Nicking balloon
By introducing a dilator and developing ring design into the score balloon, the problem of insufficient cutting depth of the score balloon is solved, achieving more effective vasodilation and reducing vascular damage.
Patent Information
- Application Number
- CN202422023509.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-20
- Publication Date
- 2025-08-01
- Estimated Expiration
- 2034-08-20
AI Technical Summary
The existing scinted balloon cutting depth is insufficient, making it difficult to fully expand the vascular stenosis lesions.
A score balloon is designed, including a main catheter, a main balloon, a score piece and an expansion member. The score piece is arranged on the outer wall of the main balloon. The expansion body in the expansion member applies thrust to the score piece when it expands, so that it expands outward, combining the fluid delivery of the thin catheter and the small balloon to enhance the cutting depth, and a developing ring is provided in the main balloon for easy positioning.
It improves the cutting depth and dilation effect of the scoring balloon on the lesion, reduces vascular damage, and reduces the probability of inflammatory response and restenosis.
Smart Images
Figure CN223170152U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical devices, and particularly relates to a cutting balloon. Background Art
[0002] Vascular interventional therapy is an important treatment method for revascularization of vascular stenosis lesions. In vascular interventional therapy, balloon catheters are usually used as the main vascular interventional treatment devices. For some stenosis lesions in blood vessels, such as calcification, plaque or fibrosis stenosis lesions, traditional balloon catheters cannot effectively dilate the stenosis lesion sites. To solve this problem, cutting balloons came into being. A cutting balloon is a special type of balloon that combines micro-cutting technology and balloon dilation. Compared with conventional balloons, the cutting balloon has the following advantages: (1) The micro-blades installed on the balloon surface can cut the significantly hyperplastic or calcified intima, effectively dilating the hard stenotic internal fistula blood vessels. (2) Compared with the blunt and disordered dilation of conventional balloons, the cutting balloon can dilate evenly and fully at a lower pressure, with less irregular tearing of the vascular intima, thus less damage to the blood vessels, relatively mild inflammatory reaction, and can also reduce the probability of restenosis of the internal fistula blood vessels. For lesions with severe calcification and thick plaques, existing cutting balloons have problems such as insufficient cutting depth and difficulty in fully dilating blood vessels. Summary of the Utility Model
[0003] Therefore, the technical problem to be solved by the utility model is that the cutting depth of the cutting balloon in the prior art is insufficient and it is difficult to fully dilate blood vessels, so as to provide a cutting balloon.
[0004] To solve the above technical problem, the technical solution of the utility model is as follows:
[0005] A cutting balloon, comprising a main catheter, a main balloon, a cutting member and an expansion member; the main balloon is arranged at the distal end of the main catheter; the cutting member is arranged on the outer wall of the main balloon and there are at least two of them; there are at least two expansion members, the interior of the cutting member is hollow, the expansion member has an inflatable body suitable for expansion and contraction, and the inflatable bodies on the two expansion members are respectively placed in the two cutting members in a one-to-one correspondence, and when the inflatable body expands, it is suitable for applying a thrust to the cutting member to expand the cutting member outward away from the main balloon.
[0006] Further, the expansion member includes a small balloon and a thin catheter, the small balloon is located in the hollow structure to form an inflatable body, and the thin catheter is communicated with the proximal end of the small balloon.
[0007] Further, the thin catheter is axially distributed on the outer wall of the main catheter, a fixing ring is sleeved on the outer wall of one end of the main catheter close to the main balloon, and the thin catheter passes through the fixing ring.
[0008] Further, the proximal end of the thin catheter is connected to a pressurizing device.
[0009] Further, the main balloon has a structure with a cylindrical middle part and tapered ends. The cylindrical structure in the middle is the working section, and the tapered ends are non-working sections. There are three notch members, and the three notch members are axially equally spaced on the working section of the main balloon. Each notch member is provided with the expansion body.
[0010] Further, the notch member is wound into a helical spring shape, and the cross-section of the notch member is triangular.
[0011] Further, the material of the notch member is any one or a combination of medical stainless steel, cobalt-chromium alloy, and nickel-titanium alloy.
[0012] Further, the outer surface of the notch member is provided with a uniformly distributed drug coating, which is suitable for avoiding intimal hyperplasia during the operation.
[0013] Further, a radiopaque ring is arranged in the main balloon.
[0014] Further, the radiopaque ring is composed of two annular bodies, and the radiopaque ring is made of platinum-iridium alloy.
[0015] The technical solution of the present utility model has the following advantages:
[0016] 1. For the notched balloon provided by the present utility model, the main balloon is contracted to facilitate transportation to the lesion site. After reaching the lesion site, the main balloon is inflated through the main catheter. The notch member cuts the lesion, and by filling and expanding the expansion body, a thrust is applied to the notch member to squeeze the notch member, so that the notch member undergoes elastic deformation, thereby increasing the notch depth of the notch member on the lesion, and further improving the expansion effect of the notched balloon.
[0017] 2. For the notched balloon provided by the present utility model, the expansion member includes a small balloon and a thin catheter. The small balloon is located in the hollow structure to form the expansion body, and the thin catheter communicates with the proximal end of the small balloon. With such a setting, the small balloon expands and contracts by transporting and extracting fluid through the thin catheter. In the inflated state, the small balloon can apply a thrust to the notch member to cause the notch member to undergo outward elastic deformation, increasing the depth of the notch member cutting the lesion.
[0018] 3. For the notched balloon provided by the present utility model, the thin catheter is axially distributed on the outer wall of the main catheter. A fixing ring is sleeved on the outer wall of one end of the main catheter close to the main balloon, and the thin catheter passes through the fixing ring. With such a setting, the thin catheter can be fixed on the outer wall of the main catheter through the fixing ring, preventing the thin catheter from moving during the operation.
[0019] 4. The notched balloon provided by the present utility model is provided with three notching members, and the three notching members are axially equidistantly spaced on the outer wall of the main balloon, and an expansion body is arranged in each notching member. With such an arrangement, the three notching members spaced equidistantly on the outer wall of the main balloon can cut the diseased part from multiple angles in the blood vessel.
[0020] 5. The notched balloon provided by the present utility model is provided with a radiopaque ring in the main balloon. With such an arrangement, it is convenient to mark the position of the working area of the main balloon during the operation, facilitating the operator to smoothly deliver the balloon to the diseased blood vessel area. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] In order to more clearly illustrate the specific embodiments of the present utility model or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present utility model. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.
[0022] Figure 1 is a three-dimensional structure diagram of the notched balloon provided by the embodiment of the present utility model;
[0023] Figure 2 is a structural schematic diagram of the notched balloon provided by the embodiment of the present utility model;
[0024] Figure 3 is a front view of the notched balloon provided by the embodiment of the present utility model;
[0025] Figure 4 is Figure 2 a cross-sectional view taken along line B-B in
[0026] Figure 5 is Figure 4 an enlarged view at position C of
[0027] Figure 6 is Figure 3 a cross-sectional view taken along line A-A in
[0028] Figure 7 is Figure 6 an enlarged view at position D of
[0029] Explanation of reference numerals: 1, main catheter; 2, main balloon; 3, notching member; 4, thin catheter; 5, fixing ring; 6, small balloon. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0030] The technical solution of the present utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some, but not all, of the embodiments of the present utility model. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present utility model without creative efforts shall fall within the protection scope of the present utility model.
[0031] In the description of the present utility model, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present utility model. The "proximal end" and "distal end" in the present utility model refer to the near and far relative to the operator. When the present utility model is in use, the end close to the doctor or the operator is the "proximal end", that is, the end where the operator is located, and the end far from the doctor or the operator is the "distal end". In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.
[0032] In the description of the present utility model, it should be noted that unless otherwise clearly defined and limited, the terms "installed", "connected", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific situations.
[0033] In addition, the technical features involved in different embodiments of the present utility model described below can be combined with each other as long as they do not conflict with each other.
[0034] As Figures 1-7 shown, a notched balloon includes a main catheter 1, a main balloon 2, a notching member 3, and an expansion member; the main balloon 2 is disposed at the distal end of the main catheter 1; the notching member 3 is disposed on the outer wall of the main balloon 2 and at least two are provided; at least two expansion members are provided, the notching member 3 is hollow inside, the expansion member has an inflatable body adapted to expand and contract, and the inflatable bodies on the two expansion members are respectively placed in the two notching members 3 one by one. When the inflatable body expands, it is adapted to apply a thrust to the notching member 3 to expand the notching member 3 outward away from the main balloon 2.
[0035] This notched balloon is transported to the lesion site by contracting the main balloon 2 for easy delivery. After reaching the lesion site, the main balloon 2 is inflated through the guiding catheter 1, and the lesion is cut by the notching member 3. By filling and expanding the expansion body, a thrust is applied to the notching member 3 to squeeze the notching member 3, causing the notching member 3 to undergo elastic deformation, thereby increasing the notching depth of the notching member 3 on the lesion and further improving the dilation effect of the notched balloon.
[0036] In this embodiment, the expansion member includes a small balloon 6 and a thin catheter 4. The small balloon 6 is located within the hollow structure to form an expansion body, and the thin catheter 4 communicates with the proximal end of the small balloon 6. With this arrangement, the small balloon 6 expands and contracts by transporting and extracting fluid through the thin catheter 4. In the inflated state, the small balloon 6 can apply a thrust to the notching member 3 to cause the notching member 3 to undergo outward elastic deformation, increasing the depth of the notching member 3 cutting the lesion. Specifically, a catheter seat is provided at the proximal end of the guiding catheter 1, and the proximal end of the thin catheter 4 is connected to a pressurizing device.
[0037] In this embodiment, the main balloon 2 has a structure with a cylindrical middle part and tapered ends. The middle cylindrical structure is the working section, and the tapered ends at both ends are non-working sections. Specifically, three notching members 3 are provided, and the three notching members 3 are axially equally spaced and distributed on the outer wall of the working section of the main balloon 2. An expansion member is provided within each notching member 3. With this arrangement, the three notching members 3 equally spaced and distributed on the outer wall of the main balloon 2 can cut the lesion site from multiple angles within the blood vessel.
[0038] Specifically, the main balloon 2 can be a compliant balloon, a semi-compliant balloon, or a non-compliant balloon. The material of the main balloon 2 is one or more of materials such as polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or other polymer materials with good biocompatibility.
[0039] Specifically, the notching member 3 is wound into a helical spring shape, and the cross-section of the notching member 3 is triangular. In an alternative embodiment, the cross-section of the notching member 3 can also be rectangular, pentagonal, or other polygonal structures.
[0040] Specifically, the material of the notching member 3 is any one or a combination of medical stainless steel, cobalt-chromium alloy, and nickel-titanium alloy.
[0041] Specifically, a uniformly distributed drug coating is provided on the outer surface of the notching member 3, which is suitable for avoiding intimal hyperplasia during the operation. In an alternative embodiment, a uniformly distributed drug coating can also be provided on the outer wall of the main balloon.
[0042] In this embodiment, a fixing ring 5 is sleeved on the outer wall of one end of the main catheter 1 close to the main balloon 2, and the thin catheter 4 is passed through the fixing ring 5. With this arrangement, the thin catheter 4 can be fixed to the outer wall of the main catheter 1 through the fixing ring 5 to prevent the thin catheter 4 from moving during the operation.
[0043] In this embodiment, an inner tube is arranged in the main balloon 2, and a developing ring is arranged on the inner tube. The developing ring is visible under X-ray. With this arrangement, it is convenient to mark the position of the working area of the main balloon 2 during the operation, so that the operator can smoothly deliver the balloon to the diseased blood vessel area. Specifically, the developing ring is composed of two annular bodies, and the developing ring is made of platinum-iridium alloy.
[0044] In summary, this notched balloon is transported to the diseased position by contracting the main balloon 2. After reaching the diseased position, the main balloon 2 is inflated through the main catheter 1, the diseased area is cut by the notching member 3, and the inflatable body is filled and inflated, so as to apply a thrust to squeeze the notching member 3, causing the notching member 3 to undergo elastic deformation, thereby increasing the notching depth of the notching member 3 on the diseased area, and further improving the dilation effect of the notched balloon.
[0045] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to enumerate all the implementation manners here. And the obvious changes or modifications derived therefrom still fall within the protection scope of the present invention.
Claims
1. A scored balloon, characterized in that, The invention comprises a main catheter (1), a main balloon (2), a scoring piece (3) and an expansion piece; the main balloon (2) is arranged at the distal end of the main catheter (1); the scoring piece (3) is arranged on the outer wall of the main balloon (2), and at least two of the scoring pieces (3) are arranged; at least two of the expansion pieces are arranged, the scoring piece (3) is hollow inside, and the expansion piece has an expansion body suitable for expansion and contraction, the expansion bodies on the two expansion pieces are placed in the two scoring pieces (3) in a one-to-one correspondence, and the expansion bodies are suitable for applying a thrust to the scoring piece (3) when expanding so that the scoring piece (3) expands away from the outside of the main balloon (2).
2. The scored balloon according to claim 1, wherein, The expansion member comprises a small balloon (6) and a thin catheter (4); the small balloon (6) is located in the hollow structure to form an expansion body; and the thin catheter (4) is connected to the proximal end of the small balloon (6).
3. The notched balloon according to claim 2, wherein The thin catheter (4) is axially distributed on the outer wall of the main catheter (1); a fixing ring (5) is sleeved on the outer wall of one end of the main catheter (1) close to the main balloon (2); and the thin catheter (4) is inserted into the fixing ring (5).
4. The scored balloon according to claim 2, wherein The proximal end of the thin catheter (4) is connected to a pressure charging device.
5. The notched balloon according to claim 1, wherein The main balloon (2) is a structure with a cylindrical middle and tapered ends. The cylindrical structure in the middle is a working section, and the tapered ends are non-working sections. Three scoring members (3) are provided, and the three scoring members (3) are axially equidistantly distributed on the working section of the main balloon (2). The expansion body is provided in each scoring member (3).
6. The notched balloon according to claim 1, wherein The notched member (3) is wound into a coil spring shape, and the cross section of the notched member (3) is triangular.
7. The notched balloon according to claim 1, wherein The material of the scoring member (3) is any one or more combinations of medical stainless steel, cobalt-chromium alloy and nickel-titanium alloy.
8. The scored balloon according to claim 1, wherein The outer surface of the scoring member (3) is provided with a uniformly distributed drug coating, which is suitable for preventing vascular intimal hyperplasia during surgery.
9. The notched balloon according to claim 5, characterized in that A developing ring is provided in the main balloon (2).
10. The notched balloon according to claim 9, wherein, The developing ring is composed of two ring-shaped bodies and is made of platinum-iridium alloy.