WO2026016841A1 - Cathéter de contre-pulsion à ballonnet de sinus coronaire - Google Patents

Cathéter de contre-pulsion à ballonnet de sinus coronaire

Info

Publication number
WO2026016841A1
WO2026016841A1 PCT/CN2025/105429 CN2025105429W WO2026016841A1 WO 2026016841 A1 WO2026016841 A1 WO 2026016841A1 CN 2025105429 W CN2025105429 W CN 2025105429W WO 2026016841 A1 WO2026016841 A1 WO 2026016841A1
Authority
WO
WIPO (PCT)
Prior art keywords
cavity
balloon
circle
catheter
coronary sinus
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/CN2025/105429
Other languages
English (en)
Chinese (zh)
Inventor
聂京闽
刘琛
岳斌
赵瑞辉
姚映忠
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai MicroPort RotaPace MedTech Co Ltd
Original Assignee
Shanghai MicroPort RotaPace MedTech Co Ltd
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
Priority claimed from CN202410965425.XA external-priority patent/CN118807087A/zh
Application filed by Shanghai MicroPort RotaPace MedTech Co Ltd filed Critical Shanghai MicroPort RotaPace MedTech Co Ltd
Publication of WO2026016841A1 publication Critical patent/WO2026016841A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/143—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the coronary sinus, e.g. for pressure-controlled intermittent coronary sinus occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/295—Balloon pumps for circulatory assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/31—Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion
    • A61M60/32—Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion of heart muscle tissues, e.g. using coronary sinus occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
    • A61M60/843—Balloon aspects, e.g. shapes or materials

Definitions

  • This invention belongs to the field of medical device technology, specifically relating to a coronary sinus balloon counterpulsation catheter.
  • Acute ST-segment elevation myocardial infarction is a rapidly progressing cardiovascular disease with high rates of disability and mortality.
  • PCI percutaneous coronary intervention
  • STEMI percutaneous coronary intervention
  • ischemic area due to the failure to effectively open previously blocked microvascular pathways, leading to higher mortality and recurrence rates. Therefore, improving microvascular circulation, including addressing issues such as microvascular embolism and microvascular remodeling, is crucial for improving the postoperative quality of life and reducing recurrence and mortality rates in STEMI patients.
  • the coronary sinus balloon counterpulsation catheter is placed in the coronary sinus (CS) via a venous access.
  • the counterpulsation device controls the periodic expansion and contraction of the coronary sinus balloon counterpulsation catheter to intermittently block blood flow in the CS, thereby controlling the intermittent increase and decrease of blood pressure in the CS, promoting the backflow of coronary venous blood and its redistribution to the damaged myocardial area. This can improve myocardial perfusion and microcirculatory dysfunction after PCI, reduce the infarct area, and improve cardiac function.
  • saline solution offers significant safety advantages as an filling medium
  • the physical properties of the liquid result in high resistance and slow flow rate during catheter transport. This leads to longer balloon inflation and depressurization times, reducing the frequency of balloon expansion and contraction, making it difficult to match the balloon's expansion and contraction frequency with the heart's.
  • the flow velocity in a catheter is closely related to the cross-sectional dimensions of the flow channel.
  • the catheter's inner and outer diameters are often limited by the accompanying access devices (such as guidewires and catheter sheaths) and vessel size during catheter design.
  • the purpose of this invention is to provide a coronary sinus balloon counterpulsation catheter, which aims to improve the safety of using the coronary sinus balloon counterpulsation catheter by using physiological saline or a liquid with similar properties as the filling medium.
  • the present invention provides a coronary sinus balloon counterpulsation catheter, comprising a catheter body and a balloon.
  • the catheter body has a first cavity and a second cavity extending axially through it and isolated from each other.
  • the first cavity is eccentrically disposed from the catheter body.
  • the cross-section of the second cavity includes a first contour line and a second contour line, wherein the first contour line is at least a portion of a first circle and the second contour line is at least a portion of a second circle.
  • the first contour line is closer to the first cavity than the second contour line, and the concave sides of both the first and second contour lines are arranged toward the first cavity.
  • the balloon is sealed and connected to the distal outer peripheral surface of the catheter body and communicates with the second cavity.
  • the width of the second cavity at a specified position in the second circle satisfies the following relationship:
  • h represents the width of the second cavity at the specified position of the second circle
  • D represents the diameter of the second circle
  • d represents the diameter of the first circle
  • e is the distance between the center of the first circle and the center of the second circle
  • ⁇ represents the angle formed by the first straight line and the second straight line
  • the first straight line refers to the straight line passing through the center of the first circle and the center of the second circle
  • the second straight line refers to the straight line passing through the specified position and the center of the second circle
  • the width of the second cavity refers to the radial dimension of the second cavity in the first circle.
  • the cross-section of the first cavity is circular, and the first cavity is coaxial with the first circle; the catheter body is coaxial with the second circle.
  • the balloon includes a proximal balloon segment and a distal balloon segment that are symmetrically arranged and directly connected.
  • the outer diameter and inner diameter of the proximal balloon segment both increase in the direction from the proximal end to the distal end, and the outer diameter and inner diameter of the distal balloon segment both decrease in the direction from the proximal end to the distal end.
  • the balloon is configured to be elastic.
  • the material used to prepare the balloon includes any one of silicone, polyurethane, and polyether block polyamide.
  • the device further includes a liquid aspiration device and a power mechanism.
  • the liquid aspiration device includes a housing and a piston.
  • the housing has an inner cavity and a connection hole communicating with the inner cavity.
  • the liquid aspiration device is connected to the proximal end of the catheter body through the connection hole and communicates with the second cavity.
  • the piston is at least partially disposed in the inner cavity and is also connected to the power mechanism.
  • the power mechanism is used to drive the piston to reciprocate along the axial direction of the connection hole.
  • the power mechanism includes a motor, a reducer, and a transmission mechanism connected in sequence; the reduction ratio of the reducer is 10:1 to 1:1, and the transmission mechanism is connected to the piston.
  • the motor is a DC motor; and/or,
  • the reducer is a planetary reducer.
  • the catheter body includes an axially connected proximal segment and a distal segment, the distal segment being configured to bend at least at its proximal end; the balloon is sealed to the outer peripheral surface of the distal segment; the sidewall of the distal segment is further provided with a flow hole communicating with the first cavity, the flow hole being located at the distal end of the balloon.
  • the angle formed by the axis of the distal segment and the axis of the proximal segment is less than or equal to 135°; and/or,
  • the axial length of the distal pipe section is 15mm to 50mm.
  • it also includes a pressure monitoring element connected to the proximal end of the catheter body and corresponding to the first cavity and/or the second cavity.
  • the coronary sinus balloon counterpulsation catheter of the present invention has the following advantages:
  • the aforementioned coronary sinus balloon counterpulsation catheter includes a catheter body and a balloon.
  • the catheter body has a first cavity and a second cavity extending axially through it and isolated from each other.
  • the first cavity is eccentrically disposed from the catheter body.
  • the cross-section of the second cavity includes a first contour line and a second contour line.
  • the first contour line is at least a portion of a first circle
  • the second contour line is at least a portion of a second circle.
  • the first contour line is closer to the first cavity than the second contour line, and the concave sides of both the first and second contour lines face the first cavity.
  • the balloon is sealed to the distal outer circumferential surface of the catheter body and communicates with the second cavity.
  • the width of the second cavity at a designated position in the second circle satisfies the following condition:
  • h represents the width of the second cavity at the designated position of the second circle
  • D represents the diameter of the second circle
  • d represents the diameter of the first circle
  • e is the distance between the center of the first circle and the center of the second circle
  • ⁇ represents the angle formed by the first straight line and the second straight line
  • the first straight line refers to the straight line passing through the center of the first circle and the center of the second circle
  • the second straight line refers to the straight line between the center of the second circle and the designated position
  • the width of the second cavity refers to the radial dimension of the second cavity in the first circle.
  • the second cavity is used for the flow of filling fluid.
  • the arrangement of the first and second cavities results in lower resistance and a faster flow rate of the filling fluid flowing in the second cavity, improving the inflation and aspiration efficiency of the balloon.
  • Figure 1 is a schematic diagram of the coronary sinus balloon counterpulsation catheter provided according to an embodiment of the present invention
  • Figure 2 is a cross-sectional view along line A-A of the catheter body of the coronary sinus balloon counterpulsation catheter provided according to an embodiment of the present invention.
  • the first circle is coaxial with the first cavity
  • the second circle is coaxial with the catheter body.
  • Figure 3 is a cross-sectional view along line A-A of the catheter body of the coronary sinus balloon counterpulsation catheter provided according to another embodiment of the present invention.
  • the first circle is not coaxial with the first cavity, and the second circle is coaxial with the catheter body.
  • Figure 4 is a partially enlarged schematic diagram of the coronary sinus balloon counterpulsation catheter provided according to an embodiment of the present invention.
  • Figure 5 is a schematic cross-sectional view of the catheter body of a prior art balloon catheter, the catheter body shown in the figure including a first cavity and a second cavity arranged coaxially.
  • connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can be internal communication between two elements or an interaction between two elements.
  • proximal and distal used in this article are based on the relative position and orientation of the various components and parts of a medical device. Although they are not restrictive, “proximal” usually refers to the end of the medical device that is closer to the operator during normal use, while “distal” refers to the end that is farther away from the operator.
  • liquid for conventional coronary sinus balloon counterpulsation catheters in existing technology, if liquid is used as the filling medium, the high flow resistance and slow flow rate of the liquid result in a longer inflation and deflation rate of the balloon. This makes it difficult to match the aspiration time of conventional coronary sinus balloon counterpulsation catheters with the patient's heart rate, thus failing to achieve the therapeutic effect.
  • the liquid here includes, but is not limited to, normal saline.
  • the purpose of this invention is to provide a coronary sinus balloon counterpulsation catheter that can use a liquid such as physiological saline as the filling medium. Through changes in its structural configuration, it shortens the inflation and deflation time of the balloon, allowing the aspiration time of the coronary sinus balloon counterpulsation catheter to match the patient's heart rate.
  • the liquid filling medium will be referred to as the filling fluid below.
  • FIG. 5 illustrates a prior art balloon catheter.
  • this prior art balloon catheter includes a catheter body 10 and a balloon (not shown).
  • the catheter body 10 has a first cavity 11 and a second cavity 12 extending axially through it.
  • the first cavity 11 and the second cavity 12 are coaxially arranged and separated by a partition wall 13.
  • the second cavity 12 surrounds the outer periphery of the first cavity 11.
  • the second cavity 12 includes a first profile line 12a and a second profile line 12b arranged coaxially, both of which are circular.
  • the first cavity 11 is used for inserting a guidewire, and the second cavity 12 is used for the flow of filling medium.
  • the filling fluid is introduced into the second cavity 12 of the prior art balloon catheter, then for the prior art balloon catheter, the filling fluid forms a laminar flow in the second cavity 12, and its unit volume flow rate can be expressed as Q, then the following formula (1) holds:
  • d represents the diameter of the first contour line 12a
  • D represents the diameter of the second contour line 12b
  • h represents the width of the second cavity 12, that is, the radial dimension of the second cavity 12 in the catheter body 10, and its value is...
  • ⁇ represents the viscosity of the filling fluid, which is a constant value for a given filling fluid
  • L represents the axial length of the catheter body 10
  • ⁇ P represents the pressure difference of the filling fluid at both ends of the second cavity 12 along the axis.
  • the aspiration time is related to the volume of the balloon and the flow rate of the filling fluid by the following formula (2):
  • t is the retraction time
  • V is the volume of the balloon, which is equal to the volume of the filling fluid inside the balloon when the balloon is inflated. Ignoring the wall thickness of the balloon, V is approximately equal to the volume V0 of the balloon in the inflated state.
  • the aspiration time can be shortened by reducing the volume of the balloon, decreasing the length of the catheter body 10, increasing the inner diameter of the outer tube, decreasing the outer diameter of the inner tube, or increasing the pressure difference of the filling fluid at both ends of the second cavity 12 axially.
  • the inner and outer diameters of the inner and outer tubes, the length of the catheter body, and the pressure difference of the filling fluid at both ends of the second cavity 12 axially all need to be determined according to clinical treatment and usage requirements and cannot be easily changed. That is, for the balloon catheter shown in Figure 5, it is difficult to optimize it so that it can also be used for coronary sinus counterpulsation when using the filling fluid.
  • the inventors considered changing the arrangement of the first cavity and the second cavity to change the hydrodynamics of the filling fluid flowing in the second cavity, thereby shortening the aspiration time of the balloon catheter.
  • the catheter body 100 has a first cavity 101 and a second cavity 102 extending axially through it and separated by a partition wall 103.
  • the first cavity 101 is eccentrically disposed from the catheter body 100.
  • the second cavity 102 includes a first contour line 102a and a second contour line 102b.
  • the first contour line 102a is at least a portion of a first circle
  • the second contour line 102b is at least a portion of a second circle.
  • the first contour line 102a is an arc segment, and the circle containing this arc segment is the first circle (as shown in Figure 3), or the first contour line 102a is the entire first circle (as shown in Figure 2);
  • the second contour line 102b is an arc segment, and the circle containing this arc segment is the second circle (as shown in Figure 3), or the second contour line 102b is the entire second circle (as shown in Figure 2).
  • the first contour line 102a is closer to the first cavity 101 than the second contour line 102b.
  • the first circle corresponds to the first contour line 12a in Figure 5
  • the second circle corresponds to the second contour line 12b in Figure 5.
  • the width of the second cavity 102 at the designated position S of the second circle satisfies the following formula (4):
  • h represents the width of the second cavity 102 at the designated position S of the second circle
  • D represents the diameter of the second circle
  • d represents the diameter of the first circle
  • e is the distance between the center O1 of the first circle and the center O2 of the second circle. It can be understood that e is less than or equal to ⁇ represents the angle formed by the first straight line l1 and the second straight line l2.
  • the first straight line l1 refers to the straight line passing through the center O1 of the first circle and the center O2 of the second circle
  • the second straight line l2 refers to the straight line passing through the center O2 of the second circle and the designated position S.
  • the width of the second cavity 102 refers to the radial dimension of the second cavity 102 in the first circle.
  • the width of the second cavity 102 at the designated position S in the second circle refers to the portion of the straight line l3 passing through the center O1 of the first circle and the designated position S between the first circle and the second circle. It should be understood that the designated position S is on the second contour line 102b.
  • the unit volume flow rate Q of the filling fluid in the second cavity 102 conforms to the following formula (5):
  • the structure of the coronary sinus balloon counterpulsation catheter provided in this embodiment of the invention is shown in Figure 1, including a catheter body 100 and a balloon 200.
  • the cross-section of the catheter body 100 is shown in Figures 2 and 3.
  • the catheter body 100 has a first cavity 101 and a second cavity 102. Both the first cavity 101 and the second cavity 102 extend through the axial direction of the catheter body 100 and are separated by a partition wall 103.
  • the first cavity 101 is eccentrically disposed from the catheter body 100.
  • the cross-section of the second cavity 102 includes a first contour line 102a and a second contour line 102b.
  • the first contour line 102a is at least a portion of a first circle
  • the second contour line 102b is at least a portion of a second circle.
  • the first contour line 102a is closer to the first cavity 101 than the second contour line 102b, and the concave sides of both the first contour line 102a and the second contour line 102b are arranged facing the first cavity 101.
  • the balloon 200 is sealed to the distal outer peripheral surface of the catheter body 100 and communicates with the second cavity 102 for the flow of filling medium.
  • the width of the second cavity 102 at the designated position S of the second contour line 102b satisfies the aforementioned formula (4).
  • the first cavity 101 has a circular cross-section
  • the second cavity 102 has a crescent-shaped cross-section.
  • the first circle is coaxially arranged with the first cavity 101
  • the second circle is coaxially arranged with the catheter body 100 (as shown in Figure 2).
  • the first circle is not coaxial with the first cavity 101
  • the second circle is coaxial with the catheter body 100 (as shown in Figure 3).
  • the first circle is coaxial with the first cavity
  • the second circle is not coaxial with the catheter body 100.
  • both the first circle and the second circle are not coaxial with the first cavity 101 and the catheter body 100.
  • the conduit body 100 is composed of an inner tube and an outer tube. Specifically, the outer tube is fitted onto the outer circumferential surface of the inner tube, and the inner surface of the outer tube is bonded to the outer surface of the inner tube with an adhesive.
  • the adhesive has a radial dimension of 0.03 mm (adhesive thickness) on the outer tube, the inner diameter of the outer tube is 1.72 mm, and the outer diameter of the inner tube is 1.25 mm.
  • the lumen of the inner tube forms the first cavity 101
  • the space between the inner circumferential surface of the outer tube and the outer circumferential surface of the inner tube forms the second cavity 102
  • the wall of the inner tube forms the partition wall 103 that separates the first cavity 101 and the second cavity 102.
  • the diameter of the first circle is 1.25 mm
  • the diameter of the second circle is 1.72 mm
  • the distance between the center O1 of the first circle and the center O2 of the second circle is 0.21 mm.
  • the length L of the catheter body 100 is 1000 mm.
  • the volume of the balloon 200 is 0.69 mL.
  • the balloon 200 is inflated with physiological saline as the filling fluid, and when the coronary sinus balloon counterpulsation catheter is aspirated, the pressure difference of physiological saline at both ends of the second cavity 102 is 1 atmosphere.
  • the inflated balloon 200 is aspirated, and the aspiration time is calculated to be 0.28 s according to formula (7), while the actual aspiration time is 0.32 s.
  • the measured aspiration time of the coronary sinus balloon counterpulsation catheter is longer than the aspiration time calculated according to formula (7) during application because the adhesive layer connecting the inner and outer tubes has a certain area, which occupies part of the space in the second cavity 102, resulting in a reduction in the flow area of the filling fluid.
  • the area of the adhesive layer connecting the inner and outer tubes should be controlled to be as small as possible.
  • the catheter body 100 may also be formed by extrusion.
  • the dimensional parameters of the coronary sinus balloon counterpulsation catheters provided in Examples 2 to 9, the aspiration time calculated according to formula (7), and the measured aspiration time are shown in Table 1 below.
  • the first circle is coaxial with the first cavity 101
  • the second circle is coaxial with the catheter body 100.
  • the catheter body 100 is formed by extrusion, the first circle is not coaxial with the first cavity 101, and the second circle is coaxial with the catheter body 100.
  • all coronary sinus balloon counterpulsation catheters provided in these examples are filled with saline solution, and during aspiration, the pressure difference between the saline solution at both ends of the second cavity 102 along its axial direction is 1 atmosphere.
  • the calculated pullback time according to formula (7) and the measured pullback time can be found that the error between the calculated pullback time and the measured pullback time is no greater than 0.04s, which shows that formula (7) has extremely high reliability.
  • the coronary sinus balloon counterpulsation catheter is itself a mechanically assisted circulatory device that improves cardiac function and blood circulation by expanding and contracting the balloon 200 at specific times during the cardiac cycle.
  • the balloon 200 inflates during ventricular systole to block the coronary sinus, increasing the pressure within the coronary sinus and forcing more blood to flow backward into the damaged area of the myocardium, thus improving myocardial blood supply.
  • the balloon 200 contracts during ventricular diastole to reduce the pressure within the coronary sinus, allowing blood to flow out of the heart normally, thereby reducing the burden on the heart.
  • the contraction time of the balloon 200 i.e., the withdrawal time of the coronary sinus balloon counterpulsation catheter, is less than the duration of ventricular diastole, the effect of reducing the burden on the heart can be achieved, thus having a therapeutic effect.
  • each cardiac cycle averages 0.8 seconds, with an average ventricular systolic period of 0.27 seconds and an average ventricular diastolic period of 0.53 seconds.
  • the measured aspiration time of the coronary sinus balloon counterpulsation catheter is no greater than 0.52 seconds, which is shorter than the duration of ventricular diastole and can meet the treatment requirements.
  • doctors adjust various parameters of the coronary sinus balloon counterpulsation catheter according to the heart rate of different patients, so as to adjust the aspiration time of the coronary sinus balloon counterpulsation catheter, so that the aspiration time matches the patient's heart rate as closely as possible, and achieves the best counterpulsation effect.
  • the catheter body 100 includes an axially connected proximal segment 110 and a distal segment 120, the distal segment 120 being configured to be flexible at least proximally.
  • the distal segment 120 includes an axially connected first sub-segment and a second sub-segment (not labeled in the figures), the first sub-segment being closer to the proximal segment 110 than the second sub-segment, and the first sub-segment being flexible.
  • the catheter body 100 can be bent at the first sub-segment. This configuration is advantageous because it better accommodates the morphology of the coronary sinus when the distal end of the coronary sinus balloon counterpulsation catheter 10 is inserted into the coronary sinus.
  • the balloon 200 is sealingly connected to the outer peripheral surface of the distal segment 120.
  • the second sub-segment is flexible, while in other embodiments, the second sub-segment is not flexible.
  • the raw materials used for extruding the catheter body 100 include a polymer base material, which includes, but is not limited to, at least one of polyamide (PA), polyether block polyamide (Pebax), polyurethane (TPU), and polyvinyl chloride (PVC). Further, the raw materials may also include inorganic additives, such as reproducible inorganic materials, thus making the catheter body 100 reproducible.
  • inorganic additives include, but are not limited to, at least one of barium sulfate, bismuth trioxide, bismuth hydroxide, basic bismuth carbonate, and tungsten.
  • the amount of inorganic additive added is less than or equal to 40% by mass percentage.
  • the connection method between the inner tube and the outer tube is not limited to the aforementioned adhesive bonding, but can also be welding or any other suitable method; or, the inner tube and the outer tube are not directly connected, but only adhere to each other by their own gravity during use.
  • the outer diameter of the inner tube can be 1.5mm to 2mm, and the inner diameter can be 0.45mm to 1.5mm, while the outer diameter of the outer tube can be 2mm to 4mm, and the inner diameter can be 1.5mm to 2mm.
  • the outer tube has a multi-layer structure, for example, including an inner layer, a middle layer, and an outer layer arranged from the inside out.
  • the material of the inner layer includes medical polymer materials, such as polytetrafluoroethylene
  • the material of the middle layer is a metal material, such as medical stainless steel
  • the material of the outer layer includes medical polymer materials.
  • the outer tube body may also be reproducible, for example, by incorporating reproducible inorganic materials such as barium sulfate and bismuth trioxide into the material of the outer layer. In the outer layer, the proportion of reproducible inorganic materials added is less than or equal to 60% by mass percentage.
  • the overall hardness of the catheter body 100 is 50A-100D, so that the catheter body 100 has good pushability and controllability.
  • the balloon 200 includes a symmetrically arranged and directly connected proximal balloon segment 210 and a distal balloon segment 220.
  • the outer and inner diameters of the proximal balloon segment 210 and the distal balloon segment 220 both increase from the proximal to the distal direction. This allows the balloon 200 to have a minimal volume, thereby shortening the aspiration time.
  • the nominal outer diameter C of the balloon 200 when inflated is 4mm to 16mm, and the axial length P is 10mm to 25mm.
  • the balloon 200 is made of an elastic material, so that when the balloon 200 is inflated, it stores elastic potential energy. Thus, when the inflation fluid is withdrawn, the balloon 200 releases this elastic potential energy to facilitate the drainage of the inflation fluid, thereby further shortening the withdrawal time.
  • the materials used to manufacture the balloon 200 include, but are not limited to, any one of silicone, polyurethane, and polyether block polyamide.
  • the coronary sinus balloon counterpulsation catheter 10 further includes a connector 300, which is connected to the proximal end of the catheter body 100 and includes a first connector portion 310, a second connector portion 320, and a third connector portion 330.
  • the first connector portion 310 is connected to the proximal end of the catheter body 100
  • the second connector portion 320 communicates with the first cavity 101
  • the third connector portion 330 communicates with the second cavity 102.
  • the second connector 320 serves two purposes: firstly, it allows the guidewire to pass through; secondly, it is correspondingly arranged with a pressure monitoring element 400, such that the pressure monitoring element 400 corresponds to at least one of the first cavity 101 and the second cavity 102. It is understood that when the pressure monitoring element 400 corresponds to the first cavity 101, it can sense the blood pressure in the coronary sinus when blood enters the first cavity 101; when the pressure monitoring element 400 corresponds to the second cavity 102, it can monitor the inflation pressure of the balloon 200 when it is inflated.
  • the specific type and arrangement of the pressure monitoring element 400 are well known to those skilled in the art and will not be elaborated here. It is understood that the coronary sinus balloon counterpulsation catheter 10 may include the pressure monitoring element 400.
  • a flow hole 104 communicating with the first cavity 101 is provided on the wall of the distal tube segment 120 of the catheter body 100 (as shown in Figure 4). In this way, when the distal end of the catheter body 100 is bent, blood enters the first cavity 101 through the flow hole 104. It should be understood that the flow hole 104 should be located on the distal side of the balloon 200.
  • the third connector 330 is used to connect to an inflatable fluid source.
  • the inflatable fluid source is an aspiration device 500.
  • the coronary sinus balloon counterpulsation catheter 10 also includes the aspiration device 500 and a power mechanism 600.
  • the aspiration device 500 is used to store the inflatable fluid
  • the power mechanism 600 is used to drive the aspiration device to inflate the balloon 200 with the inflatable fluid to inflate the balloon 200, or to aspirate the inflatable fluid from the balloon 200 to depressurize the balloon 200.
  • the aspiration device 500 includes a housing and a piston (not shown in the figure).
  • the housing is a hollow structure with an inner cavity, and the housing is also provided with a connection hole communicating with the inner cavity.
  • the aspiration device is connected to the third connector 330 through the connection hole to communicate with the second cavity 102.
  • the piston is at least partially disposed in the inner cavity.
  • the piston is also connected to the power mechanism 600 and can reciprocate linearly along the axial direction of the connection hole under the drive of the power mechanism 600 to move closer to or away from the connection hole.
  • the portion of the inner cavity located on the side of the piston closer to the connection hole is used to store the filling fluid.
  • the filling fluid When the piston moves in the direction closer to the connection hole, the filling fluid is injected into the balloon 200, causing the balloon 200 to inflate; when the piston moves in the direction away from the connection hole, the filling fluid is drawn back into the inner cavity, causing the balloon 200 to depressurize.
  • the embodiments of the present invention do not particularly limit the structure of the power mechanism 600.
  • the power mechanism 600 includes a pneumatically driven cylinder; in other embodiments, the power mechanism 600 includes a hydraulically driven cylinder; and in still other embodiments, the power mechanism 600 includes an electrically driven device.
  • the power mechanism 600 includes an electric drive device, specifically comprising a motor, a reducer, and a transmission mechanism connected in sequence.
  • the reducer has a reduction ratio of 10:1 to 1:1
  • the transmission mechanism is a linear motion mechanism connected to the piston.
  • the reduction ratio refers to the ratio of the reducer's input to its output.
  • the motor is a DC motor, such as a brushless stepper motor, which has the advantages of high speed and low noise, and can operate stably and efficiently.
  • the reducer is a high-precision planetary reducer, which can adapt to the usage requirements under different conditions.
  • the transmission mechanism includes a lead screw and nut pair, such as a ball screw and nut pair.
  • the motor is a brushless stepper motor with a rated speed of 5 r/min-60 r/min, a torque of 2 N ⁇ m-10 N ⁇ m, a step count of 2000-20000 steps, and a drive frequency of 15000 Hz-25000 Hz.
  • the rotational accuracy of the brushless stepper motor is 1.8°.
  • the filling and suction accuracy of the filling fluid by the suction device 500 is 0.5 ml.
  • the reduction ratio of the reducer is 5:1
  • the output speed of the power mechanism 600 is reduced to 1 r/min-12 r/min
  • the torque is increased to 10 N ⁇ m-50 N ⁇ m
  • the rotational accuracy at the output end reaches 0.36°
  • the filling and suction accuracy of the filling fluid by the suction device 500 can reach 0.1 ml.
  • the pressure monitoring element 400, the liquid aspiration device 500, and the power mechanism 600 can be integrated into a counterpulsation controller.
  • the coronary sinus balloon counterpulsation catheter 10 also includes components such as a contrast ring 710, a marking band 720, and a catheter fixation clip 730.
  • the contrast ring 710 is disposed on the distal outer peripheral surface of the catheter body 100 and located on the distal side of the balloon 200.
  • the marking band 720 is disposed on the outer peripheral surface of the proximal segment 110 of the catheter body 100.
  • the catheter fixation clip 730 is connected to the distal outer surface of the connector 300.
  • the functions of the contrast ring 710, the marking band 720, and the catheter fixation clip 730 are well known to those skilled in the art and will not be described in detail here.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Anesthesiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Optics & Photonics (AREA)
  • Transplantation (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un cathéter de contre-pulsion à ballonnet de sinus coronaire, comprenant un corps de cathéter et un ballonnet. Le corps de cathéter est pourvu d'un premier canal et d'un second canal qui s'étendent à travers le corps de cathéter le long de la direction axiale de celui-ci. Le premier canal est excentrique par rapport au corps de cathéter. Une section transversale du second canal comprend une première ligne de contour et une seconde ligne de contour. La première ligne de contour est au moins une partie d'un premier cercle. La seconde ligne de contour est au moins une partie d'un second cercle. La première ligne de contour est plus proche du premier canal que la seconde ligne de contour, et des côtés concaves de la première ligne de contour et de la seconde ligne de contour font tous deux face au premier canal. La largeur du second canal satisfait une relation prédéterminée. Le ballonnet est en liaison étanche avec une surface périphérique externe distale du corps de cathéter et est en communication avec le second canal. Le mode d'agencement du premier canal et du second canal permet à un liquide de remplissage s'écoulant dans le second canal de présenter une résistance relativement faible et un débit relativement élevé. Ainsi, le cathéter de contre-pulsion de ballonnet de sinus coronaire peut utiliser un liquide tel qu'une solution saline normale à la place d'un gaz en tant que milieu de remplissage, ce qui permet d'éviter l'apparition d'une aéroembolie provoquée par une rupture de ballonnet et d'améliorer la sécurité d'utilisation.
PCT/CN2025/105429 2024-07-16 2025-06-30 Cathéter de contre-pulsion à ballonnet de sinus coronaire Pending WO2026016841A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202410956309 2024-07-16
CN202410956309.1 2024-07-16
CN202410965425.XA CN118807087A (zh) 2024-07-17 2024-07-17 一种冠状静脉窦球囊反搏导管
CN202410965425.X 2024-07-17

Publications (1)

Publication Number Publication Date
WO2026016841A1 true WO2026016841A1 (fr) 2026-01-22

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010044591A1 (en) * 1991-07-16 2001-11-22 Heartport, Inc. System for cardiac procedures
JP2007268050A (ja) * 2006-03-31 2007-10-18 Tokai Medical Products:Kk バルーンカテーテル
US20160213893A1 (en) * 2013-09-09 2016-07-28 Pryor Medical Devices, Inc. Low profile occlusion catheter
US20180236203A1 (en) * 2015-03-19 2018-08-23 Prytime Medical Devices, Inc. System and method for low-profile occlusion balloon catheter
CN113797426A (zh) * 2020-06-01 2021-12-17 上海微创心脉医疗科技股份有限公司 一种球囊扩张导管
CN116688327A (zh) * 2023-06-27 2023-09-05 无锡帕母医疗技术有限公司 导管装置及心衰治疗器械
CN117298422A (zh) * 2023-10-24 2023-12-29 上海微创医疗器械（集团）有限公司 球囊扩张导管
CN118807087A (zh) * 2024-07-17 2024-10-22 上海微创旋律医疗科技有限公司 一种冠状静脉窦球囊反搏导管

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010044591A1 (en) * 1991-07-16 2001-11-22 Heartport, Inc. System for cardiac procedures
JP2007268050A (ja) * 2006-03-31 2007-10-18 Tokai Medical Products:Kk バルーンカテーテル
US20160213893A1 (en) * 2013-09-09 2016-07-28 Pryor Medical Devices, Inc. Low profile occlusion catheter
US20180236203A1 (en) * 2015-03-19 2018-08-23 Prytime Medical Devices, Inc. System and method for low-profile occlusion balloon catheter
CN113797426A (zh) * 2020-06-01 2021-12-17 上海微创心脉医疗科技股份有限公司 一种球囊扩张导管
CN116688327A (zh) * 2023-06-27 2023-09-05 无锡帕母医疗技术有限公司 导管装置及心衰治疗器械
CN117298422A (zh) * 2023-10-24 2023-12-29 上海微创医疗器械（集团）有限公司 球囊扩张导管
CN118807087A (zh) * 2024-07-17 2024-10-22 上海微创旋律医疗科技有限公司 一种冠状静脉窦球囊反搏导管

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