • the birefringence ⁇ n i (ring) of the inner layer 3 in the cross section perpendicular to the longitudinal direction x of the balloon 1 is higher than the birefringence ⁇ n o (ring) of the outer layer 2 in the cross section perpendicular to the longitudinal direction x.
  • the balloon 1 has both high pressure resistance and high compliance. This allows the balloon to be used for a variety of treatments, eliminating the need to use different balloons depending on the type of lesion or body part.
  • the refractive index refers to the relative refractive index.
  • the birefringence ⁇ n o (ring) of the outer layer 2 and the birefringence ⁇ n i (ring) of the inner layer 3 in a cross section perpendicular to the longitudinal direction x can be measured by the following method. As shown in FIG. 4 , a balloon piece obtained by cutting the balloon 1 along the longitudinal direction x and the radial direction y is used as the measurement sample 15. The sample 15 is obtained by cutting the membrane of the balloon 1 using a blade such as a knife or a laser irradiation device. The size and shape of the sample 15 are arbitrary.
  • the cross section of the sample 15 perpendicular to the longitudinal direction x of the balloon 1 may be referred to as the ring cut surface 16, and the cross section of the sample 15 along the longitudinal direction x of the balloon 1 may be referred to as the long-axis cross section 17.
  • the ring section 16 of the sample 15 is observed with a polarizing microscope, and (i) the retardation R o (ring) at the ring section 16 of the sample 15 in the inner portion 2A of the outer layer 2, and (ii) the retardation R i (ring) at the ring section 16 of the sample 15 in the inner portion 3A of the inner layer 3 are measured using a compensator. The thickness t 1 of the sample 15 is also measured.
  • the thickness t 1 is the length of the sample 15 in the direction perpendicular to the ring section 16 of the sample 15.
  • the unit of retardation is nm
  • the unit of thickness t 1 is ⁇ m.
  • the thickness t 2 is the length of the sample 15 in the direction perpendicular to the major cross section 17 of the sample 15.
  • the sample used to measure the retardation at the cross section 16 and the sample used to measure the retardation at the major cross section 17 may be the same, or may be cut out separately from the balloon.
  • the unit of retardation is nm
  • the unit of thickness t2 is ⁇ m.
  • n L n d + ⁇ n (length) (11)
  • n d n r - ⁇ n (ring)...(12)
  • b 2 ⁇ n (length) - 4 ⁇ n (ring)... (13)
  • c 2 ( ⁇ n (ring)) 2 + ⁇ n (length)) 2 -2 ⁇ n (ring) x ⁇ n (length) - 3n 2 ...
  • the refractive indices (n ro , n do , n Lo ) of the inner portion 2A of the outer layer 2 are preferably the refractive indices at the inner position in the radial direction y of the inner portion 2A, more preferably the refractive indices at the innermost region in the radial direction y when the inner portion 2A is divided into two equal parts in the radial direction y of the balloon 1, even more preferably the refractive indices at the innermost region in the radial direction y when the inner portion 2A is divided into three equal parts in the radial direction y of the balloon 1, and even more preferably the refractive indices at the innermost region in the radial direction y when the inner portion 2A is divided into four equal parts in the radial direction y of the balloon 1.
  • retardation R may be measured at any position in the longitudinal direction x of the balloon 1, but it is preferably measured in the straight tube portion 11A of the balloon 1, and more preferably in a portion of the straight tube portion of the balloon 1 that includes the center position in the longitudinal direction x. In other words, it is preferable that the measurement sample 15 is cut out from the straight tube portion 11A of the balloon 1.
  • the straight tube portion 11A will be described later.
  • the birefringence ⁇ n i (ring) of the inner layer 3 at the ring cross section 16 may be higher than the birefringence ⁇ n o (ring) of the outer layer 2 at the ring cross section 16 by 0.002 or more, 0.003 or more, 0.006 or more, 0.008 or more, 0.010 or more, or 0.030 or less, 0.025 or less, 0.020 or less, 0.018 or less, or 0.014 or less.
  • Polymer materials constituting the balloon 1 include, for example, polyolefin-based resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester-based resins such as polyethylene terephthalate and polyester elastomer; polyurethane-based resins such as polyurethane and polyurethane elastomer; polyphenylene sulfide-based resins; polyamide-based resins such as polyamide and polyamide elastomer; fluorine-based resins; silicone-based resins; and natural rubber such as latex rubber. These materials may be used alone or in combination. Among these, polyamide-based resins, polyester-based resins, and polyurethane-based resins are preferred.
  • the first polymer material constituting the outer layer 2 and the second polymer material constituting the inner layer 3 may be the same type, but it is preferable that they are different types.
  • both the first polymer material and the second polymer material are polyamide-based resins.
  • the first polymer material is polyamide and the second polymer material is polyamide elastomer.
  • the intermediate layer 4 can also be made of the polymer material described above.
  • the third polymer material making up the intermediate layer 4 may be the same type as the first polymer material making up the outer layer 2, but it is preferable that they are different types.
  • the third polymer material making up the intermediate layer 4 may be the same type as the second polymer material making up the inner layer 3, but it is preferable that they are different types.
  • the compliance (unit: mm/atm) of balloon 1 is preferably higher than that of a hypothetical single-layer balloon 50 with the same outer diameter and membrane thickness as balloon 1. This allows a single product to cover a wider range of blood vessel diameters than conventional single-layer balloons. Furthermore, because it is more flexible than conventional single-layer balloons, it prevents damage to blood vessels and provides good followability to proximal manipulations when inserting balloon 1 into the body.
  • Figures 5 and 6 show the structure of hypothetical single-layer balloon 50.
  • the balloon membrane of hypothetical single-layer balloon 50 may be made of any material, but can be made of the same material as the outer layer 2, inner layer 3, or middle layer 4 of balloon 1.
  • Figures 5 and 6 show a single-layer balloon 50 made of a polyamide layer 51.
  • the compliance of balloon 1 is preferably 1.03 times or more, preferably 1.05 times or more, preferably 1.07 times or more, preferably 1.10 times or more, preferably 1.30 times or more, and may be 1.50 times or more, of the compliance of a hypothetical single-layer balloon 50 having the same outer diameter and film thickness as balloon 1. Furthermore, the compliance of balloon 1 may be 5.00 times or less, 4.00 times or less, 3.00 times or less, or 2.70 times or less of the compliance of a hypothetical single-layer balloon 50 having the same outer diameter and film thickness as balloon 1.
  • the compliance of the balloon 1 is indicated by the slope (mm/atm) of the compliance curve that shows the relationship between the increase in the outer diameter of the balloon 1 and the inflation pressure (atm) applied to the inside of the balloon 1 within a predetermined operating range, for example, from 1 atm to the burst diameter.
  • the outer diameter of the balloon 1 can be measured using a known measuring device such as a vernier caliper.
  • the burst pressure of balloon 1 is preferably higher than the burst pressure of a hypothetical single-layer balloon 50 with the same outer diameter and film thickness as balloon 1. This allows for use even when high pressure is applied to the interior of balloon 1, giving balloon 1 a high expansion force and making it suitable for use in expanding hard lesions such as calcified areas. Furthermore, because of its good pushability, balloon 1 can be easily pushed through narrowed areas when inserted into the body.
  • the burst pressure of balloon 1 is preferably at least 1.1 times, more preferably at least 1.2 times, and even more preferably at least 1.3 times the burst pressure of a hypothetical single-layer balloon 50 having the same outer diameter and film thickness as balloon 1, and is also acceptable to be 5.0 times or less, 4.0 times or less, 3.0 times or less, 2.8 times or less, or 2.5 times or less.
  • the cross-sectional area of the inner layer 3 in a cross section perpendicular to the longitudinal direction x is preferably 30% or more, more preferably 40% or more, and even more preferably 50% or more of the cross-sectional area of the outer layer 2 in a cross section perpendicular to the longitudinal direction x.
  • the cross-sectional area of the inner layer 3 in a cross section perpendicular to the longitudinal direction x is preferably 90% or less, more preferably 80% or less, and even more preferably 70% or less of the cross-sectional area of the outer layer 2 in a cross section perpendicular to the longitudinal direction x.
  • the balloon 1 may have an expansion section 11, a distal sleeve section 12A located distal to the expansion section 11, and a proximal sleeve section 12B located proximal to the expansion section 11.
  • the distal sleeve section 12A and/or the proximal sleeve section 12B are preferably fixed to the shaft 30, which will be described later.
  • the cross-sectional area of the inner layer 3 in a cross section perpendicular to the longitudinal direction x is preferably 20% or more of the cross-sectional area of the outer layer 2, more preferably 30% or more, even more preferably 40% or more, and even more preferably 50% or more.
  • the cross-sectional area of the inner layer 3 in a cross section perpendicular to the longitudinal direction x is preferably 90% or less of the cross-sectional area of the outer layer 2, more preferably 80% or less, and even more preferably 70% or less.
  • the thickness ratio of the outer layer 2 to the inner layer 3 of the balloon 1 may be 1/9 or more, 2/8 or more, 3/7 or more, or 4/6 or more, or may be 9/1 or less, 8/2 or less, 7/3 or less, or 6/4 or less.
  • the thickness of the balloon 1, i.e., the thickness of the entire balloon including the outer layer 2 and inner layer 3, can be, for example, 10 ⁇ m or more, 30 ⁇ m or more, or 50 ⁇ m or more, and is also acceptable to set it to 150 ⁇ m or less, 120 ⁇ m or less, or 100 ⁇ m or less.
  • the numerical ranges described here may be the thickness after expansion, but are preferably the thickness before expansion.
  • the thickness described here is preferably the minimum thickness of the balloon 1.
  • the thickness of the balloon 1 can be measured using a known displacement meter.
  • physiologically active substances used in the physiologically active drug include paclitaxel, docetaxel, sirolimus, temsirolimus, everolimus, zotarolimus, biolimus A9, cilostazol, cyclosporine, and NF- ⁇ B decoy oligonucleotides.
  • the physiologically active substances used in the physiologically active drug may be used alone or in combination.
  • the balloon 1 may be coated with a physiologically active substance alone, or may be used in combination with an appropriate additive.
  • the physiologically active substance be crystalline.
  • crystalline physiologically active substances include paclitaxel, sirolimus, everolimus, and zotarolimus.
  • the additives contained together with the physiologically active substance are crystalline.
  • crystalline additives include sugars, urea, salts such as potassium iodide, ascorbic acid, polylactic acid, and polyglycolic acid.
  • the expansion section 11 of the balloon 1 may have a straight tube section 11A, a distal tapered section 11B located distal to the straight tube section 11A, and a proximal tapered section 11C located proximal to the straight tube section 11A. It is preferable that the outer diameters of the distal tapered section 11B and the proximal tapered section 11C decrease with increasing distance from the straight tube section 11A.
  • the shape of the expansion portion 11 of the balloon 1 is not particularly limited, but can be a sphere, an oval sphere, a cylinder, a cone, a frustum, or a combination of these.
  • the catheter 40 preferably has a shaft 30 and a balloon 1 disposed on the outside of the shaft 30.
  • the catheter 40 has a distal side and a proximal side, and the balloon 1 is preferably disposed on the distal side of the shaft 30.
  • the catheter 40 is configured so that fluid is supplied to the inside of the balloon 1 through the shaft 30, and the expansion and contraction of the balloon 1 can be controlled using an indeflator (balloon pressurizer).
  • the fluid may be pressurized fluid pressurized by a pump or the like.
  • the shaft 30 may have an internal flow path for the fluid used to inflate the balloon, as well as a passage for the guide wire.
  • the shaft 30 may have an outer tube 31 and an inner tube 32 placed in the lumen of the outer tube 31.
  • the lumen of the inner tube 32 functions as a passage for the guide wire, and the space between the inner tube 32 and the outer tube 31 can function as a fluid flow path.
  • the inner tube 32 extends from the distal end of the outer tube 31 and penetrates distally beyond the balloon 1, with the distal side of the balloon 1 joined to the inner tube 32 and the proximal side of the balloon 1 joined to the outer tube 31.
  • the catheter 40 may be provided with a hub 35 on the proximal side of the shaft 30.
  • the hub 35 may be provided with a fluid injection section 37 that is connected to a flow path for fluid supplied to the interior of the balloon 1.
  • the hub 35 preferably has a guidewire insertion section 36 that is connected to a guidewire insertion passage. This facilitates the operation of supplying fluid to the interior of the balloon 1 to expand or contract the balloon 1, and the operation of delivering the catheter 40 to the treatment site along the guidewire.
  • Figure 8 shows an example in which the balloon 1 is applied to a so-called over-the-wire type catheter 40 in which a guidewire is inserted from the distal side to the proximal side of the shaft 30.
  • the balloon 1 can also be applied to a so-called rapid exchange type catheter in which a guidewire is inserted partway from the distal side to the proximal side of the shaft.
  • Example 2 A two-layer tube was produced using the same material composition and molding conditions as in Example 1, and a two-layer balloon having an outer diameter of 6.00 mm and a film thickness of 40.0 ⁇ m was produced using the same blow molding conditions as in Example 1.
  • the thickness ratio of each layer to the total thickness in the radial direction of the balloon was calculated from the dimensions of the tube described in Examples 1 to 9 and Comparative Examples 1 and 2 of Patent Document 1 (e.g., ⁇ 0.37 ⁇ 0.47 ⁇ 0.82 ⁇ 0.88 mm in Example 1 of Patent Document 1).
  • RBP Ring Burst Pressure
  • the balloons in the Examples and Comparative Examples of Patent Document 1 differ in outer diameter and pressure resistance characteristics. Furthermore, (2) the operating range of inflation pressures for calculating the above-mentioned general compliance values can be freely set by those skilled in the art to a certain extent. Furthermore, (3) because the balloon outer diameter changes nonlinearly up to the time of rupture, there is a risk that convenient interpretations may be made depending on the numerical setting of the operating range of the balloon inflation pressure. Because of the above (1) to (3), we believe that it is not desirable to compare using general compliance (nominal pressure to RBP pressure). In this paper, we calculated the range from the minimum outer diameter to the maximum outer diameter that can be experimentally measured or calculated as the amount of change per unit pressure. The same applies to the degree of elongation, which will be described later.
  • the elongation (%) is the ratio of the outer diameter of the balloon to the inner diameter of the mold.
  • the elongation (%) is the ratio of the outer diameter of the balloon to the inner diameter of the mold.
  • the elongation was calculated using the formula "(outer diameter of the balloon at rupture - diameter of the balloon at a pressure of 0.1 MPa) / outer diameter of the balloon at a pressure of 0.1 MPa.”
  • the elongation of Comparative Examples 1 to 11 was calculated using the formula "(outer diameter of the balloon at RBP - mold diameter) / mold diameter.”
  • the reason for this calculation in Comparative Examples 1 to 11 is that Patent Document 1 only describes the average elongation rate from the nominal pressure to the RBP, so the outer diameter at the RBP, which is the maximum value that can be calculated and grasped (in Comparative Example 1, the outer diameter was 3.1 mm at 2.2 MPa (22 atm)), was used as the maximum diameter, and the die diameter was used as the minimum value, and the elongation was calculated.
  • the ring section of the sample (ring section 16 in Figure 4) was observed using a Nikon polarizing microscope, Nikon OPTIPHOT-POL, and a compensator was used to measure (i) the retardation R o (ring) at the ring section of the sample at the inner side of the outer layer, and (ii) the retardation R i (ring) at the ring section of the sample at the inner side of the inner layer.
  • the outer layer retardation R o (ring) was measured at a position radially outward from the inner surface of the outer layer by a distance equal to one-third of the thickness of the outer layer
  • the inner layer retardation R i (ring) was measured at a position radially outward from the inner surface of the inner layer by a distance equal to one-third of the thickness of the inner layer.
  • the measurement position for the outer layer retardation is indicated by P1
  • the measurement position for the inner layer retardation is indicated by P2.
  • Figures 13, 14, and 15 show the measurement positions for retardation on the ring cross-section and long-axis cross-section of the samples of Examples 1, 2, and 3, respectively.
  • the sample thickness t1 was also measured using an Olympus LEXT OLS4100 laser microscope.
  • balloons in which the circumferential refractive index of the inner part of the outer layer is higher than the circumferential refractive index of the inner part of the inner layer have reduced pressure-resistant performance (burst pressure, tensile strength) and/or compliance.
  • Balloon 2 Outer layer 2A: Inner portion 2B: Outer portion 3: Inner layer 3A: Inner portion 3B: Outer portion 4: Intermediate layer 5A: Distal end 5B: Proximal end 6A: Outer surface 6B: Inner surface 11: Expanded portion 11A: Straight tube portion 11B: Distal tapered portion 11C: Proximal tapered portion 12A: Distal sleeve portion 12B: Proximal sleeve portion 15: Sample 16: Ring section 17: Longitudinal cross section 20: Coating layer 30: Shaft 35: Hub 40: Catheter 50: Virtual single-layer balloon 51: Polyamide layer x: Longitudinal direction y: Radial direction p: Circumferential direction

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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)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Est proposé un ballonnet médical (1) ayant une direction longitudinale (x), une direction radiale (y) et une direction circonférentielle (p), le ballonnet médical (1) ayant une couche externe (2) qui est formée à partir d'un premier matériau polymère et une couche interne (3) qui est disposée à l'intérieur de la couche externe (2) et est formée à partir d'un second matériau polymère, la biréfringence de la couche interne (3) dans une section transversale perpendiculaire à la direction longitudinale (x) étant supérieure à la biréfringence de la couche externe (2) dans une section transversale perpendiculaire à la direction longitudinale (x). Ici, la biréfringence de la couche interne (3) est la valeur absolue d'une différence entre l'indice de réfraction dans la direction circonférentielle et l'indice de réfraction dans la direction radiale (y) d'une partie interne de la couche interne (3) lorsqu'elle est divisée en deux parties égales dans la direction radiale (y), et la biréfringence de la couche externe (2) est la valeur absolue d'une différence entre l'indice de réfraction dans la direction circonférentielle et l'indice de réfraction dans la direction radiale (y) d'une partie interne de la couche externe (2) lorsqu'elle est divisée en deux parties égales dans la direction radiale (y).
PCT/JP2025/008016 2024-03-28 2025-03-05 Ballonnet médical et cathéter Pending WO2025204640A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2024053838 2024-03-28
JP2024-053838 2024-03-28

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WO2025204640A1 true WO2025204640A1 (fr) 2025-10-02

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WO (1) WO2025204640A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012533338A (ja) * 2009-07-17 2012-12-27 ボストン サイエンティフィック サイムド，インコーポレイテッド 改善された結晶サイズおよび密度を提供する薬剤送達バルーンの核形成
WO2013047449A1 (fr) * 2011-09-29 2013-04-04 テルモ株式会社 Ballonnet de cathéter et cathéter à ballonnet
WO2014141382A1 (fr) * 2013-03-12 2014-09-18 テルモ株式会社 Ballonnet et procédé de production associé
JP2017537678A (ja) * 2014-10-27 2017-12-21 インターフェイス・アソシエイツ・インコーポレーテッド 加圧拘束アニーリングを利用する入れ子式バルーンを製造する方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012533338A (ja) * 2009-07-17 2012-12-27 ボストン サイエンティフィック サイムド，インコーポレイテッド 改善された結晶サイズおよび密度を提供する薬剤送達バルーンの核形成
WO2013047449A1 (fr) * 2011-09-29 2013-04-04 テルモ株式会社 Ballonnet de cathéter et cathéter à ballonnet
WO2014141382A1 (fr) * 2013-03-12 2014-09-18 テルモ株式会社 Ballonnet et procédé de production associé
JP2017537678A (ja) * 2014-10-27 2017-12-21 インターフェイス・アソシエイツ・インコーポレーテッド 加圧拘束アニーリングを利用する入れ子式バルーンを製造する方法

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