CN114712672A - Medicine-carrying balloon catheter - Google Patents

Medicine-carrying balloon catheter Download PDF

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Publication number
CN114712672A
CN114712672A CN202210391253.0A CN202210391253A CN114712672A CN 114712672 A CN114712672 A CN 114712672A CN 202210391253 A CN202210391253 A CN 202210391253A CN 114712672 A CN114712672 A CN 114712672A
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CN
China
Prior art keywords
balloon
drug
protrusion
balloon catheter
coating
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Granted
Application number
CN202210391253.0A
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Chinese (zh)
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CN114712672B (en
Inventor
陈茂
冯沅
徐亚鹏
杨夏燕
虞奇峰
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Chengdu Newmai Biotechnology Co ltd
West China Hospital of Sichuan University
Original Assignee
Chengdu Newmai Biotechnology Co ltd
West China Hospital of Sichuan University
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Priority to CN202210391253.0A priority Critical patent/CN114712672B/en
Publication of CN114712672A publication Critical patent/CN114712672A/en
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Publication of CN114712672B publication Critical patent/CN114712672B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • A61M2025/1004Balloons with folds, e.g. folded or multifolded
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1075Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/109Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to a medicine-carrying balloon catheter, which comprises an inflatable balloon, wherein the outer surface of the balloon is coated with medicine and is provided with a plurality of axial spinous processes, the top of each spinous process is also connected with a coating protective wing, the coating protective wing can completely cover the whole balloon main body and protect the balloon from medicine loss during transportation in a blood vessel, when the balloon is transported to a diseased region, contrast medium is filled into the balloon to fill the balloon, and a medicine coating layer coated below the coating protective wing can be exposed and released, so that the loss of the medicine in the transportation process can be reduced to the greatest extent.

Description

Medicine-carrying balloon catheter
Technical Field
The invention relates to the field of medical instruments for interventional operation, in particular to a drug-loaded balloon catheter.
Background
Percutaneous Coronary Intervention (PCI) refers to a treatment method for improving the perfusion of the blood flow of the cardiac muscle by opening the narrow or even occluded coronary artery lumen through the cardiac catheter technique. The technical classification mainly comprises percutaneous coronary artery balloon angioplasty, coronary artery stent implantation, coronary artery rotational atherectomy, cutting balloon angioplasty, coronary artery thrombosis suction and the like. Of these, coronary stenting is the most classical interventional procedure, and once implanted in the body, the stent remains permanently in the vessel, and although the technique is well-established and safe, there is still a long-term risk of in-stent restenosis and in-stent thrombosis.
The drug balloon has its unique advantages as a new emerging device in recent years. The medicine saccule is one new kind of medicine releasing saccule technology developed on the basis of saccule expanding operation, saccule forming operation and other intervention technology, and is one technology of coating antiproliferative medicine, such as taxol, onto the surface of saccule, expanding and contacting with the inner membrane of blood vessel wall to release and transfer medicine fast. Therefore, the drug-coated balloon can not only establish a channel for blood circulation through balloon expansion, but also avoid defects of in-stent restenosis, thrombus and the like after stent implantation.
When the drug coating saccule in the prior art is used for delivering drugs, the drugs are lost to a certain extent when passing through blood stream scouring and a narrow blood vessel part, so that the drug loading rate cannot meet the required requirement, and the treatment effect is not ideal.
Disclosure of Invention
The invention discloses a drug-loaded balloon catheter, and aims to solve the technical problems in the prior art.
The invention adopts the following technical scheme:
a drug-loaded balloon catheter comprising:
-an outer tube, the distal end of which is provided with an inflatable or collapsible section, the section forming a balloon;
an inner tube, which is fixedly connected to the outer tube at the distal end, and an annular cavity between the inner tube and the outer tube forms a liquid injection channel of the balloon;
the outer surface of the balloon is at least partially covered with a drug coating;
the outer surface of the balloon is provided with a plurality of spinous processes and coating protective wings which are distributed along the circumferential direction;
the drug coating covers the balloon;
the spinous processes extend along the axial direction of the balloon, each spinous process comprises a first protrusion and a second protrusion which are arranged in parallel along the circumferential direction, and the second protrusions are connected with the coating protective wings;
the coated flaps extend away from the first projection and overlie the drug coating when the balloon is not inflated.
As the preferred technical scheme, the number of the spinous processes is not less than 3, and the number of the coating wings is the same as that of the spinous processes.
Preferably, the height of the first protrusion is smaller than the height of the second protrusion.
Preferably, the first protrusion and the second protrusion have different widths.
Preferably, the cross section of the first protrusion and/or the second protrusion is triangular, wedge-shaped, rectangular or trapezoidal.
As a preferred technical scheme, the length of the first protrusion and/or the second protrusion is 2.0-50 mm; the width of the first protrusion and/or the second protrusion is 0.2-1.0 mm; the height of the first protrusion and/or the second protrusion is 0.2-1.00 mm.
Preferably, the spinous process is made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon or polyether block amide PEBAX material.
As a preferred technical solution, the drug coating comprises at least one of rapamycin, paclitaxel and a growth factor.
As a preferred technical scheme, the medicine coating is coated on the outer surface of the balloon at intervals.
As a preferred solution, the drug coating can be exposed in the inflated state of the balloon.
Preferably, the coated flap is in the form of a film and is connected to the second protrusion by means of a biocompatible glue, hot melt or laser welding.
Preferably, the coated flaps are spaced from the second protrusions.
Preferably, the coated wings extend from the second protrusion to the adjacent spinous process, and the coated wings match the outer profile of the balloon when not inflated.
As a preferred technical scheme, the cross section of the coating protective wing is arc-shaped and covers the outer surface of the medicine coating, and the radian of the coating protective wing is the same as the outer contour radian of the balloon in the unfilled state.
As a preferred solution, the coated flaps have a thickness of 10 to 100um, a length of 5.0 to 50mm and a width of 1.0 to 52 mm.
Preferably, the coated flaps are made of polyethylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer or polyethylene terephthalate.
As a preferred technical scheme, the length of the balloon is 5.0-50mm, and the diameter is 1.0-5.0 mm.
As a preferred technical scheme, the material of the balloon is nylon, polyether block amide PEBAX or polyethylene terephthalate.
As a preferable technical scheme, the far end of the balloon is also provided with a tip, and the tip is connected with the balloon in a welding, pressing or bonding mode.
As a preferred technical scheme, the drug-loaded balloon catheter further comprises a developing ring, a guide wire outlet and a catheter seat; the developing rings are arranged at two ends of the saccule; the guide wire outlet is formed by the inner tube and the outer tube and is arranged on the side wall of the outer tube; the catheter holder is arranged at the near end of the drug-carrying balloon catheter.
According to a preferable technical scheme, a hypotube is further fixedly connected between the outer tube and the catheter base, and a mark belt is arranged on the hypotube.
The technical scheme adopted by the invention can achieve the following beneficial effects:
(1) the invention provides a medicine-carrying balloon catheter, which mainly comprises an inflatable balloon, wherein the outer surface of the balloon is coated with medicines and is provided with a plurality of axial spinous processes, the top of each spinous process is also connected with a coating protective wing, the coating protective wing can completely cover the whole balloon main body, the medicines are prevented from being lost when the balloon is conveyed in a blood vessel, when the balloon is conveyed to a diseased region, a contrast agent is filled into the balloon to fill the balloon, and the medicine coating coated below the coating protective wing can be exposed and released, so that the loss of the medicines in the conveying process can be reduced to the greatest extent.
(2) The spinous process on the balloon comprises a first protrusion and a second protrusion, the second protrusion is connected with the coating protective wing, the first protrusion is covered by the coating protective wing connected to the adjacent spinous process when the balloon is not inflated, when the balloon reaches a lesion part and is inflated, the coating protective wing covered on the first protrusion is far away from the first protrusion due to the inflation of the balloon and is exposed, the exposed first protrusion can be embedded into a plaque at the lesion part of the inner wall of the blood vessel, the release effect of the medicine is enhanced, and the conveying efficiency of the medicine is improved.
(3) In combination with preoperative or intraoperative imaging observations, different regions on the balloon can be selectively provided or not provided with a drug coating to accommodate different lesion types/lesion locations.
(4) The arrangement position and the number of the coating protective wings connected on the spinous process can be adjusted according to the actual requirement by combining the imaging observation before or during the operation so as to adapt to different patients or different pathological change types/pathological change positions.
(5) In a preferred embodiment of the invention, a section of hypotube is also connected between the outer tube and the catheter hub, which has high strength, thus enabling efficient transmission of forces and torques to the distal end of the catheter.
(6) In a preferred embodiment of the invention, the balloon is provided with a developing piece, and the developing property of the balloon catheter can be improved under X-ray fluoroscopy through the arrangement of the developing piece, so that a doctor is helped to know the accurate position of the balloon, and the doctor can conveniently position the balloon for medical operation.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:
fig. 1 is a schematic structural view of a drug-loaded balloon catheter disclosed in embodiment 1 of the present invention when the balloon is not inflated;
FIG. 2 is an enlarged view of a portion of FIG. 1 at A;
fig. 3 is a perspective view of a drug-loaded balloon catheter disclosed in example 1 of the present invention after the balloon is inflated;
FIG. 4 is a cross-sectional view of a balloon disclosed in a preferred embodiment of example 1 of the present invention when unfilled;
FIG. 5 is a cross-sectional view of a balloon disclosed in a preferred embodiment of example 1 of the present invention inflated;
fig. 6 is a left side view of a balloon disclosed in a preferred embodiment of example 1 of the present invention inflated.
Description of reference numerals:
the catheter comprises a tip 1, a balloon 2, a developing ring 3, a first protrusion 4, a second protrusion 5, a drug coating 6, a coating protective wing 7, an inner tube 8, an outer tube 9, a guide wire outlet 10, a hypotube 11, a marking tape 12 and a catheter seat 13.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In order to solve the problems in the prior art, the embodiment of the application provides a drug-loaded balloon catheter, which comprises an inner tube, an outer tube and a balloon; wherein, the distal end of the outer tube is provided with a section which can be inflated or collapsed, and the section forms a saccule; the inner tube and the outer tube are fixedly connected at the far end, and an annular cavity between the inner tube and the outer tube forms a liquid injection channel of the balloon; the outer surface of the balloon is provided with a drug coating, a plurality of spinous processes and coating protective wings which are distributed along the circumferential direction; the drug coating covers the balloon; the spinous processes extend along the axial direction of the balloon, each spinous process comprises a first protrusion and a second protrusion which are arranged in parallel along the circumferential direction, and the second protrusions are connected with the coating protective wings; the coating wings extend along the axial direction of the balloon, are matched with the outer contour of the balloon when the balloon is not inflated, cover the medicine coating when the balloon is not inflated and extend to cover the first protrusions of the adjacent spinous processes.
Example 1
This embodiment 1 provides a medicine carrying balloon catheter to solve the problem that exists among the prior art. Referring to fig. 1-6, in a preferred embodiment, a drug-loaded balloon catheter includes an inner tube 8, an outer tube 9, a balloon 2, a visualization ring 3, a hypotube 11, and a catheter hub 13. The outer tube 9 and the inner tube 8 are fixedly connected at the far end, the outer tube and the inner tube form a balloon catheter together, the outer tube 9 is connected with a catheter seat 13 used for injecting contrast medium through a hypotube 11, the far end of the outer tube 9 is provided with the balloon 2 capable of being filled or collapsed, and an annular cavity between the outer tube 9 and the inner tube 8 forms a liquid injection channel of the balloon 2. Preferably, the far end of the balloon 2 is also provided with a tip 1, the tip 1 is molded by a tip molding machine and is connected with the balloon 2 in a welding, compression or bonding way; the tip 1 is used for a guide wire to penetrate into the inner tube 8 and is beneficial to the operation of the drug-loaded balloon catheter in a blood vessel; further, a guide wire outlet 10 is provided in the side wall of the outer tube 9, and the guide wire outlet 10 is formed by the inner tube 8 and the outer tube 9.
Preferably, the developing rings 3 are made of an opaque material and are pressed and held on the inner tube 8, and the number of the developing rings 3 is preferably 2, and the developing rings are respectively arranged at two ends of the balloon 2; further, the hypotube 11 is arranged between the outer tube 9 and the catheter seat 13 and is connected with the outer tube 9 through a hot melting or laser welding process, an identification tape 12 is further arranged on the hypotube 11, the identification tape 12 is a small section of PE or FEP which is good in biocompatibility and thin, and is formed through a thermal shrinkage process, or is formed into an identification band through laser marking and used for prompting a doctor of the distance of the saccule entering the body.
In a preferred embodiment, the balloon 2 has a length of 5.0-50mm and a diameter of 1.0-5.0 mm. However, since the patients have different ages, sexes, heights, weights, lesion positions, lesion conditions, and the like, in order to ensure that the balloon 2 can be well attached to the blood vessel of the affected part to function, the size of the balloon 2 can be adaptively adjusted or selected, and details are not repeated herein. Preferably, the balloon 2 may be made using nylon or polyether block amide PEBAX material.
Referring to fig. 3-6, in a preferred embodiment, the outer surface of the balloon 2 is provided with a drug coating 6, spinous processes, and coated wings 7; preferably, a plurality of spinous processes are distributed along the circumferential direction of the balloon 2, and each spinous process extends along the axial direction of the balloon 2, and preferably, each spinous process comprises a first protrusion 4 and a second protrusion 5 which are arranged side by side along the circumferential direction, wherein the second protrusion 5 is connected with a coating protection wing 7, and the coating protection wing 7 is used for covering the drug coating 6 so as to avoid the loss of the drug when the balloon 2 is conveyed in a blood vessel.
Preferably, the spinous process is fixedly adhered to the balloon 2, and the spinous process can be made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon or PEBAX material; because the spinous process and the saccule 2 have the same flexibility, the spinous process can be collapsed, curled and the like together with the saccule 2, so that the spinous process can conveniently pass through a narrow or seriously bent diseased part, the withdrawing effect is good after the saccule 2 is expanded, and the injury of a near-end blood vessel can not be caused. Meanwhile, because the spinous process and the sacculus 2 have elasticity, when the sacculus 2 bears larger pressure, the spinous process can not damage the sacculus 2 or the inner wall of the blood vessel, and the safety is good.
As shown in fig. 3-6, in a preferred embodiment, the number of spinous processes disposed on the balloon 2 is not less than 3, more preferably 3 to 10, in this embodiment, taking 3 as an example, preferably, the cross sections of the first protrusion 4 and the second protrusion 5 are triangular, wedge-shaped, rectangular or trapezoidal, and the shapes and sizes of the first protrusion 4 and the second protrusion 5 may be different; in a more preferred embodiment, the height of the first protrusions 4 is slightly less than the height of the second protrusions 5, such that the first protrusions 4 are covered by the associated coated wings 7 on the adjacent spinous processes when the balloon 2 is not inflated, facilitating delivery of the balloon 2 in a blood vessel.
Preferably, the length of the first protrusion 4 and/or the second protrusion 5 is 2.0 to 50mm, the width of the first protrusion 4 and/or the second protrusion 5 is 0.2 to 1.0mm, and the height of the first protrusion 4 and/or the second protrusion 5 is 0.2 to 1.00 mm.
In a preferred embodiment, the spinous processes are arranged continuously along the length of the balloon 2; preferably, the length or width of the plurality of spinous processes remains uniform. When actual setting is carried out, the number, the size and the setting position of the spinous processes can be specifically selected according to the imaging observation of the lesion part; for example, if the stenosis regions in the blood vessel are continuously and uniformly distributed, the plurality of spinous processes are uniformly distributed along the length direction of the balloon 2, and if the stenosis regions or lesion regions in the blood vessel are not uniformly distributed, the number and size of the spinous processes can be set according to the actual shape of the lesion regions, so that the spinous processes can be better matched with the plaque at the lesion site of the blood vessel.
Preferably, the outer surface of the balloon 23 is further covered with a drug coating 6, and the drug coating 6 is preferably one of rapamycin, paclitaxel and a growth factor to inhibit the neointimal growth of the blood vessel. Further, the drug coating 6 continuously covers the outer surface of the balloon 2, and a specific drug can be selected according to the actual lesion type.
Preferably, the drug coating 6 is also provided in the groove portion formed between the first protrusion 4 and the second protrusion 5.
In a preferred embodiment, the number of the coated wings 7 is the same as the number of the spinous processes, the coated wings 7 extend in the axial direction of the balloon 2 and have an arc-shaped cross section which matches the curvature of the outer contour of the balloon 2 when the balloon 2 is not inflated, and the coated wings 7 cover the drug coating 6 when the balloon 2 is not inflated and extend to cover the first protrusions 4 of the adjacent spinous processes. When the balloon 2 is filled with contrast medium, the coating protective wings 7 covered on the first protrusions 4 are far away from the first protrusions 4 and exposed due to the expansion of the balloon 2, the exposed first protrusions 4 can be embedded into plaques at lesion sites on the inner wall of a blood vessel, meanwhile, the medicine coating 6 covered by the coating protective wings 7 is also exposed and attached to the inner wall of the blood vessel, the release effect of the medicine can be enhanced by matching with the first protrusions 4, and the medicine conveying efficiency is improved.
Referring to fig. 6, preferably, the coated wings 7 attached to the spinous processes are not of a standard arc shape, since the balloon 2 is generally oblong conical in shape in the unfilled state, in particular the coated wings 7 at the proximal and distal positions of the balloon 2 are curved in a curve matching the outer contour of the proximal and distal ends of the balloon 2 in the unfilled state.
Referring to fig. 4-5, preferably, since the number of the coated wings 7 is the same as the number of the spinous processes, and the spinous processes are circumferentially arranged around the balloon 2 for one circle, the plurality of spinous processes divide the balloon 2 into a plurality of relatively independent circular arcs on the cross section of the balloon 2, and the radian of the coated wings 7 is required to be slightly larger than the radian of the divided independent circular arcs of the balloon 2 so as to ensure the overall coverage of the drug coating 6 and the first protrusions 4 of the adjacent spinous processes.
Preferably, the width of the coated flaps 7 requires: the coated wings 7 are sufficient to extend over and cover the first processes 4 of the adjacent spinous processes. Preferably, the thickness of the coated wings 7 requires: when the coated flap 7 extends over and covers the first protrusion 4 of the adjacent spinous process, it can smoothly transition with the adjacent coated flap 7. Preferably, all the coated wings 7 arranged outside the balloon 2 can cover the entire surface of the unfilled balloon 2.
In a preferred embodiment, the coated flap 7 is film-like and is connected to the second protrusion 5 by means of biocompatible glue or laser welding; preferably, the coated flaps 7 have a thickness of 10 to 100um, a length of 5.0 to 50mm and a width of 1.0 to 52 mm.
In a preferred embodiment, the coated wings 7 are preferably made of polyethylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer or polyethylene terephthalate material in order to ensure good flexibility of the coated wings 7 to ensure that they can bend with the spinous processes, the balloon 2 and through stenotic or tortuous vessels, and also to ensure good connection of the coated wings 7 to the second protrusions 5.
In this embodiment 1, the operation method of the drug-loaded balloon catheter is as follows:
under the monitoring of medical imaging equipment, the guiding catheter is inserted into a catheter sheath through percutaneous puncture, then the guiding catheter is penetrated, the guiding wire is conveyed to the place along the guiding catheter, then the guiding wire is penetrated into the drug-carrying balloon catheter of the invention from the tip 1 and penetrates out from the guiding wire outlet 10, the drug-carrying balloon catheter is conveyed along the guiding wire, and in the conveying process, because the drug coating 6 of the balloon 2 is covered with the coating protective wing 7, the drug can not be damaged due to friction in the conveying process; after reaching the narrow part of the coronary artery, contrast agent is injected into the balloon 2 through the catheter seat 13, so that the balloon 2 is expanded, the coating protective wing 7 covered on the first protrusion 4 of the spinous process is far away from the first protrusion 4 and exposed due to the expansion of the balloon 2, the exposed first protrusion 4 can be embedded into plaque at the pathological change part of the inner wall of the blood vessel, meanwhile, the drug coating 6 covered by the coating protective wing 7 is also exposed and attached to the inner wall of the blood vessel, the release effect of the drug can be enhanced by matching with the first protrusion 4, and the delivery efficiency of the drug is improved. When the medicine is completely released, the pump is started to pump vacuum to enable the saccule 2 to be completely retracted, and then the saccule catheter is withdrawn.
Example 2
The embodiment provides a drug-loaded balloon catheter, and the embodiment changes the specific arrangement of the spinous process on the outer surface of the balloon 2, the drug coating 6 and the coating wings 7 on the basis of the structure of the embodiment 1.
In a preferred embodiment, a plurality of spinous processes are circumferentially distributed on the outer surface of the balloon 2, a drug coating 6 is covered between the adjacent spinous processes, and a coating protective wing 7 is connected to the second protrusion 5 of the spinous processes. Preferably, during actual setting, the distribution position of the spinous process and the actual size of each spinous process can be selected according to the actual shape of the diseased blood vessel by performing imaging observation on the diseased region before or during the operation, and at this time, the length and the width of each spinous process may be different, and the relative position relationship between the spinous processes may also be irregular.
In a preferred embodiment, the length and width of the plurality of coated wings 7 attached to the spinous processes are also adapted to the actual positional relationship between the adjacent spinous processes.
In a more preferred embodiment, since patients have different ages, sexes, heights, weights, lesion positions, lesion conditions and the like, in order to ensure that the balloon 2 can be well attached to blood vessels of affected parts to play a role, the spinous processes on the balloon 2 can be arranged only in a certain section along the axial direction without penetrating through two ends of the balloon 2; furthermore, the drug coating 6 covers the outer surface of the balloon 2 at intervals according to the actual position of the lesion, and the coating wings 7 are arranged on the second protrusions 5 at intervals to correspond to the actual arrangement position of the drug coating 6, so that the release position of the drug is more accurate and controllable to adapt to more possible surgical scenes.
The invention has the following advantages:
(1) the invention provides a medicine carrying balloon catheter, which mainly comprises a full balloon, wherein the outer surface of the balloon is coated with medicines and is provided with a plurality of axial spinous processes, the top of each spinous process is also connected with a coating protective wing, the coating protective wing can completely cover the whole balloon main body to protect the balloon from losing the medicines when the balloons are conveyed in blood vessels, when the balloons are conveyed to a diseased region, a contrast agent is filled into the balloon to fill the balloons, and the medicine coating coated below the coating protective wing can be exposed and released, so that the loss of the medicines in the conveying process can be reduced to the maximum extent.
(2) The spinous process on the balloon comprises a first protrusion and a second protrusion, wherein the second protrusion is connected with a coating protective wing, the first protrusion is covered by the coating protective wing connected to the adjacent spinous process when the balloon is not inflated, when the balloon reaches a lesion part and is inflated, the coating protective wing covered on the first protrusion is far away from the first protrusion due to the inflation of the balloon and is exposed, the exposed first protrusion can be embedded into a plaque at the lesion part of the inner wall of the blood vessel, the release effect of the medicine is enhanced, and the conveying efficiency of the medicine is improved.
(3) Different areas on the balloon can be selectively provided with or without a drug coating in combination with preoperative or intraoperative imaging observation so as to adapt to different lesion types/lesion positions.
(4) The arrangement position and the number of the coating protective wings connected on the spinous process can be adjusted according to the actual requirement by combining the imaging observation before or during the operation so as to adapt to different patients or different pathological change types/pathological change positions.
(5) In a preferred embodiment of the invention, a section of hypotube is also connected between the outer tube and the catheter hub, which has a high strength, thus enabling efficient transmission of forces and torques to the distal end of the catheter.
(6) In a preferred embodiment of the invention, the balloon is provided with a developing piece, and the developing property of the balloon catheter can be improved under X-ray fluoroscopy by the arrangement of the developing piece, so that a doctor can know the accurate position of the balloon, and the doctor can conveniently position the balloon for medical operation.
While the present invention has been described with reference to the particular illustrative embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but is intended to cover various modifications, equivalent arrangements, and equivalents thereof, which may be made by those skilled in the art without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (21)

1. A drug-loaded balloon catheter, comprising:
-an outer tube, the distal end of which is provided with an inflatable or collapsible section, which forms a balloon;
-an inner tube, which is fixedly connected to the outer tube at the distal end, and an annular cavity between the inner tube and the outer tube forms a liquid injection channel of the balloon;
the outer surface of the balloon is at least partially covered with a drug coating;
the outer surface of the balloon is provided with a plurality of spinous processes and coating protective wings which are distributed along the circumferential direction;
the spinous processes extend along the axial direction of the balloon, each spinous process comprises a first protrusion and a second protrusion which are arranged in parallel along the circumferential direction, and the second protrusions are connected with the coating wings;
the coated flaps extend away from the first protrusion and overlie the drug coating when the balloon is not inflated.
2. The medicated balloon catheter of claim 1, wherein the number of spinous processes is no less than 3 and the number of coated wings is the same as the number of spinous processes.
3. The drug-loaded balloon catheter of claim 1, wherein the height of the first protrusion is less than the height of the second protrusion.
4. The drug-loaded balloon catheter of claim 1, wherein the first protrusion and the second protrusion have different widths.
5. The drug-loaded balloon catheter of claim 1, wherein the first protrusion and/or the second protrusion are triangular, wedge-shaped, rectangular, or trapezoidal in cross-section.
6. The drug-loaded balloon catheter of claim 1, wherein the first protrusion and/or the second protrusion have a length of 2.0-50 mm; the width of the first protrusion and/or the second protrusion is 0.2-1.0 mm; the height of the first protrusion and/or the second protrusion is 0.2-1.00 mm.
7. The medicated balloon catheter of claim 1, wherein the spinous process is made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon, or polyether block amide PEBAX material.
8. The drug-loaded balloon catheter of claim 1, wherein the drug coating comprises at least one of rapamycin, paclitaxel, and a growth factor.
9. The drug-loaded balloon catheter of claim 1, wherein the drug coating is spaced apart over the outer surface of the balloon.
10. The drug-loaded balloon catheter of claim 1, wherein the drug coating is exposable in the balloon inflated state.
11. The drug-loaded balloon catheter of claim 1, wherein the coated wings are film-like and are attached to the second protrusions by biocompatible glue, heat fusion, or laser welding.
12. The drug-loaded balloon catheter of claim 11, wherein the coated wings are spaced on the second protrusion.
13. The medicated balloon catheter of claim 11, wherein the coated wings extend from the second protrusion to adjacent the spinous processes, the coated wings matching the outer profile of the balloon when unfilled.
14. The drug-loaded balloon catheter of claim 13, wherein the coating wings have an arc-shaped cross section covering the outer surface of the drug coating, and the coating wings have the same radian as the outer profile of the balloon in an unfilled state.
15. The drug-loaded balloon catheter of claim 11, wherein the coated wings have a thickness of 10-100 um, a length of 5.0-50mm, and a width of 1.0-52 mm.
16. The medicated balloon catheter of claim 11, wherein the coated wings are made of polyethylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, or polyethylene terephthalate material.
17. The drug-loaded balloon catheter of claim 1, wherein the balloon has a length of 5.0-50mm and a diameter of 1.0-5.0 mm.
18. The drug-loaded balloon catheter of claim 1, wherein the balloon is made of nylon, polyether block amide (PEBAX) or polyethylene terephthalate.
19. The drug-loaded balloon catheter of any one of claims 1-18, wherein the distal end of the balloon is further provided with a tip, and the tip is connected with the balloon by welding, crimping or bonding.
20. The drug-loaded balloon catheter of claim 19, further comprising a visualization ring, a guidewire exit port, and a catheter hub; the developing rings are arranged at two ends of the saccule; the guide wire outlet is formed by the inner tube and the outer tube and is arranged on the side wall of the outer tube; the catheter seat is arranged at the near end of the drug-carrying balloon catheter.
21. The drug-loaded balloon catheter according to claim 20, wherein a hypotube is further fixedly connected between the outer tube and the catheter hub, and a marking tape is arranged on the hypotube.
CN202210391253.0A 2022-04-14 2022-04-14 Medicine carrying balloon catheter Active CN114712672B (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024106078A1 (en) * 2022-11-16 2024-05-23 株式会社カネカ Balloon for balloon catheter, balloon catheter, and manufacturing method of balloon catheter
WO2024106080A1 (en) * 2022-11-16 2024-05-23 株式会社カネカ Balloon for balloon catheter, balloon catheter, and method for manufacturing balloon catheter
WO2024106079A1 (en) * 2022-11-16 2024-05-23 株式会社カネカ Balloon for balloon catheter, balloon catheter, and method for manufacturing balloon catheter

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2106820A1 (en) * 2008-03-31 2009-10-07 Torsten Heilmann Expansible biocompatible coats comprising a biologically active substance
US20130190725A1 (en) * 2010-07-16 2013-07-25 Abbott Cardiovascular Systems Inc. Medical device having tissue engaging member and method for delivery of a therapeutic agent
WO2018008518A1 (en) * 2016-07-04 2018-01-11 株式会社カネカ Balloon catheter and method for manufacturing same
CN109381783A (en) * 2017-08-02 2019-02-26 杭州唯强医疗科技有限公司 Drug coated balloon catheter
JP2019063086A (en) * 2017-09-29 2019-04-25 テルモ株式会社 Drug coating layer and method of forming the same
CN210750825U (en) * 2019-08-12 2020-06-16 肖平喜 Wolf tooth stick type expansion drug delivery balloon
CN111375119A (en) * 2018-12-27 2020-07-07 杭州唯强医疗科技有限公司 Drug-coated balloon catheter with detachable sheath
WO2020244388A1 (en) * 2019-06-05 2020-12-10 山东百多安医疗器械股份有限公司 Surface-drug-loading inflatable balloon for vertebroplasty and preparation method therefor
CN212491101U (en) * 2020-04-30 2021-02-09 杭州唯强医疗科技有限公司 Drug-coated balloon catheter
CN113663205A (en) * 2020-04-30 2021-11-19 杭州唯强医疗科技有限公司 Drug-coated balloon catheter
CN114081675A (en) * 2021-09-28 2022-02-25 四川大学华西医院 Transcatheter aortic valve replacement auxiliary device

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2106820A1 (en) * 2008-03-31 2009-10-07 Torsten Heilmann Expansible biocompatible coats comprising a biologically active substance
US20130190725A1 (en) * 2010-07-16 2013-07-25 Abbott Cardiovascular Systems Inc. Medical device having tissue engaging member and method for delivery of a therapeutic agent
WO2018008518A1 (en) * 2016-07-04 2018-01-11 株式会社カネカ Balloon catheter and method for manufacturing same
CN109381783A (en) * 2017-08-02 2019-02-26 杭州唯强医疗科技有限公司 Drug coated balloon catheter
JP2019063086A (en) * 2017-09-29 2019-04-25 テルモ株式会社 Drug coating layer and method of forming the same
CN111375119A (en) * 2018-12-27 2020-07-07 杭州唯强医疗科技有限公司 Drug-coated balloon catheter with detachable sheath
WO2020244388A1 (en) * 2019-06-05 2020-12-10 山东百多安医疗器械股份有限公司 Surface-drug-loading inflatable balloon for vertebroplasty and preparation method therefor
CN210750825U (en) * 2019-08-12 2020-06-16 肖平喜 Wolf tooth stick type expansion drug delivery balloon
CN212491101U (en) * 2020-04-30 2021-02-09 杭州唯强医疗科技有限公司 Drug-coated balloon catheter
CN113663205A (en) * 2020-04-30 2021-11-19 杭州唯强医疗科技有限公司 Drug-coated balloon catheter
CN114081675A (en) * 2021-09-28 2022-02-25 四川大学华西医院 Transcatheter aortic valve replacement auxiliary device

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024106078A1 (en) * 2022-11-16 2024-05-23 株式会社カネカ Balloon for balloon catheter, balloon catheter, and manufacturing method of balloon catheter
WO2024106080A1 (en) * 2022-11-16 2024-05-23 株式会社カネカ Balloon for balloon catheter, balloon catheter, and method for manufacturing balloon catheter
WO2024106079A1 (en) * 2022-11-16 2024-05-23 株式会社カネカ Balloon for balloon catheter, balloon catheter, and method for manufacturing balloon catheter

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