A disposable balloon system for percutaneous puncture

Abstract

The application relates to the technical field of medical devices, and particularly discloses a disposable balloon system for percutaneous puncture, which comprises a balloon catheter unit and a pressure charging control unit; the balloon catheter unit comprises a balloon, a catheter, a scale mark and a developing mark, wherein the distal end of the catheter is a closed structure and the side wall of the catheter is provided with a catheter air hole; and the pressure charging control unit comprises a one-way valve mechanism and a locking sealing mechanism. The balloon directly fills and compresses in a wound channel to achieve hemostasis, the developing mark and the scale mark are combined to achieve accurate positioning, the one-way valve is automatically sealed and mechanically locked to prevent displacement, and the balloon system has the advantages of reliable hemostasis effect, simple operation, high safety and one-time use to avoid cross infection.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a disposable balloon system for percutaneous puncture, and more specifically, a disposable medical device that uses balloon inflation to compress and stop bleeding through the puncture wound in the body. Background Technology

[0002] Percutaneous biopsy is an important minimally invasive diagnostic and therapeutic technique in modern medicine, widely used in tissue biopsies (such as liver, kidney, lung, and thyroid biopsies), percutaneous transhepatic biliary drainage (PTCD), central venous catheter placement (CVC), and radiofrequency ablation. These procedures all require establishing a pathway from the skin to the target lesion or blood vessel using a puncture needle. After the procedure, the removal of the puncture needle or sheath leaves a narrow tissue wound (or needle tract) within the body. Because the puncture path may pass through highly vascularized tissue, bleeding through this wound is a common postoperative complication. Improper hemostasis can lead to hematomas, intra-abdominal bleeding, and in severe cases, even endanger the patient's life. Therefore, achieving rapid, effective, and reliable hemostasis of the puncture wound is crucial.

[0003] Currently, clinical methods for hemostasis of percutaneous puncture wounds mainly include: manual compression, mechanical compression devices / hemostatic devices, bioactive hemostatic material packing, and existing balloon compression devices. While manual compression is simple to operate, it is time-consuming and labor-intensive, and the pressure and location are difficult to control precisely, resulting in inconsistent hemostatic effects. Mechanical compression devices still rely on surface pressure, making it difficult to effectively transmit pressure to deep tissue bleeding points. Bioactive hemostatic material packing is difficult to control precisely in terms of packing volume and location, potentially causing foreign body reactions and allergic reactions, and is easily dispersed when blood flows out in large quantities, leading to hemostasis failure. Existing balloon compression devices (such as CN209966486U) are designed for endovascular hemostasis, and their application scenarios and working principles are fundamentally different from the compression hemostasis of tissue wounds described in this application. Furthermore, some composite devices combine a balloon with a hemostatic sponge, resulting in complex structures, numerous operating steps, and are not designed for single use, posing a risk of cross-infection.

[0004] In summary, existing technologies have the following main drawbacks: poor compression effect, traditional surface compression methods have low pressure transmission efficiency and are difficult to effectively compress deep bleeding points; cumbersome operation and reliance on experience, the effectiveness largely depends on the operator's skill and experience, and the degree of standardization is low; safety issues, the packing materials may cause adverse reactions, intravascular balloons are not suitable for tissue wound hemostasis and pose a risk of vascular damage, and non-disposable devices pose a risk of cross-infection; lack of integrated, dedicated solutions for wound hemostasis, existing technologies lack a highly integrated, easy-to-operate, precise, effective, and disposable dedicated instrument.

[0005] Therefore, this invention aims to solve the above-mentioned technical problems by providing an integrated, simple-to-operate, rapid and reliable hemostasis system suitable for various percutaneous puncture wounds and for single use. This system precisely delivers the balloon to the bleeding point deep within the wound and directly inflates it, achieving precise and effective compression of the bleeding source. Simultaneously, by integrating imaging, a one-way valve, and a locking device, it ensures operational safety and convenience. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a disposable balloon system for percutaneous puncture. This system aims to solve the problems of inaccurate compression positioning, unstable force, cumbersome operation, and the risk of cross-infection associated with traditional hemostatic devices. Specifically, this invention achieves rapid, precise, reliable, and safe disposable intra-wound hemostasis through a highly integrated instrument structure design, thereby significantly improving the safety and efficiency of percutaneous puncture surgery.

[0007] To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0008] A disposable balloon system for percutaneous puncture, comprising a balloon catheter unit and an inflation control unit;

[0009] The balloon catheter unit includes:

[0010] A balloon, made of a flexible biocompatible material, is attached to the distal end of a catheter and is used to inflate at the target location to compress and stop bleeding.

[0011] The catheter, with its proximal end connected to the pressurization control unit and its distal end connected to the balloon, is used to deliver fluid media and provide a delivery path for the balloon.

[0012] A scale marking is provided on the tube body to indicate the insertion depth;

[0013] A contrast marker is placed at the distal end of the catheter for visualization and positioning under medical imaging.

[0014] The pressurization control unit includes:

[0015] A one-way valve mechanism, connected to the proximal end of the catheter, is used to allow the fluid medium to be injected into the balloon in one direction and to prevent backflow, so as to maintain the balloon inflation state.

[0016] A locking and sealing mechanism, integrated with or adjacent to the one-way valve mechanism, is used to apply a radial locking force to the catheter to prevent it from moving during hemostasis.

[0017] Preferably, the distal end of the catheter extends into the balloon and its end is a closed structure; at least one catheter air hole is provided on the side wall of the catheter located inside the balloon, the catheter air hole enabling the inner lumen of the catheter to communicate with the inner chamber of the balloon.

[0018] Preferably, the one-way valve mechanism includes a valve body, a valve core, a spring, and a seal; the valve core is movable within the valve body, and the spring provides a biasing force to the valve core to tend towards the closed position.

[0019] Preferably, the locking and sealing mechanism includes a locking knob and a sealing ring; tightening the locking knob can compress the sealing ring, deform it, and generate a locking and sealing force on the conduit inserted therein.

[0020] Preferably, the balloon is made of a material selected from Pebax, polyamide PA, polyethylene terephthalate PET, thermoplastic polyurethane TPU, or nylon; the catheter is made of nylon 11 or nylon 12.

[0021] Preferably, the developing mark is a developing ring made of platinum-iridium alloy or tungsten.

[0022] Preferably, the outer surface of the balloon is further provided with an antibacterial coating and / or a hemostatic coating.

[0023] Compared with the prior art, the hemostatic balloon system provided by this utility model has the following significant advantages:

[0024] 1. Precise and reliable hemostasis: By directly filling and compressing the balloon inside the wound, precise and uniform radial compression of the bleeding point is achieved, overcoming the shortcomings of insufficient pressure transmission in surface compression methods. It is especially suitable for deep puncture hemostasis, greatly improving the success rate and reliability of hemostasis.

[0025] 2. Simple and quick operation: The integrated design makes the entire operation process simple and intuitive. The scale markings on the catheter assist in precise control of the insertion depth, and the contrast markers provide visual positioning, reducing operational difficulty. The one-way valve and mechanical locking mechanism make pressurization and locking operations simple and reliable, significantly shortening operation time.

[0026] 3. High safety: The entire system is designed for single use, completely eliminating the risk of cross-infection. All materials that come into contact with the human body have good biocompatibility, avoiding the risk of foreign body reactions or allergies that may arise from filler materials.

[0027] 4. High stability: The one-way valve mechanism ensures that the balloon will not leak after inflation, and the mechanical locking and sealing mechanism effectively prevents catheter displacement and achieves a seal. The dual protection mechanism ensures the stability of the balloon inflation state during hemostasis, thereby ensuring a continuous compression effect.

[0028] 5. Reasonable structural design: The design of closed distal end of the catheter and open side wall improves delivery safety and promotes uniform balloon inflation; the integrated inflation control unit is compact, easy to operate, and has good practicality and reliability. Attached Figure Description

[0029] Figure 1 This diagram illustrates the overall structure of the hemostatic balloon system provided in an embodiment of the present invention.

[0030] Figure 2 This diagram shows a cross-sectional view of the balloon catheter unit.

[0031] Figure 3 This diagram shows a cross-sectional view of the pressurization control unit.

[0032] Figure 4 This diagram shows a partially enlarged schematic of the locking and sealing mechanism;

[0033] Figure 5 This diagram illustrates the working principle of a one-way valve mechanism.

[0034] Figure 6 The diagram illustrates the usage state of the balloon system according to an embodiment of the present invention during inflation within a tissue wound.

[0035] The components represented by each number in the diagram are listed below:

[0036] 1-Balloon; 2-Catheter; 21-Closed structure; 22-Catheter vent; 3-One-way valve mechanism; 31-Valve body; 32-Valve core; 33-Spring; 34-Seal; 4-Locking mechanism; 41-Locking knob; 42-Sealing ring; 5-Development mark; 51-Development ring; 6-Gradient marking. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of this utility model clearer, the following will describe this utility model in detail with reference to the preferred embodiments and accompanying drawings. It should be noted that the following description is merely exemplary and is not intended to limit the scope of protection of this utility model.

[0038] The embodiments of this utility model will be further described in detail below with reference to the accompanying drawings, wherein, Figure 1 This is a schematic diagram of the overall structure of the hemostatic balloon system provided in this embodiment of the utility model. Figure 2 yes Figure 1 A cross-sectional schematic diagram of the mid-balloon catheter unit. Figure 3 This is a cross-sectional structural diagram of the pressurization control unit. Figure 4 This is a partially enlarged schematic diagram of the locking and sealing mechanism. Figure 5 This is a schematic diagram illustrating the working principle of a one-way valve mechanism. Figure 6 This is a reference diagram showing the balloon system of the invention in its usage state during inflation within a tissue wound.

[0039] This invention provides a disposable balloon system for percutaneous puncture procedures. The system features a highly integrated design, enabling precise internal pressure hemostasis of bleeding points within the puncture wound. Referring to the accompanying drawings, the system mainly comprises two parts: a balloon catheter unit and a pressure control unit.

[0040] The balloon catheter unit is the part that goes directly into the patient's body and includes the following core components:

[0041] 1. Balloon 1: Made of a flexible biocompatible material, preferably Pebax 7233, polyamide (PA12), or thermoplastic polyurethane (TPU). The balloon 1, when fully inflated, is approximately 10 mm (1 cm) long, and its diameter can be designed within the range of 1.5 mm to 5.0 mm according to clinical needs. Preferred sizes include 1.5 mm, 2.0 mm, and 2.5 mm to accommodate wounds created by puncture needles of different diameters. To further improve biocompatibility and delivery smoothness, a hydrophilic coating can be applied to the outer surface of the balloon 1. In a preferred embodiment, to improve the antibacterial effect during hemostasis, an antibacterial coating (such as a silver ion coating or a physical antibacterial coating) can be applied to the outer surface of the balloon 1; alternatively, in some embodiments, a hemostatic drug coating can be applied to the outer surface of the balloon 1 to further enhance the hemostatic effect of this embodiment.

[0042] 2. Catheter 2: Its distal end is securely and sealed to balloon 1 using a special welding process (e.g., laser welding, thermofusion welding, hot air welding) or adhesive bonding. Its proximal end is connected to the pressurization control unit. The outer diameter of the catheter is preferably 1.0 mm (Fr 3), while the inner diameter must ensure smooth passage of the fluid medium. The length of catheter 2 can be selected between 100 mm and 1000 mm depending on the depth of the target hemostasis site. A shorter length (100-200 mm) is chosen for superficial tissue hemostasis, and a longer length (800-1000 mm) is chosen for deep organ hemostasis. The catheter body is made of nylon 11 or nylon 12 material, possessing a certain degree of rigidity and flexibility, facilitating insertion while accurately transmitting operative force. The hardness of catheter 2 is preferably in the range of 72D-75D to balance insertion and flexibility.

[0043] Key structural features of catheter 2 include: the distal end of catheter 2 extends into the balloon 1 and its end is a closed structure 21. This closed structure can be a smooth rounded structure or a conical structure, which can effectively avoid punctures or scratches to tissues during delivery, improving operational safety. Alternatively, it can be designed as a pointed structure to facilitate the introduction of the balloon system into human tissues. At least one catheter vent 22 (preferably 2-4) is provided on the side wall of catheter 2 located inside balloon 1, and the catheter vent 22 connects the inner lumen of catheter 2 with the inner chamber of balloon 1. This design has significant advantages over the design of directly opening the distal end of catheter 2 into the inside of balloon 1: the side wall opening allows the fluid medium to flow out from multiple directions from the side, which helps balloon 1 to inflate more quickly and evenly.

[0044] 3. Scale marking 6: Printed on the catheter 2, in centimeters, starting from the distal end, to help the operator judge the insertion depth and achieve preliminary positioning.

[0045] 4. Imaging Marker 5: An imaging ring made of a high-density, biocompatible metallic material, preferably a platinum-iridium alloy ring or a tungsten ring. It is positioned at the distal end of the catheter 2 near the balloon 1. Preferably, two imaging rings 51 are provided, located at the two ends of the connection between the balloon 1 and the catheter 2, respectively. This imaging ring 51 can be clearly captured by X-ray fluorescence fluoroscopy, computed tomography (CT), or ultrasound equipment, providing real-time visual feedback to the operator and enabling precise positioning.

[0046] The pressurization control unit is the part that the operator holds in their hand. Its design directly affects the ease of operation and the reliability of the system, and includes the following core components:

[0047] 1. One-way valve mechanism 3: This is a key component of the entire system, used to allow unidirectional injection of the fluid medium and reliably prevent its backflow to maintain the inflation pressure of the balloon. This mechanism mainly includes:

[0048] Valve body 31: has a standard Luer connector interface for connecting a syringe;

[0049] Valve core 32: can move axially within the cavity of valve body 31;

[0050] Spring 33: Provides a biasing force to the valve core 32 to tend towards the closed position;

[0051] Seal 34: Usually made of TPU or rubber.

[0052] When the operator inserts the syringe and pushes it forward, the tip of the syringe pushes the valve core 32, causing its compression spring 33 to move backward and open the infusion passage; when the syringe is removed, the valve core 32 quickly returns to its original position under the restoring force of the spring 33 and squeezes the seal 34 to automatically close the passage and form a reliable seal.

[0053] 2. Locking and sealing mechanism 4: This mechanism securely locks the catheter 2 in place after the balloon 1 is fully inflated, preventing accidental slippage due to patient movement or tissue pressure, ensuring continuous compression, and also sealing the flow path within the catheter 2. This mechanism mainly includes:

[0054] Locking knob 41: Preferably made of high-strength, dimensionally stable engineering plastics such as PC, ABS or PP, and the surface may have anti-slip texture to enhance the operating feel;

[0055] Sealing seat 43: preferably made of high-strength, dimensionally stable engineering plastics such as PC, ABS or PP, and is fitted with a threaded pair 411 between it and the locking knob 41;

[0056] Sealing ring 42: A deformable elastic element made of TPU or rubber material, installed inside the sealing seat 43, and can mate with the sealing seat 43 through the tapered mating surface 431.

[0057] The proximal section of the conduit 2 passes through the sealing ring 42. When the locking knob 41 is tightened, the sealing seat 43 is pushed forward by the thread, and then the sealing ring 42 is squeezed by the tapered mating surface 431, causing it to deform radially and thus tightly "lock" the conduit 2 inside, providing great friction and achieving a seal. After the locking knob 41 is released, the sealing ring 42 elastically recovers, and the conduit 2 can move freely.

[0058] This embodiment achieves the following significant technical effects through the above-described innovative structural design:

[0059] 1. Precise and reliable hemostasis: By directly inflating and compressing the balloon 1 inside the wound, precise and uniform radial compression of the bleeding point is achieved. The design of distal closure of the catheter 2 and side wall vents 22 ensures uniform inflation of the balloon 1, avoiding stress concentration on one side; the dual positioning system of scale markings 6 and contrast markers 5 ensures that the balloon 1 can be accurately delivered to the deepest bleeding point in the wound, fundamentally solving the problems of insufficient pressure transmission and inaccurate positioning of the surface compression method.

[0060] 2. Simple and quick operation: The integrated design makes the entire operation process simple and intuitive. The one-way valve mechanism 3 achieves "seal upon needle removal", simplifying the operation; the locking and sealing mechanism 4 provides reliable position fixation and achieves sealing; the scale markings 6 and developing marks 5 greatly reduce the difficulty of operation and reliance on experience, and significantly shorten the operation time.

[0061] 3. High safety: The entire system is designed for single use, completely eliminating the risk of cross-infection. All materials in contact with the human body have good biocompatibility; the rounded tip design at the distal end of the catheter avoids tissue damage; the mechanical locking provides stable fixation force, avoiding the risk of catheter displacement.

[0062] 4. High stability: The automatic sealing feature of the one-way valve mechanism 3 ensures that the balloon will not leak after inflation; the locking sealing mechanism 4 effectively prevents the catheter 2 from shifting and achieves the sealing of the catheter 2; the dual protection mechanism together ensures the stability of the balloon inflation state within the required hemostasis time, thereby ensuring the continuous compression effect.

[0063] In summary, this utility model, through its innovative structural design, provides a disposable hemostasis solution that is effective, easy to operate, and highly safe, effectively overcoming many shortcomings of existing technologies and showing promising clinical application prospects.

[0064] It should be noted that although specific technical features such as balloon coating, catheter hardness, and imaging ring setting are mentioned in the above embodiments, those skilled in the art should understand that these are merely preferred embodiments of this utility model and not limitations thereof. Modifications and substitutions to these features without departing from the principle of this utility model should fall within the protection scope of this utility model.

[0065] In the description of this specification, references to terms such as "some embodiments," "some examples," "exemplarily," "example," "preferred," or "further" indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

Claims

1. A disposable balloon system for percutaneous puncture, characterized in that, include: A balloon catheter unit comprising an inflatable balloon (1) and a catheter (2) communicating with the balloon (1). A pressurization control unit is connected to the proximal end of the conduit (2), the pressurization control unit including a one-way valve mechanism (3) and a locking and sealing mechanism (4).

2. The disposable balloon system according to claim 1, characterized in that, The distal end of the catheter (2) extends into the interior of the balloon (1) and its end is a closed structure (21); at least one catheter air hole (22) is provided on the side wall of the catheter (2) located inside the balloon (1), and the catheter air hole (22) communicates the inner lumen of the catheter (2) with the inner chamber of the balloon (1).

3. The disposable balloon system according to claim 2, characterized in that, The distal end of the catheter (2) has a smooth round head, conical surface or pointed structure.

4. The disposable balloon system according to claim 1, characterized in that, The one-way valve mechanism (3) includes a valve body (31), a valve core (32), a spring (33), and a seal (34). The valve core (32) is movably disposed within the valve body (31), and the spring (33) acts on the valve core (32) to make it tend to close.

5. The disposable balloon system according to claim 1 or 4, characterized in that, The locking and sealing mechanism (4) includes a locking knob (41), a sealing seat (43), and a sealing ring (42). The locking knob (41) is threadedly connected to the sealing seat (43), and the sealing ring (42) is installed inside the sealing seat (43). Tightening the locking knob (41) can compress the sealing ring (42), causing it to deform and apply a locking force to the conduit (2) inserted therein.

6. The disposable balloon system according to claim 1, characterized in that, The balloon catheter unit also includes a radiopaque marker (5) for visualization and localization.

7. The disposable balloon system according to claim 6, characterized in that, The radiopaque marker (5) includes at least one radiopaque ring (51) disposed near the connection between the catheter (2) and the balloon (1), and is made of platinum-iridium alloy or tungsten.

8. The disposable balloon system according to claim 1, characterized in that, The catheter (2) is provided with scale markings (6) for indicating the insertion depth.

9. The disposable balloon system according to claim 1, characterized in that, The balloon (1) is made of one of the following materials: Pebax, polyamide (PA), polyethylene terephthalate (PET), thermoplastic polyurethane (TPU), or nylon; and / or The material of the catheter (2) is nylon 11 or nylon 12.

10. The disposable balloon system according to claim 1, characterized in that, The outer surface of the balloon (1) is provided with an antibacterial coating and / or a hemostatic coating.

11. The disposable balloon system according to claim 1, characterized in that, The balloon (1) has a length of 3 mm to 200 mm and a diameter of 1 mm to 20 mm when inflated.

12. The disposable balloon system according to claim 1, characterized in that, The outer diameter of the catheter (2) is Fr3, and its length ranges from 100mm to 1000mm.

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