Balloon catheter for releasing medicine in human body cavity

Abstract

The utility model discloses a balloon catheter for releasing drugs in a human body cavity. The balloon catheter comprises a three-cavity catheter, a drug delivery balloon and an expansion balloon, wherein the drug delivery balloon and the expansion balloon are arranged on the three-cavity catheter; the dilatation balloon is located in the drug delivery balloon, a drug delivery space is formed between the outer surface of the dilatation balloon and the inner surface of the drug delivery balloon, nylon strips are arranged on the outer surface of the drug delivery balloon, and drug release micropores are formed in the positions, between the nylon strips, of the balloon wall of the drug delivery balloon. The trachea can be expanded, drug treatment can be performed on narrow positions, multiple instruments are not needed to be matched for use, discomfort of a patient caused by the fact that the multiple instruments enter the airway for multiple times is avoided, and the risk of scratching the trachea is reduced; the dosage can be accurately controlled, and excessive liquid medicine is prevented from entering the human body; the operation is simpler, non-invasive treatment of the natural cavity of the human body can be achieved, foreign matter does not need to be implanted, and the operation can be repeated.

Description

Technical Field

[0001] The utility model relates to the technical field of human cavity medicine applying devices, in particular to a balloon catheter for releasing medicine in a human cavity. Background Art

[0002] Benign airway stenosis is a common respiratory disease that can easily cause discomfort such as coughing, pain, and foreign body sensation. In severe cases, it can also hinder the patient's normal breathing.

[0003] There are three main treatment methods currently:

[0004] The first treatment method is surgical treatment, which is to remove the tumor through traditional surgery. The disadvantage is that the postoperative wound is large and the recovery time is long.

[0005] The second treatment method is to insert a stent to open the airway. The technical problem is that the requirements for the stent are relatively strict, and inappropriate materials are very likely to cause complications, so the cost is high. In addition, the stent may shift after implantation and is more likely to fail, affecting the treatment effect.

[0006] The third treatment method is to apply the drug directly to the lesion by spraying, but the current airway spray catheter cannot accurately control the amount of medicine. As the patient breathes, a large amount of medicine will enter the alveoli and be absorbed by the human body, which not only leads to a decrease in the effect of drug treatment, but also a large amount of excess drug liquid entering the human body will cause harm. Summary of the invention

[0007] To solve the above technical problems, the utility model provides a balloon catheter for drug release in a human cavity. In order to have a basic understanding of some aspects of the disclosed embodiments, a simple summary is given below. This summary is not a general review, nor is it intended to identify key / important components or describe the scope of protection of these embodiments. Its only purpose is to present some concepts in a simple form as a preface to the detailed description that follows.

[0008] The utility model adopts the following technical solutions:

[0009] Provided is a balloon catheter for releasing drugs in a human cavity, comprising: a three-lumen catheter; and also comprising: a drug administration balloon and an expansion balloon arranged on the three-lumen catheter and connected to the cavity of the three-lumen catheter;

[0010] The expansion balloon is located inside the medication balloon, and a medication space is formed between the outer surface of the expansion balloon and the inner surface of the medication balloon. Nylon strips are arranged on the outer surface of the medication balloon, and drug release micropores are provided on the wall of the medication balloon between the nylon strips.

[0011] Furthermore, the three-lumen catheter has a first lumen, a second lumen and a third lumen; the inner end of the three-lumen catheter is provided with a head end tube connected to the third lumen, and the head end tube is located on the inner side of the drug delivery balloon; the cavity of the drug delivery balloon is connected to the first lumen, and the cavity of the expansion balloon is connected to the second lumen.

[0012] Furthermore, the balloon catheter for releasing drugs in a human cavity also includes: an adapter, which is arranged at the outer end of the three-lumen catheter; a first guide channel, a second guide channel and a third guide channel are opened in the adapter; the first guide channel is connected to the outer port of the first cavity, the second guide channel is connected to the outer port of the second cavity, and the third guide channel is connected to the outer port of the third cavity.

[0013] Furthermore, the balloon catheter for releasing drugs in a human cavity also includes: a first handle, a second handle and a third handle; a first handle pipeline is opened on the first handle, and the first handle pipeline is connected to the first guide channel; a second handle pipeline is opened on the second handle, and the second handle pipeline is connected to the second guide channel; a third handle pipeline is opened on the third handle, and the third handle pipeline is connected to the third guide channel.

[0014] Furthermore, the balloon catheter for drug release in a human body cavity further includes: a marker ring; the marker ring is arranged on the three-lumen catheter, and the marker ring is located at the outer end of the drug delivery balloon.

[0015] Furthermore, the outer diameter of the three-lumen catheter is 2.6 mm; the first lumen and the second lumen are arc-shaped lumens symmetrically arranged on both sides of the third lumen; the third lumen is a cylindrical lumen, and the inner diameter of the third lumen is 1 mm, and the wall thickness of the third lumen is 0.1 mm.

[0016] Furthermore, the expansion balloon is made of semi-compliant material; the wall thickness of the expansion balloon is 0.3-0.8 mm; and the outer diameter of the expansion balloon when it reaches the required diameter is 6 mm-15 mm.

[0017] Furthermore, the drug delivery balloon is made of compliant material; the wall thickness of the drug delivery balloon is 1 to 1.5 mm; the inner diameter of the drug delivery balloon when it reaches the required diameter is 0.2 to 0.3 mm greater than the outer diameter of the expansion balloon when it reaches the required diameter.

[0018] Furthermore, the nylon strip is a threaded nylon strip wound on the outer surface of the drug delivery balloon, and the nylon strip adopts a nylon wire with a diameter of 0.5 mm and a pitch of 2 mm; the drug release micropores are opened between two threads of the threaded nylon strip, and 25 to 100 drug release micropores are opened per square millimeter, and the pore size of the drug release micropores is 1 μm to 100 μm.

[0019] Beneficial effects brought by the utility model:

[0020] 1. This application can not only dilate the trachea, but also provide drug treatment for the stenosis. It does not require the use of multiple instruments, and it also avoids multiple instruments entering the airway multiple times to cause discomfort to the patient, and reduces the risk of scratching the trachea;

[0021] 2. The dosage can be precisely controlled to prevent excessive liquid medicine from entering the human body;

[0022] 3. Compared with the traditional airway spray catheter and implanted stent, the present application is simpler to operate;

[0023] 4. Compared with traditional surgical treatments, this application can achieve non-invasive treatment of the body's natural cavities, does not require the implantation of foreign matter, and can be performed repeatedly. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 This is a schematic diagram of the external structure of a balloon catheter for releasing drugs in a human cavity according to the utility model;

[0026] Figure 2 This is a schematic diagram of the internal structure of a balloon catheter for releasing drugs in a human cavity according to the utility model;

[0027] Figure 3 It is a connection diagram of the three-lumen catheter, the adapter, the first handle, the second handle and the third handle of the utility model;

[0028] Figure 4 It is a structural schematic diagram of the three-lumen catheter of the utility model;

[0029] Figure 5 It is a schematic diagram of the drug-delivery balloon and the expansion balloon of the utility model being located at the lesion and delivering the drug. DETAILED DESCRIPTION

[0030] The following is a detailed description of the embodiments of the utility model in conjunction with the accompanying drawings. It should be clear that the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0031] like Figure 1-5 As shown, in some illustrative embodiments, a balloon catheter for drug release in a human cavity is provided, comprising: a triple-lumen catheter 1, a drug delivery balloon 2, an expansion balloon 3, a nylon strip 4, a head end tube 5, an adapter 6, a first handle 7, a second handle 8, a third handle 9 and a marking ring 10.

[0032] Among them, this embodiment divides each pipe and channel into an outer end and an inner end. The outer end / outer side mentioned refers to the end close to the doctor's field of vision, that is, the end closer to the outside of the human body, and the other end can be used as the inner end / inner side, which is the end far away from the outside of the human body.

[0033] The three-lumen catheter 1 has a first lumen 101, a second lumen 102 and a third lumen 103 which are independent of each other. The outer ends of the first lumen 101 and the second lumen 102 are both open, and are used to dock and communicate with the adapter 6, and the inner ends are closed. Both ends of the third lumen 103 are open, and the outer end is docked and communicated with the adapter 6. When administering medicine, the inner end is connected to the airway to avoid affecting the patient's breathing during administration. The third lumen 103 is also used to pass a guide wire and enter the human body cavity along the guide wire.

[0034] The triple lumen catheter 1 uses pebax, which is a thermoplastic elastomer made of flexible polyether and hard polyamide.

[0035] The outer diameter of the three-lumen catheter 1 is 2.6 mm, and the outer diameter of the folded drug delivery balloon 2 is also 2.6 mm, which can enter a 2.8 mm endoscope, so the lesion can be accurately located by endoscope. The first lumen 101 and the second lumen 102 are arc-shaped lumens symmetrically arranged on both sides of the third lumen 103, that is, the cross-sections of the first lumen 101 and the second lumen 102 are arc-shaped. The third lumen 103 is a cylindrical lumen, and the inner diameter of the third lumen 103 is 1 mm, and the wall thickness of the third lumen 103 is 0.1 mm.

[0036] The above-mentioned shape design, position arrangement and size limitation of each lumen in the three-lumen catheter 1 can better match the trachea and fully utilize the internal space of the three-lumen catheter 1 to ensure the efficiency of drug administration, medium input and output, and gas input and output.

[0037] The medication balloon 2 and the expansion balloon 3 are arranged on the three-lumen catheter 1 and are connected to the lumen of the three-lumen catheter 1. Specifically, an outer balloon injection port 104 is provided on the wall of the first lumen 101, and the outer balloon injection port 104 connects the sac cavity of the medication balloon 2 with the first lumen 101; an inner balloon injection port 105 is provided on the wall of the second lumen 102, and the inner balloon injection port 105 connects the sac cavity of the expansion balloon 3 with the second lumen 102. The medication balloon 2 and the expansion balloon 3 are fixed to the three-lumen catheter 1 by laser welding.

[0038] The expansion balloon 3 is located inside the dosing balloon 2, and a dosing space 11 is formed between the outer surface of the expansion balloon 3 and the inner surface of the dosing balloon 2. The outer surface of the dosing balloon 2 is provided with nylon strips 4, and the capsule wall of the dosing balloon 2 has drug release micropores 201 between the nylon strips 4.

[0039] The two balloons are gradually opened by injecting liquid medicine into the medication space 11 through the first cavity 101 and injecting saline into the expansion balloon 3 through the second cavity 102 until the medication balloon 2 cannot further expand the diameter of the trachea after being attached to the tracheal wall. At this time, the physiological saline is continuously injected to increase the diameter of the expansion balloon 3, compressing the liquid medicine in the medication space 11, and the liquid medicine seeps out from the drug release micropores 201 to reach the lesion. Moreover, when the medication balloon 2 is attached to the tracheal wall, the nylon strip 4 can prevent the balloon from being completely attached to the trachea wall after the balloon is expanded. The drug release micropores 201 are opened between the nylon strips 4. When the pressure increases to a certain extent, such as 1atm, the liquid medicine will seep out from the drug release micropores 201, and the nylon strips 4 can also play a role in blocking the drug. The structural design of the present application allows the dosage of the drug to be accurately controlled to prevent excessive liquid medicine from entering the human body. Compared with the existing treatment device, the operation is simpler, and non-invasive treatment is achieved, without the need to implant foreign matter, and the operation can be repeated. At the same time, the present application can both dilate the trachea and provide drug treatment for the narrowed area, without the need for the coordinated use of multiple instruments, and also avoids multiple instruments entering the airway multiple times to cause discomfort to the patient, thereby reducing the risk of scratching the trachea.

[0040] The marking ring 10 is arranged on the three-lumen catheter 1 and is located at the outer end of the drug-delivery balloon 2, which is visible under an endoscope and is used for balloon positioning.

[0041] The inner end of the three-lumen catheter 1 is provided with a tip end tube 5 connected to the third lumen 103, and the tip end tube 5 is located inside the medication balloon 2, that is, the inner end of the three-lumen catheter 1 passes through the medication balloon 2 and the expansion balloon 3 and is connected to the tip end tube 5. The tip end tube 5 can be made of a softer tube than the three-lumen catheter 1 to ensure that the three-lumen catheter 1 will not pierce the trachea when inserted.

[0042] The expansion balloon 3 is made of semi-compliant material, usually PA. The wall thickness of the expansion balloon 3 is 0.3-0.8 mm. The outer diameter of the expansion balloon 3 when it reaches the required diameter is 6 mm-15 mm. The required diameter mentioned in this article refers to the diameter value when the balloon is expanded to be put into use.

[0043] The drug delivery balloon 2 is made of a compliant material, usually a polyether block polyamide with greater compliance. The wall thickness of the drug delivery balloon 2 is 1 to 1.5 mm. The inner diameter of the drug delivery balloon 2 when it reaches the required diameter is 0.2 to 0.3 mm larger than the outer diameter of the expansion balloon 3 when it reaches the required diameter.

[0044] The nylon strip 4 is a threaded nylon strip wound around the outer surface of the medication balloon 2, that is, the nylon strip 4 is spirally wound around the surface of the medication balloon 2, and can be bonded with glue, or the nylon strip 4 can be wrapped around the balloon surface after the medication balloon 2 is inflated, and then a heat shrink tube is put on, and finally the surface is blown with hot air at 100 to 130 degrees, and the heat shrink tube can be torn off after it is fixed.

[0045] The nylon strip 4 is made of nylon thread with a diameter of 0.5 mm and a pitch of 2 mm. The drug release micropores 201 are opened between two threads of the threaded nylon strip. On the surface of the drug delivery balloon 2 where the nylon strip 4 is not arranged, 25 to 100 drug release micropores 201 are opened per square millimeter, and the pore size of the drug release micropores 201 is 1 μm to 100 μm.

[0046] The drug-delivery balloon 2 is made of a relatively soft material. When the drug-delivery balloon 2 is expanded in the trachea until it is close to the tracheal wall, the pressure is continued to be increased. Due to the relatively soft material, the trachea cannot be subjected to sufficient pressure, and the trachea will not be expanded. Even if the drug-delivery balloon 2 is pressurized to rupture, it will not cause a tear in the trachea. Moreover, the wall of the drug-delivery balloon 2 is relatively thick, so even if there are micropores, it is not easy to rupture.

[0047] At the same time, the outer surface of the drug administration balloon 2 has spirally arranged nylon strips 4 to prevent the drug administration balloon 2 from completely adhering to the trachea wall after expansion. The drug administration balloon 2 surface between the nylon strips 4 is provided with drug release micropores 201. Since the drug administration balloon 2 has a large elasticity and the pore size of the drug release micropores 201 is small, the drug release micropores 201 are in a tightened state, and the drug solution will not flow out. When the pressure in the inner cavity of the drug administration space 11 increases to a certain extent, such as 1atm, the drug solution will seep out from the drug release micropores 201. The drug administration amount can be accurately controlled under the premise of ensuring the adequacy of drug administration, and at the same time, the drug solution can be effectively prevented from diffusing to the non-lesion part and causing damage.

[0048] The inner diameter of the dosing balloon 2 when it reaches the required diameter is 0.2mm to 0.3mm larger than the outer diameter of the expansion balloon 3 when it reaches the required diameter, which allows space for the drug liquid to flow out. If the dosing balloon 2 and the expansion balloon 3 are attached to the wall, it is difficult for the drug liquid to be discharged from the drug release micropores 201.

[0049] Since the dilation balloon 3 is harder than the medication balloon 2 and its outer diameter changes very little after reaching the nominal pressure, it is usually used for tracheal dilation.

[0050] The adapter 6 is arranged at the outer end of the three-lumen catheter 1, and the adapter 6 and the three-lumen catheter 1 are integrally formed by overmolding. A first guide channel 601, a second guide channel 602 and a third guide channel 603 are provided in the adapter; the first guide channel 601 is communicated with the outer port of the first lumen 101, the second guide channel 602 is communicated with the outer port of the second lumen 102, and the third guide channel 603 is communicated with the outer port of the third lumen 103. The structural design of the adapter 6 allows the outer ports of each lumen of the three-lumen catheter 1 to be extended, and the spacing is increased, which makes it easier to install the handle.

[0051] The first handle 7 is provided with a first handle pipeline 701, which is connected to the first guide channel 601; the second handle 8 is provided with a second handle pipeline 801, which is connected to the second guide channel 602; the third handle 9 is provided with a third handle pipeline 901, which is connected to the third guide channel 603. The first handle 7, the second handle 8 and the third handle 9 are bonded to the adapter 6 with UV glue and light-sensitive adhesive. The design of the handle is convenient for connecting to the drug delivery device, the physiological saline injection device, the emptying pump and other structures, thereby improving the convenience of operation.

[0052] Directions:

[0053] Step 1: Use an endoscope to find the area of ​​airway narrowing.

[0054] Step 2: Pass the balloon catheter of the present application through the endoscope to the stenosis site, so that the center of the balloon is located in the middle of the stenosis site of the trachea.

[0055] Step 3: Make the first handle 7 in the passage state, and use the balloon pressurizing device to inject physiological saline into the expansion balloon 3 through the second handle 8, and gradually pressurize it to the balloon nominal pressure (the pressure required when the balloon reaches the required diameter) to pre-expand the tracheal stenosis position. At this time, the drug-giving balloon 2 is wrapped around the surface of the expansion balloon 3 and expands with the expansion balloon 3.

[0056] Step 4: After the expansion balloon 3 is expanded, a balloon pressurizing device is used to provide negative pressure to first release the pressure of the expansion balloon 3 and then release the pressure of the medication balloon 2, and to remove the air in the medication balloon 2.

[0057] Step 5: Inject the required drug solution, usually 1 to 2 ml, into the drug-delivery balloon 2 through the first handle 7, and then seal the first handle 7 with a two-way valve.

[0058] Step 6: Use the balloon pressurizing device to inject physiological saline into the expansion balloon 3 through the second handle 8 to pressurize it. As the expansion balloon 3 expands, the pressure in the drug administration space 11 will increase synchronously, and the drug administration balloon 2 will expand synchronously. When the drug administration balloon 2 contacts the tracheal wall, the outer diameter will no longer increase. At this time, the pressure of the expansion balloon 3 continues to increase, the diameter of the expansion balloon 3 increases, and the drug solution is compressed. As the pressure increases, the drug solution in the drug administration balloon 2 will flow out from the drug release micropores 201 and reach the lesion site.

[0059] Step 7: First, release the pressure on the expansion balloon 3, then release the pressure on the medication balloon 2, and then rotate the balloon catheter clockwise by about 30 degrees, and repeat steps 3 and 6.

[0060] Step 8: Repeat step 7 to ensure that the entire narrow trachea is exposed to the drug solution.

[0061] Step 9: First, release the pressure of the expansion balloon 3, then release the pressure of the medication balloon 2, and then withdraw the balloon catheter.

[0062] The above is only a specific implementation of the utility model, but the protection scope of the utility model is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the utility model should be included in the protection scope of the utility model. Therefore, the protection scope of the utility model should be based on the protection scope of the claims.

Claims

1. A balloon catheter for releasing drugs in a human cavity, comprising: The three-lumen catheter is characterized in that it also includes: a drug administration balloon and an expansion balloon arranged on the three-lumen catheter and connected to the lumen of the three-lumen catheter; The expansion balloon is located inside the medication balloon, and a medication space is formed between the outer surface of the expansion balloon and the inner surface of the medication balloon. Nylon strips are arranged on the outer surface of the medication balloon, and drug release micropores are provided on the wall of the medication balloon between the nylon strips.

2. A balloon catheter for drug release in a human cavity according to claim 1, characterized in that: The three-lumen catheter has a first lumen, a second lumen and a third lumen; The inner end of the three-lumen catheter is provided with a head end tube connected to the third lumen, and the head end tube is located on the inner side of the drug administration balloon; the cavity of the drug administration balloon is connected to the first lumen, and the cavity of the expansion balloon is connected to the second lumen.

3. A balloon catheter for drug release in a human cavity according to claim 2, characterized in that: Also includes: An adapter, the adapter being arranged at the outer end of the three-lumen catheter; A first guiding channel, a second guiding channel and a third guiding channel are provided in the adapter; The first guide channel is in communication with an outer port of the first cavity, the second guide channel is in communication with an outer port of the second cavity, and the third guide channel is in communication with an outer port of the third cavity.

4. A balloon catheter for drug release in a human cavity according to claim 3, characterized in that: Also includes: A first handle, a second handle, and a third handle; The first handle has a first handle pipeline connected to the first guide channel; the second handle has a second handle pipeline connected to the second guide channel; the third handle has a third handle pipeline connected to the third guide channel.

5. A balloon catheter for drug release in a human cavity according to claim 2 or 4, characterized in that: Also includes: A marker ring; the marker ring is arranged on the three-lumen catheter, and the marker ring is located at the outer end of the drug delivery balloon.

6. A balloon catheter for drug release in a human cavity according to claim 5, characterized in that: The outer diameter of the three-lumen catheter is 2.6 mm; the first lumen and the second lumen are arc-shaped lumens symmetrically arranged on both sides of the third lumen; the third lumen is a cylindrical lumen, and the inner diameter of the third lumen is 1 mm, and the wall thickness of the third lumen is 0.1 mm.

7. A balloon catheter for drug release in a human cavity according to claim 6, characterized in that: The expansion balloon is made of semi-compliant material; the wall thickness of the expansion balloon is 0.3-0.8 mm; and the outer diameter of the expansion balloon when it reaches the required diameter is 6 mm-15 mm.

8. The balloon catheter for drug release in a human cavity according to claim 7, characterized in that: The drug delivery balloon is made of compliant material; the wall thickness of the drug delivery balloon is 1 to 1.5 mm; the inner diameter of the drug delivery balloon when it reaches the required diameter is 0.2 to 0.3 mm greater than the outer diameter of the expansion balloon when it reaches the required diameter.

9. The balloon catheter for drug release in a human cavity according to claim 8, characterized in that: The nylon strip is a threaded nylon strip wound on the outer surface of the drug delivery balloon, and the nylon strip is made of a nylon wire with a diameter of 0.5 mm and a pitch of 2 mm; The drug release micropores are arranged between two threads of the threaded nylon strip, and 25 to 100 drug release micropores are arranged per square millimeter. The pore diameter of the drug release micropores is 1 μm to 100 μm.

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