A detachable papillary balloon and balloon catheter

Abstract

The utility model relates to a detachable papillary balloon and balloon catheter, including inner layer balloon, outer layer balloon, convex part structure, the fluid passage is formed between outer layer balloon, inner layer balloon, is provided with the hole on outer layer balloon, the convex part structure includes convex part main part, barb, drug loading membrane, the hole of outer layer balloon is blocked up with convex part main part being connected on outer layer balloon, the barb is connected on convex part main part, the drug loading membrane is coated on convex part main part and / or barb, when fluid acts on convex part main part through fluid passage, hole, convex part main part can be separated from outer layer balloon. The utility model utilizes the feature that the convex part structure is less in contact with calcified lesion or narrow site, plays the pressure amplification effect, and better expands and crushes plaque, through the separation of the convex part structure and the balloon, the separated convex part structure is anchored in the vascular intima, thereby continuously administering, short residence time, long administration duration, and better treatment effect.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a separable mastoid balloon and balloon catheter. Background Technology

[0002] In interventional vascular treatment, balloon catheters are used to treat calcified lesions or arteriovenous fistulas in the lower extremities. The balloon is expanded to break up the calcification or widen the narrow area of ​​the calcification. However, for moderate to severe calcified lesions, ordinary balloons are sometimes not effective in widening the calcified area. If the calcified area is not widened, even if the balloon is eluted with drugs, the drugs cannot enter the vascular intima, affecting the treatment effect.

[0003] See patent publication number CN 222033350 U, which discloses a vascular dilation balloon with drug injection function. This balloon has multiple outwardly protruding needles on its outer wall, with drug delivery orifices located on these needles. As the inner balloon dilates, the needles penetrate the blood vessel wall and enter the plaque. Liquid drug is injected into the cavities of the inner and outer balloons, flowing into the blood vessel wall through the drug delivery orifices, thereby enhancing the drug's inhibitory effect on cell proliferation. However, this structure requires drug injection via needles, resulting in a prolonged balloon residence time within the blood vessel and a large drug injection volume. Summary of the Invention

[0004] One objective of this invention is to provide a detachable papillary balloon.

[0005] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0006] A detachable papillary balloon includes an inner balloon and an outer balloon, wherein the outer balloon is sleeved over the inner balloon, and a fluid channel is formed between the outer and inner balloons. The outer balloon has openings that communicate with the fluid channel. The balloon also includes a protrusion structure comprising a protrusion body, barbs, and a drug-loaded membrane. The protrusion body is connected to the outer balloon and seals the openings of the outer balloon. The barbs are connected to the protrusion body. The drug-loaded membrane is coated on the protrusion body and / or the barbs. When fluid flows through the fluid channel and openings onto the protrusion body, the protrusion body can detach from the outer balloon.

[0007] Preferably, in the above technical solution, the protruding body has a first end and a second end, the first end of the protruding body is connected to the outer balloon, and one end of the barb is connected to the second end of the protruding body.

[0008] More preferably, the other end of the barb extends obliquely toward the first end of the convex body, making it less likely for the convex body to detach from the vascular endothelium, thus facilitating better drug delivery.

[0009] More preferably, the other end of the barb is a pointed tip.

[0010] Preferably, the convex body is a sphere, a hemisphere, or a cone. When the convex body is a hemisphere or a cone, the end with a larger area on the convex body is connected to the outer balloon, and the barb is connected to the end with a smaller area on the convex body, which makes it easy to insert while minimizing damage to the vascular endothelium.

[0011] Preferably, the inner and outer balloons are made of nylon, polyurethane, or Pebax.

[0012] Preferably, the material of the protruding body and the barbs in the above technical solution is a metal material; the metal material can be a biodegradable material or a non-biodegradable material; the biodegradable material is magnesium, magnesium alloy, iron, iron alloy, zinc, or zinc alloy; the non-biodegradable material is stainless steel, nickel-titanium alloy, platinum-tungsten alloy, or platinum-iridium alloy. For the biodegradable material, the protruding body and the barbs will degrade over time, resulting in high safety; for the non-biodegradable material, they will remain in the blood vessel and be covered by the vascular endothelium, which is equivalent to a stent and will not cause harm to the human body.

[0013] Preferably, in the above technical solution, multiple holes are provided, and each of the protruding main bodies blocks one of the holes, and one hole can drive one of the protruding main bodies to detach.

[0014] More preferably, the hole corresponds to the center of the protruding part, so that the force on the protruding part is concentrated and uniform, and it can be stably detached.

[0015] Preferably, the above technical solution includes multiple barbs, with each of the protruding main bodies having multiple barbs connected to it, and the multiple barbs being evenly distributed.

[0016] Preferably, in the above technical solution, the outer diameter of the outer balloon is 1-18 mm and the length is 15-200 mm.

[0017] In a preferred embodiment of the above technical solution, the height of the protruding main body is 0.1-0.8mm.

[0018] In a preferred embodiment of the above technical solution, the protruding body is attached to the outer balloon by adhesive.

[0019] One objective of this invention is to provide a balloon catheter.

[0020] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0021] A balloon catheter includes a catheter and a balloon connected to the catheter. The balloon is a detachable papillary balloon. The catheter includes an outer tube, a middle tube, and an inner tube. The outer tube is sleeved outside the middle tube, and the middle tube is sleeved outside the inner tube. The proximal end of the inner balloon is connected to the distal end of the middle tube, and the distal end of the inner balloon is connected to the distal end of the inner tube, thereby enabling communication between the middle tube and the interior of the inner balloon. The proximal end of the outer balloon is connected to the distal end of the outer tube, and the distal end of the outer balloon is connected to the distal end of the inner tube, thereby enabling communication between the outer tube and the fluid channel.

[0022] Preferably, the outer tube has a filling seat at its proximal end; the middle tube has a pressurizing seat at its proximal end; and the inner tube has a guide wire cavity extending through both ends.

[0023] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art:

[0024] This invention utilizes the characteristic of the convex structure having minimal contact with calcified lesions or stenotic areas. The smaller the contact area, the greater the pressure, thus amplifying the pressure and better fragmenting the plaque. Simultaneously, the convex structure incorporates drug delivery functionality and features anchoring barbs. By detaching from the balloon via the convex structure, the detached convex structure anchors within the vascular intima, enabling continuous drug delivery. The balloon catheter of this invention has a short residence time within the blood vessel, resulting in longer drug delivery and better therapeutic effects. Attached Figure Description

[0025] Appendix Figure 1 This is a schematic diagram of the balloon catheter in this utility model;

[0026] Appendix Figure 2 This is a schematic diagram of the convex structure in this utility model. Figure 1 ;

[0027] Appendix Figure 3 This is a schematic diagram of the convex structure in this utility model. Figure 2 .

[0028] In the attached diagrams above:

[0029] 1. Balloon; 10. Inner balloon; 11. Outer balloon; 110. Hole; 12. Fluid channel;

[0030] 20. Protruding main body; 200. First end; 201. Second end; 21. Barb;

[0031] 3. Conduit; 30. Outer tube; 300. Filling tube seat; 31. Intermediate tube; 310. Pressurization tube seat; 32. Inner tube. Detailed Implementation

[0032] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0033] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0034] Example 1:

[0035] like Figure 1 The detachable mastoid balloon shown includes an inner balloon 10, an outer balloon 11, and a convex structure, which will be described in detail below.

[0036] An outer balloon 11 is fitted over the inner balloon 10, forming a fluid channel 12 between the outer balloon 11 and the inner balloon 12. The outer balloon 11 has holes 110 that communicate with the fluid channel 12, allowing fluid to be ejected through the holes 110. Multiple holes 110 can be provided, evenly distributed across the outer balloon 11.

[0037] In this embodiment, the inner balloon 10 and the outer balloon 11 are made of materials such as nylon, polyurethane, and Pebax; the outer diameter of the outer balloon 11 is 1-18mm and the length is 15-200mm. Since the inner balloon 10 is located inside the outer balloon 11, the size of the outer balloon 11 is the overall size of the balloon.

[0038] The convex structure includes a convex body 20, barbs 21, and a drug-loaded membrane (not shown in the figure). Specifically:

[0039] The protruding body 20 is connected to the outer balloon 11 and seals the holes 110 of the outer balloon 11, such as by adhesive. Since there are multiple holes 110, there are also multiple protruding bodies 20, or protruding structures. When fluid is ejected from the holes 110 and acts on the protruding body 20, the protruding body 20 is able to detach from the outer balloon 11. In this embodiment, each protruding body 20 seals one hole 110, so that one hole 110 can drive one protruding body 20 to detach. Preferably, the hole 110 corresponds to the center of the protruding body 20, so that the force on the protruding body 20 is concentrated and uniform, and it can detach stably.

[0040] The convex body 20 has a first end 200 and a second end 201. The first end 200 of the convex body 20 is connected to the outer balloon 11. Correspondingly, the shape of the convex body 20 can be a sphere, a hemisphere, or a cone. When the convex body 20 is a hemisphere... Figure 2 ),cone( Figure 3 When the protruding body 20 has a larger area, the first end 200 is connected to the outer balloon 11. The larger connection area makes it more stable. The second end 201 is the smaller area of ​​the protruding body 20, which is convenient for piercing the vascular endothelium and at the same time minimizes damage to the vascular endothelium.

[0041] In this embodiment: the height of the protruding body 20 is 0.1-0.8mm, and it can be made of metal. Specifically: the metal material can be biodegradable or non-biodegradable. Biodegradable materials include magnesium, magnesium alloy, iron, iron alloy, zinc, and zinc alloy. For biodegradable materials, the protruding body 20 will degrade over time, resulting in high safety. Non-biodegradable materials include stainless steel, nickel-titanium alloy, platinum-tungsten alloy, and platinum-iridium alloy. For non-biodegradable materials, it will remain in the blood vessel and be covered by the vascular endothelium, which is equivalent to a stent and will not cause harm to the human body.

[0042] The barb 21 is connected to the protruding body 20. Specifically, one end of the barb 21 is connected to the second end 201 of the protruding body 20, that is, preferably connected to the smaller end of the protruding body 20. The other end of the barb 21 extends obliquely towards the first end 200 of the protruding body 20. The barb 21 makes it less likely for the protruding body 20, which is inserted into the blood vessel endothelium, to fall off. The other end of the barb 21 is a pointed tip.

[0043] There are multiple barbs 21, that is, each protruding body 20 is connected to multiple barbs 21, and the multiple barbs 21 are evenly distributed.

[0044] In this embodiment, the barb 21 can also be made of metal, specifically the same as the protruding body 20. In this way, the barb 21 can be integrally formed with the protruding body 20, reducing the manufacturing difficulty.

[0045] The drug-loaded film is coated on the protruding body 20 and / or the barbs 21, preferably simultaneously coated on the protruding body 20 and the barbs 21, for better drug delivery.

[0046] Example 2:

[0047] like Figure 1 The illustrated balloon catheter includes a catheter 3 and a balloon 1, with the balloon 1 connected to the catheter 3. Specifically, the balloon 1 is the detachable mastoid balloon of Embodiment 1.

[0048] In this embodiment: the catheter 3 includes an outer tube 30, a middle tube 31, and an inner tube 32. The outer tube 30 is sleeved outside the middle tube 31, and a filling seat 300 is provided at the proximal end of the outer tube 30; the middle tube 31 is sleeved outside the inner tube 32, and a pressure seat 310 is provided at the proximal end of the middle tube 31; the inner tube 32 forms a guidewire lumen that extends through both ends of the inner tube 32.

[0049] The proximal end of the inner balloon 10 is connected to the distal end of the intermediate tube 31, and the distal end of the inner balloon 10 is connected to the distal end of the inner tube 32, so that the intermediate tube 31 is in communication with the interior of the inner balloon 10; the proximal end of the outer balloon 11 is connected to the distal end of the outer tube 30, and the distal end of the outer balloon 11 is connected to the distal end of the inner tube 32, so that the outer tube 32 is in communication with the fluid channel 12.

[0050] The following details the usage process of this embodiment:

[0051] The balloon catheter is advanced to the lesion site via the guidewire. The balloon inflation pump is connected to the inflation port 310, and pressure is applied to inflate the inner balloon 10 (the entire balloon 3), breaking up the plaque or opening up the stenotic area, so that the protruding body 20 is embedded in the vascular intima. Then, a syringe filled with normal saline is connected to the inflation port 300. Pressing the syringe allows the normal saline to continuously pressurize the protruding body 20 through the fluid channel 12 and the orifice 110 until the protruding body 20 detaches from the outer balloon 11. The pressure is then released, and the balloon catheter is withdrawn. The detached protruding body 20 remains in the vascular intima, and its surface drug-loaded membrane can continue to deliver medication.

[0052] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A separable papillary balloon, comprising an inner balloon and an outer balloon, wherein the outer balloon is sleeved over the inner balloon, a fluid channel is formed between the outer and inner balloons, and a hole is formed in the outer balloon, the hole communicating with the fluid channel, characterized in that: The balloon also includes a protruding structure, which includes a protruding body, barbs, and a drug-loaded membrane. The protruding body is connected to the outer balloon and seals the holes of the outer balloon. The barbs are connected to the protruding body. The drug-loaded membrane is coated on the protruding body and / or the barbs. When fluid acts on the protruding body through the fluid channels and holes, the protruding body can detach from the outer balloon.

2. The detachable papillary balloon according to claim 1, characterized in that: The protruding body has a first end and a second end. The first end of the protruding body is connected to the outer balloon, and one end of the barb is connected to the second end of the protruding body.

3. The detachable papillary balloon according to claim 2, characterized in that: The other end of the barb extends obliquely toward the first end of the protruding body; The other end of the barb is a pointed tip.

4. The detachable papillary balloon according to claim 1 or 2, characterized in that: The convex body is a sphere, a hemisphere, or a cone. When the convex body is a hemisphere or a cone, the end with a larger area on the convex body is connected to the outer balloon, and the barbs are connected to the end with a smaller area on the convex body.

5. The detachable papillary balloon according to claim 1, characterized in that: The inner and outer balloons are made of nylon, polyurethane, and Pebax. The protruding body and barbs are made of metal; the metal material can be biodegradable or non-biodegradable; the biodegradable material is magnesium, magnesium alloy, iron, iron alloy, zinc, or zinc alloy; the non-biodegradable material is stainless steel, nickel-titanium alloy, platinum-tungsten alloy, or platinum-iridium alloy.

6. The detachable papillary balloon according to claim 1, characterized in that: The aforementioned holes are provided in multiple ways, and each of the aforementioned protruding main bodies blocks one of the aforementioned holes; The barbs are provided in multiple ways, and each of the protruding main bodies is connected to multiple barbs, which are evenly distributed.

7. The detachable papillary balloon according to claim 1, characterized in that: The outer balloon has an outer diameter of 1-18 mm and a length of 15-200 mm. The height of the protruding main body is 0.1-0.8mm.

8. The detachable papillary balloon according to claim 1, characterized in that: The protruding part is attached to the outer balloon with glue.

9. A balloon catheter, comprising a catheter and a balloon, wherein the balloon is connected to the catheter, characterized in that: The balloon is a separable mastoid balloon as described in any one of claims 1 to 8. The catheter includes an outer tube, a middle tube, and an inner tube. The outer tube is sleeved outside the middle tube, and the middle tube is sleeved outside the inner tube. The proximal end of the inner balloon is connected to the distal end of the middle tube, and the distal end of the inner balloon is connected to the distal end of the inner tube, so that the middle tube communicates with the interior of the inner balloon. The proximal end of the outer balloon is connected to the distal end of the outer tube, and the distal end of the outer balloon is connected to the distal end of the inner tube, so that the outer tube communicates with the fluid channel.

10. The balloon catheter according to claim 9, characterized in that: The proximal end of the outer tube is provided with a filling tube seat; A pressurization tube seat is provided at the proximal end of the intermediate tube; The inner tube has a guide wire cavity that extends through both ends.

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