Drug balloon dilation catheter and use method thereofTechnical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a drug balloon dilation catheter and a use method thereof.
Background
The medicine saccule dilating technique is one new technology of expanding the pathologic blood vessel to make the pathologic blood vessel contact directly and release medicine. The common drug balloon dilation catheter comprises a balloon, an inner tube, an outer tube and a tube seat, wherein a drug coating is arranged on the surface of the balloon, a medium is filled into the balloon through a pressure port on the tube seat, the balloon is inflated by pressurizing, the balloon can squeeze a plaque of a blood vessel stenosis and is attached to the inner wall of the blood vessel after being inflated, and the drug on the balloon can be released to act on a lesion blood vessel, so that the purposes of inhibiting the proliferation of an inner membrane of the blood vessel wall and reducing the occurrence of illness are achieved.
However, existing drug balloon dilation catheters may present a risk of slippage during operation, particularly in complex vessel morphology or high blood flow velocity areas. In addition, the existing drug balloon dilation catheter can act the drug on the surface of the balloon on the lesion blood vessel after the balloon is dilated and contacted with the lesion blood vessel, and the damaged blood vessel is easy to cause vascular inflammation.
Disclosure of Invention
The invention aims to provide a novel drug balloon dilation catheter and a using method thereof.
In order to achieve the above purpose, the invention adopts the following technical scheme:
A drug balloon dilation catheter, includes inner tube, outer tube and sacculus, a part of inner tube wears to locate the inside of sacculus, outer tube cover is established the outside of inner tube just with form the chamber way between the inner tube, the chamber way can be used to the transmission is full medium in the sacculus, in order to drive the sacculus inflation or shrink, drug balloon dilation catheter still includes:
A drug patch having a plurality of disposed outside the balloon;
The supporting mechanism comprises a supporting piece with an initial state and a supporting state and a push-pull piece movably arranged in the cavity, wherein the supporting piece is provided with a plurality of supporting parts which are arranged corresponding to the medicine patches and are positioned in the balloon, when the supporting piece is in the initial state, the supporting parts are straightened and do not contact with the balloon, when the supporting piece is in the supporting state, the supporting parts arch outwards and can jack up the medicine patches corresponding to the supporting parts outwards, one end of the supporting piece is connected to the inner tube, the other end of the supporting piece is connected to the push-pull piece, and the supporting piece can be switched between the supporting state and the initial state.
According to the invention, the supporting mechanism is arranged, the supporting part on the supporting mechanism can be arched outwards and jack up the medicine patch, so that on one hand, part of the balloon wall can be anchored on the vascular wall, the connection stability between the balloon and the vascular wall is improved, the displacement of the balloon in the expanding process is prevented, and on the other hand, the medicine patch can be attached to the lesion vascular wall in advance, so that medicine is released in advance, and the inflammation caused by the opening of the blood vessel is relieved.
Preferably, the support member further has a plurality of support rings arranged along an axial direction of the inner tube, the support rings are sleeved on the outer side of the inner tube, the support ring at the most distal end is fixedly connected to the inner tube, the support ring at the most proximal end is connected to the push-pull member, the support rings except the support ring at the most distal end can slide relative to the inner tube, and one or more support parts are connected between two adjacent support rings.
In some embodiments, the support part comprises a first support arm and a second support arm which are connected in a rotating way, and the ends of the first support arm and the second support arm which are far away from each other are respectively connected to two adjacent support rings corresponding to the first support arm and the second support arm.
In some embodiments, when a plurality of the support portions are provided between the adjacent two support rings, the plurality of support portions between the adjacent two support rings are arranged around the inner tube axis.
In some embodiments, the number of supports between different adjacent two support rings is the same or different.
In some embodiments, the support portions are staggered from adjacent and proximal and/or distal support portions.
Preferably, the support portion is arched outwardly in a triangular shape when the support member is in the support state.
Preferably, the support is integrally formed.
In some embodiments, the support is integrally formed by laser engraving techniques.
Preferably, the support is made of stainless steel.
Preferably, the medicine patch comprises a first patch with a peripheral side connected to the balloon and a second patch which is positioned between the first patch and the balloon and is loaded with medicine, and the first patch is provided with a plurality of micropores for releasing the medicine.
Further preferably, the first patch completely covers the second patch with a certain margin left around.
In some embodiments, the first patch and the second patch are circular.
In some embodiments, the material of the first patch is polyethylene or polylactic acid.
In some embodiments, the material of the second patch is sodium alginate or polyvinyl alcohol.
In some embodiments, the drug is selected from one or more of antiproliferative drugs (including but not limited to paclitaxel), antithrombotic drugs (including but not limited to sirolimus).
Further, the drug is sirolimus. Sirolimus has good slow release effect on relatively stabilizing sirolimus under normal temperature, can continuously inhibit vascular smooth muscle cell proliferation, and reduces restenosis.
Preferably, the preparation method of the drug patch comprises the following steps:
s1, uniformly distributing the medicine on the surface of the second patch by adopting a dip dyeing or spraying process;
S2, covering the first patch on the outer side of the second patch, and heating the periphery of the first patch (the area outside the second patch) by using a local hot melting tool or a hot melting head to fuse the first patch with the surface of the saccule;
S3, fixing the medicine patch by thermal shrinkage, wherein the medicine patch comprises the step of uniformly blowing the first patch by using a low-temperature air blower to enable the first patch to shrink and cling to the surface of the saccule. The first patch is contracted, and simultaneously, the internal medicine patch is fixed on the surface of the saccule, and the temperature of hot air is controlled within a range which does not affect the stability of the medicine (usually not more than 50-60 ℃).
Further preferably, the method for preparing a drug patch further comprises microwaving the first patch. The microwell processing may employ laser drilling or other microwell forming operations.
In some embodiments, the microwaving is performed before the first patch covers the second patch.
In some embodiments, the microwaving treatment is performed on the first patch after the heat shrink fixing.
Preferably, the drug balloon dilation catheter further comprises a driving mechanism, the driving mechanism comprises a handle connected to the outer tube and/or the inner tube, a transmission piece and a driving assembly, the transmission piece is arranged on the handle, the transmission piece is connected between the push-pull piece and the driving assembly and controlled by the driving assembly, and the transmission piece can move with the push-pull piece so as to enable the support piece to switch between the support state and the initial state.
The invention also provides a using method of the drug balloon dilation catheter, which comprises the following steps:
(1) Placing the balloon at a vascular lesion;
(2) Controlling the movement of the push-pull member to switch the support member from an initial state to a support state, and maintaining the support member in the support state for pre-release of the medicament;
(3) Filling medium is introduced into the balloon through the cavity so that the balloon is expanded outwards and kept;
(4) And controlling the push-pull member to move so as to enable the supporting member to be switched from a supporting state to an initial state, and leading out filling medium in the balloon through the cavity so as to enable the balloon to contract and withdraw the balloon.
Preferably, the balloon wall in the inflated state is controlled to be at a height not lower than that of the support portion.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
the drug balloon dilation catheter comprises an inner tube, an outer tube, a balloon, a drug patch and a supporting mechanism, wherein a supporting part on the supporting mechanism can arch outwards and jack up the drug patch, on one hand, part of balloon wall is anchored on a blood vessel wall to prevent displacement of the balloon in the dilation process, the stability is better, and on the other hand, the drug patch can be attached to a lesion blood vessel wall in advance, so that the pre-release of the drug is realized, and the inflammation caused by the blood vessel dilation is relieved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic structural view of a drug balloon dilation catheter of example 1;
FIG. 2 is a schematic view showing the structure of the distal end portion of the drug balloon dilation catheter of example 1;
FIG. 3 is a perspective view of the distal end of the drug balloon dilation catheter of example 1;
FIG. 4 is a cross-sectional view of the distal end portion of the drug balloon dilation catheter of example 1 wherein the support member is in an initial state;
FIG. 5 is a cross-sectional view of the distal end of the drug balloon dilation catheter of example 1 wherein the support member is in a supported state and the balloon is in a contracted state;
FIG. 6 is a cross-sectional view of the distal end of the drug balloon dilation catheter of example 1 with the support member in a supported state and the balloon in an inflated state;
fig. 7 is a schematic view showing the structure of the support member of embodiment 1 in an initial state;
Fig. 8 is a schematic view showing the structure of the supporting member in the supporting state of embodiment 1;
FIG. 9 is a schematic view of the supporting portion and the supporting ring of embodiment 1;
FIG. 10 is a schematic view showing a semi-sectional structure of a drug patch of example 1;
fig. 11 is a sectional view of the drive mechanism of embodiment 1;
FIG. 12 is a physical model of the distal end of the drug balloon dilation catheter of example 1;
wherein, 1, a balloon;
2. Medicine patch, 21, first patch, 211, bonding area, 212, penetrating area, 22, second patch;
3. Support mechanism, 31, support piece, 311, support ring, 312, support part, 3121, first support arm, 3122, second support arm;
4. An inner tube;
5. An outer tube;
6. the driving mechanism 61, the handle 62, the transmission tube 63, the cam 64, the transmission rod 65, the operation part 66, the first rotating wheel 67 and the second rotating wheel;
7. A guide wire.
Detailed Description
Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
In describing embodiments of the present invention, it should be understood that the terms "distal," "proximal," and the like are used to define the orientation or positional relationship of the drug balloon dilation catheter in use, wherein the side proximal to the operator is the proximal end and the side distal to the operator is the distal end. It is merely for convenience in describing and simplifying the description of embodiments of the present invention and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the embodiments of the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the embodiments of the present invention, the meaning of "plurality" is two or more, unless explicitly defined otherwise.
In embodiments of the invention, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, or may include both the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly under and obliquely below the second feature, or simply means that the first feature is less level than the second feature.
The following disclosure provides many different implementations, or examples, for implementing different configurations of embodiments of the invention. In order to simplify the disclosure of embodiments of the present invention, components and arrangements of specific examples are described below. Of course, they are merely examples and are not intended to limit embodiments of the present invention. Furthermore, embodiments of the present invention may repeat reference numerals and/or letters in the various examples, which are for the purpose of brevity and clarity, and which do not themselves indicate the relationship between the various embodiments and/or arrangements discussed.
Existing drug balloon dilation catheters typically dilate stenosed vessels outwardly by balloon inflation while simultaneously applying the drug on the balloon to the inner wall of the vessel. Such a dilation catheter has problems in that, firstly, the balloon is easily slid during the dilation of the blood vessel due to the influence of blood flow, thus making it difficult to precisely act on the target lesion site, and secondly, it is difficult to achieve local pressurization and drug release, which easily results in poor therapeutic effect and increased risk of restenosis of the blood vessel. In view of the above problems, the present invention provides a drug balloon dilation catheter, which is provided with a support mechanism, so that a drug patch on a balloon can be lifted up to a position for releasing drug according to requirements, the balloon is prevented from sliding due to the influence of blood flow and the like, and drug patch positioning is realized. In addition, the medicine patch is released in advance in a narrow blood vessel, treats the blood vessel wall, and can relieve inflammation caused by the expansion of the blood vessel. Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
Example 1
A drug balloon dilation catheter, as shown in fig. 1 to 12, comprises a balloon 1, an inner tube 4, an outer tube 5, a drug patch 2 and a support mechanism 3.
The balloon 1 can be expanded or contracted in its radial direction, and its specific structure can be referred to the prior art, and the present invention is not particularly limited.
Part of the inner tube 4 is arranged inside the balloon 1 in a penetrating way, specifically, the distal end part of the inner tube 4 is inserted into the balloon 1 and is fixedly connected with the distal end of the balloon 1. The outer tube 5 is sleeved outside the inner tube 4, and the distal end of the outer tube is inserted into the balloon 1 and fixedly connected with the proximal end of the balloon 1. Between the outer tube 5 and the inner tube 4a lumen is formed, which can be used to transport filling medium into the balloon 1 to drive the inflation or deflation of the balloon 1. The filling medium refers to the prior art, which may be, as an example, physiological saline, contrast agent, etc.
The support mechanism 3 comprises a support member 31 having an initial state and a support state, and a push-pull member movably disposed in the lumen, which may be, for example, a tube member fitted over the outer tube and in contact with or connected to the proximal end of the support member 31, the push-pull member being controllably slidable in the axial direction of the inner tube 4.
Referring to fig. 9, the support 31 includes a plurality of support rings 311 and a support portion 312. The plurality of support rings 311 are sleeved on the inner tube 4 and are sequentially arranged at intervals along the axial direction of the inner tube 4, the support ring 311 at the far end is fixedly connected on the inner tube 4, and other support rings 311 except the support ring 311 at the far end can slide relative to the inner tube 4. One or more supporting parts 312 are connected between two adjacent supporting rings 311, and when a plurality of supporting parts 312 are arranged between two adjacent supporting rings 311, the supporting parts 312 are uniformly distributed around the axis of the inner tube 4, preferably, 2-4 supporting parts 312 are connected between two adjacent supporting rings 311. The number of the supporting portions 312 between the different adjacent two supporting rings 311 is the same or different, in this embodiment, the number of the supporting portions 312 between the different adjacent two supporting rings 311 is the same, and the supporting portions 312 between the same adjacent two supporting rings 311 are staggered with the supporting portions 312 adjacent thereto and located at the proximal end and/or the distal end. In general, the support 312 is positioned in the balloon 1, and in the initial state, the support 312 is straightened and does not contact the balloon 1, and when the support 31 is switched from the initial state to the support state, the support rings 311 other than the support ring 311 at the most distal end slide distally relative to the inner tube 4, so that the support 312 is arched outwardly, thereby lifting the wall of the balloon 1 in contact therewith outwardly, anchoring the wall of the balloon 1 in a narrow region, and preventing the balloon 1 from sliding.
As a preferred example, the support 312 is outwardly arched in a triangle. Specifically, the support portion 312 includes a first support arm 3121 and a second support arm 3122 rotatably connected, and ends of the first support arm 3121 and the second support arm 3122 remote from each other are respectively connected to the adjacent two support rings 311 corresponding thereto. When the support ring 311 slides distally relative to the inner tube 4, the support ring 311 presses the support 312, causing the joint of the first support arm 3121 and the second support arm 3122 to move in a direction away from the axis of the inner tube 4, i.e., to arch outwardly, thereby pushing a portion of the balloon 1 wall to a predetermined position, and when the support ring 311 slides reversely, the support ring 311 pulls the support 312 to straighten.
The support 31 is preferably integrally formed, for example by laser engraving techniques. Preferably, the support 31 is made of a tube made of stainless steel material.
The support ring 311 at the nearest end of the support member 31 is connected to the push-pull member, and the support member 31 can be switched between an initial state and a support state under the driving of the push-pull member.
Referring to fig. 1 to 3, the drug patch 2 has a plurality of drug patches 2 arranged outside the balloon 1, which are preferably provided in correspondence with the support portions 312, and are located in an outer region of the balloon 1 wall that is contacted when the support portions 312 are in the supported state, so that the drug patch 2 corresponding thereto can be lifted outwardly when the support portions 312 are arched outwardly.
Further, referring to fig. 10, the drug patch 2 includes a first patch 21 and a second patch 22. The first patch 21 includes a penetration area 212 in the middle and an adhesive area 211 around the penetration area 212, the penetration area 212 is provided with a plurality of micropores for releasing the medicine, and the adhesive area 211 is adhered to the balloon 1 by a hot melting process or glue. Preferably, the first patch 21 is selected from Polyethylene (PE) or polylactic acid (PLA), which have good biocompatibility and can be heat shrunk and heat melted at a relatively low temperature. The second patch 22 is located between the first patch 21 and the balloon 1 and carries a drug, which is preferably a material having good drug adsorption capacity and biocompatibility, such as sodium alginate, polyvinyl alcohol (PVA) or other biodegradable polymers. Drugs include, but are not limited to, antiproliferative drugs (such as paclitaxel) or antithrombotic drugs (such as sirolimus).
Referring to fig. 1 and 11, the drug balloon dilation catheter further comprises a drive mechanism 6, the drive mechanism 6 comprising a handle 61 connected to the outer tube 5 and/or the inner tube 4 and a transmission member and a drive assembly arranged on the handle 61, the transmission member being connected between the push-pull member and the drive assembly, controlled by the drive assembly, the transmission member being capable of moving axially along the inner tube 4 with the push-pull member to switch the support member 31 between the support state and the initial state.
In this embodiment, the proximal ends of the inner and outer tubes 4, 5 are connected to a handle 61 and the proximal end of the inner tube 4 extends beyond the outer tube 5. The handle 61 has a pressurizing lumen communicating with the lumen for the passage of filling medium and a guidewire lumen communicating with the inner tube 4 for the passage of a guidewire 7. The transmission member comprises a transmission tube 62 which is connected to the handle 61 in a threaded manner and is positioned between the inner tube 4 and the outer tube 5, a cam 63 which is connected to the transmission tube 62, and a transmission rod 64 which is fixedly connected to the cam 63, wherein when the transmission rod 64 is operated to rotate, the cam 63 on the transmission rod rotates and drives the transmission tube 62 to move spirally along the axial direction of the inner tube 4, so that the push-pull rod is driven to move axially along the inner tube 4. The driving assembly comprises an operation part 65, a first rotating wheel 66 and a second rotating wheel 67, wherein the second rotating wheel 67 is fixedly connected to the proximal end of the transmission rod 64, the first rotating wheel 66 is meshed between the operation part 65 and the second rotating wheel 67 and is provided with a plurality of rotating operation parts 65 distributed on the periphery of the second rotating wheel 67, the first rotating wheel 66 rotates and drives the second rotating wheel 67 to rotate under the driving of the operation part 65, and the second rotating wheel 67 rotates and drives the transmission rod 64 to rotate, so that the cam 63 on the transmission rod 64 moves spirally along the axial direction of the inner tube 4 along with the transmission tube 62. Of course, the driving mechanism 6 may have other structures in the prior art.
Working principle:
(1) Placing the balloon 1 at a vascular lesion;
(2) The push-pull member is controlled to move so as to switch the supporting member 31 from an initial state to a supporting state, the supporting member 31 is kept in the supporting state, and the push-pull member specifically comprises a rotating operation part 65, the operation part 65 drives a first rotating wheel 66 to rotate with a second rotating wheel 67, and the second rotating wheel 67 simultaneously rotates with a transmission rod 64 and a cam 63, so that the first transmission rod 62 is driven to move in a spiral way towards the distal end, and the push-pull rod is further driven to move towards the distal end along the axial direction of the inner tube 4, so that the supporting part 312 is outwards arched and props up the medicine patch 2, the medicine patch 2 acts on a narrow area, and the pre-release of medicine is realized;
(3) Filling medium is introduced into the balloon 1 through the cavity so as to enable the balloon to expand outwards and expand and keep, and the method specifically comprises the steps of introducing the filling medium into the balloon 1 through the pressurizing cavity so as to enable the balloon 1 to expand until the height of the balloon wall of the balloon 1 in an expanded state is greater than the height of the supporting part 312, namely the balloon 1 wall is positioned outside the supporting part 312;
(4) Controlling the movement of the push-pull member to switch the supporting member 31 from the supporting state to the initial state specifically comprises switching the supporting member 31 from the supporting state to the initial state by reversely rotating the operation part 65, and discharging the filling medium in the balloon through the filling port to shrink the balloon and withdraw the balloon.
The above embodiments are provided to illustrate the technical concept and features of the present invention and are intended to enable those skilled in the art to understand the content of the present invention and implement the same, and are not intended to limit the scope of the present invention. All equivalent changes or modifications made in accordance with the spirit of the present invention should be construed to be included in the scope of the present invention.