Blood vessel perfusion balloon based on spiral shape

Abstract

The utility model discloses a spiral blood vessel perfusion balloon which comprises a connecting part and a balloon body section and is of a spiral surrounding structure. Through reducing and conical transition at the two ends, the novel-structure balloon which bears blood vessel high pressure, effectively dilates blood vessels and reserves a spiral blood channel at the same time is formed; the connecting part is used for supporting and connecting the balloon and the catheter, and the balloon body section expands after being punched to expand the blood vessel; the connecting part forms a space volume difference with the balloon body section after being expanded, and forms a stable space which is not restrained by the balloon body together with the spiral blood channel, so that the acting time of the perfusion balloon is effectively ensured and prolonged; in the design and production of the balloon, the spiral shape is set as an expected shape, so that the accurate control of the shape of the balloon is realized, and the performance of the balloon in the interventional operation of important parts such as coronary vessels is improved.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of medical apparatus and instruments, especially to a spiral based on blood vessel perfusion balloon. BACKGROUND

[0002] With the aging of the population in China, the incidence of vascular diseases is getting higher and higher. In order to diagnose and treat vascular diseases, minimally invasive interventional surgical treatment in vascular surgery, cardiology, neurosurgery, thoracic surgery, interventional department, etc. has become the trend. Balloon system is the most important and basic angioplasty instrument in endovascular surgery, which has the function of expanding blood vessels. Among them, the perfusion balloon is a special balloon that expands in the human body cavity or blood vessel while maintaining the flow of gas or body fluid. Its perfusion and expansion functions are realized by the special structure design of the balloon part, which is supported by the outside inflation and forms a channel in the middle. Balloon expansion of diseased blood vessels and / or stent implantation and / or drug-loaded balloon to relieve stenosis of blood vessels is one of the most basic methods of modern heart and peripheral cardiovascular intervention, which is widely used in clinical practice. Whether it is a peripheral artery, coronary artery, cerebral artery, carotid artery, renal artery, etc., this method is used. It can also be used on balloon expanded heart valves.

[0003] Common expansion balloons (including simple expansion balloons, balloon expansion stents and drug-loaded balloons) are solid cylindrical or shuttle-shaped structures. They are inflated by contrast agent under pressure to expand the balloon. During the expansion of the balloon, the expanded blood vessels are completely blocked by the balloon, resulting in complete blockage of blood flow at the distal end. This blockage for more than a certain period of time can cause ischemia, and in severe cases, it can cause serious complications, such as low blood pressure and even ventricular fibrillation when expanding the left main or proximal blood vessels of the anterior descending branch of the coronary artery. However, if the expansion time is not enough, the diseased blood vessels cannot achieve the desired effect. With the development of balloons, the current market has perfusion balloon expansion catheter products for vascular stent expansion, valve implantation pre-expansion and stent expansion, such as the trueflow catheter of Bard Company and the trilobe catheter of Gore Company, and related patents CN201580084346.7, CN201780008580.0, CN201780008641.3 and CN202110829924.2, etc. The balloon part structure of such catheters is generally as follows: a plurality of small balloons are uniformly distributed around the outside of the guide wire tube in the middle, and a protective layer is coated outside the small balloons. The small balloons inflate or swell with water to lift the protective layer to a nearly circular shape in cross section to achieve expansion, and blood can flow through the channel formed between the small balloons and the guide wire tube to achieve perfusion.

[0004] The patent application No. CN220530492U, with the application date of September 21, 2022, discloses a perfusion balloon assembly. The perfusion balloon assembly includes a catheter, a first gap and a second gap are formed in the side wall of the catheter, the catheter includes an inner tube and an outer tube sleeved outside the inner tube, the inner tube and the outer tube are sealed from each other, the inner tube is configured to allow blood to enter from the distal end of the inner tube and flow out from the first gap; a liquid injection device, the liquid injection device is located at the proximal end of the catheter; a balloon, the balloon is in communication with the outer tube, the distal end of the inner tube extends through the balloon, the second gap is located on the proximal side of the balloon, the first gap is located between the second gap and the balloon, and the liquid injection device is used to inject liquid into the balloon; and a guide wire, the guide wire can pass through the inner tube through the distal end of the inner tube and the second gap.

[0005] In general, the selection is very limited, therefore, it is necessary to develop various new structures of perfusion balloon for patients and doctors to choose, and a spiral-based vascular perfusion balloon is developed to meet the above needs. Content of the utility model

[0006] In order to overcome the deficiencies of the prior art, the utility model provides a spiral-based vascular perfusion balloon, which has a dilating effect while reserving a channel for blood flow, can greatly improve the perfusion time during vascular dilation, effectively improve the dilation effect, and shorten the operation time.

[0007] To achieve the above purpose, the utility model solves its technical problems by adopting the following technical scheme: a spiral-based vascular perfusion balloon, comprising:

[0008] The balloon body is in a spiral shape, the pitch of the rest part except the two ends is constant, there is a constant pitch gap between adjacent balloon bodies, the gap is also distributed in a spiral shape along the balloon body, the balloon body and the gap form a close "screw thread" cooperation, and the balloon body is blow molded by a special process;

[0009] The connecting part includes a balloon distal end and a balloon proximal end, the connecting part is in a conical shape, is used in communication with the catheter, and guarantees the inlet and outlet of the "screw thread gap" channel in the filled state and the transportability of the balloon body in the initial state;

[0010] The contact part contacts the inner wall of the blood vessel and is used for coating a drug coating.

[0011] In some embodiments, in the inflated state, the balloon body is in a constant pitch spiral shape, and the connecting part is in a spiral conical shape.

[0012] In some embodiments, the balloon body has a cross section with uniform size and shape in the axial direction.

[0013] In some embodiments, the balloon distal end and the balloon proximal end have a cross section with varying size in the axial direction.

[0014] In some embodiments, the balloon body segment has an over-tapered helical taper to the balloon distal end and the balloon proximal end.

[0015] In some embodiments, the balloon body cross-sectional shape is one of circular, elliptical, rectangular, or trapezoidal.

[0016] In some embodiments, the balloon proximal end and the balloon distal end are symmetrical to the center, and the two end tapers are also symmetrical to the circumferential taper.

[0017] In some embodiments, the size of the thread-like gap formed by the balloon body is negatively correlated to the size of the balloon body cross-sectional dimension.

[0018] In some embodiments, the balloon body is a non-compliant balloon.

[0019] In some embodiments, the balloon body is made of one or more of nylon, polyurethane, polyamide, polyamide elastomer, polyester resin, polyester elastomer, polyolefin resin, silicone resin, natural rubber, and synthetic rubber.

[0020] Thanks to the use of the above technical solution, the utility model has the following beneficial effects compared with the prior art:

[0021] The balloon body of the utility model is helical, the gap between adjacent balloon bodies forms another helical space, the two helical spaces are nested with each other, the stable gap space enables blood to continue to flow, thereby greatly reducing the influence of the blood vessel expansion section on the downstream tissue blood supply; thereby the perfusion time during the expansion of the blood vessel can be greatly improved, the expansion effect can be effectively improved, and the operation time can be shortened; meanwhile, the balloon can carry drugs, in the case that the perfusion time is not restricted, the action time of the drugs in the diseased blood vessel is greatly improved, in addition, the balloon can also fully expand the stent, so that the expansion is more simple and effective. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed for the embodiment or technical description will be briefly introduced as follows;

[0023] Figure 1 is a schematic diagram of the inflation state of the blood vessel perfusion balloon based on the helical shape according to the utility model;

[0024] Figure 2 is a schematic diagram of the inflation state of the blood vessel perfusion balloon based on the helical shape according to the utility model;

[0025] Figure 3 is a schematic diagram of the inflation state of the blood vessel perfusion balloon based on the helical shape according to the utility model;

[0026] Figure 4 、 Figure 5 Fig. 1 and 2 are respectively schematic diagram of main body of spiral-shaped blood vessel perfusion balloon after inflation and sectional view of main body after inflation (balloon section is oval) provided by the utility model;

[0027] Figure 6 Fig. 3 is schematic diagram of main body of spiral balloon dilating blood vessel;

[0028] Figure 7 Fig. 4 is schematic diagram of main body of spiral balloon coated with drug coating;

[0029] Figure 8 Fig. 5 is schematic diagram of main body of spiral balloon dilating stent;

[0030] Figure 9 Fig. 6 is schematic diagram of spiral balloon in special blow molding process;

[0031] Figure 10 Fig. 7 is axial sectional view of spiral balloon in mold;

[0032] Figure 11 Fig. 8 is end face radial sectional view of spiral balloon mold;

[0033] Figure 12 Fig. 9 is sectional view of spiral balloon (section is circular) mold;

[0034] Figure 13 Fig. 10 is sectional view of spiral balloon (section is oval) mold;

[0035] In the figure: 10, balloon; 101, balloon proximal end; 102, balloon body; 103, balloon distal end; 104, contact part; 20, catheter. DETAILED DESCRIPTION

[0036] The content of the utility model will be further explained in detail in combination with the drawings of specific embodiments:

[0037] As shown in Figures 1 to 5 , the spiral-shaped blood vessel perfusion balloon 10 provided by the embodiment of the application can solve the problems of blood flow obstruction and limited expansion time in the existing perfusion balloon technology. Specifically, the balloon body 102, the proximal end 101 of the balloon body and the distal end 103 of the balloon body are inflated and expanded to dilate the blood vessel to achieve pipeline expansion after being pressurized; the inflated balloon body 102 and the catheter 20 generate a space difference, and together with the "spiral" gap, maintain blood circulation, achieving the purpose of prolonging perfusion time.

[0038] Further, in the embodiments of the present application, the balloon body 102 made by special blowing process can withstand high pressure liquid or gas for supporting and expanding blood vessels, and the balloon proximal end 101 and the balloon distal end 103 are preferably welded to the catheter 20.

[0039] It should be noted that the balloon body 102 as the main body for expanding blood vessels, the balloon proximal end 101 and the balloon distal end 103 only serve as connection and support, and do not bear the function of expanding blood vessels; but after inflation, they serve as the "entrance and exit" of the blood passage, and their manufacturing and design structure also affect the overall effect of the balloon.

[0040] After inflation, the balloon proximal end 101 is in a spiral shape or a conical shape; the pitch of the spiral shape can be consistent with the balloon body 102 or different; the overall axial length of the balloon proximal end 101 is less than that of the balloon body 102; the conical tip is connected to the catheter 20, and the size of the other side is the same as that of the balloon body 102 and is integrated.

[0041] Similarly, the balloon proximal end 101 and the balloon distal end 103 are almost the same, and the conical tip of the balloon distal end is integrated with the distal end of the catheter 20.

[0042] Due to the special structure of the balloon 10, after inflation, the longitudinal cross-sectional view of the balloon body 102 at any position is completely the same. It can also be described that the balloon body segment of the inflated spiral balloon for expanding blood vessels has the ability to stably maintain blood vessel expansion and blood flow.

[0043] It should be noted that the cross-sectional structure of the balloon body 102 is preferably circular or elliptical, which can provide stable support force; according to the mechanical performance of the structure and clinical application, a more suitable shape is preferred to meet the clinical needs; at the same time, it should be supplemented that a rectangular or trapezoidal shape can also be one of the preferred shapes to meet the actual needs and the needs of clinical research.

[0044] Compared with existing balloons, the main advantage of the spiral balloon is to provide a spiral gap channel for blood flow, so that blood continues to flow during the blood vessel expansion process, simplifying the steps in the previous surgical process, making the surgical time more efficient, and eliminating the fundamental drawbacks of traditional balloon expansion of blood vessels, which will be described one by one with examples.

[0045] For example, the spiral balloon is used for expanding blood vessels, and the spiral balloon is inflated to expand the blood vessel. Figure 6As shown in the figure, in some embodiments, the vessel with local lesion stenosis needs to be expanded for a period of time after being inflated by the balloon to achieve the ability of the vessel with local lesion to partially restore blood flow after being stressed; in traditional surgery, the vessel is expanded by the inflated balloon each time, which is greatly limited by blood flow obstruction causing local organ and tissue ischemia, and only repeated inflation and compression of the balloon can be operated, which has a high requirement for the professional level and operation ability of the operator; and multiple expansion of the vessel also greatly tests the performance of the balloon, and finally the surgical effect depends more on the experience and on-the-spot judgment of the operator, which has obvious uncertainty; the spiral balloon only needs to be maintained after being inflated once, and the blood flows along the gap between the balloon proximal end 102 and the balloon distal end 103, reaches the balloon proximal end 102, and then flows along the blood vessel channel where the catheter is located, so as to reduce the operation steps of the operator and improve the overall effect of surgical expansion.

[0046] As shown in the figure, Figure 7 In some embodiments, the contact part of the balloon with the blood vessel can be coated with a drug coating to achieve the purpose of accurately administering drugs to the blood vessel at the lesion site, but is also subject to perfusion time constraints, repeated operations causing drug loss, and greatly reducing the therapeutic effect of the drug; the contact part of the spiral balloon can also be coated with a drug coating, and the drug of the inflated balloon continuously acts on the blood vessel at the lesion site to improve the drug absorption rate of the blood vessel, thereby fundamentally solving the time constraint problem of drug treatment of the lesion blood vessel.

[0047] As shown in the figure, Figure 8 In some embodiments, the balloon serves as a delivery carrier of the blood vessel stent and plays a key role in the transmission and expansion release of the stent in the blood vessel; in the process of delivering the stent, positioning and expansion both need the cooperation of the balloon, which is subject to perfusion time constraints and has a high requirement for the accuracy of the release position of the stent; the spiral balloon can make the entire process free from the influence of blood flow obstruction and local ischemia, thereby providing more convenient conditions for accurate release of the stent.

[0048] As shown in the figure, Figures 12-13 In some embodiments, the cross-sectional shape of the balloon body is one of a circle, an ellipse, a rectangle, or a trapezoid.

[0049] The spiral balloon catheter device provided by the present application is described in detail above. The core principles and implementation manners of the present application are described in this paper in view of specific examples, and the above description of the embodiments is only used to help understand the scheme of the present application and its core idea. It should be pointed out that, for ordinary skilled persons in the technical field, some improvements and modifications can be made to the present application without departing from the principles of the present application, and these improvements and modifications also fall within the protection scope of the claims of the present application.

Claims

1. A helical based vascular perfusion balloon characterized by: The balloon comprises: a balloon body in the shape of a constant-pitch helix, with constant-pitch gaps between adjacent balloon bodies, the gaps also being helical, the balloon body and the gaps forming a tight "threaded" fit, the balloon body being blow-molded by a special process; a connecting portion comprising a balloon distal end and a balloon proximal end, the connecting portion being tapered, for connecting to a catheter and ensuring the passage of blood into the "threaded gap" in the inflated state, and also ensuring the delivery of the balloon body in the initial state; a contact portion for contacting the inner wall of the blood vessel, for coating a drug coating.

2. The helical based vascular perfusion balloon according to claim 1, wherein: In the inflated state, the balloon body is a constant-pitch helix, and the connecting portion is a helical taper.

3. The helical-based vascular perfusion balloon of claim 1, wherein: The balloon body has a uniform cross-sectional shape in the axial direction.

4. The helical-based vascular perfusion balloon of claim 1, wherein: The balloon distal end and the balloon proximal end have a cross-sectional shape that changes in the axial direction.

5. The helical-based vascular perfusion balloon of claim 1, wherein: The balloon body has a helical taper that extends beyond the catheter at both the balloon distal end and the balloon proximal end.

6. The helical-based vascular perfusion balloon of claim 1, wherein: The cross-sectional shape of the balloon body is one of circular, elliptical, rectangular, or trapezoidal.

7. The helical based vascular perfusion balloon according to claim 1, wherein: The balloon proximal end and the balloon distal end are symmetrical about the center, and the pitch taper at both ends is also symmetrical with the circumferential taper.

8. The helical-based vascular perfusion balloon of claim 1, wherein: The size of the "threaded gap" formed by the balloon body is negatively correlated with the size of the cross-sectional dimension of the balloon body.

9. The helical-based vascular perfusion balloon of claim 1, wherein: The balloon is a non-compliant balloon.

10. The helical-based vascular perfusion balloon of claim 1, wherein: The balloon body is made of one or more of nylon, polyurethane, polyamide, polyamide elastomer, polyester resin, polyester elastomer, polyolefin resin, silicone resin, natural rubber, and synthetic rubber.

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