Drug balloon device

Abstract

The embodiment of the utility model provides a medicine balloon device. The medicine balloon device comprises a pressurizing part which is arranged on a catheter section close to the near end and communicated with a pressurizing channel; the balloon is arranged at the near end of the catheter in a sleeving mode, a cavity wrapping the pressurizing part is formed, and the outer surface of the balloon is used for being coated with medicine; the developing ring is positioned in the cavity and sleeves the catheter; the pressurizing tube is arranged close to the far end and communicated with the catheter, and the pressurizing channel is used for pressurizing the balloon so as to expand the balloon to apply medicine to the lesion position; the connector comprises a first connecting end, a second connecting end and a penetrating pipe; the first connecting end is fixedly connected with the far end of the catheter, and the second connecting end allows a guide wire to penetrate into the guide wire channel through the penetrating pipe. By means of the design of the pressurizing pipe and the pressurizing channel, it can be ensured that the balloon can expand evenly, the risk of local excessive expansion is reduced, in addition, the pressurizing channel is connected with a feedback unit, the pressurizing pressure can be displayed in real time, and a doctor is helped to control the balloon expansion degree.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and particularly to a drug balloon device. Background Art

[0002] Benign prostatic hyperplasia (BPH) is one of the most common urodynamic diseases in middle-aged and elderly men. With the intensification of the global population aging trend, the impact of BPH on male health and quality of life has become increasingly significant. Since the first appearance of the surgical treatment of BPH at the end of the 19th century, it has undergone a major transformation from open surgery to minimally invasive endoscopic surgery. The surgical forms and techniques have been continuously developed and are still one of the most innovative research directions in the field of urology. Currently, the methods for treating BPH mainly include two categories: surgical treatment and drug treatment. Disadvantages of surgery: It affects male sexual function; surgery may cause urinary incontinence in patients. Although the incidence of urinary incontinence is very low, there is still a possibility of surgical injury to the sphincter, resulting in temporary or permanent urinary incontinence. And after surgery, hematuria or secondary bleeding may occur in the short term, and secondary infections may occur after surgery, such as acute epididymitis or acute urethritis, etc. Disadvantages of drugs: Their compliance is insufficient. Many patients cannot adhere to taking medications. Moreover, when the enlarged prostate is too large and the condition is severe, the drugs cannot achieve the therapeutic effect. At this time, patients need to consider surgical treatment. Most importantly, the drugs must be taken for a long time. Once the drugs are stopped, lower urinary tract symptoms such as difficulty in urination will worsen.

[0003] The current balloon dilation prostate surgery is to dilate the balloon to a very large diameter to tear the patient's prostate, so as to achieve the purpose that the patient can urinate normally. However, during the treatment process of prostate hyperplasia in patients, tearing the patient's prostate with a very large diameter will cause irreversible damage to the patient's prostate, and the continuous proliferation of scar tissue during the healing process of the torn prostate will cause prostate fibrosis, resulting in difficulty in urination for patients. In severe cases, the prostate will compress the vas deferens, causing adverse effects such as infertility in patients. Summary of the Invention

[0004] In view of the above-mentioned disadvantages of the prior art, the purpose of the present disclosure is to provide a drug balloon device to solve the problems in the related art.

[0005] In one embodiment of the present disclosure, a drug balloon device is provided, which includes:

[0006] A catheter, including a proximal end and a distal end; the catheter forms a pressure boosting channel and a guide wire channel, and a pressure boosting part communicating with the pressure boosting channel is provided on the catheter segment near the proximal end;

[0007] A balloon is sleeved on the proximal end of the catheter to form a cavity covering the pressurizing part, and the outer surface is for coating with drugs;

[0008] At least one imaging ring is located in the cavity and sleeved on the catheter;

[0009] A pressurizing tube is arranged near the distal end and communicates with the catheter to form a pressurizing channel that communicates through the catheter to the pressurizing part. The pressurizing channel is for pressurizing the balloon to expand the balloon for applying drugs to the lesion site; the pressurizing channel is connected to a feedback unit for displaying the pressurizing pressure;

[0010] A connector includes an opposite first connection end, a second connection end, and a through tube penetrating the first connection end and the second connection end; the first connection end is fixedly connected to the distal end of the catheter so that one end of the through tube communicates with the guide wire channel, and the second connection end is for inserting a guide wire into the guide wire channel through the through tube.

[0011] In an embodiment of the first aspect, it further includes a connecting tube, which includes a third connection end, a fourth connection end, and a pressurizing end; the third connection end is fixedly connected to the distal end and communicates with the catheter; the pressurizing end communicates with the pressurizing tube and the pressurizing channel; the fourth connection end is fixedly connected to the first end of the connector and communicates the through tube with the guide wire channel.

[0012] In an embodiment of the first aspect, there is a threaded connection between the third connection end and the distal end; and / or, there is a threaded connection between the fourth connection end and the first end of the connector.

[0013] In an embodiment of the first aspect, the other end of the pressurizing tube is threadedly connected to a pressurizing device, and the feedback unit is arranged on the pressurizing device.

[0014] In an embodiment of the first aspect, the surface of the catheter segment between the balloon and the connector is provided with scale lines, and a plurality of scale lines are spaced at intervals along the length direction of the catheter.

[0015] In an embodiment of the first aspect, the distance between each scale line is 10 mm.

[0016] In an embodiment of the first aspect, the length of the catheter is not less than 600 mm; the balloon is an ultra-high pressure balloon; and / or, the length of the balloon is between 3.0 cm and 3.5 cm.

[0017] In an embodiment of the first aspect, the drug coated on the outer surface of the balloon is a paclitaxel drug coating.

[0018] In an embodiment of the first aspect, the surface of the catheter is formed with a hydrophilic coating.

[0019] In an embodiment of the first aspect, the materials of the balloon and the catheter are medical polymer materials; the medical polymer materials include silicone, polyurethane, or ethylene vinyl acetate copolymer.

[0020] Advantages of the present disclosure: Through the design of the pressure increasing tube and the pressure increasing channel, it can ensure that the balloon expands evenly, reducing the risk of local overexpansion. In addition, the pressure increasing channel is connected to a feedback unit, which can display the pressurization pressure in real time, helping the doctor control the degree of balloon expansion and ensuring the safety and accuracy of the treatment; the connection head makes the insertion and positioning of the guide wire more convenient, improving the efficiency and accuracy of the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Showing a schematic structural diagram of the drug balloon device in an embodiment of the present disclosure.

[0022] Figure 2 Showing a schematic cross-sectional view of the connection head in the drug balloon device in an embodiment of the present disclosure.

[0023] Figure 3 Showing a schematic cross-sectional view of the catheter in the drug balloon device in an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0024] The following illustrates the embodiments of the present disclosure through specific examples, and those skilled in the art can easily understand other advantages and effects of the present disclosure from the information disclosed in the present disclosure. The present disclosure can also be implemented or applied through other different specific embodiments, and various details in the present disclosure can also be modified or changed according to different viewpoints and applications without departing from the spirit of the present disclosure. It should be noted that, without conflict, the embodiments and features in the embodiments of the present disclosure can be combined with each other.

[0025] The following takes the drawings as a reference and details the embodiments of the present disclosure so that those skilled in the art to which the present disclosure pertains can easily implement it. The present disclosure can be embodied in many different forms and is not limited to the embodiments described herein.

[0026] In the description of the present disclosure, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples", etc., mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present disclosure. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or a group of embodiments or examples. In addition, without contradiction, those skilled in the art can combine the different embodiments or examples described in the present disclosure and the features of the different embodiments or examples.

[0027] In addition, the terms "first" and "second" are used only for purposes of indication and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the representations of the present disclosure, the meaning of "a group" is two or more, unless otherwise specifically defined.

[0028] To clearly illustrate the present disclosure, devices irrelevant to the description are omitted, and the same or similar constituent elements throughout the specification are given the same reference signs.

[0029] Throughout the specification, when it is said that a device is "connected" to another device, this includes not only the case of "direct connection", but also the case of "indirect connection" with other elements placed therebetween. In addition, when it is said that a certain device "includes" a certain constituent element, unless there is a particularly contrary record, it does not exclude other constituent elements, but means that other constituent elements may also be included.

[0030] Although in some examples the terms first, second, etc. are used herein to denote various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, the first interface and the second interface, etc. are indicated. Furthermore, as used herein, the singular forms "a", "an" and "the" are also intended to include the plural forms unless the context indicates otherwise. It should be further understood that the terms "comprising", "including" indicate the presence of the stated features, steps, operations, elements, modules, items, kinds, and / or groups, but do not preclude the presence, occurrence or addition of one or a group of other features, steps, operations, elements, modules, items, kinds, and / or groups. The terms "or" and "and / or" used herein are to be interpreted as inclusive or meaning any one or any combination. Thus, "A, B or C" or "A, B and / or C" means "any one of the following: A; B; C; A and B; A and C; B and C; A, B and C". An exception to this definition occurs only when the combination of elements, functions, steps or operations is inherently mutually exclusive in some way.

[0031] The technical terms used herein are only for referring to specific embodiments and are not intended to limit the present disclosure. The singular forms used herein also include the plural forms as long as the statements do not explicitly indicate the contrary meaning. The meaning of "including" used in the specification is to embody specific characteristics, regions, integers, steps, operations, elements and / or components, and does not exclude the existence or addition of other characteristics, regions, integers, steps, operations, elements and / or components.

[0032] Although not defined differently, including the technical terms and scientific terms used herein, all terms have the same meaning as generally understood by those skilled in the technical field to which this disclosure pertains. Terms defined in commonly used dictionaries are additionally interpreted to have meanings consistent with the relevant technical literature and the currently presented message. As long as they are not defined, they should not be over-interpreted as ideal or overly formulaic meanings.

[0033] In the related art, the current balloon dilation prostate surgery is to dilate the balloon to a very large diameter to tear the patient's prostate, so as to achieve the purpose that the patient can urinate normally. However, during the treatment of prostate hyperplasia, tearing the patient's prostate with a very large diameter will cause irreversible damage to the patient's prostate, and the continuous proliferation of scar tissue during the healing process of the torn prostate will cause prostate fibrosis, resulting in difficult urination for the patient. In severe cases, the prostate will compress the vas deferens, causing adverse effects such as infertility for the patient.

[0034] In the present disclosure, through the design of the pressurizing tube and the pressurizing channel, it can be ensured that the balloon can expand uniformly, reducing the risk of local over-expansion. In addition, the pressurizing channel is connected to a feedback unit, which can display the pressurizing pressure in real time, helping the doctor control the degree of balloon expansion and ensuring the safety and accuracy of the treatment.

[0035] In Figure 1 Examples provide a drug balloon 200 device, which includes:

[0036] A catheter 100, including a proximal end and a distal end; the catheter 100 forms a pressurizing channel 120 and a guide wire channel 130, and a pressurizing part 110 communicating with the pressurizing channel 120 is provided on the catheter 100 segment near the proximal end;

[0037] A balloon 200, sleeved on the proximal end of the catheter 100, forming a cavity covering the pressurizing part 110, and the outer surface is for coating drugs;

[0038] At least one imaging ring 300, located in the cavity and sleeved on the catheter 100;

[0039] A pressurizing tube 400, provided near the distal end and communicating with the catheter 100, forming a pressurizing channel 120 that communicates through the catheter 100 to the pressurizing part 110, and the pressurizing channel 120 is for pressurizing the balloon 200 to expand the balloon 200 to apply drugs to the lesion location; the pressurizing tube 400 is connected to a feedback unit 710 for displaying the pressurizing pressure;

[0040] A connector 500 includes opposite first and second connection ends 510 and 520, and a through tube 530 passing through the first and second connection ends 510 and 520; the first connection end 510 is fixedly connected to the distal end of the catheter 100 so that one end of the through tube 530 communicates with the guide wire channel 130, and the second connection end 520 is for threading a guide wire into the guide wire channel 130 through the through tube 530.

[0041] Specifically, in some embodiments, the proximal end of the catheter 100 extends into the body and is closed at the proximal end. The balloon 200 is disposed near the proximal end and sleeved on the catheter 100 segment near the proximal end. A plurality of pressurizing portions 110 are formed on the catheter 100 segment located in the cavity of the balloon 200. The pressurizing portions 110 may be evenly distributed or randomly distributed. Optionally, the other end of the pressurizing tube 400 is threadedly connected to a pressurizing device 700, and the pressurizing device 700 is provided with the feedback unit 710. In Figure 1 The example is for simply showing the connection between the pressurizing tube 400 and the pressurizing device 700. In actual use, the pressurizing tube 400 and the pressurizing device 700 are threadedly connected for easy disassembly. The pressurizing device 700 pressurizes the balloon 200 through the pressurizing tube 400 and via the pressurizing portions 110, and determines the pressurization pressure according to the feedback unit 710. While ensuring that the balloon 200 meets the treatment standard, it also prevents excessive pressurization, which may cause the balloon 200 to become too large and cause irreversible damage to the patient. Among them, the pressurizing device 700 may be a liquid pressurizing or gas pressurizing device 700, and the pressurizing method may be selected according to the actual use situation.

[0042] To determine the position and depth of the balloon 200 in the body, at least one imaging ring 300 is further sleeved on the catheter 100 in the cavity of the balloon 200. For the balloon 200 dilation catheter 100, the imaging ring 300 can help the doctor monitor the inflation degree of the balloon 200 to ensure that the balloon 200 is correctly inflated to a predetermined size to achieve the best treatment effect. In Figure 1 In the example, two imaging rings 300 are provided, which are respectively disposed at both ends of the cavity of the balloon 200 and sleeved on the catheter 100. The doctor can clearly see the position and state of the balloon 200 under X-ray to ensure that the balloon 200 is accurately placed in the area of prostate hyperplasia and correctly inflated to achieve the treatment purpose.

[0043] During the actual operation, a connector 500 also needs to be connected to the distal end, i.e., the operating end, of the catheter 100. The connector 500 may be a Luer connector catheter seat or may be set according to actual requirements. Optionally, in Figure 1In the example, the first connection end 510 of the connector 500 is fixedly connected to the distal end of the catheter 100 through a connecting tube 600, so that the threading tube 530 passing through both ends of the connector 500 is in communication with the catheter 100, forming a guide wire channel 130 for the guide wire to pass through. Among them, as Figure 3 shown, two channels are provided in the catheter 100. One is a pressurization channel 120 for pressurizing the balloon 200, and the other is a guide wire channel 130 for the guide wire to pass through. The pressurization channel 120 is similar to the structure of a life buoy, with a hollow center forming the guide wire channel 130; the guide wire penetrates through the second connection end 520 of the connector 500 and plays a role in supporting and guiding the catheter 100 via the guide wire channel 130, ensuring that the balloon 200 can smoothly pass through narrow or complex anatomical structures, such as the prostate hyperplasia area.

[0044] Optionally, in Figure 1 the example, the connecting tube 600 includes a third connection end 610, a fourth connection end 620, and a pressurization end 630. The third connection end 610 is fixedly connected to the distal end and is in communication with the catheter 100; the pressurization end 630 is in communication with the pressurization tube 400 and the pressurization channel 120. The fourth connection end 620 is fixedly connected to the first connection end 510 of the connector 500 and is in communication with the threading tube 530 and the guide wire channel 130.

[0045] Specifically, in Figure 1 the example, the third connection end 610 of the connecting tube 600 is connected to the distal end of the catheter 100. Optionally, a threaded connection is provided between the third connection end 610 and the distal end. Therefore, corresponding threads and threaded holes can be provided between the third connection end 610 and the distal end of the catheter 100, so that the third connection end 610 is threadedly connected to the catheter 100; in some embodiments, the third connection end 610 can also be directly fixedly connected to or integrally formed with the catheter 100. The connection method between the connecting tube 600 and the catheter 100 can be set according to the actual situation. The pressurization end 630 of the connecting tube 600 and the pressurization tube 400 can be integrally formed, which not only reduces the number of interfaces, improves the structural strength of the entire device, and reduces the leakage risk caused by loose or damaged interfaces; the pressurization end 630 and the pressurization tube 400 can also be fixed by other means, but it should be noted that the airtightness between the pressurization end 630 and the pressurization tube 400 needs to be ensured.

[0046] In Figure 2In the example, the fourth connection end 620 and the first connection end 510 of the connector 500 are threadedly connected; external threads are respectively provided on the upper and lower surfaces of the fourth connection end 620, and internal threads matching the fourth connection end 620 are provided between one end of the connector 500 and the threading tube 530, so that the fourth connection end 620 and the first connection end 510 can be threadedly connected. At the same time, the threading tube 530 can be aligned with the guide wire channel 130 in the catheter 100, so that the guide wire extends into the guide wire channel 130 through the threading tube 530; in some embodiments, internal threads can also be provided on the inner surface of the fourth connection end 620, and external threads matching the internal threads of the fourth connection end 620 are provided on the outer surface of the connector 500, so that the first connection end 510 of the connector 500 is screwed into the fourth connection end 620. The connection method in this embodiment is shown in the figure, but it also belongs to the protection scope of the present disclosure. The second connection end 520 of the connector 500 can be connected to the guide wire device 800, so it can be arranged similarly to the first connection end 510, and will not be elaborated here.

[0047] Optionally, in Figure 1 In the example, scale lines are provided on the surface of the catheter 100 section between the balloon 200 and the connector 500, and a plurality of the scale lines are spaced at intervals along the length direction of the catheter 100.

[0048] Specifically, the scale lines can be used to measure the depth of insertion of the catheter 100 into the patient's body, helping the doctor accurately locate the position of the balloon 200 and ensuring that the balloon 200 can be accurately placed in the prostate hyperplasia area that needs treatment. Through the scale lines, the doctor can more precisely control the depth of insertion of the catheter 100, reduce surgical errors, and improve the accuracy of the surgery. At the same time, complications that may occur during the surgery, such as overexpansion or improper placement, can be reduced. Optionally, in some embodiments, the distance between each scale line is 10 mm, and the spacing between two adjacent scale lines can also be determined according to the actual situation.

[0049] Optionally, the length of the catheter 100 is not less than 600 mm; the longer length of the catheter 100 (not less than 600 mm) ensures sufficient insertion depth, enabling the doctor to accurately place the balloon 200 in the prostate hyperplasia area. At the same time, it also provides the doctor with sufficient operating space for precise positioning and operation; the longer catheter 100 can adapt to patients of different body types, ensuring that the balloon 200 can reach the prostate hyperplasia site and reducing the increase in surgical difficulty or the risk of complications caused by insufficient length of the catheter 100.

[0050] In some embodiments, the balloon 200 is an ultra-high pressure balloon 200, so it can withstand higher pressures and can achieve greater expansion under lower pressures, which helps to more effectively dilate the hyperplastic prostate area, improve the treatment effect. At the same time, the ultra-high pressure balloon 200 can achieve more sufficient expansion without damaging the surrounding tissues, reducing the damage to the prostate tissue and improving the safety and effect of the operation. Optionally, the length of the balloon 200 is between 3.0 cm and 3.5 cm, ensuring that the balloon 200 can completely cover the hyperplastic prostate area, while avoiding unnecessary over-expansion and reducing the impact on the surrounding tissues; it can also better adapt to the anatomical structures of most patients with prostate hyperplasia, ensuring the effectiveness of the treatment and reducing the risk of complications.

[0051] Optionally, the drug coated on the outer surface of the balloon 200 is a paclitaxel drug coating.

[0052] Specifically, paclitaxel is a broad-spectrum anti-cancer drug. When used to treat prostate hyperplasia, the paclitaxel released during the expansion of the balloon 200 can directly act on the prostate tissue, inhibit cell proliferation, reduce the prostate volume, and improve urinary flow symptoms; at the same time, since the paclitaxel drug coating on the surface of the balloon 200 may be scratched before reaching the lesion site, in order to ensure the treatment effect, the paclitaxel drug coating is set to a certain thickness to ensure that there is still enough drug amount to treat the lesion area after reaching the lesion site.

[0053] Optionally, the surface of the catheter 100 is formed with a hydrophilic coating.

[0054] Specifically, since the surface of the catheter 100 is provided with a hydrophilic coating, medical water-based lubricants can be used during intubation, improving the doctor's intubation efficiency and avoiding iatrogenic injuries; the lubricity of the hydrophilic coating reduces the friction between the catheter 100 and the urethra and prostate tissue, reducing the tissue damage and discomfort that may occur during the insertion process.

[0055] Optionally, the materials of the balloon 200 and the catheter 100 are medical polymer materials; the medical polymer materials include silicone, polyurethane or ethylene vinyl acetate copolymer; thus, they will not cause immune reactions or allergic reactions, reducing the adverse reactions that may occur in patients during use. Among them, medical polymer materials such as silicone and polyurethane have excellent flexibility and durability, can withstand bending and stretching during the operation, ensuring the stability and reliability of the device. At the same time, medical polymer materials are easy to be sterilized by high-temperature steam or other disinfection treatments, ensuring the hygiene and safety of medical devices; and have good corrosion resistance, and can remain stable even in an environment containing drugs or body fluids.

[0056] The above embodiments are only illustrative of the principles and effects of the present disclosure, and are not intended to limit the present disclosure. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present disclosure. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present disclosure should still be covered by the protection scope of the present disclosure.

Claims

1. A drug balloon device, characterized in that: include: A catheter, comprising a proximal end and a distal end; the catheter forms a pressurization channel and a guidewire channel, and a pressurization portion connected to the pressurization channel is provided on the catheter section close to the proximal end; A balloon, which is sleeved on the proximal end of the catheter to form a cavity covering the pressurized part, and the outer surface is used for coating drugs; At least one developing ring, located in the cavity and sleeved on the conduit; a pressurizing tube, arranged near the distal end and connected to the catheter, forming a pressurizing channel connected to the pressurizing part through the catheter, the pressurizing channel is used to pressurize the balloon to expand the balloon to apply medicine to the lesion; the pressurizing channel is connected to a feedback unit for displaying the pressurization pressure; A connector includes a first connecting end, a second connecting end, and a penetration tube that passes through the first connecting end and the second connecting end; the first connecting end is fixedly connected to the distal end of the catheter so that one end of the penetration tube is connected to the guide wire channel, and the second connecting end is used to insert a guide wire into the guide wire channel through the penetration tube.

2. The drug balloon device according to claim 1, characterized in that: It also includes a connecting tube, including a third connecting end, a fourth connecting end and a boosting end; the third connecting end is fixedly connected to the distal end and communicated with the catheter; the boosting end is connected to the boosting tube and the boosting channel; the fourth connecting end is fixedly connected to the first end of the connector and communicates with the penetration tube and the guide wire channel.

3. The drug balloon device according to claim 2, characterized in that: The third connection end is threadedly connected to the distal end; and / or the fourth connection end is threadedly connected to the first end of the connector.

4. The drug balloon device according to claim 1, characterized in that: The other end of the boost pipe is threadedly connected to a boost device, and the boost device is provided with the feedback unit.

5. The drug balloon device according to claim 1, characterized in that: The surface of the catheter section between the balloon and the connector is provided with scale lines, and a plurality of scale lines are arranged at intervals along the length direction of the catheter.

6. The drug balloon device according to claim 5, characterized in that: The distance between each of the scale lines is 10 mm.

7. The drug balloon device according to claim 1, characterized in that: The length of the catheter is not less than 600 mm; the balloon is an ultra-high pressure balloon; and / or the length of the balloon is between 3.0 cm and 3.5 cm.

8. The drug balloon device according to claim 1, characterized in that: The drug coated on the outer surface of the balloon is a paclitaxel drug coating.

9. The drug balloon device according to claim 1, characterized in that: A hydrophilic coating is formed on the surface of the catheter.

10. The drug balloon device according to claim 1, characterized in that: The balloon and the catheter are made of medical polymer materials; the medical polymer materials include silicone, polyurethane or ethylene vinyl acetate copolymer.

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