Balloon catheter

Abstract

The utility model provides a kind of balloon catheter, comprising: catheter, with one or more inner cavities;Balloon, is arranged at the distal end of catheter, the distal end edge of balloon is flush with the distal end face of catheter, and the injection cavity of balloon inner cavity is communicated with the catheter;Connector, is arranged at the proximal end of catheter, with one or more interfaces, and each interface is communicated with the inner cavity of catheter.The balloon catheter of the utility model can effectively expand sinus in neurosurgery pituitary tumor operation to establish surgical access.

Description

Technical Field

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

[0002] Endoscopic transnasal-sphenoidal pituitary tumor resection is currently the most preferred surgical method. Accessed through the nasal cavity, the high definition and flexibility of the endoscope allow for direct visualization and resection of the pituitary tumor. It offers advantages such as being minimally invasive, having a rapid recovery, and fewer complications, making it suitable for most pituitary tumor patients, especially those with large adenomas exceeding 1 cm in size, those with poorly controlled tumors or those unable to tolerate drug therapy, or those with progressively enlarging tumors.

[0003] However, for surgery, not only are the surgeon's superb skills and appropriate approach required, but the instruments are equally important. Traditional neuroendoscopic transnasal-sphenoid pituitary tumor resection is limited by insufficient instrument advancement. Too many instruments, such as neuroendoscopy and suction devices, cannot be simultaneously inserted into the nasal cavity through a single nostril. Therefore, surgeons have improved the instruments. The advent of multi-purpose instruments at various angles and different flexible retractors, especially the development and application of flexible nasal passages and multi-purpose suction devices with different curvatures, lengths, and diameters, which are detachable, peelable, and electrocoagulated, effectively solves problems such as difficulty in hemostasis, poor instrument positioning, and limited mobility. Based on this, the endoscopic transnasal septal approach, which minimizes trauma and postoperative complications, has been developed and applied.

[0004] Currently, most neuroendoscopic transnasal-sphenoid pituitary tumor resections involve the surgeon manually adjusting a Foley catheter, cutting off the distal end of the catheter, and keeping the balloon and catheter flush. The catheter is then gradually expanded by penetrating deeper into the nasal cavity. The existing surgical access device is the surgeon-adjusted Foley catheter, which has the following disadvantages: (1) It requires cutting off the distal end of the catheter extending beyond the balloon, increasing the procedure; (2) The catheter is a soft silicone tube, which has poor guidance, torsion, and insertion performance when penetrating deeper into the nasal cavity; (3) The catheter is too thick to accommodate a wide range of nasal cavity sizes; (4) The Foley catheter exceeds its intended use, posing medical risks; (5) The surface of the balloon catheter cannot be moistened (retaining water), making it impossible to apply adrenaline solution, increasing the difficulty of dilating the sinuses during surgery. Utility Model Content

[0005] The purpose of this invention is to provide a balloon catheter that can effectively dilate the sinuses to establish a surgical access during neurosurgical pituitary tumor surgery.

[0006] To achieve the above objectives, the present invention provides a balloon catheter, comprising: a catheter having one or more lumens; a balloon disposed at the distal end of the catheter, the distal edge of the balloon being flush with the distal end face of the catheter, and the inner lumen of the balloon communicating with the injection chamber of the catheter; and a connector disposed at the proximal end of the catheter, having one or more interfaces, each interface communicating with one inner lumen of the catheter.

[0007] In one embodiment, the balloon is one of a compliant balloon, a non-compliant balloon, a semi-compliant balloon, or a multi-stage balloon.

[0008] In one embodiment, the balloon is a single-layer balloon or a multi-layer balloon.

[0009] In one embodiment, the balloon structure is a single layer, and the outer surface of the balloon is provided with a concave structure. The shape of the concave structure is a regular or irregular circle or polygon. The depth of the concave structure is from one-thousandth to ninety-nine percent of the thickness of the balloon structure, and the area of ​​the concave structure is 1 nm. 2 ~1mm 2 .

[0010] In one embodiment, the balloon structure is double-layered or multi-layered. The outer layer of the balloon, or the outer layer and one or more layers adjacent to the outer layer, are provided with a mesh-like structure or a perforated structure. The perforated structure or mesh-like structure is in the shape of a regular or irregular circle or polygon, and the area of ​​the structure is 1 nm. 2 ~1mm 2 .

[0011] In one embodiment, the outer surface of the balloon is provided with a hydrophilic layer, a lipophilic layer, or an adhesive layer.

[0012] In one embodiment, the inflation shape of the balloon is one of the following: spherical, conical, dumbbell-shaped, olive-shaped, gourd-shaped, candied hawthorn-shaped, or mushroom-shaped.

[0013] In one embodiment, the diameter of the catheter is 0.5mm-10mm, the length is 100mm-3000mm, and the Shore hardness of the catheter is 30A-90D.

[0014] In one embodiment, the length of the compliant balloon is 3 mm to 300 mm, and the rated inflation volume is 0.1 ml to 100 ml.

[0015] In one embodiment, the balloon is a non-compliant balloon, a semi-compliant balloon, or a multi-stage balloon, with a length of 3mm to 300mm, a diameter of 3mm to 30mm, and a rated burst pressure of 5atm to 50atm.

[0016] The technical effects of this utility model are as follows:

[0017] 1. In neuroendoscopic transnasal-sphenoid pituitary tumor resection, the catheter can be used to expand the nasal cavity tissue and establish a surgical pathway. During the procedure, the catheter is easy to manipulate and can be pushed, withdrawn, twisted, and deflected. A guidewire or endoscope can be inserted into the catheter.

[0018] 2. In digestive, respiratory, urinary, cardiovascular, neurointerventional, peripheral vascular, or obstetric and gynecological surgeries, it can expand lesion tissue or precisely release drugs, and the lumen of the catheter can be connected to other instruments. Attached Figure Description

[0019] Figure 1 This is a side view of the balloon catheter of this utility model.

[0020] Figure 2 This is a schematic diagram of a single-layer balloon catheter of the present invention after surface treatment (coating or surface activation).

[0021] Figure 3 This is a schematic diagram of a single-layer balloon catheter of this utility model after the surface of the balloon has been treated with a concave hole structure.

[0022] Figure 4 This is a schematic diagram of a double-layer balloon structure of the balloon catheter of this utility model, in which a layer of mesh fabric is covered on the outside of a single-layer balloon.

[0023] Figure 5 This invention relates to a balloon catheter in which a perforated balloon is covered over a single-layer balloon.

[0024] Figure 6 This invention relates to a balloon catheter in which a multi-layered, perforated balloon body is covered over a single-layered balloon.

[0025] Figure label:

[0026] 1. Catheter; 11. Proximal end of catheter; 13. Distal end of catheter; 2. Balloon; 21. Distal end of balloon; 22. Outer layer of balloon; 3. Y-shaped connector; 31. Interface; 4. Recessed hole; 5. Perforation; 51. Perforation layer and balloon gap; 52. Multi-layer perforation layer and balloon gap; 6. Mesh fabric; 61. Mesh fabric layer and balloon gap. Detailed Implementation

[0027] To make the above-mentioned objectives, features and advantages of the utility model more apparent and understandable, the specific embodiments of the utility model are described in detail below.

[0028] Many specific details are set forth in the following description to provide a full understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0029] Reference Figure 1 and Figure 6 The balloon catheter according to this utility model includes: a catheter having at least one lumen; a balloon disposed at the distal end of the catheter, the distal edge of the balloon being flush with the distal end face of the catheter, and the lumen of the balloon communicating with the injection chamber of the catheter; and a connector disposed at the proximal end of the catheter, having one or more interfaces, each interface communicating with one lumen of the catheter.

[0030] In one embodiment of the present invention, the catheter may have an inner lumen. In this case, the connector has an interface for connecting to the inner lumen, which is used to inject liquid or gas to inflate the balloon.

[0031] In one embodiment of the present invention, the catheter may have two lumens. (See also...) Figure 1 The two lumens are the instrument lumen and the injection lumen, respectively. The connector has two interfaces: one connecting to the instrument lumen of the catheter, and the other connecting to the injection lumen. The instrument lumen is used for guiding the guidewire, and the injection lumen is used for injecting the fluid-filled balloon. In this case, the connector can be a Y-type connector, such as... Figure 1 Zhi Shi.

[0032] In one embodiment of the present invention, the catheter may have three or more lumens. In this case, the connector is a multi-channel connector with multiple interfaces that connect to the three or more lumens.

[0033] The structure and shape of the conduit and connector of this utility model can be any shape that conforms to the concept of this utility model.

[0034] The balloon of the balloon catheter according to this utility model can be one of a compliant balloon, a non-compliant balloon, a semi-compliant balloon, or a multi-stage balloon.

[0035] The length of the compliant balloon can be 3mm to 300mm, and the rated inflation volume can be 0.1ml to 100ml.

[0036] Non-compliant balloons, semi-compliant balloons, or multi-stage balloons, with a length of 3mm to 300mm, a diameter of 3mm to 30mm, and a rated burst pressure of 5atm to 50atm.

[0037] The balloon of the balloon catheter according to this utility model can be a single-layer balloon or a multi-layer balloon.

[0038] The balloon of the balloon catheter according to this utility model can be made of a single material, or a blend of multiple materials, or a multilayer composite material. For example, the balloon material can be one or more of the following materials: thermoplastic polyurethane (TPU), silicone, latex, polyether block amide (PEBAX), nylon, nylon / PEBAX blend, polyethylene terephthalate (PET), polycarbonate-based PU, silicone rubber polyurethane (PU), polyethylene, polypropylene, polyether ether ketone, polytetrafluoroethylene, polyvinyl fluoride (PVC), cotton, yarn, silk, etc., or a blend or multilayer composite material.

[0039] Reference Figure 2 According to this invention, the outer layer 22 of the balloon catheter can be provided with a hydrophilic layer, a lipophilic layer, or an adhesive layer. The material of the outer layer 22 can be one or more of the following materials: polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyacrylic acid (PAA), polyethylene glycol (PEG), polyvinyl alcohol (PVA), natural polysaccharides and derivatives (such as chitosan, hyaluronic acid, etc.), silica (SiO2) nanoparticles, titanium dioxide (TiO2), polymethyl methacrylate sulfobetaine (PSBMA), magnesium stearate, polytetrafluoroethylene (PTFE), perfluoropolyether (PFPE), polyurethane acrylate (PUA), polydimethylsiloxane (PDMS), fluorinated silanes (such as FAS-17), paraffin wax, carbon nanotube arrays, poly(N-isopropylacrylamide) (PNIPAM), and a gradient coating of "hydrophilic bottom layer + hydrophobic top layer", or a blend or block composite material.

[0040] In one embodiment of the present invention, the balloon structure may be single-layered, and the surface of the balloon may have a concave structure. (Refer to...) Figure 3 The concave structure has a regular or irregular circular or polygonal shape, and its depth is between one-thousandth and ninety-nine percent of the thickness of the balloon structure. The area of ​​the concave structure is 1 nm. 2 ~1mm 2 The depth of the concave structure is preferably 10% to 20% of the thickness of the balloon structure, and the area of ​​the concave structure is 0.01 mm. 2 ~0.1mm 2The concave openings are distributed across the balloon surface. By varying the density, size, shape, and angle of the openings relative to the balloon's surface plane, different surface energies are achieved, resulting in hydrophobic / lipophilic or adhesive properties. In use, the uninflated balloon is pre-soaked in liquid, gel, or powder (granular) medication. The medication adheres to the concave openings on the balloon surface. The balloon catheter is then placed at the intended lesion location. Next, liquid or gas is injected into the balloon catheter through the connector to inflate the balloon. The inflated balloon expands the lesion tissue while simultaneously delivering the medication to the lesion, thus releasing the drug.

[0041] In one embodiment according to the present invention, reference is made to... Figure 5 and Figure 6 The balloon structure can be double-layered or multi-layered, with the outer layer (or multiple layers) having a perforated structure. The area of ​​the perforated structure is 1 nm. 2 ~1mm 2 Perforations are distributed on the surface of the balloon. Through variations in density, size, and shape of the perforations, combined with a double-layer (or multi-layer) structure, they bind, adhere to, or encapsulate liquid, gel, or powder (particulate) substances, achieving the overall hydrophobic / lipophilic or adhesive properties of the balloon. Figure 5 In the illustrated embodiment, the outer layer of the balloon has a perforated structure. During use, the uninflated balloon is pre-soaked in liquid, gel, or powder (granular) medication. At this point, the medication adheres to the perforated layer (outer balloon layer), the adjacent balloon layer, the space between the perforated layer and the balloon, and within the perforated structure. The balloon catheter is then placed at the intended lesion location. Next, liquid or gas is injected into the balloon catheter through the connector to inflate the balloon. The inflated balloon expands the lesion tissue while simultaneously delivering medication to the lesion, thus releasing the medication directly to the lesion. Figure 6 In the illustrated embodiment, the outer layer of the balloon and one or more adjacent layers are perforated, i.e., it has multiple perforated layers. During use, the uninflated balloon is pre-soaked with liquid, gel, or powder (granular) medication. At this time, medication adheres to the multiple perforated layers, the gaps between each layer, the gaps between the multiple perforated layers and the balloon (and the balloon layers adjacent to the multiple perforated layers), and within the perforated structures. The balloon catheter is then placed at the intended lesion location. Next, liquid or gas is injected into the balloon catheter through the connector to inflate the balloon. The inflated balloon can expand the lesion tissue while simultaneously adhering the medication to the lesion, thus releasing the medication to the lesion.

[0042] In one embodiment according to the present invention, reference is made to... Figure 4 The balloon structure can be double-layered or multi-layered. The outer layer (or multiple layers) of the balloon has a mesh-like fabric structure that can adsorb or adhere liquid, gel, or powder (particulate) substances, achieving the overall balloon's hydrophobic / lipophilic or adhesive properties. Figure 4 In the illustrated embodiment, the outer layer of the balloon has a mesh-like fabric structure. During use, the uninflated balloon is pre-soaked in liquid, gel, or powder (granular) medication. At this point, the medication adheres to the mesh-like fabric layer (outer balloon layer), the adjacent balloon layer, the gap between the mesh-like fabric layer and the balloon, and within the mesh-like fabric structure. The balloon catheter is then placed at the intended lesion location. Next, liquid or gas is injected into the balloon catheter through the connector to inflate the balloon. The inflated balloon expands the lesion tissue while simultaneously delivering medication to the lesion, thus releasing the medication to the lesion.

[0043] In another embodiment, the outer layer of the balloon and one or more adjacent layers are provided with a mesh fabric structure, i.e., it has multiple mesh fabric layers. In use, the uninflated balloon is pre-soaked with liquid, gel, or powder (granular) medication. At this time, medication adheres to the multiple mesh fabric layers (outer balloon layer), the gaps between each layer, the gaps between the multiple mesh fabric layers and the balloon (the balloon layers adjacent to the multiple mesh fabric layers), and within the mesh fabric structure. The balloon catheter is then placed at the intended lesion location. Next, liquid or gas is injected into the balloon catheter through the connector to inflate the balloon. The inflated balloon expands the lesion tissue while simultaneously applying medication to the lesion, releasing the medication directly to the lesion.

[0044] In one embodiment of the present invention, the inflation shape of the balloon can be selected according to the shape of the lesion, and conventionally it can be one of the following: spherical, conical, dumbbell-shaped, olive-shaped, gourd-shaped, candied hawthorn-shaped, or mushroom-shaped. Figure 1 The invention is shown as spherical, but is not limited thereto.

[0045] The balloon catheter of this utility model can be made of one or more composite structures of the above materials, such as silicone rubber, latex, polyurethane, polyether block amide (PEBAX), polytetrafluoroethylene, polyether ether ketone, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, polyurethane, polyethylene terephthalate, nylon, ABS, polycarbonate, thermoplastic elastomer (TPE), metal wire / tube (stainless steel, nickel-titanium alloy, cobalt-chromium-nickel alloy, platinum-iridium alloy, gold, silver).

[0046] The diameter of the balloon catheter according to this utility model can be 0.5mm-10mm, and the length can be 100mm-3000mm.

[0047] The Shore hardness of the balloon catheter according to this invention can be 30A-90D.

[0048] Although some specific embodiments of the present invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the present invention. The scope of the present invention is defined by the appended claims.

Claims

1. A balloon catheter, characterized in that, include: A catheter having one or more lumens; A balloon is placed at the distal end of the catheter, with the distal edge of the balloon flush with the distal end face of the catheter, and the inner lumen of the balloon communicating with the injection lumen of the catheter. The connector, located at the proximal end of the catheter, has one or more interfaces, each interface communicating with one lumen of the catheter.

2. The balloon catheter according to claim 1, characterized in that, The balloon can be one of a compliant balloon, a non-compliant balloon, a semi-compliant balloon, or a multi-stage balloon.

3. The balloon catheter according to claim 1, characterized in that, The balloon can be a single-layer balloon or a multi-layer balloon.

4. The balloon catheter according to claim 3, characterized in that, The balloon structure is a single layer, with a concave structure on the outer surface of the balloon. The shape of the concave structure is a regular or irregular circle or polygon. The depth of the concave structure is one-thousandth to ninety-nine percent of the thickness of the balloon structure, and the area of ​​the concave structure is 1 nm. 2 ~1mm 2 .

5. The balloon catheter according to claim 3, characterized in that, The balloon structure is double-layered or multi-layered. The outer layer of the balloon, or the outer layer and one or more adjacent layers, are provided with a mesh-like structure or perforated structure. The perforated structure or mesh-like structure is regular or irregular in shape, either circular or polygonal, and the area of ​​the structure is 1 nm. 2 ~1mm 2 .

6. The balloon catheter according to claim 1, characterized in that, The outer surface of the balloon is provided with a hydrophilic layer, a lipophilic layer, or an adhesive layer.

7. The balloon catheter according to claim 1, characterized in that, The inflated shape of the sac can be one of the following: spherical, conical, dumbbell-shaped, olive-shaped, gourd-shaped, candied hawthorn-shaped, or mushroom-shaped.

8. The balloon catheter according to claim 1, characterized in that, The diameter of the catheter is 0.5mm-10mm, the length is 100mm-3000mm, and the Shore hardness of the catheter is 30A-90D.

9. The balloon catheter according to claim 1, characterized in that, The length of the compliant balloon is 3mm to 300mm, and the rated inflation volume is 0.1ml to 100ml.

10. The balloon catheter according to claim 1, characterized in that, Non-compliant balloons, semi-compliant balloons, or multi-stage balloons, with a length of 3mm to 300mm, a diameter of 3mm to 30mm, and a rated burst pressure of 5atm to 50atm.

Images