Ultrasonic permeation-enhancing medicine balloon catheter and ultrasonic permeation-enhancing treatment device

Abstract

The invention relates to an ultrasonic penetration enhancing drug balloon catheter and an ultrasonic penetration enhancing treatment device. The effects of inhibiting proliferation of expanded vascular smooth muscle cells and preventing restenosis after blood vessel expansion are achieved through paclitaxel, rapamycin or derivatives of paclitaxel, rapamycin or derivatives of paclitaxel, rapamycin or derivatives of paclitaxel, rapamycin or derivatives of paclitaxel and rapamycin. The medicine is wrapped on the inner turn-over face, falling of the medicine can be effectively reduced in the conveying process, the balloon can be tightly attached to the diseased region after being pressurized and expanded, the medicine at the wrapped part is exposed, and the medicine can reach the focus more accurately and is continuously released at the diseased region; meanwhile, the risk of far-end embolism caused by the fact that the medicine particles which are washed away in the conveying process flow to far-end blood vessels along with blood can be avoided. And by using the permeation-promoting ultrasonic assembly, the absorption of the medicine in the blood vessel can be promoted, the action rate of the medicine in the human body can be improved, and the high action effect can be obtained by low medicine dosage.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an ultrasonic infiltration drug balloon catheter and an ultrasonic infiltration treatment device. Background Art

[0002] Drug-eluting balloons are commonly used to treat cardiovascular diseases. They can inhibit the proliferation of dilated vascular smooth muscle cells and prevent restenosis after vascular dilation. Drug-eluting balloons have significant therapeutic effects in interventional treatment. The drug coating is applied to the surface of the balloon, and the balloon is delivered to the lesion site through a catheter. The balloon expands in the blood vessel. The balloon expansion time is short. It is necessary to ensure that the drug coating is transferred to the blood vessel wall during the balloon inflation period and that the drug can be effectively released to improve the absorption of water-insoluble therapeutic agents; at the same time, the integrity of the drug coating must be ensured during the delivery of the drug balloon.

[0003] The traditional drug delivery method is mainly to spray the drug directly on the balloon surface, and a few have the theory of adhering nano drug-loaded microspheres on the balloon surface. However, there are some problems of particle shedding, which can cause distal embolism; at the same time, due to the flushing of blood during the delivery process, the drug loss rate is very large, and the effective drug reaching the lesion is very low. At the same time, the drug particles that fall off during the delivery process can also cause distal embolism.

[0004] The drug balloon simply relies on balloon inflation to squeeze the blood vessel wall, sticking the drug to the inner wall of the blood vessel, which is automatically absorbed by the patient. The actual drug content that acts on the lesion is low and the absorption rate is low. Summary of the invention

[0005] The purpose of the present application is to provide an ultrasonic osmosis drug balloon catheter and an ultrasonic osmosis treatment device, which can avoid the loss of drug particles during transportation and the risk of embolism, while promoting the absorption of drugs in blood vessels and improving the effectiveness of drugs in the human body.

[0006] In order to achieve the above-mentioned object, in a first aspect, the present invention provides an ultrasonic osmosis drug balloon catheter, comprising: an outer tube and a drug balloon catheter;

[0007] The outer tube is connected to a handle, and the drug balloon catheter extends into the outer tube through the handle and can be axially retracted relative to the distal tube opening of the outer tube;

[0008] The drug balloon catheter comprises a traction tube and a drug balloon connected to the distal end of the traction tube, wherein the traction tube is connected to a traction tube head end, one axial end of the drug balloon is connected to the side wall portion of the traction tube near the distal end, and the other axial end is connected to the traction tube head end;

[0009] The drug balloon can be compressed and accommodated inside the outer tube. In the compressed and accommodated state, the head end of the traction tube stays on the axial inner side of the outer tube, and an outward extension distance is left between the distal end of the head end of the traction tube and the distal end of the outer tube.

[0010] The drug balloon comprises an inverted surface located on a segment corresponding to the outward extension interval, and an oppositely arranged outverted surface, wherein both the inverted surface and the outverted surface are outer surfaces of the drug balloon, and the outverted surface is in linear contact or annular contact with the inner wall of the outer tube;

[0011] The inner inverted surface is coated with medicine, and an ultrasonic component is arranged inside the medicine balloon.

[0012] In an optional embodiment, the drug balloon is filled with a sound-conducting liquid, and a plurality of perfusion holes for filling the sound-conducting liquid are provided on the side wall of the traction tube, and the plurality of perfusion holes are evenly distributed on the same circumference of the traction tube;

[0013] The perfusion hole is arranged near the distal end of the traction tube and communicates with the cavity of the drug balloon. The head end of the traction tube includes a solid structure connected to the distal end of the traction tube.

[0014] In an optional embodiment, a perfusion valve is provided in the lumen of the traction tube, the perfusion valve is provided on the proximal side adjacent to the perfusion hole, and the lumen between the distal end of the traction tube and the perfusion valve constitutes the perfusion chamber of the traction tube.

[0015] In an optional embodiment, the perfusion valve includes two connecting valve plates arranged opposite to each other, and opening and closing valve flaps respectively connected to the connecting valve plates, the roots of the two connecting valve plates are respectively connected to the inner tube walls of the traction tube, the opening and closing valve flaps are connected to each other and bent toward the distal end of the traction tube.

[0016] In an optional embodiment, the hardness of the connecting valve plate is greater than the hardness of the opening and closing valve flap, the opening and closing valve flap includes a flexible silicone sheet bonded to the connecting valve plate, and the contour edge of the connecting valve plate is bonded to the inner tube wall of the traction tube.

[0017] In an optional embodiment, the ultrasonic component includes one or more groups disposed inside the drug balloon, and each group of the ultrasonic components includes an ultrasonic cable and an ultrasonic electrode sheet.

[0018] In an optional embodiment, the traction tube includes a cable cavity and a pressure chamber, the ultrasound cable extends from the inside of the drug balloon and is connected to an external ultrasound device through the cable cavity, and the perfusion valve is arranged between the pressure chamber and the perfusion cavity;

[0019] The proximal end of the traction tube is connected with a traction tube joint, and the traction tube joint includes a charging port and a cable port, the charging port is communicated with the charging cavity, and the cable port is communicated with the cable cavity.

[0020] In an optional embodiment, the drug is uniformly coated on the inner surface, and includes a mixture of one or more of paclitaxel, rapamycin, and rapamycin derivatives.

[0021] In an optional embodiment, a developing ring is provided on the outer side wall of the distal end of the traction tube, or the distal end of the traction tube includes a metal developing block with a solid structure.

[0022] In a second aspect, the present invention provides a set of sonophoresis treatment devices, including an ultrasonic device and a sonophoresis drug balloon catheter according to any one of the aforementioned embodiments, wherein the ultrasonic device is electrically connected to the ultrasonic component via an ultrasonic cable;

[0023] The drug balloon in the compressed lying state is delivered to the proximal end of the lesion through the handle, and the traction tube is pushed outward or the outer tube is withdrawn, so that the drug balloon is exposed from the distal end of the outer tube by means of the contact and friction between the everted surface of the balloon and the inner wall of the outer tube;

[0024] After suctioning the traction tube, the sound-conducting liquid is filled into the drug balloon, so that the balloon is inflated and fits against the blood vessel wall, and the drug balloon is pushed to the distal end. Combined with the contact and friction between the surface of the drug balloon and the blood vessel wall or the lesion, the inner surface is turned outward to expose the drug to the lesion.

[0025] Turn on the ultrasonic device to promote drug absorption, and push and pull the traction tube back and forth to drive the coated drugs on different parts to act on the lesions on different axes, forming a relatively dynamic release effect;

[0026] After the operation, use the suction tube to overcome the elastic closing pressure of the perfusion valve through the suction negative pressure, open the perfusion valve, and suck out the sound-conducting fluid in the balloon and traction tube. After the balloon is deflated, withdraw the entire balloon.

[0027] Through the outer tube and the drug balloon catheter, the drug balloon catheter can be axially retracted relative to the distal tube opening of the outer tube, and can lie in the outer tube during the delivery of the drug balloon catheter, thereby reducing the scouring of the drug by the blood flow during delivery.

[0028] The traction tube and the drug balloon included in the drug balloon catheter constitute the main functional structure relative to the outer tube. By connecting the two axial ends of the drug balloon to the distal end of the traction tube and the head end of the traction tube respectively, and combining the fact that in the compressed lying state, the head end of the traction tube stays on the axial inner side of the outer tube, and an outward extension space is left between the distal end of the head end of the traction tube and the distal end of the outer tube in the compressed lying state, a reverse inward-turning structure of the balloon body can be formed, which is beneficial to wrapping the balloon part coated with the drug and facilitates the outward extension deformation of the balloon.

[0029] The drug balloon includes an inverted surface located on a segment corresponding to the outward extension spacing, and an oppositely arranged outward surface. Both the inverted surface and the outward surface are the outer surfaces of the drug balloon. By evenly coating the drug on the inverted surface, effective wrapping and shielding are achieved to prevent the drug from being washed away by the blood flow.

[0030] The linear contact or annular contact between the everted surface and the inner wall of the outer tube can form effective contact friction, thereby facilitating the reliability of the outward deformation of the balloon when it is extended.

[0031] By coating the drug on the inner surface of the drug balloon and arranging an ultrasonic component inside the drug balloon, a good ultrasonic permeation effect can be formed to promote the efficient absorption of the drug.

[0032] The ultrasonic osmosis drug balloon catheter of the present invention inhibits the proliferation of dilated vascular smooth muscle cells through paclitaxel, rapamycin or its derivatives, and prevents restenosis after vascular dilation. The drug is coated on the inner inverted surface, which can effectively reduce drug shedding during delivery. After the balloon is pressurized and expanded, it can fit tightly with the lesion site, so that the drug in the wrapped site is exposed, and the drug reaches the lesion more accurately and is continuously released at the lesion site; at the same time, it can also avoid the risk of drug particles washed away during delivery flowing to the distal blood vessels with blood, causing distal embolism.

[0033] The use of ultrasonic components with permeation-enhancing effects can promote the absorption of drugs in blood vessels, increase the effectiveness of drugs in the human body, and achieve high effects with low drug doses.

[0034] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0036] Figure 1 It is a schematic diagram of the structure of the ultrasonic osmosis drug balloon catheter in the balloon compression and lying state;

[0037] Figure 2 A schematic diagram of the structure of the ultrasonic drug-enhanced balloon catheter after the balloon is released and pressurized;

[0038] Figure 3 It is a schematic diagram of the structure of the drug balloon and the traction tube;

[0039] Figure 4 is a schematic diagram of the cross-sectional structure of the traction tube;

[0040] Figure 5 It is a structural schematic diagram of the filling valve;

[0041] Figure 6 This is a schematic diagram of the structure of the ultrasonic permeation treatment device at the lesion site.

[0042] icon:

[0043] 1-outer tube; 11-handle;

[0044] 2-traction tube; 21-traction tube head end; 22-infusion hole; 23-infusion cavity; 24-cable cavity; 25-charging cavity; 26-traction tube joint; 27-charging port; 28-cable port;

[0045] 3-drug balloon; 31-inverted surface; 32-outverted surface; 33-drug;

[0046] 4-ultrasound component; 41-ultrasound cable; 42-ultrasound electrode sheet;

[0047] 5-filling valve; 51-connecting valve plate; 52-opening and closing valve disc;

[0048] 6-Location of the lesion. DETAILED DESCRIPTION

[0049] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0050] In the description of this application, it should be noted that the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0051] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0052] The ultrasonic permeation drug balloon catheter in the present application is used in the treatment of cardiovascular diseases, and mainly plays the role of inhibiting the proliferation of dilated vascular smooth muscle cells and preventing restenosis after vascular dilation.

[0053] See also Figure 1 , and combined with Figure 2-Figure 3 Specifically, by changing the structure of the drug balloon 3 and adding the necessary structure of the ultrasonic component 4, the drug 33 can be effectively wrapped by the inverted balloon during the delivery process, and can be reliably exposed when reaching the lesion site 6, and the efficient absorption of the drug 33 exposed and attached to the lesion site 6 can be promoted, thereby improving the treatment effect.

[0054] The ultrasonic osmosis drug balloon catheter of the present invention has a main structure including an outer tube 1 and a drug balloon 3 catheter, and the osmosis-enhancing functional structure includes an ultrasonic component 4 capable of generating ultrasonic waves.

[0055] Specifically, the balloon is expanded and contracted, deformed, and administered through the main structure, and the ultrasonic component 4 is used to assist in the penetration-promoting operation, so that the drug 33 exposed and attached to the lesion site 6 can be efficiently absorbed.

[0056] The outer tube 1 is connected to a handle 11, and the drug balloon 3 catheter is inserted into the outer tube 1 through the handle 11, and the drug balloon 3 catheter can be axially extended and retracted relative to the distal tube opening of the outer tube 1, so that the balloon can be extended and retracted, thereby achieving the adhesion effect of the drug 33 after the balloon is pressurized and expanded, and the overall withdrawal from the blood vessel after treatment.

[0057] The drug balloon 3 catheter includes a traction tube 2 and a drug balloon 3 connected to the distal end of the traction tube 2. The telescopic movement of the drug balloon 3 is mainly controlled by the traction tube 2. Specifically, during the control process, the traction tube 2 is pushed and pulled, or the outer tube 1 is pushed and pulled by the handle 11 to control the relative matching relationship between the traction tube 2 and the outer tube 1, thereby realizing the telescopic movement of the drug balloon 3 at the distal end of the traction tube 2.

[0058] Through the cooperation between the traction tube 2 and the outer tube 1 , the drug balloon 3 can be compressed and accommodated inside the outer tube 1 , and at the same time, the drug balloon 3 can be exposed outside the distal end of the outer tube 1 .

[0059] The traction tube 2 is connected to a traction tube head end 21, one axial end, i.e., one end in the length direction, of the drug balloon 3 is connected to the side wall portion of the traction tube 2 near the distal end, and the other axial end is connected to the traction tube head end 21. More specifically, the proximal end of the drug balloon 3 is connected to the side wall portion of the traction tube 2 near the distal end, and the distal end of the drug balloon 3 is connected to the traction tube head end 21.

[0060] Through the above-mentioned arrangement, in the compressed lying state, by stopping the traction tube head end 21 on the axial inner side of the outer tube 1, and leaving an outward extension distance between the distal end of the traction tube head end 21 and the distal end of the outer tube 1, the drug balloon 3 can be made to protrude forward from the distal end of the traction tube head end 21 from near to far under the action of the contact friction force with the outer tube 1 through the retraction of the traction tube 2 relative to the outer tube 1, so that the circumferential capsule body of the drug balloon 3 as a whole presents a state of protruding forward from near to far from the distal end of the traction tube head end 21, and the protruding part can form an inverted surface 31 of the drug balloon 3 that is turned inward from far to near, which is beneficial to the effective wrapping of the drug 33 coated on the inverted surface 31, prevents the drug 33 from being washed away during the transportation process, and avoids the risk of distal embolism caused by the lost drug 33 particles flowing with the blood to the distal blood vessels.

[0061] Therefore, the medicine balloon 3 includes an inner turn surface 31 located on the segment corresponding to the extended spacing, and an outer turn surface 32 arranged oppositely. The inner turn surface 31 specifically includes a segment from the connection between the distal end of the medicine balloon 3 and the traction tube head end 21 to the folding portion between the inner turn surface 31 and the outer turn surface 32; and the outer turn surface 32 specifically includes a segment from the connection between the proximal end of the medicine balloon 3 and the traction tube 2 to the folding portion between the inner turn surface 31 and the outer turn surface 32.

[0062] The inverted surface 31 and the outverted surface 32 in this application are specifically defined for the state where the drug balloon 3 is compressed and lying in the outer tube 1. In view of the composition of the above-mentioned main structure, the inverted surface 31 and the outverted surface 32 are both the outer surfaces of the drug balloon 3. Except for the process in which the traction tube 2 retracts relative to the outer tube 1 to form an inverted and wrapped state, in order to facilitate the pushing process, the inverted surface 31 can be gradually expanded and opened, exposing the drug 33 and fitting with the lesion 6. The friction contact between the balloon and the outer tube 1 cannot be ignored. Specifically, the linear contact or annular contact between the outverted surface 32 and the inner wall of the outer tube 1 can form the contact friction between the outer tube 1 and the outer surface of the balloon, so that the drug balloon 3 can maintain the reliable inverted or outward deformation under the action of the contact friction force with the outer tube 1, thereby providing the necessary friction anchoring effect for the inverted or outward expansion of the drug balloon 3.

[0063] It should be pointed out that although there is contact friction between the outer tube 1 and the outer surface of the balloon, in the process of controlling the displacement of the traction tube 2 relative to the outer tube 1, it cannot be ruled out that the drug balloon 3 completely breaks free from the contact and cooperation with the outer tube 1, which is conducive to the outward expansion of the drug balloon 3 and the complete exposure of the inner inversion surface 31.

[0064] The above supplementary explanation is not difficult to understand during the withdrawal process. As the outer surface of the balloon contacts the inner wall of the outer tube 1, the contact annular surface or contact ring can be used as the friction anchoring basis. By continuously withdrawing the traction tube 2 relative to the outer tube 1, the balloon segment near the distal end of the balloon is continuously turned inward.

[0065] Especially during the extension process, with the continuous extension of the traction tube head end 21 and the continuous extension of the traction tube 2, in the initial stage, the inner surface 31 coated with the drug 33 can be continuously unfolded based on the contact annular surface or contact ring between the outer surface of the balloon, that is, the outer surface 32 of the balloon and the inner wall of the outer tube 1 as the friction anchoring basis. When the distal tube mouth of the outer tube 1 is relatively far away from the traction tube 2, the separation trend between the outer tube 1 and the balloon will break through the anchoring friction of the contact annular surface or the contact ring, so that the drug balloon 3 can completely break free from the restraint of the outer tube 1, and then can be completely exposed to the lesion site 6, which is conducive to the subsequent drug 33 action and ultrasonic permeation.

[0066] Of course, since the filled and expanded drug balloon 3 can fit tightly with the diseased area 6 of the vascular stenosis, based on the effect of the friction anchoring foundation mentioned above, while controlling the traction tube 2 to extend and retract within a certain range front and back, the drugs 33 coated on different parts of the inner turn surface 31 can act on the diseased areas 6 at different positions in an orderly and phased manner, and then combined with the effect of ultrasound, the penetration of the drugs 33 in the diseased area 6 can be promoted.

[0067] The ultrasonic component 4 is disposed inside the drug balloon 3 , and specifically plays an ultrasonic permeation effect on the drug 33 acting on the lesion site 6 .

[0068] From the perspective of mechanism, in the process of ultrasonic penetration, the present invention mainly uses the cavitation effect of ultrasound. The cavitation effect is that under the action of ultrasound, the vibration of cavitation bubbles at the interface of corneocytes and lipid molecular layers causes the vibration of the lipid bilayer of the stratum corneum, and at the same time, the shock wave generated by the rupture of cavitation bubbles at the interface will cause the disorder of the arrangement of lipids in the stratum corneum. The vibration of cavitation bubbles can penetrate a large amount of water into the disordered lipid area to form aqueous channels, and the drug 33 diffuses faster through these channels.

[0069] Ultrasound-assisted drug 33 delivery is used in tumor treatment. By increasing the permeability of chemotherapy drugs 33 in the tumor site through ultrasound, the lethality of drugs 33 on tumor cells can be improved and the side effects on healthy cells can be reduced.

[0070] The ultrasonic component 4 in the present invention uses ultrasound to enhance the permeability of the drug 33 coated on the outer surface of the drug balloon 3 to the lesion site 6, and utilizes the combination of precise ultrasonic parameter settings and microbubble technology of "ultrasound-assisted drug 33 delivery" in the vascular endothelium to significantly improve the local penetration and therapeutic effect of the drug 33.

[0071] The drug 33 delivery system avoids the loss of drug 33 and the formation of blood clots due to the shedding of drug 33 particles in the human body during the delivery process, thereby improving the effective utilization rate and safety of drug 33.

[0072] Ultrasound can form temporary micropores on the cell membrane, making it easier for the drug 33 to enter the cells at the lesion site 6. It increases the concentration of the drug 33 in the target cells and enhances the therapeutic effect. The microbubbles in the sound-conducting liquid will vibrate and burst under the action of ultrasound (200-2000kpa). The shock waves and microjets generated during the rupture can increase the permeability of tissues and cells and promote the entry of the drug 33 into the cells.

[0073] Under the action of ultrasound, microbubbles in the sound-conducting liquid will vibrate and burst, and the shock waves and micro-jets generated during the bursting will precisely act on the lesion location. Under the joint action of the ultrasound device, the microbubbles will burst, and the shock waves generated will act on the drug 33 released from the outer surface of the drug balloon 3, precisely acting on the lesion location, greatly improving the absorption rate of the drug 33.

[0074] Combination Figure 4-Figure 5In one specific embodiment, the drug balloon 3 is filled and expanded by filling it with a sound-conducting liquid. A plurality of perfusion holes 22 for filling it with the sound-conducting liquid are provided on the side wall of the traction tube 2. The plurality of perfusion holes 22 are evenly distributed on the same circumference of the traction tube 2, or are arranged at intervals on different circumferences of the traction tube 2, so as to achieve the technical purpose of allowing the sound-conducting liquid to be filled into the drug balloon 3 through the perfusion holes 22.

[0075] The perfusion hole 22 is arranged near the distal end of the traction tube 2 and communicates with the cavity of the drug balloon 3, so that the sound-conducting liquid filled in the traction tube 2 can flow into the cavity of the drug balloon 3, and at the same time facilitates the subsequent suction and removal of the sound-conducting liquid.

[0076] Different from the conventional balloon tip, in order to prevent leakage of the acoustic guiding fluid, the traction tube head end 21 in this embodiment includes a solid structure connected to the distal end of the traction tube 2 .

[0077] At the same time, in order to facilitate observation during surgery, a metal developing ring is welded on the outer wall of the distal end of the traction tube 2, or a solid metal developing block is directly used at the distal end of the traction tube 2, which can facilitate development and achieve good distal balloon occlusion performance.

[0078] In order to enable the filling and introduction of the sound-conducting liquid, a perfusion valve 5 is provided in the lumen of the traction tube 2. The perfusion valve 5 is arranged on the proximal side adjacent to the perfusion hole 22. The lumen between the distal end of the traction tube 2 and the perfusion valve 5 constitutes the perfusion chamber 23 of the traction tube 2.

[0079] By externally filling the sound-conducting liquid, the filling valve 5 can be pushed open in a compressed form under the action of the filling pressure, so that the sound-conducting liquid enters the filling cavity 23. Furthermore, the filling hole 22 is opened on the side wall of the filling cavity 23, so that the sound-conducting liquid enters the interior of the drug balloon 3 from the filling cavity 23 through the filling hole 22 under the action of external filling pressure.

[0080] The perfusion valve 5 in this embodiment is mainly opened or closed by its own elasticity. When the external filling pressure is greater than the elastic force of the perfusion valve 5 itself, it can be opened forward under the external pressure; or when there is suction pressure externally, the suction force can overcome the elastic force of the perfusion valve 5 itself, and it can be opened in the reverse direction under the external suction pressure. After opening, it can restore to a normal closed state through its own structure.

[0081] See also Figure 5 Specifically, the filling valve 5 includes two connecting valve plates 51 arranged opposite to each other, and opening and closing valve flaps 52 respectively connected to the connecting valve plates 51. The connecting valve plates 51 are specifically a rigid structure, while the opening and closing valve flaps 52 are a flexible structure.

[0082] The roots of the two connecting valve plates 51 are respectively connected to the inner tube wall of the traction tube 2 to form a rigid foundation of the perfusion valve 5, and the opening and closing valve flaps 52 are butted against each other to butt and seal the lumen of the traction tube 2. Based on the flexible structure of the opening and closing valve flaps 52 mentioned above, in a natural state, the two opening and closing valve flaps 52 bend toward the distal end of the traction tube 2, and the bent ends are butted against each other to form a herringbone-shaped fitting closed structure on the lumen cross-section of the traction tube 2.

[0083] During the external pressurization process, the filling pressure of the sound-conducting liquid can overcome the state of the flexible fitting closure in the same positive direction, that is, in the distal direction, so that a gap appears in the positive fitting closure, thereby allowing the sound-conducting liquid to enter the perfusion cavity 23 normally.

[0084] When the filling of the sound-conducting liquid is completed and the external pressure is stopped, the two opening and closing valve flaps 52 can keep bending toward the far end of the traction tube 2 under their own elastic binding force, and the bent ends are connected to each other to close the perfusion valve 5 in turn.

[0085] After the ultrasonic operation is completed, the filled sound-conducting liquid needs to be suctioned out. When the external suction force is greater than the positive bending elastic force of the opening and closing valve flap 52, the two opening and closing valve flaps 52 bend in the opposite direction, that is, they overcome the flexible fitting and closed state in the proximal direction, so that the sound-conducting liquid is suctioned out. After the drug balloon 3 is suctioned back and deflated, the drug balloon 3 is withdrawn into the outer tube 1 through the traction tube 2 and finally removed as a whole.

[0086] With respect to the above process, the hardness of the connecting valve plate 51 is greater than the hardness of the opening and closing valve flap 52. The opening and closing valve flap 52 includes a flexible silicone sheet bonded to the connecting valve plate 51. The contour edge of the connecting valve plate 51 is bonded to the inner tube wall of the traction tube 2. The flexible silicone sheets can be connected or overlapped with each other to realize the deformation process under different states.

[0087] In another specific embodiment, from the functional perspective of the ultrasonic component 4, the ultrasonic component 4 includes one or more groups arranged inside the drug balloon 3, and each group of ultrasonic components 4 includes an ultrasonic cable 41 and an ultrasonic electrode sheet 42. The multiple groups of ultrasonic components 4 can be evenly spaced around the circumference of the drug balloon 3, which can enhance the uniformity of ultrasonic penetration.

[0088] See also Figure 4 , and combined with Figure 1-Figure 2 Specifically, the traction tube 2 in this embodiment is a multi-lumen tube structure, including a cable cavity 24 and a charging cavity 25. The ultrasonic cable 41 extends from the inside of the drug balloon 3 and is connected to the external ultrasonic equipment through the cable cavity 24. The perfusion valve 5 is arranged between the charging cavity 25 and the perfusion cavity 23. The opening and closing of the perfusion valve 5 controls the opening and closing of the filling channel.

[0089] From the perspective of facilitating control, the proximal end of the traction tube 2 is connected to a traction tube joint 26 , and the traction tube joint 26 includes a charging port 27 and a cable port 28 . The charging port 27 is communicated with the charging chamber 25 , and the cable port 28 is communicated with the cable chamber 24 .

[0090] During operation, the telescopic fit relationship of the traction tube 2 relative to the outer tube 1 can be controlled through the cooperation between the handle 11 and the traction tube joint 26 .

[0091] By docking an external charging device with the charging port 27 and connecting the ultrasonic cable 41 extending from the cable port 28 with the external ultrasonic device, the sound-conducting liquid can be filled and ultrasonic control operations can be performed respectively.

[0092] The drug 33 is evenly coated on the inner turning surface 31, and includes a mixture of one or more of paclitaxel, rapamycin and rapamycin derivatives. In this embodiment, paclitaxel is preferred. The content of the drug 33 is 2ug / mm, achieving a good therapeutic effect.

[0093] The ultrasonic osmosis drug balloon catheter of the present invention can avoid the washout loss of the drug 33 during the delivery process to the greatest extent and ensure the ultrasonic osmosis effect.

[0094] The present invention also provides an ultrasonic permeation treatment device for applying the drug 33 to the lesion 6 and promoting ultrasonic permeation. The ultrasonic permeation treatment device comprises an ultrasonic device and the ultrasonic permeation drug balloon catheter, wherein the ultrasonic device is electrically connected to the ultrasonic component 4 via an ultrasonic cable 41 .

[0095] Combination Figure 6 During the use of the ultrasonic osmosis treatment device, the main steps include extending and releasing the drug balloon 3 and ultrasonic osmosis operation. Specifically, the drug balloon 3 is first extended and released, and the drug balloon 3 in the compressed lying state is delivered to the proximal end of the lesion site 6 through the handle 11, and the traction tube 2 is pushed outward or the outer tube 1 is withdrawn, and the drug balloon 3 is exposed from the distal end of the outer tube 1 by means of the contact and friction between the balloon's everted surface 32 and the inner wall of the outer tube 1, until it is free from the restraint of the outer tube 1.

[0096] After suctioning the traction tube 2, the sound-conducting liquid is filled into the drug balloon 3. The suction is mainly used to discharge the gas in the traction tube 2, which is beneficial to the introduction of the sound-conducting liquid and prevents the phenomenon that the internal gas pushes out and cannot be filled.

[0097] After the sound-conducting liquid is filled, the filled balloon is made to fit against the blood vessel wall, and the drug balloon 3 is pushed distally. Combined with the contact and friction between the surface of the drug balloon 3 and the blood vessel wall or the lesion site 6, the inverted surface 31 is turned over and outward to expose the drug 33 to act on the lesion site 6.

[0098] Then, the ultrasonic device is turned on to promote the penetration and absorption of the drug 33 on the lesion site 6. During the treatment process, after completing the ultrasonic penetration of the lesion component at a certain site, the traction tube 2 can be pushed and pulled back and forth to control the surface of another part of the drug balloon 3, that is, to control the surface of the balloon part that has not been attached to the lesion site 6 and still retains the drug 33 to adhere to the lesion site 6 on another axial site for penetration promotion, so as to drive the coated drugs 33 at different sites to act on the lesions 6 on different axial sites, thereby forming a relatively dynamic release effect;

[0099] After completing the treatment of the lesion site 6 with the penetration-enhancing drug 33, use a suction tube to overcome the elastic closing pressure of the perfusion valve 5 by suctioning negative pressure, open the perfusion valve 5, and suck out the sound-conducting liquid in the drug balloon 3 and the traction tube 2. After the balloon is deflated, first withdraw the deflated balloon back into the outer tube 1 and then withdraw it as a whole.

[0100] The ultrasonic permeation treatment device of the present invention can utilize the means of "ultrasound-assisted drug 33 delivery" of paclitaxel drugs 33 in the vascular endothelium, relying on ultrasound and microbubble technology to significantly improve the local penetration and treatment effect of the drug 33.

[0101] The handle 11 on the outer tube 1 and the traction tube connector 26 on the traction tube 2 can realize the coordinated control and power supply of the traction tube 2 and the injection and withdrawal of the acoustic guiding liquid, thereby improving the operation efficiency.

[0102] The ultrasonic temperature generator of the ultrasonic equipment is set to 37-42°C, and the ultrasonic technical parameters are set:

[0103] The frequency of low-frequency ultrasound is 20kHz-3MHz, which can effectively cause microbubble oscillation and pore-forming effect.

[0104] By using low to medium intensity, preferably 0.5-2 W / cm 2 , for drug 33 delivery. Too high an intensity may cause thermal effects and tissue damage, while too low an intensity may not effectively activate microbubbles and enhance drug 33 penetration.

[0105] Incorporating pulsed mode, rather than continuous wave, for drug 33 delivery reduces heat accumulation while maintaining an effective mechanical effect.

[0106] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0107] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A sonophoresis drug balloon catheter, characterized in that: include: outer tube and drug balloon catheter; The outer tube is connected to a handle, and the drug balloon catheter extends into the outer tube through the handle and can be axially retracted relative to the distal tube opening of the outer tube; The drug balloon catheter comprises a traction tube and a drug balloon connected to the distal end of the traction tube, wherein the traction tube is connected to a traction tube head end, one axial end of the drug balloon is connected to the side wall portion of the traction tube near the distal end, and the other axial end is connected to the traction tube head end; The drug balloon can be compressed and accommodated inside the outer tube. In the compressed and accommodated state, the head end of the traction tube stays on the axial inner side of the outer tube, and an outward extension distance is left between the distal end of the head end of the traction tube and the distal end of the outer tube. The drug balloon comprises an inverted surface located on a segment corresponding to the outward extension interval, and an oppositely arranged outverted surface, wherein both the inverted surface and the outverted surface are outer surfaces of the drug balloon, and the outverted surface is in linear contact or annular contact with the inner wall of the outer tube; The inner inverted surface is coated with medicine, and an ultrasonic component is arranged inside the medicine balloon.

2. The ultrasonic osmosis drug balloon catheter according to claim 1, characterized in that: The drug balloon is filled with a sound-conducting liquid, and a plurality of perfusion holes for filling the sound-conducting liquid are provided on the side wall of the traction tube, and the plurality of perfusion holes are evenly distributed on the same circumference of the traction tube; The perfusion hole is arranged near the distal end of the traction tube and communicates with the cavity of the drug balloon. The head end of the traction tube includes a solid structure connected to the distal end of the traction tube.

3. The ultrasonic osmosis drug balloon catheter according to claim 2, characterized in that: A perfusion valve is arranged in the lumen of the traction tube, and the perfusion valve is arranged on the proximal side adjacent to the perfusion hole. The lumen between the distal end of the traction tube and the perfusion valve constitutes the perfusion cavity of the traction tube.

4. The ultrasonic osmosis drug balloon catheter according to claim 3, characterized in that: The injection valve includes two connecting valve plates arranged opposite to each other, and opening and closing valve flaps respectively connected to the connecting valve plates. The roots of the two connecting valve plates are respectively connected to the inner tube walls of the traction tube, and the opening and closing valve flaps are connected to each other and bent toward the distal end of the traction tube.

5. The sono-osmotic drug balloon catheter according to claim 4, characterized in that: The hardness of the connecting valve plate is greater than that of the opening and closing valve flap. The opening and closing valve flap comprises a flexible silicone sheet bonded to the connecting valve plate. The contour edge of the connecting valve plate is bonded to the inner tube wall of the traction tube.

6. The sonophoresis drug balloon catheter according to claim 3, characterized in that: The ultrasonic component includes one or more groups arranged inside the drug balloon, and each group of the ultrasonic component includes an ultrasonic cable and an ultrasonic electrode sheet.

7. The sono-osmotic drug balloon catheter according to claim 6, characterized in that: The traction tube comprises a cable cavity and a pressure chamber, the ultrasound cable extends from the inside of the drug balloon and is connected to an external ultrasound device through the cable cavity, and the perfusion valve is arranged between the pressure chamber and the perfusion cavity; The proximal end of the traction tube is connected with a traction tube joint, and the traction tube joint includes a charging port and a cable port, the charging port is communicated with the charging cavity, and the cable port is communicated with the cable cavity.

8. The sono-osmotic drug balloon catheter according to claim 3, characterized in that: The drug is evenly coated on the inner surface and includes a mixture of paclitaxel, rapamycin, and one or more rapamycin derivatives.

9. The sono-osmotic drug balloon catheter according to claim 3, characterized in that: A developing ring is arranged on the outer side wall of the distal end of the traction tube, or the distal end of the traction tube comprises a metal developing block with a solid structure.

10. A set of ultrasonic osmosis treatment devices, characterized in that: The invention comprises an ultrasonic device and a sono-osmotic drug balloon catheter according to any one of claims 1 to 9, wherein the ultrasonic device is electrically connected to the ultrasonic component via an ultrasonic cable; The drug balloon in the compressed lying state is delivered to the proximal end of the lesion through the handle, and the traction tube is pushed outward or the outer tube is withdrawn, so that the drug balloon is exposed from the distal end of the outer tube by means of the contact and friction between the everted surface of the balloon and the inner wall of the outer tube; After suctioning the traction tube, the sound-conducting liquid is filled into the drug balloon, so that the balloon is inflated and fits against the blood vessel wall, and the drug balloon is pushed to the distal end. Combined with the contact and friction between the surface of the drug balloon and the blood vessel wall or the lesion, the inner surface is turned outward to expose the drug to the lesion. Turn on the ultrasonic device to promote drug absorption, and push and pull the traction tube back and forth to drive the coated drugs on different parts to act on the lesions on different axes, forming a relatively dynamic release effect; After the operation, use the suction tube to overcome the elastic closing pressure of the perfusion valve through the suction negative pressure, open the perfusion valve, and suck out the sound-conducting fluid in the balloon and traction tube. After the balloon is deflated, withdraw the entire balloon.

Images