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WO2012026717A2 - Cathéter à ballonnet doté d'un film de libération de médicament - Google Patents

Cathéter à ballonnet doté d'un film de libération de médicament Download PDF

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Publication number
WO2012026717A2
WO2012026717A2 PCT/KR2011/006163 KR2011006163W WO2012026717A2 WO 2012026717 A2 WO2012026717 A2 WO 2012026717A2 KR 2011006163 W KR2011006163 W KR 2011006163W WO 2012026717 A2 WO2012026717 A2 WO 2012026717A2
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WO
WIPO (PCT)
Prior art keywords
film
balloon
drug delivery
inflatable balloon
drug
Prior art date
Application number
PCT/KR2011/006163
Other languages
English (en)
Korean (ko)
Other versions
WO2012026717A3 (fr
Inventor
김용년
Original Assignee
(주)이화바이오메딕스
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
Priority claimed from KR1020110049923A external-priority patent/KR101230657B1/ko
Application filed by (주)이화바이오메딕스 filed Critical (주)이화바이오메딕스
Publication of WO2012026717A2 publication Critical patent/WO2012026717A2/fr
Publication of WO2012026717A3 publication Critical patent/WO2012026717A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • 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
    • 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
    • A61M2025/109—Balloon 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
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046—Solid microneedles
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles

Definitions

  • the present invention relates to a balloon catheter provided with a drug delivery film, and more particularly, to provide a film of a biocompatible material capable of supporting and continually releasing a drug on a inflatable balloon surface of the balloon catheter, thereby providing a drug to the treatment site.
  • the present invention relates to a balloon catheter provided with a film for drug delivery capable of delivering continuously.
  • the present invention is to apply the micro-projection structure to the inflatable balloon of the balloon catheter in order to more efficiently and safely deliver the required drug in the appropriate place, the micro-projection of the film of biocompatible material that can carry and release the required drug
  • the present invention relates to a balloon catheter provided with a film for drug delivery, which can accurately and continuously deliver a drug to a treatment site by providing a structure on the balloon surface to which the catheter is accurately positioned at the treatment site.
  • the present invention provides a microneedle by surface treatment on a film of biocompatible material capable of supporting and continually releasing the necessary drug, and then the film of the biocompatible material having the fine needle formed thereon is an inflatable balloon surface of a balloon catheter.
  • the balloon catheter is provided with a drug delivery film which provides a path for narrow blood vessels upon inflation of the balloon and accurately and reliably secures the microneedles on the film to the vessel wall while simultaneously delivering the drug accurately and continuously to the treatment site. It is about.
  • the present invention is a tactic by applying a bioadhesive on the surface of the film while reducing the risk of blood clots even if the catheter is introduced into a narrow vessel by hydrophilic surface treatment of a film of a biocompatible material that can carry and release the necessary drugs
  • the microneedles on the film as described above can be more effectively and stably fixed to the blood vessel wall, and the side of the film, in which the microneedles are not formed in the drug release process, is first biodegraded, and then the microneedles fixed to the blood vessel wall are sequentially biodegraded, thereby causing side effects such as thrombus formation.
  • the present invention relates to a balloon catheter provided with a drug delivery film capable of safely delivering a drug to a treatment site.
  • thrombolytics may be injected into blood vessels, and the treatment physician may increase the effectiveness of treatment through a procedure such as stent insertion, vasodilation or vascular bypass surgery.
  • a metal stent is introduced into the coronary artery, and the stent structure is spread out from the stenosis to treat the stenosis.
  • drugs such as thrombolytics are used.
  • Silver was injected separately from the stent, and there was a problem that the surgical treatment and the medication were performed separately from each other.
  • drug-released vascular stents coated with drugs on metallic stents have been developed and used.
  • the stent has a fundamental problem of the resorption of blood vessels due to long-term transplantation into the narrowed coronary arteries, etc., and thus stent thrombosis and late vessel restenosis may occur. Therefore, in the technical field to which the present invention belongs, it is required to develop a technology that can effectively deliver drugs to the treatment site inside the body without using a stent implanted in the blood vessel.
  • the catheter is a device that refers to a medical means that is directly inserted into the body, the catheter for a variety of body insertion, such as vascular injection, coronary artery dilation, urethral insertion, airway insertion, laparoscopic catheter in the medical field
  • a balloon catheter for coronary artery dilatation includes, for example, an inflatable balloon formed near a tip of a guide tube inserted into a narrow blood vessel, and fluid is introduced through the conduit connected to the balloon to expand the balloon.
  • a guide wire for facilitating insertion into the narrow vessel of the catheter and performing a procedure has a structure embedded in the conduit.
  • the drug is absorbed into a hydrogel-based balloon
  • the balloon is embedded in the catheter's internal space
  • the catheter is introduced into the vessel at the treatment site
  • the balloon is slid out of the catheter to inflate the balloon to inflate the drug and cause blood clots.
  • the tissue US Pat. No. 5,868,719
  • the drug delivery balloon catheter has a problem of having to absorb the drug in the balloon in advance and the problem of infection that may occur and the drug absorbed in the inflatable balloon
  • the catheter is moved to the treatment site, and the needle is passed through the catheter body through the drug delivery lumen in the catheter, and the needle is inserted through the hole formed on one side of the catheter to stab the flexible needle into the tissue to be treated and inject the drug.
  • US Patent Publication No. 2008/0004596 A1 US Patent Publication No. 2008/0004596 A1
  • the movement and fixation of the catheter to the treatment site is difficult, as well as exposing the needle through the catheter hole and precisely stabbing it in the tissue is not a highly skilled procedure. It was difficult to do the procedure.
  • the present invention belongs, it is a balloon-type catheter that is easy to manufacture and use and is hygienic and precisely inserted at the treatment site while being precisely inserted through blood vessels and urethra.
  • the conventional drug delivery and delivery to the treatment site using the balloon catheter has a limitation in the inconvenience of manufacturing and use, and the continuous delivery of the drug to the correct treatment site.
  • the inventors have intensively studied, and applied a micro-projection structure to the inflatable balloon of the balloon catheter, and a film of a biocompatible material capable of supporting and continuously releasing the necessary drug on the balloon surface to which the microprojection structure is applied.
  • the provided balloon catheter was designed, and after forming the fine needle by surface treatment on the film of the biocompatible material capable of supporting and continuously releasing the necessary drug, the film of the biocompatible material formed with the fine needle was expanded to the inflatable catheter.
  • the present invention provides a balloon catheter provided with a film for drug delivery, which can deliver a film of a biocompatible material capable of supporting and continuously releasing a necessary drug on the inflatable balloon surface of the balloon catheter and continuously delivering the drug to the treatment site.
  • the purpose is to provide.
  • the present invention applies a microprojection structure to an inflatable balloon of a balloon catheter in order to more efficiently and safely deliver a necessary drug, and a film of a biocompatible material capable of supporting and continually releasing a drug required by the microprojection. It is an object of the present invention to provide a balloon catheter provided with a film for drug delivery, which can accurately and continuously deliver a drug to a treatment site while accurately positioning the catheter at the treatment site by providing the structure on the balloon surface to which the structure is applied.
  • the present invention is to form a fine needle by the surface treatment on the film of the biocompatible material capable of supporting and continuously release the necessary drug and then the film of the biocompatible material on which the fine needle is formed, the inflatable balloon surface of the balloon catheter Balloon catheter provided with a film for drug delivery to secure narrow blood vessel passage during balloon inflation and to accurately and stably fix the microneedles on the film to the blood vessel wall while delivering the drug accurately and continuously to the treatment site.
  • the purpose is to provide.
  • the present invention is a hydrophilic surface treatment of a film of a biocompatible material capable of supporting and continuously release the necessary drug to apply the bioadhesive to the surface of the film while reducing the risk of blood clots even if the catheter is introduced into a narrow vessel
  • the microneedles on the film as described above can be more effectively and stably fixed to the blood vessel wall, and the side of the film, in which the microneedles are not formed in the drug release process, is first biodegraded, and then the microneedles fixed to the blood vessel wall are sequentially biodegraded, thereby causing side effects such as thrombus formation.
  • An object of the present invention is to provide a balloon catheter provided with a drug delivery film that can safely deliver a drug to a treatment site.
  • the present invention can not only continuously and continuously deliver various drugs by providing multiple films of biocompatible materials capable of supporting and continuously releasing various drugs in a multi-layer on the inflatable balloon surface.
  • the film by forming fine holes in the film, it provides biodegradability in which the film can be broken down into fine pieces during drug delivery, and also provides biocompatibility and elastic properties to prevent secondary diseases such as blood clots, re-epithelialization, and inflammatory reactions.
  • the purpose is to provide a balloon catheter that does not induce.
  • An inflatable catheter provided with a film for drug delivery of an embodiment of the present invention comprises an inflatable balloon, a conduit having a conduit in communication with the inflatable balloon and introducing a balloon for inflating the inflatable balloon with the inflatable balloon;
  • a film of biocompatible material capable of sustaining release comprising: a film provided surrounding the inflatable balloon; and a micro-projection formed on the inflatable balloon outer surface and positioned in the space between the inflatable balloon and the film;
  • the catheter when the inflatable balloon is introduced into the inflatable balloon through the connecting pipe, when the inflatable balloon is inflated, the catheter is secured at the correct position of the treatment site to secure the passage of blood vessels, and the inflatable balloon
  • the shape of the film is deformed like the micro protrusions, and the film portion deformed into the shape of the micro protrusions and the micro protrusions are fixed to the treatment part in the body so that the drug supported on the film is treated. It can be delivered accurately and slowly and continuously at the site.
  • a balloon catheter provided with a drug delivery film of another embodiment of the present invention comprises a conduit having an inflatable balloon and a conduit in communication with the inflatable balloon and introducing a balloon for inflating the inflatable balloon into the inflatable balloon;
  • a film of biocompatible material capable of supporting and continuously releasing a drug comprising: a film provided surrounding the inflatable balloon; and a fine needle formed on the surface of the film, wherein the inflatable balloon is used to expand the balloon.
  • the plurality of fine needles may be provided, the plurality of fine needles are formed at regular intervals in the axial direction of the catheter on the surface of the film It may be formed at regular intervals in the circumferential direction of the film surrounding the inflatable balloon.
  • a plurality of fine needles may be formed along a folding line of the film that occurs when the film surrounding the inflatable balloon is folded before the inflatable balloon is inflated.
  • the plurality of fine needles are in the axial direction of the catheter when the film surrounding the inflatable balloon is folded (folding) before the inflatable balloon is inflated Located in a lying state, when the inflatable balloon is inflated, the film surrounding the inflatable balloon is unfolded, and accordingly characterized in that it is erected with a constant angle with respect to the axial direction of the catheter.
  • the film before the balloon is expanded, the film is introduced into the narrow vessel in the folded state so that the fine needles formed along the folding line do not damage the vessel wall, and the vessel is narrowed when the balloon is inflated.
  • the microneedle on the film is erected toward the vessel wall while securing the passage of the film, so that the film is accurately and stably fixed to the vessel wall so that the drug contained in the film can be accurately and continuously delivered to the treatment site, for example, the tissue inside the vessel wall. do.
  • each fine needle has a larger diameter at the proximal end located on the film and a smaller diameter as it moves away from the proximal end, but at the tip of the fine needle.
  • the bulge is pointed and can be fixed accurately and stably in tissues such as blood vessel walls.
  • the fine needle may be formed in a streamline shape having a constant angle from the base end to the tip.
  • the microneedle is firmly fixed to the blood vessel wall by the blood flow, thereby reducing the risk of the drug delivery film falling off and making it adhere to the blood vessel wall, thereby facilitating drug delivery.
  • the fine needle may be formed by extending the hook structure downward from the tip portion. In this case, once the fine needle is fixed to a tissue such as a blood vessel wall, the fine needle is not easily separated by the hook structure.
  • the fine needle is formed by at least one surface treatment selected from the group consisting of corona surface treatment, high frequency surface treatment, plasma surface treatment and laser surface treatment.
  • the surface treatment is preferably a hydrophilic surface treatment, the hydrophilic surface treatment can reduce the risk of blood clots even if the catheter is introduced into a narrow vessel.
  • the present invention is not limited thereto, and various film processing and forming methods may be used.
  • the surface of the film can be applied to the bioadhesive to make the fine needle more effectively and stably fixed to the blood vessel wall.
  • biored glutamate examples include fibrinogen, blood coagulant XIII factor with fibrinogen, cyanoacrylate, dermalin glue, marine bioadhesive, and various biocompatible agents known in the art may be used. to be.
  • the film surrounding the inflatable balloon is expanded to take a substantially cylindrical shape, the circumference of the unfolded cylindrical film
  • the film may be formed to be stepped along the direction.
  • the fine needle may be formed on a thick projecting portion.
  • the holes are formed in the film so that the film can be decomposed into fine pieces during drug delivery to prevent the formation of blood clots.
  • any material may be used as the material of the film as long as it is a biocompatible material capable of supporting and continuously releasing a necessary drug, for example, PEG (polyethyleneglycol) Polymer material of -PCLA (poly (epsilon-caprolactone-co-D, L-lactide)), or polymer material of PEG (polyethyleneglycol) -PLGA (poly (lactic-co-glycolic acid)), or capro to such polymer material
  • Polymeric materials to which at least one substance selected from the group consisting of lactones, glycolides, lactide, paradioxanone and trimethylenecarbonate are added may be used (see Korean Patent Nos.
  • Balloon catheter provided with the drug delivery film of the present invention, the outer separation conduit that is directly bonded to the connection pipe, and is in close contact with the inner wall of the external separation conduit is located in communication with the connection pipe fluid for inflating the balloon in the connection pipe It may include an internal separation conduit for introducing the.
  • one end of the inner separation conduit preferably extends through the one end of the outer separation conduit to the inside of the connecting tube.
  • the outer separation conduit helps to firmly connect with the connector at the same time serves to guide the coupling of them when combined with the connector.
  • one end of the inner separation conduit preferably has a shape that is sharpened toward the tip.
  • a guide wire may be positioned at an interval from an inner wall of the inner separation conduit.
  • the guide wire extends deep inside the connecting pipe through one end of the inner separation conduit.
  • the balloon catheter provided with the drug delivery film of the present invention is provided with rigidity to the connective duct during a surgical procedure for inserting into the blood vessel, thereby facilitating the catheter's intravascular insertion and entry into the blood vessel.
  • the balloon inflation fluid is introduced through the gap between the inner wall of the inner separation conduit and the guide wire, the flow rate of the balloon inflation fluid can be adjusted by adjusting the gap.
  • the balloon catheter provided with the drug delivery film of the present invention may further include a joint member for connecting the outer separation conduit and the inner separation conduit with the fluid connection for balloon expansion.
  • the inflation port of the joint member is inserted and connected to the balloon inflation fluid tube, and the outlet port of the joint member is inserted into and connected to the outer separation conduit and the inner separation conduit.
  • the balloon expansion fluid connecting tube inserted through the inlet port is tightly inserted into the inlet guide tube formed in the joint member, and the outer separation conduit and the inner separation conduit inserted through the outlet port are the inlet guide.
  • the balloon-expanding fluid introduced through the balloon-expansion fluid connection tube is inserted into the outflow guide tube formed in the joint member in communication with the pipe and is introduced through the balloon-expansion fluid connection pipe through the inner separation conduit. It will be exported to the outflow port.
  • the balloon catheter provided with the drug delivery film of the present invention may further include a balloon inflation fluid injecting hub that connects the balloon inflation fluid connector with a fluid supply device.
  • the balloon catheter provided with the drug delivery film of the present invention the blood flow extending from the leading end of the conduit to the position of the connection pipe formed inside the inflatable balloon and the blood flow hole and is coupled to the blood flow hole formed in the connection pipe It may further include a flow tube.
  • the blood flow pipe is formed in a shape that is curved at a slightly upward angle at a portion coupled to the blood flow hole, and its opening is formed long in the longitudinal direction.
  • the blood flow tube must fit snugly into the blood flow hole of the connector, otherwise there is a risk of the balloon-inflating fluid leaking through the connector.
  • the inflatable balloon When the additional blood flow tube is installed, the inflatable balloon is inflated to secure the catheter in the correct position and secure the passage of blood vessels, and the drug contained in the film is delivered to the treated portion accurately and slowly and continuously.
  • the catheter may allow blood to flow smoothly through the blood flow tube without disturbing the flow of blood.
  • the balloon catheter provided with the drug delivery film of the present invention may further include a sealing cap for sealing between the inflatable balloon and the blood flow tube.
  • the sealing cap has a through passage formed in a portion corresponding to the inner passage of the blood flow tube so that blood can flow smoothly through the blood flow tube as described above.
  • the balloon inflation fluid may be air or contrast agent.
  • the inflatable balloon is preferably made of a material having elasticity (elasticity) which is easily expanded when an expansion fluid such as nylon, stretchable synthetic resin, polyamide, polyetheramide, etc. is introduced as a material suitable for living bodies.
  • the length of the fine protrusions may be approximately 100 ⁇ m, and it is preferable to configure the shape of the film when the balloon is inflated but does not penetrate the film.
  • the microprojection can be formed in a fine cylindrical shape on the outer surface of the inflatable balloon.
  • the present invention is not limited thereto, and may be made of balloons of various materials according to treatment conditions, such as the treatment site, the thickness of blood vessel into which the catheter is inserted, and the length and shape of the micro-projection may be variously selected.
  • the drug supported on the film and delivered to the treatment site includes a thrombolytic agent, antiproliferative agent, immunosuppressant agent, anti-inflammatory agent, vaccine, hormone, insulin, gene therapy agent, Protein therapeutics injection, or endothelial cell promoter.
  • a thrombolytic agent antiproliferative agent
  • immunosuppressant agent anti-inflammatory agent
  • vaccine anti-inflammatory agent
  • hormone hormone
  • insulin gene therapy agent
  • Protein therapeutics injection or endothelial cell promoter
  • the catheter can be accurately positioned at the treatment site and the drug can be delivered while being accurately and continuously released at the treatment site.
  • the present invention can deliver the necessary drugs more efficiently, safely and continuously where appropriate.
  • the present invention applies a micro-projection structure to an inflatable balloon of a balloon catheter, and provides a balloon of a biocompatible material capable of supporting and continuously releasing a necessary drug on the balloon surface to which the micro-projection structure is applied.
  • the drug is carried on the film is delivered to the vascular inner wall slowly and continuously released.
  • the present invention is to form a microneedle by surface treatment on a film of biocompatible material capable of supporting and continually release the necessary drug and then the film of the biocompatible material formed with the fine needle on the inflatable balloon surface of the balloon catheter to provide a narrow vessel passage during balloon inflation and to accurately and stably fix the microneedles on the film to the vessel wall, while the drug contained in the film is precisely and continuously applied to the treatment site, for example tissue inside the vessel wall. There is an advantage to deliver.
  • the present invention by applying a bioadhesive to the surface of the film while reducing the risk of blood clots, even if the catheter is introduced into a narrow vessel by hydrophilic surface treatment of the film of the biocompatible material that can carry and release the necessary drug
  • the microneedles on the film as described above are more effectively and stably fixed to the blood vessel wall, and during the drug release process, the film portion in which the microneedles are not formed is first biodegraded, and then the microneedles fixed to the blood vessel wall are biodegraded sequentially, without side effects such as thrombus generation.
  • the present invention can not only continuously and continuously deliver various drugs by providing multiple films of biocompatible materials capable of supporting and continuously releasing various drugs in a multi-layer on the inflatable balloon surface.
  • the present invention provides biodegradability in which the film can be broken down into fine pieces during drug delivery, and also provides biocompatibility and elastic properties to prevent secondary diseases such as blood clots, re-epithelialization, and inflammatory reactions. There are additional benefits that do not cause them.
  • FIG. 1 is a perspective view of a balloon catheter provided with a drug delivery film of the first embodiment of the present invention is coupled.
  • Figure 2 is an exploded perspective view of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention in a disassembled state.
  • Figure 3 is a longitudinal cross-sectional view of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention is coupled.
  • Figure 4 is an enlarged cross-sectional view showing an enlarged portion A of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG.
  • FIG. 5 is an enlarged cross-sectional view illustrating an enlarged portion B of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
  • FIG. 6 is an enlarged cross-sectional view of a portion C of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
  • FIG. 7 is an enlarged cross-sectional view illustrating a portion D of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
  • FIG. 8 is an enlarged cross-sectional view showing an enlarged portion E of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG.
  • FIG. 9 is a perspective view of the balloon catheter provided with the drug delivery film of the second embodiment of the present invention is coupled.
  • FIG. 10 is a perspective view and a partially enlarged view showing a state in which a film of the first form surrounding the inflatable balloon is folded in a balloon catheter provided with a drug delivery film of a second embodiment of the present invention.
  • FIG. 11 is a front view and a perspective view illustrating a state in which the film of the first form of FIG. 10 is coupled to the inflatable balloon in the folded state.
  • FIG. 12 is a perspective view and a partially enlarged view showing a state in which a second type of film surrounding the inflatable balloon is folded in a balloon catheter provided with a drug delivery film of a second embodiment of the present invention.
  • FIG. 13 is a front view and a perspective view illustrating a state in which the film of the second form of FIG. 12 is coupled to the inflatable balloon in the folded state.
  • FIG 14 to 16 are perspective views showing the microneedle and the unfolded state of the various types of film surrounding the inflatable balloon in the balloon catheter provided with the drug delivery film of the second embodiment of the present invention by the expansion of the balloon.
  • FIG. 17 is an enlarged cross-sectional view illustrating the E-section of the balloon catheter provided with the drug delivery film of the second embodiment of the present invention shown in FIG. 9 after being cut in the longitudinal direction.
  • Balloon catheter (100a) provided with the drug delivery film of the first embodiment of the present invention as shown in Figures 1, 2, 7 and 8 is introduced into the body through blood vessels for balloon expansion, such as air
  • An inflatable balloon 82 which is inflated by the fluid F and inserted into the treatment site T and connected to the inflatable balloon 82 is connected to the inflatable balloon 82 to flow the balloon-inflating fluid F into the inflatable balloon 82.
  • a conduit 80 having a connecting tube 84, a film 20a provided surrounding the inflatable balloon 82 as a film of a biocompatible material capable of supporting and continuously releasing the necessary drug M; And, as a major component, a micro-projection 88 formed on the outer surface of the inflatable balloon 82 and located in the space d between the inflatable balloon 82 and the film 20a.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention protrudes from the shape of the film 20a when the inflatable balloon 82 is inflated.
  • the micro protrusions 88 are fixed along the outer circumferential surface so that the drug M supported on the film 20a is gradually and continuously delivered to the treatment site T by fixing the deformed film portion to the treatment site T by deforming to the treatment site T.
  • the film 20a provided while surrounding the inflatable balloon 82 as a film of a compatible material has a basic configuration.
  • the inflatable catheter 100a provided with the drug delivery film of the first embodiment of the present invention is inserted from the opening of the front end of the conduit 80 and expandable.
  • the blood flow tube 70 passing through the balloon 82 and the connecting tube 84 may be further assembled.
  • the blood flow pipe 70 extends to the blood flow hole 86 formed at one side of the outer circumferential surface of the connection pipe 84 and is fitted to fit the blood flow hole 86.
  • the blood flow tube 70 is formed in a curved shape at a slightly upward angle at a portion coupled to the blood flow hole 86 and the opening portion 76 has a length. It is formed long in the direction.
  • the blood flow pipe 70 should fit snugly into the blood flow hole 86, otherwise the risk of balloon inflation fluid F entering through the expansion fluid flow space fS of the connection pipe 84 will leak out. Because of this.
  • Figure 6 is an enlarged cross-sectional view showing a longitudinal cross-sectional view of the C portion of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention
  • the blood flow pipe 70 is coupled to the blood flow hole 86 Partly blocks the expansion fluid flow space fS in the longitudinal direction, that is, the vertical direction, but there is a space in the transverse direction, that is, the horizontal direction, so that the flow of the balloon-inflating fluid F is not disturbed.
  • the inflatable balloon 82 When the blood flow tube 70 is further installed, the inflatable balloon 82 is inflated to secure the catheter 100a at the treatment site T while securing a passage of blood vessels, and when the inflatable balloon 82 is expanded, the inflatable balloon 82 is expanded. As the space d between the balloon 82 and the film 20a becomes narrow (d ⁇ d '), the film portion 20a is deformed like the microprojection 88 and deformed into the microprojection shape. When the micro-projection 88 is fixed to the treatment site T in the body and the drug M carried on the film 20a is delivered to the treatment site T while being released (see FIGS. 7 and 8), the catheter 100a may allow blood to flow smoothly through the inner passage BP and the opening 76 of the blood flow tube 70 without disturbing the flow of blood in the blood vessel BB (FIGS. 6 to 6). 8).
  • the catheter 100 may be inserted into the balloon catheter 100a provided with the drug delivery film of the present invention. 80) the rigidity is given to the whole to facilitate insertion of the catheter 100a into the blood vessel and entry into the blood vessel.
  • the blood flow tube 70 may be composed of various materials, for example, biocompatible plastics, synthetic resins, and the like, in addition to the above materials.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention has a tip between the inflatable balloon 82 and the blood flow tube 70. It may be further provided with a sealing cap 90 for sealing the. Accordingly, the balloon-expanding fluid F is prevented from flowing out of the tip of the catheter 100a by the sealing cap 90, and the sealing cap 90 is an internal passage of the blood flow pipe 70.
  • a through passage 92 is formed at a portion corresponding to the BP to allow blood to flow smoothly through the inner passage BP and the opening 76 of the blood flow tube 70 as described above.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention by the combination of the above components, the balloon is inflated through the connecting pipe 84 as shown in FIGS. 5, 7 and 8.
  • the catheter 100a is secured at the correct position of the treatment site T to secure the passage of blood vessels.
  • the space d between the inflatable balloon 82 and the film 20a is narrowed (d ⁇ d ')
  • the shape of the film 20a is deformed like the fine protrusions 88 and then deformed into the shape of the fine protrusions.
  • the film portion 20a and the micro-projection 88 are fixed to the treatment site T in the body so that the drug M loaded on the film 20a can be delivered while being accurately and continuously released to the treatment site T. Can be.
  • the balloon-inflating fluid (F) such as air flows into the connecting pipe 84 through the expansion fluid passage (P), as shown in FIG.
  • the inflatable balloon 82 is expanded to expand the inflatable balloon 82.
  • the portion of the film deformed into the shape of the fine protrusions before and after the shape of the film 20a is deformed like the fine protrusions 88 while the space d between the 82 and the film 20a is narrowed (d ⁇ d ').
  • 20a and the micro-projection 88 are fixed to the treatment site T in the body so that the drug M supported on the film 20a can be delivered while being accurately and continuously continuously released to the treatment site T ( 7 and 8).
  • the balloon inflation fluid F as described above may be air or a contrast agent.
  • the balloon-inflating fluid F of the present invention is not limited thereto, and any material capable of inflating the inflatable balloon 82 as a fluid may be used.
  • the inflatable balloon 82 is made of a material having elasticity (elasticity) that is easily expanded when a balloon-inflating fluid (F) such as nylon, stretchable synthetic resin, polyamide, and polyetheramide is introduced as a material suitable for living body. It is desirable to. However, it will be readily understood by those skilled in the art that the present invention is not limited thereto and may be made using balloon materials known in the art with respect to balloon catheter.
  • F balloon-inflating fluid
  • the length of the inflatable balloon 82 may range from approximately 5 mm to 50 mm, and its inner diameter may vary within the range of approximately 0.5 mm to 5 mm.
  • the connecting pipe 84 may be made integrally with the same material as that of the inflatable balloon 82, or alternatively manufactured separately from a biocompatible polymer material such as polyurethane, nylon, or PET, and then UV or heat adhesive. A type of adhesive can be used to attach to the inflatable balloon 82.
  • the length of the connector 84 may range from approximately 100 mm to 2000 mm, and its inner diameter may range from approximately 0.2 mm to 2.0 mm.
  • a plurality of fine protrusions 88 are formed on the outer surface of the inflatable balloon 82 at regular intervals, and the shape of the inflatable balloon 82 may be configured to deform the shape of the film but not penetrate the film.
  • the microprojection 88 can be formed in a fine cylindrical shape on the outer surface of the inflatable balloon.
  • the fine protrusions 88 may be formed by applying a microneedle forming method using a nylon material known in the art.
  • the present invention is not limited thereto, and may be made of balloons of various materials according to treatment conditions, such as the treatment site, the thickness of blood vessel into which the catheter is inserted, and the length and shape of the fine protrusion may be variously selected.
  • the length of the fine protrusions 88 may be approximately 100 ⁇ m.
  • the film is deformed into a protrusion by the micro-projection 88 and the micro-projection by adjusting the expansion degree of the inflatable balloon 82 by adjusting the length of the micro-projection 88 or the amount of inflow of the balloon-inflating fluid F.
  • the portion 20a can adjust the depth at which it is inserted into the tissue inside the blood vessel wall and thus the delivery depth of the drug.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is an outer separation conduit 40 which is directly bonded and bonded to the connecting pipe 84,
  • the inner separation conduit is placed in close contact with the inner wall of the outer separation conduit 40 and communicates with the connection pipe 84 to introduce the balloon expansion fluid F into the connection pipe 84 through the expansion fluid passage P. And 50.
  • one end of the outer separation conduit 40 is joined with the connection tube 84.
  • the outer separation conduit 40 is manufactured separately from the same material as the connecting pipe 84, for example, a biocompatible polymer material such as polyurethane, nylon or PET, and then using an ultraviolet or heat adhesive type adhesive. It can be attached to the connecting pipe (84).
  • the inner separation conduit 50 is inserted into the outer separation conduit 40 and assembled, wherein one end of the inner separation conduit 50 is It may extend beyond one end of the outer separation conduit 40 to the interior of the connection tube 84.
  • the inner separation conduit 50 serves to guide the coupling of the outer separation conduit 40 and the connection pipe 84 as described above when the outer separation conduit ( 40 helps to firmly engage the connector 84.
  • one end of the inner separation conduit 50 preferably has a shape that is sharpened toward the tip.
  • the guide wire 60 is inserted and positioned at intervals with the inner wall of the inner separation conduit 50, the expansion fluid passage (P) ).
  • the guide wire 60 preferably extends deep inside the connection pipe 84 through one end of the internal separation conduit 50.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is provided with rigidity to the connecting pipe 84, for example, in a surgical procedure of inserting the blood vessel into the blood vessel of the catheter and the blood vessel. It is easy to enter inside.
  • the expansion fluid passage by adjusting the interval since the balloon expansion fluid (F) is introduced through the interval between the inner wall of the inner separation conduit 50 and the guide wire 60, that is, the expansion fluid passage (P). It is possible to adjust the flow amount of the balloon for expanding fluid (F) flowing through (P).
  • the guide wire 60 may be made of a material such as stainless steel or super-elastic alloy, in addition to a variety of materials, for example, biocompatible plastic, synthetic resin, etc. Those skilled in the art will readily understand.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention has a fluid for inflating the external separation conduit 40 and the internal separation conduit 50. It may further include a joint member 30 for connecting to the connecting pipe 18.
  • the inflation port 32 of the joint member 30 is inserted and connected to the balloon inflation fluid tube 18, and the outlet port 36 of the joint member 30 is connected to the inlet port 32.
  • An outer separation conduit and an inner separation conduit 40, 50 and the guide wire 60 are inserted and connected.
  • the balloon-inflating fluid connection pipe 18 inserted through the inflow port 32 is tightly inserted into the inflow guide tube 31 formed in the joint member 30. It is caught by the step portion 324, and the external separation conduit and the internal separation conduit 40, 50 and the guide wire 60 inserted through the outlet port 36 is in communication with the inlet guide tube 31 Being in close contact with the outflow guide tube 33 formed in the joint member 30 is in communication with the balloon expansion fluid connection tube 18 to inflate the balloon introduced through the balloon expansion fluid connection pipe 18 Fluid F is directed to the outlet port 36 between the inner separation conduit 50 and the guide wire 60. That is, the balloon expansion fluid (F) is the expansion passage (P) formed between the inner passage (19) of the balloon expansion fluid connection pipe 18, and the inner separation conduit (50) and the guide wire (60). Through the outlet port 36 of the joint member 30.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is a fluid supply device (not shown) for the balloon expansion fluid connector 18 It may further include a balloon injecting hub 10 for inflating the balloon.
  • the balloon inflation hub 10 includes a body 12, a coupling part 13, and a handle part 14.
  • the handle portion 14 is formed in the shape of a wing on both sides of the body 12 is easy to grip and the coupling portion 13 is formed with a screw thread. Therefore, in the state where the user grasps both wings of the handle part 14 by hand, the fluid supply device (not shown) may be coupled to the coupling part 13 by screwing and detaching.
  • the balloon inflation fluid injection hub 10 Balloon inflation fluid (F) through the inlet (15) and the inner passage (19) of the balloon inflation fluid connector (18) coupled to the balloon inflation fluid injection hub (10) as described above The same flows into the joint member 30.
  • the following describes the filter device 100b of the second embodiment which is a modification of the filter device 100a of the first embodiment of the present invention as described above.
  • the same reference numerals are assigned to the same components as the above-described first embodiment, and the detailed description will be omitted.
  • the filter device 100b of the second embodiment of the present invention is in communication with the inflatable balloon 82 and the inflatable balloon 82, and the balloon for expanding the fluid (F) is the inflatable balloon (
  • the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention communicates with the inflatable balloon 82 and the inflatable balloon 82 and the fluid for inflating the balloon.
  • a film 20a of biocompatible material which is introduced into the patient's narrow blood vessels in a folded state prior to expansion of the inflatable balloon 82 and on its surface while securing a passage of narrow blood vessels upon expansion of the inflatable balloon 82.
  • the formed fine needle 250 is erected toward the vessel wall of the treatment site (T), thereby accurately and stably fixed to the vessel wall to carry the film (20a) to accurately and continuously deliver the drug (M) to the treatment site (T). Let it be the basic structure.
  • the balloon inflation fluid injecting hub 10 and the balloon inflation fluid connector 18 constituting the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention as shown in FIG. 9.
  • the balloon catheter 100b provided with the delivery film will be described.
  • FIG. 10 and FIG. 11 show a state in which the first type film 20b surrounding the inflatable balloon 82 is folded in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention.
  • the state in which the first type of film 20b is coupled to the inflatable balloon 82 in the folded state is shown.
  • the film 20b of the first form in the folded state extends corresponding to the length of the inflatable balloon 82 such that its cross section surrounds the inflatable balloon 82 in the form of a pinwheel or windmill. It is.
  • the first type film 20b in the folded state includes a first wing part 210, a second wing part 220, a third wing part 230, and a fourth wing part 240 in a clockwise direction.
  • the center is empty for insertion of the inflatable balloon 82.
  • the space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240 is relatively sufficient, and they meet each other at the base thereof to form a film of the first type. Form a folding line of the film resulting from the folded state (20b).
  • a plurality of fine needles 250 may be formed on the film 20b of the first shape, and the plurality of fine needles 250 may be formed on the surface of the film 20b of the first shape in the axial direction of the catheter. And formed at regular intervals, and may also be formed at regular intervals in the circumferential direction of the film 20b of the first form surrounding the inflatable balloon 82. For example, as shown in FIGS. 10 and 11, a folding line of the film 20b of the first form as described above, which occurs when the film 20b of the first form is folded. A plurality of fine needles 250 of the first shape in the space between the first wing 210, the second wing 220, the third wing 230 and the fourth wing 240 along the It is formed on the film 20b.
  • FIG. 12 and Figure 13 the second state of the film 20b surrounding the inflatable balloon 82 in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention is folded, The state in which the second type of film 20b is coupled to the inflatable balloon 82 in the folded state is shown.
  • the film 20b of the second form has a slight structural difference with respect to the film 20b of the first form, with a larger space in the center for the insertion of the inflatable balloon 82 compared to the film 20b of the first form.
  • the space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240 is narrower than that of the film 20b of the first type. have.
  • a plurality of fine needles 250 are formed on the surface of the film 20b of the second type at regular intervals in the axial direction of the catheter, and surround the inflatable balloon 82. It is formed also in the circumferential direction of the film 20b of a 2nd aspect at regular intervals. For example, as illustrated in FIGS. 12 and 13, a first line is formed along a folding line of the second type film 20b that is generated when the second type film 20b is folded. In the space between the wing portion 210, the second wing portion 220, the third wing portion 230, and the fourth wing portion 240, the plurality of fine needles 250 are formed of the second type film 20b.
  • the plurality of fine needles 250 are disposed in the space between the wing portions in such a manner as to be in close contact with or in contact with the bottom surface of the adjacent wing portion.
  • the volume of the first type film 20b and the second type film 20b must be minimized in a folded state to prevent friction with the blood vessel wall.
  • the fine needle 250 formed on the second type film 20b also does not damage the blood vessel wall unless exposed to the outside of the folded first type film 20b and the second type film 20b. Therefore, in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention, it is important to manufacture the folded film 20b so that the fine needle 250 is not exposed to the outside of the film 20b.
  • the film 20b of the first shape has a fine needle because there is enough space between the first wing portion 210, the second wing portion 220, the third wing portion 230, and the fourth wing portion 240. While there is an advantage of sufficient space for arranging 250 along the folding line, it is disadvantageous to introduce into narrow vessels due to the large diameter of the imaginary cylinder that connects the end of the wing (see FIG. 11 (b)).
  • the film 20b of the second form has a narrow space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240.
  • the space for arranging the needle 250 along the folding line is narrow, it is difficult to manufacture the film 20b by folding the film 20b so that the fine needle 250 formed on the film 20b is not exposed to the outside. Since the diameter of the imaginary cylinder is almost the same as that of the inflatable balloon 82, it is advantageous to introduce into narrow vessels (see FIG. 13 (b)).
  • 100b may introduce the film 20b into a narrow vessel in a folded state before the balloon is inflated, and the fine needle 250 formed along the folding line may not damage the vessel wall.
  • the fine needle 250 formed on the film 20b may be formed on the film by at least one surface treatment selected from the group consisting of corona surface treatment, high frequency surface treatment, plasma surface treatment, and laser surface treatment.
  • the surface treatment is preferably a hydrophilic surface treatment that can reduce the risk of blood clots even if the catheter 100b is introduced into a narrow vessel.
  • the present invention is not limited thereto, and various film processing and forming methods may be used.
  • any biocompatible material that can carry and release the necessary drug can be used.
  • a polymer of polyethyleneglycol (PEG) -PCLA poly (epsilon-caprolactone-co-D, L-lactide)) may be used.
  • biodegradable PLGA poly (lactic-co-glycolic acid)
  • PEG polyethyleneglycol
  • a polymer material to which the above-described materials are added at least one material selected from the group consisting of caprolactone, glycolide, lactide, paradioxanone and trimethylene carbonate, which shows long-term biodegradability, may be used. It can be used as a material of (see Korean Patent Nos. 10-0668046 and 10-0832552).
  • the drug (M) can be continuously and accurately released and delivered to the treatment area, as well as providing elasticity, biocompatibility, and biodegradability, causing secondary diseases such as re-epithelialization and inflammatory reaction. It also offers the advantages of For example, since the film 20a used in the first embodiment of the present invention uses a stretchable biocompatible material, the shape of the film 20a protrudes by the microprojection 88 when the balloon 82 is inflated as described above. As it is transformed into a treatment site (T) to move forward and fixed, thereby supporting the drug (M) is slowly and continuously released to the treatment site (T) can be delivered.
  • the film of the present invention is not limited to the film of the material as described above, it will be readily understood by those skilled in the art that various drugs may be supported on the film and used.
  • the fine needle 250 formed on the surface of the film 20b has a large diameter of the proximal end 252 located on the film 20b and the proximal end ( The farther away from the 252, the smaller the diameter, the tip 254, which is the end of the fine needle 250, is sharply formed and can be accurately and stably fixed to a tissue such as a blood vessel wall.
  • the fine needle 250 may be formed in a streamlined shape having a constant angle from the proximal end 252 to the tip 254.
  • the fine needle 250 when the fine needle 250 is formed to have a directionality, the fine needle 250 firmly fixes the film 20b to the blood vessel wall by blood flow, thereby reducing the risk of the film 20b falling off and the blood vessel wall.
  • the drug delivery can be facilitated by being in close contact with.
  • the fine needle 250 may be formed by extending the fish hook structure 256 downward from the tip 254 (see FIGS. 10, 12 and 15). In this case, once the fine needle 250 is fixed to the treatment site T, the fine needle 250 is not easily separated from the treatment site T by the fish hook structure 256.
  • the fine needle 250 may be more effectively and stably fixed to the blood vessel wall.
  • biored glutamate examples include fibrinogen, blood coagulant XIII factor with fibrinogen, cyanoacrylate, dermalin glue, marine bioadhesive, and various biocompatible agents known in the art may be used. to be.
  • the film 20b surrounding the inflatable balloon is expanded to take a substantially cylindrical shape.
  • 14 to 16 illustrate the microneedle 250 and the state in which the various shapes of the film 20b surrounding the inflatable balloon are unfolded by the expansion of the balloon.
  • the unfolded cylindrical film 20b may be composed of a flat portion 260 and a thick projecting portion 270.
  • the fine needle 250 may be formed on the protruding portion 270 having a thick thickness.
  • drugs supported on the films 20a and 20b of the present invention and delivered to the treatment site include thrombolytic agents, antiproliferative agents, immunosuppressants, anti-inflammatory agents, vaccines, hormones, insulin, gene therapy, protein therapeutic injections, or endothelial cells. It may be a promoter.
  • minute holes 262 may be formed in the film 20b.
  • the film 20b may be decomposed into fine pieces during drug delivery to prevent the formation of blood clots.
  • the balloon inflation fluid injection hub 10 of the balloon catheter 100a, 100b provided with the drug delivery films of the first and second embodiments of the present invention is coupled to a fluid supply device (not shown).
  • a fluid supply device not shown.
  • the surgeon uses the sealing cap 90 as a tip to make the balloon catheter 100a, 100b provided with the drug delivery film.
  • it is inserted into the body through blood vessels.
  • the guide wire 60 and the blood flow tube 70 inserted and installed inside the catheter 100a and 100b give rigidity to the catheter 100a and 100b to facilitate the insertion and advancement of the catheter 100a and 100b in the blood vessel. Let's do it.
  • the film 20b surrounding the inflatable balloon 82 of the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention is introduced into a narrow vessel in a folded state, which is formed in the film 20b.
  • the fine needle 250 is positioned in the axial direction of the catheter 100b in a state in which the film 20b is folded before the expandable balloon 82 is inflated so that the fine needle 250 is formed along the folding line. ) Does not damage the vessel wall.
  • the surgeon confirms that the front ends of the catheters 100a and 100b enter the treatment site T through an imaging device (not shown), and the balloon-inflating fluid F accommodated in the fluid supply device (not shown).
  • the inflatable balloon 82 expands and the space between the inflatable balloon 82 and the blood flow tube 70 Expands and thus expands inflatable balloon 82.
  • the surgeon passes the balloon-inflating fluid F, which is a contrast medium, to the sealing cap 90 from the balloon-inflating fluid injection hub 10 of the catheter 100a, 100b before the catheter 100a, 100b is inserted into the blood vessel.
  • the catheter (100a, 100b) of the insertion After only injecting enough to expand the expansion fluid (P) of the catheter (100a, 100b) is inserted into the body through the blood vessels, the catheter (100a, 100b) of the insertion, advancing and reaching the treatment site (T) imaging device (Not shown) can be more easily confirmed.
  • the drug is delivered.
  • Balloon inflation fluid through inflatable fluid path (P) and expansion fluid flow space (fS) from the balloon inflation fluid injection hub (10) of the balloon catheter (100a, 100b) provided with the film to the sealing cap (90)
  • the inflow of (F) is increased to inflate the inflatable balloon 82.
  • the space between the inflatable balloon 82 and the blood flow tube 70 is expanded and accordingly.
  • the inflatable balloon 82 is also expanded so that the space d between the inflatable balloon 82 and the film 20a is narrowed (d ⁇ d ') and the shape of the film 20a is deformed like the fine protrusions 88.
  • the film portion 20a and the microprojection 88 deformed into the shape of the microprojection are fixed to the treatment site T in the body, so that the drug M supported on the film 20a is eventually treated at the treatment site ( It is precisely and slowly and continuously released in T).
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is the inflatable balloon 82 while fixing the inflatable balloon 82 accurately to the desired treatment site T in the body through the micro-projection 88. ),
  • the film 20a surrounding the inflatable balloon 82 is deformed like the shape of the micro-projection 88 by the expansion of) and is fixed to the treatment site T to gradually sustain the drug M supported on the film 20a.
  • the degree of deformation (before ⁇ after) of the shape of the film 20a like the fine protrusions 88 is also adjusted, so that the film 20a and the fine protrusions 88 are adjusted.
  • the space between the inflatable balloon 82 and the blood flow tube 70 is expanded and thus expandable.
  • the balloon 82 is also expanded so that the inflatable balloon 82 secures a narrow passage of blood vessels. Then, when the inflatable balloon 82 expands, the film 20b surrounding the inflatable balloon 82 is unfolded and the fine needle 250 has a constant angle with respect to the axial direction of the catheter, and the blood vessel wall of the treatment site T is expanded.
  • the tip 254 of the fine needle 250 is inserted into the blood vessel wall while being accurately and stably fixed to the film 20b on the treatment site T, and the drug M supported on the film 20b is the treatment site. (T), for example, correctly and continuously delivered to tissues inside the vascular lining.
  • the fine needle 250 is formed.
  • the fine needle 250 is not easily pulled out of the treatment site T by the fish hook structure 256
  • the fine needle 252 is the tip 254 from the proximal end 252
  • the cylindrical film 20b is composed of a flat portion 260 and a thick protruding portion 270 and a fine needle 250.
  • the thin flat portion 260 in which the fine needle 250 is not formed in the drug release process is first biodegraded, and then the fine needle 250 fixed to the blood vessel wall is formed.

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Abstract

L'invention concerne un cathéter à ballonnet dans lequel un film de libération de médicament est prévu, un film en matière biocompatible pouvant supporter un médicament nécessaire et libérer en continu un médicament étant prévu sur la surface d'un ballonnet expansible d'un cathéter à ballonnet, ce qui permet la libération continue du médicament dans une zone de traitement. L'invention permet la fixation stable et précise d'un film en matière biocompatible pouvant supporter le médicament nécessaire et libérer en continu le médicament dans les parois d'un vaisseau d'une zone de traitement, et permet la libération précise et continue de médicament dans une zone à traiter, par exemple, le tissu à l'intérieur de la paroi interne d'un vaisseau sanguin. De plus, selon l'invention, il est possible de libérer séquentiellement ou continuellement divers médicaments tout en réduisant le risque de thrombose, en conférant la biodégradabilité, la biocompatibilité et l'élasticité à un film capable de supporter le médicament nécessaire et de libérer continuellement le médicament, sans induire de maladies secondaires telles que la génération de thrombus, la ré-épithélialisation, la réponse inflammatoire et similaire.
PCT/KR2011/006163 2010-08-25 2011-08-20 Cathéter à ballonnet doté d'un film de libération de médicament WO2012026717A2 (fr)

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KR10-2010-0082688 2010-08-25
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KR1020110049923A KR101230657B1 (ko) 2010-08-25 2011-05-26 약물 전달용 필름이 제공된 풍선 카테터

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CN114748728A (zh) * 2021-01-08 2022-07-15 苏州林华医疗器械股份有限公司 持续正压静脉留置针

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JP2000517213A (ja) * 1996-08-30 2000-12-26 デルカス システムズ，インコーポレイテッド 閉塞部分バイパスを備えたバルーンカテーテル
US20030097116A1 (en) * 2001-11-16 2003-05-22 Putz David A. Drug delivery catheter assembly with inflatable balloon
KR20060048258A (ko) * 2004-06-08 2006-05-18 코디스 코포레이션 미세 돌출부를 사용하는 약물 전달 장치
US20090227949A1 (en) * 2008-03-06 2009-09-10 Boston Scientific Scimed, Inc. Balloon catheter devices with folded balloons

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Publication number Priority date Publication date Assignee Title
JPH0663145A (ja) * 1992-08-19 1994-03-08 Buaayu:Kk 血管内投薬用バルーンカテーテル
JP2000517213A (ja) * 1996-08-30 2000-12-26 デルカス システムズ，インコーポレイテッド 閉塞部分バイパスを備えたバルーンカテーテル
US20030097116A1 (en) * 2001-11-16 2003-05-22 Putz David A. Drug delivery catheter assembly with inflatable balloon
KR20060048258A (ko) * 2004-06-08 2006-05-18 코디스 코포레이션 미세 돌출부를 사용하는 약물 전달 장치
US20090227949A1 (en) * 2008-03-06 2009-09-10 Boston Scientific Scimed, Inc. Balloon catheter devices with folded balloons

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114748728A (zh) * 2021-01-08 2022-07-15 苏州林华医疗器械股份有限公司 持续正压静脉留置针

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