A self-expanding balloon catheter

Abstract

The application discloses a self-expanding balloon catheter and relates to the technical field of medical devices, which comprises a main pipe body, a self-expanding balloon and an outer sheath pipe, the outer sheath pipe is sleeved on the main pipe body and is in sliding connection with the main pipe body, the self-expanding balloon is provided with two groups and is located at the proximal end and the distal end of the main pipe body, the main pipe body comprises a medicine injection channel with a medicine release side hole, and the side hole is located between the two groups of self-expanding balloons, and the outer sheath pipe is used for restraining the self-expanding balloon. Through the arrangement, the self-expanding balloon is adopted, the balloon can be self-inflated and expanded, and it is not necessary to rely on external injection of gas or liquid, which is favorable for simplifying the operation process and shortening the operation time; in a non-working state, the balloon is restrained by the outer sheath pipe and is in a contracted state, so that the overall diameter of the catheter is reduced, and it is favorable for sending the catheter to a target lesion position; the outer sheath pipe is withdrawn, the restriction of the balloon is released, the double balloons are self-inflated in a cavity and form a closed medicine perfusion treatment cavity, and it is favorable for realizing local and accurate treatment of non-blood vessel cavity lesions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a self-expanding balloon catheter. Background Technology

[0002] Non-vascular cavity diseases, including those of the digestive, genitourinary, and respiratory tracts, are common clinical conditions involving various disease types such as tumors, inflammation, and infections, and represent a significant public health issue impacting population health. Drug therapy is an indispensable and crucial part of non-vascular cavity disease treatment, with common medications including anti-tumor drugs (chemotherapeutic agents, targeted therapies, immunotherapies, etc.), anti-inflammatory drugs (steroids, antihistamines, nonsteroidal anti-inflammatory drugs, etc.), antacids (proton pump inhibitors, H2 receptor antagonists, etc.), and antibiotics. Systemic administration via oral and intravenous infusion is currently the primary route of drug delivery for non-vascular cavity diseases; however, its clinical pharmacokinetic characteristics and efficacy are still insufficient and require further optimization. Its limitations mainly include: 1) weak targeted drug delivery capability and low drug concentration at the lesion site, significantly limiting the therapeutic effect and easily inducing drug resistance; 2) systemic drug exposure to non-target tissues, which easily leads to drug-related adverse reactions.

[0003] For non-vascular cavity diseases, intracavitary drug delivery is an effective strategy to overcome the shortcomings of existing systemic drug administration methods. It utilizes the physiological characteristic of the gastrointestinal mucosa to absorb substances within cavities. By improving drug formulations, modifying drug molecules, and developing novel delivery devices, drugs can be delivered transcavitarily to the diseased tissue, increasing local tissue drug concentration and reducing systemic drug exposure, thereby improving clinical efficacy and reducing drug-related adverse reaction rates. However, the unique physiological and anatomical structure of non-vascular cavities, characterized by "physiological clearance," results in rapid drug transport and short local retention time within the cavity, leading to insufficient effective contact with the lesion site and consequently, inadequate drug absorption by the diseased tissue. Therefore, this is a key factor limiting the efficiency of transcavitary drug delivery.

[0004] Intracavitary local drug infusion is an effective method for delivering drugs locally through cavities. It overcomes the "physiological clearance" effect of non-vascular cavities, thereby prolonging the contact time between the drug and the lesion and increasing the amount of drug absorbed by the lesion. The core technology of intracavitary local drug infusion lies in using specially designed instruments to construct a temporarily closed treatment cavity within the diseased cavity, and then achieving the goal of controllable local high-concentration drug infusion treatment of the lesion through intracavitary drug infusion.

[0005] Dual-balloon catheters are a novel type of medical device for local drug infusion within cavities. They consist of a single-lumen or multi-lumen catheter with a drug-release side port, and at least two balloons located distal to the side port. After insertion into the diseased cavity, the balloons expand to form a local drug treatment cavity, enabling local drug infusion therapy. However, in existing dual-balloon catheter systems, the balloons are primarily made of silicone and other polymeric materials (polyurethane, PVC, polyethylene phthalate, polytetrafluoroethylene, polyurethane, polyisoprene, etc.). These materials do not possess self-expansion or expansion properties. Therefore, in practical use, additional gas or liquid needs to be injected into the balloon to inflate it. However, there is a potential risk of balloon rupture due to excessive gas or liquid injection, which not only reduces the therapeutic effect but may also lead to adverse reactions such as tissue damage within the cavity. To address the above needs, this invention provides a self-expanding balloon catheter; the balloon itself has automatic expansion characteristics, requiring no additional gas or liquid injection to expand it, thus avoiding the risk of adverse reactions caused by balloon rupture due to excessive inflation / fluid injection during surgery. Summary of the Invention

[0006] The purpose of this invention is to overcome the deficiencies in the prior art and to propose a self-expanding balloon catheter.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: A self-expanding balloon catheter, characterized in that it comprises a main tube, a self-expanding balloon, and an outer sheath, wherein the outer sheath is sleeved on the main tube and slidably connected to the main tube; two sets of self-expanding balloons are provided, the two sets of self-expanding balloons being located at the proximal and distal ends of the main tube, respectively; the outer sheath is used to block the self-expanding balloon before it expands; a drug release orifice is provided on the side wall of the main tube, the drug release orifice being located between the two sets of self-expanding balloons.

[0008] Furthermore, the main body includes a drug injection conduit and a guidewire channel tube, the guidewire channel tube being disposed inside the drug injection conduit, and the guidewire channel tube and the drug injection conduit being disposed independently; The end of the drug injection catheter is provided with a drug injection catheter sheath connector; the end of the guidewire channel tube is provided with a guidewire channel tube sheath connector; and the self-expanding balloon is disposed on the outer wall of the drug injection catheter.

[0009] Furthermore, the distal end of the drug injection catheter is a closed blind end, the drug release orifice is the only drug discharge orifice, and the orifice diameter is 1mm-2mm.

[0010] Furthermore, the distance between the end of the drug injection catheter and the distal self-expanding balloon is greater than 1 cm, and a metal imaging ring is provided at the distal end of the drug injection catheter, the metal imaging ring being located between the distal self-expanding balloon and the end of the drug injection catheter.

[0011] Furthermore, the materials used to prepare the drug injection catheter and outer sheath are polymer materials.

[0012] Furthermore, the distance between the two self-inflating balloons ranges from 0.01 to 100 cm, and the distance is greater than the axial length of the cavity lesion.

[0013] Furthermore, the self-inflating balloon includes a balloon skeleton and a covering membrane, wherein the covering membrane is a single outer covering membrane, a double-layer covering membrane consisting of an inner covering membrane and an outer covering membrane, or an integrated covering membrane.

[0014] Furthermore, the balloon skeleton is made of a metal material with memory and elastic properties; the coating material includes any one or more polymer coating materials or derivative materials.

[0015] Furthermore, the geometry of the balloon skeleton is spherical, elliptical, semi-elliptical, umbrella-shaped, basket-shaped, or rectangular.

[0016] Furthermore, the diameter of the outer sheath is larger than the diameter of the outer wall of the main tube and the diameter of the self-expanding balloon in the compressed state, but smaller than the diameter of the self-expanding balloon in the expanded state.

[0017] Beneficial effects

[0018] Compared with the prior art, the beneficial effects of the present invention are as follows: 1) The double balloon design can block the distal and proximal cavities of esophageal lesions to form a drug infusion closed cavity, and helps to fix the catheter to the lesion site and prevent the drug infusion fluid in the closed cavity from overflowing into the distal cavity.

[0019] 2) The infusion catheter between the two balloons is equipped with a drug release side hole, through which the drug infusion solution can flow into the closed cavity formed by the expansion of the two balloons for local drug infusion therapy, so as to increase the drug concentration in non-vascular lesions and reduce non-targeted systemic exposure of drugs.

[0020] 3) The self-expanding balloon design allows the balloon to expand automatically without relying on external gas or liquid injection. When not in use, the balloon is in a contracted state, and its expansion is constrained by the outer sheath, resulting in a smaller overall diameter of the double-balloon catheter, which is beneficial for delivery to non-vascular lesion sites. Retracting the outer sheath can relieve its constraint on the balloon's expansion, allowing the balloon to expand within the cavity to form a closed treatment cavity, which simplifies the surgical procedure and shortens the operation time.

[0021] 4) The self-expanding balloon is made of metal materials with good memory properties and elasticity. Because these metal materials themselves have good DSA imaging properties, it is beneficial for the positioning of the balloon and the assessment of its expansion during the operation, thereby increasing the success rate and safety of the operation. Attached Figure Description

[0022] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof.

[0023] Figure 1 This is a schematic cross-sectional view of the self-expanding balloon catheter in its contracted state.

[0024] Figure 2 This is a schematic diagram of the functional segment and cross-sectional structure of a self-expanding balloon catheter in its contracted state.

[0025] Figure 3 This is a schematic cross-sectional view of a self-expanding balloon catheter in its expanded state.

[0026] Figure 4 This is a schematic diagram of the functional segment and cross-sectional structure of a self-expanding balloon catheter in its expanded state.

[0027] In the diagram: 1. Guidewire channel sheath connector; 2. Drug injection catheter sheath connector; 3. Guidewire channel tube; 4. Drug injection catheter; 5. Outer sheath; 6. Drug release port; 7. First self-expanding balloon; 8. Second self-expanding balloon; 9. Contrast ring; 11. Balloon lumen; 12. Sliding gap; 13. Blind end; 14. Balloon skeleton; 15. Outer membrane; 16. Inner membrane; 17. Integrated membrane. Detailed Implementation

[0028] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0029] In the description of this invention, it should be understood that the terms "upper", "lower", "front", "rear", "left", "right", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention 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. Therefore, they should not be construed as limitations on this invention.

[0030] Reference Figure 1 - Figure 4A novel self-expanding balloon catheter, comprising a main tube, a first self-expanding balloon 7, a second self-expanding balloon 8, and an outer sheath 5, is used for intraluminal local drug infusion therapy for non-vascular cavity diseases.

[0031] The main body consists of a guidewire channel tube 3, a drug injection catheter 4, a guidewire channel tube sheath connector 1, and a drug injection catheter sheath connector 2.

[0032] The first self-expanding balloon 7 and the second self-expanding balloon 8 are located proximally and distally to the drug infusion catheter 4, respectively. The drug infusion catheter 4 can pass through the middle of the balloons, but the self-expanding balloons are not connected to the drug infusion catheter 4. After full expansion, the first self-expanding balloon 7 and the second self-expanding balloon 8 can seal the proximal and distal cavities of the lesion to form a closed cavity for drug infusion. The distance between the first self-expanding balloon 7 and the second self-expanding balloon 8 should be greater than the axial length of the lesion. Considering that the axial length of non-vascular cavities is usually no more than 100 cm, the distance between the first self-expanding balloon 7 and the second self-expanding balloon 8 can be between 0.01 and 100 cm. The specific length range can be set according to the actual situation, so that the range of the closed cavity formed after expansion exceeds the range of the lesion, ensuring adequate treatment of the lesion.

[0033] Both the first self-expanding balloon 7 and the second self-expanding balloon 8 have good self-expanding properties. They can automatically expand to a preset shape and size without relying on the injection of external gas or liquid. Furthermore, the first self-expanding balloon 7 and the second self-expanding balloon 8 exist independently and are not connected to each other, so their automatic expansion behavior does not affect each other.

[0034] The length of the drug injection catheter 4 should be greater than that of the first self-expanding balloon 7 and the second self-expanding balloon 8. The proximal end of the catheter is connected to the sheath connector 2, which is the drug injection port. The distal end of the drug injection catheter 4 should extend at least 1 cm beyond the second self-expanding balloon 8. The distal end of the catheter is a closed blind end 13. A metal imaging ring 9 is provided at the distal end of the catheter, which can provide imaging function under X-ray and play a positioning role.

[0035] The drug infusion catheter 4 has a hollow guidewire channel 3 in the center, allowing the guidewire to pass through. The main body 3 of the local drug infusion balloon catheter can slide along the metal guidewire, delivering the device to the lesion site in the esophagus. The guidewire channel 3 is not connected to the drug infusion catheter 4.

[0036] The drug injection catheter 4 has a drug release port 6 on its side wall between the first self-expanding balloon 7 and the second self-expanding balloon 8. The drug injected through the drug injection catheter 4 can flow into the closed cavity formed by the expansion of the first self-expanding balloon 7 and the second self-expanding balloon 8 through the drug release port 6, so that the drug can fully contact the lesion in the cavity. The diameter of the drug release port 6 should be between 1 mm and 2 mm, and the number of drug release ports 6 should be no less than 4. At the same time, after the treatment is completed, the drug can be recovered through the drug release port 6.

[0037] The drug injection catheter 4, guidewire channel tube 3, first self-expanding balloon 7, second self-expanding balloon 8, and outer sheath tube 5 are not interconnected.

[0038] The materials used to prepare the drug injection catheter 4 include, but are not limited to, high molecular weight materials such as polyurethane, polytetrafluoroethylene, polyamide, polyether block polyamide, and polyether ether ketone.

[0039] The first self-expanding balloon 7 and the second self-expanding balloon 8 are structurally composed of a balloon skeleton 14 and a covering membrane; the covering membrane can be any one of the following forms: a single outer covering membrane 15, a double covering membrane of inner covering membrane 16 and outer covering membrane 15, and an integrated covering membrane 17, wherein the layers are closely fitted or fused together to form a stable integrated structure.

[0040] The first self-expanding balloon 7 and the second self-expanding balloon 8, and the balloon skeleton 14 are mainly made of any metal material with good memory properties and elasticity, including but not limited to nickel-titanium alloy, nickel-titanium wire, cobalt-chromium alloy, stainless steel, and memory alloy; wherein, the materials used to prepare the first self-expanding balloon 7 and the second self-expanding balloon 8 may be the same or different.

[0041] The balloon skeleton 14 provides radial support and lumen expansion capability. Its structure is compressible and can actively expand through self-inflation to form the balloon cavity 11.

[0042] The balloon skeleton 14 can be manufactured by any manufacturing process, including but not limited to laser cutting, weaving, electroforming, 3D or 4D printing; wherein, the manufacturing processes of the first self-expanding balloon 7 and the second self-expanding balloon 8 can be the same or different.

[0043] The balloon skeleton 14 has any geometric shape, including but not limited to spherical, elliptical, semi-elliptical, umbrella-shaped, basket-shaped, and rectangular shapes; wherein the first self-inflating balloon 7 and the second self-inflating balloon 8 may have the same or different geometric shapes.

[0044] The balloon skeleton 14 has a diameter ranging from 0 to 300 mm and a balloon length ranging from 0 to 500 mm; the diameters of the first self-expanding balloon 7 and the second self-expanding balloon 8 may be the same or different.

[0045] The balloon is covered with a membrane 15, 16 or 17. The balloon membrane can completely close the balloon skeleton to ensure that after the first self-expanding balloon 7 and the second self-expanding balloon 8 are fully expanded, the closed cavity that can be formed in the proximal and distal cavities of the lesion can be blocked, and the drug solution exists only in the closed cavity without overflowing to non-treatment sites.

[0046] The balloon is covered with a membrane 15, 16 or 17. The membrane material includes any one or more polymer membrane materials or derivative materials, including but not limited to polyurethane, polytetrafluoroethylene, silicone, polyamide, polyester fiber, silicone, polyester, etc. The membrane materials of the first self-expanding balloon 7 and the second self-expanding balloon 8 may be the same or different.

[0047] The balloon is covered with a membrane 15, 16 or 17, which is obtained by any combination of one or more of the following techniques: lamination, bonding, dipping, spraying, suturing or fusion. The membrane covering method of the first self-expanding balloon 7 and the second self-expanding balloon 8 may be the same or different.

[0048] The first self-expanding balloon 7 and the second self-expanding balloon 8 are fixed to the outside of the drug injection catheter 4. The fixing method can be one or more combinations, including but not limited to: adhesion, fixing ring, welding, embedding, and suturing.

[0049] The outer sheath 5 is located outside the drug injection catheter 4, the first self-expanding balloon 7, and the second self-expanding balloon 8. The diameter of the outer sheath 5 should be larger than the diameter of the drug injection catheter 4 and the first self-expanding balloon 7 and the second self-expanding balloon 8 in their compressed state, but smaller than the diameter of the first self-expanding balloon 7 and the second self-expanding balloon 8 in their expanded state.

[0050] The outer sheath 5 can slide freely along the drug injection catheter 4 and form a sliding gap 12 with the drug injection catheter. In the non-working state, it can restrict the expansion of the first self-expanding balloon 7 and the second self-expanding balloon 8, reducing the overall diameter of the self-expanding balloon catheter to facilitate the delivery of the catheter to the non-vascular lumen lesion. In the working state, moving the outer sheath 5 back can release its restriction on the expansion of the first self-expanding balloon 7 and the second self-expanding balloon 8, and the first self-expanding balloon 7 and the second self-expanding balloon 8 can expand accordingly to form a closed cavity for drug perfusion.

[0051] The materials used to prepare the outer sheath 5 include, but are not limited to, high molecular weight materials such as polyurethane, polytetrafluoroethylene, polyamide, polyether block polyamide, and polyether ether ketone.

[0052] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A self-expanding balloon catheter, characterized in that, It includes a main tube, a self-inflating balloon, and an outer sheath. The outer sheath is fitted onto the main tube and slidably connected to it. There are two sets of self-inflating balloons, located at the proximal and distal ends of the main tube, respectively. The outer sheath is used to block the self-inflating balloon before it inflates. The side wall of the main tube has a drug release hole located between the two sets of self-inflating balloons.

2. The self-expanding balloon catheter according to claim 1, characterized in that, The main body includes a drug injection catheter and a guidewire channel tube. The guidewire channel tube is disposed inside the drug injection catheter, and the guidewire channel tube and the drug injection catheter are independently disposed. The end of the drug injection catheter is provided with a drug injection catheter sheath connector; the end of the guidewire channel tube is provided with a guidewire channel tube sheath connector; and the self-expanding balloon is disposed on the outer wall of the drug injection catheter.

3. A self-expanding balloon catheter according to claim 2, characterized in that, The distal end of the drug injection catheter is a closed blind end, and the drug release orifice is the only drug discharge orifice with a diameter of 1mm-2mm.

4. A self-expanding balloon catheter according to claim 2, characterized in that, The distance between the end of the drug injection catheter and the distal self-expanding balloon is greater than 1 cm. A metal imaging ring is provided at the distal end of the drug injection catheter, and the metal imaging ring is located between the distal self-expanding balloon and the end of the drug injection catheter.

5. A self-expanding balloon catheter according to claim 1, characterized in that, The materials used to prepare the drug injection catheter and outer sheath are polymer materials.

6. A self-expanding balloon catheter according to claim 1, characterized in that, The distance between the two self-expanding balloons ranges from 0.01 to 100 cm, and the distance is greater than the axial length of the cavity lesion.

7. A self-expanding balloon catheter according to claim 1, characterized in that, The self-inflating balloon includes a balloon skeleton and a covering membrane, wherein the covering membrane is a single outer covering membrane, a double-layer covering membrane consisting of an inner covering membrane and an outer covering membrane, or an integrated covering membrane.

8. A self-expanding balloon catheter according to claim 7, characterized in that, The balloon skeleton is made of a metal material with memory and elastic properties; the coating material includes any one or more polymer coating materials or derivative materials.

9. A self-expanding balloon catheter according to claim 7, characterized in that, The geometry of the balloon skeleton can be spherical, elliptical, semi-elliptical, umbrella-shaped, basket-shaped, or rectangular.

10. A self-expanding balloon catheter according to claim 1, characterized in that, The diameter of the outer sheath is larger than the diameter of the outer wall of the main tube and the diameter of the self-expanding balloon in the compressed state, but smaller than the diameter of the self-expanding balloon in the expanded state.

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