CN114712672B - Medicine carrying balloon catheter - Google Patents

Medicine carrying balloon catheter Download PDF

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Publication number
CN114712672B
CN114712672B CN202210391253.0A CN202210391253A CN114712672B CN 114712672 B CN114712672 B CN 114712672B CN 202210391253 A CN202210391253 A CN 202210391253A CN 114712672 B CN114712672 B CN 114712672B
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CN
China
Prior art keywords
balloon
drug
protrusion
balloon catheter
loaded
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CN202210391253.0A
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Chinese (zh)
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CN114712672A (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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Application filed by Chengdu Newmai Biotechnology Co ltd, West China Hospital of Sichuan University filed Critical Chengdu Newmai Biotechnology Co ltd
Priority to CN202210391253.0A priority Critical patent/CN114712672B/en
Publication of CN114712672A publication Critical patent/CN114712672A/en
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Classifications

    • 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 a balloon capable of filling, wherein the outer surface of the balloon is coated with medicine, a plurality of axial spinous processes are arranged, the top of each spinous process is also connected with a coating protecting wing, the coating protecting wings can completely cover the whole balloon main body, the medicine can not be lost when the balloon is conveyed in a blood vessel, when the balloon is conveyed to a lesion site, the balloon is filled with contrast agent, and the medicine coating coated below the coating protecting wings can be exposed and released, so that the loss of the medicine in the conveying 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 procedures, in particular to a medicine-carrying balloon catheter.
Background
Percutaneous coronary intervention (percutaneous coronary intervention, PCI) refers to a treatment that uses cardiac catheter techniques to open up stenosed and even occluded coronary lumens, thereby improving blood perfusion of the myocardium. The technical classification mainly comprises percutaneous coronary balloon angioplasty, coronary stent implantation, coronary rotational atherectomy, cutting balloon angioplasty, intra-coronary thrombus aspiration and the like. Among them, coronary stenting is the most classical interventional approach, and once implanted, the stent remains permanently in the vessel, and although the technology is very mature and very safe, there is still a risk of long-term intra-stent restenosis and intra-stent thrombosis.
Drug balloons have its unique advantages as a new device in recent years. The medicine saccule is a novel therapeutic saccule medicine release technology developed on the basis of interventional technologies such as saccule dilatation, saccule forming and the like, and is a technology of coating antiproliferative medicines such as paclitaxel on the surface of the saccule, when the saccule reaches a lesion part, the blood vessel wall is spread and dilated, and when the saccule contacts with the inner membrane of the blood vessel wall, the medicines are quickly released and transferred in the local blood vessel wall, and the medicines locally play a role in resisting the proliferation of the blood vessel inner membrane, so that the restenosis of the blood vessel after the vascular interventional operation is prevented. Therefore, the drug-coated balloon can not only build a channel for blood circulation through the expansion of the balloon, but also avoid the defects of restenosis, thrombus and the like in the stent after the stent implantation operation.
When the balloon with the medicine coating in the prior art is used for delivering medicines, the medicines are lost to a certain extent when the medicines pass through the blood flow scouring and the narrow vascular parts, so that the medicine loading capacity can not reach the required requirements, and the treatment effect is not ideal.
Disclosure of Invention
The invention discloses a medicine carrying 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 fixedly connected to the outer tube at a distal end, the annular cavity therebetween forming a fluid-filling channel of the balloon;
at least a partial area of the outer surface of the balloon is covered with a drug coating;
the outer surface of the saccule is provided with a plurality of spinous processes and coating 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 protrusion is connected with the coating protective wing;
the coated wings extend away from the first protrusion and overlie the drug coating when the balloon is not inflated.
As a preferable technical scheme, the number of the spinous processes is not less than 3, and the number of the coated wings is the same as that of the spinous processes.
As a preferred embodiment, the height of the first protrusion is smaller than the height of the second protrusion.
As a preferred embodiment, the first protrusion and the second protrusion have different widths.
As a preferred solution, the cross section of the first protrusion and/or the second protrusion is triangular, wedge-shaped, rectangular or trapezoidal.
As a preferable technical scheme, the length of the first protrusion and/or the second protrusion is 2.0-50mm; the width of the first protrusion and/or the second protrusion is 0.2-1.0mm; the height of the first protrusion and/or the second protrusion is 0.2-1.00mm.
As a preferred solution, the spinous processes are made of polyethylene, polypropylene, polystyrene, polyvinylchloride, polyamide, nylon or polyether block amide PEBAX material.
As a preferred embodiment, the drug coating comprises at least one of rapamycin, paclitaxel and a growth factor.
As a preferred technical solution, the drug coating is spaced over the outer surface of the balloon.
As a preferred solution, the drug coating can be exposed in the balloon-filled state.
As a preferred technical scheme, the coating protecting wing is in a film shape and is connected with the second protrusion through biocompatible glue, hot melting or laser welding.
As a preferred technical solution, the coating wings are arranged on the second protrusions at intervals.
As a preferred solution, the coated wings extend from the second protrusions to the adjacent spinous processes, the coated wings matching the outer contour of the balloon when not inflated.
As the preferable technical scheme, the cross section of the coating protective wing is arc-shaped and covers the outer surface of the drug coating, and the radian of the coating protective wing is the same as the radian of the outer contour of the balloon in an unfilled state.
As a preferred technical scheme, the thickness of the coating protective wing is 10-100 um, the length is 5.0-50mm, and the width is 1.0-52 mm.
As a preferred embodiment, the coated wings are made of polyethylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer or polyethylene terephthalate material.
As a preferable technical scheme, the length of the balloon is 5.0-50mm, and the diameter is 1.0-5.0mm.
As a preferable technical scheme, the material of the balloon is nylon, polyether block amide PEBAX or polyethylene terephthalate.
As a preferable technical scheme, the distal end of the balloon is also provided with a tip, and the tip is connected with the balloon in a welding, crimping or bonding mode.
As the preferable technical proposal, the medicine carrying saccule catheter also comprises a developing ring, a guide wire outlet and a catheter seat; the developing rings are arranged at two ends of the balloon; 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 proximal end of the drug-carrying balloon catheter.
As an optimal technical scheme, a hypotube is fixedly connected between the outer tube and the catheter seat, and a marking 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 a balloon capable of filling, wherein the outer surface of the balloon is coated with medicine, a plurality of axial spinous processes are arranged, the top of each spinous process is also connected with a coating protecting wing, the coating protecting wings can completely cover the whole balloon body, the medicine is not lost when the balloon is conveyed in a blood vessel, when the balloon is conveyed to a lesion site, contrast agent is filled into the balloon to fill the balloon, and the medicine coating coated below the coating protecting wings is exposed and released, so that the loss of the medicine in the conveying process can be reduced to the greatest extent.
(2) The spinous processes on the balloon comprise a first protrusion and a second protrusion, wherein the second protrusion is connected with a coating protection wing, the first protrusion is covered by the coating protection wing connected to the adjacent spinous processes when the balloon is not filled, when the balloon reaches a lesion part and is filled, the coating protection wing covered on the first protrusion is far away from the first protrusion and is exposed due to the expansion of the balloon, the exposed first protrusion can be embedded into plaque at the lesion part of the inner wall of a blood vessel, the drug release effect is enhanced, and the drug delivery efficiency is improved.
(3) In connection with pre-or intra-operative imaging, different regions on the balloon may be optionally provided with or without drug coatings to accommodate different lesion types/locations.
(4) In combination with preoperative or intra-operative imaging, the arrangement positions and the number of the coating wings connected to the spinous processes can be adjusted according to actual needs so as to adapt to different patients or different lesion types/lesion positions.
(5) In a preferred embodiment of the invention, a length of hypotube is also connected between the outer tube and the catheter hub, which is capable of efficiently transmitting forces and torque to the distal end of the catheter due to its high strength.
(6) In a preferred embodiment of the invention, the balloon is provided with the developing part, and the developing property of the balloon catheter can be improved under X-ray perspective through the arrangement of the developing part, so that doctors are helped to know the precise position of the balloon, and the positioning of the doctors is facilitated for medical operation.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments are briefly described below to form a part of the present invention, and the exemplary embodiments of the present invention and the description thereof illustrate the present invention and do not constitute undue limitations of the present invention. In the drawings:
FIG. 1 is a schematic diagram of a drug-loaded balloon catheter according to example 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 the drug-loaded balloon catheter disclosed in example 1 of the present invention after balloon inflation;
FIG. 4 is a cross-sectional view of a balloon disclosed in a preferred embodiment of example 1 of the present invention when not inflated;
FIG. 5 is a cross-sectional view of a balloon disclosed in a preferred embodiment of example 1 of the present invention when inflated;
fig. 6 is a left side view of the balloon disclosed in a preferred embodiment of example 1 of the present invention when inflated.
Reference numerals illustrate:
tip 1, balloon 2, developing ring 3, first protrusion 4, second protrusion 5, drug coating 6, coating wings 7, inner tube 8, outer tube 9, guidewire outlet 10, hypotube 11, identification band 12, catheter hub 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 specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be 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 explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In order to solve the problems existing 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, the section forming a balloon; the inner tube is fixedly connected with the outer tube at the far end, and the annular cavity between the inner tube and the outer tube forms a liquid injection channel of the saccule; the outer surface of the saccule is provided with a drug coating and a plurality of spinous processes and coating wings 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 protrusion is connected with the coating protective wing; the coated wings extend along the axial direction of the balloon, the coated wings are matched with the outer contour of the balloon when the balloon is not inflated, and the coated wings cover the drug coating when the balloon is not inflated and extend to cover the first protrusions of the adjacent spinous processes.
Example 1
Embodiment 1 provides a drug-loaded balloon catheter to solve the problems in the prior art. Referring to fig. 1-6, in a preferred embodiment, the 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 two form a balloon catheter together, the outer tube 9 is connected with a catheter seat 13 for injecting contrast agent through a hypotube 11, the far end of the outer tube 9 is provided with a balloon 2 which can be inflated 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 distal end of the balloon 2 is also provided with a tip 1, and the tip 1 is molded by a tip molding machine and is connected with the balloon 2 by welding, crimping or bonding; the tip 1 is used for penetrating a guide wire into the inner tube 8 and is beneficial to the operation of the drug-carrying balloon catheter in a blood vessel; further, a guide wire outlet 10 is provided in the side wall of the outer tube 9, the guide wire outlet 10 being formed by the inner tube 8 and the outer tube 9.
Preferably, the developing rings 3 are made of X-ray opaque materials and are pressed and held on the inner tube 8, and the number of the developing rings 3 is preferably 2 and respectively arranged at two ends of the balloon 2; further, the hypotube 11 is disposed between the outer tube 9 and the catheter seat 13, and is connected with the outer tube 9 by a hot melting or laser welding process, and the hypotube 11 is further provided with a marking tape 12, wherein the marking tape 12 is a small section of PE or FEP with good biocompatibility and thinner, and is formed by a thermal shrinkage process, or is formed by laser marking to form a marking zone for prompting a doctor of the distance of the balloon entering the body.
In a preferred embodiment, the balloon 2 has a length of 5.0-50mm and a diameter of 1.0-5.0mm. However, since the patients have different ages, sexes, heights, weights, lesion locations, lesion conditions, etc., the sizes of the balloon 2 can be adaptively adjusted or selected in order to ensure that the balloon 2 can be well attached to the affected blood vessels to function, and will not be described in detail herein. Preferably, balloon 2 may be made using nylon or polyether block amide PEBAX materials.
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, preferably, each spinous process comprises a first protrusion 4 and a second protrusion 5 which are arranged in parallel along the circumferential direction, wherein the second protrusions 5 are connected with a coating protecting wing 7, and the coating protecting 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 adhered and fixed with the balloon 2, and the spinous process can be made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon or PEBAX materials; since the spinous process is flexible as the balloon 2, the spinous process can collapse, curl, etc. along with the balloon 2, is convenient to pass through a narrow or severely curved lesion, and has a good retracting effect after the balloon 2 is expanded, without causing damage to the proximal blood vessel. Meanwhile, as the spinous process and the saccule 2 have elasticity, the spinous process can not damage the saccule 2 or the inner wall of a blood vessel when the saccule 2 bears larger pressure, and the safety is good.
As shown in fig. 3 to 6, in a preferred embodiment, the number of spinous processes on the balloon 2 is not less than 3, more preferably 3 to 10, in this embodiment, 3 are taken as an example, preferably, the cross sections of the first protrusion 4 and the second protrusion 5 are triangular, wedge-shaped, rectangular or trapezoid, 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 coating wings 7 attached to the adjacent spinous processes when the balloon 2 is not inflated, facilitating the delivery of the balloon 2 in the blood vessel.
Preferably, the length of the first protrusions 4 and/or the second protrusions 5 is 2.0-50mm, the width of the first protrusions 4 and/or the second protrusions 5 is 0.2-1.0mm, and the height of the first protrusions 4 and/or the second protrusions 5 is 0.2-1.00mm.
In a preferred embodiment, the spinous processes are disposed continuously along the length of the balloon 2; preferably, the length or width of the plurality of spinous processes remains uniform. When the actual setting is carried out, the number, the size and the setting positions of the spinous processes can be specifically selected according to the imaging observation of the lesion part; for example, if the narrow area in the blood vessel is continuously and uniformly distributed, the spinous processes are uniformly distributed along the length direction of the balloon 2, and if the narrow area or the lesion area in the blood vessel is unevenly distributed, the number and the size of the spinous processes can be set according to the actual shape of the lesion area, so that the spinous processes can be better matched with the plaque at the lesion part 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 growth of an angiogenic intima. Further, the drug coating 6 continuously covers the outer surface of the balloon 2, and a specific drug may be selected according to the actual lesion type.
Preferably, the drug coating 6 is also provided in the groove 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, and the coated wings 7 extend along the axial direction of the balloon 2, have an arc-shaped cross section and match the outer contour curvature of the balloon 2 when not inflated, and the coated wings 7 cover the drug coating 6 when the balloon 2 is not inflated and extend to the first protrusions 4 of the adjacent spinous processes. When the balloon 2 is filled with contrast agent, the coating wings 7 covered on the first protrusions 4 are far away from the first protrusions 4 and exposed due to the inflation of the balloon 2, the exposed first protrusions 4 can be embedded into plaques at lesions of the inner walls of blood vessels, and meanwhile, the drug coatings 6 covered by the coating wings 7 are exposed and attached to the inner walls of the blood vessels, so that the drug release effect can be enhanced by matching with the first protrusions 4, and the drug delivery efficiency can be improved.
Referring to fig. 6, preferably, because the shape of the balloon 2 in the unfilled state is generally elongated, the coated wings 7 attached to the spinous processes are not in a standard arc, and in particular, the coated wings 7 at the proximal and distal positions of the balloon 2 have a curvature that matches the outer contours of the proximal and distal ends of the balloon 2 in the unfilled state.
Referring to fig. 4-5, preferably, since the number of coated wings 7 is the same as the number of spinous processes, and the spinous processes are circumferentially disposed around the balloon 2, the plurality of spinous processes divide the balloon 2 into a plurality of relatively independent arcs in the cross section of the balloon 2, and the arc of the coated wings 7 is required to be slightly greater than the arc of the divided independent arcs of the balloon 2 to ensure full coverage of the drug coating 6 with the first protrusions 4 of the adjacent spinous processes.
Preferably, the width of the coated wings 7 requires: the coated wings 7 are sufficient to extend over and cover the first protrusions 4 of the adjacent spinous processes. Preferably, the thickness of the coated wings 7 requires: the coated flap 7 may smoothly transition with the adjacent coated flap 7 as it extends over and overlies the first projection 4 of the adjacent spinous process. Preferably, all the coated wings 7 arranged outside the balloon 2 can cover the whole surface of the unfilled balloon 2.
In a preferred embodiment, the coated wings 7 are film-shaped and are connected to the second protrusions 5 by means of biocompatible glue or laser welding; preferably, the thickness of the coated wings 7 is 10-100 um, the length is 5.0-50mm and the width is 1.0-52 mm.
In a preferred embodiment, to ensure good flexibility of the coated wings 7 to ensure that they flex with the spinous processes, the balloon 2 and pass through narrow or curved blood vessels, while also ensuring that the coated wings 7 are well connected to the second protrusions 5, the coated wings 7 are preferably made of polyethylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer or polyethylene terephthalate material.
In this embodiment 1, the operation method of the drug-loading balloon catheter is as follows:
under the monitoring of medical imaging equipment, a catheter sheath is inserted through percutaneous puncture, then a guide catheter is penetrated, a guide wire is conveyed in place along the guide catheter, then the guide wire is penetrated into the medicine carrying balloon catheter from the tip 1 and is penetrated out from the guide wire outlet 10, and the medicine carrying balloon catheter is conveyed along the guide wire, and in the conveying process, as the medicine coating 6 of the balloon 2 is covered with the coating protecting wings 7, the medicine can be prevented from being rubbed and lost in the conveying process; after reaching the coronary artery stenosis, the balloon 2 is inflated by injecting contrast medium into the balloon 2 through the catheter seat 13, at the moment, the coating wings 7 covered on the first protrusions 4 of the spinous processes are far away from the first protrusions 4 and exposed due to the inflation of the balloon 2, the exposed first protrusions 4 can be embedded into plaques at lesions of the inner walls of the blood vessels, and meanwhile, the drug coating 6 covered by the coating wings 7 is exposed and attached to the inner walls of the blood vessels, so that the drug release effect can be enhanced by matching with the first protrusions 4, and the drug delivery efficiency can be improved. When the medicine is completely released, the pump is started to vacuumize to enable the balloon 2 to completely retract, and then the balloon catheter is withdrawn.
Example 2
The present embodiment provides a drug-loaded balloon catheter, and changes the specific arrangement of the spinous process, the drug coating 6 and the coating wings 7 on the outer surface of the balloon 2 based on the structure of 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 adjacent spinous processes, and a coating protecting wing 7 is connected to the second protrusion 5 of the spinous process. Preferably, when the actual setting is performed, the distribution position of the spinous processes and the actual size of each spinous process can be selected according to the actual shape of the lesion blood vessel according to the imaging observation of the lesion part before or during the operation, at this time, the length and the width of each spinous process can be different, and the relative position relationship between the spinous processes can 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 accommodate the actual positional relationship between adjacent spinous processes.
In a more preferred embodiment, 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 fitted to the affected blood vessel to function, the spinous processes on the balloon 2 can be arranged on a certain section along the axial direction without penetrating through both ends of the balloon 2; furthermore, the drug coating 6 is covered on 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 positions of the drug coating 6, so that the release positions of the drug are 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 balloon capable of filling, wherein the outer surface of the balloon is coated with medicine, a plurality of axial spinous processes are arranged, the top of each spinous process is also connected with a coating protecting wing, the coating protecting wings can completely cover the whole balloon body, the medicine is not lost when the balloon is conveyed in a blood vessel, when the balloon is conveyed to a lesion site, contrast agent is filled into the balloon to fill the balloon, and the medicine coating coated below the coating protecting wings is exposed and released, so that the loss of the medicine in the conveying process can be reduced to the greatest extent.
(2) The spinous processes on the balloon comprise a first protrusion and a second protrusion, wherein the second protrusion is connected with a coating protection wing, the first protrusion is covered by the coating protection wing connected to the adjacent spinous processes when the balloon is not filled, when the balloon reaches a lesion part and is filled, the coating protection wing covered on the first protrusion is far away from the first protrusion and is exposed due to the expansion of the balloon, the exposed first protrusion can be embedded into plaque at the lesion part of the inner wall of a blood vessel, the drug release effect is enhanced, and the drug delivery efficiency is improved.
(3) In connection with pre-or intra-operative imaging, different regions on the balloon may be optionally provided with or without drug coatings to accommodate different lesion types/locations.
(4) In combination with preoperative or intra-operative imaging, the arrangement positions and the number of the coating wings connected to the spinous processes can be adjusted according to actual needs so as to adapt to different patients or different lesion types/lesion positions.
(5) In a preferred embodiment of the invention, a length of hypotube is also connected between the outer tube and the catheter hub, which is capable of efficiently transmitting forces and torque to the distal end of the catheter due to its high strength.
(6) In a preferred embodiment of the invention, the balloon is provided with the developing part, and the developing property of the balloon catheter can be improved under X-ray perspective through the arrangement of the developing part, so that doctors are helped to know the precise position of the balloon, and the positioning of the doctors is facilitated for medical operation.
The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.

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, said section forming a balloon;
-an inner tube fixedly connected to the outer tube at a distal end, an annular cavity therebetween forming a fluid-filling channel of the balloon;
at least a partial area of the outer surface of the balloon is covered with a drug coating;
the outer surface of the balloon is provided with a plurality of spinous processes and coating 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 and adjacent along the circumferential direction, and the second protrusions are connected with the coating wings;
the coated wings extend away from the first protrusion and cover the drug coating and the adjacent first protrusion of the spinous process when the balloon is not inflated.
2. The drug-loaded balloon catheter of claim 1, wherein the number of spinous processes is not 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 is different than the second protrusion in width.
5. The drug-loaded balloon catheter of claim 1, wherein the first protrusion and/or the second protrusion has a triangular, wedge, rectangular or trapezoidal cross-section.
6. The drug-loaded balloon catheter of claim 1, wherein the length of the first protrusion and/or the second protrusion is 2.0-50mm; the width of the first protrusion and/or the second protrusion is 0.2-1.0mm; the height of the first protrusion and/or the second protrusion is 0.2-1.00mm.
7. The drug-loaded balloon catheter of claim 1, wherein the spinous process is made of polyethylene, polypropylene, polystyrene, polyvinylchloride, 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 from and covering an outer surface of the balloon.
10. The drug-loaded balloon catheter of claim 1, wherein the drug coating is capable of being exposed 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, hot melt or laser welding.
12. The drug-loaded balloon catheter of claim 11, wherein the coated guard is disposed on the second protrusion at intervals.
13. The drug-loaded balloon catheter of claim 11, wherein the coated wings extend from the second protrusion to the adjacent spinous process, the coated wings matching the outer profile of the balloon when not inflated.
14. The drug-loaded balloon catheter of claim 13, wherein the cross-section of the coated wings is arcuate and covers the outer surface of the drug coating, and wherein the arc of the coated wings is the same as the arc of the outer profile of the balloon in the unfilled state.
15. The drug-loaded balloon catheter of claim 11, wherein the thickness of the coated wings is 10-100 um, the length is 5.0-50mm, and the width is 1.0-52 mm.
16. The drug-loaded 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 1.0-5.0mm.
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, the tip being connected to the balloon by welding, crimping, or bonding.
20. The drug-loaded balloon catheter of claim 19, further comprising a visualization ring, a guidewire outlet, and a catheter hub; the developing rings are arranged at two ends of the balloon; the guide wire outlet is formed by the inner tube and the outer tube, and the guide wire outlet is arranged on the side wall of the outer tube; the catheter seat is arranged at the proximal end of the drug-carrying balloon catheter.
21. The drug-loaded balloon catheter of claim 20, wherein a hypotube is further affixed between the outer tube and the catheter hub, and an identification band is provided on the hypotube.
CN202210391253.0A 2022-04-14 2022-04-14 Medicine carrying balloon catheter Active CN114712672B (en)

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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
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

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