CN115089288B

CN115089288B - Renal artery ablation system

Info

Publication number: CN115089288B
Application number: CN202211022421.5A
Authority: CN
Inventors: 祁勇翔; 聂芳芳; 党泽方; 唐乃杰; 缪永生; 罗雷
Original assignee: Shanghai Biomagic Medical Co ltd
Current assignee: Shanghai Biomagic Medical Co ltd
Priority date: 2022-08-25
Filing date: 2022-08-25
Publication date: 2022-11-15
Anticipated expiration: 2042-08-25
Also published as: CN115089288A

Abstract

The invention discloses a renal artery ablation system, which belongs to the field of medical instruments and comprises a balloon part, wherein the balloon part comprises a balloon far-end cone part, a balloon supporting part and a balloon near-end cone part which are sequentially connected from far to near along the axial direction; the position adjusting area is connected with the near end and/or the far end of the medicine delivery area, the outer diameter of the position adjusting area is smaller than or equal to that of the medicine delivery area, and the position of the medicine delivery area can be adjusted by the position adjusting area. When the balloon delivery device is used, the drug delivery holes in the drug delivery area deliver drugs to the blood vessel wall, the outer diameter of the position adjusting area is smaller than or equal to that of the drug delivery area, under the action of the position adjusting area, the balloon supporting portion can be ensured to be overlapped with the central axis of the corresponding blood vessel wall as far as possible, and the drug delivery effect of the drug delivery area on a target area is improved.

Description

Renal artery ablation system

Technical Field

The invention relates to the field of medical instruments, in particular to a renal artery ablation system.

Background

Renal artery sympathetic nerve activation is an important factor in the development and progression of hypertension. Its major pathological manifestations include renin release, an increase in the reabsorption of sodium by the renal tubules, and a decrease in renal blood flow. Renal sympathetic afferents may also modulate systemic sympathetic nerve activity. Percutaneous renal artery sympathetic nerve ablation, an interventional technique that has emerged in recent years, selectively partially blocks the renal artery sympathetic afferent and efferent nerve fibers by localized thermal injury.

At present, a common ablation tool comprises an ablation catheter and a balloon, a minimally invasive intervention mode is adopted, chemical agents can reach the balloon through the catheter, and the balloon is in contact with the wall of a renal artery blood vessel, so that the chemical agents act on the wall of the blood vessel. The balloon is impacted in the moment of injecting the medicament, and the position of the balloon is unstable due to the small contact area between the balloon and the wall of the renal artery blood vessel, so that the drug delivery position is inaccurate and the treatment effect is influenced due to the displacement of the balloon in the wall of the renal artery blood vessel.

Disclosure of Invention

The invention aims to provide a renal artery ablation system to solve the technical problem that a balloon delivered drug is easy to displace to cause inaccurate drug delivery position in the prior art.

As the conception, the technical scheme adopted by the invention is as follows:

the utility model provides a renal artery ablation system, includes sacculus portion, sacculus portion includes sacculus distal end pyramis, sacculus supporting part and sacculus proximal end pyramis that connect gradually by far and near along the axial, the sacculus supporting part includes:

a drug delivery region having a plurality of drug delivery pores distributed over a surface thereof;

and the position adjusting area is connected with the near end and/or the far end of the drug delivery area, the outer diameter of the position adjusting area is smaller than or equal to that of the drug delivery area, and the position of the drug delivery area can be adjusted by the position adjusting area.

Wherein, the outer diameter of the position adjusting area is gradually reduced from far to near.

Wherein the position adjusting area is connected with the drug delivery area through a frustum.

The position adjusting device at least comprises a position adjusting area and a constraining structure, wherein the constraining structure at least comprises constraining parts distributed on the periphery of the position adjusting area, and the constraining parts can limit the radial expansion of the position adjusting area.

The balloon distal end conical part comprises a balloon distal end section and a first transition section which are sequentially connected from far to near, the balloon distal end section is a closed end, and the first transition section is in a conical frustum shape; the constraining structure further includes a constraining distal connecting rod connected to a distal end of the constraint, the constraining distal connecting rod located outside of the first transition segment and the drug delivery region.

Wherein, be provided with first transition structure on the restraint distal end connecting rod, first transition structure is W shape, V-arrangement, U-shaped, S-shaped or L shape extension.

The balloon proximal end conical part comprises a second transition section and a balloon proximal end section which are sequentially connected from far to near, and the second transition section is in a cone frustum shape; the constraining structure further includes a constraining proximal connecting rod connected to a proximal end of the constraint, the constraining proximal connecting rod located outside of the second transition segment.

The renal artery ablation system further comprises a catheter part connected with the balloon part, the catheter part at least comprises an inner tube and a middle tube, the middle tube is sleeved outside the inner tube, the inner tube is fixedly connected with the balloon far-end section, and the balloon near-end section is fixed with the middle tube.

The constraining structure further comprises a constraining proximal end part connected with the constraining proximal end connecting rod, and the constraining proximal end part, the balloon proximal end section and the middle tube are fixed together.

The catheter part further comprises an outer tube, the outer tube is sleeved outside the middle tube, the constraint structure further comprises a constraint proximal end portion connected with the constraint proximal end connecting rod, and the constraint proximal end portion is fixed with the outer tube.

The invention has the beneficial effects that:

when the renal artery ablation system provided by the invention is used, the drug delivery area is in contact with the blood vessel wall, the drug delivery holes deliver the drug to the blood vessel wall, the outer diameter of the position adjusting area is smaller than or equal to that of the drug delivery area, and under the action of the position adjusting area, the balloon supporting part can be ensured to be overlapped with the central axis of the corresponding blood vessel wall as far as possible in the renal artery, so that the drug delivery effect of the drug delivery area on a target area is improved. Meanwhile, the balloon can be impacted during drug delivery, so that the balloon extends to the far end, the position adjusting area can play a role in anchoring when the balloon supporting portion is expanded, the drug delivery area is dragged, and the degree of the drug delivery area extending forwards to the far end is avoided or reduced.

Drawings

FIG. 1 is a schematic view of a renal artery ablation system provided in accordance with an embodiment of the present invention;

FIG. 2 is a schematic view of a balloon portion according to one embodiment of the present invention;

FIG. 3 is a schematic view of another balloon portion provided in accordance with an embodiment of the present invention;

FIG. 4 is a schematic view of a further balloon portion provided in accordance with an embodiment of the present invention;

FIG. 5 is a schematic view of a drug reservoir portion provided in accordance with an embodiment of the present invention;

FIG. 6 is a schematic view of a constraint structure and balloon portion provided in accordance with a second embodiment of the invention;

FIG. 7 is a schematic view of another constraint and a balloon portion provided in accordance with a second embodiment of the invention;

FIG. 8 is a schematic view of a constraint structure and balloon portion engaged with the distal end of a renal artery provided in accordance with a second embodiment of the invention;

FIG. 9 is a schematic view of a constraint structure and balloon portion provided in accordance with a third embodiment of the invention;

FIG. 10 is a schematic view of another constraint and a balloon portion provided in accordance with a third embodiment of the invention;

FIG. 11 is a schematic view of a medicine reservoir portion provided in accordance with a fourth embodiment of the present invention;

fig. 12 is a schematic view of a medicine reservoir portion provided in accordance with a fifth embodiment of the present invention.

In the figure:

110. a balloon portion; 111. a balloon distal taper; 1111. a balloon distal section; 1112. a first transition section; 112. a balloon support portion; 1121. a drug delivery region; 1122. a position adjustment area; 1123. a drug delivery aperture; 113. a balloon proximal taper; 1131. a second transition section; 1132. a balloon proximal segment;

120. a conduit portion; 121. an inner tube; 122. a middle tube; 123. a proximal luer fitting; 124. an outer tube;

130. a medicine storage part; 131. a first luer switch valve; 132. a first circular tube shaped medicine storage device; 133. a second luer switch valve; 134. a third luer lock valve; 135. a second circular tube-shaped medicine storage device;

140. a constraint structure; 141. constraining the distal portion; 142. a constrained distal connecting rod; 1421. a first transition structure; 143. a restraint section; 144. constraining the proximal connecting rod; 1441. a second transition structure; 145. constraining the proximal portion;

200. a pharmaceutical formulation;

300. distal to the renal artery.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.

In the description of the present invention, unless expressly stated or limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, e.g., as meaning permanently connected, removably connected, or integral to one another; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. "beneath," "under" and "beneath" a first feature includes the first feature being directly beneath and obliquely beneath the second feature, or simply indicating that the first feature is at a lesser elevation than the second feature.

The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.

Example one

Referring to fig. 1 and 2, an embodiment of the present invention provides a renal artery ablation system including a drug delivery balloon system and a drug formulation 200. The drug delivery balloon system includes a balloon portion 110, a catheter portion 120, and a drug reservoir portion 130, which are connected in sequence from distal to proximal to form an overall structure of the drug delivery balloon system. Wherein the drug reservoir portion 130 is pre-loaded with a pharmaceutical formulation 200.

The balloon portion 110 functions to mechanically support the distal renal artery and to deliver the drug formulation 200 at the region of conformance. The catheter portion 120 includes at least an inner tube 121, a middle tube 122 and a proximal luer 123, the inner tube 121 being for the passage of a guidewire, and the middle tube 122 and the inner tube 121 being for the passage of the pharmaceutical formulation 200 therebetween. The reservoir portion 130 is connected to the proximal luer fitting 123 for storage and reconstitution of the pharmaceutical formulation 200. In use, the liquid drug preparation 200 flows through the interior of the drug reservoir portion 130, passes through the gap between the inner tube 121 and the middle tube 122, reaches the interior of the balloon portion 110, and is ejected under high pressure to act on the wall of the renal artery blood vessel. The proximal luer 123 is an existing structure, and a female luer is used in this embodiment. The reservoir portion 130 is connected to an existing pressure filling device that provides pressure for the flow of the pharmaceutical formulation 200.

The balloon portion 110 includes a balloon distal end tapered portion 111, a balloon support portion 112, and a balloon proximal end tapered portion 113 that are connected in this order from the distal end to the proximal end in the axial direction. Because the vascular wall is cylindric, generally set up sacculus portion 110 to well air sacculus structure, and sacculus portion 110 has the axis, when using, guarantees sacculus portion 110 and the coincidence of the axis of vascular wall as far as possible.

The balloon distal taper portion 111 is a hollow tubular structure, and includes a balloon distal section 1111 and a first transition section 1112 connected in sequence from the distal end to the proximal end. The far-end section 1111 of the balloon is a closed end and is a thin-wall tube structure with a smaller diameter, and the inner tube 121 is connected with the closed end. The first transition segment 1112 is in a truncated cone shape, the diameter of the first transition segment gradually increases from far to near, and the projection trajectory can be an oblique straight line, a hyperbolic curve or an exponential line.

The balloon support 112 has a hollow tubular structure including a drug delivery region 1121 and a position adjustment region 1122. The position adjustment region 1122 may be provided at the distal end of the drug delivery region 1121, or the position adjustment region 1122 may be provided at the proximal end of the drug delivery region 1121, or the position adjustment region 1122 may be provided at both the proximal end and the distal end of the drug delivery region 1121.

In the present embodiment, the position adjustment region 1122 is disposed at the proximal end of the drug delivery region 1121. Wherein the first transition segment 1112 is connected to the drug delivery region 1121, and the maximum diameter of the first transition segment 1112 is equal to the outer diameter of the drug delivery region 1121. The outer diameter of the drug delivery region 1121 is greater than or equal to the inner diameter of the distal opening of the renal artery, so that the drug delivery region 1121 is tightly attached to the inner wall of the blood vessel, and the drug delivery efficiency of the tissue of the blood vessel wall is improved. Further, it is preferable that the outer diameter of the drug delivery region 1121 is greater than the inner diameter of the distal opening of the renal artery by 0mm to 2.0mm, so as to avoid the risk of acute spasm and tearing of the blood vessel caused by over-expansion of the balloon.

The drug delivery region 1121 is distributed with a plurality of drug delivery holes 1123 on the surface thereof for drug delivery. The position adjustment region 1122 is not used for drug delivery, so that only the drug delivery holes 1123 need to be formed in the drug delivery region 1121, and there is no need to excessively form the drug delivery holes 1123, which can avoid the waste of drugs in the non-target treatment vessel region.

Wherein, the drug delivery hole 1123 is a micron-sized small hole with a diameter of 1-999 μm, and is further optimized to 5-20 μm. The number of the micropores is 1-100, the flow rate under the high pressure state (8-20 atm) is 0.1-10mL/min while ensuring that the pharmaceutical preparation 200 can smoothly pass through the micropores, the rotating frequency of the clinical pressure filling device is acceptable by doctors, and the patient can tolerate the single liquid injection amount. The plurality of drug delivery apertures 1123 may be evenly distributed or unevenly distributed across the surface of the drug delivery region 1121.

Referring to fig. 2, the outer diameter of the position adjustment region 1122 is equal to the outer diameter of the drug delivery region 1121, which facilitates manufacturing and the position adjustment region 1122 can adjust the position of the drug delivery region 1121. When the device is used, the drug delivery region 1121 is in contact with a blood vessel wall, the drug delivery holes 1123 deliver drugs to the blood vessel wall, and under the action of the position adjusting region 1122, the posture of the balloon support portion 112 can be adjusted inside the renal artery, so that the balloon support portion 112 is ensured to be overlapped with a central axis of the corresponding blood vessel wall as much as possible, and the drug delivery effect of the drug delivery region 1121 on a target region is improved. Meanwhile, the balloon is impacted at the moment of drug delivery, so that the balloon extends to the distal end, the position adjusting region 1122 can play a role in anchoring when the balloon supporting portion 112 is expanded, the position of the drug delivery region 1121 is adjusted, the drug delivery region 1121 is dragged, and the degree of the drug delivery region 1121 extending forward to the distal end is avoided or reduced.

If only the drug delivery region 1121 is designed in the balloon support portion 112, and the position adjustment region 1122 is not designed, the balloon support portion 112 may deflect or be positioned incorrectly when being expanded in a blood vessel, which may cause poor attachment between the drug delivery region 1121 and a renal artery of a target treatment segment, and decrease the drug delivery efficiency, or due to drug impact, the balloon may extend distally, and the distal end of the balloon support portion 112 may partially exceed the edge of the distal end of the renal artery, so as to obstruct blood flow of a blood vessel inside the kidney, and cause adverse reactions such as thrombus caused by renal ischemia or turbulence. According to the medical general knowledge, the renal artery of the target treatment section is located at the periphery of the far-end blood vessel of the renal artery, the periphery of the far-end blood vessel of the renal artery is closely attached to sympathetic nerves for controlling hypertension, the medicine is delivered to the inner wall of the far-end blood vessel of the renal artery through the medicine delivery holes 1123, the medicine adhered to the inner wall can penetrate through the thickness of the blood vessel, acts at the periphery of the far-end blood vessel of the renal artery and enters the interior of the sympathetic nerves, and the killing effect on the sympathetic nerves is better.

The axial length design of the drug delivery region 1121 refers to the length of a region where the outside of the distal opening of the renal artery closely fits the sympathetic nerves controlling hypertension, and the axial length is preliminarily designed to be less than 30mm. According to the common medical knowledge, the average lengths of the left and right major renal arteries are 41.1 + -12.4 mm and 33.8 + -12.5 mm, respectively, where it is assumed that the axial length of the drug delivery region 1121 should be less than the total length of the renal arteries, 30mm. Further designed to be 5-15mm. By setting the axial length of the drug delivery region 1121 to be less than half of the total length of the renal artery, it is considered that the drug delivery region 1121 occupies the distal half of the length of the renal artery, which can satisfy the administration requirement; in order to ensure the effect of nerve ablation, the lower limit is designed to be 5mm; the position adjustment region 1122 occupies the proximal half of the length of the renal artery, so a design lower limit of 15mm can provide adjustment to the drug delivery region 1121.

The axial length of the drug delivery region 1121 is designed to ensure that the total dose of the drug that kills the target sympathetic nerve at the renal artery is sufficient to ensure the blood pressure lowering effect of the refractory hypertension. At the same time, injury to non-target renal artery regions, including inflammatory responses caused by mechanical expansion of the drug delivery region 1121 and non-target neurotoxic responses caused by agents used for nerve killing, can also be avoided or attenuated. According to the medical common knowledge, the non-target renal artery region is located at the periphery of a proximal blood vessel of the renal artery, sympathetic nerves at the periphery of the proximal blood vessel are looser and farther away from the blood vessel, and the medicine has lower efficiency of penetrating the blood vessel wall to act on the corresponding sympathetic nerves, so the non-target renal artery region is formed.

Referring to fig. 3, the outer diameter of the position adjustment region 1122 is smaller than the outer diameter of the drug delivery region 1121. In use, the drug delivery region 1121 is in contact with the vessel wall, the drug delivery holes 1123 deliver the drug to the vessel wall, and since the outer diameter of the position adjustment region 1122 is smaller than the outer diameter of the drug delivery region 1121, the position adjustment region 1122 does not cause mechanical expansion injury and inflammatory reaction to the vessel wall; under the action of the position adjustment region 1122, the posture of the balloon support portion 112 can be adjusted inside the renal artery, so as to ensure that the balloon support portion 112 coincides with the central axis of the corresponding blood vessel wall as much as possible, and improve the drug delivery effect of the drug delivery region 1121 on the target region. Meanwhile, the balloon is impacted at the moment of drug delivery, so that the balloon extends to the distal end, the position adjusting region 1122 can play a role in anchoring when the balloon supporting portion 112 is expanded, the position of the drug delivery region 1121 is adjusted, the drug delivery region 1121 is dragged, and the degree of the drug delivery region 1121 extending forward to the distal end is avoided or reduced.

The position adjustment region 1122 is connected to the drug delivery region 1121 by a frustum. The difference between the outer diameter of the position adjustment region 1122 and the inner diameter of the distal opening of the renal artery is between-0.5 mm and 0.5mm, so that even if the position adjustment region 1122 is expanded to a certain extent at the moment of drug delivery, the vessel wall is not excessively expanded, and severe mechanical vasodilation injury and inflammatory reaction are not caused to the vessel wall; on the other hand, the position adjustment region 1122 and the drug delivery region 1121 can both be stably attached to the vessel wall, and the position adjustment region 1122 can perform better supporting and position adjusting functions on the drug delivery region 1121, so that the drug delivery region 1121 is stable in position.

Referring to FIG. 4, the outer diameter of the position adjustment region 1122 decreases from distal to proximal. The maximum outer diameter of the position adjustment region 1122 is equal to the outer diameter of the drug delivery region 1121, and the difference between the outer diameter of the position adjustment region 1122 and the inner diameter of the renal artery distal opening is between-0.5 mm and 0.5 mm. On one hand, mechanical expansion injury and inflammatory reaction of the position adjusting region 1122 on the vessel wall are reduced, and on the other hand, the drug delivery region 1121 can be supported and position adjusted, so that the position of the drug delivery region 1121 is stable.

The balloon proximal cone portion 113 is a hollow tubular structure, and includes a second transition section 1131 and a balloon proximal section 1132 connected in sequence from the distal end to the proximal end. The balloon proximal end portion 1132 is a thin-wall tube structure with a smaller diameter, and is the liquid inflow end of the balloon portion 110 for the inflow of the external working liquid. The second transition section 1131 is in the shape of a truncated cone, the diameter of which gradually decreases from far to near, and the projection trajectory can be an oblique straight line, a hyperbolic curve or an exponential line.

The balloon proximal section 1132 is connected to the middle tube 122 and the second transition section 1131 is connected to the position adjustment region 1122. The maximum diameter of the second transition section 1131 is the same as the outer diameter of the proximal end of the position adjustment region 1122, which can reduce the mechanical dilatation injury to the renal artery in the non-target region and reduce the inflammatory response caused by the mechanical dilatation injury. The position of the blood vessel wall corresponding to the maximum diameter region of the second transition section 1131 is not rich in sympathetic nerves for controlling blood pressure, and is not an ideal treatment region for renal artery chemical ablation.

Referring to fig. 1 and 5, the reservoir portion 130 is connected to the proximal luer fitting 123 for storage and reconstitution of a pharmaceutical formulation 200. In use, liquid flows through the interior of the medicine storage device part 130, passes through the gap between the inner tube 121 and the middle tube 122, reaches the interior of the balloon part 110, and is ejected under the action of high pressure to act on the wall of the renal artery blood vessel rich in sympathetic nerves.

In this embodiment, the medicine storage device portion 130 is a single medicine storage device, and includes a first luer switch valve 131, a first circular tube-shaped medicine storage device 132 and a second luer switch valve 133 connected in sequence from the far side to the near side. The proximal luer fitting 123 is connected to a first luer lock valve 131 and a second luer lock valve 133 is connected to a proximal pressure filling means. The first circular tube shaped drug reservoir 132 is loaded with one or more lyophilized powders of pharmaceutical formulation 200 for applications including but not limited to anti-cell proliferation, neurotoxicity, anti-platelet, anti-coagulation, thrombolysis, and blood lipid lowering, specifically including rapamycin and its derivatives, taxanes, vinca alkaloids, ixabepilone or anhydrous ethanol. Wherein, luer switch valve is current valve structure.

Example two

Fig. 6 to 8 show a second embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the differences between the second embodiment and the first embodiment will be described. The difference is that the periphery of the sacculus part 110 is provided with a restraining structure 140, and the restraining structure 140 at least can restrain the capability of the sacculus part 110 to deform along the radial direction and reduce the mechanical expansion injury and the secondary inflammatory response to the non-treatment segment renal artery which is not rich in sympathetic nerves.

The constraint structure 140 includes a constraint distal portion 141, a constraint distal connecting rod 142, a constraint portion 143, a constraint proximal connecting rod 144 and a constraint proximal portion 145 connected in sequence from distal to proximal.

The constraining portions 143 are distributed on the outer periphery of the position adjustment region 1122, and the constraining portions 143 can restrict radial expansion of the position adjustment region 1122. Under high pressure, the position adjustment region 1122 made of polymer material has a relatively weak ability to resist pressure deformation, and may have an actual contour outer diameter similar to that of the drug delivery region 1121. The reduced mechanical expansion of the renal arteries by position adjustment zone 1122, and a reduction in the inflammatory response associated with the injury to the mechanical expansion, may not be achieved with insignificant differences in outer diameter. The constraining structure 140 is configured to forcibly limit radial expansion of the polymeric position-adjusting region 1122 during balloon expansion by its own stiffening structure, such that the outer diameter of the outline of the position-adjusting region 1122 meets the small-size state of the desired target, thereby reducing the mechanical dilatation injury and secondary inflammatory response to the non-sympathetic-segment renal artery.

The distal constraining portion 141 originates outside of the balloon distal segment 1111 of the balloon distal taper 111 and is fixed thereto to ensure that the entirety of the constraining structure 140 does not fall off the system during balloon expansion and contraction. The connection mode can be laser welding, hot melting welding or glue welding.

The constraining distal connecting rod 142 is located outside of the first transition segment 1112 of the balloon distal cone portion 111 and the drug delivery region 1121 of the balloon support portion 112. The constraining distal connecting rod 142 is located between the constraining distal portion 141 and the constraining portion 143 in an elongate rod configuration. Constraining the distal connecting rod 142 can limit radial expansion of the first transition segment 1112 of the balloon distal cone portion 111 and the drug delivery region 1121 of the balloon support portion 112.

Before and after balloon expansion, the profile length of the balloon support portion 112 does not change, but the profile length of the first transition segment 1112 of the balloon distal end cone portion 111 becomes longer. The contour length refers to the length of the outer contour. Specifically, in the balloon-deflated state, the projection of the first transition segment 1112 of the balloon distal cone portion 111 is a right triangle, the hypotenuse is the profile length, and the short bottom side extending parallel to the axial direction is considered as the profile length in the balloon-deflated state. After the balloon is expanded, the outer peripheral surface of the first transition segment 1112 of the balloon distal taper portion 111 is stretched in the radial direction, and the difference between the bevel edge and the bottom short edge is the amount of length deformation of the restraining distal connecting rod 142 after the balloon is expanded.

After the balloon is expanded, the constraint distal end connecting rod 142 may be broken due to the tensile force action of the constraint distal end connecting rod 142 as the constraint distal end connecting rod 142 is lengthened; constraining the junction of distal section 141 and balloon distal segment 1111 from pulling off; the restraining part 143 adjacent to the restraining distal end connecting rod 142 is lengthened by the axial pulling force, so that the restraining part 143 covers the outside of the drug delivery region 1121 of the balloon supporting portion 112, the outline diameter of the drug delivery region 1121 is reduced, the effective contact area with the target renal artery is reduced, the sympathetic nerve killing rate is reduced, and the treatment effect of the intractable hypertension is further influenced.

Therefore, the elongate shaft-shaped constraining distal connecting rod 142 is provided with a first transition structure 1421, and the first transition structure 1421 extends in a W-shape, V-shape, U-shape, S-shape or L-shape for feedback compensation of the elongation of the profile length of the constraining distal connecting rod 142 after balloon expansion. In the deflated state of the balloon, the contours of the first transition structures 1421 are in a curved state; in the balloon-expanded state, the first transition structures 1421 are straightened by the force applied thereto, thereby satisfying the requirement of restraining the length of the distal connecting rod 142 from extending.

The specific size of the different first transition structures 1421 and the number of first transition structures 1421 on the distal connecting rod 142 need to be referred to the actual size of the balloon, which at least includes the nominal diameter of the balloon and the included angle between the balloon distal taper portion 111 and the horizontal line. The number of the constrained distal connecting rods 142 is 1-20, preferably 2-6.

After expansion, the balloon portion 110 will contact the outer, constraining distal connecting rod 142 and cause a significant deformation of the latter, which increases in outer diameter significantly. Because the restraining distal connecting rod 142 is an elongate rod structure, the inherent support force of the structure is negligible, and the mechanical restraint and limitation on the inner drug delivery region 1121 during deformation is also negligible. The maximum outer diameter of the drug delivery region 1121 is determined by the mechanical properties of the material of the drug delivery region 1121 itself, the original structural design (wall thickness and original outer diameter), and the pressurization pressure. Even under the action of the constrained distal connecting rod 142, the outer diameter of the contour of the drug delivery region 1121 is still greater than or equal to the inner diameter of the opening of the renal artery distal end 300, so as to ensure that the drug delivery region 1121 is tightly combined with the inner wall of the blood vessel, and improve the drug delivery efficiency of the tissue of the blood vessel wall. Further, it is preferable that the outer diameter of the drug delivery region 1121 is still larger than the inner diameter of the opening of the renal artery distal end 300 by 0mm-2.0mm, so as to avoid the risk of acute spasm and tearing of the blood vessel caused by over-expansion of the balloon.

The constraining portion 143 is connected to the constraining distal end connecting rod 142 and the constraining proximal end connecting rod 144, respectively. The constraints 143 can ensure a low profile diameter for the location adjustment zone 1122, reducing mechanical dilatation damage to non-target vessels by the system. Specifically, the restraint portion 143 includes a plurality of restraint bars provided around the outer periphery of the position adjustment region 1122, the plurality of restraint bars being arranged at intervals in the axial direction of the position adjustment region 1122. Since the restraint lever is provided around the outer periphery of the position adjustment region 1122, the radial expansion of the position adjustment region 1122 can be restricted. The restraint rod extends in a V shape or a spiral shape. The restraining bar in fig. 6 has a V-shaped structure, and the restraining bar in fig. 7 has a spiral structure. In addition, the constraining portion 143 may also be a multi-mesh structure, and the mesh shape is a diamond, a circle or a hexagon, which is not limited herein.

After balloon expansion, the restriction 143 is in intimate contact with the position adjustment region 1122 and expands radially under the latter. Under the restriction of its own structure, when the outer diameter of the restriction portion 143 reaches the maximum expanded outer diameter, the outer diameter dimension does not increase with the increase of the charging pressure of the inner position adjustment region 1122, that is, reaches the upper limit of its own diameter dimension, and plays a role of restricting the maximum outer diameter of the position adjustment region 1122.

The maximum expanded outer diameter of the restraint portion 143 is smaller than the renal artery reference vessel diameter, i.e., the two are in clearance fit, thereby reducing mechanical expansion of the position adjustment region 1122 on the renal artery and reducing inflammatory response due to mechanical expansion injury. The outside of the blood vessel corresponding to the location adjustment zone 1122 is not rich in sympathetic nerves for controlling blood pressure, and is not an ideal treatment zone for chemical ablation of the renal arteries.

The constraining proximal connecting bar 144 is located outside of the second transition section 1131 of the balloon proximal taper 113. The constrained proximal connecting rod 144 is in an elongated rod configuration between the constraining portion 143 and the constrained proximal portion 145.

The second transition section 1131 of the balloon proximal taper 113 has a longer profile length before and after balloon expansion. The principle is similar to constraining the distal connecting rod 142. Specifically, in the balloon deflated state, the projection of the second transition section 1131 of the balloon proximal cone portion 113 is a right triangle, the hypotenuse is the profile length, and the short bottom side extending parallel to the axial direction is considered as the profile length in the balloon deflated state. After the balloon is expanded, the outer peripheral surface of the second transition section 1131 of the balloon proximal cone portion 113 is stretched in the radial direction, and the difference between the bevel edge and the bottom short edge is the length deformation amount of the restraining distal connecting rod 142 after the balloon is expanded.

The lengthening of the restraining proximal connector 144 after balloon expansion may cause the restraining proximal connector 144 to break under tension. Therefore, a second transition 1441 is disposed on the elongated proximal constraining connecting rod 144, and the second transition 1441 extends in a W-shape, V-shape, U-shape, S-shape or L-shape for feedback compensation of the elongation of the profile length of the balloon expanded proximal constraining connecting rod 144. In the balloon-deflated state, the contours of these second transition structures 1441 are in a curved state; in the balloon-expanded state, these second transition structures 1441 are straightened by the force applied thereto, and the requirement of restraining the elongation of the proximal connecting rod 144 is satisfied.

The specific size of the different second transition structures 1441 on the proximal connecting rod 144 and the number of the second transition structures 1441 need to be referred to the actual size of the balloon, which at least includes the nominal diameter of the balloon and the included angle between the balloon distal taper portion 111 and the horizontal line. The number of the constrained proximal connecting rods 144 is 1-20, preferably 1-6. After expansion, the balloon portion 110 will contact the outer constrained proximal connecting rod 144 and cause the latter to deform significantly, assuming a conical configuration.

Constraining proximal portion 145 begins outside of balloon proximal segment 1132 and is fixed to balloon proximal segment 1132. Because balloon proximal segment 1132 is fixedly connected to middle tube 122, proximal portion 145 is constrained while fixedly connected to middle tube 122. It is ensured that the restraining structure 140 as a whole does not fall off the system during balloon expansion and contraction. The connection mode can be laser welding, hot melting welding or glue welding.

The constraining proximal portion 145 is fixedly attached to the balloon proximal section 1132, in combination with the constraining distal portion 141 being fixed to the balloon distal section 1111, such that the constraining structure 140 is integrally fixed to the outside of the balloon portion 110. As the balloon portion 110 is expanded, the axial length between the constraining distal portion 141 and the constraining proximal portion 145 of the constraining structure 140 is constant. The external force causing the overall deformation of the constraining structure 140 is only the radial expansion contact force from the balloon portion 110, causing the radial tensile deformation of the constraining distal connecting rods 142 and the constraining proximal connecting rods 144 and the diameter expansion deformation of the constraining portion 143.

EXAMPLE III

Fig. 9 and 10 show a third embodiment, wherein the same or corresponding parts as the second embodiment are provided with the same reference numerals as the second embodiment. For the sake of simplicity, only the points of difference between the third embodiment and the second embodiment will be described. The catheter portion 120 further includes an outer tube 124, the outer tube 124 is disposed outside the middle tube 122, the constraining proximal portion 145 is fixedly connected to the outer tube 124, and the balloon proximal portion 1132 is fixed to the middle tube 122, so that the constraining structure 140 can move axially relative to the balloon portion 110. Outer tube 124 may limit deformation of constraining structure 140.

When the balloon portion 110 is expanded, if the constraining structure 140 is deformed unexpectedly, which causes the constrained proximal connecting rod 144 to be stretched distally, the covering area of the constraining structure 140 in the position adjusting region 1122 will be reduced, and especially a proximal region of the position adjusting region 1122 will be partially covered by the constrained proximal connecting rod 144. The restraining force of restraining proximal connecting rod 144 against the expansion of position adjustment region 1122 is almost negligible, so the maximum profile outer diameter of the proximal region of position adjustment region 1122 will exceed the predetermined maximum safe outer diameter. That is, the proximal region of the position adjustment zone 1122, when the balloon is maximally inflated, is more mechanically distended and damaged to the inner wall of the non-targeted renal artery that does not include rich sympathetic nerves, causing severe smooth muscle cell hyperproliferation and migration, resulting in restenosis of the renal artery. Therefore, in order to prevent this, the restraining proximal end 145 may be fixedly connected to the outer tube 124, and the outer tube 124 drags the restraining proximal end 145 to adjust the posture of the restraining structure 140, so as to reduce the probability that the restraining proximal end connecting rod 144 covers the proximal end region of the position adjustment region 1122.

The constraining section 143 is connected to the constraining distal end connecting rod 142 and the constraining proximal end connecting rod 144, respectively. The restraint 143 can ensure a small profile diameter of the position adjustment region 1122, reducing mechanical dilation damage to non-target vessels by the system. Specifically, the restraint portion 143 includes a plurality of restraint bars provided around the outer periphery of the position adjustment region 1122, the plurality of restraint bars being arranged at intervals in the axial direction of the position adjustment region 1122. Since the restraint lever is provided around the outer periphery of the position adjustment region 1122, radial expansion of the position adjustment region 1122 can be restricted. The restraint rod extends in a V shape or a spiral shape. The restraining bar of fig. 9 has a V-shaped structure, and the restraining bar of fig. 10 has a spiral structure. In addition, the constraining portion 143 may also be a multi-mesh structure, and the mesh shape is a diamond, a circle or a hexagon, which is not limited herein.

Example four

Fig. 11 shows a fourth embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the points of difference between the fourth embodiment and the first embodiment will be described. The difference is that the medicine storage part 130 is a serial multi-medicine storage device. The in-line multi-reservoir includes a first Lu Erkai off valve 131, a second luer on-off valve 133, a third luer on-off valve 134, a first circular tube reservoir 132 and a second circular tube reservoir 135. In the multi-drug reservoir in series, the proximal luer 123 is connected to the first luer switch valve 131, and the first round tubular drug reservoir 132 and the second round tubular drug reservoir 135 are connected in series through the second luer switch valve 133. When the number of the medicine storages is larger than 2, the number of the luer switch valves can be adjusted, and the serial connection of the medicine storages is ensured. The first circular tube-shaped drug reservoir 132 and the second circular tube-shaped drug reservoir 135 are loaded with one or more lyophilized powders of pharmaceutical preparations for applications including, but not limited to, anti-cell proliferation, neurotoxicity, anti-platelet, anti-coagulation, thrombolysis, and blood lipid reduction, specifically including rapamycin and its derivatives, taxanes, vinca alkaloids, ixabepilone or anhydrous ethanol. In the multiple drug reservoirs connected in series, the drug preparations 200 in the first circular tube-shaped drug reservoir 132 and the second circular tube-shaped drug reservoir 135 enter the balloon portion 110 sequentially under the action of a single liquid, and act on the wall of the target renal artery blood vessel.

EXAMPLE five

Fig. 12 shows a fifth embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the points of difference between the fifth embodiment and the first embodiment will be described. The difference is that the medicine storage part 130 is a parallel multi-medicine storage device. The parallel multi-reservoir includes a first Lu Erkai off valve 131, a second luer on-off valve 133, a third luer on-off valve 134, a first circular tube reservoir 132 and a second circular tube reservoir 135. In the parallel multi-drug reservoir, the first round tube-shaped drug reservoir 132 and the second round tube-shaped drug reservoir 135 are connected in parallel through the first luer switch valve 131, and the first luer switch valve 131 is simultaneously connected with the proximal luer connector 123. When the number of the medicine storages is larger than 2, the number and the design of the luer switch valves can be adjusted, and the parallel connection of the medicine storages is ensured. The first circular tube-shaped drug reservoir 132 and the second circular tube-shaped drug reservoir 135 are loaded with one or more lyophilized powders of pharmaceutical preparations for applications including, but not limited to, anti-cell proliferation, neurotoxicity, anti-platelet, anti-coagulation, thrombolysis, and blood lipid reduction, specifically including rapamycin and its derivatives, taxanes, vinca alkaloids, ixabepilone or anhydrous ethanol. In the parallel connection multiple medicine reservoirs, the medicine preparations 200 in the first round tubular medicine reservoir 132 and the second round tubular medicine reservoir 135 can enter the inside of the balloon part 110 sequentially under the action of single liquid and act on the wall of the target renal artery blood vessel; alternatively, the drug formulation 200 in the first round tube reservoir 132 may be injected into the balloon at intervals, for example, 2 minutes after the drug formulation 200 in the second round tube reservoir 135 is injected into the balloon by adjusting the first luer lock valve 131.

The foregoing embodiments are merely illustrative of the principles and features of this invention, and the invention is not limited to the embodiments described above, but rather, is susceptible to various changes and modifications without departing from the spirit and scope of the invention, as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. The renal artery ablation system is characterized by comprising a balloon portion (110), wherein the balloon portion (110) comprises a balloon distal end cone portion (111), a balloon supporting portion (112) and a balloon proximal end cone portion (113) which are sequentially connected from far to near along the axial direction, and the balloon supporting portion (112) comprises:

a drug delivery region (1121) having a plurality of drug delivery holes (1123) distributed over a surface of the drug delivery region (1121);

a position adjustment region (1122) connected to a proximal end of the drug delivery region (1121), an outer diameter of the position adjustment region (1122) being smaller than or equal to an outer diameter of the drug delivery region (1121), the position adjustment region (1122) being capable of adjusting a position of the drug delivery region (1121);

the renal artery ablation system further comprises a constraint structure (140), wherein the constraint structure (140) comprises a constraint distal end part (141), a constraint distal end connecting rod (142) and a constraint part (143), which are sequentially connected from far to near, the constraint part (143) is distributed on the periphery of the position adjustment region (1122), and the constraint part (143) can limit radial expansion of the position adjustment region (1122);

the balloon distal end cone part (111) comprises a balloon distal end section (1111) and a first transition section (1112) which are sequentially connected from far to near, the balloon distal end section (1111) is a closed end, the first transition section (1112) is in a truncated cone shape, the restraining distal end part (141) starts from the outside of the balloon distal end section (1111) and is fixed with the balloon distal end section, the restraining distal end connecting rod (142) is positioned outside the first transition section (1112) and the drug delivery area (1121), and the restraining distal end connecting rod (142) is in an elongated rod structure.

2. The renal artery ablation system of claim 1, wherein the outer diameter of the position adjustment zone (1122) gradually decreases from distal to proximal.

3. The renal artery ablation system of claim 1, wherein the position adjustment region (1122) and the drug delivery region (1121) are connected by a frustum.

4. The renal artery ablation system of claim 1, wherein the constraining distal connecting rod (142) has a first transition structure (1421) disposed thereon, the first transition structure (1421) extending in a W-shape, V-shape, U-shape, S-shape, or L-shape.

5. The renal artery ablation system according to claim 1, wherein the balloon proximal cone portion (113) includes a second transition section (1131) and a balloon proximal section (1132) connected in series from distal to proximal, the second transition section (1131) being of a truncated cone shape; the constraining structure (140) further comprises a constraining proximal connecting rod (144) connected to a proximal end of the constraining portion (143), the constraining proximal connecting rod (144) being located outside of the second transition section (1131).

6. The renal artery ablation system according to claim 5, further comprising a catheter portion (120) connected to the balloon portion (110), wherein the catheter portion (120) includes at least an inner tube (121) and a middle tube (122), the middle tube (122) is sleeved outside the inner tube (121), the inner tube (121) is fixedly connected to the balloon distal section (1111), and the balloon proximal section (1132) is fixed to the middle tube (122).

7. The renal artery ablation system of claim 6, wherein the constraining structure (140) further comprises a constrained proximal end portion (145) connected to the constrained proximal connection rod (144), the constrained proximal end portion (145), the balloon proximal segment (1132), and the middle tube (122) being secured together.

8. The renal artery ablation system of claim 6, wherein the catheter portion (120) further comprises an outer tube (124), the outer tube (124) being sleeved outside the middle tube (122), the constraining structure (140) further comprising a constrained proximal end portion (145) connected to the constrained proximal connecting rod (144), the constrained proximal end portion (145) being fixed to the outer tube (124).