WO2020038024A1 - Cathéter à ballonnet revêtu d'un médicament anti-flexion - Google Patents

Cathéter à ballonnet revêtu d'un médicament anti-flexion Download PDF

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Publication number
WO2020038024A1
WO2020038024A1 PCT/CN2019/086659 CN2019086659W WO2020038024A1 WO 2020038024 A1 WO2020038024 A1 WO 2020038024A1 CN 2019086659 W CN2019086659 W CN 2019086659W WO 2020038024 A1 WO2020038024 A1 WO 2020038024A1
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WO
WIPO (PCT)
Prior art keywords
drug
coated balloon
sheath
bend
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2019/086659
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English (en)
Chinese (zh)
Inventor
张庭超
丘信炯
王泽涛
李敬
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Endonom Medtech Co Ltd
Original Assignee
Hangzhou Endonom Medtech Co Ltd
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 CN201810978143.8A external-priority patent/CN109793976A/zh
Priority claimed from CN201821380087.XU external-priority patent/CN209611965U/zh
Application filed by Hangzhou Endonom Medtech Co Ltd filed Critical Hangzhou Endonom Medtech Co Ltd
Publication of WO2020038024A1 publication Critical patent/WO2020038024A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material

Definitions

  • the invention relates to the technical field of medical instruments, in particular to an anti-bend drug-coated balloon catheter.
  • the present invention provides a drug-coated balloon catheter with a low dose loss rate and avoiding bending of the push catheter.
  • An embodiment of the present invention provides an anti-bend drug-coated balloon catheter, including a push catheter and a drug-coated balloon fixed to a distal end of the push catheter.
  • the drug-coated balloon catheter further includes a sheath and a sliding mechanism connected to the proximal end of the sheath.
  • the sliding mechanism includes a support member sleeved outside the push catheter and connected to the sheath and A sliding member between the supporting members, the sliding member sliding along the axial direction of the pushing catheter through the supporting member, so that the drug-coated balloon is contained in the sheath or exposed to the Out of the sheath.
  • the support is a hollow cylindrical structure, and the support is sleeved on the proximal end of the pushing catheter.
  • the supporting member is made of a hard material, and the hard material is selected from at least one of stainless steel, polyvinyl chloride or polyformaldehyde.
  • the sheath, the sliding member and the supporting member are arranged coaxially.
  • the distal end of the slider is fixedly connected to the sheath
  • the proximal end of the slider is slidingly connected to the support
  • the drug-coated balloon is housed in the sheath before expansion.
  • the sliding member moves relative to the support toward the proximal end of the pushing catheter, the drug-coated balloon is exposed outside the sheath.
  • the distal end of the support is sleeved inside the sheath when the drug-coated balloon is exposed outside the sheath.
  • the outer diameter of the supporting member is smaller than the inner diameter of the sheath, and the inner diameter of the supporting member is larger than the outer diameter of the pushing catheter.
  • the distal end of the slider is fixedly connected to the sheath, and the proximal end of the slider is fixedly connected to the support.
  • the support member is a telescopic structure, and has an extended state in an initial state and a compressed state when an axial force is applied.
  • the support member is in an extended state, the drug-coated balloon is accommodated in the support member.
  • the support member is in a compressed state, the drug-coated balloon is exposed outside the sheath.
  • the supporting member is a bellows.
  • the support member is a plurality of sleeves sleeved with each other, and each of the sleeves is layered together when the drug-coated balloon is exposed outside the sheath.
  • a diameter of each of the sleeves gradually increases from a proximal end of the support member to a distal end of the support member.
  • a stopper is provided at the proximal end of each sleeve, and the stopper extends toward the central axis of the sleeve, and the stopper of each sleeve is slidably sleeved adjacent to the corresponding one of the sleeves. Outside the sleeve of the stop.
  • a distal end of each of the sleeves provided separately from the sliding member is provided with a damping member, and the damping member and the stopper block each other to limit a length of relative extension of two adjacent sleeves.
  • the damping member has a ring shape, and the damping member is sleeved outside the corresponding sleeve.
  • the diameter difference between any two adjacent sleeves ranges from 0.4 mm to 1.2 mm.
  • several of the sleeves include a first sleeve and a second sleeve slidingly sleeved outside the first sleeve, the first sleeve is fixed to the sliding member, and the second sleeve It is fixed to the pushing catheter.
  • the plurality of sleeves further include a plurality of third sleeves sandwiched between the first sleeve and the second sleeve.
  • the pushing catheter is fixed to the catheter seat.
  • the pushing catheter is fixed to the catheter seat through the second sleeve.
  • the distal end of the sheath is provided with a contraction cover, and the distal end of the contraction cover gradually gathers and receives the distal end of the pushing catheter.
  • the shrink cover is provided with at least one expansion joint in the axial direction.
  • the minimum diameter of the contraction cover is smaller than the maximum diameter of the drug-coated balloon before expansion.
  • the anti-bend drug-coated balloon catheter provided by the embodiment of the present invention is provided with a sheath and a sliding mechanism, so that the drug-coated balloon is accommodated in the sheath before sliding, and slides
  • the sliding of the mechanism can drive the sheath to retreat near the proximal end of the push catheter, so that the drug coating is released to the diseased part of the blood vessel. Therefore, the design of the sheath not only protects the drug coating on the surface of the balloon body, but also reduces the drug loss rate of the drug-coated balloon catheter during delivery.
  • the supporting member of the sliding mechanism is sleeved on the pushing catheter, when the sliding member slides the support toward the proximal end of the pushing catheter to drive the sheath back, the impact of the movement of the sliding member on the pushing catheter can be prevented, which can be avoided
  • the pushing catheter is bent, and the smoothness of the retracting of the sheath is increased.
  • FIG. 1 is a schematic structural diagram of a bend-resistant drug-coated balloon catheter according to a first embodiment of the present invention.
  • FIG. 2 is a partial cross-sectional structure diagram of the anti-bend drug-coated balloon catheter in FIG. 1.
  • FIG. 3 is a cross-sectional view of the anti-bend drug-coated balloon catheter of FIG. 1, taken along line III-III.
  • FIG. 4 is a cross-sectional view of another embodiment of the push catheter of the anti-bend drug-coated balloon catheter of FIG. 3.
  • FIG. 5 is a schematic structural view of the shrinkage cover of the sheath of the anti-bend drug-coated balloon catheter in FIG. 1 in a closed state.
  • FIG. 6 is a schematic structural view of the shrinkage cover of the sheath of the anti-bend drug-coated balloon catheter in FIG. 1 in an opened state;
  • FIG. 7 to 9 are schematic views of the use state of the anti-bend drug-coated balloon catheter in FIG. 1; wherein, FIG. 7 is a schematic diagram of the drug-coated balloon catheter reaching the blood vessel at the lesion site; and FIG. 8 is the withdrawal of the sheath A schematic diagram of a drug-coated balloon exposed to a blood vessel; FIG. 9 is a schematic diagram of a drug-coated balloon expansion.
  • FIG. 10 is a schematic diagram of a part of a structure of a drug-coated balloon catheter provided by a second embodiment of the present invention.
  • FIG. 11 is a schematic structural diagram of a portion of a bend-resistant drug-coated balloon catheter according to a third embodiment of the present invention.
  • FIG. 12 is a partial cross-sectional structure diagram of the support of the anti-bend drug-coated balloon catheter in FIG. 11.
  • the end of the instrument near the operator is usually called the proximal end (that is, the operation end), and the end of the instrument remote from the operator is called the distal end (that is, the insertion end).
  • the distal end refers to an end where the instrument can be freely inserted into an animal or a human body.
  • the near end is the end for user or machine operation or the end for connecting other devices.
  • first, second, etc. does not refer to any order or importance, but uses the terms first, second, etc. to distinguish one element from another.
  • FIG. 1 shows a drug-coated balloon catheter 100 provided by an embodiment of the present invention.
  • the drug-coated balloon catheter 100 includes a catheter seat 10, a push catheter 20, a drug-coated balloon 30, a sheath 40, and a sliding mechanism 50.
  • the pushing catheter 20 has opposite proximal and distal ends. The proximal end of the push catheter 20 is fixed to the catheter hub 10.
  • the drug-coated balloon 30 is fixed to the distal end of the push catheter 20.
  • the sheath 40 is sleeved outside the drug-coated balloon 30 and is connected to the sliding mechanism 50.
  • the sliding mechanism 50 includes a supporting member 51 sleeved outside the pushing catheter 20 and a sliding member 52 connected between the sheath 40 and the supporting member 51. The sliding member 52 slides along the axial direction of the pushing catheter 20 through the supporting member 51, so that the drug-coated balloon 30 is contained in the sheath 40 or exposed outside the sheath 40.
  • the sheath 40, the support member 51, and the slider 52 are disposed coaxially.
  • the support member 51 has a hollow cylindrical structure.
  • the support member 51 is sleeved on the proximal end of the pushing catheter 20.
  • the distal end of the support member 51 (that is, the end adjacent to the sheath 40) is fixed to the proximal end of the slider 52, and the proximal end of the support member 51 (that is, the end away from the sheath 40) is fixed to the catheter seat 10 or the pushing catheter 20. .
  • the distal end of the slider 52 is fixed to the proximal end of the sheath 40, and the proximal end of the slider 52 is slidingly connected to the distal end of the support member 51.
  • the drug-coated balloon 30 is contained in the sheath 40 before expansion. When the slider 52 moves relative to the support 51 toward the proximal end of the push catheter 20, the drug-coated balloon 30 is exposed outside the sheath 40.
  • the sliding member 52 is operated to drive the sheath 40 to slide along the axial direction of the pushing catheter 20 so as to realize the delivery of the drug loaded by the drug-coated balloon 30 to the diseased site, that is, the movement of the sheath 40 can extend the drug-coated balloon 30
  • the sheath 40 is taken out and exposed to a diseased part, such as a narrow blood vessel, thereby reducing the amount of medicine lost due to the scouring of the drug coating 32 by blood flow during the delivery process, and improving the drug utilization rate.
  • the supporting member 51 is a rigid supporting member.
  • the support 51 is made of a hard material.
  • the hard material is selected from at least one of stainless steel, polyvinyl chloride, or polyformaldehyde, and other materials with harder materials are also suitable for the present invention.
  • the outer diameter of the support member 51 is smaller than the inner diameter of the sheath 40, and the inner diameter of the support member 51 is larger than the outer diameter of the pushing catheter 20.
  • the proximal end of the sheath 40 is sleeved on the distal end of the support 51, that is, the distal end of the support 51 is exposed on the drug-coated balloon 30 on the sheath 40.
  • the outer sleeve is sleeved inside the sheath 40.
  • the distance between the slider 52 and the catheter hub 10 when the drug-coated balloon 30 is exposed outside the sheath 40 is smaller than the distance between the slider 52 and the catheter hub 10 when the drug-coated balloon 30 is accommodated in the sheath 40. . In this way, the distance between the slider 52 and the catheter holder 10 can be adjusted to improve the permeability of the drug-coated balloon catheter 100 in a curved human blood vessel, and the sheath 40 can slide smoothly relative to the pushing catheter 20.
  • the catheter holder 10 is disposed at the proximal end of the pushing catheter 20.
  • the catheter holder 10 may be directly fixed to the pushing catheter 20 or fixed to the pushing catheter 20 through the support 51.
  • the catheter hub 10 is provided with a guide wire port 11 and a filling port 13. It can be understood that the user may set one or more guide wire ports 11 and filling ports 13 on the catheter base 10 according to the actual state of the diseased tissue and the time required for filling.
  • the pushing catheter 20 passes through both ends of the drug-coated balloon 30 in the axial direction, and is sealingly connected with the drug-coated balloon 30.
  • the push catheter 20 includes a first portion 21 housed inside the drug-coated balloon 30 and a second portion 22 exposed outside the drug-coated balloon 30.
  • the first portion 21 of the pushing catheter 20 is provided with a balloon filling port 211 that communicates with the drug-coated balloon 30.
  • a guide wire cavity 201 and a filling cavity 202 are disposed along the axial direction inside the pushing catheter 20.
  • the guide wire cavity 201 is isolated from the filling cavity 202 and is arranged side by side.
  • the guide wire port 11 communicates with the guide wire cavity 201 so that the guide wire passes through the guide wire port 11 and passes through the guide wire cavity 201.
  • the guidewire lumen 201 extends axially through the distal and proximal ends of the push catheter 20.
  • the filling cavity 202 communicates with the filling port 13 and the balloon filling port 211.
  • the filling port 13, the filling cavity 202, and the balloon filling port 211 form a channel for filling or releasing the pressure of the drug-coated balloon 30, so as to realize the passage or extraction of liquid into the drug-coated balloon 30 for drug coating.
  • the layer balloon 30 is filled or decompressed.
  • the filling port 13 can be connected to an external pressure pump, and the liquid enters or flows out of the drug-coated balloon 30 through the filling port 13, the filling cavity 202, and the balloon filling port 211, so as to achieve the filling expansion of the drug-coated balloon 30. Or relieve pressure.
  • the user may set one or more guide wire cavities 201 and filling cavities 202 inside the push catheter 20 according to the actual state of the diseased tissue and the time required for filling.
  • the pushing catheter 20 a is a hollow cylindrical structure.
  • the pushing catheter 20 a includes an outer tube 203 and an inner tube 204 sleeved inside the outer tube 203.
  • the lumen of the inner tube 204 serves as a guide wire cavity 201a
  • the space formed between the inner tube 204 and the outer tube 203 serves as a filling cavity 202a.
  • the push catheter 20 may be sleeved with multiple tubes to form corresponding guide wire cavities 201 and filling cavities 202.
  • the first portion 21 of the pushing catheter 20 is further provided with a developing positioning device 23.
  • the development positioning device 23 is made of a radiopaque material.
  • the radiopaque material is preferably a noble metal material such as platinum or tantalum.
  • the developing and positioning device 23 may adopt various forms such as a ring shape, a filament shape, a belt shape, or a dot shape, and is fixed to the pushing catheter 20 by a technical method commonly used in the art such as crimping, hot melting, bonding, welding, or riveting. .
  • two development positioning devices 23 are provided at positions of the first portion 21 of the push catheter 20 corresponding to the two ends of the drug-coated balloon 30 to accurately position the position of the drug-coated balloon 30.
  • a distal end of the push catheter 20 is fixedly provided with a drug-coated balloon 30.
  • the fixing manner of the drug-coated balloon 30 may be welding, bonding, or fixing by a fixing member, and other common technical means in the art, which are not repeated here.
  • the drug-coated balloon 30 includes a balloon body 31 and a drug coating 32 covering an outer surface of the balloon body 31.
  • the balloon body 31 is an expandable balloon. Specifically, in this embodiment, the balloon body 31 can be selectively filled or discharged, so that the adherence of the drug-coated balloon 30 can be improved.
  • the drug coating 32 covers the entire outer surface of the balloon body 31. In another embodiment, the drug coating 32 may cover a part of the outer surface of the balloon body 31. It can be understood that, in other embodiments, the number of the drug-coated balloons 30 may also be multiple, so as to expand multiple lesions at the same time. For example, multiple drug-coated balloons 30 are fixedly disposed at the distal ends of the same push catheter 20, respectively, and the axial distance between two adjacent drug-coated balloons 30 may be zero, or according to the lesion site. Set at intervals. The shapes and diameters of the plurality of drug-coated balloons 30 may be the same or different.
  • the setting of multiple drug-coated balloons 30 can not only be processed for different lesions at the same time, but also after one of the drug-coated balloons 30 is filled, the drug-coated balloons 30 can also have the ability to block blood.
  • the effect of flow prevents the drug coating 32 on the surface of another drug-coated balloon 30 from being washed away by blood flow.
  • the first-filled balloon body 31 may not be provided with a drug coating layer 32 to reduce the cost of the device.
  • the active drug coating 32 contains an active drug that inhibits the proliferation of smooth muscle cells.
  • the drug coating 32 further includes a carrier.
  • the carrier can be used to promote the rapid release of the active drug from the outer surface of the balloon body 31 or to promote the absorption of diseased tissue.
  • the carrier is, for example, but is not limited to an organic acid salt or a polyhydric alcohol. In this embodiment, mannitol is used as the carrier.
  • the active drug is a drug (for example, paclitaxel, rapamycin, etc.) that has the effect of inhibiting the proliferation of smooth muscle cells, and paclitaxel is used in this embodiment.
  • the active drug coating 32 is mainly formed on the balloon body 31 by a coating method, and the coating method is an existing conventional coating technology, and details are not described herein again.
  • the cylindrical working section 311 of the drug-coated balloon 30 can ensure that the filled drug-coated balloon 30 has good adherence and can effectively transfer the active drug to the inner wall of the blood vessel at the lesion site.
  • the drug-coated balloon 30 is folded into a wing, and is contained in a sheath 40.
  • the drug-coated balloon 30 is substantially oval.
  • the balloon body 31 of the drug-coated balloon 30 includes a working section 311 and two connecting sections 312.
  • the connecting sections 312 are respectively disposed at opposite ends of the working section 311.
  • the working section 311 of the drug-coated balloon 30 is disposed in the middle of the drug-coated balloon 30.
  • the working section 311 is substantially cylindrical, so that after the drug-coated balloon 30 is expanded, the working section 311 can be fitted to the blood vessel at the diseased part.
  • the length of the drug-coated balloon 30 ranges from 30 to 320 mm.
  • the length of the working section 311 (ie, the effective length of the drug-coated balloon 30) ranges from 20-300 mm.
  • the effective length refers to the length that can be attached to the inner wall of a blood vessel after the balloon is expanded.
  • the diameter of the working section 311 is 2-15mm.
  • the size and diameter of the drug-coated balloon 30 can be selected according to the diameter of the blood vessel at the lesion site that needs to be expanded.
  • the two connecting sections 312 of the drug-coated balloon 30 are substantially tapered.
  • the two connecting segments 312 of the drug-coated balloon 30 are fixedly connected to opposite sides of the first portion 21 of the pushing catheter 20, respectively.
  • the drug coating 32 may be disposed at a position of the balloon body 31 corresponding to the working section 311.
  • the sheath 40 is movably sleeved outside the pushing catheter 20 and accommodates the drug-coated balloon 30 to coat the drug-coated 32 on the outer surface of the drug-coated balloon 30. Protect it.
  • the sheath 40 is movable in the axial direction of the pushing catheter 20.
  • the drug-coated balloon 30 is housed in a sheath 40 before expansion.
  • the sheath 40 is preferably a tubular structure, and can be sheathed on the outside of the drug-coated balloon 30 after being folded and rolled.
  • the inner diameter of the sheath 40 is 0 to 0.10 mm larger than the maximum outer diameter of the drug-coated balloon 30 after the flaps are expanded and rolled.
  • the sheath 40 is made of a biocompatible material.
  • the biocompatible material is, for example, but not limited to a material having a low coefficient of friction such as e-PTFE, PTFE, FEP, or PET.
  • the biocompatible material may also be, but is not limited to, highly elastic materials such as silica gel, polyurethane, and polyetheramide.
  • the sheath 40 is made of a material with a low coefficient of friction.
  • the sheath 40 is provided with a contraction cover 41 near the distal end of the pushing catheter 20.
  • the shrink cover 41 has a substantially circular truncated cone shape. The diameter of the contraction cover 41 gradually decreases toward the distal end of the push catheter 20, that is, the contraction cover 41 gradually gathers toward the distal end and accommodates the distal end of the push catheter 20.
  • the contraction cover 41 may cover or be connected to the distal end portion of the sheath 40.
  • the shrink cover 41 is provided with at least one expansion joint 411 in the axial direction. When the expansion slit 411 is opened, the drug-coated balloon 30 extends from the distal end side of the sheath 40 and is exposed to the outside of the sheath 40.
  • the minimum diameter of the contraction cover 41 is smaller than the maximum diameter of the drug-coated balloon 30 and larger than the diameter of the distal end of the push catheter 20 Therefore, the drug-coated balloon 30 cannot extend the contraction cover 41 before expansion, and the distal end of the pushing catheter 20 can penetrate the distal end of the contraction cover 41.
  • the expansion joint 411 is a tearable structure. That is, the expansion slit 411 of the shrinkage cover 41 does not penetrate the outer side wall of the shrinkage cover 41.
  • the contraction cover 41 before the drug-coated balloon 30 is not expanded, the contraction cover 41 is provided with a plurality of openings 412 arranged at intervals along the axial direction (as shown in FIG. 1). A plurality of openings 412 are linearly arranged to form an expansion joint 411.
  • the contraction cover 41 has opposite distal and proximal ends, and the distal end of the contraction cover 41 is at least partially connected at the position of the expansion slit 411 before the drug-coated balloon 30 is expanded.
  • the sheath 40 can protect the drug coating 32 on the outer surface of the drug-coated balloon 30, and reduce the amount of drug loss caused by the blood in the blood vessel.
  • the sheath 40 is retracted (that is, the sheath 40 slides toward the proximal end of the push catheter 20), and the expansion joint 411 of the contraction cover 41 is covered by the drug-coated balloon 30.
  • the diameter of the distal opening of the shrinking cover 41 increases, so that the drug-coated balloon 30 received in the sheath 40 can protrude from the distal end of the sheath 40 and the distal end of the shrinking cover 41 and be exposed.
  • the drug-coated balloon 30 is then filled and expanded, and the drug-coated 32 is released from the outer surface of the balloon body 31 and transferred to the inner wall of the blood vessel of the diseased site.
  • the shrinking cover 41 of the sheath 40 is torn, and the proximal end of the sheath 40 (that is, the end facing away from the shrinking cover 41) is gradually sheathed.
  • the length of the entire drug-coated balloon catheter 100 can be further reduced, thereby improving the permeability of the drug-coated balloon catheter 100 in a curved human blood vessel.
  • the material of the shrinkage cover 41 and the material of the sheath 40 may be the same or different. In order to simplify the production process, it is preferable to use the same material for integral molding.
  • FIG. 7 to FIG. 9 show the process of treating the diseased part 2 of the blood vessel 1 by using the drug-coated balloon catheter 100 provided by the first embodiment of the present invention.
  • the distal end portion of the drug-coated balloon catheter 100 is first delivered to the vicinity of the diseased part 2 of the blood vessel 1, and the drug-coated balloon 30 is aligned with the diseased part.
  • the sheath 40 retracts toward the proximal end of the pushing catheter 20, that is, the sheath 40 slides toward the proximal end of the pushing catheter 20 until the drug-coated balloon 30 is exposed outside the sheath 40.
  • the drug-coated balloon 30 is exposed to the lesion 2 of the blood vessel 1.
  • the drug-coated balloon 30 is filled. After the drug-coated balloon 30 is filled, the blood vessel 1 of the lesion 2 is fully expanded. The drug-coated balloon 32 is released from the surface of the drug-coated balloon 30 and transferred to The blood vessel wall exerts its effect. After that, the drug-coated balloon 30 can be decompressed, withdrawn from the patient's body, and the operation can be completed.
  • the drug-coated balloon catheter provided in this embodiment is provided with a sheath and a sliding mechanism to accommodate the drug-coated balloon in the sheath before being expanded, and the sliding of the sliding mechanism can drive the sheath to push the catheter closer to the catheter.
  • the proximal end of the is retracted so that the drug coating is released at the diseased site of the blood vessel. Therefore, the design of the sheath not only protects the drug coating on the surface of the balloon body, but also reduces the drug loss rate of the drug-coated balloon catheter during delivery. Further, the drug-coated balloon catheter provided in this embodiment can reduce the total drug load and is safer to use.
  • a support is provided at the proximal end of the sheath, and the support is sheathed outside the pushing catheter.
  • the shape of the catheter can avoid the bending of the soft pushing catheter to ensure the smoothness of the sheath retracting, and does not increase and thicken the overall outer diameter of the drug-coated balloon catheter.
  • FIG. 10 it is a drug-resistant balloon-coated balloon catheter provided by a second embodiment of the present invention.
  • the structure of the drug-coated balloon catheter 200 is similar to that of the drug-coated balloon catheter 100 of the first embodiment. Therefore, the size, name, The positional relationship of each component and the like can be referred to the drug-coated balloon catheter 100, and details are not described herein again.
  • the difference is that the support member 51a of the sliding mechanism 50a is a telescopic structure, and has an extended state in an initial state and a compressed state when an axial force is applied, and the slider 52a is fixedly connected to the support member 51a.
  • the support 51a is a bellows structure. An end of the support member 51 a adjacent to the sheath 40 is fixed on the sliding member 52 a, and an end of the support member 51 a away from the sheath 40 is fixed on the pushing catheter 20 or the catheter holder 10.
  • the axial length of the support member 51a when the drug-coated balloon 30 is exposed outside the sheath 40 is smaller than the axial length of the support member 51a when the drug-coated balloon 30 is accommodated in the sheath 40, that is, the slider 52a is in the drug
  • the distance between the coated balloon 30 and the catheter hub 10 when exposed outside the sheath 40 is smaller than the distance between the slider 52a and the catheter hub 10 when the drug coated balloon 30 is received in the sheath 40.
  • the support member 51a when the drug-coated balloon 30 is contained in the sheath 40, the support member 51a is in an extended state in the initial state; when the drug-coated balloon 30 is exposed outside the sheath 40, the support member 51a is on the shaft The state of compression when stressed. That is, when the sliding member 52a drives the sheath 40 to withdraw toward the proximal end of the pushing catheter 20, the supporting member 51a receives an axial external force, so that the axial length of the supporting member 51a is reduced, that is, the supporting member 51a is protecting the protective member 51a. When the sleeve 40 slides toward the proximal end of the pushing catheter 20, compression deformation occurs, so that the drug-coated balloon 30 is exposed outside the sheath 40.
  • the axial length of the support 51a of the drug-coated balloon catheter 200 can be adjusted to improve the permeability of the drug-coated balloon catheter 200 in a curved human blood vessel, and the sheath 40 can be relatively smooth with respect to the pushing catheter 20 slide.
  • the drug-coated balloon catheter provided in this embodiment is provided with a sheath and a sliding mechanism to accommodate the drug-coated balloon in the sheath before being expanded, and the sliding of the sliding mechanism can drive the sheath to push the catheter closer to the catheter.
  • the proximal end of the is retracted so that the drug coating is released at the diseased site of the blood vessel. Therefore, the design of the sheath not only protects the drug coating on the surface of the balloon body, but also reduces the drug loss rate of the drug-coated balloon catheter during delivery.
  • the support member is a retractable bellows structure
  • the sliding member drives the sheath to retract toward the proximal end of the pushing catheter
  • the supporting member is compressed without affecting the shape of the pushing catheter, thereby avoiding the soft
  • the pushing catheter is bent to ensure the smoothness of the sheath retracting, and does not increase and thicken the overall outer diameter of the drug-coated balloon catheter.
  • the structure of the drug-coated balloon catheter 300 is similar to that of the drug-coated balloon catheter 100 of the second embodiment. Therefore, the size, name, The positional relationship of each component and the like can be referred to the drug-coated balloon catheter 200, and details are not described herein again.
  • the support member 51b includes a plurality of sleeves 510b sleeved with each other, and each sleeve 510b is layered together when the drug-coated balloon 30 is exposed outside the sheath 40.
  • the multiple sleeves 510b are nested with each other, and the sheath 40 is axially relative to the push catheter 20
  • the proximal end of the push catheter 20 is moved to expose the drug-coated balloon 30 to the environment of the blood vessel. In this way, the operator can drive the axial relative movement between the sheath 40 and the pushing catheter 20 by controlling the axial sliding of the slider 52b.
  • FIG. 12 is a partial cross-sectional structural diagram of the support member 51b of the anti-bend drug-coated balloon catheter 300.
  • the supporting member 51b is a telescopic structure formed by at least two sleeves 510b.
  • Each sleeve 510b is a hollow cylindrical structure.
  • the pushing catheter 20 passes through the opposite ends of each of the sleeves 510b in order.
  • the proximal end of each cannula 510b i.e., the end remote from the slider 52b
  • the stopper 5101b extends along the center axis of the sleeve 510b.
  • the inner diameter of the stopper 5101b of each sleeve 510b is equal to or slightly larger than the outer diameter of the sleeve 510b adjacent to the stopper 5101b, so that the stopper 5101b of each sleeve 510b is slidably sleeved adjacent to the stopper 5101b.
  • Each sleeve 510b is provided with a smoothly rounded corner or chamfer 5102b at the stop 5101b to increase the smoothness when multiple sleeves 510b are nested together.
  • each sleeve 510b provided separately from the sliding member 52b is provided with a damping member 5103b.
  • the damping member 5103b and the stopper 5101b stop each other to restrict the relative extension of two adjacent sleeves 510b. length.
  • the damping member 5103b is sleeved on the distal end of the sleeve 510b.
  • the damper 5103b is a ring-shaped washer. It can be understood that, in other embodiments, the damping member 5103b may also be a stopper (not shown) provided on the distal end of the sleeve 510b.
  • the damping member 5103b is made of a rigid material, such as a steel plate. In this way, by using the damping member 5103b, it is possible to ensure that each of the sleeves 510b is in a straight state during assembly, so as to facilitate the assembly of the sleeves 510b.
  • the distal end of the support member 51b is fixed to the proximal end of the slider 52b, and the proximal end of the support member 51b is fixed to the pushing catheter 20 or the catheter base 10.
  • the diameter of the support member 51b gradually increases from the proximal end of the support member 51b to the distal end of the support member 51b.
  • the proximal end of the support 51b can be fixed to the distal end of the push catheter 20.
  • the diameter of the support member 51b gradually decreases from the proximal end of the support member 51b to the distal end of the support member 51b. In this way, the proximal end of the support member 51b can be fixed to the catheter holder 10.
  • the diameter difference between any two adjacent sleeves 510b ranges from about 0.4 mm to 1.2 mm.
  • the plurality of sleeves 510b includes a first sleeve 511b and a second sleeve 512b slidably sleeved on the first sleeve 511b.
  • the first sleeve 511b is fixed to the sliding member 52b
  • the second sleeve 512b is fixed to the pushing catheter 20 or the catheter holder 10.
  • the first sleeve 511b is the sleeve 510b closest to the slider 52b
  • the second sleeve 512b is the sleeve 510b closest to the catheter seat 10.
  • the first sleeve 511b and the second sleeve 512b are fixedly connected, for example, but are not limited to methods such as welding, bonding, and connection through a connector.
  • the plurality of sleeves 510b further includes a plurality of third sleeves 513b sandwiched between the first sleeve 511b and the second sleeve 512b. It can be understood that the third sleeve 513b can be omitted, and the number of the third sleeve 513b can be designed according to the actual sliding distance of the actual sliding member 52b.
  • the pushing catheter 20 is directly fixed to the catheter holder 10.
  • the push catheter 20 is fixed to the catheter hub 10 through a second sleeve 512b.
  • the outer diameter of the pushing catheter 20 is equal to the inner diameter of the second sleeve 512b.
  • the supporting member 51b is a telescopic structure formed by four sleeves 510b.
  • the four sleeves 510b include a first sleeve 511b, a second sleeve 512b, and two third sleeves 513b which are sleeved with each other, and a first sleeve 511b, two third sleeves 513b, and a second sleeve 512b are sequentially arranged in a direction away from the distal end of the push catheter 20.
  • the diameter difference between the first sleeve 511b and its adjacent third sleeve 513b is about 1mm
  • the diameter difference between the two adjacent third sleeves 513b is about 0.8mm
  • the third sleeve 513b is adjacent to it
  • the diameter difference between the second sleeves 512b is about 0.6 mm.
  • the diameters of the four cannulas 510b gradually decrease until the inner diameter of the second cannula 512b closest to the proximal end of the push catheter 20 is approximately the same as the outer diameter of the push catheter 20 to ensure that the drug coating is not increased and thickened.
  • the overall outer diameter of the layered balloon catheter is increased, thereby improving the permeability of the drug-coated balloon catheter 300 in a curved human blood vessel.
  • the sheath 40 when the drug-coated balloon catheter 300 is in an initial state, the sheath 40 is sleeved outside the drug-coated balloon 30, and the first sleeve 511b, the second sleeve 512b, and two third sleeves 513b are connected in sequence, and the damping member 5103b and the stopping portion 5101b stop each other to limit the length of the two adjacent sleeves 510b that are relatively extended.
  • the operator operates the slider 52b to retreat toward the proximal end of the pushing catheter 20, and drives the first sleeve 511b directly connected to the slider 52b to retreat proximally.
  • the stop 5101b of the sleeve 511b reaches the proximal end of the third sleeve 513b adjacent thereto, and the stop 5101b of one third sleeve 513b reaches the proximal end of the third sleeve 513b adjacent thereto, and wherein The stop 5101b of the other third sleeve 513b reaches the proximal end of the second sleeve 512b adjacent to the third sleeve 513b, that is, each sleeve 510b slides toward an end away from the damping member 5103b adjacent to it, so that each sleeve 510b is stacked one after another, at this time, the drug-coated balloon 30 is exposed outside the sheath 40 and is exposed to the blood.
  • each sleeve 510b is substantially the same as the outside diameter of the adjacent sleeve 510b, it can not only continue to retract and finally realize the stacking between multiple sleeves 510b, but also avoid When the sleeves 510b are stacked between each other or are too fast, the sheath 40 retracts quickly and uniformly, and the drug-coated balloon 30 is exposed to the blood quickly and uniformly, avoiding the sheath 40 and the drug coating 32.
  • the anti-bend drug-coated balloon catheter provided in this embodiment is provided with a sheath and a sliding mechanism to accommodate the drug-coated balloon in the sheath before being expanded, and the sliding of the sliding mechanism can drive the sheath Withdraw towards the proximal end near the push catheter to release the drug coating on the diseased site of the blood vessel. Therefore, the design of the sheath not only protects the drug coating on the surface of the balloon body, but also reduces the drug loss rate of the drug-coated balloon catheter during delivery. Further, the anti-bend drug-coated balloon catheter provided in this embodiment can reduce the total drug load and is safer to use.
  • the support member is a plurality of sleeves sleeved with each other, and each sleeve is nested layer by layer when the drug-coated balloon is exposed outside the sheath, when the slider drives the sheath toward the proximal end of the pushing catheter When retreating, it will not affect the shape of the pushing catheter, and it can avoid the bending of the soft pushing catheter to ensure the smoothness of the retracting of the sheath, and does not increase and thicken the overall outer diameter of the drug-coated balloon catheter.

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

Abstract

L'invention concerne un cathéter à ballonnet revêtu de médicament anti-flexion (100), comprenant un cathéter de poussée (20) et un ballonnet revêtu de médicament (30) fixé à une extrémité distale du cathéter de poussée (20). Le cathéter à ballonnet revêtu de médicament (100) comprend en outre une gaine (40) et un mécanisme coulissant (50) relié à la gaine (40) ; le mécanisme coulissant (50) comprend un élément de support (51) emmanché à l'extérieur du cathéter de poussée (20) et un élément coulissant (52) entre la gaine (40) et l'élément de support (51) ; l'élément coulissant (52) coulisse dans la direction axiale du cathéter de poussée (20) au moyen de l'élément de support (51), de telle sorte que le ballonnet revêtu de médicament (30) est logé dans la gaine (40) ou exposé à l'extérieur de la gaine (40). Pendant le processus de transport du cathéter à ballonnet revêtu de médicament anti-flexion (100), non seulement le taux de perte de médicament peut être réduit, mais la flexion du cathéter de poussée (20) peut également être évitée.
PCT/CN2019/086659 2018-08-24 2019-05-13 Cathéter à ballonnet revêtu d'un médicament anti-flexion Ceased WO2020038024A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201810978143.8A CN109793976A (zh) 2018-08-24 2018-08-24 防弯折的药物涂层球囊导管
CN201810978143.8 2018-08-24
CN201821380087.XU CN209611965U (zh) 2018-08-24 2018-08-24 防弯折的药物涂层球囊导管
CN201821380087.X 2018-08-24

Publications (1)

Publication Number Publication Date
WO2020038024A1 true WO2020038024A1 (fr) 2020-02-27

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PCT/CN2019/086659 Ceased WO2020038024A1 (fr) 2018-08-24 2019-05-13 Cathéter à ballonnet revêtu d'un médicament anti-flexion

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5846259A (en) * 1994-02-18 1998-12-08 C. R. Bard, Inc. Telescoping catheter and method of use
US20050004553A1 (en) * 2003-07-02 2005-01-06 Medtronic Ave, Inc. Sheath catheter having variable over-the-wire length and methods of use
CN101291637A (zh) * 2005-10-18 2008-10-22 爱德华兹生命科学公司 具有瓣膜导管的心瓣膜输送系统
US20120172968A1 (en) * 2006-04-27 2012-07-05 William A. Cook Australila Pty. Ltd. Controlled sequential deployment
US20130110085A1 (en) * 2011-10-26 2013-05-02 Josephine Branch Craige Adamson Catheter With Proximally Adjustable Length
CN103298517A (zh) * 2010-09-17 2013-09-11 雅培心血管系统有限公司 长度和直径可调整的球囊导管

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5846259A (en) * 1994-02-18 1998-12-08 C. R. Bard, Inc. Telescoping catheter and method of use
US20050004553A1 (en) * 2003-07-02 2005-01-06 Medtronic Ave, Inc. Sheath catheter having variable over-the-wire length and methods of use
CN101291637A (zh) * 2005-10-18 2008-10-22 爱德华兹生命科学公司 具有瓣膜导管的心瓣膜输送系统
US20120172968A1 (en) * 2006-04-27 2012-07-05 William A. Cook Australila Pty. Ltd. Controlled sequential deployment
CN103298517A (zh) * 2010-09-17 2013-09-11 雅培心血管系统有限公司 长度和直径可调整的球囊导管
US20130110085A1 (en) * 2011-10-26 2013-05-02 Josephine Branch Craige Adamson Catheter With Proximally Adjustable Length

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