Blood vessel dilatation balloon and dilatation balloon assembly

Abstract

The invention discloses a blood vessel dilatation balloon and a dilatation balloon assembly, which effectively overcome the problems of local stress concentration, blood vessel injury, drug loss, high restenosis rate and the like in the traditional balloon dilatation through innovative designs such as a spiral rib structure, sectional type inflation control and accurate drug release. A combined structure of the inflatable sheet and the air bag is adopted, progressive dilation can be achieved, instantaneous impact force on the blood vessel wall is reduced, interlayer and fracture risks are reduced, and meanwhile dilation uniformity is improved. Through precise control of the pressure piece and the vent hole, it is ensured that the balloon is further inflated after reaching the set pressure, and vascular injury caused by excessive dilatation is prevented. In addition, the closed groove in the spiral rib is of a fillet structure, medicine is gradually released during expansion, the medicine retention rate is increased, instantaneous loss is avoided, and the risk of restenosis after operation is further reduced.

Description

Technical Field

[0001] The invention belongs to the field of nasotracheal intubation, and in particular relates to a vascular dilation balloon and a dilation balloon assembly. Background Art

[0002] Vasodilator balloons are widely used in the treatment of vascular stenosis lesions such as coronary arteries and peripheral arteries, mainly for restoring blood flow through mechanical expansion. However, existing common balloon dilatation has many limitations, mainly including excessive local stress on the vascular wall, severe elastic retraction of the vessel, and high restenosis rate. During the expansion process of traditional balloons, radial pressure is evenly applied to the vascular wall, which can easily cause local damage, dissection, and even vascular rupture in high-risk lesions (such as calcified lesions, long-segment stenosis, or tortuous blood vessels), affecting the surgical effect and patient prognosis. In addition, the dilated blood vessels may be partially re-occluded due to elastic retraction, thereby reducing the long-term patency rate and requiring further treatment after surgery.

[0003] In order to reduce the risk of vascular damage and improve the dilation effect, drug-coated balloons have been introduced into the clinic. This technology coats anti-proliferative drugs (such as paclitaxel and rapamycin) on the balloon surface to inhibit excessive proliferation of vascular smooth muscle cells after surgery and reduce the occurrence of restenosis. However, traditional DCBs still have problems with uneven drug release and high drug loss rate, resulting in a short retention time of the drug in the blood vessel wall, reducing the anti-proliferative effect. In addition, due to the uncontrollable drug release rate, some DCBs may release excessive drugs in a short period of time, increasing the risk of local toxicity and causing blood vessel wall damage or inflammatory response.

[0004] Existing improvement plans include cutting balloons and degradable stents. The cutting balloon adds microblades on the balloon surface to destroy hardened plaques and reduce expansion pressure, but its high invasiveness may increase the risk of vascular tearing. Although degradable stents can reduce the disadvantages of long-term stent implantation, the implantation process is complicated and there is still a problem of insufficient support.

[0005] In view of this, the present invention is proposed. Summary of the invention

[0006] The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a vascular dilation balloon and a dilation balloon assembly, which solve the problems raised in the above-mentioned background technology.

[0007] In order to solve the above technical problems, the basic concept of the technical solution adopted by the present invention is:

[0008] A vascular dilatation balloon, comprising: a joint, one end of the joint being connected to a tube body, a plurality of deformable wires being arranged around the inner wall of the tube body, a balloon structure being arranged outside the first end of the tube body, and a dilatation balloon assembly for inflating the balloon structure being arranged outside the second end of the tube body;

[0009] The balloon structure includes a balloon body connected to the tube body, the balloon body is provided with a connecting sleeve that can be deformed together with the balloon body, and the balloon body is connected to the expansion balloon assembly;

[0010] The exterior of the connecting sleeve is in a spiral structure after being closed and forms a plurality of spiral ribs, and a drug dispersing structure is arranged on the exterior of each of the spiral ribs.

[0011] Optionally, the drug dispersing structure includes a slot opened inside the spiral rib, a closed slot is opened above the slot, a dispersing drug is arranged inside the slot, and the closed slot is in a sealed state when the balloon body is not inflated. After the balloon body is inflated and expanded, the closed slot expands due to tension.

[0012] Optionally, the balloon body includes three inflatable sheets, an airbag is arranged between every two of the inflatable sheets, the spiral ribs are a structure formed after the airbag is closed, the angle between every two of the inflatable sheets is 120°, and the inflatable sheets and the airbags are interconnected and provided with pressure pieces, and the expansion balloon assembly is respectively connected to the three inflatable sheets.

[0013] Optionally, the pressure piece includes a pressure plate, a vent hole is opened between the inflation plate and the airbag, the pressure plate is arranged inside the vent hole, and after the pressure plate is broken, the gas in the inflation plate enters the airbag along the vent hole to achieve inflation of the airbag.

[0014] Optionally, the pressure at which the pressure sheet breaks is equal to the pressure at which the inflatable sheet is filled with air, and the tip of the pressure sheet is a rounded structure.

[0015] Optionally, the three inflatable sheets and the side walls of the airbag are tightly fitted to form a balloon.

[0016] Optionally, the emitting drug includes but is not limited to one of PEEK, polyurethane, and PLGA. Optionally, a rounded structure is provided at the edge of the notch of the closed groove.

[0017] A novel dilatation balloon assembly for a nasotracheal intubation comprises a plurality of inflation tubes, wherein a plurality of channels are provided inside the tube body, and the inflation tubes are located inside the channels, an annular groove is provided below the channels, an annular tube is provided inside the annular groove, the annular tube and the inflation tubes are connected, an inflation tube is provided at the edge of the second end of the tube body, the inflation tube passes through the tube body and is connected to the annular tube.

[0018] Optionally, a sealing plug is provided on the outside of the air pumping pipe, and the size of the sealing plug is the same as the opening of the air pumping pipe.

[0019] After adopting the above technical solution, the present invention has the following beneficial effects compared with the prior art. Of course, any product implementing the present invention does not necessarily need to achieve all the advantages described below at the same time:

[0020] The present invention effectively overcomes the problems of local stress concentration, vascular damage, drug loss and high restenosis rate in traditional balloon dilatation through innovative designs such as spiral rib structure, segmented inflation control and precise drug release. The combined structure of inflatable sheet and airbag can achieve progressive expansion, reduce the instantaneous impact force on the vascular wall, reduce the risk of dissection and rupture, and improve the uniformity of expansion. Through the precise control of the pressure sheet and the vent, it is ensured that the balloon is further inflated only after reaching the set pressure to prevent vascular damage caused by excessive expansion. In addition, the closed groove on the spiral rib adopts a rounded structure to gradually release the drug during expansion, improve the drug retention rate, avoid instantaneous loss, and further reduce the risk of postoperative restenosis. After the overall structure is optimized, the present invention not only improves the compliance and permeability of the balloon, is suitable for complex vascular lesions, but also can improve the long-term vascular patency while reducing vascular damage.

[0021] The specific implementation modes of the present invention are further described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings described below are only some embodiments. For those skilled in the art, other drawings can be obtained based on these drawings without creative work.

[0023] In the figure:

[0024] Figure 1 It is a schematic diagram of the three-dimensional structure of the vasodilator balloon;

[0025] Figure 2 It is a schematic diagram of the three-dimensional structure of the expansion balloon assembly;

[0026] Figure 3 This is a schematic diagram of the internal three-dimensional structure of the vasodilator balloon;

[0027] Figure 4 It is a schematic diagram of the explosion structure of the balloon body and the connecting sleeve;

[0028] Figure 5 It is a schematic diagram of the cross-sectional structure above the connecting sleeve;

[0029] Figure 6 for Figure 3 Schematic diagram of the structure at A in the middle;

[0030] Figure 7 for Figure 4 Schematic diagram of the structure at point B in the middle.

[0031] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0032] 1. Connector; 2. Tube body; 3. Wire; 4. Balloon body; 5. Connecting sleeve; 6. Spiral rib; 7. Notch; 8. Closed groove; 9. Inflatable sheet; 10. Airbag; 11. Vent hole; 12. Pressure sheet; 13. Inflatable tube; 14. Channel; 15. Annular groove; 16. Annular tube.

[0033] It should be noted that these drawings and textual descriptions are not intended to limit the conceptual scope of the present invention in any way, but are intended to illustrate the concept of the present invention for those skilled in the art by referring to specific embodiments. DETAILED DESCRIPTION

[0034] The present invention will now be described in further detail with reference to the accompanying drawings.

[0035] See also Figure 1-7 As shown, in this embodiment, a vascular expansion balloon is provided, including a connector 1, one end of the connector 1 is connected to a tube body 2, a plurality of deformable wires 3 are arranged around the inner wall of the tube body 2, a balloon structure is arranged outside the first end of the tube body 2, and an expansion balloon assembly for inflating the balloon is arranged outside the second end of the tube body 2; a plurality of deformable wires 3 are arranged around the inner wall of the tube body 2, which can effectively enhance the structural strength and flexibility of the tube body 2. This design can provide better support during balloon expansion and prevent the tube body 2 from being deformed or twisted under pressure.

[0036] In addition, the deformable guide wire 3 not only enhances the structural strength of the tube body 2, but also plays a guiding role during the balloon expansion process, so that the balloon can expand evenly along a predetermined direction, reducing the risk of local over-expansion, thereby improving the treatment effect.

[0037] The balloon structure includes a balloon body 4 connected to the tube body 2, and a connecting sleeve 5 that can be deformed together with the balloon body 4 is provided outside the balloon body 4, and the balloon body 4 is connected to the expansion balloon assembly;

[0038] The outside of the connecting sleeve 5 is in a spiral structure after closing and forms a plurality of spiral ribs 6, and a drug dispersing structure is arranged on the outside of each spiral rib 6. The expansion mode of the traditional balloon is radially symmetrical, which may cause excessive local stress, especially in calcified lesions or irregular stenosis areas, which may easily cause blood vessel tearing. The present invention adopts a spiral twisted balloon, which will generate a torsional force along the axial direction when expanding, thereby reducing single-point high pressure and improving the uniformity of expansion. In addition, during the expansion process, the spiral surface drives the blood vessel to rotate slightly, reduces the damage to the vascular endothelium, and promotes the uniform distribution of the drug.

[0039] The present invention effectively overcomes the problems of local stress concentration, vascular damage, drug loss and high restenosis rate existing in traditional balloon angioplasty through innovative designs such as spiral rib structure, segmented inflation control and precise drug release. The combined structure of inflation sheet and airbag can achieve progressive expansion, reduce the instantaneous impact force on the blood vessel wall, reduce the risk of dissection and rupture, and improve the uniformity of expansion. Through the precise control of the pressure sheet and the vent, it is ensured that the balloon is further inflated only after reaching the set pressure to prevent vascular damage caused by excessive expansion. In addition, the closed groove on the spiral rib adopts a rounded structure to gradually release the drug during expansion, improve the drug retention rate, avoid instantaneous loss, and further reduce the risk of postoperative restenosis. After the overall structure is optimized, the present invention not only improves the compliance and permeability of the balloon, and is suitable for complex vascular lesions, but also can improve the long-term vascular patency while reducing vascular damage.

[0040] In this embodiment, the drug dispensing structure includes a notch 7 provided inside the spiral rib 6, a closed groove 8 provided above the notch 7, a dispensing drug provided inside the notch 7, and the closed groove 8 is in a sealed state when the balloon is not inflated, and after the balloon is inflated and expanded, the closed groove 8 is expanded due to tension. This design achieves precise drug release by providing the notch 7 and the closed groove 8 inside the spiral rib 6. When not inflated, the closed groove 8 is sealed to prevent drug leakage; when inflated and expanded, the closed groove 8 is expanded due to tension, and the drug is released evenly, reducing waste and improving treatment effect and safety.

[0041] In this embodiment, the balloon body 4 includes three inflatable sheets 9, and an airbag 10 is arranged between every two inflatable sheets 9. The spiral rib 6 is a structure formed after the airbag 10 is closed. The angle between every two inflatable sheets 9 is 120°, and the inflatable sheets 9 and the airbag 10 are interconnected and provided with a pressure piece, and the expansion balloon assembly is respectively connected to the three inflatable sheets 9. The expansion mode of the traditional balloon is usually unidirectional radial expansion. During the expansion process, the balloon will simultaneously apply uniform radial pressure to the vascular wall. However, in vascular stenosis, calcified lesions or curved sections, the structure and elasticity of the vascular wall may be different, resulting in uneven local stress distribution, which is easy to cause high stress concentration areas, thereby increasing the risk of vascular damage, such as intimal tearing, dissection formation or acute vascular rupture. In addition, the rapid expansion of the traditional balloon in a short period of time may produce a large shear force on the vascular wall, thereby causing intimal damage, accelerating the proliferation of vascular smooth muscle cells, and increasing the risk of postoperative restenosis.

[0042] The present invention adopts a combined structure of an inflatable sheet 9 and an airbag 10, and through segmented inflation and expansion, the balloon presents a progressive pressure release mechanism during the expansion process, that is, in the early stage of expansion, the inflatable sheet 9 is gradually inflated to provide a preliminary expansion force, and then the internal airbag 10 is gradually inflated according to the expansion demand, forming a dynamic adaptive expansion to avoid excessive expansion of the blood vessel at one time. This design can not only effectively reduce the instantaneous stress of the blood vessel wall and reduce the mechanical shear force on the endothelium, but also adjust the expansion force according to the physiological characteristics of different blood vessel segments, improve the accuracy of the expansion process, reduce the possibility of postoperative blood vessel retraction, and thus improve the long-term patency rate and treatment effect.

[0043] The pressure piece includes a pressure sheet 12, and a vent 11 is provided between the inflatable sheet 9 and the airbag 10. The pressure sheet 12 is arranged inside the vent 11. After the pressure sheet 12 is broken, the gas in the inflatable sheet 9 enters the airbag 10 along the vent 11 to achieve inflation of the airbag 10. Through the combined design of the pressure sheet 12 and the vent 11, precise pressure control and progressive inflation are achieved. The pressure sheet 12 acts as a controllable release valve between the airbag 10 and the inflatable sheet 9. In the early stage of balloon expansion, the inflatable sheet 9 is inflated first to provide initial expansion force. When the internal pressure reaches the set threshold, the pressure sheet 12 will break, allowing gas to enter the airbag 10 through the vent 11, thereby gradually increasing the expansion force. This progressive inflation method can effectively prevent the instantaneous over-inflation of the airbag, ensure that the pressure during the expansion process is always maintained within a safe range, and avoid balloon rupture and vascular damage caused by uneven inflation or excessive pressure. At the same time, the design can also adapt to vascular lesion areas with different diameters and hardnesses, improve the accuracy of expansion, reduce the risk of interventional treatment, and enhance the safety and reliability of clinical applications.

[0044] In this embodiment, the pressure at which the pressure sheet 12 breaks is equal to the pressure after the inflatable sheet 9 is filled with air, and the tip of the pressure sheet 12 is a rounded structure. The three inflatable sheets 9 and the side walls of the airbag 10 fit tightly together to form a balloon. The present invention adopts a structure in which three inflatable sheets 9 and the airbag 10 are combined, and the side walls thereof fit tightly together to form a stable balloon shape when expanded. This structural design can ensure that the balloon gradually expands during the inflation process, provide uniform support force, reduce local high-pressure areas, and avoid blood vessel damage caused by uneven deformation. At the same time, by accurately setting the breaking pressure of the pressure sheet 12, it will only break after the inflatable sheet 9 is fully filled with air, thereby allowing gas to enter the airbag 10, ensuring that the expansion process complies with progressive inflation control, avoiding one-time inflation that is too fast or excessive expansion, and reducing mechanical damage to the blood vessel wall.

[0045] In addition, in order to further reduce the friction and trauma between the balloon and the blood vessel wall, the pressure sheet 12 adopts a rounded structure design, which will not form a sharp edge after breaking, thereby reducing the potential stimulation to the blood vessel endothelium and enhancing biocompatibility. This optimization not only improves the safety of the balloon, but also reduces the risk of damage to vascular endothelial cells and the possibility of postoperative thrombosis.

[0046] In addition, since the three inflatable sheets 9 and the airbag 10 are closely fitted to form an integral balloon, this structure can enhance the compliance and permeability of the balloon, making it more adaptable in complex vascular lesions such as curved lesions or multi-segment stenosis. This design allows the balloon to pass smoothly when entering the stenotic lesion area, and at the same time, it fits more evenly with the blood vessel wall during expansion, reducing excessive pressure concentration on the blood vessel wall and improving the expansion effect.

[0047] In this embodiment, the drug to be released includes but is not limited to one of PEEK, polyurethane, and PLGA.

[0048] In this embodiment, a rounded structure is provided at the edge of the notch 7 of the closed groove 8. The present invention adopts a rounded structure design at the edge of the notch 7 of the closed groove 8. This optimization can significantly reduce the shear force and friction force on the blood vessel wall during balloon expansion, reduce the stimulation to the fragile blood vessel tissue, and thus improve the safety of the operation. Especially in narrow, calcified or curved diseased blood vessels, the rounded edge can better conform to the morphological changes of the blood vessels, reduce the local stress concentration caused by balloon deformation, and avoid additional damage to the blood vessel wall.

[0049] In addition, the rounded structure can also optimize the stability of drug release. When the balloon is expanded, the closed groove 8 will expand due to tension, releasing the drug stored inside, and the rounded edge design can ensure that the slot maintains smooth fluid dynamics during the opening and closing process, preventing the drug from unevenly diffusing or instantaneous scouring and loss due to edge effects, thereby increasing the drug's retention time and bioavailability in the blood vessel wall. This optimization not only improves the effectiveness of drug delivery, but also reduces the side effects that may be caused by uneven drug release, making the vascular expansion balloon more accurate and safer in interventional treatment.

[0050] A novel dilatation balloon assembly for a nasotracheal intubation includes a plurality of inflation tubes 13, a plurality of channels 14 are provided inside the tube body 2, and the inflation tubes 13 are located inside the channels 14, an annular groove 15 is provided below the channels 14, an annular tube 16 is provided inside the annular groove 15, the annular tube 16 and the inflation tube 13 are connected, and an air pumping tube 17 is provided at the second end edge of the tube body 2, the air pumping tube 17 passes through the tube body 2 and is connected to the annular tube 16. Through the layout of the plurality of inflation tubes 13 and the internal channels 14, combined with the structure of the annular groove 15 and the annular tube 16, multi-path inflation and balanced pressure distribution are achieved, and the stability and uniformity of the inflation process are improved.

[0051] In this embodiment, a sealing plug is provided outside the pumping pipe 13, and the size of the sealing plug is the same as the opening of the pumping pipe 13. The sealing plug matching the size of the opening is provided outside the pumping pipe 13, which can effectively prevent gas leakage.

[0052] The present invention is not limited to the above-mentioned embodiments. Anyone should be aware that any structural changes made under the enlightenment of the present invention, and any technical solutions that are the same or similar to the present invention, fall within the protection scope of the present invention. The technology, shape, and structural parts not described in detail in the present invention are all well-known technologies.

Claims

1. A vasodilator balloon, characterized in that: include: A connector (1), one end of the connector (1) being connected to a tube (2), a plurality of deformable wires (3) being arranged around the inner wall of the tube (2), a balloon structure being arranged outside the first end of the tube (2), and an expansion balloon assembly for inflating the balloon structure being arranged outside the second end of the tube (2); The balloon structure comprises a balloon body (4) connected to the tube body (2); a connecting sleeve (5) is provided on the outside of the balloon body (4) and can be deformed together with the balloon body (4); and the balloon body (4) and the expansion balloon assembly are connected; The exterior of the connecting sleeve (5) is in a spiral structure after being closed and forms a plurality of spiral ribs (6), and a drug dispersing structure is arranged on the exterior of each of the spiral ribs (6).

2. A vasodilator balloon according to claim 1, characterized in that: The drug dispensing structure comprises a notch (7) provided inside the spiral rib (6), a closed groove (8) provided above the notch (7), a dispensing drug provided inside the notch (7), and the closed groove (8) is in a sealed state when the balloon body (4) is not inflated. After the balloon body (4) is inflated and expanded, the closed groove (8) is expanded due to tension.

3. A vasodilator balloon according to claim 1, characterized in that: The balloon body (4) comprises three inflatable sheets (9), an airbag (10) is arranged between every two of the inflatable sheets (9), the angle between every two of the inflatable sheets (9) is 120°, and the inflatable sheets (9) and the airbag (10) are interconnected and provided with a pressure piece, and the expansion balloon assembly is respectively connected to the three inflatable sheets (9).

4. A vasodilator balloon according to claim 1, characterized in that: The pressure piece comprises a pressure sheet (12), a vent hole (11) is provided between the inflation sheet (9) and the airbag (10), and the pressure sheet (12) is arranged inside the vent hole (11). After the pressure sheet (12) is broken, the gas in the inflation sheet (9) enters the airbag (10) along the vent hole (11) to achieve inflation of the airbag (10).

5. A vasodilator balloon according to claim 1, characterized in that: The pressure at which the pressure sheet (12) breaks is equal to the pressure at which the inflatable sheet (9) is filled with air, and the tip of the pressure sheet (12) is a rounded structure.

6. A vasodilator balloon according to claim 1, characterized in that: The three inflatable sheets (9) and the side walls of the airbag (10) are tightly fitted together to form a balloon.

7. The vasodilator balloon according to claim 1, characterized in that: The dispersible drug includes but is not limited to one of PEEK, polyurethane, and PLGA.

8. The vasodilator balloon according to claim 1, characterized in that: A rounded structure is provided at the edge of the notch (7) of the closed groove (8).

9. A novel dilatation balloon assembly for nasotracheal intubation according to claim 1, characterized in that: The invention comprises a plurality of inflation tubes (13), a plurality of channels (14) are provided inside the tube body (2), and the inflation tubes (13) are located inside the channels (14), an annular groove (15) is provided below the channels (14), an annular tube (16) is provided inside the annular groove (15), the annular tube (16) and the inflation tubes (13) are connected, and an air pumping tube (17) is provided at the second end edge of the tube body (2), and the air pumping tube (13) passes through the tube body (2) and is connected to the annular tube (16).

10. The novel dilatation balloon assembly for nasotracheal intubation according to claim 9, characterized in that: A sealing plug is provided outside the air pumping pipe (17), and the size of the sealing plug is the same as the opening of the air pumping pipe (17).

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