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WO2025204185A1 - Cathéter à ballonnets - Google Patents

Cathéter à ballonnets

Info

Publication number
WO2025204185A1
WO2025204185A1 PCT/JP2025/004132 JP2025004132W WO2025204185A1 WO 2025204185 A1 WO2025204185 A1 WO 2025204185A1 JP 2025004132 W JP2025004132 W JP 2025004132W WO 2025204185 A1 WO2025204185 A1 WO 2025204185A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
region
proximal
distal
balloon catheter
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/JP2025/004132
Other languages
English (en)
Japanese (ja)
Inventor
真弘 小嶋
千菜美 佐古
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 WO2025204185A1 publication Critical patent/WO2025204185A1/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 balloon catheter.
  • angioplasty which uses a balloon catheter to expand the narrowed area.
  • Angioplasty is a minimally invasive treatment that does not require open chest surgery like bypass surgery, and is widely performed.
  • Aortic stenosis is a condition in which the aortic valve hardens due to calcification, making it difficult to open and impeding blood flow.
  • Treatment for aortic stenosis can involve open-chest surgery and catheter placement of a biological valve (artificial valve), replacing the hardened aortic valve with a biological valve.
  • Placed bioprosthetic valves deteriorate over time due to calcification, wear, and other factors. When an implanted bioprosthetic valve deteriorates, it must be replaced.
  • One procedure under consideration for replacing a bioprosthetic valve is to apply high pressure to the implanted bioprosthetic valve using a braided balloon catheter or multiple balloon catheters, causing it to deform or break; the valve's lumen is then expanded, and a new bioprosthetic valve is then placed inside the deformed or broken bioprosthetic valve using techniques such as transcatheter aortic valve replacement.
  • Patent Document 1 discloses a catheter characterized by having an expansion means composed of multiple expansion elements, with the walls of the multiple expansion elements combined to form a substantially circular cross section when the expansion means is inflated.
  • Patent Document 2 discloses a balloon catheter having multiple balloon members, with multiple outer balloon members arranged to surround the outer surface of an inner balloon member.
  • Patent Document 3 discloses a balloon catheter having multiple balloons that expand independently without being affected by the other balloons and that are separated and do not come into contact with the other balloons after expansion.
  • Patent Document 4 discloses a device having a perfusion balloon with an internal passage and a balloon arranged in the internal passage of the perfusion balloon.
  • Patent Document 5 discloses a catheter including first, second, and third balloons that can be inflated and deflated independently of each other.
  • the present invention aims to provide a balloon catheter that is less likely to shift the balloon's position and can accurately apply pressure to the desired location.
  • a balloon catheter including a plurality of balloons arranged in parallel with each other in the circumferential direction; a covering material disposed radially outward of the balloon group,
  • the balloons constituting the balloon group each have a straight pipe portion, a distal tapered portion located distal to the straight pipe portion, and a proximal tapered portion located proximal to the straight pipe portion,
  • the balloon group has a central region including a midpoint in a longitudinal direction, a distal region located distal to the central region, and a proximal region located proximal to the central region, the coating is disposed on at least the distal region and the proximal region;
  • a balloon catheter, wherein the maximum outer diameter of the balloon catheter in the central region is smaller than the maximum outer diameter of the balloon catheter in the distal region and the maximum outer diameter of the balloon catheter in the proximal region.
  • the covering material includes a distal covering material disposed in the distal region and a proximal covering material disposed in the proximal region, The balloon catheter according to [1], wherein the covering material is not provided in the central region.
  • a covering material is disposed in at least the distal and proximal regions, and the maximum outer diameter of the balloon catheter in the central region is smaller than the maximum outer diameter of the balloon catheter in the distal region and the maximum outer diameter of the balloon catheter in the proximal region, so that the central region of the balloon group has a concave shape when the balloon group is in an expanded state. Therefore, this concave portion of the balloon can hold the stenosis area, biological valve, etc., making it less likely for the balloon to shift position.
  • FIG. 1 is an overall view of a balloon catheter according to an embodiment of the present invention.
  • 2 is an enlarged view of a portion of the balloon catheter shown in FIG. 1 where a balloon is disposed.
  • 3 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along line III-III.
  • 4 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along line IV-IV.
  • 2 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along the line VV.
  • 10 is an enlarged view of a portion of a balloon catheter according to another embodiment of the present invention in which a balloon is disposed.
  • FIG. 7 shows a cross-sectional view of the balloon catheter shown in FIG. 6 along line VII-VII.
  • a balloon catheter has a balloon group including a plurality of balloons arranged parallel to one another in the circumferential direction, and a covering material arranged radially outward of the balloon group.
  • the balloons constituting the balloon group have a straight tube section, a distal tapered section located distal to the straight tube section, and a proximal tapered section located proximal to the straight tube section.
  • the balloon group has a central region including a midpoint in the longitudinal direction, a distal region located distal to the central region, and a proximal region located proximal to the central region.
  • the covering material is arranged in at least the distal and proximal regions, and the maximum outer diameter of the balloon catheter in the central region is smaller than the maximum outer diameter of the balloon catheter in the distal region and the maximum outer diameter of the balloon catheter in the proximal region.
  • Figure 1 is an overall view of a balloon catheter according to one embodiment of the present invention
  • Figure 2 is an enlarged view of the portion of the balloon catheter shown in Figure 1 where a balloon is located.
  • Figure 3 is a III-III cross-sectional view of the balloon catheter shown in Figure 1, showing a cross-sectional view perpendicular to the longitudinal direction of the central region where a group of balloons is present.
  • Figure 4 is a IV-IV cross-sectional view of the balloon catheter shown in Figure 1, showing a cross-sectional view perpendicular to the longitudinal direction of the distal region where a group of balloons is present.
  • Figure 5 is a V-V cross-sectional view of the balloon catheter shown in Figure 1, showing a cross-sectional view perpendicular to the longitudinal direction of the proximal region where a group of balloons is present.
  • Figure 6 is an enlarged view of the portion where a balloon is located in a balloon catheter according to another embodiment of the present invention, and
  • Figure 7 is a VII-VII cross-sectional view of the balloon catheter shown in Figure 6, showing a cross-sectional view perpendicular to the longitudinal direction of the central region where a group of balloons is present.
  • the balloon 10 has a longitudinal direction x, a radial direction y connecting the centroid of the outer edge of the balloon 10 to a point on the outer edge in a cross section perpendicular to the longitudinal direction x, and a circumferential direction z along the outer edge of the balloon 10 in a cross section perpendicular to the longitudinal direction x.
  • the direction toward the user in the longitudinal direction x is referred to as the proximal side
  • the direction opposite the proximal side, i.e., toward the patient being treated is referred to as the distal side.
  • each component or part when each component or part is divided into two equal parts in the longitudinal direction x of the balloon 10, the part of each component or part located on the distal side is referred to as the distal part of each component or part, and the part of each component or part located on the proximal side is referred to as the proximal part of each component or part.
  • the distal end of each component or part is the end located most distally of each component or part.
  • the proximal end of each component or part is the end located most proximal of each component or part.
  • end includes the peripheral portion of the end. That is, the distal end refers to the distal end and the area surrounding the distal end, and the proximal end refers to the proximal end and the area surrounding the proximal end.
  • Components and parts other than the balloon 10 also have longitudinal, radial, and circumferential directions, which may or may not be the same as the longitudinal direction x, radial direction y, and circumferential direction z of the balloon 10. However, for ease of understanding, this specification will be described as assuming that all components and parts have the same longitudinal, radial, and circumferential directions as the longitudinal direction x, radial direction y, and circumferential direction z of the balloon 10.
  • a balloon group 11 having multiple balloons 10 is located at the distal portion of the balloon catheter 1.
  • the balloon 10 can be expanded by introducing fluid into the inner cavity of the balloon 10, and can be deflated by discharging fluid from the inner cavity of the balloon 10.
  • fluid can be introduced or discharged using an indeflator (balloon pressurizer).
  • the fluid can be, for example, saline or a mixture of a contrast agent and saline.
  • the fluid may also be pressurized fluid pressurized by a pump or the like.
  • Examples of materials that can be used to form the balloon 10 include polyamide resins such as nylon 11 and nylon 12, polyester resins such as polyethylene terephthalate and polybutylene terephthalate, polyurethane resins, and thermoplastic elastomers such as polyether block amide copolymers.
  • the balloons 10 constituting the balloon group 11 have a straight tube section 111, a distal tapered section 112 located distal to the straight tube section 111, and a proximal tapered section 113 located proximal to the straight tube section 111. Since the balloon 10 has the straight tube section 111, the distal tapered section 112, and the proximal tapered section 113, it is also preferable that the balloon group 11 has a straight tube section, a distal tapered section located distal to the straight tube section, and a proximal tapered section located proximal to the straight tube section.
  • the straight tube portion 111 is preferably generally cylindrical and has approximately the same diameter in the longitudinal direction x, but may have different diameters in the longitudinal direction x.
  • the distal tapered portion 112 and the proximal tapered portion 113 are preferably formed into a generally conical or truncated conical shape, with diameters decreasing as they move away from the straight tube portion 111. Because the straight tube portion 111 has the largest diameter, when the balloon group 11 is expanded at a lesion such as a stenosis, the straight tube portions of the balloons 10 constituting the balloon group 11 can sufficiently contact the lesion, facilitating treatment such as dilation of the lesion.
  • the distal tapered portion 112 and the proximal tapered portion 113 have reduced diameters, the outer diameters of the proximal and distal ends of the balloons 10 constituting the balloon group 11 can be reduced when the balloon group 11 is deflated, making it easier to insert the balloon catheter 1 into a body cavity.
  • the balloons 10 constituting the balloon group 11 preferably further have a distal sleeve portion 114 located distal to the distal tapered portion 112, and a proximal sleeve portion 115 located proximal to the proximal tapered portion 113.
  • the straight tube portion 111, distal tapered portion 112, and proximal tapered portion 113 are portions that expand when fluid is introduced into the balloon 10, whereas the distal sleeve portion 114 and proximal sleeve portion 115 preferably do not expand.
  • At least a portion of the distal sleeve portion 114 and at least a portion of the proximal sleeve portion 115 can be configured to be easily fixed to other objects, such as the shaft 70 of the balloon catheter 1. Details of the shaft 70 will be described later.
  • the balloon group 11 has a central region 121 that includes a midpoint P3 in the longitudinal direction x, a distal region 122 that is located distal to the central region 121, and a proximal region 123 that is located proximal to the central region 121.
  • the central region 121 is the portion that includes the midpoint P3 of the length of the balloon group 11 in the longitudinal direction x.
  • the central region 121 is a region that includes the midpoint P3 in the longitudinal direction x of the balloon group 11.
  • the central region 121 is preferably a region that includes the midpoint in the longitudinal direction x of the straight pipe portion 111 of each balloon 10 included in the balloon group 11.
  • the central region 121 is preferably a region that has a length in the longitudinal direction x that is 20% or more of the length of the straight pipe portion 111, more preferably a region that has a length of 25% or more of the length of the straight pipe portion 111, and even more preferably a region that has a length of 30% or more of the length of the straight pipe portion 111.
  • the distal region 122 is a region located distal to the central region 121.
  • the distal region 122 is preferably a region having a length in the longitudinal direction x that is 20% or more of the length of the straight tube portion 111, more preferably a region having a length that is 25% or more of the length of the straight tube portion 111, and even more preferably a region having a length that is 30% or more of the length of the straight tube portion 111.
  • the size of the distal region 122 is more likely to be appropriate.
  • the proximal region 123 is a region located proximal to the central region 121. In the longitudinal direction x, there may be a further region different from the central region 121 and the proximal region 123 between the central region 121 and the proximal region 123, but it is preferable that the central region 121 and the proximal region 123 are adjacent to each other. In other words, it is preferable that the proximal end of the central region 121 and the distal end of the proximal region 123 are in contact.
  • proximal region 123 there may be a further region different from the proximal region 123 proximal to the proximal region 123, but it is preferable that the proximal region 123 is a region that includes the proximal end 111p of the straight tube section 111.
  • the proximal region 123 is preferably a region having a length in the longitudinal direction x that is 20% or more of the length of the straight pipe section 111, more preferably a region having a length that is 25% or more of the length of the straight pipe section 111, and even more preferably a region having a length that is 30% or more of the length of the straight pipe section 111.
  • the size of the proximal region 123 is more likely to be appropriate.
  • the covering material 100 is a member disposed radially outward from the balloon group 11.
  • the covering material 100 is disposed in at least the distal region 122 and the proximal region 123. In other words, the covering material 100 may or may not be disposed in the central region 121.
  • the maximum outer diameter D121 of the balloon catheter 1 in the central region 121 is smaller than the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 and the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123.
  • the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 is larger than the maximum outer diameter D121 of the balloon catheter 1 in the central region 121
  • the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123 is larger than the maximum outer diameter D121 of the balloon catheter 1 in the central region 121.
  • the maximum outer diameter D121 of the balloon catheter 1 in the central region 121, the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122, and the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123 refer to the outer diameters of the balloon group 11 when inflated.
  • the balloon group 11 being inflated can be rephrased as the expanded state of the balloon group 11, and refers to a state in which fluid is introduced into the lumen of each of the multiple balloons 10 that make up the balloon group 11, and all of the balloons 10 that make up the balloon group 11 are inflated.
  • the maximum outer diameter D121 of the balloon catheter 1 in the central region 121 is smaller than the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 and the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123, when the balloon group 11 is inflated, the outer diameter of the balloon catheter 1 in the central region 121 becomes smaller than the outer diameters of the balloon catheter 1 in the distal region 122 and the proximal region 123, forming a concave portion in the central region 121. Because a stenosis, biological valve, etc. can be sandwiched and held in this concave portion of the balloon group 11, the balloon catheter 1 is less likely to shift position when inflated.
  • the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 may be larger or smaller than the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123, but is preferably the same as the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123.
  • the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 and the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123 being the same means that the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 and the maximum outer diameter D123 in the proximal region 123 are approximately the same, and specifically means that the maximum outer diameter D122 in the distal region 122 is between 90% and 110% of the maximum outer diameter D123 in the proximal region 123.
  • the maximum outer diameter D121 of the balloon catheter 1 in the central region 121 is preferably 80% or more, more preferably 85% or more, and even more preferably 90% or more of the maximum outer diameter D122 of the balloon catheter 1 in the distal region 122 and the maximum outer diameter D123 of the balloon catheter 1 in the proximal region 123.
  • the guidewire tube 192 may be made of, for example, polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyetherketone resins such as PEEK, polyetherpolyamide resins, polyurethane resins, polyimide resins, fluorine-containing resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins.
  • polyimide resins are preferred as the material for the guidewire tube 192.
  • Using polyimide resin as the material for the guidewire tube 192 improves the slipperiness of the guidewire tube 192.
  • a hub 5 may be provided on the proximal side of the shaft 70.
  • the hub 5 may also be provided with a fluid injection section 6 that is connected to a flow path for fluid supplied to the interior of the balloon 10.
  • the coating applied to the shaft 70 can be a hydrophilic or hydrophobic coating depending on the purpose, and can be applied by immersing the shaft 70 in a hydrophilic or hydrophobic coating agent, applying a hydrophilic or hydrophobic coating agent to the outer wall of the shaft 70, or covering the outer wall of the shaft 70 with a hydrophilic or hydrophobic coating agent.
  • the coating agent may contain drugs, additives, etc.
  • Balloon catheter 5 Hub 6: Fluid injection section 10: Balloon 11: Balloon group 40: Inner balloon 40d: Distal end of inner balloon 40p: Proximal end of inner balloon 50: Outer balloon 50d: Distal end of outer balloon 50p: Proximal end of outer balloon 51: First outer balloon 52: Second outer balloon 70: Shaft 75: Distal shaft 76: Proximal shaft 93: Guidewire lumen 100: Coating material 101: Distal coating material 102: Proximal coating material 111: Straight tube section 111d: Distal end of straight tube section 111p: Proximal end of straight tube section 112: Distal tapered section 113: Proximal tapered section 114: Distal sleeve Sleeve portion 115: proximal sleeve portion 121: central region 122: distal region 123: proximal region 191: guidewire port 192: guidewire tube 193: distal tip member 194: X-ray opaque marker P3: midpoint of balloon

Landscapes

  • 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

L'invention concerne un cathéter à ballonnets (1) comprenant : un groupe de ballonnets (11) qui comprend une pluralité de ballonnets (10) qui sont disposés de façon à être parallèles les uns aux autres dans la direction circonférentielle z ; et un matériau de recouvrement (100) qui est disposé sur l'extérieur dans la direction radiale du groupe de ballonnets (11). Le groupe de ballonnets (11) comprend : une région centrale (121) qui comprend un point médian (P3) dans la direction longitudinale x ; une région distale (122) qui est davantage du côté distal que la région centrale (121) ; et une région proximale (123) qui est davantage du côté proximal que la région centrale (121). Le matériau de recouvrement (100) est disposé au niveau d'au moins la région distale (122) et la région proximale (123), et le diamètre externe maximal (D121) du cathéter à ballonnets (1) au niveau de la région centrale (121) est inférieur au diamètre externe maximal (D122) du cathéter à ballonnets (1) au niveau de la région distale (122) et au diamètre externe maximal (D123) du cathéter à ballonnets (1) au niveau de la région proximale (123).
PCT/JP2025/004132 2024-03-25 2025-02-07 Cathéter à ballonnets Pending WO2025204185A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2024-047738 2024-03-25
JP2024047738 2024-03-25

Publications (1)

Publication Number Publication Date
WO2025204185A1 true WO2025204185A1 (fr) 2025-10-02

Family

ID=97217256

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2025/004132 Pending WO2025204185A1 (fr) 2024-03-25 2025-02-07 Cathéter à ballonnets

Country Status (1)

Country Link
WO (1) WO2025204185A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012505050A (ja) * 2008-10-10 2012-03-01 インターバルブ， インコーポレイテッド 弁形成術用カテーテルおよび方法
CN117398219A (zh) * 2023-11-01 2024-01-16 中国医学科学院阜外医院 一种防窜动的球囊扩张导管及主动脉瓣扩张装置
US20240058129A1 (en) * 2020-08-25 2024-02-22 Edwards Lifesciences Corporation Medical balloon sensing assembly and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012505050A (ja) * 2008-10-10 2012-03-01 インターバルブ， インコーポレイテッド 弁形成術用カテーテルおよび方法
US20240058129A1 (en) * 2020-08-25 2024-02-22 Edwards Lifesciences Corporation Medical balloon sensing assembly and method
CN117398219A (zh) * 2023-11-01 2024-01-16 中国医学科学院阜外医院 一种防窜动的球囊扩张导管及主动脉瓣扩张装置

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