WO2021177102A1 - バルーンカテーテル - Google Patents

バルーンカテーテル Download PDF

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Publication number
WO2021177102A1
WO2021177102A1 PCT/JP2021/006826 JP2021006826W WO2021177102A1 WO 2021177102 A1 WO2021177102 A1 WO 2021177102A1 JP 2021006826 W JP2021006826 W JP 2021006826W WO 2021177102 A1 WO2021177102 A1 WO 2021177102A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
balloon
tubular member
lumen
cross
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.)
Ceased
Application number
PCT/JP2021/006826
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
俊彦 宇都
真太郎 大角
弘規 ▲高▼田
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
Priority to CN202180017774.3A priority Critical patent/CN115243751B/zh
Priority to US17/908,593 priority patent/US12515068B2/en
Priority to JP2022505140A priority patent/JP7757272B2/ja
Publication of WO2021177102A1 publication Critical patent/WO2021177102A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N2005/0602—Apparatus for use inside the body for treatment of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0609—Stomach and/or esophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0632—Constructional aspects of the apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity

Definitions

  • the present invention relates to a balloon catheter used when irradiating tissues such as cancer cells with light in internal lumens such as blood vessels and digestive tracts.
  • a photosensitizer is administered into the body by intravenous injection or intraperitoneal administration, and the photosensitizer is accumulated in the target tissue such as cancer cells to accumulate light of a specific wavelength.
  • the photosensitizer is excited by irradiating the target tissue with.
  • energy conversion occurs, generating reactive oxygen species.
  • the target tissue can be removed.
  • ablation tissue cauterization
  • the target tissue is irradiated with laser light and cauterized.
  • a light irradiation medical device irradiates a treatment part, which is a target tissue such as a cancer cell, with light of a specific wavelength in an internal lumen such as a blood vessel or a digestive tract. Used for.
  • a light irradiation medical device an optical fiber is arranged in a catheter tube to irradiate a target tissue with light.
  • light irradiation medical devices are delivered to the treatment site alone, they are generally used together with a delivery catheter or an endoscope.
  • endoscopic treatment the light irradiation medical device is placed in the body from the distal side of the forceps opening of the endoscope through the forceps opening of the endoscope and delivered to the treatment site.
  • Patent Document 1 describes a balloon composed of a tubular substrate having a peripheral end portion and a hand end portion, and a balloon member arranged at the peripheral end portion and surrounding a certain portion of the peripheral end portion of the tubular substrate. It is a catheter, and the optical device extends from the hand end to the peripheral end, and this optical device has a light emitting end arranged in a balloon member fixed to a tubular substrate near the peripheral end.
  • the optical device extends into the conduit of the tubular substrate, and the outer wall of the end of the tubular substrate extends into the balloon member and extends the conduit. It is described that the light emitting end portion of the optical device is exposed in the balloon member by being imaged and at least partially removed in advance, and it is described that an optical fiber is used for the light emitting end portion. ing.
  • the shaft has an inner tube and an outer tube, a balloon is arranged at the tip of the outer tube, and the inner tube is arranged from the rear of the outer tube through the inside of the balloon to the tip of the balloon.
  • Described is a laser fiber induction catheter characterized in that it is provided within an inner tube at the center of the balloon.
  • the optical fiber also bends when the balloon catheter is placed in the bent internal lumen. Further, when the balloon catheters of Patent Documents 1 and 2 are arranged in the lumen of the body, the balloon is restrained in the lumen of the body, and the optical fiber is bent even when the balloon is compressed and the length in the axial direction is shortened. Therefore, the position of the optical fiber inside the balloon deviates from the center of the cross section of the balloon perpendicular to the longitudinal direction, and the target tissue cannot be sufficiently irradiated with light, so that photodynamic therapy cannot be sufficiently performed. There is also a problem that the target tissue is irradiated with light stronger than expected and the internal tissue may be perforated.
  • the present invention has been made in view of the above circumstances, and an object of the present invention is that the position of the optical fiber is easily removed from an endoscope or the like, and the position of the optical fiber is obtained even when the shaft is bent or the balloon is compressed. Is to provide a balloon catheter that is central to the cross section of a balloon that is perpendicular to the longitudinal direction.
  • the first balloon catheter that was able to solve the above problems includes a first shaft having a first lumen and a second lumen, a second shaft arranged on the distal side of the first shaft, and a second shaft.
  • the cross-sectional area of the resin forming the first shaft is larger than the cross-sectional area of either one having a large cross-sectional area of the first lumen and the second lumen, and the tubular member. That the proximal end is joined to the distal end of the first lumen, the proximal end of the balloon is joined to the second shaft, and the distal end of the balloon is joined to the tubular member. It is a feature.
  • the second balloon catheter that was able to solve the above-mentioned problems is arranged on the inner cylinder portion having the first lumen, the first shaft provided with the second lumen, and the distal side of the first shaft. It has a second shaft, a balloon arranged on the distal side of the second shaft, and a tubular member arranged inside the balloon and having a light transmission rate of 90% or more. At least a portion of the outer surface of the tube is fixed to the inner surface of the first shaft, the proximal end of the tubular member is joined to the distal end of the inner tube, and the proximal end of the balloon is , And the distal end of the balloon is joined to a second shaft, characterized in that it is joined to a tubular member.
  • the length of the second shaft in the longitudinal direction is preferably 10 times or more the minimum outer diameter of the second shaft.
  • the position of the central axis of the outer shape of the second shaft and the position of the central axis of the outer shape of the tubular member are different in the cross section perpendicular to the longitudinal direction at the proximal end of the second shaft. Is preferable.
  • the cross-sectional area of the gap formed between the inner surface of the second shaft and the outer surface of the tubular member is the lumen of the second shaft. It is preferably 40% or more of the cross-sectional area.
  • the optical fiber is arranged in the lumen of the tubular member.
  • the distal end of the tubular member is occluded.
  • the inner surface of the second shaft has a protrusion that contacts the outer surface of the tubular member.
  • the cross-sectional area of the resin forming the first shaft in the cross section perpendicular to the longitudinal direction is larger than the cross-sectional area of either one having a larger cross-sectional area of the first lumen and the second lumen.
  • the proximal end of the tubular member is joined to the distal end of the first lumen
  • the proximal end of the balloon is joined to the second shaft
  • the distal end of the balloon is joined to the tubular member.
  • the tubular member in which the optical fiber is placed in the lumen is joined to the distal end of the first lumen, which is proximal to the proximal end of the balloon, rather than to the proximal end of the balloon. From the distal end of the balloon to the distal end of the first lumen, the tubular member is not fixed to anything else and can move freely. As a result, the optical fiber can be located at the center of the cross section of the balloon perpendicular to the longitudinal direction even when the shaft of the balloon catheter is bent or the balloon is compressed.
  • the first shaft includes an inner cylinder portion having a first lumen and a second lumen, and at least a part of the outer surface of the inner cylinder portion is on the inner surface of the first shaft. It is fixed, the proximal end of the tubular member is joined to the distal end of the inner cylinder, the proximal end of the balloon is joined to the second shaft, and the distal end of the balloon is joined to the tubular member. Therefore, when the balloon catheter is removed from the endoscope or the like, the force for pulling the balloon catheter is easily transmitted to the proximal end and the distal end of the balloon, and the balloon catheter can be easily removed from the endoscope or the like.
  • the tubular member is joined to the distal end of the inner cylinder portion, the tubular member is free from the distal end of the balloon in the longitudinal direction to the distal end of the first lumen without being fixed to another object. Can move to. Therefore, by arranging the optical fiber in the lumen of the tubular member, the optical fiber is positioned at the center of the cross section of the balloon perpendicular to the longitudinal direction even when the shaft of the balloon catheter is bent or the balloon is compressed. It becomes possible to do.
  • a cross-sectional view taken along the longitudinal direction of the first balloon catheter according to the embodiment of the present invention is shown.
  • the II-II cross-sectional view of the balloon catheter shown in FIG. 1 is shown.
  • a cross-sectional view taken along the longitudinal direction of a second balloon catheter according to an embodiment of the present invention is shown.
  • the IV-IV cross-sectional view of the balloon catheter shown in FIG. 3 is shown.
  • a cross-sectional view perpendicular to the longitudinal direction of the second shaft of the balloon catheter according to another embodiment of the present invention is shown.
  • FIG. 1 is a cross-sectional view of the first balloon catheter 1 along the longitudinal direction according to the embodiment of the present invention
  • FIG. 2 is a sectional view of II-II perpendicular to the longitudinal direction of the balloon catheter 1 shown in FIG. Is.
  • the balloon catheter 1 of the present invention includes a first shaft 10 having a first lumen 11 and a second lumen 12, and a second shaft 20 arranged on the distal side of the first shaft 10.
  • the balloon 30 is arranged on the distal side of the second shaft 20, and the tubular member 40 is arranged inside the balloon 30 and has a light transmission rate of 90% or more.
  • the proximal end 40p of the member 40 is joined to the distal end 11d of the first lumen 11, the proximal end 30p of the balloon 30 is joined to the second shaft 20, and the distal end 30d of the balloon 30. Is joined to the tubular member 40.
  • the material constituting the first shaft 10 is a resin, and as shown in FIG. 2, the cross-sectional areas of the resin forming the first shaft 10 in the cross section perpendicular to the longitudinal direction are the first lumen 11 and the first.
  • the cross-sectional area of 2 lumens 12 is larger than the cross-sectional area of either one.
  • the cross-sectional area of the resin forming the first shaft 10 is larger than the larger cross-sectional area.
  • the cross-sectional area of the resin forming the first shaft 10 is larger than the cross-sectional area of either the first lumen 11 or the second lumen 12.
  • the cross-sectional area of the resin forming the first shaft 10 is larger than the cross-sectional area of either the first rumen 11 and the second rumen 12 having a large cross-sectional area, and is close to the tubular member 40.
  • the position end 40p is joined to the distal end 11d of the first lumen 11, the proximal end 30p of the balloon 30 is joined to the second shaft 20, and the distal end 30d of the balloon 30 is joined to the tubular member 40.
  • the proximal end 30p of the balloon 30 is connected to the first shaft 10 via the second shaft 20, and the distal end 30d of the balloon 30 is connected to the first shaft 10 via the tubular member 40.
  • the structure Since the structure is connected, the force for pulling the first shaft 10 is easily transmitted to both the proximal end 30p and the distal end 30d of the balloon 30. Therefore, it is possible to improve the removability when the balloon catheter 1 is removed from an endoscope or the like.
  • the proximal end 40p of the tubular member 40 is joined to the distal end 11d of the first lumen 11, the proximal end 30p of the balloon 30 is joined to the second shaft 20, and the distal end of the balloon 30.
  • the tubular member 40 is joined to the distal end 11d of the first lumen 11 located on the proximal side of the proximal end 30p of the balloon 30. Therefore, in the longitudinal direction of the balloon catheter 1, the tubular member 40 is not fixed to another object between the distal end 30d of the balloon 30 and the distal end 11d of the first lumen 11, and the balloon catheter 1 is adjusted to the bent state.
  • the tubular member 40 can be freely repositioned and bent.
  • the optical fiber can be arranged at the center of the cross section of the balloon 30 perpendicular to the longitudinal direction in a state where the optical fiber is inserted through the tubular member 40. It makes it easier to perform photodynamic therapy.
  • the proximal end 30p of the balloon 30 is preferably joined to the distal end 20d of the second shaft 20, and the distal end 30d of the balloon 30 is joined to the distal end 40d of the tubular member 40. Is preferable.
  • the joint between the tubular member 40 and the first lumen 11, the joint between the balloon 30 and the second shaft 20, and the joint between the balloon 30 and the tubular member 40 may be directly joined to each other, and may be directly joined to each other through other members. May be joined. Examples of the joining of the tubular member 40 and the first lumen 11, the joining of the balloon 30 and the second shaft 20, and the joining of the balloon 30 and the tubular member 40 include methods such as welding and adhesion.
  • the proximal side refers to the user, that is, the operator's hand side with respect to the longitudinal direction of the first shaft 10
  • the distal side refers to the direction opposite to the proximal side, that is, the treatment target side. ..
  • the direction from the proximal side to the distal side of the first shaft 10 or the direction from the distal side to the proximal side is referred to as a longitudinal direction.
  • the longitudinal direction can be rephrased as the perspective direction of the first shaft 10.
  • the first shaft 10 extends in the longitudinal direction and has a tubular structure including a first lumen 11 and a second lumen 12.
  • first lumen 11 the distal end 11d of the first lumen 11 is joined to the tubular member 40, and an optical fiber, a stylet, or the like can be arranged inside the first lumen 11 and the tubular member 40.
  • the second lumen 12 communicates with the lumen of the balloon 30 and can serve as a path for supplying fluid to the inside of the balloon 30.
  • the first shaft 10 may include at least the first lumen 11 and the second lumen 12, and may further have lumens different from those of the first lumen 11 and the second lumen 12.
  • the first shaft 10 preferably has flexibility. Since the first shaft 10 has flexibility, the first shaft 10 becomes flexible and easy to bend. Therefore, the balloon catheter 1 can be easily inserted into the body.
  • the material constituting the first shaft 10 is a resin, and as shown in FIG. 2, the cross-sectional areas of the resin forming the first shaft 10 in the cross section perpendicular to the longitudinal direction are the first lumen 11 and the second lumen 12.
  • the cross-sectional area of is larger than the cross-sectional area of either one.
  • the cross-sectional area of the second lumen 12 is larger than the cross-sectional area of the first lumen 11, the cross-sectional area of the second lumen 12 and the first shaft 10 are formed. Compare with the cross-sectional area of the resin to be used.
  • first shaft 10 When the cross-sectional area of the first lumen 11 and the cross-sectional area of the second lumen 12 are the same, either the cross-sectional area of the first lumen 11 or the cross-sectional area of the second lumen 12 is used as the first shaft 10. It may be used for comparison with the cross-sectional area of the resin to be formed.
  • the rigidity of the first shaft 10 can be increased by having the cross-sectional area of the resin forming the first shaft 10 larger than the cross-sectional area of either the first lumen 11 and the second lumen 12 having a large cross-sectional area. ..
  • the cross-sectional area of the resin forming the first shaft 10 is 1.1 times or more the cross-sectional area of either one having a large cross-sectional area of the first lumen 11 and the second lumen 12. Is preferable, 1.2 times or more is more preferable, and 1.3 times or more is further preferable.
  • the first It is possible to sufficiently increase the rigidity of 1 shaft 10.
  • the cross-sectional area of the resin forming the first shaft 10 is preferably 5 times or less, preferably 4 times or less, the cross-sectional area of either one having a large cross-sectional area of the first lumen 11 and the second lumen 12. More preferably, it is more preferably 3 times or less.
  • the first It is possible to secure the area of the first lumen 11 and the second lumen 12 possessed by the one shaft 10, and to insert an optical fiber, a stylet, etc. into the first lumen 11 and a balloon 30 to the second lumen 12. The supply and removal of the expansion fluid can be smoothly performed.
  • the material constituting the first shaft 10 is, for example, a polyolefin resin such as polyethylene or polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, or a vinyl chloride resin. , Polyether polyamide resin, polyurethane resin, polyimide resin, synthetic resin such as fluorine resin such as PTFE, PFA, ETFE and the like. These may be used alone or in combination of two or more. Above all, the material constituting the first shaft 10 preferably contains a polyolefin-based resin, a polyamide-based resin, and a fluorine-based resin.
  • the material constituting the first shaft 10 contains a polyolefin resin, a polyamide resin, and a fluorine resin, the first shaft 10 has flexibility and the surface of the first shaft 10 is slippery. Therefore, the balloon catheter 1 having good insertability can be obtained.
  • the second shaft 20 has a tubular structure extending in the longitudinal direction and having a lumen.
  • the second shaft 20 is arranged on the distal side of the first shaft 10. That is, the second shaft 20 is arranged on the distal side of the distal end 10d of the first shaft 10.
  • a tubular member 40 is arranged in the lumen of the second shaft 20.
  • the second shaft 20 preferably has flexibility. Since the second shaft 20 has flexibility, the second shaft 20 becomes flexible, and the insertability of the balloon catheter 1 can be improved.
  • the second shaft 20 may be composed of a plurality of members, but is preferably composed of one tubular member. Since the second shaft 20 is composed of one tubular member, the second shaft 20 becomes flexible. As a result, when the balloon catheter 1 is inserted into the bent body lumen, the second shaft 20 is easily bent, and the insertability of the balloon catheter 1 can be improved.
  • the material constituting the second shaft 20 is, for example, a polyolefin resin such as polyethylene or polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, or a vinyl chloride resin. , Polyether polyamide resin, polyurethane resin, polyimide resin, synthetic resin such as fluorine resin such as PTFE, PFA, ETFE, metal such as stainless steel, carbon steel, nickel titanium alloy and the like. These may be used alone or in combination of two or more. Above all, it is preferable that the material constituting the second shaft 20 contains the same material as the material constituting the first shaft 10.
  • the material constituting the second shaft 20 contains the same material as the material constituting the first shaft 10, the physical properties such as hardness and surface slipperiness of the first shaft 10 and the second shaft 20 are close to each other. Therefore, the balloon catheter 1 can be easily inserted into the body. Further, when the first shaft 10 and the second shaft 20 are directly joined, the joining strength between the first shaft 10 and the second shaft 20 can be increased.
  • the balloon 30 is arranged on the distal side of the second shaft 20. That is, the balloon 30 is arranged distal to the distal end 20d of the second shaft 20. Further, the proximal end 30p of the balloon 30 is joined to the second shaft 20, and the distal end 30d of the balloon 30 is joined to the tubular member 40. The proximal end 30p of the balloon 30 is preferably joined to the distal end 20d of the second shaft 20.
  • the balloon 30 is configured so that fluid is supplied from the fluid feeder to the inside of the balloon 30 through the first shaft 10 and the second shaft 20.
  • the balloon 30 can be expanded.
  • the balloon 30 can be contracted by removing the fluid inside the balloon 30 from the balloon 30.
  • the fluid supplied to the inside of the balloon 30 may be a pressure fluid pressurized by a pump or the like.
  • the type of fluid supplied into the balloon 30 for example, a liquid such as physiological saline, a contrast medium, or a mixed solution thereof, or a gas such as air, nitrogen, or carbon dioxide can be used.
  • the fluid supplied into the balloon 30 is preferably a gas. Since the fluid supplied into the balloon 30 is a gas, the fluid existing in the balloon 30 is less likely to interfere with the emission light of the optical fiber arranged inside the balloon 30 when performing photodynamic therapy. Become.
  • the balloon 30 preferably has a straight tube portion 31. Since the balloon 30 has the straight tube portion 31, the area where the balloon 30 and the luminal wall in the body are in contact with each other can be increased. Therefore, the balloon 30 can be fixed in the lumen of the body, and photodynamic therapy can be easily performed.
  • the balloon 30 is located at the proximal taper portion connected to the straight tube portion 31 on the proximal side of the proximal end 31p of the straight tube portion 31 and on the distal side of the distal end 31d of the straight tube portion 31. It has a distal taper portion connected to the straight pipe portion 31, and the proximal taper portion and the distal taper portion are formed so as to decrease in diameter as the distance from the straight pipe portion 31 increases. preferable.
  • the proximal side tapered portion and the distal side tapered portion formed so that the diameter of the balloon 30 decreases as the distance from the straight tube portion 31 increases, the strength of the balloon 30 can be increased, and the balloon can be increased.
  • the balloon 30 can be prevented from being damaged when a force is applied to the 30. Further, since the step generated when the balloon 30 is wound around the shaft can be reduced, the balloon 30 can be easily inserted into the lumen in the body.
  • the balloon 30 can be configured so that the distal taper portion swells from the proximal taper portion through the straight pipe portion 31 when a fluid is supplied.
  • the inflatable portion is regarded as the balloon 30.
  • the material constituting the balloon 30 is, for example, a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer, a polyester resin such as polyethylene terephthalate or a polyester elastomer, a polyurethane resin such as polyurethane or a polyurethane elastomer, or a polyphenylene sulfide type.
  • a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer
  • a polyester resin such as polyethylene terephthalate or a polyester elastomer
  • a polyurethane resin such as polyurethane or a polyurethane elastomer
  • a polyphenylene sulfide type examples thereof include polyamide resins such as resins, polyamides and polyamide elastomers, vinyl chloride resins, fluororesins, silicone resins, and natural rubbers such as latex rubber. Only one of
  • the material constituting the balloon 30 is preferably a polyamide resin, a polyester resin, or a polyurethane resin.
  • the material constituting the balloon 30 is a polyamide resin, a polyester resin, or a polyurethane resin, the balloon 30 can be made thinner and its flexibility can be improved.
  • the tubular member 40 extends in the longitudinal direction and has a lumen. Further, the tubular member 40 is arranged inside the balloon 30, and the proximal end 40p of the tubular member 40 is joined to the distal end 11d of the first lumen 11.
  • the tubular member 40 can have an optical fiber, a stylet, or the like arranged inside.
  • the balloon catheter 1 Since the balloon catheter 1 has the tubular member 40, the path through which the fluid for expanding the balloon 30 passes when performing photodynamic therapy using the balloon catheter 1 in which the optical fiber is arranged in the tubular member 40. And the path into which the optical fiber is inserted can be different. Therefore, the fluid that expands the balloon 30 does not come into contact with the optical fiber, and the fluid that expands the balloon 30 is less likely to cause adverse effects such as deterioration of the optical fiber.
  • a stylet is inserted into the tubular member 40 to deliver the balloon catheter 1 to the treatment portion, and then the stylet is removed from the tubular member 40 and an optical fiber is inserted to facilitate the photodynamic therapy procedure. It is also possible to proceed and shorten the time required for the procedure.
  • the tubular member 40 may have a light transmittance of 90% or more, preferably 91% or more, more preferably 93% or more, and further preferably 95% or more.
  • the upper limit of the light transmittance of the tubular member 40 is not particularly limited, and can be, for example, 100% or less.
  • the material constituting the tubular member 40 is, for example, a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer, a polyester resin such as polyethylene terephthalate or a polyester elastomer, a polyurethane resin such as polyurethane or a polyurethane elastomer, or polyphenylene sulfide.
  • a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer
  • a polyester resin such as polyethylene terephthalate or a polyester elastomer
  • a polyurethane resin such as polyurethane or a polyurethane elastomer
  • polyphenylene sulfide examples thereof include polyamide-based resins, polyamides, polyamide-based resins such as polyamide elastomers, vinyl chloride-based resins, fluorine-based resins, silicone-based resins, and natural rubbers such
  • the material constituting the tubular member 40 preferably contains a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, and a fluorine resin. Since the material constituting the tubular member 40 contains a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, and a fluorine resin, the slipperiness of the surface of the tubular member 40 can be enhanced, and the tubular member 40 can be made more slippery. It becomes easy to insert or remove an optical fiber, a stylet, or the like in the 40.
  • the tubular member 40 preferably has flexibility. Since the tubular member 40 has flexibility, the tubular member 40 becomes flexible, and the tubular member 40 also easily bends when the balloon catheter 1 is inserted into the bent internal lumen. Therefore, it is possible to improve the insertability of the balloon catheter 1 into the body.
  • the distal end 40d of the tubular member 40 is preferably located distal to the distal end 30d of the balloon 30. Since the distal end 40d of the tubular member 40 is distal to the distal end 30d of the balloon 30, the rigidity of the distal end of the balloon catheter 1 is increased. Therefore, it becomes easy to insert the balloon catheter 1 into the body. Further, since the distal end 40d of the tubular member 40 is on the distal side of the distal end 30d of the balloon 30, the tubular member 40 is present over the entire length of the balloon 30 in the longitudinal direction. As a result, when the optical fiber is arranged in the tubular member 40, the optical fiber can be present in the entire straight tube portion 31 of the balloon 30 in the longitudinal direction, which facilitates photodynamic therapy.
  • the balloon catheter 1 preferably has a handle portion on the proximal side.
  • the handle portion preferably has a lumen extending in the longitudinal direction that communicates with the first lumen 11.
  • the lumen that the handle portion has and communicates with the first lumen 11 can be used as an insertion passage for an optical fiber, a stylet, or the like to be inserted into the lumen of the tubular member 40.
  • the handle portion includes a fluid injection portion and has a lumen communicating with the second lumen 12.
  • the lumen that the handle portion has and communicates with the second lumen 12 can be used as a fluid supply and removal path for expanding the balloon 30.
  • the proximal end 20p of the second shaft 20 is preferably joined to the distal end 10d of the first shaft 10. That is, it is preferable that the first shaft 10 and the second shaft 20 are directly joined. Since the proximal end 20p of the second shaft 20 is joined to the distal end 10d of the first shaft 10, the second shaft 20 can be easily joined to the first shaft 10. As a result, the efficiency of manufacturing the balloon catheter 1 can be improved.
  • FIG. 3 is a cross-sectional view taken along the longitudinal direction of the second balloon catheter 1 according to the embodiment of the present invention
  • FIG. 4 is an IV-IV perpendicular to the longitudinal direction of the balloon catheter 1 shown in FIG. It is a cross-sectional view.
  • the first shaft 10 of the balloon catheter 1 includes an inner cylinder portion 50 having a first lumen 11 and a second lumen portion 12, and is provided on the outer surface of the inner cylinder portion 50. At least a part is fixed to the inner surface of the first shaft 10.
  • the first shaft 10 includes an inner cylinder portion 50 having a first lumen 11 and a second lumen 12, and at least a part of the outer surface of the inner cylinder portion 50 is fixed to the inner surface of the first shaft 10, and is tubular.
  • the proximal end 40p of the member 40 is joined to the distal end 50d of the inner cylinder 50, the proximal end 30p of the balloon 30 is joined to the second shaft 20, and the distal end 30d of the balloon 30 is tubular.
  • the proximal end 30p of the balloon 30 is connected to the first shaft 10 via the second shaft 20, and the distal end 30d of the balloon 30 is connected to the first shaft 10 via the tubular member 40.
  • the structure is connected to one shaft 10.
  • the force that pulls the first shaft 10 toward the hand side is easily transmitted to both the distal end 30d and the proximal end 30p of the balloon 30, and the balloon catheter 1 is removed.
  • the sex can be improved.
  • the proximal end 30p of the balloon 30 is preferably joined to the distal end 20d of the second shaft 20, and the distal end 30d of the balloon 30 is joined to the distal end 40d of the tubular member 40. It is preferable to have.
  • the proximal end 40p of the tubular member 40 is joined to the distal end 50d of the inner cylinder portion 50, the proximal end 30p of the balloon 30 is joined to the second shaft 20, and the distal end of the balloon 30 is joined.
  • the tubular member 40 is fixed to another object in the longitudinal direction of the balloon catheter 1 from the distal end 30d of the balloon 30 to the distal end 11d of the first lumen 11. Instead, the tubular member 40 can be freely repositioned or bent according to the bent state of the balloon catheter 1.
  • the optical fiber when performing photodynamic therapy for irradiating the target tissue with light, the optical fiber can be arranged at the center of the cross section of the balloon 30 perpendicular to the longitudinal direction in a state where the optical fiber is inserted through the tubular member 40. Photodynamic therapy becomes easier to perform.
  • the inner cylinder portion 50 extends in the longitudinal direction.
  • the inner cylinder portion 50 is joined to the tubular member 40, and an optical fiber, a stylet, or the like can be arranged in the lumen of the tubular member 40 through the inner cylinder portion 50.
  • Examples of the method of fixing at least a part of the outer surface of the inner cylinder portion 50 to the inner surface of the first shaft 10 include welding, adhesion, fixing via other parts, and the like.
  • the length L1 of the second shaft 20 in the longitudinal direction is preferably 10 times or more the minimum outer diameter of the second shaft 20.
  • the length L1 of the second shaft 20 in the longitudinal direction indicates the distance between the distal end 20d of the second shaft 20 and the proximal end 20p of the second shaft 20 in the longitudinal direction. Since the length L1 of the second shaft 20 is 10 times or more the minimum outer diameter of the second shaft 20, the length L1 of the second shaft 20 can be made sufficient and is joined to the tubular member 40. The distance from the distal end 30d of the balloon 30 to the distal end 11d of the first lumen 11 joined to the proximal end 40p of the tubular member 40 can be increased.
  • the tubular member 40 is adjusted to the bent state of the balloon catheter 1 at the portion where the tubular member 40 is not joined to another object. It is possible to freely change the position and bend. As a result, the tubular member 40 is located at the center of the cross section of the balloon 30 perpendicular to the longitudinal direction, and when the optical fiber is inserted into the lumen of the tubular member 40, the optical fiber is easily positioned at the center of the balloon 30. Dynamic therapy can be performed efficiently.
  • the length L1 of the second shaft 20 in the longitudinal direction is preferably 10 times or more the minimum outer diameter of the second shaft 20, and more preferably 11 times or more the minimum outer diameter of the second shaft 20. It is more preferable that the diameter is 12 times or more the minimum outer diameter of the second shaft 20.
  • the balloon 30 joined to the tubular member 40 is tubular from the distal end 30d. The distance to the distal end 11d of the first lumen 11 joined to the proximal end 40p of the member 40 can be sufficiently separated.
  • the upper limit of the ratio between the length L1 of the second shaft 20 and the minimum outer diameter of the second shaft 20 can be, for example, 600 times or less, 400 times or less, and 200 times or less.
  • the position of the central axis C20 of the outer shape of the second shaft 20 and the central axis C40 of the outer shape of the tubular member 40 is different. Since the position of the central axis C20 of the outer shape of the second shaft 20 and the position of the central axis C40 of the outer shape of the tubular member 40 are different, the tubular member 40 is formed in the respective lumens of the second shaft 20 and the balloon 30. It becomes easier to freely change the position and bend.
  • the tubular member 40 is easy to move according to the bent state of the balloon catheter 1, and the tubular member 40 is located at the center of the cross section of the balloon 30 perpendicular to the longitudinal direction. It will be easier to position. As a result, when the optical fiber is inserted through the tubular member 40, the optical fiber is located at the center of the balloon 30, which facilitates photodynamic therapy.
  • the cross-sectional area of the gap portion formed by the inner surface of the second shaft 20 and the outer surface of the tubular member 40 is the second shaft 20. It is preferably 40% or more of the cross-sectional area of the lumen of.
  • the cross-sectional area of the gap formed between the inner surface of the second shaft 20 and the outer surface of the tubular member 40 is 40% or more of the cross-sectional area of the lumen of the second shaft 20, so that the inside of the second shaft 20
  • the tubular member 40 can move freely in the above. Therefore, even when the second shaft 20 is bent, the optical fiber arranged in the lumen of the tubular member 40 is likely to be located at the center of the cross section of the balloon 30 perpendicular to the longitudinal direction, and photodynamically. The therapy becomes easier.
  • the cross-sectional area of the gap formed by the inner surface of the second shaft 20 and the outer surface of the tubular member 40 is the cross-sectional area of the lumen of the second shaft 20. It is preferably 40% or more, more preferably 45% or more, and even more preferably 50% or more.
  • the lower limit of the ratio between the cross-sectional area of the gap formed by the inner surface of the second shaft 20 and the outer surface of the tubular member 40 and the cross-sectional area of the lumen of the second shaft 20 is set in the above range. As a result, the tubular member 40 can easily move freely in the lumen of the second shaft 20.
  • the upper limit of the ratio between the cross-sectional area of the gap portion formed by the inner surface of the second shaft 20 and the outer surface of the tubular member 40 and the cross-sectional area of the lumen of the second shaft 20 is, for example, 99%. Hereinafter, it can be 97% or less and 95% or less.
  • the optical fiber is arranged in the lumen of the tubular member 40.
  • the balloon catheter 1 can be used for photodynamic therapy, and the fluid that expands the balloon 30 does not come into contact with the optical fiber, so that the balloon 30 is expanded.
  • the fluid to be used is less likely to cause adverse effects such as deterioration of the optical fiber.
  • the lumen of the tubular member 40 is provided with an optical fiber, and the optical fiber is fixed to the tubular member 40 on the distal side of the straight tube portion 31 of the balloon 30.
  • the cutting edge of optical fiber has low light intensity, and the light intensity may not be sufficient for photodynamic therapy.
  • the fixed position of the optical fiber may be distal to the straight tube 31 of the balloon 30 or distal to the distal taper of the balloon 30. preferable. When the fixed position of the optical fiber is distal to the straight tube portion 31 of the balloon 30 or distal to the distal tapered portion, a sufficient amount of light in photodynamic therapy can be secured.
  • the optical fiber is preferably fixed to the tubular member 40 on the distal side of the tapered portion on the distal side of the balloon 30. Since the optical fiber is fixed to the tubular member 40 on the distal side of the tapered portion on the distal side of the balloon 30, the amount of light in photodynamic therapy can be sufficiently secured. Further, since the distal end of the optical fiber is on the distal side of the distal end 30d of the balloon 30, the rigidity of the distal end of the balloon catheter 1 is increased. Therefore, it becomes easy to insert the balloon catheter 1 into the body.
  • the optical fiber is fixed to the tubular member 40 on the proximal side of the distal end 60d of the tip tip 60, which will be described later. Since the optical fiber is fixed to the tubular member 40 on the proximal side of the distal end 60d of the tip tip 60, a sufficient amount of light in photodynamic therapy can be secured. Further, the hardness of the distal end 60d of the tip tip 60 is unlikely to increase, and it is possible to prevent the balloon catheter 1 from perforating the internal lumen.
  • the distal end 40d of the tubular member 40 is preferably closed. Due to the obstruction of the distal end 40d of the tubular member 40, when the balloon catheter 1 is placed in the lumen of the body, for example, gastrointestinal mucus, blood, etc. are discharged from the distal end 40d of the tubular member 40 to the tubular member 40. You can prevent it from getting inside. As a result, it is possible to prevent adverse effects such as deterioration of the optical fiber due to contact of gastrointestinal mucus, blood, etc. with the optical fiber or stylet arranged in the lumen of the tubular member 40.
  • a method of closing the distal end 40d of the tubular member 40 for example, another component such as a tip tip 60 is provided at the distal end 40d of the tubular member 40, or an adhesive or the like is applied to the distal end 40d of the tubular member 40. Examples include pouring, crushing the distal end 40d of the tubular member 40, and the like. Above all, as shown in FIG. 1, it is preferable to provide the tip tip 60 at the distal end 40d of the tubular member 40 to close the distal end 40d of the tubular member 40. Since the tip 60 is provided at the distal end 40d of the tubular member 40, the rigidity of the distal end 40d of the tubular member 40 is increased. As a result, the rigidity of the distal end portion of the balloon catheter 1 is also increased, so that the insertability of the balloon catheter 1 can be improved.
  • a tip tip 60 is provided at the distal end 40d of the tubular member 40, or an adhesive or the like is applied to the distal end 40d of the tub
  • the color of the tip tip 60 is preferably different from the color of the tubular member 40.
  • the difference between the color of the tip tip 60 and the color of the tubular member 40 means that at least one of the hue, lightness, and saturation defined in JIS Z8721 is different. Since the color of the tip tip 60 is different from the color of the tubular member 40, the tip tip 60 is easily visible under an endoscope. As a result, the positions of the tip tip 60 and the balloon 30 can be easily confirmed in the lumen of the body.
  • FIG. 5 is a cross-sectional view perpendicular to the longitudinal direction of the second shaft 20 of the balloon catheter 1 according to another embodiment of the present invention.
  • the inner surface of the second shaft 20 has a protrusion 70 that comes into contact with the outer surface of the tubular member 40.
  • the protrusion 70 can determine the position of the tubular member 40 in the second shaft 20.
  • the position of the tubular member 40 can be regulated so as not to deviate significantly from the central axis of the balloon 30.
  • the protrusion 70 is not joined to the tubular member 40.
  • the protrusion 70 is preferably arranged on the inner surface of the distal end of the second shaft 20.
  • a protrusion 70 in contact with the outer surface of the tubular member 40 is provided on the inner surface of the distal end of the second shaft 20 so that the tubular member 40 is located at the center of the second shaft 20 in a cross section perpendicular to the longitudinal direction.
  • the number of protrusions 70 arranged on the inner surface of the second shaft 20 is preferably a plurality. Since the number of protrusions 70 is plural, the position of the tubular member 40 in the second shaft 20 can be easily regulated by the protrusions 70.
  • the first balloon catheter of the present invention comprises a first shaft having a first lumen and a second lumen, a second shaft arranged on the distal side of the first shaft, and a second shaft. It has a balloon arranged on the distal side and a tubular member arranged inside the balloon and having a light transmission rate of 90% or more, and the material constituting the first shaft is a resin.
  • the cross-sectional area of the resin forming the first shaft is larger than the cross-sectional area of either one having a large cross-sectional area of the first lumen and the second lumen, and is close to the tubular member.
  • the position end is joined to the distal end of the first lumen, the proximal end of the balloon is joined to the second shaft, and the distal end of the balloon is joined to a tubular member.
  • the cross-sectional area of the resin forming the first shaft in the cross section perpendicular to the longitudinal direction is larger than the cross-sectional area of either the first rumen or the second rumen having a large cross-sectional area, and the proximal end of the tubular member is the first rumen.
  • the force applied to the balloon catheter is exerted by the distal end of the balloon being joined to the distal end of the balloon, the proximal end of the balloon being joined to the second shaft, and the distal end of the balloon being joined to a tubular member.
  • the tubular member in which the optical fiber is placed in the lumen is joined to the distal end of the first lumen, which is proximal to the proximal end of the balloon, rather than to the proximal end of the balloon. From the distal end of the balloon to the distal end of the first lumen, the tubular member is not fixed to anything else and can move freely. As a result, the optical fiber can be arranged at the center of the cross section of the balloon perpendicular to the longitudinal direction even when the shaft of the balloon catheter is bent or the balloon is compressed.
  • the second balloon catheter of the present invention includes an inner cylinder portion having a first lumen, a first shaft including a second lumen, and a second shaft arranged on the distal side of the first shaft. It has a balloon arranged on the distal side of the second shaft and a tubular member arranged inside the balloon and having a light transmission rate of 90% or more, and is outside the inner cylinder portion. At least a portion of the surface is fixed to the inner surface of the first shaft, the proximal end of the tubular member is joined to the distal end of the inner cylinder, and the proximal end of the balloon is the second shaft. The distal end of the balloon is joined to a tubular member.
  • the first shaft has an inner cylinder portion having a first lumen and a second lumen, and at least a part of the outer surface of the inner cylinder portion is fixed to the inner surface of the first shaft, and the proximal end of the tubular member is It is joined to the distal end of the inner cylinder, the proximal end of the balloon is joined to the second shaft, and the distal end of the balloon is joined to the tubular member, so that the balloon can be viewed from an endoscope or the like.
  • the pulling force of the balloon catheter is easily transmitted to the proximal and distal ends of the balloon, which makes it easier to remove the balloon catheter from an endoscope or the like.
  • the tubular member is joined to the distal end of the first lumen, the tubular member is not fixed to another object from the distal end of the balloon in the longitudinal direction to the distal end of the first lumen, and is free. Can move to. Therefore, by arranging the optical fiber in the lumen of the tubular member, the optical fiber is arranged at the center of the cross section of the balloon perpendicular to the longitudinal direction even when the shaft of the balloon catheter is bent or the balloon is compressed. It becomes possible to do.
  • Balloon catheter 10 1st shaft 10d: Distal end of 1st shaft 11: 1st lumen 11d: Distal end of 1st lumen 11p: Proximal end of 1st lumen 12: 2nd lumen 20: 2nd Shaft 20d: Distal end of second shaft 20p: Proximal end of second shaft 30: Balloon 30d: Distal end of balloon 30p: Proximal end of balloon 31: Straight tube 31d: Distal end of straight tube 31p: Proximal end of straight tube 40: Tubular member 40d: Distal end of tubular member 40p: Proximal end of tubular member 50: Inner cylinder 50d: Distal end of inner cylinder 60: Tip tip 60d: Tip Distal end of tip 70: Protrusion L1: Length of second shaft C20: Central axis of outer shape of second shaft C40: Central axis of outer shape of tubular member

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PCT/JP2021/006826 2020-03-06 2021-02-24 バルーンカテーテル Ceased WO2021177102A1 (ja)

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US17/908,593 US12515068B2 (en) 2020-03-06 2021-02-24 Balloon catheter
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US20230097865A1 (en) 2023-03-30
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CN115243751A (zh) 2022-10-25
CN115243751B (zh) 2024-08-27

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