WO2020253739A1 - Medical balloon, balloon catheter and medical device - Google Patents

Medical balloon, balloon catheter and medical device Download PDF

Info

Publication number
WO2020253739A1
WO2020253739A1 PCT/CN2020/096642 CN2020096642W WO2020253739A1 WO 2020253739 A1 WO2020253739 A1 WO 2020253739A1 CN 2020096642 W CN2020096642 W CN 2020096642W WO 2020253739 A1 WO2020253739 A1 WO 2020253739A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
medical
medical balloon
recesses
sub
Prior art date
Application number
PCT/CN2020/096642
Other languages
French (fr)
Chinese (zh)
Inventor
刘云云
李明华
谢志永
�田�浩
寸雨曦
Original Assignee
微创神通医疗科技(上海)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 微创神通医疗科技(上海)有限公司 filed Critical 微创神通医疗科技(上海)有限公司
Publication of WO2020253739A1 publication Critical patent/WO2020253739A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02Dilators made of swellable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials

Definitions

  • the present invention relates to the technical field of medical equipment, in particular to a medical balloon, a balloon catheter and a medical device.
  • Balloon dilatation is an important technology in the field of interventional therapy and is widely used in coronary heart disease, cerebral thrombosis, and aneurysm lesions. And other diseases are being treated. Medical balloons need to have better support performance to achieve the treatment of diseased blood vessels.
  • Fig. 1 shows a blood vessel 1 with a disease.
  • the radius of curvature r of the blood vessel 1 at the location of the disease is ⁇ .
  • the linear medical balloon 2 is fed into the blood vessel 1 through the catheter 3.
  • the medical balloon 2 expands, but it cannot adapt to the blood vessel 1 itself.
  • the medical balloon 2 stretches the blood vessel 1 so that the radius of curvature r of the blood vessel 1 increases to ⁇ , which in turn causes excessive tearing of the blood vessel 1 in the areas A and B in Fig. 2, causing the blood vessel 1 to tear or tear Spasms.
  • the stress in the B area is relatively concentrated, which easily causes the connection point of the medical balloon 2 and the catheter 3 to be discounted.
  • the purpose of the present invention is to provide a medical balloon, a balloon catheter and a medical device.
  • the medical balloon of the present invention has good bending performance, can adapt well to the shape of blood vessels, and avoid excessive tearing of blood vessels.
  • the present invention provides a medical balloon, which includes a balloon body and a recess formed on the outer surface of the balloon body.
  • the recessed portion extends along the circumferential direction of the balloon body.
  • the recessed portion is a continuous annular groove, or the recessed portion includes at least two sub-recessed portions spaced apart along the circumference of the balloon body.
  • each of the recesses extends along the circumferential direction of the balloon body, and the two or more recesses are along the The balloon bodies are arranged sequentially in the axial direction.
  • the concave portion has a spiral structure and spirally surrounds along the axis of the balloon body.
  • the recess includes at least two sub-recesses in a spiral structure, at least two of the sub-recesses are arranged in sequence along the axial direction of the balloon body and connected to each other, and the two connected sub-recesses The direction of rotation of the depression is opposite.
  • the recess includes at least two sub-recesses in a spiral structure, and at least two of the sub-recesses are spaced apart along the axial direction of the balloon body
  • the shape of the recessed portion is at least one of an arc, a square, a trapezoid, or a V-shape.
  • the outer diameter of the balloon body is tapered from the proximal end to the distal end.
  • the present invention provides a balloon catheter, which includes the medical balloon as described above and a catheter connected to the proximal end of the medical balloon.
  • the present invention provides a medical device, which includes the aforementioned balloon catheter and a stent crimped on the medical balloon of the balloon catheter.
  • the stent has a pipe network structure and includes a pole and a connecting rod connected to each other along the axial direction of the stent;
  • the stent and the medical balloon are in an expanded state, at least a part of the probe is positioned on the balloon body of the medical balloon.
  • the connecting rod is positioned at a recess of the medical balloon.
  • both ends of the wave rod are respectively positioned on the balloon body on both sides of the recessed portion, and the length of the two ends of the wave rod positioned on the balloon body is not less than 0.5mm.
  • the lengths of the two end portions of the probes positioned on the balloon body are equal.
  • one end of the wave rod is positioned on the balloon body on one side of the recessed portion, the other end is positioned at the recessed portion, and the wave rod is positioned on the balloon body
  • the length of is not less than 1/2 of the full length of the pole.
  • all the wave rods are positioned on the balloon body.
  • the medical balloon, balloon catheter and medical device of the present invention have the following advantages:
  • the medical balloon of the present invention includes a balloon body and a concave portion formed on the outer surface of the balloon body.
  • the concave portion improves the bending performance of the medical balloon, thereby improving its bending ability to better adapt to blood vessels Its shape reduces the damage of blood vessels caused by excessive tearing of blood vessels.
  • Figure 1 is a schematic diagram of the structure of a diseased blood vessel
  • FIG. 2 is a schematic diagram of a cylindrical medical balloon in the prior art being delivered into a diseased blood vessel;
  • Figures 3a and 3b are structural schematic diagrams of a medical balloon provided according to an embodiment of the present invention.
  • the recessed portion shown in Figure 3a includes a plurality of sub-recessed portions spaced along the circumference of the balloon body, as shown in Figure 3b.
  • the depression is a continuous annular groove;
  • Figure 4 is a schematic diagram of the medical balloon shown in Figure 3b when it is delivered into a diseased blood vessel;
  • FIG. 3b are schematic diagrams of various deformed structures of the medical balloon shown in FIG. 3b;
  • Fig. 6 is a schematic diagram of the bending principle of the medical balloon shown in Fig. 3b, in which only a circle of recesses is shown;
  • Fig. 7 is a schematic diagram of the bending principle of the medical balloon shown in Fig. 5c;
  • FIG. 8a and 8b are structural schematic diagrams of a medical balloon provided according to another embodiment of the present invention, wherein the balloon body of the medical balloon shown in FIG. 8a is formed with a spiral structure recessed portion, as shown in FIG. 8b Two sub-recesses in a spiral structure are formed on the balloon body of the medical balloon of, and the rotation directions of the two sub-recesses are the same;
  • Fig. 9 is a schematic structural diagram of a medical device provided according to an embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the positional relationship between the stent and the medical balloon in the medical device according to an embodiment of the present invention.
  • Fig. 11 is an enlarged schematic diagram of C in Fig. 10;
  • Fig. 12 is a schematic diagram of another positioning method of the stent of the medical device in Fig. 10;
  • FIG. 13 is a schematic diagram of the positional relationship between the stent and the medical balloon in the medical device according to another embodiment of the present invention.
  • Fig. 14 is an enlarged schematic view of D in Fig. 13.
  • L 1 the axial maximum length of the recess
  • L 2 the axial length of the sub-balloon
  • H the depth of the recess.
  • proximal and distal refer to the relative position, relative position, and direction of elements or actions relative to each other from the perspective of the doctor using the medical balloon, although the “proximal” and “distal”
  • end is not restrictive, but the “proximal” usually refers to the end of the medical balloon that is close to the doctor during normal operation, and the “distal” usually refers to the end that first enters the blood vessel in the patient's body.
  • all size descriptions in this article refer to the size of the medical balloon when it is in an expanded state, unless the content clearly indicates otherwise.
  • circumferential refers to the direction surrounding the axis of the medical balloon and at right angles, acute angles or obtuse angles to the axis of the medical balloon, that is, on any plane that is not parallel to the axis of the medical balloon, unless The content is clearly stated separately.
  • the core idea of the present invention is to provide a medical balloon.
  • the medical balloon includes a balloon body and a recess formed on the outer surface of the balloon body.
  • the concave portion improves the bending performance of the medical balloon, thereby improving the bending ability of the balloon without affecting the supporting performance of the balloon to better adapt to the shape of the blood vessel, and reducing the damage of the blood vessel caused by excessive tearing of the blood vessel .
  • the balloon body of the medical balloon 10 includes at least two interconnected sub-balloons 11 (five sub-balloons 11 are illustrated in the figure).
  • the balloon 11 is preferably integrally formed, and at least one circle of recesses 12 is formed at the connection position of the two adjacent sub-balloons 11 (four circles of recesses are illustrated in the figure), and at least one circle of the recesses 12 is formed. It extends along the circumferential direction of the balloon body, that is, the extending direction of the recess 12 is at a right angle, an acute angle or an obtuse angle with the axial direction of the balloon body.
  • the concave portion 12 may also be in the form of a non-full circle of less than 360°. For example, the concave portion 12 may occupy half or three-quarters of a circumferential circle.
  • the recess 12 is a circle to further illustrate the medical balloon of the present invention, but those skilled in the art should be able to modify the following description to apply it to the case where the recess 12 is not a circle.
  • the medical balloon 10 is made of elastic polymer materials such as polyamide fiber (nylon), block polyetheramide elastomer (PEBAX), thermoplastic polyurethane elastomer (TPU), etc.
  • a recess 12 is formed adjacent to the connection position of the two sub-balloons 11, so that the medical balloon 10 forms a multi-segment structure.
  • the outer diameter of the medical balloon 10 at the connection point is reduced, thereby reducing the pressure of the medical balloon.
  • the outer diameter in the grip state improves the compliance during delivery and the ability to reach the distal blood vessel; on the other hand, the stretching site of the medical balloon 10 is increased, thereby increasing the stretching range of the medical balloon 10 and improving the medical balloon
  • the bending performance of the capsule 10 improves its bending ability.
  • a circle of the recesses 12 may include at least two sub-recesses 121, and the at least two sub-recesses 121 are arranged at a circumferential interval at the junction of two adjacent sub-balloons 11.
  • the at least two sub-recesses 121 may be arranged along a circumference on a plane perpendicular to the axis of the medical balloon 10 to form a circular arrangement, or on a plane that is not perpendicular and parallel to the axis of the medical balloon 10
  • the circle is arranged to form an elliptical arrangement.
  • the bending ability of the medical balloon 10 at the position where the concave portion 12 is provided is enhanced, thereby improving the bending ability of the medical balloon 10 at the position prescribed by the concave portion 12.
  • the shape and number of the recesses 12 provided on the medical balloon 10 are not limited, as long as they can achieve the purpose of improving the bending performance of the medical balloon 10.
  • a circle of the concave portion 12 can also be a continuous annular groove, and the continuous annular groove can be perpendicular to the axis of the medical balloon 10 (that is, the plane where the continuous annular groove is located). It is perpendicular to the axis of the medical balloon 10), or not perpendicular to the axis (that is, the plane where the continuous annular groove is located is not perpendicular and not parallel to the axis of the medical balloon 10). In this way, the bending performance of the medical balloon 10 in the entire circumferential direction is improved, so that the medical balloon 10 can obtain better bending performance in any direction, so that it is not necessary to set the bending direction of the blood vessel 20 during use.
  • the delivery position of the medical balloon 10 is determined, which reduces the operational difficulty of medical staff when using the medical balloon 10.
  • At least two circles of recesses 12 are formed on the outer surface of the balloon body, so that the medical balloon 10 is axially divided into more of the sub-balloons 11 (ie, segments). ), so that the medical balloon 10 has better bending performance in multiple regions, and can simultaneously comply with the bending of adjacent blood vessel segments in different directions or different arcs.
  • the proximal end of the medical balloon 10 is connected to a catheter 30, and is sent into the blood vessel 20 through the catheter 30 and then expanded.
  • the blood vessel 20 is stretched and its radius of curvature r is Increase to ⁇ .
  • the medical balloon 10 has better bending performance and its adaptability to the shape of the blood vessel 20 is improved, the radius of curvature ⁇ of the blood vessel 20 at this time is smaller than the radius of curvature of the blood vessel 20 when a cylindrical medical balloon is used. Value ⁇ , thereby reducing the possibility of the blood vessel 20 being torn or spasm being excessively torn.
  • the force generated when the medical balloon 10 is bent is transmitted to the connection point between the medical balloon 10 and the catheter 30. Because the medical balloon 10 has good adaptability to the blood vessel 20, the vicinity of the connection point is reduced. The stress is concentrated, thereby avoiding the connection point of the medical balloon 10 and the catheter 30 from being discounted.
  • the size of the recessed portion 12 is selected according to actual conditions.
  • the maximum dimension L 1 of each circle of recessed portion 12 along the axial direction of the medical balloon 10 (the maximum axial length L of the recessed portion 12 1 ) Generally, it is not greater than 3 mm.
  • the minimum value of the dimension H (the depth H of the recess 12) of the recess 12 in the radial direction of the medical balloon 10 can be 0.1 mm, and the maximum value can be no more than half of the radial dimension of the medical balloon 10.
  • the axial dimension L 2 of the sub-balloon 11 (the axial length of the working section of the sub-balloon, that is, the axial length of the straight section of the sub-balloon) is based on the size of the medical balloon 10 and the size of the sub-balloon 11 It depends on the number.
  • the form of the recessed portion 12 can have multiple choices.
  • the recessed portion 12 can be a single V-shaped viewed from the axial section of the medical balloon 10 , Trapezoid, square or arc, etc., and each circle of recesses 12 can be a single shape or a combination of multiple shapes.
  • the recesses 12 shown in Figure 5d can be considered as a combination of half trapezoid and half square.
  • the recessed portion 12, here can also be regarded as a right-angled trapezoidal recessed portion 12.
  • the medical balloon 10 includes at least two circles of depressions 12
  • the at least two circles of depressions 12 may adopt the same or different forms.
  • the three circles of depressions 12 shown in FIG. 5e adopt three forms, respectively.
  • the shape of the recess 12 on the axial section of the medical balloon 10 is preferably a trapezoid or a square.
  • 6 is a schematic diagram of the bending of the medical balloon 10 when the shape of the recess 12 is V-shaped.
  • FIG. 7 is a schematic diagram of the bending of the medical balloon 10 when the shape of the recess 12 is a trapezoid.
  • the medical balloon 10 is in the two trapezoids. Stretching at the shoulder line, therefore, compared with the V-shaped recessed portion, the trapezoidal recessed portion 12 has double the stretching point, and the trapezoidal recessed portion 12 has a larger surface area and space than the V-shaped recessed portion.
  • the recessed portion 12 is larger, which is also more favorable for the medical balloon 10 to squeeze into the recessed portion 12.
  • the trapezoidal or square concave portion 12 has a better effect on improving the bending performance of the medical balloon 10.
  • the recess 12 can be processed into a square or trapezoid shape, and the depth H of the recess 12 should be as large as possible.
  • the square or trapezoidal recess 12 is also easier to process.
  • the medical balloon 10 in the embodiment of the present invention is blow-molded by a medical balloon mold with grooves, and the specific method is a well-known technology in the art, so it will not be repeated here.
  • the balloon body of the medical balloon 10 has opposite proximal and distal ends. From the proximal end to the distal end, after the medical balloon 10 is expanded, the radial direction of the balloon body The size can be completely the same, for example, when the medical balloon 10 is used to expand the stent; after the medical balloon 10 is expanded, the radial size of the balloon body can also be different, for example, to match For blood vessels whose diameters gradually decrease from the proximal end to the distal end, after the medical balloon 10 is expanded, the outer diameter of the balloon body is correspondingly tapered from the proximal end to the distal end.
  • the recessed portion 12 spirally surrounds along the axis of the balloon body to form a spiral structure.
  • the recessed portion 12 in this embodiment may be a continuous spiral groove; or, as shown in FIG. 8b, the recessed portion 12 may include multiple sub-recesses 121, such as two sub-recesses.
  • the two sub-recesses 121 have the same rotation direction and are arranged at intervals along the axial direction of the balloon body; or, the recessed portion 12 may include at least two sub-recesses 121, for example, two sub-recesses 121.
  • the rotation directions of the two sub-recesses 121 are opposite and they communicate with each other.
  • the rotation directions of the two adjacent sub-recesses 121 are opposite; of course, The sub-recesses 121 with opposite rotation directions may also be distributed at intervals along the axial direction of the balloon body.
  • the pitch of the spiral recess 12 may be the same value, or may be set in different sections. value.
  • the recessed portion 12 may be a single V-shaped, trapezoidal, square, arc, etc., or a combination of various shapes.
  • the embodiment of the present invention also provides a balloon catheter including the aforementioned medical balloon 10, such as an integral exchange balloon catheter or a quick exchange balloon catheter, the balloon catheter 10 also includes a catheter 30.
  • the catheter 30 is connected to the proximal end of the medical balloon 10.
  • an embodiment of the present invention also provides a medical device including the balloon catheter. 10 and 11 in detail, the medical device further includes a stent 40 crimped on the medical balloon 10, the stent 40 is a tube network structure and has at least two stent rings 41, at least Two stent rings 41 are arranged at intervals along the axial direction, and each stent ring 41 is formed by a plurality of poles 411 arranged in a ring around the axis of the stent 40, and at the same time, two adjacent stent rings 41 are connected by a connecting rod 42; Wherein, the wave rod 411 includes a straight rod section, and a plurality of wave rods 411 are connected to form a stent ring 41, so the stent ring 41 has poor bending performance in the axial direction.
  • the connecting rod 42 can be n-shaped, s-shaped or w-shaped, and has good bending performance in the axial direction.
  • the entire stent 40 is wrapped around the outside of the medical balloon 10. When the medical balloon 10 expands, the medical balloon 10 props up the stent 40 from the inside of the stent 40 to open the stent 40.
  • the positioning positions of the wave rod 411 and the connecting rod 42 relative to the medical balloon 10 are not strictly limited.
  • the medical balloon 10 and the stent 40 are in an expanded state, at least a part of the rod 411 is positioned on the balloon body, so that when the medical balloon 10 is expanded
  • the rod 411 of the stent 40 can be stretched by the balloon body and maintain its support in the radial direction to achieve the purpose of treating diseased blood vessels.
  • the connecting rod 42 can be positioned at the recess 12 or on the balloon body.
  • the optional positioning method of the stent 40 is introduced. It should be understood that the following position descriptions are based on the positional relationship between the medical balloon 10 and the stent 40 in an expanded state.
  • a part of the rod 411 is positioned on the sub-balloon 11 (that is, the balloon body).
  • the sub-balloon 11 that is, the balloon body.
  • Figures 10 and 11 show the first positioning method of the wave rod 411: the two ends of the wave rod 411 are respectively pressed and held on each side.
  • the sub-balloons 11 on both sides of the recessed portion 12 are used to prevent the probe 411 from falling into the recessed portion 12 when the medical balloon 10 is expanded, thereby restricting the full opening of the stent 40.
  • the length of the pole 411 along the axial direction of the medical balloon 10 is generally 2-10 mm, and the length of the pole 411 is greater than the axial maximum dimension L1 of the recess 12 after the expansion of the medical balloon 10
  • the length is at least 1 mm.
  • the length of each end is not less than 0.5 mm.
  • the pole 411 shows a second positioning method of the pole 411: one end of the pole 411 is pressed and held on the sub-balloon 11, the other end is suspended on the recess 12, and the pole 411 is positioned at The length of the sub-balloon 11 is at least half the length of the wave rod 411, and the connecting rod 42 can be positioned at the recess 12 at this time.
  • the medical balloon 10 expands at the bend of the blood vessel 20, the concave portion 12 stretches and bends accordingly.
  • the overall bending of the medical balloon 10 transmits the bending force to the connecting rod 42 and drives the connecting rod. 42 Stretching and bending drive the bracket 40 to bend as a whole
  • the wave rods 411 are all positioned on the sub-balloon 11, and the connecting rod 42 is positioned on The recess 12 is as shown in Figs. 13 and 14.
  • the connecting rod 42 is stretched and bent synchronously with the concave portion 12 of the medical balloon 10, and the wave rod 411 can be stably expanded by the expanded sub-balloon to fully expand the stent To achieve the purpose of supporting the blood vessel wall.
  • the concave portion 12 spirally surrounds the axis of the balloon body to form a spiral structure, as shown in FIG. 8a, because the concave portion 12 of the spiral structure is always not perpendicular to the axis of the balloon body Therefore, the risk of insufficient opening of the stent 40 due to the plunger 411 or the connecting rod 42 of the stent 40 perpendicular to the axis of the balloon body falling into the recess 12 can be reduced.
  • the recessed portion 12 may include a plurality of sub-recesses 121, such as two sub-recesses 121 shown in FIG. 8b. The two sub-recesses 121 have the same rotation direction and are along the axis of the balloon body.
  • the stent 40 is arranged to be spaced apart, so that while reducing the risk of insufficient opening of the stent 40, the contact area between the stent and the balloon at the interval between the two sub-recesses 121 can also be increased, thereby further improving the success rate of opening the stent 40.
  • the medical device provided in this embodiment may include a medical device used for the treatment of stenosis lesions in vascular locations such as intracranial, coronary or peripheral blood vessels, may also include a medical device used for the treatment of aneurysm lesions, and may also include other tubes used for the biliary tract. Medical device for the treatment of cavitary lesions.
  • the depression 12 is formed on the outer surface of the balloon body, so that the medical balloon 10 has better bending performance, thereby improving the effect of the medical balloon 10 on the blood vessel 20.
  • the compliance of the medical balloon 10 prevents excessive tearing of the blood vessel 20 during the expansion process of the medical balloon 10 to cause blood vessel damage.
  • the shapes and sizes of these recesses 12 may be the same or different.
  • the axial cross-sectional shape may be the same or different.
  • the concave portion 12 is formed by a continuous annular groove
  • the axial cross-sectional shape of the annular groove may be a combination of different shapes, or a single shape.
  • the recess 12 is formed by a plurality of sub-recesses 121 arranged at intervals
  • the shape of each sub-recess 121 may be the same or different.

Abstract

Provided are a medical balloon (10), a balloon catheter and a medical device (30). The medical balloon (10) comprises a balloon body and recesses (12) formed in an outer surface of the balloon body. The advantage thereof lies in that by means of the recesses (12), the bending performance of the medical balloon (10) is improved, and the adaptability of the medical balloon (10) to a blood vessel (20) is improved, thereby reducing the tearing of the blood vessel (20) when the medical balloon (10) is delivered into a bent portion of the blood vessel (20), so as to prevent the blood vessel (20) from being damaged.

Description

一种医用球囊、球囊导管及医疗装置Medical balloon, balloon catheter and medical device 技术领域Technical field
本发明涉及医疗器械技术领域,具体涉及一种医用球囊、球囊导管及医疗装置。The present invention relates to the technical field of medical equipment, in particular to a medical balloon, a balloon catheter and a medical device.
背景技术Background technique
随着医疗科技的快速发展,介入治疗已经成为与内科、外科并列的支柱性学科,而球囊扩张作为介入治疗领域中一项重要的技术,被广泛应用于冠心病、脑血栓、动脉瘤病变等疾病的治疗中。医用球囊需要具备较好的支撑性能,以实现对于病变血管的治疗。With the rapid development of medical technology, interventional therapy has become a pillar subject alongside internal medicine and surgery. Balloon dilatation is an important technology in the field of interventional therapy and is widely used in coronary heart disease, cerebral thrombosis, and aneurysm lesions. And other diseases are being treated. Medical balloons need to have better support performance to achieve the treatment of diseased blood vessels.
传统的医用球囊为圆柱体结构,其弯曲性能不佳,因而在通过弯曲血管到达病变位置的过程中医用球囊对血管的顺应能力较差,推送阻力大。图1示出了一种发生病变的血管1,病变位置处的血管1的曲率半径r值为α。如图2所示,将一直线型的医用球囊2通过导管3送入所述血管1中,当医用球囊2到达病变位置时,医用球囊2扩张,但其无法适应血管1自身的形状,因此医用球囊2将血管1撑开,使得血管1的曲率半径r值增大至β,进而在图2中的A区域和B区域对血管1造成过度撕扯而导致血管1撕裂或痉挛。同时,在B区域的应力较为集中,容易造成医用球囊2与导管3的连接点打折。The traditional medical balloon has a cylindrical structure, and its bending performance is not good. Therefore, the medical balloon has poor compliance with the blood vessel during the process of reaching the diseased position through the curved blood vessel, and the pushing resistance is large. Fig. 1 shows a blood vessel 1 with a disease. The radius of curvature r of the blood vessel 1 at the location of the disease is α. As shown in Figure 2, the linear medical balloon 2 is fed into the blood vessel 1 through the catheter 3. When the medical balloon 2 reaches the lesion position, the medical balloon 2 expands, but it cannot adapt to the blood vessel 1 itself. Shape, so the medical balloon 2 stretches the blood vessel 1 so that the radius of curvature r of the blood vessel 1 increases to β, which in turn causes excessive tearing of the blood vessel 1 in the areas A and B in Fig. 2, causing the blood vessel 1 to tear or tear Spasms. At the same time, the stress in the B area is relatively concentrated, which easily causes the connection point of the medical balloon 2 and the catheter 3 to be discounted.
因此,需要设计一种医用球囊,具备一定的支撑强度以对管腔病变起到治疗作用的同时,还能够具备较好的顺应性和过弯能力,以避免对血管的损伤并提升医疗装置的治疗效果。Therefore, it is necessary to design a medical balloon that has a certain support strength to treat luminal lesions, but also has better compliance and bending ability to avoid damage to blood vessels and improve medical devices The therapeutic effect.
发明内容Summary of the invention
本发明的目的在于提供一种医用球囊、球囊导管及医疗装置,本发明所述的医用球囊具有良好的弯曲性能,可以很好地适应血管的形状,避免对血管造成过度撕扯。The purpose of the present invention is to provide a medical balloon, a balloon catheter and a medical device. The medical balloon of the present invention has good bending performance, can adapt well to the shape of blood vessels, and avoid excessive tearing of blood vessels.
为实现上述目的,本发明提供的一种医用球囊,包括球囊本体以及形成 于所述球囊本体之外表面的凹陷部。In order to achieve the above objective, the present invention provides a medical balloon, which includes a balloon body and a recess formed on the outer surface of the balloon body.
可选地,所述凹陷部沿所述球囊本体的周向延伸。Optionally, the recessed portion extends along the circumferential direction of the balloon body.
可选地,所述凹陷部为连续的环形凹槽,或者所述凹陷部包括至少两个沿所述球囊本体的周向间隔设置的子凹陷部。Optionally, the recessed portion is a continuous annular groove, or the recessed portion includes at least two sub-recessed portions spaced apart along the circumference of the balloon body.
可选地,所述球囊本体的外表面上形成有两个以上所述凹陷部,每个所述凹陷部沿所述球囊本体的周向延伸,两个以上的所述凹陷部沿所述球囊本体的轴向依次布置。Optionally, more than two recesses are formed on the outer surface of the balloon body, each of the recesses extends along the circumferential direction of the balloon body, and the two or more recesses are along the The balloon bodies are arranged sequentially in the axial direction.
可选地,所述凹陷部呈螺旋结构,并沿所述球囊本体的轴线螺旋环绕。Optionally, the concave portion has a spiral structure and spirally surrounds along the axis of the balloon body.
可选地,所述凹陷部包括至少两个呈螺旋结构的子凹陷部,至少两个所述子凹陷部沿所述球囊本体的轴向依次排布并相互连接,且相互连接的两个子凹陷部的旋向相反。Optionally, the recess includes at least two sub-recesses in a spiral structure, at least two of the sub-recesses are arranged in sequence along the axial direction of the balloon body and connected to each other, and the two connected sub-recesses The direction of rotation of the depression is opposite.
可选地,所述凹陷部包括至少两个呈螺旋结构的子凹陷部,至少两个所述子凹陷部沿所述球囊本体的轴向间隔分布Optionally, the recess includes at least two sub-recesses in a spiral structure, and at least two of the sub-recesses are spaced apart along the axial direction of the balloon body
可选地,在所述医用球囊的轴向截面上,所述凹陷部的形状为弧形、方形、梯形或V形中的至少一种。Optionally, on the axial section of the medical balloon, the shape of the recessed portion is at least one of an arc, a square, a trapezoid, or a V-shape.
可选地,当所述医用球囊处于扩张状态时,所述球囊本体的外径从近端到远端渐缩。Optionally, when the medical balloon is in an expanded state, the outer diameter of the balloon body is tapered from the proximal end to the distal end.
此外,为实现上述目的,本发明提供了一种球囊导管,包括如前所述的医用球囊和与所述医用球囊的近端连接的导管。In addition, in order to achieve the above object, the present invention provides a balloon catheter, which includes the medical balloon as described above and a catheter connected to the proximal end of the medical balloon.
另外,为实现上述目的,本发明提供了一种医疗装置,包括如前所述的球囊导管和压握在所述球囊导管的医用球囊上的支架。In addition, in order to achieve the above-mentioned object, the present invention provides a medical device, which includes the aforementioned balloon catheter and a stent crimped on the medical balloon of the balloon catheter.
可选地,所述支架呈管网状结构并包括沿所述支架的轴向相互连接的波杆和连接杆;Optionally, the stent has a pipe network structure and includes a pole and a connecting rod connected to each other along the axial direction of the stent;
其中,当所述支架和所述医用球囊处于扩张状态时,至少部分所述波杆被定位于所述医用球囊的球囊本体上。Wherein, when the stent and the medical balloon are in an expanded state, at least a part of the probe is positioned on the balloon body of the medical balloon.
可选地,当所述支架和所述医用球囊处于扩张状态时,所述连接杆被定位于所述医用球囊的凹陷部处。Optionally, when the stent and the medical balloon are in an expanded state, the connecting rod is positioned at a recess of the medical balloon.
可选地,所述波杆的两端分别定位于所述凹陷部两侧的所述球囊本体上, 定位于所述球囊本体上的所述波杆的两端部分的长度均不小于0.5mm。Optionally, both ends of the wave rod are respectively positioned on the balloon body on both sides of the recessed portion, and the length of the two ends of the wave rod positioned on the balloon body is not less than 0.5mm.
可选地,定位于所述球囊本体上的所述波杆的两端部分的长度相等。Optionally, the lengths of the two end portions of the probes positioned on the balloon body are equal.
可选地,所述波杆的一端定位于所述凹陷部一侧的所述球囊本体上,另一端定位于所述凹陷部处,且所述波杆的定位于所述球囊本体上的长度不小于所述波杆的全长的1/2。Optionally, one end of the wave rod is positioned on the balloon body on one side of the recessed portion, the other end is positioned at the recessed portion, and the wave rod is positioned on the balloon body The length of is not less than 1/2 of the full length of the pole.
可选地,全部所述波杆被定位于所述球囊本体上。Optionally, all the wave rods are positioned on the balloon body.
与现有技术相比,本发明的医用球囊、球囊导管及医疗装置具有如下优点:Compared with the prior art, the medical balloon, balloon catheter and medical device of the present invention have the following advantages:
本发明的医用球囊包括球囊本体以及形成于所述球囊本体之外表面的凹陷部,通过所述凹陷部改善医用球囊的弯曲性能,进而提高其过弯能力以更好地适应血管的形状,减少因对血管的过度撕扯而造成的血管损伤。The medical balloon of the present invention includes a balloon body and a concave portion formed on the outer surface of the balloon body. The concave portion improves the bending performance of the medical balloon, thereby improving its bending ability to better adapt to blood vessels Its shape reduces the damage of blood vessels caused by excessive tearing of blood vessels.
附图说明Description of the drawings
图1是病变血管的结构示意图;Figure 1 is a schematic diagram of the structure of a diseased blood vessel;
图2是现有技术中的圆柱体医用球囊被送入病变血管的示意图;2 is a schematic diagram of a cylindrical medical balloon in the prior art being delivered into a diseased blood vessel;
图3a和图3b是本发明根据一实施例所提供的医用球囊的结构示意图,其中图3a所示凹陷部包括多个沿球囊本体周向间隔设置的子凹陷部,图3b所示的凹陷部为连续的环形凹槽;Figures 3a and 3b are structural schematic diagrams of a medical balloon provided according to an embodiment of the present invention. The recessed portion shown in Figure 3a includes a plurality of sub-recessed portions spaced along the circumference of the balloon body, as shown in Figure 3b. The depression is a continuous annular groove;
图4是图3b所示医用球囊被送入病变血管时的示意图;Figure 4 is a schematic diagram of the medical balloon shown in Figure 3b when it is delivered into a diseased blood vessel;
图5a-图5e分别是图3b所示医用球囊的各种变形结构示意图;5a to 5e are schematic diagrams of various deformed structures of the medical balloon shown in FIG. 3b;
图6是图3b所示医用球囊的弯曲原理示意图,图中仅示出一圈凹陷部;Fig. 6 is a schematic diagram of the bending principle of the medical balloon shown in Fig. 3b, in which only a circle of recesses is shown;
图7是图5c所示医用球囊的弯曲原理示意图;Fig. 7 is a schematic diagram of the bending principle of the medical balloon shown in Fig. 5c;
图8a和图8b是本发明根据另一实施例提供的医用球囊的结构示意图,其中图8a所示的医用球囊的球囊本体上形成有一个呈螺旋结构的凹陷部,图8b所示的医用球囊的球囊本体上形成有两个呈螺旋结构的子凹陷部,且两个子凹陷部的旋向相同;8a and 8b are structural schematic diagrams of a medical balloon provided according to another embodiment of the present invention, wherein the balloon body of the medical balloon shown in FIG. 8a is formed with a spiral structure recessed portion, as shown in FIG. 8b Two sub-recesses in a spiral structure are formed on the balloon body of the medical balloon of, and the rotation directions of the two sub-recesses are the same;
图9是本发明根据一实施例提供的医疗装置的结构示意图;Fig. 9 is a schematic structural diagram of a medical device provided according to an embodiment of the present invention;
图10是本发明根据一实施例提供的医疗装置中支架与医用球囊的位置关 系示意图;10 is a schematic diagram of the positional relationship between the stent and the medical balloon in the medical device according to an embodiment of the present invention;
图11为图10中的C处放大示意图;Fig. 11 is an enlarged schematic diagram of C in Fig. 10;
图12是图10中医疗设备的支架的另一种定位方式示意图;Fig. 12 is a schematic diagram of another positioning method of the stent of the medical device in Fig. 10;
图13是本发明根据另一实施例提供的医疗装置中支架与医用球囊的位置关系示意图;13 is a schematic diagram of the positional relationship between the stent and the medical balloon in the medical device according to another embodiment of the present invention;
图14是图13中D处的放大示意图。Fig. 14 is an enlarged schematic view of D in Fig. 13.
图中:In the figure:
10、2-医用球囊;10. 2-Medical balloon;
11-子球囊,12-凹陷部;121-子凹陷部;11-sub-balloon, 12-depression; 121-sub-depression;
20,1-血管;20,1-vascular;
30,3-导管;30,3-catheter;
40-支架;40-bracket;
41-支架环;41-Stent ring;
411-波杆;411-pole;
42-连接杆;42-Connecting rod;
r-血管的曲率半径;r- the radius of curvature of the blood vessel;
L 1-凹陷部的轴向最大长度;L 2-子球囊的轴向长度;H-凹陷部的深度。 L 1 -the axial maximum length of the recess; L 2 -the axial length of the sub-balloon; H-the depth of the recess.
具体实施方式Detailed ways
为使本发明的目的、优点和特征更加清楚,以下结合附图对本发明提出的医用球囊、球囊导管和医疗装置作进一步详细说明。需要说明的是,附图均采用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。In order to make the purpose, advantages and features of the present invention clearer, the medical balloon, balloon catheter and medical device proposed by the present invention will be described in further detail below in conjunction with the accompanying drawings. It should be noted that the drawings all adopt imprecise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.
如在本说明书和所附权利要求中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,复数对象“多个”指两个或两个以上,除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外,以及术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接。可以是机械连接,也可以是电连接。可以 是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural items, and the plural items "plurality" refer to two or more, unless the content clearly indicates otherwise outer. As used in this specification and the appended claims, the term "or" is generally used to include the meaning of "and/or", unless the content clearly indicates otherwise, as well as the terms "installed" and "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 internal communication between two elements or the interaction between two elements. For those of ordinary skill in the art, the specific meaning of the above-mentioned terms in the present invention can be understood according to specific circumstances. The same or similar reference signs in the drawings represent the same or similar components.
在本文中,术语“近端”、“远端”是从使用该医用球囊的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向,尽管“近端”、“远端”并非是限制性的,但是“近端”通常指该医用球囊在正常操作过程中靠近医生的一端,而“远端”通常是指首先进入患者体内血管的一端。此外,本文中所有涉及的尺寸描述均是指医用球囊处于扩张状态时的尺寸,除非内容另外明确指出外。本文中所出现的术语“周向”是指围绕医用球囊的轴线且与医用球囊的轴线成直角、锐角或钝角的方向,即在任一不平行于医用球囊的轴线的平面上,除非内容另外明确指出外。In this article, the terms "proximal" and "distal" refer to the relative position, relative position, and direction of elements or actions relative to each other from the perspective of the doctor using the medical balloon, although the "proximal" and "distal" The "end" is not restrictive, but the "proximal" usually refers to the end of the medical balloon that is close to the doctor during normal operation, and the "distal" usually refers to the end that first enters the blood vessel in the patient's body. In addition, all size descriptions in this article refer to the size of the medical balloon when it is in an expanded state, unless the content clearly indicates otherwise. The term "circumferential" as used herein refers to the direction surrounding the axis of the medical balloon and at right angles, acute angles or obtuse angles to the axis of the medical balloon, that is, on any plane that is not parallel to the axis of the medical balloon, unless The content is clearly stated separately.
本发明的核心思想在于提供一种医用球囊,该医用球囊包括球囊本体和形成于所述球囊本体的外表面上的凹陷部。通过所述凹陷部改善医用球囊的弯曲性能,进而在不影响球囊的支撑性能的同时提高其过弯能力以更好地适应血管的形状,减少因对血管的过度撕扯而造成的血管损伤。The core idea of the present invention is to provide a medical balloon. The medical balloon includes a balloon body and a recess formed on the outer surface of the balloon body. The concave portion improves the bending performance of the medical balloon, thereby improving the bending ability of the balloon without affecting the supporting performance of the balloon to better adapt to the shape of the blood vessel, and reducing the damage of the blood vessel caused by excessive tearing of the blood vessel .
以下结合附图进行描述。The description is given below with reference to the drawings.
请参阅图3a和图3b,在一个实施例中,所述医用球囊10的球囊本体包括至少两个相互连接的子球囊11(图中示例为五个子球囊11),这些子球囊11较佳地一体成型,并且在相邻两个所述子球囊11的连接位置形成有至少一圈凹陷部12(图中示例为四圈凹陷部),至少一圈所述凹陷部12沿球囊本体的周向延伸,即凹陷部12的延伸方向与球囊本体的轴向成直角、锐角或钝角。在其他实施例中,所述凹陷部12也可以是小于360°的非一整圈的形式,例如所述凹陷部12可以是占周向一圈的一半或者四分之三等。Referring to Figures 3a and 3b, in one embodiment, the balloon body of the medical balloon 10 includes at least two interconnected sub-balloons 11 (five sub-balloons 11 are illustrated in the figure). The balloon 11 is preferably integrally formed, and at least one circle of recesses 12 is formed at the connection position of the two adjacent sub-balloons 11 (four circles of recesses are illustrated in the figure), and at least one circle of the recesses 12 is formed. It extends along the circumferential direction of the balloon body, that is, the extending direction of the recess 12 is at a right angle, an acute angle or an obtuse angle with the axial direction of the balloon body. In other embodiments, the concave portion 12 may also be in the form of a non-full circle of less than 360°. For example, the concave portion 12 may occupy half or three-quarters of a circumferential circle.
以下描述中,假定凹陷部12为一圈来进一步说明本发明的医用球囊,但本领域技术人员应当能够修改以下描述,将其应用于凹陷部12不是一圈的情况。In the following description, it is assumed that the recess 12 is a circle to further illustrate the medical balloon of the present invention, but those skilled in the art should be able to modify the following description to apply it to the case where the recess 12 is not a circle.
一般而言,所述医用球囊10采用聚酰胺纤维(nylon)、嵌段聚醚酰胺弹 性体(PEBAX)、热塑性聚氨酯弹性体(TPU)等之类的弹性高分子材料制成,而在相邻两个子球囊11的连接位置处形成凹陷部12,使得所述医用球囊10形成多节段结构,一方面减小医用球囊10在连接处的外径,从而减小医用球囊压握状态下的外径,提高输送时的顺应性和到达远端血管的能力;另一方面增加了医用球囊10的拉伸位点,从而增加医用球囊10的拉伸范围,改善医用球囊10自身的弯曲性能,提高其过弯能力。Generally speaking, the medical balloon 10 is made of elastic polymer materials such as polyamide fiber (nylon), block polyetheramide elastomer (PEBAX), thermoplastic polyurethane elastomer (TPU), etc. A recess 12 is formed adjacent to the connection position of the two sub-balloons 11, so that the medical balloon 10 forms a multi-segment structure. On the one hand, the outer diameter of the medical balloon 10 at the connection point is reduced, thereby reducing the pressure of the medical balloon. The outer diameter in the grip state improves the compliance during delivery and the ability to reach the distal blood vessel; on the other hand, the stretching site of the medical balloon 10 is increased, thereby increasing the stretching range of the medical balloon 10 and improving the medical balloon The bending performance of the capsule 10 improves its bending ability.
如图3a所示,一圈所述凹陷部12可包括至少两个子凹陷部121,至少两个子凹陷部121在相邻两个子球囊11的连接处沿周向间隔地布置。这里,至少两个子凹陷部121可以沿与医用球囊10的轴线垂直的平面上的圆周布置而形成圆形的排布,也可以沿与医用球囊10的轴线不垂直且不平行的平面上的圆周布置而形成椭圆形的排布。如此,医用球囊10在设置有凹陷部12的位置处弯曲能力增强,从而改善医用球囊10在凹陷部12所处方位上的过弯能力。本实施例对设置于医用球囊10上的凹陷部12的形状和数量并不做限定,只要其能够达到改善医用球囊10弯曲性能的目的即可。As shown in FIG. 3 a, a circle of the recesses 12 may include at least two sub-recesses 121, and the at least two sub-recesses 121 are arranged at a circumferential interval at the junction of two adjacent sub-balloons 11. Here, the at least two sub-recesses 121 may be arranged along a circumference on a plane perpendicular to the axis of the medical balloon 10 to form a circular arrangement, or on a plane that is not perpendicular and parallel to the axis of the medical balloon 10 The circle is arranged to form an elliptical arrangement. In this way, the bending ability of the medical balloon 10 at the position where the concave portion 12 is provided is enhanced, thereby improving the bending ability of the medical balloon 10 at the position prescribed by the concave portion 12. In this embodiment, the shape and number of the recesses 12 provided on the medical balloon 10 are not limited, as long as they can achieve the purpose of improving the bending performance of the medical balloon 10.
如图3b所示,一圈所述凹陷部12也可为连续的环形凹槽,该连续的环形凹槽既可以与医用球囊10的轴线垂直(即,该连续的环形凹槽所在的平面与医用球囊10的轴线垂直),也可以与该轴线不垂直(即,该连续的环形凹槽所在的平面与医用球囊10的轴线不垂直且不平行)。如此,所述医用球囊10在整个周向上的弯曲性能均得到改善,使得医用球囊10可以在任意方向上获得较好的过弯性能,从而在使用时无需针对血管20的弯曲方向而设定医用球囊10输送方位,减小了医护人员使用该医用球囊10时的操作难度。As shown in FIG. 3b, a circle of the concave portion 12 can also be a continuous annular groove, and the continuous annular groove can be perpendicular to the axis of the medical balloon 10 (that is, the plane where the continuous annular groove is located). It is perpendicular to the axis of the medical balloon 10), or not perpendicular to the axis (that is, the plane where the continuous annular groove is located is not perpendicular and not parallel to the axis of the medical balloon 10). In this way, the bending performance of the medical balloon 10 in the entire circumferential direction is improved, so that the medical balloon 10 can obtain better bending performance in any direction, so that it is not necessary to set the bending direction of the blood vessel 20 during use. The delivery position of the medical balloon 10 is determined, which reduces the operational difficulty of medical staff when using the medical balloon 10.
在本发明较佳实施例中,在球囊本体的外表面上形成有至少两圈凹陷部12,从而将医用球囊10沿轴向分隔成更多个所述子球囊11(即节段),使得医用球囊10在多个区域具有较好的弯曲性能,并能够同时顺应相邻血管段在不同方向上的或不同弧度的弯曲。In a preferred embodiment of the present invention, at least two circles of recesses 12 are formed on the outer surface of the balloon body, so that the medical balloon 10 is axially divided into more of the sub-balloons 11 (ie, segments). ), so that the medical balloon 10 has better bending performance in multiple regions, and can simultaneously comply with the bending of adjacent blood vessel segments in different directions or different arcs.
请继续参阅图4,并结合图3b,所述医用球囊10的近端与一导管30连接,并通过所述导管30送入血管20后扩张,血管20被撑开且其曲率半径r被增大至γ。因医用球囊10具有较好的弯曲性能,其对血管20形状的适应 性得以改善,故此时血管20的曲率半径值γ小于采用圆柱体的医用球囊时血管20被撑开后的曲率半径值β,进而降低血管20被过度撕扯而出现撕裂或痉挛的可能性。与此同时,医用球囊10弯曲时产生的作用力被传递至医用球囊10与导管30的连接点处,因医用球囊10对血管20具有良好的适应性,降低了所述连接点附近的应力集中,从而避免了医用球囊10与导管30的连接点打折。Please continue to refer to FIG. 4 and in conjunction with FIG. 3b, the proximal end of the medical balloon 10 is connected to a catheter 30, and is sent into the blood vessel 20 through the catheter 30 and then expanded. The blood vessel 20 is stretched and its radius of curvature r is Increase to γ. Because the medical balloon 10 has better bending performance and its adaptability to the shape of the blood vessel 20 is improved, the radius of curvature γ of the blood vessel 20 at this time is smaller than the radius of curvature of the blood vessel 20 when a cylindrical medical balloon is used. Value β, thereby reducing the possibility of the blood vessel 20 being torn or spasm being excessively torn. At the same time, the force generated when the medical balloon 10 is bent is transmitted to the connection point between the medical balloon 10 and the catheter 30. Because the medical balloon 10 has good adaptability to the blood vessel 20, the vicinity of the connection point is reduced. The stress is concentrated, thereby avoiding the connection point of the medical balloon 10 and the catheter 30 from being discounted.
如图3b所示,所述凹陷部12的尺寸依据实际情况进行选择,例如,每一圈凹陷部12沿医用球囊10轴向上的最大尺寸L 1(凹陷部12的轴向最大长度L 1)一般不大于3mm,凹陷部12沿医用球囊10径向上的尺寸H(凹陷部12的深度H)的最小值可为0.1mm、最大值不大于医用球囊10径向尺寸的一半。所述子球囊11的轴向尺寸L 2(子球囊的工作段的轴向长度,即子球囊的平直段的轴向长度)根据医用球囊10的尺寸及子球囊11的个数而定。 As shown in Figure 3b, the size of the recessed portion 12 is selected according to actual conditions. For example, the maximum dimension L 1 of each circle of recessed portion 12 along the axial direction of the medical balloon 10 (the maximum axial length L of the recessed portion 12 1 ) Generally, it is not greater than 3 mm. The minimum value of the dimension H (the depth H of the recess 12) of the recess 12 in the radial direction of the medical balloon 10 can be 0.1 mm, and the maximum value can be no more than half of the radial dimension of the medical balloon 10. The axial dimension L 2 of the sub-balloon 11 (the axial length of the working section of the sub-balloon, that is, the axial length of the straight section of the sub-balloon) is based on the size of the medical balloon 10 and the size of the sub-balloon 11 It depends on the number.
进一步地,所述凹陷部12的形式可以有多种选择,例如,如图5a至图5e所示,从医用球囊10的轴向切面上看,所述凹陷部12可为单一的V形、梯形、方形或弧形等,并且每一圈凹陷部12可以是单一的形状,也可以是多种形状的组合,例如图5d所示的凹陷部12可以认为是一半梯形与一半方形组合形成的凹陷部12,此处,也可以认为是直角梯形的凹陷部12。当医用球囊10包含至少两圈凹陷部12时,所述至少两圈凹陷部12可以采用相同或不同的形式,例如图5e所示的三圈凹陷部12分别采用了三种形式。Further, the form of the recessed portion 12 can have multiple choices. For example, as shown in FIGS. 5a to 5e, the recessed portion 12 can be a single V-shaped viewed from the axial section of the medical balloon 10 , Trapezoid, square or arc, etc., and each circle of recesses 12 can be a single shape or a combination of multiple shapes. For example, the recesses 12 shown in Figure 5d can be considered as a combination of half trapezoid and half square. The recessed portion 12, here, can also be regarded as a right-angled trapezoidal recessed portion 12. When the medical balloon 10 includes at least two circles of depressions 12, the at least two circles of depressions 12 may adopt the same or different forms. For example, the three circles of depressions 12 shown in FIG. 5e adopt three forms, respectively.
对于同一形状的凹陷部12,当凹陷部12的轴向最大长度L 1为一确定值时,凹陷部12的深度H越大,医用球囊10扩张时,凹陷部12的内部空间就越大,从而更有利于医用球囊10的拉伸弯曲。而当所述凹陷部12的深度H为一确定值时,所述凹陷部12在医用球囊10的轴向切面上的形状优选为梯形或方形。图6所示为所述凹陷部12的形状为V形时医用球囊10的弯曲示意图,所述医用球囊10沿箭头所示方向弯曲时,医用球囊10在V形的脊线处拉伸;图7所示为所述凹陷部12的形状为梯形时所述医用球囊10弯曲的示意图,所述医用球囊10沿箭头所示方向弯曲时,医用球囊10在梯形的两个肩线处拉伸,由此,梯形的凹陷部12相较于V形的凹陷部而言,其拉伸位 点增加了一倍,并且,梯形的凹陷部12的表面积和空间较V形的凹陷部12更大,也更有利于医用球囊10向凹陷部12的内部挤压。同理,当所述凹陷部12的形状为方形时,其效果与梯形凹陷部12的效果相当。因而凹陷部12的深度相同时,梯形或方形的凹陷部12对医用球囊10的弯曲性能改善效果更好。 For the concave portion 12 of the same shape, when the axial maximum length L 1 of the concave portion 12 is a certain value, the greater the depth H of the concave portion 12, the larger the internal space of the concave portion 12 will be when the medical balloon 10 is expanded , Which is more conducive to the stretching and bending of the medical balloon 10. When the depth H of the recess 12 is a certain value, the shape of the recess 12 on the axial section of the medical balloon 10 is preferably a trapezoid or a square. 6 is a schematic diagram of the bending of the medical balloon 10 when the shape of the recess 12 is V-shaped. When the medical balloon 10 is bent in the direction indicated by the arrow, the medical balloon 10 is pulled at the ridgeline of the V-shape. 7 is a schematic diagram of the bending of the medical balloon 10 when the shape of the recess 12 is a trapezoid. When the medical balloon 10 is bent in the direction shown by the arrow, the medical balloon 10 is in the two trapezoids. Stretching at the shoulder line, therefore, compared with the V-shaped recessed portion, the trapezoidal recessed portion 12 has double the stretching point, and the trapezoidal recessed portion 12 has a larger surface area and space than the V-shaped recessed portion. The recessed portion 12 is larger, which is also more favorable for the medical balloon 10 to squeeze into the recessed portion 12. Similarly, when the shape of the recess 12 is square, the effect is equivalent to that of the trapezoidal recess 12. Therefore, when the depth of the concave portion 12 is the same, the trapezoidal or square concave portion 12 has a better effect on improving the bending performance of the medical balloon 10.
由此,实践中所述凹陷部12可加工成方形或梯形,并且凹陷部12的深度H应尽可能的大。此外,从医用球囊10的加工角度上来说,方形或梯形的凹陷部12也更易于加工。本发明实施例中的医用球囊10采用带有凹槽的医用球囊模具吹塑成型,其具体方法为本领域的公知技术,因而此处不再一一赘述。Therefore, in practice, the recess 12 can be processed into a square or trapezoid shape, and the depth H of the recess 12 should be as large as possible. In addition, from the perspective of processing the medical balloon 10, the square or trapezoidal recess 12 is also easier to process. The medical balloon 10 in the embodiment of the present invention is blow-molded by a medical balloon mold with grooves, and the specific method is a well-known technology in the art, so it will not be repeated here.
进一步地,所述医用球囊10的球囊本体具有相对的近端和远端,从所述近端到所述远端,所述医用球囊10扩张后,所述球囊本体的径向尺寸可以是完全一致的,例如利用所述医用球囊10扩张支架时即是如此;所述医用球囊10扩张后,所述球囊本体的径向尺寸也可以是不同的,例如,为了匹配从近端到远端直径逐渐减小的血管,所述医用球囊10扩张后,所述球囊本体的外径也相应地从近端到远端渐缩。Further, the balloon body of the medical balloon 10 has opposite proximal and distal ends. From the proximal end to the distal end, after the medical balloon 10 is expanded, the radial direction of the balloon body The size can be completely the same, for example, when the medical balloon 10 is used to expand the stent; after the medical balloon 10 is expanded, the radial size of the balloon body can also be different, for example, to match For blood vessels whose diameters gradually decrease from the proximal end to the distal end, after the medical balloon 10 is expanded, the outer diameter of the balloon body is correspondingly tapered from the proximal end to the distal end.
请参阅图8a和图8b,在另一个实施例中,所述凹陷部12沿所述球囊本体的轴线螺旋环绕形成螺旋结构。如图8a所示,本实施例所述的凹陷部12可以是一连续的螺旋状凹槽;或者,如图8b所示,所述凹陷部12可包括多个子凹陷部121,例如两个子凹陷部121,两个所述子凹陷部121的旋向相同并沿所述球囊本体的轴向间隔布置;又或者,所述凹陷部12可包括至少两个子凹陷部121,例如两个子凹陷部121,两个所述子凹陷部121的旋向相反且两者相互连通,若所述子凹陷部121的数量多于三个,则相邻的两个子凹陷部121的旋向相反;当然,旋向相反的子凹陷部121也可以沿球囊本体的轴向间隔分布。Please refer to Figs. 8a and 8b. In another embodiment, the recessed portion 12 spirally surrounds along the axis of the balloon body to form a spiral structure. As shown in FIG. 8a, the recessed portion 12 in this embodiment may be a continuous spiral groove; or, as shown in FIG. 8b, the recessed portion 12 may include multiple sub-recesses 121, such as two sub-recesses. The two sub-recesses 121 have the same rotation direction and are arranged at intervals along the axial direction of the balloon body; or, the recessed portion 12 may include at least two sub-recesses 121, for example, two sub-recesses 121. The rotation directions of the two sub-recesses 121 are opposite and they communicate with each other. If the number of the sub-recesses 121 is more than three, the rotation directions of the two adjacent sub-recesses 121 are opposite; of course, The sub-recesses 121 with opposite rotation directions may also be distributed at intervals along the axial direction of the balloon body.
另外,本实施例中对于螺旋状的凹陷部12的螺距并没有严格限制,沿所述球囊本体的轴向,所述凹陷部12的螺距可以是同一值,也可以是分段设置的不同值。In addition, there is no strict limitation on the pitch of the spiral recess 12 in this embodiment. Along the axial direction of the balloon body, the pitch of the recess 12 may be the same value, or may be set in different sections. value.
此外,在本实施例中,从医用球囊10的轴向切面上看,所述凹陷部12可为单一的V形、梯形、方形或弧形等,也可以是各种形状的组合。In addition, in this embodiment, viewed from the axial section of the medical balloon 10, the recessed portion 12 may be a single V-shaped, trapezoidal, square, arc, etc., or a combination of various shapes.
请参考图4,本发明实施例还提供了一种包括前述医用球囊10的球囊导管,例如是整体交换式球囊导管或快速交换式球囊导管,所述球囊导管10还包括导管30,所述导管30与所述医用球囊10的近端连接。4, the embodiment of the present invention also provides a balloon catheter including the aforementioned medical balloon 10, such as an integral exchange balloon catheter or a quick exchange balloon catheter, the balloon catheter 10 also includes a catheter 30. The catheter 30 is connected to the proximal end of the medical balloon 10.
进一步地,如图9所示,本发明实施例还提供了一种包括所述球囊导管的医疗装置。详细地,请参阅图10及图11,所述医疗装置还包括压握于所述医用球囊10上的支架40,所述支架40呈管网状结构并具有至少两个支架环41,至少两个支架环41沿轴向间隔布置,且每个支架环41由若干个波杆411围绕支架40的轴线布置成环形而形成,同时相邻两个支架环41之间通过连接杆42连接;其中,所述波杆411包括直杆段,若干个波杆411连接形成支架环41,由此支架环41在轴向上的弯曲性能不佳。而所述连接杆42可呈n形、s形或w形,并在轴向上具有较好的弯曲性能。整个支架40包裹于所述医用球囊10的外部,当所述医用球囊10扩张时,医用球囊10从所述支架40的内部将支架40撑起而使支架40打开。Further, as shown in FIG. 9, an embodiment of the present invention also provides a medical device including the balloon catheter. 10 and 11 in detail, the medical device further includes a stent 40 crimped on the medical balloon 10, the stent 40 is a tube network structure and has at least two stent rings 41, at least Two stent rings 41 are arranged at intervals along the axial direction, and each stent ring 41 is formed by a plurality of poles 411 arranged in a ring around the axis of the stent 40, and at the same time, two adjacent stent rings 41 are connected by a connecting rod 42; Wherein, the wave rod 411 includes a straight rod section, and a plurality of wave rods 411 are connected to form a stent ring 41, so the stent ring 41 has poor bending performance in the axial direction. The connecting rod 42 can be n-shaped, s-shaped or w-shaped, and has good bending performance in the axial direction. The entire stent 40 is wrapped around the outside of the medical balloon 10. When the medical balloon 10 expands, the medical balloon 10 props up the stent 40 from the inside of the stent 40 to open the stent 40.
实际应用中,所述波杆411和所述连接杆42相对于所述医用球囊10的设置位置并没有严格的限制。较佳的,当所述医用球囊10和所述支架40处于扩张状态时,所述波杆411的至少一部分被定位在所述球囊本体上,如此,在所述医用球囊10扩张时,所述支架40的波杆411可以被所述球囊本体撑开并保持其在径向上的支撑,以达到对病变血管的治疗目的。而根据所述支架环41的数量以及波杆411的具体定位方式,所述连接杆42既可以定位于所述凹陷部12处,也可以定位于所述球囊本体上。In practical applications, the positioning positions of the wave rod 411 and the connecting rod 42 relative to the medical balloon 10 are not strictly limited. Preferably, when the medical balloon 10 and the stent 40 are in an expanded state, at least a part of the rod 411 is positioned on the balloon body, so that when the medical balloon 10 is expanded The rod 411 of the stent 40 can be stretched by the balloon body and maintain its support in the radial direction to achieve the purpose of treating diseased blood vessels. According to the number of the stent rings 41 and the specific positioning method of the pole 411, the connecting rod 42 can be positioned at the recess 12 or on the balloon body.
接下来以所述凹陷部12沿所述球囊本体的周向布置为例介绍支架40可选的定位方式。应理解,下文中的位置描述均是基于所述医用球囊10和支架40处于扩张状态下的位置关系。Next, taking the arrangement of the recess 12 along the circumferential direction of the balloon body as an example, the optional positioning method of the stent 40 is introduced. It should be understood that the following position descriptions are based on the positional relationship between the medical balloon 10 and the stent 40 in an expanded state.
在一个实施例中,所述波杆411的一部分被定位于所述子球囊11(即所述的球囊本体)上。本实施例中,所述波杆411的具体定位方式有两种选择,图10及图11示出了波杆411的第一种定位方式:所述波杆411的两端分别压 握于所述凹陷部12两侧的子球囊11上,以避免医用球囊10扩张时波杆411落入凹陷部12内而限制支架40的充分打开。更为具体地,所述波杆411沿医用球囊10轴向的长度一般为2-10mm,并且波杆411的长度较所述医用球囊10扩张后凹陷部12的轴向最大尺寸L1要长至少1mm,如此,当所述波杆411的两端压握于两个所述子球囊11上的长度相等或大致相等时,每一端的该长度不小于0.5mm。图12示出了波杆411的第二种定位方式:所述波杆411的一端压握于所述子球囊11上、另一端悬空于凹陷部12上,并且所述波杆411定位于所述子球囊11上的长度至少为该波杆411长度的一半,此时所述连接杆42可被定位于所述凹陷部12处。当所述医用球囊10在血管20的弯曲处扩张时,所述凹陷部12随之拉伸并弯曲,同时医用球囊10的整体弯曲会将弯曲力传递至连接杆42,并带动连接杆42拉伸和弯曲进而带动支架40整体弯曲In one embodiment, a part of the rod 411 is positioned on the sub-balloon 11 (that is, the balloon body). In this embodiment, there are two options for the specific positioning method of the wave rod 411. Figures 10 and 11 show the first positioning method of the wave rod 411: the two ends of the wave rod 411 are respectively pressed and held on each side. The sub-balloons 11 on both sides of the recessed portion 12 are used to prevent the probe 411 from falling into the recessed portion 12 when the medical balloon 10 is expanded, thereby restricting the full opening of the stent 40. More specifically, the length of the pole 411 along the axial direction of the medical balloon 10 is generally 2-10 mm, and the length of the pole 411 is greater than the axial maximum dimension L1 of the recess 12 after the expansion of the medical balloon 10 The length is at least 1 mm. Thus, when the lengths of the two ends of the wave rod 411 pressed on the two sub-balloons 11 are equal or approximately equal, the length of each end is not less than 0.5 mm. FIG. 12 shows a second positioning method of the pole 411: one end of the pole 411 is pressed and held on the sub-balloon 11, the other end is suspended on the recess 12, and the pole 411 is positioned at The length of the sub-balloon 11 is at least half the length of the wave rod 411, and the connecting rod 42 can be positioned at the recess 12 at this time. When the medical balloon 10 expands at the bend of the blood vessel 20, the concave portion 12 stretches and bends accordingly. At the same time, the overall bending of the medical balloon 10 transmits the bending force to the connecting rod 42 and drives the connecting rod. 42 Stretching and bending drive the bracket 40 to bend as a whole
又如,在另一个实施例中,当所述医用球囊10和支架40处于扩张状态时,所述波杆411全部被定位于所述子球囊11上,所述连接杆42被定位于所述凹陷部12处,即如图13和图14所示。当医用球囊10弯曲时,所述连接杆42随所述医用球囊10的凹陷部12同步拉伸弯曲,同时所述波杆411可被扩张的子球囊稳定撑开,以充分扩张支架达到支撑血管壁的目的。For another example, in another embodiment, when the medical balloon 10 and the stent 40 are in an expanded state, the wave rods 411 are all positioned on the sub-balloon 11, and the connecting rod 42 is positioned on The recess 12 is as shown in Figs. 13 and 14. When the medical balloon 10 is bent, the connecting rod 42 is stretched and bent synchronously with the concave portion 12 of the medical balloon 10, and the wave rod 411 can be stably expanded by the expanded sub-balloon to fully expand the stent To achieve the purpose of supporting the blood vessel wall.
在又一个实施例中,所述凹陷部12沿所述球囊本体的轴线螺旋环绕形成螺旋结构,如图8a所示,由于螺旋结构的凹陷部12始终不垂直于所述球囊本体的轴线,因而能够降低因与球囊本体的轴线垂直的支架40的波杆411或连接杆42掉入凹陷部12中而使支架40打开不充分的风险。更进一步的,所述凹陷部12可包括多个子凹陷部121,例如图8b所示的两个子凹陷部121,两个所述子凹陷部121的旋向相同并沿所述球囊本体的轴向间隔布置,如此,在降低支架40打开不充分的风险的同时,在两个子凹陷部121的间隔处还能够增加支架与球囊的接触面积,进一步提升支架40打开的成功率。In yet another embodiment, the concave portion 12 spirally surrounds the axis of the balloon body to form a spiral structure, as shown in FIG. 8a, because the concave portion 12 of the spiral structure is always not perpendicular to the axis of the balloon body Therefore, the risk of insufficient opening of the stent 40 due to the plunger 411 or the connecting rod 42 of the stent 40 perpendicular to the axis of the balloon body falling into the recess 12 can be reduced. Furthermore, the recessed portion 12 may include a plurality of sub-recesses 121, such as two sub-recesses 121 shown in FIG. 8b. The two sub-recesses 121 have the same rotation direction and are along the axis of the balloon body. The stent 40 is arranged to be spaced apart, so that while reducing the risk of insufficient opening of the stent 40, the contact area between the stent and the balloon at the interval between the two sub-recesses 121 can also be increased, thereby further improving the success rate of opening the stent 40.
本实施例提供的医疗装置可包括用于颅内、冠脉或外周等血管位置狭窄病变治疗的医疗装置,也可包括用于动脉瘤病变治疗的医疗装置,还可包括用于胆道等其它管腔病变治疗的医疗装置。The medical device provided in this embodiment may include a medical device used for the treatment of stenosis lesions in vascular locations such as intracranial, coronary or peripheral blood vessels, may also include a medical device used for the treatment of aneurysm lesions, and may also include other tubes used for the biliary tract. Medical device for the treatment of cavitary lesions.
综上所述,根据本发明实施例提供的技术方案,通过在球囊本体的外表面上形成凹陷部12,使得医用球囊10具有较好的弯曲性能,从而提高医用球囊10对血管20的顺应性,避免医用球囊10扩张过程中对血管20过度撕扯而造成血管损伤。In summary, according to the technical solution provided by the embodiments of the present invention, the depression 12 is formed on the outer surface of the balloon body, so that the medical balloon 10 has better bending performance, thereby improving the effect of the medical balloon 10 on the blood vessel 20. The compliance of the medical balloon 10 prevents excessive tearing of the blood vessel 20 during the expansion process of the medical balloon 10 to cause blood vessel damage.
此外,球囊表面上的凹陷部12在多个的情况下,这些凹陷部12的形状和尺寸可以相同或不相同。还有,针对同一个凹陷部12,其轴向截面形状可以相同或不相同。例如由一个连续的环形凹槽构成凹陷部12时,环形凹槽的轴向截面形状可以是不同形状的组合,也可以是单一的形状。又例如由间隔布置的多个子凹陷部121构成凹陷部12时,各个子凹陷部121的形状可以相同或不相同。In addition, when there are multiple recesses 12 on the balloon surface, the shapes and sizes of these recesses 12 may be the same or different. Also, for the same recess 12, the axial cross-sectional shape may be the same or different. For example, when the concave portion 12 is formed by a continuous annular groove, the axial cross-sectional shape of the annular groove may be a combination of different shapes, or a single shape. For another example, when the recess 12 is formed by a plurality of sub-recesses 121 arranged at intervals, the shape of each sub-recess 121 may be the same or different.
虽然本发明披露如上,但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。Although the present invention is disclosed as above, it is not limited to this. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. In this way, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention is also intended to include these modifications and variations.

Claims (17)

  1. 一种医用球囊,其特征在于,包括球囊本体以及形成于所述球囊本体之外表面的凹陷部。A medical balloon, which is characterized by comprising a balloon body and a recess formed on the outer surface of the balloon body.
  2. 根据权利要求1所述的医用球囊,其特征在于,所述凹陷部沿所述球囊本体的周向延伸。The medical balloon according to claim 1, wherein the recessed portion extends along the circumferential direction of the balloon body.
  3. 根据权利要求2所述的医用球囊,其特征在于,所述凹陷部为连续的环形凹槽,或者所述凹陷部包括至少两个沿所述球囊本体的周向间隔设置的子凹陷部。The medical balloon according to claim 2, wherein the recessed portion is a continuous annular groove, or the recessed portion includes at least two sub-recessed portions spaced apart along the circumference of the balloon body .
  4. 根据权利要求2所述的医用球囊,其特征在于,所述球囊本体的外表面上形成有两个以上所述凹陷部,每个所述凹陷部沿所述球囊本体的周向延伸,两个以上的所述凹陷部沿所述球囊本体的轴向依次布置。The medical balloon according to claim 2, wherein more than two recesses are formed on the outer surface of the balloon body, and each recess extends along the circumferential direction of the balloon body , Two or more of the recesses are arranged in sequence along the axial direction of the balloon body.
  5. 根据权利要求1所述的医用球囊,其特征在于,所述凹陷部呈螺旋结构,并沿所述球囊本体的轴线螺旋环绕。The medical balloon according to claim 1, wherein the recessed portion has a spiral structure and spirally surrounds along the axis of the balloon body.
  6. 根据权利要求5所述的医用球囊,其特征在于,所述凹陷部包括至少两个呈螺旋结构的子凹陷部,至少两个所述子凹陷部沿所述球囊本体的轴向依次排布并相互连接,且相互连接的两个子凹陷部的旋向相反。The medical balloon according to claim 5, wherein the recessed portion comprises at least two sub-recesses in a spiral structure, and the at least two sub-recesses are arranged in sequence along the axial direction of the balloon body. The cloths are connected to each other, and the rotation directions of the two connected sub-recesses are opposite.
  7. 根据权利要求5所述的医用球囊,其特征在于,所述凹陷部包括至少两个呈螺旋结构的子凹陷部,至少两个所述子凹陷部沿所述球囊本体的轴向间隔分布。The medical balloon according to claim 5, wherein the recessed portion comprises at least two sub-recesses in a spiral structure, and at least two of the sub-recesses are spaced apart along the axial direction of the balloon body .
  8. 根据权利要求1-7中任一项所述的医用球囊,其特征在于,在所述医用球囊的轴向截面上,所述凹陷部的形状为弧形、方形、梯形或V形中的至少一种。The medical balloon according to any one of claims 1-7, wherein in the axial cross-section of the medical balloon, the shape of the recess is arc, square, trapezoid or V-shaped. At least one of.
  9. 根据权利要求1-7中任一项所述的医用球囊,其特征在于,当所述医用球囊处于扩张状态时,所述球囊本体的外径从近端到远端渐缩。The medical balloon according to any one of claims 1-7, wherein when the medical balloon is in an expanded state, the outer diameter of the balloon body is tapered from the proximal end to the distal end.
  10. 一种球囊导管,其特征在于,包括如权利要求1-9中任一项所述的医用球囊和与所述医用球囊的近端连接的导管。A balloon catheter, which is characterized by comprising the medical balloon according to any one of claims 1-9 and a catheter connected to the proximal end of the medical balloon.
  11. 一种医疗装置,其特征在于,包括如权利要求10所述的球囊导管和 压握在所述球囊导管的医用球囊上的支架。A medical device, characterized by comprising the balloon catheter according to claim 10 and a stent crimped on the medical balloon of the balloon catheter.
  12. 根据权利要求11所述的医疗装置,其特征在于,所述支架呈管网状结构并包括沿所述支架的轴向相互连接的波杆和连接杆;The medical device according to claim 11, wherein the stent has a tube network structure and includes a wave rod and a connecting rod connected to each other along the axial direction of the stent;
    其中,当所述支架和所述医用球囊处于扩张状态时,至少部分所述波杆被定位于所述医用球囊的球囊本体上。Wherein, when the stent and the medical balloon are in an expanded state, at least a part of the probe is positioned on the balloon body of the medical balloon.
  13. 根据权利要求12所述的医疗装置,其特征在于,当所述支架和所述医用球囊处于扩张状态时,所述连接杆被定位于所述医用球囊的凹陷部处。The medical device according to claim 12, wherein when the stent and the medical balloon are in an expanded state, the connecting rod is positioned at a recess of the medical balloon.
  14. 根据权利要求12所述的医疗装置,其特征在于,所述波杆的两端分别定位于所述凹陷部两侧的所述球囊本体上,定位于所述球囊本体上的所述波杆的两端部分的长度均不小于0.5mm。The medical device according to claim 12, wherein the two ends of the wave rod are respectively positioned on the balloon body on both sides of the concave portion, and the waves positioned on the balloon body The length of both ends of the rod is not less than 0.5mm.
  15. 根据权利要求14所述的医疗装置,其特征在于,定位于所述球囊本体上的所述波杆的两端部分的长度相等。The medical device according to claim 14, wherein the lengths of the two end portions of the poles positioned on the balloon body are equal.
  16. 根据权利要求12或13所述的医疗装置,其特征在于,所述波杆的一端定位于所述凹陷部一侧的所述球囊本体上,另一端定位于所述凹陷部处,且所述波杆的定位于所述球囊本体上的长度不小于所述波杆的全长的1/2。The medical device according to claim 12 or 13, wherein one end of the wave rod is positioned on the balloon body on one side of the recess, and the other end is positioned at the recess, and The length of the wave rod positioned on the balloon body is not less than 1/2 of the full length of the wave rod.
  17. 根据权利要求12或13所述的医疗装置,其特征在于,全部所述波杆被定位于所述球囊本体上。The medical device according to claim 12 or 13, characterized in that, all the probes are positioned on the balloon body.
PCT/CN2020/096642 2019-06-18 2020-06-17 Medical balloon, balloon catheter and medical device WO2020253739A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910528527.4A CN112089951A (en) 2019-06-18 2019-06-18 Medical balloon, balloon catheter and medical device
CN201910528527.4 2019-06-18

Publications (1)

Publication Number Publication Date
WO2020253739A1 true WO2020253739A1 (en) 2020-12-24

Family

ID=73748890

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/096642 WO2020253739A1 (en) 2019-06-18 2020-06-17 Medical balloon, balloon catheter and medical device

Country Status (2)

Country Link
CN (1) CN112089951A (en)
WO (1) WO2020253739A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113877042B (en) * 2021-09-26 2023-07-11 广东博迈医疗科技股份有限公司 Medical balloon, balloon catheter and medical device

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6478807B1 (en) * 2000-06-08 2002-11-12 Advanced Cardiovascular Systems, Inc. Pre-formed expandable member having grooves
US20030055378A1 (en) * 2001-09-14 2003-03-20 Wang Yiqun Bruce Conformable balloons
US20090227949A1 (en) * 2008-03-06 2009-09-10 Boston Scientific Scimed, Inc. Balloon catheter devices with folded balloons
CN102512747A (en) * 2011-12-27 2012-06-27 微创医疗器械(上海)有限公司 Medicine eluting balloon catheter
CN104254362A (en) * 2012-01-24 2014-12-31 夸利梅德创新医药产品有限公司 Balloon catheter
CN204092804U (en) * 2014-07-18 2015-01-14 北京普益盛济科技有限公司 Mild hypothermia therapy foley's tube

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6478807B1 (en) * 2000-06-08 2002-11-12 Advanced Cardiovascular Systems, Inc. Pre-formed expandable member having grooves
US20030055378A1 (en) * 2001-09-14 2003-03-20 Wang Yiqun Bruce Conformable balloons
US20090227949A1 (en) * 2008-03-06 2009-09-10 Boston Scientific Scimed, Inc. Balloon catheter devices with folded balloons
CN102512747A (en) * 2011-12-27 2012-06-27 微创医疗器械(上海)有限公司 Medicine eluting balloon catheter
CN104254362A (en) * 2012-01-24 2014-12-31 夸利梅德创新医药产品有限公司 Balloon catheter
CN204092804U (en) * 2014-07-18 2015-01-14 北京普益盛济科技有限公司 Mild hypothermia therapy foley's tube

Also Published As

Publication number Publication date
CN112089951A (en) 2020-12-18

Similar Documents

Publication Publication Date Title
JP5666912B2 (en) Drug delivery catheter having a radially expandable centering support member
JP2011524209A5 (en)
JPH0626576B2 (en) Device for performing angiogenesis
JP2004024625A (en) Catheter and medical tube
JP2011505918A5 (en)
US20110066159A1 (en) Medical retrieval device
CN102500041A (en) Balloon dilatation catheter
JPH0615005A (en) Balloon expansion catheter
CN111228634B (en) Adjustable sacculus pipe
WO2020253739A1 (en) Medical balloon, balloon catheter and medical device
JP2019532761A (en) Steering tool
US10022127B2 (en) Double bellow occluder for sclerotherapy
CN212016424U (en) Medical balloon, balloon catheter and medical device
WO2022242546A1 (en) Medical catheter and medical apparatus
CN211561528U (en) Adjustable sacculus pipe
CN113197620B (en) Nerve micro-catheter
CN201625318U (en) Special developing element and conduit provided with same
CN107661162A (en) A kind of stent delivery system
JP4705715B2 (en) Balloon catheter
CN219208650U (en) Anti-deformation balloon
CN219558424U (en) Ureter whole-course expansion sacculus catheter
JP7423191B2 (en) Spiral balloon auxiliary device and its usage
CN215306217U (en) Biliary tract expansion bougie with multiple expansion functions
CN117339093B (en) Internal medicine feeding device
CN220025863U (en) Nick sacculus

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20827458

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20827458

Country of ref document: EP

Kind code of ref document: A1